e Working BSA (006 PBS-BSA) Thaw two 50-ml aliquots of stock BSA (06) Add 900 ml of working PBS (OOlM) Final volume = 1000 ml 006 PBS-BSA Store at 2-8 degC The solution is stable for 3 months

f 1 Gluteraldehyde - To be made after volume of washed packed cells is obtained (Refer to treatment of SRBCs in 3g)

Gluteraldehyde is received as a 25 solution

A volume of 1 solution equal to 2250 ml is needed

(2250) (1) = (X) (25) (2250) (001) = (X) (025) ~ = X = 90 ml of 25 gluteraldehyde 025

Add 2250 - 90 ml or 2160 ml of 085 saline

g SRBC (10 sheep red blood cells) Process within 1 week of receipt

(1) Spin down 2 L of SRBS at 2500 rpm for 5 minutes Remove

supernatent Wash three times with 085 saline removinsupernatent after each centrifugation Measure final volume of packed cells

(2) Add nine volumes of 1 gluteraldehyde

ie packed cell volume (pcv) = 250 mI 10 solution = packed cell volume X 10 10 solution = 2500 mI 1 gluteraldehyde = 2500 - 250 (pcv) = 2250 ml 2250 ml of 1 = 90 ml of 25

10 treated SRBCs 250 ml packed cells

90 ml 25 gluteraldehyde 2160 ml 085 saline ~ gm NaN3 (01 Sodium azide) 2500 ml Final volume

(3) Mix and let stand for 2 hours at room temperature shakinoccasionally

(4) Wash three times with 085 saline as before or until centrifuged supernatent is free of cell matter

(5) Wash twice with distilled water aspirating supernatent each time

210

amp

( t

(6) Dilute to a 10 solution in saline with 01 sodium azide preservative

250 ml packed cells 2250 ml of 085 saline ~ gm NaN3 2500 ml Final volume

(7) Store at 2-8 degC The solution is stable for 1 year

h Microtiter plates -- non-sterile rigid U plates

i Sources of reagents

(1) NaNl Sigma catalog no 5-2002 500 g Store at roon temperature (22-28 degC)

(2) BSA (bovine serum albumin) Sigma catalog no A-78H~ 10 gm Store at 2-8 degC

(3) Sheep red blood cells Colorado Serum Co catalog lL)

CSl15 two bottles 500 ml each Store at 2-8 degC Process within 1 week of receipt

(4) Antigen Centers for Disease Control contact Dr HHrold Russell (1-404-639-3929) or Dr Knox Harrell (ext 1~52) Store at 2-8 degC

(5) Control sera Centers for Disease Control contact Dr Harold Russell (1-404-639-3929) Store lyophilized iera at 2-8 degC

4 Calibration

a Calibration is to be performed each day on the diluters

(1) Rinse each diluter in distilled water (2) Dip the diluter in working PBS-BSA to top of groove~ (3) Blot on 50 ul Go-No-Go Blotter paper to check volumE (4) If the ring is too small rewash and repeat the test If

the ring is accurate roll the diluter along the blcter to dry the sides and insert into arm

b Volume dispensed is checked daily

(1) Visually check levels in wells looking for equal 1Eels

(2) Fill one row of a blank plate from a precalibrated 5(1 ul dropper Check level visually with automated dispener level

211

(3) If volumes are too high or low check tubing for plugs or adjust the syringe volume

(4) If volumes are unequal check tubing for plugs or check to see that the syringe is fastened securely

5 Quality Control Material

a Positive control Add 2 ml distilled water to lyophilized material Aliquot in 50-ul volumes and freeze at -10 degC or lower

b Negative control Use a human random sample tested as negative Aliquot in 50-ul volumes and freeze at -10 degc or lower

c The positive and negative controls will be run daily in duplicate on different plates The negative control should have a titer of (110 The positive control should have a titer of 1320plusmnone dilution (1160-1640) If these titers are not obtained the run must be repeated

d Further include in the run one sample of PBS-BSA to be titlred as a participant sample The PBS-BSA should show no agglutination If agglutination is seen the run must be repeated with new PBS-BSA

6 Procedures for Cell Preparations

(These procedures may be done while sera are inactivating)

a Adsorbing cells Spin down an adequate volume of 10 aldehyde-treated SRBCs (025 ml per participant sample or control) Remove supernatant and RESUSPEND TO ORIGINAL VOLlJ~ with working PBS-BSA Mix well (The solution is good for 1 day )

b Sensitized and Nonsensitized Cells

(1) Centrifuge 3 ml of 10 aldehyde-treated SRBCs Decant supernatant

(2) Resuspend cells with 30 ml of OOlM PBS (total volume iii 30 ml of 10 of 10 SRBCs)

(3) Remove 10 ml of 1 0 SRBCs Label as Heterophile Cap tube

(4) To remaining 20 ml of 10 RBCs add 02 ml of antigen Label as Test Cap tube

(5) Incubate both tubes for 1 hour in a 37 degC water bath inverting gently every 20 minutes

(6) Centrifuge both tubes at 3000 rpm for 5 minutes Wash twice with OOlM PBS Decant final supernatant

212

(7) To the Heterophile tube add 19 m1 PBS-BSA To 1le test tube add 38 m1 PBS-BSA The SRBC concentrliion is now 050 The cells are good for 1 day

c Flow Chart Test and Heterophile Cells

(For step 6b(2) above)

3 m1 10 SRBC

SpinDecant

QS to 30 m1 with PBS

Test Heterophile

20 m1 SRBC 10 m1 SRBC

02 m1 Antigen

37 degc - 1 hour 37 degc - 1 hOll~

Wash two times Wash two times

38 m1 PBS-BSA 19 m1 PBS-BSA

7 Hemagglutination Procedure

a To 50 u1 of serum (participant ot control) add 200 u1 )f PBS-BSA (15 dilution) Mix well cover and incubatl~ in the 56 degc water bath for a minimum of 30 minutes (not to eJ ~eed 1 hour) bull

b REMOVE the tubes from the heating block Cool at room temperature for a minimum of 10 minutes

c To each tube add 250 u1 (025 m1) of 10 adsorbing SRBC~ Shake gently to mix Let the tube sit at room tempera11re for 30 minutes (1 hour maximum) Shake it gently every 10ninutes

d Centrifuge at 3000 rpm for 5 minutes When done tralL~fer the tube to the plate within 30 minutes

e Label plates

f To well 1 of the microtiter plate add 01 m1 of the appropriate supernatant with a 100-u1 MLA pipet

ll 213

r

g Set the machine to dispense 005 ml of working PBS-BSA to WElls 2-12 of the plate

h Dilute sera through 12 wells with the automatic diluter (Diluters pick up 50 ul each time making two-fold dilution5 from 110 to 120480) Rinse and blot the tips after each plate

1 Add 0025 ml of Heterophile cells to the heterophile plat Es with the automatic dispenser

j Add 0025 ml of Test cells to the test plates with the automatic dispenser

k Mix by gentle rotation on the counter Cover and stack on 9

nonvibrating surface Incubate at room temperature overnigt (22-28 OC)

1 Read and report the following morning The value reported Is the last well showing complete agglutination

8 References

a Jones WL Hambie EA Immune response to Pseudomonas In Rose NR Friedman H eds Manual of clinical immunology 2nd ed Washington DC American Society for Microbiology 1980504-5

b Russell H Microhemagglutination test for Pseudomonas pseudomallei (melioidosis) antibodies test procedure Atlanta Centers for Disease Control 1985

c Russell H Preparation of fresh sheet erythrocytes test procedure Atlanta Centers for Disease Control 1985

214

V ANALYTICAL METHODS

ce Occult Blood in Stool Specimens

1 Principle

The Hemoccult test is a simplified standardized variati(o of the guaiac test for occult blood It contains specially prellred guaiac-impregnated paper and is ready for use without adcltional preparation

When a small stool specimen containing occult blood is al)lied to Hemoccult test paper the hemoglobin comes in contact witil the guaiac Application of Hemoccult developer creates a guaiacperoxidase-like reaction which if occult blood i~ present turns the test paper blue within 60 seconds

The test reacts with hemoglobin released from lysed cell~ When blood is present hemolysis is promoted by substances in he stool primarily water and salts

The test depends on the oxidation of a phenolic compound alpha guaiaconic acid which yields a blue-colored conjugated structure Hemoglobin exerts a peroxidase-like activity and facilitates the oxidation of this phenolic compound by h)clrogen peroxide

2 Specimen

A very small stool sample is required thinly applied to Lhe slide

The slide may be prepared and developed immediately or prlpared and stored for up to 12 days

Participants with bleeding from other conditions that may show up in the stool specimen (~ hemorrhoids) are not approprJate test subjects while such bleeding is active

Whenever possible participants should be placed on a meat-free high-residue diet starting 2 days before and continuing through the test period Such a diet may reduce the number of false-positive reactions and may also provide roughage to help uncover silent lesions that may bleed intermittently

3 Reagents Supplies and Storage

a Hemoccult slides -- High-quality filter paper impregnated with natural guaiac resin Store at room temperature (15-30 oC) and protect from heat and light

b Hemoccult developer -- A developing solution containin1 a stabilized dilute mixture of hydrogen peroxide (less tlen 6)

215

and 75 denatured ethyl alcohol in aqueous solution Store 81

room temperature (15-30 OC)

4 Quality Control Material

a Both a positive and negative performance monitor are located under the flap and below the specimen windows on the back of the slides

b The positive monitor contains a hemoglobin-derived catalyst that when developer is applied turns blue within 30 seconds

c The negative monitor contains no such catalyst and should not turn blue after the developer is applied

d If the performance monitors do not react as expected the tes1 results should be regarded as invalid

S Procedure

For physician

a Collect a small stool sample on one end of the applicator

b Apply a thin smear inside box A

c Reuse applicator to obtain a second sample from a different part of the stool Apply a thin smear inside box B

d Close cover Make sure that the slide is labeled with the participant identification and the date the specimen was collected

e Deliver to the laboratory

Participant testing

f Check the slide to see if the stool is present

g Open the flap in the back of the slide and apply two drops 01 developer to the guaiac paper directly over each smear

h Read the results within 60 seconds

Control testing

i Apply one drop only of developer between the positive and negative performance monitors

j Read the results within 30 seconds

Important note Follow the procedure exactly as outlined above Always develop the test read the results interpret them and make a decision about whether the fecal specimen is

1 ~

216 I

~ i

-----------==--======-~~=m~~~~~mm~~~mm~~nm~m~~~mm~am~~~~

I

positive or negative for occult blood before you develol the performance monitors Do not apply developer to the moritors before interpreting the test results Any blue originaling from the performance monitors should be ignored in readlng the specimen test results

6 Reference

Smith-Kline Diagnostics Hemoccult product instructions [Iacket insert] Sunnyvale California Smith-Kline Diagnostics 1983

217

V ANALYTICAL METHODS

DD Serologic Test for Syphilis Hynson Wescott and Dunning RPR

1 Principle

The Rapid Plasma Reagin (RPR) is a screening test for syphilis that detects the presence of a nonspecific antibody to syphilil called reagin

Reagin is nonspecific in that it will react with cardiolipin tile antigen in this test Cardiolipin which is extracted from beE heart is bound to charcoal particles so that when the antigen-antibody reaction produces flocculation which is visit e to the unaided eye

2 Specimen

a Serum is the specimen of choice

b Store at 2-8 degc for no more than 2 days

c Store at -20 degC or -70 degc for longer periods

d A volume of 50 ul is required for each test

3 Reagents Supplies and Sto[ag

a RPR Antigen HWD catalog no 8703-33 (obtain through CMS) 0003 cardiolipin 0020-0022 lecithin 009 cholesterol 00125M EDTA OOlM NasHP04 001975 charcoal and 10 choline chloride with 01 Merthiolate

Store at 2-8 0C After being opened reagent is usable for months

Transfer to plastic dispensing bottle and label with the reagent name lot number expiration date and date opened

Warm to 23-29 0C before use

b Test control card Hynson Wescott and Dunning Catalog no 8767-09 (obtain from eMS)

c Control sera SP no B6734-l0 from Dade Store at 2-8 degC One vial each of reactive minimally reactive and nonreactbe

d Plastic coated cards with 18 mm circles CMS no 098-392 fom Hynson Wescott and Dunning

4 Ouality Control Material

a Record room temperature which should be between 23-29 degC (The temperature of the serum and RPR card test antigen shou i also be between 23 0-29 0C)

218

l I

l l

l

l t

b Check the 20-gauge needle for delivery of 60 drops per ml plusmn2 drops (Use the antigen suspension for this test)

c The rotator must be checked and should be set at 100 rpDI plusmn5 rpm

d RPR test control cards MUST be run daily Expected values Reactive (R)

Nonreactive (N) Reactive minimal (RM)

Record lot number and expiration date on control card

e Dade liquid controls must be run on each card

5 Procedure

Note Participant specimens are to be run singly The te~ s on EVERY reactive specimen must be repeated to verify t le result

a Hold the dispenser between thumb and forefinger near thE stirring or sealed end Squeeze and do not release pre~ mreuntil the open end is below the surface of the specimen Hold the specimen tube vertically to minimize stirring of thE cellular elements Release finger pressure to draw up the sample

b Hold the dispenser in a perpendicular position directly I)ver the card to receive the specimen (not touching the card surface) squeeze the dispenser allowing one drop to fE 1 onto the card

c Invert the dispenser and with sealed stirring end sprE lId the specimen within the circle (If preferred the sample remaining in the dispenser may be discharged into specinln tube from which it was drawn) Discard stirrer

Repeat the procedure for the number of specimens to be t Isted

d Shake the antigen dispensing bottle before use Holdineuro the bottle in a vertical position dispense one or two drop~ in the dispensing bottle cap to make sure that the needle pass~ge is clear and that it is delivering 160 ml of antigen ThEll place one free falling drop (20-gauge yellow hub needle) onto each test area DO NOT RESTIR ANTIGEN SUSPENSION AND SPECllffiNS ARE MIXED DURING ROTATION Pick up predropped antigen 1 om bottle cap

e Rotate the RPR 8 minutes under the humidifying cover C1I the mechanical rotator at 100 rpm

f Remove the RPR card from the rotator platform and gentl~ rotate and tilt the card three to four times This helps differentiate nonreactive from minimally reactive result

219

shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

220

i

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VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

amp

( t

(6) Dilute to a 10 solution in saline with 01 sodium azide preservative

250 ml packed cells 2250 ml of 085 saline ~ gm NaN3 2500 ml Final volume

(7) Store at 2-8 degC The solution is stable for 1 year

h Microtiter plates -- non-sterile rigid U plates

i Sources of reagents

(1) NaNl Sigma catalog no 5-2002 500 g Store at roon temperature (22-28 degC)

(2) BSA (bovine serum albumin) Sigma catalog no A-78H~ 10 gm Store at 2-8 degC

(3) Sheep red blood cells Colorado Serum Co catalog lL)

CSl15 two bottles 500 ml each Store at 2-8 degC Process within 1 week of receipt

(4) Antigen Centers for Disease Control contact Dr HHrold Russell (1-404-639-3929) or Dr Knox Harrell (ext 1~52) Store at 2-8 degC

(5) Control sera Centers for Disease Control contact Dr Harold Russell (1-404-639-3929) Store lyophilized iera at 2-8 degC

4 Calibration

a Calibration is to be performed each day on the diluters

(1) Rinse each diluter in distilled water (2) Dip the diluter in working PBS-BSA to top of groove~ (3) Blot on 50 ul Go-No-Go Blotter paper to check volumE (4) If the ring is too small rewash and repeat the test If

the ring is accurate roll the diluter along the blcter to dry the sides and insert into arm

b Volume dispensed is checked daily

(1) Visually check levels in wells looking for equal 1Eels

(2) Fill one row of a blank plate from a precalibrated 5(1 ul dropper Check level visually with automated dispener level

211

(3) If volumes are too high or low check tubing for plugs or adjust the syringe volume

(4) If volumes are unequal check tubing for plugs or check to see that the syringe is fastened securely

5 Quality Control Material

a Positive control Add 2 ml distilled water to lyophilized material Aliquot in 50-ul volumes and freeze at -10 degC or lower

b Negative control Use a human random sample tested as negative Aliquot in 50-ul volumes and freeze at -10 degc or lower

c The positive and negative controls will be run daily in duplicate on different plates The negative control should have a titer of (110 The positive control should have a titer of 1320plusmnone dilution (1160-1640) If these titers are not obtained the run must be repeated

d Further include in the run one sample of PBS-BSA to be titlred as a participant sample The PBS-BSA should show no agglutination If agglutination is seen the run must be repeated with new PBS-BSA

6 Procedures for Cell Preparations

(These procedures may be done while sera are inactivating)

a Adsorbing cells Spin down an adequate volume of 10 aldehyde-treated SRBCs (025 ml per participant sample or control) Remove supernatant and RESUSPEND TO ORIGINAL VOLlJ~ with working PBS-BSA Mix well (The solution is good for 1 day )

b Sensitized and Nonsensitized Cells

(1) Centrifuge 3 ml of 10 aldehyde-treated SRBCs Decant supernatant

(2) Resuspend cells with 30 ml of OOlM PBS (total volume iii 30 ml of 10 of 10 SRBCs)

(3) Remove 10 ml of 1 0 SRBCs Label as Heterophile Cap tube

(4) To remaining 20 ml of 10 RBCs add 02 ml of antigen Label as Test Cap tube

(5) Incubate both tubes for 1 hour in a 37 degC water bath inverting gently every 20 minutes

(6) Centrifuge both tubes at 3000 rpm for 5 minutes Wash twice with OOlM PBS Decant final supernatant

212

(7) To the Heterophile tube add 19 m1 PBS-BSA To 1le test tube add 38 m1 PBS-BSA The SRBC concentrliion is now 050 The cells are good for 1 day

c Flow Chart Test and Heterophile Cells

(For step 6b(2) above)

3 m1 10 SRBC

SpinDecant

QS to 30 m1 with PBS

Test Heterophile

20 m1 SRBC 10 m1 SRBC

02 m1 Antigen

37 degc - 1 hour 37 degc - 1 hOll~

Wash two times Wash two times

38 m1 PBS-BSA 19 m1 PBS-BSA

7 Hemagglutination Procedure

a To 50 u1 of serum (participant ot control) add 200 u1 )f PBS-BSA (15 dilution) Mix well cover and incubatl~ in the 56 degc water bath for a minimum of 30 minutes (not to eJ ~eed 1 hour) bull

b REMOVE the tubes from the heating block Cool at room temperature for a minimum of 10 minutes

c To each tube add 250 u1 (025 m1) of 10 adsorbing SRBC~ Shake gently to mix Let the tube sit at room tempera11re for 30 minutes (1 hour maximum) Shake it gently every 10ninutes

d Centrifuge at 3000 rpm for 5 minutes When done tralL~fer the tube to the plate within 30 minutes

e Label plates

f To well 1 of the microtiter plate add 01 m1 of the appropriate supernatant with a 100-u1 MLA pipet

ll 213

r

g Set the machine to dispense 005 ml of working PBS-BSA to WElls 2-12 of the plate

h Dilute sera through 12 wells with the automatic diluter (Diluters pick up 50 ul each time making two-fold dilution5 from 110 to 120480) Rinse and blot the tips after each plate

1 Add 0025 ml of Heterophile cells to the heterophile plat Es with the automatic dispenser

j Add 0025 ml of Test cells to the test plates with the automatic dispenser

k Mix by gentle rotation on the counter Cover and stack on 9

nonvibrating surface Incubate at room temperature overnigt (22-28 OC)

1 Read and report the following morning The value reported Is the last well showing complete agglutination

8 References

a Jones WL Hambie EA Immune response to Pseudomonas In Rose NR Friedman H eds Manual of clinical immunology 2nd ed Washington DC American Society for Microbiology 1980504-5

b Russell H Microhemagglutination test for Pseudomonas pseudomallei (melioidosis) antibodies test procedure Atlanta Centers for Disease Control 1985

c Russell H Preparation of fresh sheet erythrocytes test procedure Atlanta Centers for Disease Control 1985

214

V ANALYTICAL METHODS

ce Occult Blood in Stool Specimens

1 Principle

The Hemoccult test is a simplified standardized variati(o of the guaiac test for occult blood It contains specially prellred guaiac-impregnated paper and is ready for use without adcltional preparation

When a small stool specimen containing occult blood is al)lied to Hemoccult test paper the hemoglobin comes in contact witil the guaiac Application of Hemoccult developer creates a guaiacperoxidase-like reaction which if occult blood i~ present turns the test paper blue within 60 seconds

The test reacts with hemoglobin released from lysed cell~ When blood is present hemolysis is promoted by substances in he stool primarily water and salts

The test depends on the oxidation of a phenolic compound alpha guaiaconic acid which yields a blue-colored conjugated structure Hemoglobin exerts a peroxidase-like activity and facilitates the oxidation of this phenolic compound by h)clrogen peroxide

2 Specimen

A very small stool sample is required thinly applied to Lhe slide

The slide may be prepared and developed immediately or prlpared and stored for up to 12 days

Participants with bleeding from other conditions that may show up in the stool specimen (~ hemorrhoids) are not approprJate test subjects while such bleeding is active

Whenever possible participants should be placed on a meat-free high-residue diet starting 2 days before and continuing through the test period Such a diet may reduce the number of false-positive reactions and may also provide roughage to help uncover silent lesions that may bleed intermittently

3 Reagents Supplies and Storage

a Hemoccult slides -- High-quality filter paper impregnated with natural guaiac resin Store at room temperature (15-30 oC) and protect from heat and light

b Hemoccult developer -- A developing solution containin1 a stabilized dilute mixture of hydrogen peroxide (less tlen 6)

215

and 75 denatured ethyl alcohol in aqueous solution Store 81

room temperature (15-30 OC)

4 Quality Control Material

a Both a positive and negative performance monitor are located under the flap and below the specimen windows on the back of the slides

b The positive monitor contains a hemoglobin-derived catalyst that when developer is applied turns blue within 30 seconds

c The negative monitor contains no such catalyst and should not turn blue after the developer is applied

d If the performance monitors do not react as expected the tes1 results should be regarded as invalid

S Procedure

For physician

a Collect a small stool sample on one end of the applicator

b Apply a thin smear inside box A

c Reuse applicator to obtain a second sample from a different part of the stool Apply a thin smear inside box B

d Close cover Make sure that the slide is labeled with the participant identification and the date the specimen was collected

e Deliver to the laboratory

Participant testing

f Check the slide to see if the stool is present

g Open the flap in the back of the slide and apply two drops 01 developer to the guaiac paper directly over each smear

h Read the results within 60 seconds

Control testing

i Apply one drop only of developer between the positive and negative performance monitors

j Read the results within 30 seconds

Important note Follow the procedure exactly as outlined above Always develop the test read the results interpret them and make a decision about whether the fecal specimen is

1 ~

216 I

~ i

-----------==--======-~~=m~~~~~mm~~~mm~~nm~m~~~mm~am~~~~

I

positive or negative for occult blood before you develol the performance monitors Do not apply developer to the moritors before interpreting the test results Any blue originaling from the performance monitors should be ignored in readlng the specimen test results

6 Reference

Smith-Kline Diagnostics Hemoccult product instructions [Iacket insert] Sunnyvale California Smith-Kline Diagnostics 1983

217

V ANALYTICAL METHODS

DD Serologic Test for Syphilis Hynson Wescott and Dunning RPR

1 Principle

The Rapid Plasma Reagin (RPR) is a screening test for syphilis that detects the presence of a nonspecific antibody to syphilil called reagin

Reagin is nonspecific in that it will react with cardiolipin tile antigen in this test Cardiolipin which is extracted from beE heart is bound to charcoal particles so that when the antigen-antibody reaction produces flocculation which is visit e to the unaided eye

2 Specimen

a Serum is the specimen of choice

b Store at 2-8 degc for no more than 2 days

c Store at -20 degC or -70 degc for longer periods

d A volume of 50 ul is required for each test

3 Reagents Supplies and Sto[ag

a RPR Antigen HWD catalog no 8703-33 (obtain through CMS) 0003 cardiolipin 0020-0022 lecithin 009 cholesterol 00125M EDTA OOlM NasHP04 001975 charcoal and 10 choline chloride with 01 Merthiolate

Store at 2-8 0C After being opened reagent is usable for months

Transfer to plastic dispensing bottle and label with the reagent name lot number expiration date and date opened

Warm to 23-29 0C before use

b Test control card Hynson Wescott and Dunning Catalog no 8767-09 (obtain from eMS)

c Control sera SP no B6734-l0 from Dade Store at 2-8 degC One vial each of reactive minimally reactive and nonreactbe

d Plastic coated cards with 18 mm circles CMS no 098-392 fom Hynson Wescott and Dunning

4 Ouality Control Material

a Record room temperature which should be between 23-29 degC (The temperature of the serum and RPR card test antigen shou i also be between 23 0-29 0C)

218

l I

l l

l

l t

b Check the 20-gauge needle for delivery of 60 drops per ml plusmn2 drops (Use the antigen suspension for this test)

c The rotator must be checked and should be set at 100 rpDI plusmn5 rpm

d RPR test control cards MUST be run daily Expected values Reactive (R)

Nonreactive (N) Reactive minimal (RM)

Record lot number and expiration date on control card

e Dade liquid controls must be run on each card

5 Procedure

Note Participant specimens are to be run singly The te~ s on EVERY reactive specimen must be repeated to verify t le result

a Hold the dispenser between thumb and forefinger near thE stirring or sealed end Squeeze and do not release pre~ mreuntil the open end is below the surface of the specimen Hold the specimen tube vertically to minimize stirring of thE cellular elements Release finger pressure to draw up the sample

b Hold the dispenser in a perpendicular position directly I)ver the card to receive the specimen (not touching the card surface) squeeze the dispenser allowing one drop to fE 1 onto the card

c Invert the dispenser and with sealed stirring end sprE lId the specimen within the circle (If preferred the sample remaining in the dispenser may be discharged into specinln tube from which it was drawn) Discard stirrer

Repeat the procedure for the number of specimens to be t Isted

d Shake the antigen dispensing bottle before use Holdineuro the bottle in a vertical position dispense one or two drop~ in the dispensing bottle cap to make sure that the needle pass~ge is clear and that it is delivering 160 ml of antigen ThEll place one free falling drop (20-gauge yellow hub needle) onto each test area DO NOT RESTIR ANTIGEN SUSPENSION AND SPECllffiNS ARE MIXED DURING ROTATION Pick up predropped antigen 1 om bottle cap

e Rotate the RPR 8 minutes under the humidifying cover C1I the mechanical rotator at 100 rpm

f Remove the RPR card from the rotator platform and gentl~ rotate and tilt the card three to four times This helps differentiate nonreactive from minimally reactive result

219

shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

220

i

k

l

t l

VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

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VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

(3) If volumes are too high or low check tubing for plugs or adjust the syringe volume

(4) If volumes are unequal check tubing for plugs or check to see that the syringe is fastened securely

5 Quality Control Material

a Positive control Add 2 ml distilled water to lyophilized material Aliquot in 50-ul volumes and freeze at -10 degC or lower

b Negative control Use a human random sample tested as negative Aliquot in 50-ul volumes and freeze at -10 degc or lower

c The positive and negative controls will be run daily in duplicate on different plates The negative control should have a titer of (110 The positive control should have a titer of 1320plusmnone dilution (1160-1640) If these titers are not obtained the run must be repeated

d Further include in the run one sample of PBS-BSA to be titlred as a participant sample The PBS-BSA should show no agglutination If agglutination is seen the run must be repeated with new PBS-BSA

6 Procedures for Cell Preparations

(These procedures may be done while sera are inactivating)

a Adsorbing cells Spin down an adequate volume of 10 aldehyde-treated SRBCs (025 ml per participant sample or control) Remove supernatant and RESUSPEND TO ORIGINAL VOLlJ~ with working PBS-BSA Mix well (The solution is good for 1 day )

b Sensitized and Nonsensitized Cells

(1) Centrifuge 3 ml of 10 aldehyde-treated SRBCs Decant supernatant

(2) Resuspend cells with 30 ml of OOlM PBS (total volume iii 30 ml of 10 of 10 SRBCs)

(3) Remove 10 ml of 1 0 SRBCs Label as Heterophile Cap tube

(4) To remaining 20 ml of 10 RBCs add 02 ml of antigen Label as Test Cap tube

(5) Incubate both tubes for 1 hour in a 37 degC water bath inverting gently every 20 minutes

(6) Centrifuge both tubes at 3000 rpm for 5 minutes Wash twice with OOlM PBS Decant final supernatant

212

(7) To the Heterophile tube add 19 m1 PBS-BSA To 1le test tube add 38 m1 PBS-BSA The SRBC concentrliion is now 050 The cells are good for 1 day

c Flow Chart Test and Heterophile Cells

(For step 6b(2) above)

3 m1 10 SRBC

SpinDecant

QS to 30 m1 with PBS

Test Heterophile

20 m1 SRBC 10 m1 SRBC

02 m1 Antigen

37 degc - 1 hour 37 degc - 1 hOll~

Wash two times Wash two times

38 m1 PBS-BSA 19 m1 PBS-BSA

7 Hemagglutination Procedure

a To 50 u1 of serum (participant ot control) add 200 u1 )f PBS-BSA (15 dilution) Mix well cover and incubatl~ in the 56 degc water bath for a minimum of 30 minutes (not to eJ ~eed 1 hour) bull

b REMOVE the tubes from the heating block Cool at room temperature for a minimum of 10 minutes

c To each tube add 250 u1 (025 m1) of 10 adsorbing SRBC~ Shake gently to mix Let the tube sit at room tempera11re for 30 minutes (1 hour maximum) Shake it gently every 10ninutes

d Centrifuge at 3000 rpm for 5 minutes When done tralL~fer the tube to the plate within 30 minutes

e Label plates

f To well 1 of the microtiter plate add 01 m1 of the appropriate supernatant with a 100-u1 MLA pipet

ll 213

r

g Set the machine to dispense 005 ml of working PBS-BSA to WElls 2-12 of the plate

h Dilute sera through 12 wells with the automatic diluter (Diluters pick up 50 ul each time making two-fold dilution5 from 110 to 120480) Rinse and blot the tips after each plate

1 Add 0025 ml of Heterophile cells to the heterophile plat Es with the automatic dispenser

j Add 0025 ml of Test cells to the test plates with the automatic dispenser

k Mix by gentle rotation on the counter Cover and stack on 9

nonvibrating surface Incubate at room temperature overnigt (22-28 OC)

1 Read and report the following morning The value reported Is the last well showing complete agglutination

8 References

a Jones WL Hambie EA Immune response to Pseudomonas In Rose NR Friedman H eds Manual of clinical immunology 2nd ed Washington DC American Society for Microbiology 1980504-5

b Russell H Microhemagglutination test for Pseudomonas pseudomallei (melioidosis) antibodies test procedure Atlanta Centers for Disease Control 1985

c Russell H Preparation of fresh sheet erythrocytes test procedure Atlanta Centers for Disease Control 1985

214

V ANALYTICAL METHODS

ce Occult Blood in Stool Specimens

1 Principle

The Hemoccult test is a simplified standardized variati(o of the guaiac test for occult blood It contains specially prellred guaiac-impregnated paper and is ready for use without adcltional preparation

When a small stool specimen containing occult blood is al)lied to Hemoccult test paper the hemoglobin comes in contact witil the guaiac Application of Hemoccult developer creates a guaiacperoxidase-like reaction which if occult blood i~ present turns the test paper blue within 60 seconds

The test reacts with hemoglobin released from lysed cell~ When blood is present hemolysis is promoted by substances in he stool primarily water and salts

The test depends on the oxidation of a phenolic compound alpha guaiaconic acid which yields a blue-colored conjugated structure Hemoglobin exerts a peroxidase-like activity and facilitates the oxidation of this phenolic compound by h)clrogen peroxide

2 Specimen

A very small stool sample is required thinly applied to Lhe slide

The slide may be prepared and developed immediately or prlpared and stored for up to 12 days

Participants with bleeding from other conditions that may show up in the stool specimen (~ hemorrhoids) are not approprJate test subjects while such bleeding is active

Whenever possible participants should be placed on a meat-free high-residue diet starting 2 days before and continuing through the test period Such a diet may reduce the number of false-positive reactions and may also provide roughage to help uncover silent lesions that may bleed intermittently

3 Reagents Supplies and Storage

a Hemoccult slides -- High-quality filter paper impregnated with natural guaiac resin Store at room temperature (15-30 oC) and protect from heat and light

b Hemoccult developer -- A developing solution containin1 a stabilized dilute mixture of hydrogen peroxide (less tlen 6)

215

and 75 denatured ethyl alcohol in aqueous solution Store 81

room temperature (15-30 OC)

4 Quality Control Material

a Both a positive and negative performance monitor are located under the flap and below the specimen windows on the back of the slides

b The positive monitor contains a hemoglobin-derived catalyst that when developer is applied turns blue within 30 seconds

c The negative monitor contains no such catalyst and should not turn blue after the developer is applied

d If the performance monitors do not react as expected the tes1 results should be regarded as invalid

S Procedure

For physician

a Collect a small stool sample on one end of the applicator

b Apply a thin smear inside box A

c Reuse applicator to obtain a second sample from a different part of the stool Apply a thin smear inside box B

d Close cover Make sure that the slide is labeled with the participant identification and the date the specimen was collected

e Deliver to the laboratory

Participant testing

f Check the slide to see if the stool is present

g Open the flap in the back of the slide and apply two drops 01 developer to the guaiac paper directly over each smear

h Read the results within 60 seconds

Control testing

i Apply one drop only of developer between the positive and negative performance monitors

j Read the results within 30 seconds

Important note Follow the procedure exactly as outlined above Always develop the test read the results interpret them and make a decision about whether the fecal specimen is

1 ~

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-----------==--======-~~=m~~~~~mm~~~mm~~nm~m~~~mm~am~~~~

I

positive or negative for occult blood before you develol the performance monitors Do not apply developer to the moritors before interpreting the test results Any blue originaling from the performance monitors should be ignored in readlng the specimen test results

6 Reference

Smith-Kline Diagnostics Hemoccult product instructions [Iacket insert] Sunnyvale California Smith-Kline Diagnostics 1983

217

V ANALYTICAL METHODS

DD Serologic Test for Syphilis Hynson Wescott and Dunning RPR

1 Principle

The Rapid Plasma Reagin (RPR) is a screening test for syphilis that detects the presence of a nonspecific antibody to syphilil called reagin

Reagin is nonspecific in that it will react with cardiolipin tile antigen in this test Cardiolipin which is extracted from beE heart is bound to charcoal particles so that when the antigen-antibody reaction produces flocculation which is visit e to the unaided eye

2 Specimen

a Serum is the specimen of choice

b Store at 2-8 degc for no more than 2 days

c Store at -20 degC or -70 degc for longer periods

d A volume of 50 ul is required for each test

3 Reagents Supplies and Sto[ag

a RPR Antigen HWD catalog no 8703-33 (obtain through CMS) 0003 cardiolipin 0020-0022 lecithin 009 cholesterol 00125M EDTA OOlM NasHP04 001975 charcoal and 10 choline chloride with 01 Merthiolate

Store at 2-8 0C After being opened reagent is usable for months

Transfer to plastic dispensing bottle and label with the reagent name lot number expiration date and date opened

Warm to 23-29 0C before use

b Test control card Hynson Wescott and Dunning Catalog no 8767-09 (obtain from eMS)

c Control sera SP no B6734-l0 from Dade Store at 2-8 degC One vial each of reactive minimally reactive and nonreactbe

d Plastic coated cards with 18 mm circles CMS no 098-392 fom Hynson Wescott and Dunning

4 Ouality Control Material

a Record room temperature which should be between 23-29 degC (The temperature of the serum and RPR card test antigen shou i also be between 23 0-29 0C)

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b Check the 20-gauge needle for delivery of 60 drops per ml plusmn2 drops (Use the antigen suspension for this test)

c The rotator must be checked and should be set at 100 rpDI plusmn5 rpm

d RPR test control cards MUST be run daily Expected values Reactive (R)

Nonreactive (N) Reactive minimal (RM)

Record lot number and expiration date on control card

e Dade liquid controls must be run on each card

5 Procedure

Note Participant specimens are to be run singly The te~ s on EVERY reactive specimen must be repeated to verify t le result

a Hold the dispenser between thumb and forefinger near thE stirring or sealed end Squeeze and do not release pre~ mreuntil the open end is below the surface of the specimen Hold the specimen tube vertically to minimize stirring of thE cellular elements Release finger pressure to draw up the sample

b Hold the dispenser in a perpendicular position directly I)ver the card to receive the specimen (not touching the card surface) squeeze the dispenser allowing one drop to fE 1 onto the card

c Invert the dispenser and with sealed stirring end sprE lId the specimen within the circle (If preferred the sample remaining in the dispenser may be discharged into specinln tube from which it was drawn) Discard stirrer

Repeat the procedure for the number of specimens to be t Isted

d Shake the antigen dispensing bottle before use Holdineuro the bottle in a vertical position dispense one or two drop~ in the dispensing bottle cap to make sure that the needle pass~ge is clear and that it is delivering 160 ml of antigen ThEll place one free falling drop (20-gauge yellow hub needle) onto each test area DO NOT RESTIR ANTIGEN SUSPENSION AND SPECllffiNS ARE MIXED DURING ROTATION Pick up predropped antigen 1 om bottle cap

e Rotate the RPR 8 minutes under the humidifying cover C1I the mechanical rotator at 100 rpm

f Remove the RPR card from the rotator platform and gentl~ rotate and tilt the card three to four times This helps differentiate nonreactive from minimally reactive result

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shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

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VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

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4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

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b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

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Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

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number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

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2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

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4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

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6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

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I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

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F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

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5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

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Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

(7) To the Heterophile tube add 19 m1 PBS-BSA To 1le test tube add 38 m1 PBS-BSA The SRBC concentrliion is now 050 The cells are good for 1 day

c Flow Chart Test and Heterophile Cells

(For step 6b(2) above)

3 m1 10 SRBC

SpinDecant

QS to 30 m1 with PBS

Test Heterophile

20 m1 SRBC 10 m1 SRBC

02 m1 Antigen

37 degc - 1 hour 37 degc - 1 hOll~

Wash two times Wash two times

38 m1 PBS-BSA 19 m1 PBS-BSA

7 Hemagglutination Procedure

a To 50 u1 of serum (participant ot control) add 200 u1 )f PBS-BSA (15 dilution) Mix well cover and incubatl~ in the 56 degc water bath for a minimum of 30 minutes (not to eJ ~eed 1 hour) bull

b REMOVE the tubes from the heating block Cool at room temperature for a minimum of 10 minutes

c To each tube add 250 u1 (025 m1) of 10 adsorbing SRBC~ Shake gently to mix Let the tube sit at room tempera11re for 30 minutes (1 hour maximum) Shake it gently every 10ninutes

d Centrifuge at 3000 rpm for 5 minutes When done tralL~fer the tube to the plate within 30 minutes

e Label plates

f To well 1 of the microtiter plate add 01 m1 of the appropriate supernatant with a 100-u1 MLA pipet

ll 213

r

g Set the machine to dispense 005 ml of working PBS-BSA to WElls 2-12 of the plate

h Dilute sera through 12 wells with the automatic diluter (Diluters pick up 50 ul each time making two-fold dilution5 from 110 to 120480) Rinse and blot the tips after each plate

1 Add 0025 ml of Heterophile cells to the heterophile plat Es with the automatic dispenser

j Add 0025 ml of Test cells to the test plates with the automatic dispenser

k Mix by gentle rotation on the counter Cover and stack on 9

nonvibrating surface Incubate at room temperature overnigt (22-28 OC)

1 Read and report the following morning The value reported Is the last well showing complete agglutination

8 References

a Jones WL Hambie EA Immune response to Pseudomonas In Rose NR Friedman H eds Manual of clinical immunology 2nd ed Washington DC American Society for Microbiology 1980504-5

b Russell H Microhemagglutination test for Pseudomonas pseudomallei (melioidosis) antibodies test procedure Atlanta Centers for Disease Control 1985

c Russell H Preparation of fresh sheet erythrocytes test procedure Atlanta Centers for Disease Control 1985

214

V ANALYTICAL METHODS

ce Occult Blood in Stool Specimens

1 Principle

The Hemoccult test is a simplified standardized variati(o of the guaiac test for occult blood It contains specially prellred guaiac-impregnated paper and is ready for use without adcltional preparation

When a small stool specimen containing occult blood is al)lied to Hemoccult test paper the hemoglobin comes in contact witil the guaiac Application of Hemoccult developer creates a guaiacperoxidase-like reaction which if occult blood i~ present turns the test paper blue within 60 seconds

The test reacts with hemoglobin released from lysed cell~ When blood is present hemolysis is promoted by substances in he stool primarily water and salts

The test depends on the oxidation of a phenolic compound alpha guaiaconic acid which yields a blue-colored conjugated structure Hemoglobin exerts a peroxidase-like activity and facilitates the oxidation of this phenolic compound by h)clrogen peroxide

2 Specimen

A very small stool sample is required thinly applied to Lhe slide

The slide may be prepared and developed immediately or prlpared and stored for up to 12 days

Participants with bleeding from other conditions that may show up in the stool specimen (~ hemorrhoids) are not approprJate test subjects while such bleeding is active

Whenever possible participants should be placed on a meat-free high-residue diet starting 2 days before and continuing through the test period Such a diet may reduce the number of false-positive reactions and may also provide roughage to help uncover silent lesions that may bleed intermittently

3 Reagents Supplies and Storage

a Hemoccult slides -- High-quality filter paper impregnated with natural guaiac resin Store at room temperature (15-30 oC) and protect from heat and light

b Hemoccult developer -- A developing solution containin1 a stabilized dilute mixture of hydrogen peroxide (less tlen 6)

215

and 75 denatured ethyl alcohol in aqueous solution Store 81

room temperature (15-30 OC)

4 Quality Control Material

a Both a positive and negative performance monitor are located under the flap and below the specimen windows on the back of the slides

b The positive monitor contains a hemoglobin-derived catalyst that when developer is applied turns blue within 30 seconds

c The negative monitor contains no such catalyst and should not turn blue after the developer is applied

d If the performance monitors do not react as expected the tes1 results should be regarded as invalid

S Procedure

For physician

a Collect a small stool sample on one end of the applicator

b Apply a thin smear inside box A

c Reuse applicator to obtain a second sample from a different part of the stool Apply a thin smear inside box B

d Close cover Make sure that the slide is labeled with the participant identification and the date the specimen was collected

e Deliver to the laboratory

Participant testing

f Check the slide to see if the stool is present

g Open the flap in the back of the slide and apply two drops 01 developer to the guaiac paper directly over each smear

h Read the results within 60 seconds

Control testing

i Apply one drop only of developer between the positive and negative performance monitors

j Read the results within 30 seconds

Important note Follow the procedure exactly as outlined above Always develop the test read the results interpret them and make a decision about whether the fecal specimen is

1 ~

216 I

~ i

-----------==--======-~~=m~~~~~mm~~~mm~~nm~m~~~mm~am~~~~

I

positive or negative for occult blood before you develol the performance monitors Do not apply developer to the moritors before interpreting the test results Any blue originaling from the performance monitors should be ignored in readlng the specimen test results

6 Reference

Smith-Kline Diagnostics Hemoccult product instructions [Iacket insert] Sunnyvale California Smith-Kline Diagnostics 1983

217

V ANALYTICAL METHODS

DD Serologic Test for Syphilis Hynson Wescott and Dunning RPR

1 Principle

The Rapid Plasma Reagin (RPR) is a screening test for syphilis that detects the presence of a nonspecific antibody to syphilil called reagin

Reagin is nonspecific in that it will react with cardiolipin tile antigen in this test Cardiolipin which is extracted from beE heart is bound to charcoal particles so that when the antigen-antibody reaction produces flocculation which is visit e to the unaided eye

2 Specimen

a Serum is the specimen of choice

b Store at 2-8 degc for no more than 2 days

c Store at -20 degC or -70 degc for longer periods

d A volume of 50 ul is required for each test

3 Reagents Supplies and Sto[ag

a RPR Antigen HWD catalog no 8703-33 (obtain through CMS) 0003 cardiolipin 0020-0022 lecithin 009 cholesterol 00125M EDTA OOlM NasHP04 001975 charcoal and 10 choline chloride with 01 Merthiolate

Store at 2-8 0C After being opened reagent is usable for months

Transfer to plastic dispensing bottle and label with the reagent name lot number expiration date and date opened

Warm to 23-29 0C before use

b Test control card Hynson Wescott and Dunning Catalog no 8767-09 (obtain from eMS)

c Control sera SP no B6734-l0 from Dade Store at 2-8 degC One vial each of reactive minimally reactive and nonreactbe

d Plastic coated cards with 18 mm circles CMS no 098-392 fom Hynson Wescott and Dunning

4 Ouality Control Material

a Record room temperature which should be between 23-29 degC (The temperature of the serum and RPR card test antigen shou i also be between 23 0-29 0C)

218

l I

l l

l

l t

b Check the 20-gauge needle for delivery of 60 drops per ml plusmn2 drops (Use the antigen suspension for this test)

c The rotator must be checked and should be set at 100 rpDI plusmn5 rpm

d RPR test control cards MUST be run daily Expected values Reactive (R)

Nonreactive (N) Reactive minimal (RM)

Record lot number and expiration date on control card

e Dade liquid controls must be run on each card

5 Procedure

Note Participant specimens are to be run singly The te~ s on EVERY reactive specimen must be repeated to verify t le result

a Hold the dispenser between thumb and forefinger near thE stirring or sealed end Squeeze and do not release pre~ mreuntil the open end is below the surface of the specimen Hold the specimen tube vertically to minimize stirring of thE cellular elements Release finger pressure to draw up the sample

b Hold the dispenser in a perpendicular position directly I)ver the card to receive the specimen (not touching the card surface) squeeze the dispenser allowing one drop to fE 1 onto the card

c Invert the dispenser and with sealed stirring end sprE lId the specimen within the circle (If preferred the sample remaining in the dispenser may be discharged into specinln tube from which it was drawn) Discard stirrer

Repeat the procedure for the number of specimens to be t Isted

d Shake the antigen dispensing bottle before use Holdineuro the bottle in a vertical position dispense one or two drop~ in the dispensing bottle cap to make sure that the needle pass~ge is clear and that it is delivering 160 ml of antigen ThEll place one free falling drop (20-gauge yellow hub needle) onto each test area DO NOT RESTIR ANTIGEN SUSPENSION AND SPECllffiNS ARE MIXED DURING ROTATION Pick up predropped antigen 1 om bottle cap

e Rotate the RPR 8 minutes under the humidifying cover C1I the mechanical rotator at 100 rpm

f Remove the RPR card from the rotator platform and gentl~ rotate and tilt the card three to four times This helps differentiate nonreactive from minimally reactive result

219

shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

220

i

k

l

t l

VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

g Set the machine to dispense 005 ml of working PBS-BSA to WElls 2-12 of the plate

h Dilute sera through 12 wells with the automatic diluter (Diluters pick up 50 ul each time making two-fold dilution5 from 110 to 120480) Rinse and blot the tips after each plate

1 Add 0025 ml of Heterophile cells to the heterophile plat Es with the automatic dispenser

j Add 0025 ml of Test cells to the test plates with the automatic dispenser

k Mix by gentle rotation on the counter Cover and stack on 9

nonvibrating surface Incubate at room temperature overnigt (22-28 OC)

1 Read and report the following morning The value reported Is the last well showing complete agglutination

8 References

a Jones WL Hambie EA Immune response to Pseudomonas In Rose NR Friedman H eds Manual of clinical immunology 2nd ed Washington DC American Society for Microbiology 1980504-5

b Russell H Microhemagglutination test for Pseudomonas pseudomallei (melioidosis) antibodies test procedure Atlanta Centers for Disease Control 1985

c Russell H Preparation of fresh sheet erythrocytes test procedure Atlanta Centers for Disease Control 1985

214

V ANALYTICAL METHODS

ce Occult Blood in Stool Specimens

1 Principle

The Hemoccult test is a simplified standardized variati(o of the guaiac test for occult blood It contains specially prellred guaiac-impregnated paper and is ready for use without adcltional preparation

When a small stool specimen containing occult blood is al)lied to Hemoccult test paper the hemoglobin comes in contact witil the guaiac Application of Hemoccult developer creates a guaiacperoxidase-like reaction which if occult blood i~ present turns the test paper blue within 60 seconds

The test reacts with hemoglobin released from lysed cell~ When blood is present hemolysis is promoted by substances in he stool primarily water and salts

The test depends on the oxidation of a phenolic compound alpha guaiaconic acid which yields a blue-colored conjugated structure Hemoglobin exerts a peroxidase-like activity and facilitates the oxidation of this phenolic compound by h)clrogen peroxide

2 Specimen

A very small stool sample is required thinly applied to Lhe slide

The slide may be prepared and developed immediately or prlpared and stored for up to 12 days

Participants with bleeding from other conditions that may show up in the stool specimen (~ hemorrhoids) are not approprJate test subjects while such bleeding is active

Whenever possible participants should be placed on a meat-free high-residue diet starting 2 days before and continuing through the test period Such a diet may reduce the number of false-positive reactions and may also provide roughage to help uncover silent lesions that may bleed intermittently

3 Reagents Supplies and Storage

a Hemoccult slides -- High-quality filter paper impregnated with natural guaiac resin Store at room temperature (15-30 oC) and protect from heat and light

b Hemoccult developer -- A developing solution containin1 a stabilized dilute mixture of hydrogen peroxide (less tlen 6)

215

and 75 denatured ethyl alcohol in aqueous solution Store 81

room temperature (15-30 OC)

4 Quality Control Material

a Both a positive and negative performance monitor are located under the flap and below the specimen windows on the back of the slides

b The positive monitor contains a hemoglobin-derived catalyst that when developer is applied turns blue within 30 seconds

c The negative monitor contains no such catalyst and should not turn blue after the developer is applied

d If the performance monitors do not react as expected the tes1 results should be regarded as invalid

S Procedure

For physician

a Collect a small stool sample on one end of the applicator

b Apply a thin smear inside box A

c Reuse applicator to obtain a second sample from a different part of the stool Apply a thin smear inside box B

d Close cover Make sure that the slide is labeled with the participant identification and the date the specimen was collected

e Deliver to the laboratory

Participant testing

f Check the slide to see if the stool is present

g Open the flap in the back of the slide and apply two drops 01 developer to the guaiac paper directly over each smear

h Read the results within 60 seconds

Control testing

i Apply one drop only of developer between the positive and negative performance monitors

j Read the results within 30 seconds

Important note Follow the procedure exactly as outlined above Always develop the test read the results interpret them and make a decision about whether the fecal specimen is

1 ~

216 I

~ i

-----------==--======-~~=m~~~~~mm~~~mm~~nm~m~~~mm~am~~~~

I

positive or negative for occult blood before you develol the performance monitors Do not apply developer to the moritors before interpreting the test results Any blue originaling from the performance monitors should be ignored in readlng the specimen test results

6 Reference

Smith-Kline Diagnostics Hemoccult product instructions [Iacket insert] Sunnyvale California Smith-Kline Diagnostics 1983

217

V ANALYTICAL METHODS

DD Serologic Test for Syphilis Hynson Wescott and Dunning RPR

1 Principle

The Rapid Plasma Reagin (RPR) is a screening test for syphilis that detects the presence of a nonspecific antibody to syphilil called reagin

Reagin is nonspecific in that it will react with cardiolipin tile antigen in this test Cardiolipin which is extracted from beE heart is bound to charcoal particles so that when the antigen-antibody reaction produces flocculation which is visit e to the unaided eye

2 Specimen

a Serum is the specimen of choice

b Store at 2-8 degc for no more than 2 days

c Store at -20 degC or -70 degc for longer periods

d A volume of 50 ul is required for each test

3 Reagents Supplies and Sto[ag

a RPR Antigen HWD catalog no 8703-33 (obtain through CMS) 0003 cardiolipin 0020-0022 lecithin 009 cholesterol 00125M EDTA OOlM NasHP04 001975 charcoal and 10 choline chloride with 01 Merthiolate

Store at 2-8 0C After being opened reagent is usable for months

Transfer to plastic dispensing bottle and label with the reagent name lot number expiration date and date opened

Warm to 23-29 0C before use

b Test control card Hynson Wescott and Dunning Catalog no 8767-09 (obtain from eMS)

c Control sera SP no B6734-l0 from Dade Store at 2-8 degC One vial each of reactive minimally reactive and nonreactbe

d Plastic coated cards with 18 mm circles CMS no 098-392 fom Hynson Wescott and Dunning

4 Ouality Control Material

a Record room temperature which should be between 23-29 degC (The temperature of the serum and RPR card test antigen shou i also be between 23 0-29 0C)

218

l I

l l

l

l t

b Check the 20-gauge needle for delivery of 60 drops per ml plusmn2 drops (Use the antigen suspension for this test)

c The rotator must be checked and should be set at 100 rpDI plusmn5 rpm

d RPR test control cards MUST be run daily Expected values Reactive (R)

Nonreactive (N) Reactive minimal (RM)

Record lot number and expiration date on control card

e Dade liquid controls must be run on each card

5 Procedure

Note Participant specimens are to be run singly The te~ s on EVERY reactive specimen must be repeated to verify t le result

a Hold the dispenser between thumb and forefinger near thE stirring or sealed end Squeeze and do not release pre~ mreuntil the open end is below the surface of the specimen Hold the specimen tube vertically to minimize stirring of thE cellular elements Release finger pressure to draw up the sample

b Hold the dispenser in a perpendicular position directly I)ver the card to receive the specimen (not touching the card surface) squeeze the dispenser allowing one drop to fE 1 onto the card

c Invert the dispenser and with sealed stirring end sprE lId the specimen within the circle (If preferred the sample remaining in the dispenser may be discharged into specinln tube from which it was drawn) Discard stirrer

Repeat the procedure for the number of specimens to be t Isted

d Shake the antigen dispensing bottle before use Holdineuro the bottle in a vertical position dispense one or two drop~ in the dispensing bottle cap to make sure that the needle pass~ge is clear and that it is delivering 160 ml of antigen ThEll place one free falling drop (20-gauge yellow hub needle) onto each test area DO NOT RESTIR ANTIGEN SUSPENSION AND SPECllffiNS ARE MIXED DURING ROTATION Pick up predropped antigen 1 om bottle cap

e Rotate the RPR 8 minutes under the humidifying cover C1I the mechanical rotator at 100 rpm

f Remove the RPR card from the rotator platform and gentl~ rotate and tilt the card three to four times This helps differentiate nonreactive from minimally reactive result

219

shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

220

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t l

VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

V ANALYTICAL METHODS

ce Occult Blood in Stool Specimens

1 Principle

The Hemoccult test is a simplified standardized variati(o of the guaiac test for occult blood It contains specially prellred guaiac-impregnated paper and is ready for use without adcltional preparation

When a small stool specimen containing occult blood is al)lied to Hemoccult test paper the hemoglobin comes in contact witil the guaiac Application of Hemoccult developer creates a guaiacperoxidase-like reaction which if occult blood i~ present turns the test paper blue within 60 seconds

The test reacts with hemoglobin released from lysed cell~ When blood is present hemolysis is promoted by substances in he stool primarily water and salts

The test depends on the oxidation of a phenolic compound alpha guaiaconic acid which yields a blue-colored conjugated structure Hemoglobin exerts a peroxidase-like activity and facilitates the oxidation of this phenolic compound by h)clrogen peroxide

2 Specimen

A very small stool sample is required thinly applied to Lhe slide

The slide may be prepared and developed immediately or prlpared and stored for up to 12 days

Participants with bleeding from other conditions that may show up in the stool specimen (~ hemorrhoids) are not approprJate test subjects while such bleeding is active

Whenever possible participants should be placed on a meat-free high-residue diet starting 2 days before and continuing through the test period Such a diet may reduce the number of false-positive reactions and may also provide roughage to help uncover silent lesions that may bleed intermittently

3 Reagents Supplies and Storage

a Hemoccult slides -- High-quality filter paper impregnated with natural guaiac resin Store at room temperature (15-30 oC) and protect from heat and light

b Hemoccult developer -- A developing solution containin1 a stabilized dilute mixture of hydrogen peroxide (less tlen 6)

215

and 75 denatured ethyl alcohol in aqueous solution Store 81

room temperature (15-30 OC)

4 Quality Control Material

a Both a positive and negative performance monitor are located under the flap and below the specimen windows on the back of the slides

b The positive monitor contains a hemoglobin-derived catalyst that when developer is applied turns blue within 30 seconds

c The negative monitor contains no such catalyst and should not turn blue after the developer is applied

d If the performance monitors do not react as expected the tes1 results should be regarded as invalid

S Procedure

For physician

a Collect a small stool sample on one end of the applicator

b Apply a thin smear inside box A

c Reuse applicator to obtain a second sample from a different part of the stool Apply a thin smear inside box B

d Close cover Make sure that the slide is labeled with the participant identification and the date the specimen was collected

e Deliver to the laboratory

Participant testing

f Check the slide to see if the stool is present

g Open the flap in the back of the slide and apply two drops 01 developer to the guaiac paper directly over each smear

h Read the results within 60 seconds

Control testing

i Apply one drop only of developer between the positive and negative performance monitors

j Read the results within 30 seconds

Important note Follow the procedure exactly as outlined above Always develop the test read the results interpret them and make a decision about whether the fecal specimen is

1 ~

216 I

~ i

-----------==--======-~~=m~~~~~mm~~~mm~~nm~m~~~mm~am~~~~

I

positive or negative for occult blood before you develol the performance monitors Do not apply developer to the moritors before interpreting the test results Any blue originaling from the performance monitors should be ignored in readlng the specimen test results

6 Reference

Smith-Kline Diagnostics Hemoccult product instructions [Iacket insert] Sunnyvale California Smith-Kline Diagnostics 1983

217

V ANALYTICAL METHODS

DD Serologic Test for Syphilis Hynson Wescott and Dunning RPR

1 Principle

The Rapid Plasma Reagin (RPR) is a screening test for syphilis that detects the presence of a nonspecific antibody to syphilil called reagin

Reagin is nonspecific in that it will react with cardiolipin tile antigen in this test Cardiolipin which is extracted from beE heart is bound to charcoal particles so that when the antigen-antibody reaction produces flocculation which is visit e to the unaided eye

2 Specimen

a Serum is the specimen of choice

b Store at 2-8 degc for no more than 2 days

c Store at -20 degC or -70 degc for longer periods

d A volume of 50 ul is required for each test

3 Reagents Supplies and Sto[ag

a RPR Antigen HWD catalog no 8703-33 (obtain through CMS) 0003 cardiolipin 0020-0022 lecithin 009 cholesterol 00125M EDTA OOlM NasHP04 001975 charcoal and 10 choline chloride with 01 Merthiolate

Store at 2-8 0C After being opened reagent is usable for months

Transfer to plastic dispensing bottle and label with the reagent name lot number expiration date and date opened

Warm to 23-29 0C before use

b Test control card Hynson Wescott and Dunning Catalog no 8767-09 (obtain from eMS)

c Control sera SP no B6734-l0 from Dade Store at 2-8 degC One vial each of reactive minimally reactive and nonreactbe

d Plastic coated cards with 18 mm circles CMS no 098-392 fom Hynson Wescott and Dunning

4 Ouality Control Material

a Record room temperature which should be between 23-29 degC (The temperature of the serum and RPR card test antigen shou i also be between 23 0-29 0C)

218

l I

l l

l

l t

b Check the 20-gauge needle for delivery of 60 drops per ml plusmn2 drops (Use the antigen suspension for this test)

c The rotator must be checked and should be set at 100 rpDI plusmn5 rpm

d RPR test control cards MUST be run daily Expected values Reactive (R)

Nonreactive (N) Reactive minimal (RM)

Record lot number and expiration date on control card

e Dade liquid controls must be run on each card

5 Procedure

Note Participant specimens are to be run singly The te~ s on EVERY reactive specimen must be repeated to verify t le result

a Hold the dispenser between thumb and forefinger near thE stirring or sealed end Squeeze and do not release pre~ mreuntil the open end is below the surface of the specimen Hold the specimen tube vertically to minimize stirring of thE cellular elements Release finger pressure to draw up the sample

b Hold the dispenser in a perpendicular position directly I)ver the card to receive the specimen (not touching the card surface) squeeze the dispenser allowing one drop to fE 1 onto the card

c Invert the dispenser and with sealed stirring end sprE lId the specimen within the circle (If preferred the sample remaining in the dispenser may be discharged into specinln tube from which it was drawn) Discard stirrer

Repeat the procedure for the number of specimens to be t Isted

d Shake the antigen dispensing bottle before use Holdineuro the bottle in a vertical position dispense one or two drop~ in the dispensing bottle cap to make sure that the needle pass~ge is clear and that it is delivering 160 ml of antigen ThEll place one free falling drop (20-gauge yellow hub needle) onto each test area DO NOT RESTIR ANTIGEN SUSPENSION AND SPECllffiNS ARE MIXED DURING ROTATION Pick up predropped antigen 1 om bottle cap

e Rotate the RPR 8 minutes under the humidifying cover C1I the mechanical rotator at 100 rpm

f Remove the RPR card from the rotator platform and gentl~ rotate and tilt the card three to four times This helps differentiate nonreactive from minimally reactive result

219

shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

220

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VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

and 75 denatured ethyl alcohol in aqueous solution Store 81

room temperature (15-30 OC)

4 Quality Control Material

a Both a positive and negative performance monitor are located under the flap and below the specimen windows on the back of the slides

b The positive monitor contains a hemoglobin-derived catalyst that when developer is applied turns blue within 30 seconds

c The negative monitor contains no such catalyst and should not turn blue after the developer is applied

d If the performance monitors do not react as expected the tes1 results should be regarded as invalid

S Procedure

For physician

a Collect a small stool sample on one end of the applicator

b Apply a thin smear inside box A

c Reuse applicator to obtain a second sample from a different part of the stool Apply a thin smear inside box B

d Close cover Make sure that the slide is labeled with the participant identification and the date the specimen was collected

e Deliver to the laboratory

Participant testing

f Check the slide to see if the stool is present

g Open the flap in the back of the slide and apply two drops 01 developer to the guaiac paper directly over each smear

h Read the results within 60 seconds

Control testing

i Apply one drop only of developer between the positive and negative performance monitors

j Read the results within 30 seconds

Important note Follow the procedure exactly as outlined above Always develop the test read the results interpret them and make a decision about whether the fecal specimen is

1 ~

216 I

~ i

-----------==--======-~~=m~~~~~mm~~~mm~~nm~m~~~mm~am~~~~

I

positive or negative for occult blood before you develol the performance monitors Do not apply developer to the moritors before interpreting the test results Any blue originaling from the performance monitors should be ignored in readlng the specimen test results

6 Reference

Smith-Kline Diagnostics Hemoccult product instructions [Iacket insert] Sunnyvale California Smith-Kline Diagnostics 1983

217

V ANALYTICAL METHODS

DD Serologic Test for Syphilis Hynson Wescott and Dunning RPR

1 Principle

The Rapid Plasma Reagin (RPR) is a screening test for syphilis that detects the presence of a nonspecific antibody to syphilil called reagin

Reagin is nonspecific in that it will react with cardiolipin tile antigen in this test Cardiolipin which is extracted from beE heart is bound to charcoal particles so that when the antigen-antibody reaction produces flocculation which is visit e to the unaided eye

2 Specimen

a Serum is the specimen of choice

b Store at 2-8 degc for no more than 2 days

c Store at -20 degC or -70 degc for longer periods

d A volume of 50 ul is required for each test

3 Reagents Supplies and Sto[ag

a RPR Antigen HWD catalog no 8703-33 (obtain through CMS) 0003 cardiolipin 0020-0022 lecithin 009 cholesterol 00125M EDTA OOlM NasHP04 001975 charcoal and 10 choline chloride with 01 Merthiolate

Store at 2-8 0C After being opened reagent is usable for months

Transfer to plastic dispensing bottle and label with the reagent name lot number expiration date and date opened

Warm to 23-29 0C before use

b Test control card Hynson Wescott and Dunning Catalog no 8767-09 (obtain from eMS)

c Control sera SP no B6734-l0 from Dade Store at 2-8 degC One vial each of reactive minimally reactive and nonreactbe

d Plastic coated cards with 18 mm circles CMS no 098-392 fom Hynson Wescott and Dunning

4 Ouality Control Material

a Record room temperature which should be between 23-29 degC (The temperature of the serum and RPR card test antigen shou i also be between 23 0-29 0C)

218

l I

l l

l

l t

b Check the 20-gauge needle for delivery of 60 drops per ml plusmn2 drops (Use the antigen suspension for this test)

c The rotator must be checked and should be set at 100 rpDI plusmn5 rpm

d RPR test control cards MUST be run daily Expected values Reactive (R)

Nonreactive (N) Reactive minimal (RM)

Record lot number and expiration date on control card

e Dade liquid controls must be run on each card

5 Procedure

Note Participant specimens are to be run singly The te~ s on EVERY reactive specimen must be repeated to verify t le result

a Hold the dispenser between thumb and forefinger near thE stirring or sealed end Squeeze and do not release pre~ mreuntil the open end is below the surface of the specimen Hold the specimen tube vertically to minimize stirring of thE cellular elements Release finger pressure to draw up the sample

b Hold the dispenser in a perpendicular position directly I)ver the card to receive the specimen (not touching the card surface) squeeze the dispenser allowing one drop to fE 1 onto the card

c Invert the dispenser and with sealed stirring end sprE lId the specimen within the circle (If preferred the sample remaining in the dispenser may be discharged into specinln tube from which it was drawn) Discard stirrer

Repeat the procedure for the number of specimens to be t Isted

d Shake the antigen dispensing bottle before use Holdineuro the bottle in a vertical position dispense one or two drop~ in the dispensing bottle cap to make sure that the needle pass~ge is clear and that it is delivering 160 ml of antigen ThEll place one free falling drop (20-gauge yellow hub needle) onto each test area DO NOT RESTIR ANTIGEN SUSPENSION AND SPECllffiNS ARE MIXED DURING ROTATION Pick up predropped antigen 1 om bottle cap

e Rotate the RPR 8 minutes under the humidifying cover C1I the mechanical rotator at 100 rpm

f Remove the RPR card from the rotator platform and gentl~ rotate and tilt the card three to four times This helps differentiate nonreactive from minimally reactive result

219

shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

220

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VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

positive or negative for occult blood before you develol the performance monitors Do not apply developer to the moritors before interpreting the test results Any blue originaling from the performance monitors should be ignored in readlng the specimen test results

6 Reference

Smith-Kline Diagnostics Hemoccult product instructions [Iacket insert] Sunnyvale California Smith-Kline Diagnostics 1983

217

V ANALYTICAL METHODS

DD Serologic Test for Syphilis Hynson Wescott and Dunning RPR

1 Principle

The Rapid Plasma Reagin (RPR) is a screening test for syphilis that detects the presence of a nonspecific antibody to syphilil called reagin

Reagin is nonspecific in that it will react with cardiolipin tile antigen in this test Cardiolipin which is extracted from beE heart is bound to charcoal particles so that when the antigen-antibody reaction produces flocculation which is visit e to the unaided eye

2 Specimen

a Serum is the specimen of choice

b Store at 2-8 degc for no more than 2 days

c Store at -20 degC or -70 degc for longer periods

d A volume of 50 ul is required for each test

3 Reagents Supplies and Sto[ag

a RPR Antigen HWD catalog no 8703-33 (obtain through CMS) 0003 cardiolipin 0020-0022 lecithin 009 cholesterol 00125M EDTA OOlM NasHP04 001975 charcoal and 10 choline chloride with 01 Merthiolate

Store at 2-8 0C After being opened reagent is usable for months

Transfer to plastic dispensing bottle and label with the reagent name lot number expiration date and date opened

Warm to 23-29 0C before use

b Test control card Hynson Wescott and Dunning Catalog no 8767-09 (obtain from eMS)

c Control sera SP no B6734-l0 from Dade Store at 2-8 degC One vial each of reactive minimally reactive and nonreactbe

d Plastic coated cards with 18 mm circles CMS no 098-392 fom Hynson Wescott and Dunning

4 Ouality Control Material

a Record room temperature which should be between 23-29 degC (The temperature of the serum and RPR card test antigen shou i also be between 23 0-29 0C)

218

l I

l l

l

l t

b Check the 20-gauge needle for delivery of 60 drops per ml plusmn2 drops (Use the antigen suspension for this test)

c The rotator must be checked and should be set at 100 rpDI plusmn5 rpm

d RPR test control cards MUST be run daily Expected values Reactive (R)

Nonreactive (N) Reactive minimal (RM)

Record lot number and expiration date on control card

e Dade liquid controls must be run on each card

5 Procedure

Note Participant specimens are to be run singly The te~ s on EVERY reactive specimen must be repeated to verify t le result

a Hold the dispenser between thumb and forefinger near thE stirring or sealed end Squeeze and do not release pre~ mreuntil the open end is below the surface of the specimen Hold the specimen tube vertically to minimize stirring of thE cellular elements Release finger pressure to draw up the sample

b Hold the dispenser in a perpendicular position directly I)ver the card to receive the specimen (not touching the card surface) squeeze the dispenser allowing one drop to fE 1 onto the card

c Invert the dispenser and with sealed stirring end sprE lId the specimen within the circle (If preferred the sample remaining in the dispenser may be discharged into specinln tube from which it was drawn) Discard stirrer

Repeat the procedure for the number of specimens to be t Isted

d Shake the antigen dispensing bottle before use Holdineuro the bottle in a vertical position dispense one or two drop~ in the dispensing bottle cap to make sure that the needle pass~ge is clear and that it is delivering 160 ml of antigen ThEll place one free falling drop (20-gauge yellow hub needle) onto each test area DO NOT RESTIR ANTIGEN SUSPENSION AND SPECllffiNS ARE MIXED DURING ROTATION Pick up predropped antigen 1 om bottle cap

e Rotate the RPR 8 minutes under the humidifying cover C1I the mechanical rotator at 100 rpm

f Remove the RPR card from the rotator platform and gentl~ rotate and tilt the card three to four times This helps differentiate nonreactive from minimally reactive result

219

shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

220

i

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t l

VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

V ANALYTICAL METHODS

DD Serologic Test for Syphilis Hynson Wescott and Dunning RPR

1 Principle

The Rapid Plasma Reagin (RPR) is a screening test for syphilis that detects the presence of a nonspecific antibody to syphilil called reagin

Reagin is nonspecific in that it will react with cardiolipin tile antigen in this test Cardiolipin which is extracted from beE heart is bound to charcoal particles so that when the antigen-antibody reaction produces flocculation which is visit e to the unaided eye

2 Specimen

a Serum is the specimen of choice

b Store at 2-8 degc for no more than 2 days

c Store at -20 degC or -70 degc for longer periods

d A volume of 50 ul is required for each test

3 Reagents Supplies and Sto[ag

a RPR Antigen HWD catalog no 8703-33 (obtain through CMS) 0003 cardiolipin 0020-0022 lecithin 009 cholesterol 00125M EDTA OOlM NasHP04 001975 charcoal and 10 choline chloride with 01 Merthiolate

Store at 2-8 0C After being opened reagent is usable for months

Transfer to plastic dispensing bottle and label with the reagent name lot number expiration date and date opened

Warm to 23-29 0C before use

b Test control card Hynson Wescott and Dunning Catalog no 8767-09 (obtain from eMS)

c Control sera SP no B6734-l0 from Dade Store at 2-8 degC One vial each of reactive minimally reactive and nonreactbe

d Plastic coated cards with 18 mm circles CMS no 098-392 fom Hynson Wescott and Dunning

4 Ouality Control Material

a Record room temperature which should be between 23-29 degC (The temperature of the serum and RPR card test antigen shou i also be between 23 0-29 0C)

218

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b Check the 20-gauge needle for delivery of 60 drops per ml plusmn2 drops (Use the antigen suspension for this test)

c The rotator must be checked and should be set at 100 rpDI plusmn5 rpm

d RPR test control cards MUST be run daily Expected values Reactive (R)

Nonreactive (N) Reactive minimal (RM)

Record lot number and expiration date on control card

e Dade liquid controls must be run on each card

5 Procedure

Note Participant specimens are to be run singly The te~ s on EVERY reactive specimen must be repeated to verify t le result

a Hold the dispenser between thumb and forefinger near thE stirring or sealed end Squeeze and do not release pre~ mreuntil the open end is below the surface of the specimen Hold the specimen tube vertically to minimize stirring of thE cellular elements Release finger pressure to draw up the sample

b Hold the dispenser in a perpendicular position directly I)ver the card to receive the specimen (not touching the card surface) squeeze the dispenser allowing one drop to fE 1 onto the card

c Invert the dispenser and with sealed stirring end sprE lId the specimen within the circle (If preferred the sample remaining in the dispenser may be discharged into specinln tube from which it was drawn) Discard stirrer

Repeat the procedure for the number of specimens to be t Isted

d Shake the antigen dispensing bottle before use Holdineuro the bottle in a vertical position dispense one or two drop~ in the dispensing bottle cap to make sure that the needle pass~ge is clear and that it is delivering 160 ml of antigen ThEll place one free falling drop (20-gauge yellow hub needle) onto each test area DO NOT RESTIR ANTIGEN SUSPENSION AND SPECllffiNS ARE MIXED DURING ROTATION Pick up predropped antigen 1 om bottle cap

e Rotate the RPR 8 minutes under the humidifying cover C1I the mechanical rotator at 100 rpm

f Remove the RPR card from the rotator platform and gentl~ rotate and tilt the card three to four times This helps differentiate nonreactive from minimally reactive result

219

shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

220

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VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

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1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

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4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

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D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

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t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

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b Check the 20-gauge needle for delivery of 60 drops per ml plusmn2 drops (Use the antigen suspension for this test)

c The rotator must be checked and should be set at 100 rpDI plusmn5 rpm

d RPR test control cards MUST be run daily Expected values Reactive (R)

Nonreactive (N) Reactive minimal (RM)

Record lot number and expiration date on control card

e Dade liquid controls must be run on each card

5 Procedure

Note Participant specimens are to be run singly The te~ s on EVERY reactive specimen must be repeated to verify t le result

a Hold the dispenser between thumb and forefinger near thE stirring or sealed end Squeeze and do not release pre~ mreuntil the open end is below the surface of the specimen Hold the specimen tube vertically to minimize stirring of thE cellular elements Release finger pressure to draw up the sample

b Hold the dispenser in a perpendicular position directly I)ver the card to receive the specimen (not touching the card surface) squeeze the dispenser allowing one drop to fE 1 onto the card

c Invert the dispenser and with sealed stirring end sprE lId the specimen within the circle (If preferred the sample remaining in the dispenser may be discharged into specinln tube from which it was drawn) Discard stirrer

Repeat the procedure for the number of specimens to be t Isted

d Shake the antigen dispensing bottle before use Holdineuro the bottle in a vertical position dispense one or two drop~ in the dispensing bottle cap to make sure that the needle pass~ge is clear and that it is delivering 160 ml of antigen ThEll place one free falling drop (20-gauge yellow hub needle) onto each test area DO NOT RESTIR ANTIGEN SUSPENSION AND SPECllffiNS ARE MIXED DURING ROTATION Pick up predropped antigen 1 om bottle cap

e Rotate the RPR 8 minutes under the humidifying cover C1I the mechanical rotator at 100 rpm

f Remove the RPR card from the rotator platform and gentl~ rotate and tilt the card three to four times This helps differentiate nonreactive from minimally reactive result

219

shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

220

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l

t l

VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

shygtgtgt------------------- ----

g Read immediately by using an incandescent lamp on the bench

h Remove the needle rinse it in water air dry it Recap the bottle Store at 2-8 dege

6 References

a Brown WJ ed Syphilis a synopsis Atlanta US Departmet of Health Education and Welfare 1968 Public Health ServicE publication no 1660

b Hynson Wescott and Dunning RPR-card antigen suspension [package insert] Baltimore Hynson Wescott and Dunning 1981

c Hynson Wescott and Dunning RPR test control cards insert Baltimore Hynson Wescott and Dunning 1981

d Venereal Disease Research Laboratory Manual of tests for syphilis Atlanta US Department of Health Education anl Welfare 1969 HEW publication no (CDC) 79-8347 (originally PHS publication no 411)

220

i

k

l

t l

VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

i

k

l

t l

VI QUALITY CONTROL FOR ANALYTICAL PROCEDURES A General Guidelines

1 New Controls

At least 20 runs of control material are made before the controls are used in the study Each run is be performed as a normal study participant run ~ the controls are placed within the rn and the run is as long as an average study run

Values for the controls will be entered into the Community Halth Computer (CHC) data management system These data are transEerred to an IBM personal computer by the quality control supervisor who processes them to compute means standard deviations ranges and successive ranges for each parameter and each level of contrll Preliminary average run means standard deviations of the melns and average ranges are established after 20 control runs vaLues are adjusted after 50 control runs

Charts are printed for use on the benches with control limit of 95 and 99 confidence for run means ranges and successive ranges The technologists monitor their daily quality contrll and plot values on each chart These charts are used to monitor trends and changes in precision over time

3 Bench Monitoring of Quality Control QC

Any values f~lling outside the 95 control limits on ANY of ~echarts (mean range or successive range) are reported to the quality control supervisor for a decision on whether the run is acceptable Any value falling outside the 95 control limi ti on 2 successive days or outside 99 control limits on 1 day automatically causes the run to be rejected Remedial actiolls include the following

a Check for recording errors If none are found check and recalibrate the instruments as appropriate

b Redilute the controls if applicable c Check all reagents and redo or exchange bottles if necessary d After the problem is resolved repeat the out-of-control In

e Document the problem and remedial action on the remedial ation log

221

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

4 Flow Chart--Bench Quality Control

Run out of control

No yes----gtOut of acceptance limits------gtRemedial

Report Out of 95 or 99 limits

action---shyo

---shySupervisor

OK No OK

OK Not OK------------ shyReport

Report

lt------Supervilor Remediallt------lt

Report lt-----OK lt-------Action lt-----Pathologlst

5 Quality Control Data Transfer

All quality control (QC) results are transferred weekly from the CHC mainframe computer system to the IBM personal computer by th QC supervisor Data are to be processed by using the CDC-prepard statistical QC program that provides a chronological summary of tun means ranges and successive ranges in the form of tables and control charts These tables and charts are to be printed as a permanent hard copy record for review by the QC supervisor and CC (as requested) The QC data are then sent to CDC via Crosstalk Eor independent statistical evaluation and review CDC then providel feedback to the Lovelace Clinical Laboratory monthly (or sooner If a problem is identified that needs more immediate attention)

6 Blind Samples

Blind samples are run daily to total 5 of the study specimens These split specimens are randomly assigned and labeled by the Q supervisor in such a way that the real identification is disguised from the performing technologists When all laboratory tests are completed and reported for the day the QC supervisor identifies the blinds to enable CDC to match them to the original participant

7 Avoidance of Systematic Error

Systematic error is minimized as follows

a Initial methods are maintained without modifications

222

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

II

b Specimen integrity is maintained by strict adherence to collection processing and storage protocols and by docllilenting of these procedures

c Instruments are calibrated or the calibration is validatell daily before the study specimens are analyzed

d Study specimens are analyzed separately from specimens no involved in the study

e Parallel runs are performed for all new reagents that are not controls New calibrating material requires 10 parallel [uns all other reagents require 4 parallel runs A parallel rn is a repeat of a finished run with the new reagent substitutel for the old A regression analysis is done on the original a~d the new data and before the new reagent is used the QC supervisor determines on the basis of the results whether the new reagent is acceptable

8 Additional Quality Assurance

a This laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing program Samples received every 2 to 3 months are tested for the followinl analytes

HematologyCoagulation Leukocyte count Monocytes Hemoglobin Eosinophils Hematocrit Plasma cells Red cell count Nuclea ted red blood cell n Mean corpuscular volume Hypochromasia Mean corpuscular hemoglobin Poikilocytosis Platelets Microcytosis Early leukocytes Macrocytosis Metamyelocytes Basophilic stippling Banded neutrophils Hypersegmentation Segmented neutrophils Howell-Jolly bodies Lymphocytes Basophils Atypical lymphocytes Prothrombin time

Serology Syphilis serology (RPR) Lymphocyte subsets Absolute number of mononuclear cells Lymphocyte differentiation antigen Total T lymphocytes Helper-inducer T lymphocytes Cytoxic suppressor T lymphocytes

223

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

Chemistry Tests Blood urea nitrogen Hepatitis B surface antigen Creatinine Hepatitis B surface antigen Bilirubin total antibody Aspartate aminotransferase Hepatitis B core antigen Alanine aminotransferase antibody Gamma glutamyl transferase Thyroxine Alkaline phosphatase T3 uptake Lactic dehydrogenase Thyroid stimulating hormone Creatine kinase Cortisol (morning) Cholesterol Dehydroepiandosterone-S04 HDL cholesterol Luteinizing hormone Triglycerides Follicle stimulating hormone Total protein Testosterone Albumin Immunoglobulin A Glucose fasting Immunoglobulin G

Immunoglobulin M

Urinalysis Tests Specific gravity White blood cells pH Red blood cells Hemoglobin Epithelial cells Bilirubin Renal tubular cells Urobilinogen Hyaline casts Ketones Granular casts Glucose White blood cell casts Protein Red blood cell casts Crystals Other casts

l2-Hour Uine Tests Creatininel2-hout Uroporphyrins Coporporphyrins

Results are reported to the College of American Pathologists rated by the College and returned to the laboratory for rev ~w and comments by the pathologist and supervisors Reports of results are also sent to designated CDC personnel

b Materials are used from the CDC-NHLBI Lipid Standardization Program to periodically check proficiency for cholesterol triglycerides and HDL cholesterol

c Materials from the World Health Organization (WHO standards) lre used to periodically check proficiency for immunoglobulins A G and M

B Assay and Bench Control Information

Quality control (QC) assays are to be reported in the units given below Assays to which QC does not apply are indicated with an Ni for the level of QC and number of measures When QC does apply t1I

224

Tnmm

1

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

I r

number of levels of QC material and the number of times each q~ material is measured in a given run are indicated For examp~ cholesterol has two levels of QC (a low normal and a high ll)rmal control) each is measured in quadruplicate each analytic run The first measure is for the beginning of the run the second and hird for random positions in the middle of the run and the fourth for the end of the run (Note Each run has about 23 participant saIl)les and one (1) blind repeat control) For control material measured In duplicate the first measure is for the beginning of the run Ild the second for the end of the run

1 Hemoto10gy Tests

Assay Name Result Units

Levels ~

No Per

oj Measures LI~rel of QC

Leukocyte count kmm3 2 ~ Hemoglobin gdl 2 i Hematocrit 2 ~ Red cell count mllmm3 2 ~

Mean corpuscular volume f1 2 ~

Mean corpuscular hemoglobin pg 2 ~

Mean corpuscular hemoglobin concentration 2 ~

Platelets kmm3 2 i Early leukocytes NA El Metamyelocytes NA U Banded neutrophils 2 middot1 Segmented neutrophils 2 middot1 Lymphocyte~ 2 middot1 Atypical lymphocytes 2 middot1 Monocytes 2 middot1 Eosinophils 2 middot1

Basophils 2 middot1

Plasma cells 2 I Nucleated red blood cells 2 I Polychromasia Comment or NP NA ~ l Hypochromasia Comment or NP NA ]Il

Poikilocytosis Comment or NP NA fill Microcytosis Comment or NP NA IiJl Macrocytosis Comment or NP NA IiJc Basophilic stippling Comment or NP NA IiJ Hypersegmentation Comment or NP NA IiI Howell-Jolly bodies Comment or NP NA IiI Sedimentation rate mmh 4 specimens Prothrombin time sec 2 J

(Note For erythrocyte sedimentation rate four fresh b100( specimens are to be collected and analyzed in duplicate on each run day Specimens can to be drawn from diffelent individuals from one day to the next)

225

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

2 Urinalysis Tests

Results Levels No of Assay Name Units of OC Measures

Specific gravity ReI den 1 2 pH pH unit 1 2 Hemoglobin Comment 1 2 Bilirubin Comment 1 2 Urobilinogen mgdl 1 2 Ketones mgdl 1 2 Glucose mgdl 1 2 Protein mgdl 1 2 Appearance Comment NA NA Color Comment NA NA Red blood cells Rbchpf NA NA White blood cells Wbchpf NA NA Epithelial cells Celllpf NA NA Renal tubular cells Celllpf NA NA Hyaline casts Castlpf NA NA Granular casts Castlpf NA NA WBC casts Castlpf NA NA RBC casts Castlpf NA NA Other casts Castlpf NA NA

3 12 Hour Urine Tests

Urine creatinine mgdl 2 4 Porphobilinogen ugml 1 2 D-glucaric acid ugml 1 2 Uroporphyrins ugL 1 2 Heptacarboxylporphyrin ugL 1 2 Coproporphyrin I ugL 1 2

4 Chemistry Tests

Blood urea nitrogen mgdl 2 4 Serum creatinine mgdl 2 4 Total bilirubin mgdl 2 4 Conjugated bilirubin Comment or NP NA NA Unconjugated bilirubin mgdl 2 4 Aspartate aminoshy

transferase (SGOT) IUL 2 4 Alanine aminoshy

transferase (SGPT) IUL 2 4

226

WI

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

4 Chemistry Tests (Continued)

Assay Name Results Units

Levels 2LQi

No of Measures

Gamma glutamyl transferase IUL 2 4

Alkaline phosphatase lUlL 2 4 Lactic dehydrogenase IUL 2 4 Creatine phosphokinase IUL 2 4 Cholesterol mgdl 2 4 HDL cholesterol mgdl 2 4 Glycerol blank mgdl 2 4 Triglycerides mgdl 2 4 Total protein gdl 2 4 Albumin gdl 2 4 Fasting glucose mgdl 2 4 Hepatitis B surface

antigen Comment NA NA Antibody to hepatitis

B surface antigen Comment NA NA Antibody to hepatitis

B core antigen comment NA NA Thyroxine-T4 ugdl 2 2 T3 Uptake 2 2 Thyroid stimulating hormone mIUL 2 2 Cortisol (morning) ugdl 2 2 Dehydroepiandrosterone-S04 ugdl 2 2 Luteinizing hormone IUL 2 2 Follicle stimulating

hormone IUL 2 2 Testosterone ngdl 2 2 Delta-aminolevulinic acid ugdl 1 2 Immunoglobulin A mgdl 2 2 Immunoglobulin G mgdl 2 2 Immunoglobulin M mgdl 2 2

5 LYmRhocyte Subsets

T-lymphocyte (relative) T-lymphocyte (absolute)

kmm3

2 NA

2 NA

B-lymphocyte (relative) B-lymphocyte (absolute)

kmm3

2 NA

2 NA

T4-lymphocyte (relative) T4-lymphocyte (absolute)

kmm3 NA

2 NA

2

TS-lymphocyte (relative) TS-lymphocyte (absolute)

kmm3 NA

2 NA

2

T4TS ratio Ratio 2 2

227

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

6 Semen Analysis

Results Levels No of Assay Name Units ~ Measures

Sperm concentration Cellsml 2 1 Percent motile sperm 2 1 Mean linear velocity Total mean area

urnsec urn2

2 2

1 1

Total mean perimeter mic 2 1 Total mean lengthwidth

ratio Ratio 2 1 Total mean major axis

length urn 2 1

7 Other Tests

Occult blood (feces) Comment NA NA Breath alcohol (day 1) NA NA Patient preparation-l (day 1) Comment NA NA Breath alcohol (day 2) NA NA Patient preparation-2 (day 2) Comment NA NA Collection time for

l2-Hour urine sample h NA NA Collection status Comment NA NA

Definitionsect Qf Codes

RBC Red blood cells WBC = White blood cells pg Picagrams ng Nanograms ug Micrograms mg Milligrams g Grams fl Femptoliters dl Deciliters ml Milliliters L Liters k One thousand Percent mm3 = Cubic millimeters mm Millimeters sec Seconds h Hour IU International units mIU = Milli-international units reI den = Relative density lpf Low Power fields hpf High Power fields urn micrometers

228

I

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

D Statistical Formulas

These formulas are to be used to compute means standard devtions and ranges for statistical QC

Run mean Xj iXji)n

Grand mean X ltiXj )N

= 2 Standard deviation Sx sqrtO(Xj - X) N - 1)

Range Rj (largest Xji - smallest Xji)

Average range R = (lRj)N

Successive range Rs X (day 2) - X (day 1)

Average successive range Rs (lRs)N

Coefficient of variation CV (100)SxX

Symbol interpretation n = number replicates per contrc1 i replicate j control N number of runs

E Control Limits for Quality Control (QC) Charts

These formulas are to be used to calculate control limits fOI QC charts used at the bench by the laboratory technician

-Mean Charts 95 Control limits X plusmn (1 96)Sx

-99 Control limits X plusmn (258)Sx

Range Charts 95 Control Limit (246)R (for duplicates)

99 Control Limit (327)R

Range Charts 95 Control Limit (1855)R (for quadruplicates) -

99 Control Limit (2290)R

229

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

F Acceptable Performance for Laboratory Assay Controls

The following criteria constitute acceptable performance standards outlined in the Lovelace Veterans Health Study contract with CDC Control limits calculated for bench control mean charts should net exceed these limits Each month throughout the study the quality control (QC) supervisors and CDC working independently will monitor variations in measurements

1 Acceptable Performance Terms and Definitions

a CV Coefficient of variation b SD Standard deviation c PSD Pooled standard deviation d AD Average difference between replicates over eight runs

2 Hematology Profile Acceptable Performance

a Hematocrit 30 (CV) b Hemoglobin 20 (CV) c RBC count 20 (CV) d RBC indices (MCV MCH MCHC) 20 (CV) e WBC count 30 (CV) f WBC differential

(1) Lymphocytes 50 (CV) (2) Segmented neutrophi1s 30 (CV) (3) Atypical lymphocytes 20 (SD) (4) Others (mono eos baso banded neut) 10 (SD)

g Platelet count 40 (CV) h Erythrocyte sedimentation rate (mmh) lt20 (AD) i Prothrombin time 20 (CV)

3 Urinalysis

a Specific gravity 01 (CV) b pH NA c Dipstick (HGB bi1i urobi1 ketones NA

glucose protein) d Microscopy (RBC casts epi WBC) NA

4 12-Hour Urinalysis (UA)

a Creatinine quantitative 60 (CV) b D-g1ucaric acid 150 (CV) c Porphobilinogen 150 (CV) d HPLC prophyrin (uro and copro) 100 (CV)

230

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

t

t

5 Routine and S~ecific Chemistry Assays

a Blood urea nitrogen 20 (CV) b Fasting glucose 40 (CV) c Creatinine serum

(1) Level I (low) 01 (SD) (2) Level II (high) 04 (SD)

d Cholesterol 20 (CV) e HDL-cholesterol 40 (CV) f Triglycerides 30 (CV) g SGOT (AST) 40 (CV) h SGPT (ALT) 50 (CV) 1 Alkaline phosphatase 50 (CV) j LDH 30 (CV) k CPK 30 (CV) 1 GGT 50 (CV) m Bilirubin (total and unconjugated) 50 (CV) n Total protein 50 (CV) o Albumin 50 (CV) p Delta-aminolevulinic acid 150 (CV)

6 SteroidHormone Chemistry Assays

a Cortisol (morning) 100 (CV) b Luteinizing hormone 100 (CV) c Testosterone 100 (CV) d T3 uptake 100 (CV) eo TSH 100 (CV) f FSH 1000 (CV) g DHEAS 100 (CV) h T4 (thyroxine) 100 (CV)

7 Immunology Profile

a T and B cell subsets (relative) (1) T-lymphocytes () 50 (PSD) (2) B-lymphocytes () 20 (PSD) (3) T4-lymphocytes () 50 (PSD) (4) T8-lymphocytes () 30 (PSD) (5) T4T8 ratio 03 (PSD)

b IgA 100 (CV) c IgG 100 (CV) d IgM 100 (CV)

231

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

a Sperm concentration 100 (CV) b Percent motile sperm 100 (CV) c Mean linear velocity 100 (CV) d Total mean area 100 (CV) e Total mean perimeter 50 (CV) r Total mean lengthwidth ratio 50 (CV) g Total mean major axis length 50 (CV)

9 Miscellaneous Tests

a RPR (syphilis serology) NA b Hepatitis B antibodiesantigens

(1) HBsAG NA (2) HBcAB NA (3) HBsAB NA

c Occult blood (stool) NA d Melioidosis Titer-mean plusmn 1 dilution

8 Semen Ana1ysis

lt I

J

1

1

232

Ii W

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

VII SUMMARY OF QUALITY CONTROL DATA

A Overview

In general QC data indicate good precision for all laborator assays except for the melioidosis titer over the 16-month examination period of the Vietnam Experience Study (VES) ThE efforts of Lovelace Clinical Laboratory to conform to the accEptable performance criteria of the contract were successful and LOVElace provided high quality laboratory data The quality of these JesuIts are supported by the QC data presented in Part B of this sectlon

In Part B summary statistics of QC data for hematologic serlmurine chemistry steroidhormone and immunologic quantitative measurements as well as sperm count and measures of sperm rrctility morphology and morphometry are presented in Tables 1-57 and Figures 1-36 In these tables means standard deviations and coeffjcients of variation are used to summarize measurement error for benet control material associated with each assay The standard delmiddotiation was computed as the square root of the total variance estimatEd over the period of use The total variance was the sum of the wit Lin- and among-day (or analytic run) components estimated from a one--LY analysis of variance The coefficient of variation was compl1ed as the standard deviation divided by the mean value of the contrel material over the period of use Coefficients of variation Bloe not presented for relative measures such as white blood cell differentials and T- and B-lymphocyte subsets

Long-term trends are shown in the figures as plots of monthl~ mean values given for bench control material associated with each lssay Plots of monthly mean values are not given for hematologic mEISUreS because bench control materials were changed every few weeks 10 avoid problems with instability For hematology assays overlappirL runs of old and new control material at the time of changeover were used to ensure consistency in measurement over time Plots el monthly means are also not given for T- and B-lymphocyte substts because these control materials were blood specimens drawn fIEsh each analytic day from 2 individuals in a pool of 19 volunteers

Monthly mean values shows two notable trends

First QC data obtained for D-glucaric acid between SeptEmber 23 1985 and January 16 1986 shows a systematic downwrd trend (Figure 11) Second QC data for the total porphyJin screen test obtained between September 23 1985 and JaDlary 9 1986 shows a systematic upward trend (Figure 13) Both D-glucaric acid and total porphyrin screen values were reevaluated for a sample of participant specimens obtainEd during this time The results suggested no systematic c~ange in participant values Therefore participant values obtai~ed during this time were accepted The total porphyrin scrEen test

233

was used only to identify participant urine samples with elevated porphyrin values during the first 6-months of the study Porphyrins in these samples were then quantified by using high performance liquid chromatography (HPLC) After January 9 1986 the porphryin screen test was stopped and porphyrins were quantified by using the HPLC method for all participant samples subsequently collected

The laboratory encountered some problems that resulted in loss of data

Because of a calibrator problem identified by the manufacturer total bilirubin values were determined to be falsely elevated for participant samples analyzed from February 17 1986 through July 2 1986 The calibrator proved to be unstable over time No attempt was made to recover these participant data because of the instability of bilirubin (particularly when exposed to light) in frozen serum samples maintained over time Thus QC and participant data for this assay were removed from the analysis Unconjugated bilirubin determinations were not affected since a different calibrator was used for that assay

Statistical analysis of melioidosis titers indicated substantial variation according to the technician performing the assay As a result sera from 183 veterans examined at Lovelace were reassessed by the CDC laboratory personnel who designed the melioidosis protocol used in the VES Results showed poor agreement between the titer reported by Lovelace and the titer reported by CDC (on the same veterans serum sample) The reasons for this discrepancy are not clear since both laboratories used the same procedure Because of uncertainty about the accuracy of these titers and the potential bias in the direction of artificially high titers neither the QC nor the participant results for melioidosis titers are reported

QC data for selected sperm measures obtained from automated semen analysis are summarized in Table 57 According to the performance guidelines the sperm measures for each of the control specimens wee acceptable

B Analysis of Variance Tables and Long-Term Quality Control Charts

Quality control data for specific bioassays are shown in Tables 1-5 and Figures 1-36

234

i1

I lr I

l

t I 1

Table 1 Summary of Quality Control Data Hematocrit

Control Name

Lot No

Begin Date

End Date

Mean ()

Standard Deviation

Coefficient of Variation

No (I )servations

72 72

100 100 108 108 104 104 108 108

8 8

136 136 168 168 108 108 36 36

PARA-8H1 PARA-8N1 PARA-8H2 PARA-8N2 PARA8H2B PARA8N2B PARA8H2C PARA8N2C PARA8H2D PARA8N2D PARA8H1D PARA8N1D TRICOH2A TRICON2A TRICOH2B TRICON2B TRiCOH2C TRICON2C HIGH880A NORM880A

H538-85 N538-85 H538-85 N538-85 H588-85 N588-85 H598-85 N598-85 H5118-86 N5118-86 H5118-86 N5118-86 H1121-86 N1121-86 H1122-86 N1122-86 H1123-86 N1123-86 H1123-86 N1123-86

060385 060385 071585 071585 082785 082785 101585 101585 120485 120485 012186 012186 020686 020686 040786 040786 070786 070786 090886 090886

070885 070885 082685 082685 101485 101485 120385 120385 020586 020586 012986 012986 040386 040386 070186 070186 090486 090486 092586 092586

489 361 505 371 497 394 535 404 508 408 536 415 527 394 469 337 442 348 462 359

042 039 082 059 071 057 073 049 066 051 294 148 071 053 073 051 084 062 059 038

086 107 162 160 143 144 136 121 129 125 549 357 136 135 156 151 190 177 128 105

Table 2 Summary of Quality Control Data Hemoglobin

Control Name

Lot No

Begin Date

End Date

Mean (gdl)

Standard Deviation

Coefficient of Variation

No () bservations

PARA-8H1 PARA-8N1 PARA-8H2 PARA-8N2 PARA8H2B PARA8N2B PARA8H2C PARA8N2C PARA8H2D PARA8N2D PARA8H1D PARA8N1D TRICOH2A TRICON2A TRICOH2B TRICON2B TRICOH2C TRiCON2C HIGH880A NORM880A

H538-85 N538-85 H538-85 N538-85 H588-85 N588-85 H598-85 N598-85 H5118-86 N5118-86 H5118-86 N5118-86 H1121-86 N1121-86 H1122-86 N1122-86 H1123-86 N1123-86 H1123-86 N1123-86

060385 060385 071585 071585 082785 082785 101585 101585 120485 120485 012186 012186 020686 020686 040786 040786 070786 070786 090886 090886

070885 070885 082685 082685 101485 101485 120385 120385 020586 020586 012986 012986 040386 040386 070186 070186 090486 090486 092586 092586

187 136 182 134 177 139 185 137 180 141 182 142 181 131 167 121 163 128 164 130

015 012 021 014 030 023 022 016 020 020 025 013 024 016 024 017 019 021 015 011

081 090 113 108 167 168 117 119 110 140 139 095 133 121 143 137 115 163 092 086

72 72

100 100 108 108 104104 108 108

16 16

132 132 168 168 108 108 36 36

235

Table 3 Summary of Quality Control Data Mean Corpuscular Cell Volume

No Control Lot Begin End Mean Standard Coefficient of Name --_ _-shy

No Date Date (fl) Deviation Variation Observa tons

PARA-8H1 H538-85 060385 070885 898 037 042 7~

PARA-8N1 N538-85 060385 070885 838 036 043 7~

PARA-8H2 H538-85 071585 082685 913 093 101 10e PARA-8N2 N538-85 071585 082685 848 077 091 10e PARA8H2B H588-85 082785 101485 897 061 068 10E PARA8N2B N588-85 082785 101485 839 060 071 10E PARA8H2C H598-85 101585 120385 927 057 062 104 PARA8N2C N598-85 101585 120385 863 048 056 104 PARA8H2D H5118-86 120485 020586 893 038 042 10E PARA8N2D N5118-86 120485 020586 845 046 054 10E PARA8H1D H5118-86 012186 012986 931 342 368 E PARA8N1D N5118-86 012186 012986 872 424 486 E TRICOH2A H1121-86 020686 040386 889 097 109 13E TRICON2A N1121-86 020686 040386 886 104 118 13E TRICOH2B H1122-86 040786 070186 894 131 147 168 TRICON2B N1122-86 040786 070186 837 123 147 16E TRICOH2C H1123-86 070786 090486 862 050 058 10e TRICON2C N1123-86 070786 090486 832 042 051 10E HIGH880A H1123-86 090886 092586 904 051 056 36 NORM880A N1123-86 090886 092586 868 035 041 36

Table 4 Summary of Quality Control Data Mean Corpuscular Hemoglobin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (pg) Deviation Variation Observa Ions

PARA-8H1 H538-85 060385 070885 343 028 081 72 PARA-8N1 N538-85 060385 070885 316 035 110 72 PARA-8H2 H538-85 071585 082685 329 045 136 100 PARA-8N2 N538-85 071585 082685 306 048 155 100 PARA8H2B H588-85 082785 101485 320 060 187 108 PARA8N2B N588-85 082785 101485 295 056 190 108 PARA8H2C H598-85 101585 120385 320 049 154 104 PARA8N2C N598-85 101585 120385 292 047 160 104 PARA8H2D H5118-86 120485 020586 316 047 148 108 PARA8N2D N5118-86 120485 020586 292 056 193 108 PARA8H1D H5118-86 012186 012986 317 061 191 16 PARA8N1D N5118-86 012186 012986 296 058 196 16 TRICOH2A H1121-86 020686 040386 305 045 148 132 TRICON2A N1121-86 020686 040386 295 041 138 132 TRICOH2B H1122-86 040786 070186 317 029 092 168 TRICON2B N1122-86 040786 070186 301 035 118 168 TRICOH2C H1123-86 070786 090486 318 061 193 108 TRICON2C N1123-86 070786 090486 306 064 209 108 HIGH880A H1123-86 090886 092586 322 049 152 36 NORM880A N1123-86 090886 092586 316 046 147 36

236

Table 5

Control

Summary of Quality Control Data Mean Corpuscular Hemoglobin Concen t atlon

Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation 01 ervations

72 PARA-8H1 H538-85 060385 070885 382 037 096 PARA-8N1 N538-85 060385 070885 377 043 113 72 PARA-8H2 H538-85 071585 082685 360 060 168 100 PARA-8N2 N538-85 071585 082685 360 069 190 100 PARA8H2B H588-85 082785 101485 357 063 176 108 PARA8N2B N588-85 082785 101485 352 062 175 108 PARA8H2C H598-85 101585 120385 346 056 161 104 PARA8N2C N598-85 101585 120385 339 057 167 104 PARA8H2D H5118-86 120485 020586 354 054 151 108 PARA8N2D N5118-86 120485 020586 345 069 201 108 PARASH1D H5118-86 012186 012986 342 176 514 8 PARA8N1D N5118-86 012186 012986 342 106 309 8 TRICOH2A H1121-86 020686 040386 343 067 197 132 TRICON2A N1121-86 020686 040386 333 058 175 132 TRICOH2B H1122-86 040786 070186 355 052 146 168 TRICON2B N1122-86 040786 070186 360 052 144 168 TRICOH2C H1123-86 070786 090486 369 072 194 108 TRICON2C N1123-86 070786 090486 367 074 202 108 HIGH880A H1123-86 090886 092586 356 058 162 36 NORM880A N1123-86 090886 092586 364 056 153 36

Table 6 Summary of Quality Control Data Platelet Count

Control Name

Lot No

Begin Date

End Date

Mean (kmm3)

Standard Deviation

Coefficient of Variation

No CIiservations

PARA-8H1 PARA-8N1 PARA-8H2 PARA-8N2 PARA8H2B PARA8N2B PARA8H2C PARA8N2C PARA8H2D PARA8N2D PARA8H1D PARA8N1D TRICOH2A TRICON2A TRICOH2B TRICON2B TRICOH2C TRICON2C HIGH880A NORM880A

H538-85 N538-85 H538-85 N538-85 H588-85 N588-85 H598-85 N598-85

H5118-86 N5118-86 H5118-86 N5118-86 H1121-86 N1121-86 H1122-86 N1122-86 H1123-86 N1123-86 H1123-86 N1123-86

060385 060385 071585 071585 082785 082785 101585 101585 120485 120485 012186 012186 020686 020686 040786 040786 070786 070786 090886 090886

070885 070885 082685 082685 101485 101485 120385 120385 020586 020586 012986 012986 040386 040386 070186 070186 090486 090486 092586 092586

6592 2590 6362 2477 5985 2309 6381 2423 6194 2481 6567 2572 5909 2935 5857 2460 5109 2740 5129 2679

1198 918

1616 875

1511 706

1290 812

1528 854

2509 1440 1615 809

1723 959

1467 938

1334 761

182 355 254 353 253 306 202 335 247 344 382 560 273 276 294 390 287 342 260 284

72 72

100 100 108108104 104 108 108

16 16

132 132 168 168 108 108 36 36

iIi

r +

237

jTable 7 Summary of Quality Control Data Red Cell Count

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (milmm3) Deviation Variation Observ I Ions

PARA-8H1 H538-85 060385 070885 54 004 079 7 PARA-8N1 N538-85 060385 070885 43 004 097 7 PARA-8H2 H538-85 071585 082685 55 006 100 10( I PARA-8N2 N538-85 071585 082685 44 005 106 10(1 PARA8H2B H588-85 082785 101485 55 006 115 101 PARABN2B N588-85 082785 101485 47 005 112 101 PARABH2C H598-85 101585 120385 58 007 125 10 PARA8N2C N598-85 101585 120385 47 005 109 10 PARABH2D H5118-86 120485 020586 57 007 129 101 PARA8N2D N5118-86 120485 020586 48 011 223 101 PARA8H1D H5118-86 012186 012986 58 010 178 H PARA8N1D N5118-86 012186 012986 48 010 214 H TRICOH2A H1121-86 020686 040386 59 005 087 131 TRICON2A N1121-86 020686 040386 44 004 099 131 TRICOH2B H1122-86 040786 070186 52 008 143 161 TRICON2B N1122-86 040786 070186 40 006 138 161 TRICOH2C H1123-86 070786 090486 51 009 180 101 TRICON2C N1123-86 070786 090486 42 007 178 101 HIGH880A H1123-86 090886 092586 51 005 104 3 NORM880A N1123-86 090886 092586 41 004 093 3

Table B Summary of Quality Control Data White Cell Count

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (kmm3) Deviation Variation Observ I ions

PARA-8H1 H538-85 060385 070885 306 041 135 7 PARA-8N1 N538-85 060385 070885 77 016 212 7 PARA-8H2 H538-85 071585 082685 305 059 195 10( PARA-8N2 N538-85 071585 082685 77 017 222 10( PARA8H2B H588-85 082785 101485 276 061 223 101 PARA8N2B N588-85 082785 101485 78 022 287 101 PARA8H2C H598-85 101585 120385 288 049 170 10 PARA8N2C N598-85 101585 120385 77 019 254 10 PARA8H2D H5118-86 120485 020586 290 060 209 101 PARA8N2D N5118-86 120485 020586 84 026 308 101 PARA8H1D H5118-86 012186 012986 293 051 173 H PARA8N1D N5118-86 012186 012986 84 020 237 H TRICOH2A H1121-86 020686 040386 313 078 248 13 TRICON2A N1121-86 020686 040386 90 023 261 131 TRICOH2B H1122-86 040786 070186 286 053 185 161 TRICON2B N1122-86 040786 070186 90 016 173 161 TRICOH2C H1123-86 070786 090486 214 046 216 101 TRICON2C N1123-86 070786 090486 77 021 273 101 HIGH880A H1123-86 090886 092586 197 017 085 3t NORM880A N1123-86 090886 092586 72 011 148 3

238

rwmw

iii

f

Table 9 Summary of Quality Control Data Relative 8asophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation C Iservatlons

188 DIFF--LI SET 1 060385 090385 06 048 DIFF-LII SET 1 060385 090385 00 016 188 DIFF-LIB SET 2 090485 120685 07 055 208 DIFFLlIB SET 2 090485 120685 01 035 208 DIFF-LIC SET 3 120985 OS2986 06 056 360 DIFFLlIC SET 3 120985 OS2986 01 026 360 DIFF-LID SET 4 060286 092586 04 049 200 DIFFLIID SET 4 060286 092586 05 050 200

Table 10 Summary of Quality Control Data Relative Eoslnophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation o t servatlons

188 DIFF--LI SET 1 060385 090385 31 092 DIFF-LII SET 1 060385 090385 05 052 188 DIFF-LIB SET 2 090485 120685 37 145 208 DIFFLlIB SET 2 090485 120685 08 095 208 DIFF-LIC SET 3 120985 OS2986 29 111 360 DIFFLlIC SET 3 120985 OS2986 08 062 360 DIFF-LID SET 4 060286 092586 84 101 200 DIFFLIID SET 4 060286 092586 09 055 200

Table 11 Summary of Quality Control Data Relative Atypical Lymphocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation Ot i ervatlons

DIFF--LI SET 1 060385 090385 20 155 188 DIFF-LII SET 1 060385 090385 34 180 188 DIFF-LIB SET 2 090485 120685 17 099 208 DIFFLlIB SET 2 090485 120685 45 180 208 DIFF-LIC SET 3 120985 OS2986 21 134 360 DIFFLlIC SET 3 120985 OS2986 37 196 360 DIFF-LID SET 4 060286 092586 41 191 200 DIFFLIID SET 4 060286 092586 23 146 200

f

Table 12 Summary of Quality Control Data Relative Monocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation at servatlons DIFF--LI SET 1 060385 090385 68 175 188 DIFF-LII SET 1 060385 090385 80 176 188 DIFF-LIB SET 2 090485 120685 79 127 208 DIFFLlIB SET 2 090485 120685 75 142 208 DIFF-LIC SET 3 120985 OS2986 68 104 360 DIFFLlIC SET 3 120985 OS2986 80 121 360 DIFF-LID SET 4 060286 092586 47 115 200 DIFFLIID SET 4 060286 092586 118 122 200

239

1

I

~

J

Table 13 Summary of Quality Control Data Relative Band Neutrophlls

Control Lot Begin End Mean Standard No Name No

~--- -- ---~-

DIFF--U SET 1 ~

Date Date

090385

() Deviation Observa ons

060385 34 152 188 DIFF-Lil SET 1 060385 090385 16 080 188 DIFF-LiB SET 2 090485 120685 36 115 208 DIFFLlIB SET 2 090485 120685 14 090 208 DIFF-LiC SET 3 120985 OS2986 30 096 360 DIFFLlIC SET 3 120985 OS2986 16 079 360 DIFF-LiD SET 4 060286 092586 22 083 200 DIFFLIID SET 4 060286 092586 09 063 200

Table 14

Control

Summary of Quality Control Data Relative Segmented Neutrophlls

Lot Begin End Mean Standard No Name

DIFF--U

No

SET 1

Date

060385

Date

090385

()

589

Deviation

505

Observat I inS

188 DIFF-Lil SET 1 060385 090385 579 400 188 DIFF-LiB SET 2 090485 120685 575 272 208 DIFFLlIB SET 2 090485 120685 576 329 208 DIFF-LiC SET 3 120985 OS2986 585 185 360 DIFFLlIC SET 3 120985 OS2986 567 207 360 DIFF-LiD SET 4 060286 092586 420 190 200 DIFFLIID SET 4 060286 092586 567 170 200

Table 15

Control

Summary of Quality Control Data Relative Lymphocytes

Lot Begin End Mean Standard No Name No Date Date ()

252

Deviation

398

Observa Ions

188 DIFF--LI SET 1 060385 090385 DIFF-Lil SET 1 060385 090385 284 304 188 DIFF-LiB SET 2 090485 120685 246 256 208 DIFFLlIB SET 2 090485 120685 281 204 208 DIFF-LiC SET 3 120985 OS2986 257 189 360 DIFFLlIC SET 3 120985 OS2986 291 197 360 DIFF-LiD SET 4 060286 092586 382 182 200 DIFFLIID SET 4 060286 092586 268 143 200

240

Table 16 Summary of Quality Control Data Relative B-Lymphocytes _shy

Control Begin End Mean Standard No Name Date Date () Deviation o J servations

59 HUMAN-01 060385 090186 93 165 HUMAN-02 060385 092586 106 178 118 HUMAN-03 060385 091186 173 245 94 HUMAN-04 060485 090486 59 127 98 HUMAN-05 060485 081986 86 160 114 HUMAN-06 060485 041086 99 166 27 HUMAN-07 060585 070786 98 272 66 HUMAN-08 060685 092386 86 182 64 HUMAN-09 061385 080486 116 179 72 HUMAN-10 061885 090986 96 126 55 HUMAN-11 090385 051286 101 197 46 HUMAN-12 090485 092386 89 177 58 HUMAN-13 090585 090585 117 007 2 HUMAN-14 091085 091885 53 278 6 HUMAN-15 091285 071786 111 158 88 HUMAN-16 071086 091686 70 133 14 HUMAN-17 072986 092586 107 074 10 HUMAN-18 090986 092286 78 283 4 HUMAN-19 091686 092286 127 155 4

Table 17 Summary of Quality Control Data Relative T-Lymphocytes

Control Name

Begin Date

End Date

Mean ()

Standard Deviation

No o J servations

HUMAN-01 HUMAN-02 HUMAN-03 HUMAN-04 HUMAN-05 HUMAN-06 HUMAN-07 HUMAN-08 HUMAN-09 HUMAN-10 HUMAN-11 HUMAN-12 HUMAN-13 HUMAN-14 HUMAN-15 HUMAN-16 HUMAN-17 HUMAN-18 HUMAN-19

060385 060385 060385 060485 060485 060485 060585 060685 061385 061885 090385 090485 090585 091085 091285 071086 072986 090986 091686

090186 092586 091186 090486 081986 041086 070786 092386 080486 090986 051286 092386 090585 091885 071786 091686 092586 092286 092286

573 711 663 712 776 716 745 791 685 752 789 773 752 773 769 737 707 735 744

636 455 312 419 486 290 605 269 408 524 346 373 099 483 510 290 546 455 462

59 118

94 98

114 26 66 64 72 55 46 58

2 6

88 14 10 4 4

I r

l 241

Table 18 Summary of Quality Control Data Relative T4-Lymphocytes ----- Control Begin End Mean Standard No Name Date Date

bull-__-______ () Deviation Observatill 1S

HUMAN-01 060385 090186 386 511 59 HUMAN-02 060385 092586 534 375 118 HUMAN-03 060385 091186 437 376 94 HUMAN-04 060485 090486 482 358 98 HUMAN-05 060485 081986 531 401 114 HUMAN-06 060485 041086 440 334 27 HUMAN-07 060585 070786 419 629 66 HUMAN-08 060685 092386 503 454 64 HUMAN-09 061385 080486 456 353 72 HUMAN-10 061885 090986 511 421 55 HUMAN-11 090385 051286 582 340 46 HUMAN-12 090485 092386 443 356 58 HUMAN-13 090585 090585 590 269 2 HUMAN-14 091085 091885 551 200 6 HUMAN-15 091285 071786 525 406 88 HUMAN-16 071086 091686 347 290 14 HUMAN-17 072986 092586 537 295 10 HUMAN-18 090986 092286 527 300 4 HUMAN-19 091686 092286 547 738 4

Table 19 Summary of Quality Control Data Relative T8-Lymphocytes

Control Begin End Mean Standard No Name Date Date () Deviation Observatlc 115

HUMAN-01 060385 090186 310 273 59 HUMAN-02 060385 092586 291 204 118 HUMAN-03 060385 091186 218 188 94 HUMAN-04 060485 090486 314 211 98 HUMAN-05 060485 081986 288 189 114 HUMAN-06 060485 041086 321 145 27 HUMAN-07 060585 070786 387 473 66 HUMAN-08 060685 092386 349 429 64 HUMAN-09 061385 080486 256 166 71 HUMAN-10 061885 090986 234 193 55 HUMAN-11 090385 051286 220 156 46 HUMAN-12 090485 092386 293 341 58 HUMAN-13 090585 090585 178 064 2 HUMAN-14 091085 091885 208 136 6 HUMAN-15 091285 071786 258 248 88 HUMAN-16 071086 091686 442 113 14 HUMAN-17 072986 092586 216 371 10 HUMAN-18 090986 092286 244 104 4 HUMAN-19 091686 092286 254 236 4

242

Table 20 Summary of Quality Control Data T4(Ta Ratio -~- ---------~-------- ---~--~----~--~-laquo-------~~ bullbull

Control Begin End Mean Standard No Name Date Date (Ratio) Deviation ( I )servations

HUMAN-01 060385 090186 13 022 59 HUMAN-02 060385 092586 18 020 118 HUMAN-03 060385 091186 20 024 94 HUMAN-04 060485 090486 15 016 98 HUMAN-05 060485 081986 19 017 114 HUMAN-06 060485 041086 14 012 27 HUMAN-07 060585 070786 11 027 66 HUMAN-08 060685 092386 15 028 64 HUMAN-09 061385 080486 18 014 71 HUMAN-10 061885 090986 22 028 55 HUMAN-11 090385 051286 27 023 46 HUMAN-12 090485 092386 15 022 58 HUMAN-13 090585 090585 33 002 2 HUMAN-14 091085 091885 27 017 6 HUMAN-15 091285 071786 21 022 88 HUMAN-16 071086 091686 08 008 14 HUMAN-17 072986 092586 25 036 10 HUMAN-18 090986 092286 22 008 4 HUMAN-19 091686 092286 21 015 4

It

243

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

I lr I

l

t I 1

Table 1 Summary of Quality Control Data Hematocrit

Control Name

Lot No

Begin Date

End Date

Mean ()

Standard Deviation

Coefficient of Variation

No (I )servations

72 72

100 100 108 108 104 104 108 108

8 8

136 136 168 168 108 108 36 36

PARA-8H1 PARA-8N1 PARA-8H2 PARA-8N2 PARA8H2B PARA8N2B PARA8H2C PARA8N2C PARA8H2D PARA8N2D PARA8H1D PARA8N1D TRICOH2A TRICON2A TRICOH2B TRICON2B TRiCOH2C TRICON2C HIGH880A NORM880A

H538-85 N538-85 H538-85 N538-85 H588-85 N588-85 H598-85 N598-85 H5118-86 N5118-86 H5118-86 N5118-86 H1121-86 N1121-86 H1122-86 N1122-86 H1123-86 N1123-86 H1123-86 N1123-86

060385 060385 071585 071585 082785 082785 101585 101585 120485 120485 012186 012186 020686 020686 040786 040786 070786 070786 090886 090886

070885 070885 082685 082685 101485 101485 120385 120385 020586 020586 012986 012986 040386 040386 070186 070186 090486 090486 092586 092586

489 361 505 371 497 394 535 404 508 408 536 415 527 394 469 337 442 348 462 359

042 039 082 059 071 057 073 049 066 051 294 148 071 053 073 051 084 062 059 038

086 107 162 160 143 144 136 121 129 125 549 357 136 135 156 151 190 177 128 105

Table 2 Summary of Quality Control Data Hemoglobin

Control Name

Lot No

Begin Date

End Date

Mean (gdl)

Standard Deviation

Coefficient of Variation

No () bservations

PARA-8H1 PARA-8N1 PARA-8H2 PARA-8N2 PARA8H2B PARA8N2B PARA8H2C PARA8N2C PARA8H2D PARA8N2D PARA8H1D PARA8N1D TRICOH2A TRICON2A TRICOH2B TRICON2B TRICOH2C TRiCON2C HIGH880A NORM880A

H538-85 N538-85 H538-85 N538-85 H588-85 N588-85 H598-85 N598-85 H5118-86 N5118-86 H5118-86 N5118-86 H1121-86 N1121-86 H1122-86 N1122-86 H1123-86 N1123-86 H1123-86 N1123-86

060385 060385 071585 071585 082785 082785 101585 101585 120485 120485 012186 012186 020686 020686 040786 040786 070786 070786 090886 090886

070885 070885 082685 082685 101485 101485 120385 120385 020586 020586 012986 012986 040386 040386 070186 070186 090486 090486 092586 092586

187 136 182 134 177 139 185 137 180 141 182 142 181 131 167 121 163 128 164 130

015 012 021 014 030 023 022 016 020 020 025 013 024 016 024 017 019 021 015 011

081 090 113 108 167 168 117 119 110 140 139 095 133 121 143 137 115 163 092 086

72 72

100 100 108 108 104104 108 108

16 16

132 132 168 168 108 108 36 36

235

Table 3 Summary of Quality Control Data Mean Corpuscular Cell Volume

No Control Lot Begin End Mean Standard Coefficient of Name --_ _-shy

No Date Date (fl) Deviation Variation Observa tons

PARA-8H1 H538-85 060385 070885 898 037 042 7~

PARA-8N1 N538-85 060385 070885 838 036 043 7~

PARA-8H2 H538-85 071585 082685 913 093 101 10e PARA-8N2 N538-85 071585 082685 848 077 091 10e PARA8H2B H588-85 082785 101485 897 061 068 10E PARA8N2B N588-85 082785 101485 839 060 071 10E PARA8H2C H598-85 101585 120385 927 057 062 104 PARA8N2C N598-85 101585 120385 863 048 056 104 PARA8H2D H5118-86 120485 020586 893 038 042 10E PARA8N2D N5118-86 120485 020586 845 046 054 10E PARA8H1D H5118-86 012186 012986 931 342 368 E PARA8N1D N5118-86 012186 012986 872 424 486 E TRICOH2A H1121-86 020686 040386 889 097 109 13E TRICON2A N1121-86 020686 040386 886 104 118 13E TRICOH2B H1122-86 040786 070186 894 131 147 168 TRICON2B N1122-86 040786 070186 837 123 147 16E TRICOH2C H1123-86 070786 090486 862 050 058 10e TRICON2C N1123-86 070786 090486 832 042 051 10E HIGH880A H1123-86 090886 092586 904 051 056 36 NORM880A N1123-86 090886 092586 868 035 041 36

Table 4 Summary of Quality Control Data Mean Corpuscular Hemoglobin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (pg) Deviation Variation Observa Ions

PARA-8H1 H538-85 060385 070885 343 028 081 72 PARA-8N1 N538-85 060385 070885 316 035 110 72 PARA-8H2 H538-85 071585 082685 329 045 136 100 PARA-8N2 N538-85 071585 082685 306 048 155 100 PARA8H2B H588-85 082785 101485 320 060 187 108 PARA8N2B N588-85 082785 101485 295 056 190 108 PARA8H2C H598-85 101585 120385 320 049 154 104 PARA8N2C N598-85 101585 120385 292 047 160 104 PARA8H2D H5118-86 120485 020586 316 047 148 108 PARA8N2D N5118-86 120485 020586 292 056 193 108 PARA8H1D H5118-86 012186 012986 317 061 191 16 PARA8N1D N5118-86 012186 012986 296 058 196 16 TRICOH2A H1121-86 020686 040386 305 045 148 132 TRICON2A N1121-86 020686 040386 295 041 138 132 TRICOH2B H1122-86 040786 070186 317 029 092 168 TRICON2B N1122-86 040786 070186 301 035 118 168 TRICOH2C H1123-86 070786 090486 318 061 193 108 TRICON2C N1123-86 070786 090486 306 064 209 108 HIGH880A H1123-86 090886 092586 322 049 152 36 NORM880A N1123-86 090886 092586 316 046 147 36

236

Table 5

Control

Summary of Quality Control Data Mean Corpuscular Hemoglobin Concen t atlon

Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation 01 ervations

72 PARA-8H1 H538-85 060385 070885 382 037 096 PARA-8N1 N538-85 060385 070885 377 043 113 72 PARA-8H2 H538-85 071585 082685 360 060 168 100 PARA-8N2 N538-85 071585 082685 360 069 190 100 PARA8H2B H588-85 082785 101485 357 063 176 108 PARA8N2B N588-85 082785 101485 352 062 175 108 PARA8H2C H598-85 101585 120385 346 056 161 104 PARA8N2C N598-85 101585 120385 339 057 167 104 PARA8H2D H5118-86 120485 020586 354 054 151 108 PARA8N2D N5118-86 120485 020586 345 069 201 108 PARASH1D H5118-86 012186 012986 342 176 514 8 PARA8N1D N5118-86 012186 012986 342 106 309 8 TRICOH2A H1121-86 020686 040386 343 067 197 132 TRICON2A N1121-86 020686 040386 333 058 175 132 TRICOH2B H1122-86 040786 070186 355 052 146 168 TRICON2B N1122-86 040786 070186 360 052 144 168 TRICOH2C H1123-86 070786 090486 369 072 194 108 TRICON2C N1123-86 070786 090486 367 074 202 108 HIGH880A H1123-86 090886 092586 356 058 162 36 NORM880A N1123-86 090886 092586 364 056 153 36

Table 6 Summary of Quality Control Data Platelet Count

Control Name

Lot No

Begin Date

End Date

Mean (kmm3)

Standard Deviation

Coefficient of Variation

No CIiservations

PARA-8H1 PARA-8N1 PARA-8H2 PARA-8N2 PARA8H2B PARA8N2B PARA8H2C PARA8N2C PARA8H2D PARA8N2D PARA8H1D PARA8N1D TRICOH2A TRICON2A TRICOH2B TRICON2B TRICOH2C TRICON2C HIGH880A NORM880A

H538-85 N538-85 H538-85 N538-85 H588-85 N588-85 H598-85 N598-85

H5118-86 N5118-86 H5118-86 N5118-86 H1121-86 N1121-86 H1122-86 N1122-86 H1123-86 N1123-86 H1123-86 N1123-86

060385 060385 071585 071585 082785 082785 101585 101585 120485 120485 012186 012186 020686 020686 040786 040786 070786 070786 090886 090886

070885 070885 082685 082685 101485 101485 120385 120385 020586 020586 012986 012986 040386 040386 070186 070186 090486 090486 092586 092586

6592 2590 6362 2477 5985 2309 6381 2423 6194 2481 6567 2572 5909 2935 5857 2460 5109 2740 5129 2679

1198 918

1616 875

1511 706

1290 812

1528 854

2509 1440 1615 809

1723 959

1467 938

1334 761

182 355 254 353 253 306 202 335 247 344 382 560 273 276 294 390 287 342 260 284

72 72

100 100 108108104 104 108 108

16 16

132 132 168 168 108 108 36 36

iIi

r +

237

jTable 7 Summary of Quality Control Data Red Cell Count

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (milmm3) Deviation Variation Observ I Ions

PARA-8H1 H538-85 060385 070885 54 004 079 7 PARA-8N1 N538-85 060385 070885 43 004 097 7 PARA-8H2 H538-85 071585 082685 55 006 100 10( I PARA-8N2 N538-85 071585 082685 44 005 106 10(1 PARA8H2B H588-85 082785 101485 55 006 115 101 PARABN2B N588-85 082785 101485 47 005 112 101 PARABH2C H598-85 101585 120385 58 007 125 10 PARA8N2C N598-85 101585 120385 47 005 109 10 PARABH2D H5118-86 120485 020586 57 007 129 101 PARA8N2D N5118-86 120485 020586 48 011 223 101 PARA8H1D H5118-86 012186 012986 58 010 178 H PARA8N1D N5118-86 012186 012986 48 010 214 H TRICOH2A H1121-86 020686 040386 59 005 087 131 TRICON2A N1121-86 020686 040386 44 004 099 131 TRICOH2B H1122-86 040786 070186 52 008 143 161 TRICON2B N1122-86 040786 070186 40 006 138 161 TRICOH2C H1123-86 070786 090486 51 009 180 101 TRICON2C N1123-86 070786 090486 42 007 178 101 HIGH880A H1123-86 090886 092586 51 005 104 3 NORM880A N1123-86 090886 092586 41 004 093 3

Table B Summary of Quality Control Data White Cell Count

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (kmm3) Deviation Variation Observ I ions

PARA-8H1 H538-85 060385 070885 306 041 135 7 PARA-8N1 N538-85 060385 070885 77 016 212 7 PARA-8H2 H538-85 071585 082685 305 059 195 10( PARA-8N2 N538-85 071585 082685 77 017 222 10( PARA8H2B H588-85 082785 101485 276 061 223 101 PARA8N2B N588-85 082785 101485 78 022 287 101 PARA8H2C H598-85 101585 120385 288 049 170 10 PARA8N2C N598-85 101585 120385 77 019 254 10 PARA8H2D H5118-86 120485 020586 290 060 209 101 PARA8N2D N5118-86 120485 020586 84 026 308 101 PARA8H1D H5118-86 012186 012986 293 051 173 H PARA8N1D N5118-86 012186 012986 84 020 237 H TRICOH2A H1121-86 020686 040386 313 078 248 13 TRICON2A N1121-86 020686 040386 90 023 261 131 TRICOH2B H1122-86 040786 070186 286 053 185 161 TRICON2B N1122-86 040786 070186 90 016 173 161 TRICOH2C H1123-86 070786 090486 214 046 216 101 TRICON2C N1123-86 070786 090486 77 021 273 101 HIGH880A H1123-86 090886 092586 197 017 085 3t NORM880A N1123-86 090886 092586 72 011 148 3

238

rwmw

iii

f

Table 9 Summary of Quality Control Data Relative 8asophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation C Iservatlons

188 DIFF--LI SET 1 060385 090385 06 048 DIFF-LII SET 1 060385 090385 00 016 188 DIFF-LIB SET 2 090485 120685 07 055 208 DIFFLlIB SET 2 090485 120685 01 035 208 DIFF-LIC SET 3 120985 OS2986 06 056 360 DIFFLlIC SET 3 120985 OS2986 01 026 360 DIFF-LID SET 4 060286 092586 04 049 200 DIFFLIID SET 4 060286 092586 05 050 200

Table 10 Summary of Quality Control Data Relative Eoslnophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation o t servatlons

188 DIFF--LI SET 1 060385 090385 31 092 DIFF-LII SET 1 060385 090385 05 052 188 DIFF-LIB SET 2 090485 120685 37 145 208 DIFFLlIB SET 2 090485 120685 08 095 208 DIFF-LIC SET 3 120985 OS2986 29 111 360 DIFFLlIC SET 3 120985 OS2986 08 062 360 DIFF-LID SET 4 060286 092586 84 101 200 DIFFLIID SET 4 060286 092586 09 055 200

Table 11 Summary of Quality Control Data Relative Atypical Lymphocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation Ot i ervatlons

DIFF--LI SET 1 060385 090385 20 155 188 DIFF-LII SET 1 060385 090385 34 180 188 DIFF-LIB SET 2 090485 120685 17 099 208 DIFFLlIB SET 2 090485 120685 45 180 208 DIFF-LIC SET 3 120985 OS2986 21 134 360 DIFFLlIC SET 3 120985 OS2986 37 196 360 DIFF-LID SET 4 060286 092586 41 191 200 DIFFLIID SET 4 060286 092586 23 146 200

f

Table 12 Summary of Quality Control Data Relative Monocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation at servatlons DIFF--LI SET 1 060385 090385 68 175 188 DIFF-LII SET 1 060385 090385 80 176 188 DIFF-LIB SET 2 090485 120685 79 127 208 DIFFLlIB SET 2 090485 120685 75 142 208 DIFF-LIC SET 3 120985 OS2986 68 104 360 DIFFLlIC SET 3 120985 OS2986 80 121 360 DIFF-LID SET 4 060286 092586 47 115 200 DIFFLIID SET 4 060286 092586 118 122 200

239

1

I

~

J

Table 13 Summary of Quality Control Data Relative Band Neutrophlls

Control Lot Begin End Mean Standard No Name No

~--- -- ---~-

DIFF--U SET 1 ~

Date Date

090385

() Deviation Observa ons

060385 34 152 188 DIFF-Lil SET 1 060385 090385 16 080 188 DIFF-LiB SET 2 090485 120685 36 115 208 DIFFLlIB SET 2 090485 120685 14 090 208 DIFF-LiC SET 3 120985 OS2986 30 096 360 DIFFLlIC SET 3 120985 OS2986 16 079 360 DIFF-LiD SET 4 060286 092586 22 083 200 DIFFLIID SET 4 060286 092586 09 063 200

Table 14

Control

Summary of Quality Control Data Relative Segmented Neutrophlls

Lot Begin End Mean Standard No Name

DIFF--U

No

SET 1

Date

060385

Date

090385

()

589

Deviation

505

Observat I inS

188 DIFF-Lil SET 1 060385 090385 579 400 188 DIFF-LiB SET 2 090485 120685 575 272 208 DIFFLlIB SET 2 090485 120685 576 329 208 DIFF-LiC SET 3 120985 OS2986 585 185 360 DIFFLlIC SET 3 120985 OS2986 567 207 360 DIFF-LiD SET 4 060286 092586 420 190 200 DIFFLIID SET 4 060286 092586 567 170 200

Table 15

Control

Summary of Quality Control Data Relative Lymphocytes

Lot Begin End Mean Standard No Name No Date Date ()

252

Deviation

398

Observa Ions

188 DIFF--LI SET 1 060385 090385 DIFF-Lil SET 1 060385 090385 284 304 188 DIFF-LiB SET 2 090485 120685 246 256 208 DIFFLlIB SET 2 090485 120685 281 204 208 DIFF-LiC SET 3 120985 OS2986 257 189 360 DIFFLlIC SET 3 120985 OS2986 291 197 360 DIFF-LiD SET 4 060286 092586 382 182 200 DIFFLIID SET 4 060286 092586 268 143 200

240

Table 16 Summary of Quality Control Data Relative B-Lymphocytes _shy

Control Begin End Mean Standard No Name Date Date () Deviation o J servations

59 HUMAN-01 060385 090186 93 165 HUMAN-02 060385 092586 106 178 118 HUMAN-03 060385 091186 173 245 94 HUMAN-04 060485 090486 59 127 98 HUMAN-05 060485 081986 86 160 114 HUMAN-06 060485 041086 99 166 27 HUMAN-07 060585 070786 98 272 66 HUMAN-08 060685 092386 86 182 64 HUMAN-09 061385 080486 116 179 72 HUMAN-10 061885 090986 96 126 55 HUMAN-11 090385 051286 101 197 46 HUMAN-12 090485 092386 89 177 58 HUMAN-13 090585 090585 117 007 2 HUMAN-14 091085 091885 53 278 6 HUMAN-15 091285 071786 111 158 88 HUMAN-16 071086 091686 70 133 14 HUMAN-17 072986 092586 107 074 10 HUMAN-18 090986 092286 78 283 4 HUMAN-19 091686 092286 127 155 4

Table 17 Summary of Quality Control Data Relative T-Lymphocytes

Control Name

Begin Date

End Date

Mean ()

Standard Deviation

No o J servations

HUMAN-01 HUMAN-02 HUMAN-03 HUMAN-04 HUMAN-05 HUMAN-06 HUMAN-07 HUMAN-08 HUMAN-09 HUMAN-10 HUMAN-11 HUMAN-12 HUMAN-13 HUMAN-14 HUMAN-15 HUMAN-16 HUMAN-17 HUMAN-18 HUMAN-19

060385 060385 060385 060485 060485 060485 060585 060685 061385 061885 090385 090485 090585 091085 091285 071086 072986 090986 091686

090186 092586 091186 090486 081986 041086 070786 092386 080486 090986 051286 092386 090585 091885 071786 091686 092586 092286 092286

573 711 663 712 776 716 745 791 685 752 789 773 752 773 769 737 707 735 744

636 455 312 419 486 290 605 269 408 524 346 373 099 483 510 290 546 455 462

59 118

94 98

114 26 66 64 72 55 46 58

2 6

88 14 10 4 4

I r

l 241

Table 18 Summary of Quality Control Data Relative T4-Lymphocytes ----- Control Begin End Mean Standard No Name Date Date

bull-__-______ () Deviation Observatill 1S

HUMAN-01 060385 090186 386 511 59 HUMAN-02 060385 092586 534 375 118 HUMAN-03 060385 091186 437 376 94 HUMAN-04 060485 090486 482 358 98 HUMAN-05 060485 081986 531 401 114 HUMAN-06 060485 041086 440 334 27 HUMAN-07 060585 070786 419 629 66 HUMAN-08 060685 092386 503 454 64 HUMAN-09 061385 080486 456 353 72 HUMAN-10 061885 090986 511 421 55 HUMAN-11 090385 051286 582 340 46 HUMAN-12 090485 092386 443 356 58 HUMAN-13 090585 090585 590 269 2 HUMAN-14 091085 091885 551 200 6 HUMAN-15 091285 071786 525 406 88 HUMAN-16 071086 091686 347 290 14 HUMAN-17 072986 092586 537 295 10 HUMAN-18 090986 092286 527 300 4 HUMAN-19 091686 092286 547 738 4

Table 19 Summary of Quality Control Data Relative T8-Lymphocytes

Control Begin End Mean Standard No Name Date Date () Deviation Observatlc 115

HUMAN-01 060385 090186 310 273 59 HUMAN-02 060385 092586 291 204 118 HUMAN-03 060385 091186 218 188 94 HUMAN-04 060485 090486 314 211 98 HUMAN-05 060485 081986 288 189 114 HUMAN-06 060485 041086 321 145 27 HUMAN-07 060585 070786 387 473 66 HUMAN-08 060685 092386 349 429 64 HUMAN-09 061385 080486 256 166 71 HUMAN-10 061885 090986 234 193 55 HUMAN-11 090385 051286 220 156 46 HUMAN-12 090485 092386 293 341 58 HUMAN-13 090585 090585 178 064 2 HUMAN-14 091085 091885 208 136 6 HUMAN-15 091285 071786 258 248 88 HUMAN-16 071086 091686 442 113 14 HUMAN-17 072986 092586 216 371 10 HUMAN-18 090986 092286 244 104 4 HUMAN-19 091686 092286 254 236 4

242

Table 20 Summary of Quality Control Data T4(Ta Ratio -~- ---------~-------- ---~--~----~--~-laquo-------~~ bullbull

Control Begin End Mean Standard No Name Date Date (Ratio) Deviation ( I )servations

HUMAN-01 060385 090186 13 022 59 HUMAN-02 060385 092586 18 020 118 HUMAN-03 060385 091186 20 024 94 HUMAN-04 060485 090486 15 016 98 HUMAN-05 060485 081986 19 017 114 HUMAN-06 060485 041086 14 012 27 HUMAN-07 060585 070786 11 027 66 HUMAN-08 060685 092386 15 028 64 HUMAN-09 061385 080486 18 014 71 HUMAN-10 061885 090986 22 028 55 HUMAN-11 090385 051286 27 023 46 HUMAN-12 090485 092386 15 022 58 HUMAN-13 090585 090585 33 002 2 HUMAN-14 091085 091885 27 017 6 HUMAN-15 091285 071786 21 022 88 HUMAN-16 071086 091686 08 008 14 HUMAN-17 072986 092586 25 036 10 HUMAN-18 090986 092286 22 008 4 HUMAN-19 091686 092286 21 015 4

It

243

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 3 Summary of Quality Control Data Mean Corpuscular Cell Volume

No Control Lot Begin End Mean Standard Coefficient of Name --_ _-shy

No Date Date (fl) Deviation Variation Observa tons

PARA-8H1 H538-85 060385 070885 898 037 042 7~

PARA-8N1 N538-85 060385 070885 838 036 043 7~

PARA-8H2 H538-85 071585 082685 913 093 101 10e PARA-8N2 N538-85 071585 082685 848 077 091 10e PARA8H2B H588-85 082785 101485 897 061 068 10E PARA8N2B N588-85 082785 101485 839 060 071 10E PARA8H2C H598-85 101585 120385 927 057 062 104 PARA8N2C N598-85 101585 120385 863 048 056 104 PARA8H2D H5118-86 120485 020586 893 038 042 10E PARA8N2D N5118-86 120485 020586 845 046 054 10E PARA8H1D H5118-86 012186 012986 931 342 368 E PARA8N1D N5118-86 012186 012986 872 424 486 E TRICOH2A H1121-86 020686 040386 889 097 109 13E TRICON2A N1121-86 020686 040386 886 104 118 13E TRICOH2B H1122-86 040786 070186 894 131 147 168 TRICON2B N1122-86 040786 070186 837 123 147 16E TRICOH2C H1123-86 070786 090486 862 050 058 10e TRICON2C N1123-86 070786 090486 832 042 051 10E HIGH880A H1123-86 090886 092586 904 051 056 36 NORM880A N1123-86 090886 092586 868 035 041 36

Table 4 Summary of Quality Control Data Mean Corpuscular Hemoglobin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (pg) Deviation Variation Observa Ions

PARA-8H1 H538-85 060385 070885 343 028 081 72 PARA-8N1 N538-85 060385 070885 316 035 110 72 PARA-8H2 H538-85 071585 082685 329 045 136 100 PARA-8N2 N538-85 071585 082685 306 048 155 100 PARA8H2B H588-85 082785 101485 320 060 187 108 PARA8N2B N588-85 082785 101485 295 056 190 108 PARA8H2C H598-85 101585 120385 320 049 154 104 PARA8N2C N598-85 101585 120385 292 047 160 104 PARA8H2D H5118-86 120485 020586 316 047 148 108 PARA8N2D N5118-86 120485 020586 292 056 193 108 PARA8H1D H5118-86 012186 012986 317 061 191 16 PARA8N1D N5118-86 012186 012986 296 058 196 16 TRICOH2A H1121-86 020686 040386 305 045 148 132 TRICON2A N1121-86 020686 040386 295 041 138 132 TRICOH2B H1122-86 040786 070186 317 029 092 168 TRICON2B N1122-86 040786 070186 301 035 118 168 TRICOH2C H1123-86 070786 090486 318 061 193 108 TRICON2C N1123-86 070786 090486 306 064 209 108 HIGH880A H1123-86 090886 092586 322 049 152 36 NORM880A N1123-86 090886 092586 316 046 147 36

236

Table 5

Control

Summary of Quality Control Data Mean Corpuscular Hemoglobin Concen t atlon

Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation 01 ervations

72 PARA-8H1 H538-85 060385 070885 382 037 096 PARA-8N1 N538-85 060385 070885 377 043 113 72 PARA-8H2 H538-85 071585 082685 360 060 168 100 PARA-8N2 N538-85 071585 082685 360 069 190 100 PARA8H2B H588-85 082785 101485 357 063 176 108 PARA8N2B N588-85 082785 101485 352 062 175 108 PARA8H2C H598-85 101585 120385 346 056 161 104 PARA8N2C N598-85 101585 120385 339 057 167 104 PARA8H2D H5118-86 120485 020586 354 054 151 108 PARA8N2D N5118-86 120485 020586 345 069 201 108 PARASH1D H5118-86 012186 012986 342 176 514 8 PARA8N1D N5118-86 012186 012986 342 106 309 8 TRICOH2A H1121-86 020686 040386 343 067 197 132 TRICON2A N1121-86 020686 040386 333 058 175 132 TRICOH2B H1122-86 040786 070186 355 052 146 168 TRICON2B N1122-86 040786 070186 360 052 144 168 TRICOH2C H1123-86 070786 090486 369 072 194 108 TRICON2C N1123-86 070786 090486 367 074 202 108 HIGH880A H1123-86 090886 092586 356 058 162 36 NORM880A N1123-86 090886 092586 364 056 153 36

Table 6 Summary of Quality Control Data Platelet Count

Control Name

Lot No

Begin Date

End Date

Mean (kmm3)

Standard Deviation

Coefficient of Variation

No CIiservations

PARA-8H1 PARA-8N1 PARA-8H2 PARA-8N2 PARA8H2B PARA8N2B PARA8H2C PARA8N2C PARA8H2D PARA8N2D PARA8H1D PARA8N1D TRICOH2A TRICON2A TRICOH2B TRICON2B TRICOH2C TRICON2C HIGH880A NORM880A

H538-85 N538-85 H538-85 N538-85 H588-85 N588-85 H598-85 N598-85

H5118-86 N5118-86 H5118-86 N5118-86 H1121-86 N1121-86 H1122-86 N1122-86 H1123-86 N1123-86 H1123-86 N1123-86

060385 060385 071585 071585 082785 082785 101585 101585 120485 120485 012186 012186 020686 020686 040786 040786 070786 070786 090886 090886

070885 070885 082685 082685 101485 101485 120385 120385 020586 020586 012986 012986 040386 040386 070186 070186 090486 090486 092586 092586

6592 2590 6362 2477 5985 2309 6381 2423 6194 2481 6567 2572 5909 2935 5857 2460 5109 2740 5129 2679

1198 918

1616 875

1511 706

1290 812

1528 854

2509 1440 1615 809

1723 959

1467 938

1334 761

182 355 254 353 253 306 202 335 247 344 382 560 273 276 294 390 287 342 260 284

72 72

100 100 108108104 104 108 108

16 16

132 132 168 168 108 108 36 36

iIi

r +

237

jTable 7 Summary of Quality Control Data Red Cell Count

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (milmm3) Deviation Variation Observ I Ions

PARA-8H1 H538-85 060385 070885 54 004 079 7 PARA-8N1 N538-85 060385 070885 43 004 097 7 PARA-8H2 H538-85 071585 082685 55 006 100 10( I PARA-8N2 N538-85 071585 082685 44 005 106 10(1 PARA8H2B H588-85 082785 101485 55 006 115 101 PARABN2B N588-85 082785 101485 47 005 112 101 PARABH2C H598-85 101585 120385 58 007 125 10 PARA8N2C N598-85 101585 120385 47 005 109 10 PARABH2D H5118-86 120485 020586 57 007 129 101 PARA8N2D N5118-86 120485 020586 48 011 223 101 PARA8H1D H5118-86 012186 012986 58 010 178 H PARA8N1D N5118-86 012186 012986 48 010 214 H TRICOH2A H1121-86 020686 040386 59 005 087 131 TRICON2A N1121-86 020686 040386 44 004 099 131 TRICOH2B H1122-86 040786 070186 52 008 143 161 TRICON2B N1122-86 040786 070186 40 006 138 161 TRICOH2C H1123-86 070786 090486 51 009 180 101 TRICON2C N1123-86 070786 090486 42 007 178 101 HIGH880A H1123-86 090886 092586 51 005 104 3 NORM880A N1123-86 090886 092586 41 004 093 3

Table B Summary of Quality Control Data White Cell Count

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (kmm3) Deviation Variation Observ I ions

PARA-8H1 H538-85 060385 070885 306 041 135 7 PARA-8N1 N538-85 060385 070885 77 016 212 7 PARA-8H2 H538-85 071585 082685 305 059 195 10( PARA-8N2 N538-85 071585 082685 77 017 222 10( PARA8H2B H588-85 082785 101485 276 061 223 101 PARA8N2B N588-85 082785 101485 78 022 287 101 PARA8H2C H598-85 101585 120385 288 049 170 10 PARA8N2C N598-85 101585 120385 77 019 254 10 PARA8H2D H5118-86 120485 020586 290 060 209 101 PARA8N2D N5118-86 120485 020586 84 026 308 101 PARA8H1D H5118-86 012186 012986 293 051 173 H PARA8N1D N5118-86 012186 012986 84 020 237 H TRICOH2A H1121-86 020686 040386 313 078 248 13 TRICON2A N1121-86 020686 040386 90 023 261 131 TRICOH2B H1122-86 040786 070186 286 053 185 161 TRICON2B N1122-86 040786 070186 90 016 173 161 TRICOH2C H1123-86 070786 090486 214 046 216 101 TRICON2C N1123-86 070786 090486 77 021 273 101 HIGH880A H1123-86 090886 092586 197 017 085 3t NORM880A N1123-86 090886 092586 72 011 148 3

238

rwmw

iii

f

Table 9 Summary of Quality Control Data Relative 8asophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation C Iservatlons

188 DIFF--LI SET 1 060385 090385 06 048 DIFF-LII SET 1 060385 090385 00 016 188 DIFF-LIB SET 2 090485 120685 07 055 208 DIFFLlIB SET 2 090485 120685 01 035 208 DIFF-LIC SET 3 120985 OS2986 06 056 360 DIFFLlIC SET 3 120985 OS2986 01 026 360 DIFF-LID SET 4 060286 092586 04 049 200 DIFFLIID SET 4 060286 092586 05 050 200

Table 10 Summary of Quality Control Data Relative Eoslnophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation o t servatlons

188 DIFF--LI SET 1 060385 090385 31 092 DIFF-LII SET 1 060385 090385 05 052 188 DIFF-LIB SET 2 090485 120685 37 145 208 DIFFLlIB SET 2 090485 120685 08 095 208 DIFF-LIC SET 3 120985 OS2986 29 111 360 DIFFLlIC SET 3 120985 OS2986 08 062 360 DIFF-LID SET 4 060286 092586 84 101 200 DIFFLIID SET 4 060286 092586 09 055 200

Table 11 Summary of Quality Control Data Relative Atypical Lymphocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation Ot i ervatlons

DIFF--LI SET 1 060385 090385 20 155 188 DIFF-LII SET 1 060385 090385 34 180 188 DIFF-LIB SET 2 090485 120685 17 099 208 DIFFLlIB SET 2 090485 120685 45 180 208 DIFF-LIC SET 3 120985 OS2986 21 134 360 DIFFLlIC SET 3 120985 OS2986 37 196 360 DIFF-LID SET 4 060286 092586 41 191 200 DIFFLIID SET 4 060286 092586 23 146 200

f

Table 12 Summary of Quality Control Data Relative Monocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation at servatlons DIFF--LI SET 1 060385 090385 68 175 188 DIFF-LII SET 1 060385 090385 80 176 188 DIFF-LIB SET 2 090485 120685 79 127 208 DIFFLlIB SET 2 090485 120685 75 142 208 DIFF-LIC SET 3 120985 OS2986 68 104 360 DIFFLlIC SET 3 120985 OS2986 80 121 360 DIFF-LID SET 4 060286 092586 47 115 200 DIFFLIID SET 4 060286 092586 118 122 200

239

1

I

~

J

Table 13 Summary of Quality Control Data Relative Band Neutrophlls

Control Lot Begin End Mean Standard No Name No

~--- -- ---~-

DIFF--U SET 1 ~

Date Date

090385

() Deviation Observa ons

060385 34 152 188 DIFF-Lil SET 1 060385 090385 16 080 188 DIFF-LiB SET 2 090485 120685 36 115 208 DIFFLlIB SET 2 090485 120685 14 090 208 DIFF-LiC SET 3 120985 OS2986 30 096 360 DIFFLlIC SET 3 120985 OS2986 16 079 360 DIFF-LiD SET 4 060286 092586 22 083 200 DIFFLIID SET 4 060286 092586 09 063 200

Table 14

Control

Summary of Quality Control Data Relative Segmented Neutrophlls

Lot Begin End Mean Standard No Name

DIFF--U

No

SET 1

Date

060385

Date

090385

()

589

Deviation

505

Observat I inS

188 DIFF-Lil SET 1 060385 090385 579 400 188 DIFF-LiB SET 2 090485 120685 575 272 208 DIFFLlIB SET 2 090485 120685 576 329 208 DIFF-LiC SET 3 120985 OS2986 585 185 360 DIFFLlIC SET 3 120985 OS2986 567 207 360 DIFF-LiD SET 4 060286 092586 420 190 200 DIFFLIID SET 4 060286 092586 567 170 200

Table 15

Control

Summary of Quality Control Data Relative Lymphocytes

Lot Begin End Mean Standard No Name No Date Date ()

252

Deviation

398

Observa Ions

188 DIFF--LI SET 1 060385 090385 DIFF-Lil SET 1 060385 090385 284 304 188 DIFF-LiB SET 2 090485 120685 246 256 208 DIFFLlIB SET 2 090485 120685 281 204 208 DIFF-LiC SET 3 120985 OS2986 257 189 360 DIFFLlIC SET 3 120985 OS2986 291 197 360 DIFF-LiD SET 4 060286 092586 382 182 200 DIFFLIID SET 4 060286 092586 268 143 200

240

Table 16 Summary of Quality Control Data Relative B-Lymphocytes _shy

Control Begin End Mean Standard No Name Date Date () Deviation o J servations

59 HUMAN-01 060385 090186 93 165 HUMAN-02 060385 092586 106 178 118 HUMAN-03 060385 091186 173 245 94 HUMAN-04 060485 090486 59 127 98 HUMAN-05 060485 081986 86 160 114 HUMAN-06 060485 041086 99 166 27 HUMAN-07 060585 070786 98 272 66 HUMAN-08 060685 092386 86 182 64 HUMAN-09 061385 080486 116 179 72 HUMAN-10 061885 090986 96 126 55 HUMAN-11 090385 051286 101 197 46 HUMAN-12 090485 092386 89 177 58 HUMAN-13 090585 090585 117 007 2 HUMAN-14 091085 091885 53 278 6 HUMAN-15 091285 071786 111 158 88 HUMAN-16 071086 091686 70 133 14 HUMAN-17 072986 092586 107 074 10 HUMAN-18 090986 092286 78 283 4 HUMAN-19 091686 092286 127 155 4

Table 17 Summary of Quality Control Data Relative T-Lymphocytes

Control Name

Begin Date

End Date

Mean ()

Standard Deviation

No o J servations

HUMAN-01 HUMAN-02 HUMAN-03 HUMAN-04 HUMAN-05 HUMAN-06 HUMAN-07 HUMAN-08 HUMAN-09 HUMAN-10 HUMAN-11 HUMAN-12 HUMAN-13 HUMAN-14 HUMAN-15 HUMAN-16 HUMAN-17 HUMAN-18 HUMAN-19

060385 060385 060385 060485 060485 060485 060585 060685 061385 061885 090385 090485 090585 091085 091285 071086 072986 090986 091686

090186 092586 091186 090486 081986 041086 070786 092386 080486 090986 051286 092386 090585 091885 071786 091686 092586 092286 092286

573 711 663 712 776 716 745 791 685 752 789 773 752 773 769 737 707 735 744

636 455 312 419 486 290 605 269 408 524 346 373 099 483 510 290 546 455 462

59 118

94 98

114 26 66 64 72 55 46 58

2 6

88 14 10 4 4

I r

l 241

Table 18 Summary of Quality Control Data Relative T4-Lymphocytes ----- Control Begin End Mean Standard No Name Date Date

bull-__-______ () Deviation Observatill 1S

HUMAN-01 060385 090186 386 511 59 HUMAN-02 060385 092586 534 375 118 HUMAN-03 060385 091186 437 376 94 HUMAN-04 060485 090486 482 358 98 HUMAN-05 060485 081986 531 401 114 HUMAN-06 060485 041086 440 334 27 HUMAN-07 060585 070786 419 629 66 HUMAN-08 060685 092386 503 454 64 HUMAN-09 061385 080486 456 353 72 HUMAN-10 061885 090986 511 421 55 HUMAN-11 090385 051286 582 340 46 HUMAN-12 090485 092386 443 356 58 HUMAN-13 090585 090585 590 269 2 HUMAN-14 091085 091885 551 200 6 HUMAN-15 091285 071786 525 406 88 HUMAN-16 071086 091686 347 290 14 HUMAN-17 072986 092586 537 295 10 HUMAN-18 090986 092286 527 300 4 HUMAN-19 091686 092286 547 738 4

Table 19 Summary of Quality Control Data Relative T8-Lymphocytes

Control Begin End Mean Standard No Name Date Date () Deviation Observatlc 115

HUMAN-01 060385 090186 310 273 59 HUMAN-02 060385 092586 291 204 118 HUMAN-03 060385 091186 218 188 94 HUMAN-04 060485 090486 314 211 98 HUMAN-05 060485 081986 288 189 114 HUMAN-06 060485 041086 321 145 27 HUMAN-07 060585 070786 387 473 66 HUMAN-08 060685 092386 349 429 64 HUMAN-09 061385 080486 256 166 71 HUMAN-10 061885 090986 234 193 55 HUMAN-11 090385 051286 220 156 46 HUMAN-12 090485 092386 293 341 58 HUMAN-13 090585 090585 178 064 2 HUMAN-14 091085 091885 208 136 6 HUMAN-15 091285 071786 258 248 88 HUMAN-16 071086 091686 442 113 14 HUMAN-17 072986 092586 216 371 10 HUMAN-18 090986 092286 244 104 4 HUMAN-19 091686 092286 254 236 4

242

Table 20 Summary of Quality Control Data T4(Ta Ratio -~- ---------~-------- ---~--~----~--~-laquo-------~~ bullbull

Control Begin End Mean Standard No Name Date Date (Ratio) Deviation ( I )servations

HUMAN-01 060385 090186 13 022 59 HUMAN-02 060385 092586 18 020 118 HUMAN-03 060385 091186 20 024 94 HUMAN-04 060485 090486 15 016 98 HUMAN-05 060485 081986 19 017 114 HUMAN-06 060485 041086 14 012 27 HUMAN-07 060585 070786 11 027 66 HUMAN-08 060685 092386 15 028 64 HUMAN-09 061385 080486 18 014 71 HUMAN-10 061885 090986 22 028 55 HUMAN-11 090385 051286 27 023 46 HUMAN-12 090485 092386 15 022 58 HUMAN-13 090585 090585 33 002 2 HUMAN-14 091085 091885 27 017 6 HUMAN-15 091285 071786 21 022 88 HUMAN-16 071086 091686 08 008 14 HUMAN-17 072986 092586 25 036 10 HUMAN-18 090986 092286 22 008 4 HUMAN-19 091686 092286 21 015 4

It

243

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 5

Control

Summary of Quality Control Data Mean Corpuscular Hemoglobin Concen t atlon

Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation 01 ervations

72 PARA-8H1 H538-85 060385 070885 382 037 096 PARA-8N1 N538-85 060385 070885 377 043 113 72 PARA-8H2 H538-85 071585 082685 360 060 168 100 PARA-8N2 N538-85 071585 082685 360 069 190 100 PARA8H2B H588-85 082785 101485 357 063 176 108 PARA8N2B N588-85 082785 101485 352 062 175 108 PARA8H2C H598-85 101585 120385 346 056 161 104 PARA8N2C N598-85 101585 120385 339 057 167 104 PARA8H2D H5118-86 120485 020586 354 054 151 108 PARA8N2D N5118-86 120485 020586 345 069 201 108 PARASH1D H5118-86 012186 012986 342 176 514 8 PARA8N1D N5118-86 012186 012986 342 106 309 8 TRICOH2A H1121-86 020686 040386 343 067 197 132 TRICON2A N1121-86 020686 040386 333 058 175 132 TRICOH2B H1122-86 040786 070186 355 052 146 168 TRICON2B N1122-86 040786 070186 360 052 144 168 TRICOH2C H1123-86 070786 090486 369 072 194 108 TRICON2C N1123-86 070786 090486 367 074 202 108 HIGH880A H1123-86 090886 092586 356 058 162 36 NORM880A N1123-86 090886 092586 364 056 153 36

Table 6 Summary of Quality Control Data Platelet Count

Control Name

Lot No

Begin Date

End Date

Mean (kmm3)

Standard Deviation

Coefficient of Variation

No CIiservations

PARA-8H1 PARA-8N1 PARA-8H2 PARA-8N2 PARA8H2B PARA8N2B PARA8H2C PARA8N2C PARA8H2D PARA8N2D PARA8H1D PARA8N1D TRICOH2A TRICON2A TRICOH2B TRICON2B TRICOH2C TRICON2C HIGH880A NORM880A

H538-85 N538-85 H538-85 N538-85 H588-85 N588-85 H598-85 N598-85

H5118-86 N5118-86 H5118-86 N5118-86 H1121-86 N1121-86 H1122-86 N1122-86 H1123-86 N1123-86 H1123-86 N1123-86

060385 060385 071585 071585 082785 082785 101585 101585 120485 120485 012186 012186 020686 020686 040786 040786 070786 070786 090886 090886

070885 070885 082685 082685 101485 101485 120385 120385 020586 020586 012986 012986 040386 040386 070186 070186 090486 090486 092586 092586

6592 2590 6362 2477 5985 2309 6381 2423 6194 2481 6567 2572 5909 2935 5857 2460 5109 2740 5129 2679

1198 918

1616 875

1511 706

1290 812

1528 854

2509 1440 1615 809

1723 959

1467 938

1334 761

182 355 254 353 253 306 202 335 247 344 382 560 273 276 294 390 287 342 260 284

72 72

100 100 108108104 104 108 108

16 16

132 132 168 168 108 108 36 36

iIi

r +

237

jTable 7 Summary of Quality Control Data Red Cell Count

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (milmm3) Deviation Variation Observ I Ions

PARA-8H1 H538-85 060385 070885 54 004 079 7 PARA-8N1 N538-85 060385 070885 43 004 097 7 PARA-8H2 H538-85 071585 082685 55 006 100 10( I PARA-8N2 N538-85 071585 082685 44 005 106 10(1 PARA8H2B H588-85 082785 101485 55 006 115 101 PARABN2B N588-85 082785 101485 47 005 112 101 PARABH2C H598-85 101585 120385 58 007 125 10 PARA8N2C N598-85 101585 120385 47 005 109 10 PARABH2D H5118-86 120485 020586 57 007 129 101 PARA8N2D N5118-86 120485 020586 48 011 223 101 PARA8H1D H5118-86 012186 012986 58 010 178 H PARA8N1D N5118-86 012186 012986 48 010 214 H TRICOH2A H1121-86 020686 040386 59 005 087 131 TRICON2A N1121-86 020686 040386 44 004 099 131 TRICOH2B H1122-86 040786 070186 52 008 143 161 TRICON2B N1122-86 040786 070186 40 006 138 161 TRICOH2C H1123-86 070786 090486 51 009 180 101 TRICON2C N1123-86 070786 090486 42 007 178 101 HIGH880A H1123-86 090886 092586 51 005 104 3 NORM880A N1123-86 090886 092586 41 004 093 3

Table B Summary of Quality Control Data White Cell Count

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (kmm3) Deviation Variation Observ I ions

PARA-8H1 H538-85 060385 070885 306 041 135 7 PARA-8N1 N538-85 060385 070885 77 016 212 7 PARA-8H2 H538-85 071585 082685 305 059 195 10( PARA-8N2 N538-85 071585 082685 77 017 222 10( PARA8H2B H588-85 082785 101485 276 061 223 101 PARA8N2B N588-85 082785 101485 78 022 287 101 PARA8H2C H598-85 101585 120385 288 049 170 10 PARA8N2C N598-85 101585 120385 77 019 254 10 PARA8H2D H5118-86 120485 020586 290 060 209 101 PARA8N2D N5118-86 120485 020586 84 026 308 101 PARA8H1D H5118-86 012186 012986 293 051 173 H PARA8N1D N5118-86 012186 012986 84 020 237 H TRICOH2A H1121-86 020686 040386 313 078 248 13 TRICON2A N1121-86 020686 040386 90 023 261 131 TRICOH2B H1122-86 040786 070186 286 053 185 161 TRICON2B N1122-86 040786 070186 90 016 173 161 TRICOH2C H1123-86 070786 090486 214 046 216 101 TRICON2C N1123-86 070786 090486 77 021 273 101 HIGH880A H1123-86 090886 092586 197 017 085 3t NORM880A N1123-86 090886 092586 72 011 148 3

238

rwmw

iii

f

Table 9 Summary of Quality Control Data Relative 8asophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation C Iservatlons

188 DIFF--LI SET 1 060385 090385 06 048 DIFF-LII SET 1 060385 090385 00 016 188 DIFF-LIB SET 2 090485 120685 07 055 208 DIFFLlIB SET 2 090485 120685 01 035 208 DIFF-LIC SET 3 120985 OS2986 06 056 360 DIFFLlIC SET 3 120985 OS2986 01 026 360 DIFF-LID SET 4 060286 092586 04 049 200 DIFFLIID SET 4 060286 092586 05 050 200

Table 10 Summary of Quality Control Data Relative Eoslnophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation o t servatlons

188 DIFF--LI SET 1 060385 090385 31 092 DIFF-LII SET 1 060385 090385 05 052 188 DIFF-LIB SET 2 090485 120685 37 145 208 DIFFLlIB SET 2 090485 120685 08 095 208 DIFF-LIC SET 3 120985 OS2986 29 111 360 DIFFLlIC SET 3 120985 OS2986 08 062 360 DIFF-LID SET 4 060286 092586 84 101 200 DIFFLIID SET 4 060286 092586 09 055 200

Table 11 Summary of Quality Control Data Relative Atypical Lymphocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation Ot i ervatlons

DIFF--LI SET 1 060385 090385 20 155 188 DIFF-LII SET 1 060385 090385 34 180 188 DIFF-LIB SET 2 090485 120685 17 099 208 DIFFLlIB SET 2 090485 120685 45 180 208 DIFF-LIC SET 3 120985 OS2986 21 134 360 DIFFLlIC SET 3 120985 OS2986 37 196 360 DIFF-LID SET 4 060286 092586 41 191 200 DIFFLIID SET 4 060286 092586 23 146 200

f

Table 12 Summary of Quality Control Data Relative Monocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation at servatlons DIFF--LI SET 1 060385 090385 68 175 188 DIFF-LII SET 1 060385 090385 80 176 188 DIFF-LIB SET 2 090485 120685 79 127 208 DIFFLlIB SET 2 090485 120685 75 142 208 DIFF-LIC SET 3 120985 OS2986 68 104 360 DIFFLlIC SET 3 120985 OS2986 80 121 360 DIFF-LID SET 4 060286 092586 47 115 200 DIFFLIID SET 4 060286 092586 118 122 200

239

1

I

~

J

Table 13 Summary of Quality Control Data Relative Band Neutrophlls

Control Lot Begin End Mean Standard No Name No

~--- -- ---~-

DIFF--U SET 1 ~

Date Date

090385

() Deviation Observa ons

060385 34 152 188 DIFF-Lil SET 1 060385 090385 16 080 188 DIFF-LiB SET 2 090485 120685 36 115 208 DIFFLlIB SET 2 090485 120685 14 090 208 DIFF-LiC SET 3 120985 OS2986 30 096 360 DIFFLlIC SET 3 120985 OS2986 16 079 360 DIFF-LiD SET 4 060286 092586 22 083 200 DIFFLIID SET 4 060286 092586 09 063 200

Table 14

Control

Summary of Quality Control Data Relative Segmented Neutrophlls

Lot Begin End Mean Standard No Name

DIFF--U

No

SET 1

Date

060385

Date

090385

()

589

Deviation

505

Observat I inS

188 DIFF-Lil SET 1 060385 090385 579 400 188 DIFF-LiB SET 2 090485 120685 575 272 208 DIFFLlIB SET 2 090485 120685 576 329 208 DIFF-LiC SET 3 120985 OS2986 585 185 360 DIFFLlIC SET 3 120985 OS2986 567 207 360 DIFF-LiD SET 4 060286 092586 420 190 200 DIFFLIID SET 4 060286 092586 567 170 200

Table 15

Control

Summary of Quality Control Data Relative Lymphocytes

Lot Begin End Mean Standard No Name No Date Date ()

252

Deviation

398

Observa Ions

188 DIFF--LI SET 1 060385 090385 DIFF-Lil SET 1 060385 090385 284 304 188 DIFF-LiB SET 2 090485 120685 246 256 208 DIFFLlIB SET 2 090485 120685 281 204 208 DIFF-LiC SET 3 120985 OS2986 257 189 360 DIFFLlIC SET 3 120985 OS2986 291 197 360 DIFF-LiD SET 4 060286 092586 382 182 200 DIFFLIID SET 4 060286 092586 268 143 200

240

Table 16 Summary of Quality Control Data Relative B-Lymphocytes _shy

Control Begin End Mean Standard No Name Date Date () Deviation o J servations

59 HUMAN-01 060385 090186 93 165 HUMAN-02 060385 092586 106 178 118 HUMAN-03 060385 091186 173 245 94 HUMAN-04 060485 090486 59 127 98 HUMAN-05 060485 081986 86 160 114 HUMAN-06 060485 041086 99 166 27 HUMAN-07 060585 070786 98 272 66 HUMAN-08 060685 092386 86 182 64 HUMAN-09 061385 080486 116 179 72 HUMAN-10 061885 090986 96 126 55 HUMAN-11 090385 051286 101 197 46 HUMAN-12 090485 092386 89 177 58 HUMAN-13 090585 090585 117 007 2 HUMAN-14 091085 091885 53 278 6 HUMAN-15 091285 071786 111 158 88 HUMAN-16 071086 091686 70 133 14 HUMAN-17 072986 092586 107 074 10 HUMAN-18 090986 092286 78 283 4 HUMAN-19 091686 092286 127 155 4

Table 17 Summary of Quality Control Data Relative T-Lymphocytes

Control Name

Begin Date

End Date

Mean ()

Standard Deviation

No o J servations

HUMAN-01 HUMAN-02 HUMAN-03 HUMAN-04 HUMAN-05 HUMAN-06 HUMAN-07 HUMAN-08 HUMAN-09 HUMAN-10 HUMAN-11 HUMAN-12 HUMAN-13 HUMAN-14 HUMAN-15 HUMAN-16 HUMAN-17 HUMAN-18 HUMAN-19

060385 060385 060385 060485 060485 060485 060585 060685 061385 061885 090385 090485 090585 091085 091285 071086 072986 090986 091686

090186 092586 091186 090486 081986 041086 070786 092386 080486 090986 051286 092386 090585 091885 071786 091686 092586 092286 092286

573 711 663 712 776 716 745 791 685 752 789 773 752 773 769 737 707 735 744

636 455 312 419 486 290 605 269 408 524 346 373 099 483 510 290 546 455 462

59 118

94 98

114 26 66 64 72 55 46 58

2 6

88 14 10 4 4

I r

l 241

Table 18 Summary of Quality Control Data Relative T4-Lymphocytes ----- Control Begin End Mean Standard No Name Date Date

bull-__-______ () Deviation Observatill 1S

HUMAN-01 060385 090186 386 511 59 HUMAN-02 060385 092586 534 375 118 HUMAN-03 060385 091186 437 376 94 HUMAN-04 060485 090486 482 358 98 HUMAN-05 060485 081986 531 401 114 HUMAN-06 060485 041086 440 334 27 HUMAN-07 060585 070786 419 629 66 HUMAN-08 060685 092386 503 454 64 HUMAN-09 061385 080486 456 353 72 HUMAN-10 061885 090986 511 421 55 HUMAN-11 090385 051286 582 340 46 HUMAN-12 090485 092386 443 356 58 HUMAN-13 090585 090585 590 269 2 HUMAN-14 091085 091885 551 200 6 HUMAN-15 091285 071786 525 406 88 HUMAN-16 071086 091686 347 290 14 HUMAN-17 072986 092586 537 295 10 HUMAN-18 090986 092286 527 300 4 HUMAN-19 091686 092286 547 738 4

Table 19 Summary of Quality Control Data Relative T8-Lymphocytes

Control Begin End Mean Standard No Name Date Date () Deviation Observatlc 115

HUMAN-01 060385 090186 310 273 59 HUMAN-02 060385 092586 291 204 118 HUMAN-03 060385 091186 218 188 94 HUMAN-04 060485 090486 314 211 98 HUMAN-05 060485 081986 288 189 114 HUMAN-06 060485 041086 321 145 27 HUMAN-07 060585 070786 387 473 66 HUMAN-08 060685 092386 349 429 64 HUMAN-09 061385 080486 256 166 71 HUMAN-10 061885 090986 234 193 55 HUMAN-11 090385 051286 220 156 46 HUMAN-12 090485 092386 293 341 58 HUMAN-13 090585 090585 178 064 2 HUMAN-14 091085 091885 208 136 6 HUMAN-15 091285 071786 258 248 88 HUMAN-16 071086 091686 442 113 14 HUMAN-17 072986 092586 216 371 10 HUMAN-18 090986 092286 244 104 4 HUMAN-19 091686 092286 254 236 4

242

Table 20 Summary of Quality Control Data T4(Ta Ratio -~- ---------~-------- ---~--~----~--~-laquo-------~~ bullbull

Control Begin End Mean Standard No Name Date Date (Ratio) Deviation ( I )servations

HUMAN-01 060385 090186 13 022 59 HUMAN-02 060385 092586 18 020 118 HUMAN-03 060385 091186 20 024 94 HUMAN-04 060485 090486 15 016 98 HUMAN-05 060485 081986 19 017 114 HUMAN-06 060485 041086 14 012 27 HUMAN-07 060585 070786 11 027 66 HUMAN-08 060685 092386 15 028 64 HUMAN-09 061385 080486 18 014 71 HUMAN-10 061885 090986 22 028 55 HUMAN-11 090385 051286 27 023 46 HUMAN-12 090485 092386 15 022 58 HUMAN-13 090585 090585 33 002 2 HUMAN-14 091085 091885 27 017 6 HUMAN-15 091285 071786 21 022 88 HUMAN-16 071086 091686 08 008 14 HUMAN-17 072986 092586 25 036 10 HUMAN-18 090986 092286 22 008 4 HUMAN-19 091686 092286 21 015 4

It

243

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

jTable 7 Summary of Quality Control Data Red Cell Count

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (milmm3) Deviation Variation Observ I Ions

PARA-8H1 H538-85 060385 070885 54 004 079 7 PARA-8N1 N538-85 060385 070885 43 004 097 7 PARA-8H2 H538-85 071585 082685 55 006 100 10( I PARA-8N2 N538-85 071585 082685 44 005 106 10(1 PARA8H2B H588-85 082785 101485 55 006 115 101 PARABN2B N588-85 082785 101485 47 005 112 101 PARABH2C H598-85 101585 120385 58 007 125 10 PARA8N2C N598-85 101585 120385 47 005 109 10 PARABH2D H5118-86 120485 020586 57 007 129 101 PARA8N2D N5118-86 120485 020586 48 011 223 101 PARA8H1D H5118-86 012186 012986 58 010 178 H PARA8N1D N5118-86 012186 012986 48 010 214 H TRICOH2A H1121-86 020686 040386 59 005 087 131 TRICON2A N1121-86 020686 040386 44 004 099 131 TRICOH2B H1122-86 040786 070186 52 008 143 161 TRICON2B N1122-86 040786 070186 40 006 138 161 TRICOH2C H1123-86 070786 090486 51 009 180 101 TRICON2C N1123-86 070786 090486 42 007 178 101 HIGH880A H1123-86 090886 092586 51 005 104 3 NORM880A N1123-86 090886 092586 41 004 093 3

Table B Summary of Quality Control Data White Cell Count

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (kmm3) Deviation Variation Observ I ions

PARA-8H1 H538-85 060385 070885 306 041 135 7 PARA-8N1 N538-85 060385 070885 77 016 212 7 PARA-8H2 H538-85 071585 082685 305 059 195 10( PARA-8N2 N538-85 071585 082685 77 017 222 10( PARA8H2B H588-85 082785 101485 276 061 223 101 PARA8N2B N588-85 082785 101485 78 022 287 101 PARA8H2C H598-85 101585 120385 288 049 170 10 PARA8N2C N598-85 101585 120385 77 019 254 10 PARA8H2D H5118-86 120485 020586 290 060 209 101 PARA8N2D N5118-86 120485 020586 84 026 308 101 PARA8H1D H5118-86 012186 012986 293 051 173 H PARA8N1D N5118-86 012186 012986 84 020 237 H TRICOH2A H1121-86 020686 040386 313 078 248 13 TRICON2A N1121-86 020686 040386 90 023 261 131 TRICOH2B H1122-86 040786 070186 286 053 185 161 TRICON2B N1122-86 040786 070186 90 016 173 161 TRICOH2C H1123-86 070786 090486 214 046 216 101 TRICON2C N1123-86 070786 090486 77 021 273 101 HIGH880A H1123-86 090886 092586 197 017 085 3t NORM880A N1123-86 090886 092586 72 011 148 3

238

rwmw

iii

f

Table 9 Summary of Quality Control Data Relative 8asophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation C Iservatlons

188 DIFF--LI SET 1 060385 090385 06 048 DIFF-LII SET 1 060385 090385 00 016 188 DIFF-LIB SET 2 090485 120685 07 055 208 DIFFLlIB SET 2 090485 120685 01 035 208 DIFF-LIC SET 3 120985 OS2986 06 056 360 DIFFLlIC SET 3 120985 OS2986 01 026 360 DIFF-LID SET 4 060286 092586 04 049 200 DIFFLIID SET 4 060286 092586 05 050 200

Table 10 Summary of Quality Control Data Relative Eoslnophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation o t servatlons

188 DIFF--LI SET 1 060385 090385 31 092 DIFF-LII SET 1 060385 090385 05 052 188 DIFF-LIB SET 2 090485 120685 37 145 208 DIFFLlIB SET 2 090485 120685 08 095 208 DIFF-LIC SET 3 120985 OS2986 29 111 360 DIFFLlIC SET 3 120985 OS2986 08 062 360 DIFF-LID SET 4 060286 092586 84 101 200 DIFFLIID SET 4 060286 092586 09 055 200

Table 11 Summary of Quality Control Data Relative Atypical Lymphocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation Ot i ervatlons

DIFF--LI SET 1 060385 090385 20 155 188 DIFF-LII SET 1 060385 090385 34 180 188 DIFF-LIB SET 2 090485 120685 17 099 208 DIFFLlIB SET 2 090485 120685 45 180 208 DIFF-LIC SET 3 120985 OS2986 21 134 360 DIFFLlIC SET 3 120985 OS2986 37 196 360 DIFF-LID SET 4 060286 092586 41 191 200 DIFFLIID SET 4 060286 092586 23 146 200

f

Table 12 Summary of Quality Control Data Relative Monocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation at servatlons DIFF--LI SET 1 060385 090385 68 175 188 DIFF-LII SET 1 060385 090385 80 176 188 DIFF-LIB SET 2 090485 120685 79 127 208 DIFFLlIB SET 2 090485 120685 75 142 208 DIFF-LIC SET 3 120985 OS2986 68 104 360 DIFFLlIC SET 3 120985 OS2986 80 121 360 DIFF-LID SET 4 060286 092586 47 115 200 DIFFLIID SET 4 060286 092586 118 122 200

239

1

I

~

J

Table 13 Summary of Quality Control Data Relative Band Neutrophlls

Control Lot Begin End Mean Standard No Name No

~--- -- ---~-

DIFF--U SET 1 ~

Date Date

090385

() Deviation Observa ons

060385 34 152 188 DIFF-Lil SET 1 060385 090385 16 080 188 DIFF-LiB SET 2 090485 120685 36 115 208 DIFFLlIB SET 2 090485 120685 14 090 208 DIFF-LiC SET 3 120985 OS2986 30 096 360 DIFFLlIC SET 3 120985 OS2986 16 079 360 DIFF-LiD SET 4 060286 092586 22 083 200 DIFFLIID SET 4 060286 092586 09 063 200

Table 14

Control

Summary of Quality Control Data Relative Segmented Neutrophlls

Lot Begin End Mean Standard No Name

DIFF--U

No

SET 1

Date

060385

Date

090385

()

589

Deviation

505

Observat I inS

188 DIFF-Lil SET 1 060385 090385 579 400 188 DIFF-LiB SET 2 090485 120685 575 272 208 DIFFLlIB SET 2 090485 120685 576 329 208 DIFF-LiC SET 3 120985 OS2986 585 185 360 DIFFLlIC SET 3 120985 OS2986 567 207 360 DIFF-LiD SET 4 060286 092586 420 190 200 DIFFLIID SET 4 060286 092586 567 170 200

Table 15

Control

Summary of Quality Control Data Relative Lymphocytes

Lot Begin End Mean Standard No Name No Date Date ()

252

Deviation

398

Observa Ions

188 DIFF--LI SET 1 060385 090385 DIFF-Lil SET 1 060385 090385 284 304 188 DIFF-LiB SET 2 090485 120685 246 256 208 DIFFLlIB SET 2 090485 120685 281 204 208 DIFF-LiC SET 3 120985 OS2986 257 189 360 DIFFLlIC SET 3 120985 OS2986 291 197 360 DIFF-LiD SET 4 060286 092586 382 182 200 DIFFLIID SET 4 060286 092586 268 143 200

240

Table 16 Summary of Quality Control Data Relative B-Lymphocytes _shy

Control Begin End Mean Standard No Name Date Date () Deviation o J servations

59 HUMAN-01 060385 090186 93 165 HUMAN-02 060385 092586 106 178 118 HUMAN-03 060385 091186 173 245 94 HUMAN-04 060485 090486 59 127 98 HUMAN-05 060485 081986 86 160 114 HUMAN-06 060485 041086 99 166 27 HUMAN-07 060585 070786 98 272 66 HUMAN-08 060685 092386 86 182 64 HUMAN-09 061385 080486 116 179 72 HUMAN-10 061885 090986 96 126 55 HUMAN-11 090385 051286 101 197 46 HUMAN-12 090485 092386 89 177 58 HUMAN-13 090585 090585 117 007 2 HUMAN-14 091085 091885 53 278 6 HUMAN-15 091285 071786 111 158 88 HUMAN-16 071086 091686 70 133 14 HUMAN-17 072986 092586 107 074 10 HUMAN-18 090986 092286 78 283 4 HUMAN-19 091686 092286 127 155 4

Table 17 Summary of Quality Control Data Relative T-Lymphocytes

Control Name

Begin Date

End Date

Mean ()

Standard Deviation

No o J servations

HUMAN-01 HUMAN-02 HUMAN-03 HUMAN-04 HUMAN-05 HUMAN-06 HUMAN-07 HUMAN-08 HUMAN-09 HUMAN-10 HUMAN-11 HUMAN-12 HUMAN-13 HUMAN-14 HUMAN-15 HUMAN-16 HUMAN-17 HUMAN-18 HUMAN-19

060385 060385 060385 060485 060485 060485 060585 060685 061385 061885 090385 090485 090585 091085 091285 071086 072986 090986 091686

090186 092586 091186 090486 081986 041086 070786 092386 080486 090986 051286 092386 090585 091885 071786 091686 092586 092286 092286

573 711 663 712 776 716 745 791 685 752 789 773 752 773 769 737 707 735 744

636 455 312 419 486 290 605 269 408 524 346 373 099 483 510 290 546 455 462

59 118

94 98

114 26 66 64 72 55 46 58

2 6

88 14 10 4 4

I r

l 241

Table 18 Summary of Quality Control Data Relative T4-Lymphocytes ----- Control Begin End Mean Standard No Name Date Date

bull-__-______ () Deviation Observatill 1S

HUMAN-01 060385 090186 386 511 59 HUMAN-02 060385 092586 534 375 118 HUMAN-03 060385 091186 437 376 94 HUMAN-04 060485 090486 482 358 98 HUMAN-05 060485 081986 531 401 114 HUMAN-06 060485 041086 440 334 27 HUMAN-07 060585 070786 419 629 66 HUMAN-08 060685 092386 503 454 64 HUMAN-09 061385 080486 456 353 72 HUMAN-10 061885 090986 511 421 55 HUMAN-11 090385 051286 582 340 46 HUMAN-12 090485 092386 443 356 58 HUMAN-13 090585 090585 590 269 2 HUMAN-14 091085 091885 551 200 6 HUMAN-15 091285 071786 525 406 88 HUMAN-16 071086 091686 347 290 14 HUMAN-17 072986 092586 537 295 10 HUMAN-18 090986 092286 527 300 4 HUMAN-19 091686 092286 547 738 4

Table 19 Summary of Quality Control Data Relative T8-Lymphocytes

Control Begin End Mean Standard No Name Date Date () Deviation Observatlc 115

HUMAN-01 060385 090186 310 273 59 HUMAN-02 060385 092586 291 204 118 HUMAN-03 060385 091186 218 188 94 HUMAN-04 060485 090486 314 211 98 HUMAN-05 060485 081986 288 189 114 HUMAN-06 060485 041086 321 145 27 HUMAN-07 060585 070786 387 473 66 HUMAN-08 060685 092386 349 429 64 HUMAN-09 061385 080486 256 166 71 HUMAN-10 061885 090986 234 193 55 HUMAN-11 090385 051286 220 156 46 HUMAN-12 090485 092386 293 341 58 HUMAN-13 090585 090585 178 064 2 HUMAN-14 091085 091885 208 136 6 HUMAN-15 091285 071786 258 248 88 HUMAN-16 071086 091686 442 113 14 HUMAN-17 072986 092586 216 371 10 HUMAN-18 090986 092286 244 104 4 HUMAN-19 091686 092286 254 236 4

242

Table 20 Summary of Quality Control Data T4(Ta Ratio -~- ---------~-------- ---~--~----~--~-laquo-------~~ bullbull

Control Begin End Mean Standard No Name Date Date (Ratio) Deviation ( I )servations

HUMAN-01 060385 090186 13 022 59 HUMAN-02 060385 092586 18 020 118 HUMAN-03 060385 091186 20 024 94 HUMAN-04 060485 090486 15 016 98 HUMAN-05 060485 081986 19 017 114 HUMAN-06 060485 041086 14 012 27 HUMAN-07 060585 070786 11 027 66 HUMAN-08 060685 092386 15 028 64 HUMAN-09 061385 080486 18 014 71 HUMAN-10 061885 090986 22 028 55 HUMAN-11 090385 051286 27 023 46 HUMAN-12 090485 092386 15 022 58 HUMAN-13 090585 090585 33 002 2 HUMAN-14 091085 091885 27 017 6 HUMAN-15 091285 071786 21 022 88 HUMAN-16 071086 091686 08 008 14 HUMAN-17 072986 092586 25 036 10 HUMAN-18 090986 092286 22 008 4 HUMAN-19 091686 092286 21 015 4

It

243

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

iii

f

Table 9 Summary of Quality Control Data Relative 8asophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation C Iservatlons

188 DIFF--LI SET 1 060385 090385 06 048 DIFF-LII SET 1 060385 090385 00 016 188 DIFF-LIB SET 2 090485 120685 07 055 208 DIFFLlIB SET 2 090485 120685 01 035 208 DIFF-LIC SET 3 120985 OS2986 06 056 360 DIFFLlIC SET 3 120985 OS2986 01 026 360 DIFF-LID SET 4 060286 092586 04 049 200 DIFFLIID SET 4 060286 092586 05 050 200

Table 10 Summary of Quality Control Data Relative Eoslnophils

Control Lot Begin End Mean Standard No Name No Date Date () Deviation o t servatlons

188 DIFF--LI SET 1 060385 090385 31 092 DIFF-LII SET 1 060385 090385 05 052 188 DIFF-LIB SET 2 090485 120685 37 145 208 DIFFLlIB SET 2 090485 120685 08 095 208 DIFF-LIC SET 3 120985 OS2986 29 111 360 DIFFLlIC SET 3 120985 OS2986 08 062 360 DIFF-LID SET 4 060286 092586 84 101 200 DIFFLIID SET 4 060286 092586 09 055 200

Table 11 Summary of Quality Control Data Relative Atypical Lymphocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation Ot i ervatlons

DIFF--LI SET 1 060385 090385 20 155 188 DIFF-LII SET 1 060385 090385 34 180 188 DIFF-LIB SET 2 090485 120685 17 099 208 DIFFLlIB SET 2 090485 120685 45 180 208 DIFF-LIC SET 3 120985 OS2986 21 134 360 DIFFLlIC SET 3 120985 OS2986 37 196 360 DIFF-LID SET 4 060286 092586 41 191 200 DIFFLIID SET 4 060286 092586 23 146 200

f

Table 12 Summary of Quality Control Data Relative Monocytes

Control Lot Begin End Mean Standard No Name No Date Date () Deviation at servatlons DIFF--LI SET 1 060385 090385 68 175 188 DIFF-LII SET 1 060385 090385 80 176 188 DIFF-LIB SET 2 090485 120685 79 127 208 DIFFLlIB SET 2 090485 120685 75 142 208 DIFF-LIC SET 3 120985 OS2986 68 104 360 DIFFLlIC SET 3 120985 OS2986 80 121 360 DIFF-LID SET 4 060286 092586 47 115 200 DIFFLIID SET 4 060286 092586 118 122 200

239

1

I

~

J

Table 13 Summary of Quality Control Data Relative Band Neutrophlls

Control Lot Begin End Mean Standard No Name No

~--- -- ---~-

DIFF--U SET 1 ~

Date Date

090385

() Deviation Observa ons

060385 34 152 188 DIFF-Lil SET 1 060385 090385 16 080 188 DIFF-LiB SET 2 090485 120685 36 115 208 DIFFLlIB SET 2 090485 120685 14 090 208 DIFF-LiC SET 3 120985 OS2986 30 096 360 DIFFLlIC SET 3 120985 OS2986 16 079 360 DIFF-LiD SET 4 060286 092586 22 083 200 DIFFLIID SET 4 060286 092586 09 063 200

Table 14

Control

Summary of Quality Control Data Relative Segmented Neutrophlls

Lot Begin End Mean Standard No Name

DIFF--U

No

SET 1

Date

060385

Date

090385

()

589

Deviation

505

Observat I inS

188 DIFF-Lil SET 1 060385 090385 579 400 188 DIFF-LiB SET 2 090485 120685 575 272 208 DIFFLlIB SET 2 090485 120685 576 329 208 DIFF-LiC SET 3 120985 OS2986 585 185 360 DIFFLlIC SET 3 120985 OS2986 567 207 360 DIFF-LiD SET 4 060286 092586 420 190 200 DIFFLIID SET 4 060286 092586 567 170 200

Table 15

Control

Summary of Quality Control Data Relative Lymphocytes

Lot Begin End Mean Standard No Name No Date Date ()

252

Deviation

398

Observa Ions

188 DIFF--LI SET 1 060385 090385 DIFF-Lil SET 1 060385 090385 284 304 188 DIFF-LiB SET 2 090485 120685 246 256 208 DIFFLlIB SET 2 090485 120685 281 204 208 DIFF-LiC SET 3 120985 OS2986 257 189 360 DIFFLlIC SET 3 120985 OS2986 291 197 360 DIFF-LiD SET 4 060286 092586 382 182 200 DIFFLIID SET 4 060286 092586 268 143 200

240

Table 16 Summary of Quality Control Data Relative B-Lymphocytes _shy

Control Begin End Mean Standard No Name Date Date () Deviation o J servations

59 HUMAN-01 060385 090186 93 165 HUMAN-02 060385 092586 106 178 118 HUMAN-03 060385 091186 173 245 94 HUMAN-04 060485 090486 59 127 98 HUMAN-05 060485 081986 86 160 114 HUMAN-06 060485 041086 99 166 27 HUMAN-07 060585 070786 98 272 66 HUMAN-08 060685 092386 86 182 64 HUMAN-09 061385 080486 116 179 72 HUMAN-10 061885 090986 96 126 55 HUMAN-11 090385 051286 101 197 46 HUMAN-12 090485 092386 89 177 58 HUMAN-13 090585 090585 117 007 2 HUMAN-14 091085 091885 53 278 6 HUMAN-15 091285 071786 111 158 88 HUMAN-16 071086 091686 70 133 14 HUMAN-17 072986 092586 107 074 10 HUMAN-18 090986 092286 78 283 4 HUMAN-19 091686 092286 127 155 4

Table 17 Summary of Quality Control Data Relative T-Lymphocytes

Control Name

Begin Date

End Date

Mean ()

Standard Deviation

No o J servations

HUMAN-01 HUMAN-02 HUMAN-03 HUMAN-04 HUMAN-05 HUMAN-06 HUMAN-07 HUMAN-08 HUMAN-09 HUMAN-10 HUMAN-11 HUMAN-12 HUMAN-13 HUMAN-14 HUMAN-15 HUMAN-16 HUMAN-17 HUMAN-18 HUMAN-19

060385 060385 060385 060485 060485 060485 060585 060685 061385 061885 090385 090485 090585 091085 091285 071086 072986 090986 091686

090186 092586 091186 090486 081986 041086 070786 092386 080486 090986 051286 092386 090585 091885 071786 091686 092586 092286 092286

573 711 663 712 776 716 745 791 685 752 789 773 752 773 769 737 707 735 744

636 455 312 419 486 290 605 269 408 524 346 373 099 483 510 290 546 455 462

59 118

94 98

114 26 66 64 72 55 46 58

2 6

88 14 10 4 4

I r

l 241

Table 18 Summary of Quality Control Data Relative T4-Lymphocytes ----- Control Begin End Mean Standard No Name Date Date

bull-__-______ () Deviation Observatill 1S

HUMAN-01 060385 090186 386 511 59 HUMAN-02 060385 092586 534 375 118 HUMAN-03 060385 091186 437 376 94 HUMAN-04 060485 090486 482 358 98 HUMAN-05 060485 081986 531 401 114 HUMAN-06 060485 041086 440 334 27 HUMAN-07 060585 070786 419 629 66 HUMAN-08 060685 092386 503 454 64 HUMAN-09 061385 080486 456 353 72 HUMAN-10 061885 090986 511 421 55 HUMAN-11 090385 051286 582 340 46 HUMAN-12 090485 092386 443 356 58 HUMAN-13 090585 090585 590 269 2 HUMAN-14 091085 091885 551 200 6 HUMAN-15 091285 071786 525 406 88 HUMAN-16 071086 091686 347 290 14 HUMAN-17 072986 092586 537 295 10 HUMAN-18 090986 092286 527 300 4 HUMAN-19 091686 092286 547 738 4

Table 19 Summary of Quality Control Data Relative T8-Lymphocytes

Control Begin End Mean Standard No Name Date Date () Deviation Observatlc 115

HUMAN-01 060385 090186 310 273 59 HUMAN-02 060385 092586 291 204 118 HUMAN-03 060385 091186 218 188 94 HUMAN-04 060485 090486 314 211 98 HUMAN-05 060485 081986 288 189 114 HUMAN-06 060485 041086 321 145 27 HUMAN-07 060585 070786 387 473 66 HUMAN-08 060685 092386 349 429 64 HUMAN-09 061385 080486 256 166 71 HUMAN-10 061885 090986 234 193 55 HUMAN-11 090385 051286 220 156 46 HUMAN-12 090485 092386 293 341 58 HUMAN-13 090585 090585 178 064 2 HUMAN-14 091085 091885 208 136 6 HUMAN-15 091285 071786 258 248 88 HUMAN-16 071086 091686 442 113 14 HUMAN-17 072986 092586 216 371 10 HUMAN-18 090986 092286 244 104 4 HUMAN-19 091686 092286 254 236 4

242

Table 20 Summary of Quality Control Data T4(Ta Ratio -~- ---------~-------- ---~--~----~--~-laquo-------~~ bullbull

Control Begin End Mean Standard No Name Date Date (Ratio) Deviation ( I )servations

HUMAN-01 060385 090186 13 022 59 HUMAN-02 060385 092586 18 020 118 HUMAN-03 060385 091186 20 024 94 HUMAN-04 060485 090486 15 016 98 HUMAN-05 060485 081986 19 017 114 HUMAN-06 060485 041086 14 012 27 HUMAN-07 060585 070786 11 027 66 HUMAN-08 060685 092386 15 028 64 HUMAN-09 061385 080486 18 014 71 HUMAN-10 061885 090986 22 028 55 HUMAN-11 090385 051286 27 023 46 HUMAN-12 090485 092386 15 022 58 HUMAN-13 090585 090585 33 002 2 HUMAN-14 091085 091885 27 017 6 HUMAN-15 091285 071786 21 022 88 HUMAN-16 071086 091686 08 008 14 HUMAN-17 072986 092586 25 036 10 HUMAN-18 090986 092286 22 008 4 HUMAN-19 091686 092286 21 015 4

It

243

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

1

I

~

J

Table 13 Summary of Quality Control Data Relative Band Neutrophlls

Control Lot Begin End Mean Standard No Name No

~--- -- ---~-

DIFF--U SET 1 ~

Date Date

090385

() Deviation Observa ons

060385 34 152 188 DIFF-Lil SET 1 060385 090385 16 080 188 DIFF-LiB SET 2 090485 120685 36 115 208 DIFFLlIB SET 2 090485 120685 14 090 208 DIFF-LiC SET 3 120985 OS2986 30 096 360 DIFFLlIC SET 3 120985 OS2986 16 079 360 DIFF-LiD SET 4 060286 092586 22 083 200 DIFFLIID SET 4 060286 092586 09 063 200

Table 14

Control

Summary of Quality Control Data Relative Segmented Neutrophlls

Lot Begin End Mean Standard No Name

DIFF--U

No

SET 1

Date

060385

Date

090385

()

589

Deviation

505

Observat I inS

188 DIFF-Lil SET 1 060385 090385 579 400 188 DIFF-LiB SET 2 090485 120685 575 272 208 DIFFLlIB SET 2 090485 120685 576 329 208 DIFF-LiC SET 3 120985 OS2986 585 185 360 DIFFLlIC SET 3 120985 OS2986 567 207 360 DIFF-LiD SET 4 060286 092586 420 190 200 DIFFLIID SET 4 060286 092586 567 170 200

Table 15

Control

Summary of Quality Control Data Relative Lymphocytes

Lot Begin End Mean Standard No Name No Date Date ()

252

Deviation

398

Observa Ions

188 DIFF--LI SET 1 060385 090385 DIFF-Lil SET 1 060385 090385 284 304 188 DIFF-LiB SET 2 090485 120685 246 256 208 DIFFLlIB SET 2 090485 120685 281 204 208 DIFF-LiC SET 3 120985 OS2986 257 189 360 DIFFLlIC SET 3 120985 OS2986 291 197 360 DIFF-LiD SET 4 060286 092586 382 182 200 DIFFLIID SET 4 060286 092586 268 143 200

240

Table 16 Summary of Quality Control Data Relative B-Lymphocytes _shy

Control Begin End Mean Standard No Name Date Date () Deviation o J servations

59 HUMAN-01 060385 090186 93 165 HUMAN-02 060385 092586 106 178 118 HUMAN-03 060385 091186 173 245 94 HUMAN-04 060485 090486 59 127 98 HUMAN-05 060485 081986 86 160 114 HUMAN-06 060485 041086 99 166 27 HUMAN-07 060585 070786 98 272 66 HUMAN-08 060685 092386 86 182 64 HUMAN-09 061385 080486 116 179 72 HUMAN-10 061885 090986 96 126 55 HUMAN-11 090385 051286 101 197 46 HUMAN-12 090485 092386 89 177 58 HUMAN-13 090585 090585 117 007 2 HUMAN-14 091085 091885 53 278 6 HUMAN-15 091285 071786 111 158 88 HUMAN-16 071086 091686 70 133 14 HUMAN-17 072986 092586 107 074 10 HUMAN-18 090986 092286 78 283 4 HUMAN-19 091686 092286 127 155 4

Table 17 Summary of Quality Control Data Relative T-Lymphocytes

Control Name

Begin Date

End Date

Mean ()

Standard Deviation

No o J servations

HUMAN-01 HUMAN-02 HUMAN-03 HUMAN-04 HUMAN-05 HUMAN-06 HUMAN-07 HUMAN-08 HUMAN-09 HUMAN-10 HUMAN-11 HUMAN-12 HUMAN-13 HUMAN-14 HUMAN-15 HUMAN-16 HUMAN-17 HUMAN-18 HUMAN-19

060385 060385 060385 060485 060485 060485 060585 060685 061385 061885 090385 090485 090585 091085 091285 071086 072986 090986 091686

090186 092586 091186 090486 081986 041086 070786 092386 080486 090986 051286 092386 090585 091885 071786 091686 092586 092286 092286

573 711 663 712 776 716 745 791 685 752 789 773 752 773 769 737 707 735 744

636 455 312 419 486 290 605 269 408 524 346 373 099 483 510 290 546 455 462

59 118

94 98

114 26 66 64 72 55 46 58

2 6

88 14 10 4 4

I r

l 241

Table 18 Summary of Quality Control Data Relative T4-Lymphocytes ----- Control Begin End Mean Standard No Name Date Date

bull-__-______ () Deviation Observatill 1S

HUMAN-01 060385 090186 386 511 59 HUMAN-02 060385 092586 534 375 118 HUMAN-03 060385 091186 437 376 94 HUMAN-04 060485 090486 482 358 98 HUMAN-05 060485 081986 531 401 114 HUMAN-06 060485 041086 440 334 27 HUMAN-07 060585 070786 419 629 66 HUMAN-08 060685 092386 503 454 64 HUMAN-09 061385 080486 456 353 72 HUMAN-10 061885 090986 511 421 55 HUMAN-11 090385 051286 582 340 46 HUMAN-12 090485 092386 443 356 58 HUMAN-13 090585 090585 590 269 2 HUMAN-14 091085 091885 551 200 6 HUMAN-15 091285 071786 525 406 88 HUMAN-16 071086 091686 347 290 14 HUMAN-17 072986 092586 537 295 10 HUMAN-18 090986 092286 527 300 4 HUMAN-19 091686 092286 547 738 4

Table 19 Summary of Quality Control Data Relative T8-Lymphocytes

Control Begin End Mean Standard No Name Date Date () Deviation Observatlc 115

HUMAN-01 060385 090186 310 273 59 HUMAN-02 060385 092586 291 204 118 HUMAN-03 060385 091186 218 188 94 HUMAN-04 060485 090486 314 211 98 HUMAN-05 060485 081986 288 189 114 HUMAN-06 060485 041086 321 145 27 HUMAN-07 060585 070786 387 473 66 HUMAN-08 060685 092386 349 429 64 HUMAN-09 061385 080486 256 166 71 HUMAN-10 061885 090986 234 193 55 HUMAN-11 090385 051286 220 156 46 HUMAN-12 090485 092386 293 341 58 HUMAN-13 090585 090585 178 064 2 HUMAN-14 091085 091885 208 136 6 HUMAN-15 091285 071786 258 248 88 HUMAN-16 071086 091686 442 113 14 HUMAN-17 072986 092586 216 371 10 HUMAN-18 090986 092286 244 104 4 HUMAN-19 091686 092286 254 236 4

242

Table 20 Summary of Quality Control Data T4(Ta Ratio -~- ---------~-------- ---~--~----~--~-laquo-------~~ bullbull

Control Begin End Mean Standard No Name Date Date (Ratio) Deviation ( I )servations

HUMAN-01 060385 090186 13 022 59 HUMAN-02 060385 092586 18 020 118 HUMAN-03 060385 091186 20 024 94 HUMAN-04 060485 090486 15 016 98 HUMAN-05 060485 081986 19 017 114 HUMAN-06 060485 041086 14 012 27 HUMAN-07 060585 070786 11 027 66 HUMAN-08 060685 092386 15 028 64 HUMAN-09 061385 080486 18 014 71 HUMAN-10 061885 090986 22 028 55 HUMAN-11 090385 051286 27 023 46 HUMAN-12 090485 092386 15 022 58 HUMAN-13 090585 090585 33 002 2 HUMAN-14 091085 091885 27 017 6 HUMAN-15 091285 071786 21 022 88 HUMAN-16 071086 091686 08 008 14 HUMAN-17 072986 092586 25 036 10 HUMAN-18 090986 092286 22 008 4 HUMAN-19 091686 092286 21 015 4

It

243

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 16 Summary of Quality Control Data Relative B-Lymphocytes _shy

Control Begin End Mean Standard No Name Date Date () Deviation o J servations

59 HUMAN-01 060385 090186 93 165 HUMAN-02 060385 092586 106 178 118 HUMAN-03 060385 091186 173 245 94 HUMAN-04 060485 090486 59 127 98 HUMAN-05 060485 081986 86 160 114 HUMAN-06 060485 041086 99 166 27 HUMAN-07 060585 070786 98 272 66 HUMAN-08 060685 092386 86 182 64 HUMAN-09 061385 080486 116 179 72 HUMAN-10 061885 090986 96 126 55 HUMAN-11 090385 051286 101 197 46 HUMAN-12 090485 092386 89 177 58 HUMAN-13 090585 090585 117 007 2 HUMAN-14 091085 091885 53 278 6 HUMAN-15 091285 071786 111 158 88 HUMAN-16 071086 091686 70 133 14 HUMAN-17 072986 092586 107 074 10 HUMAN-18 090986 092286 78 283 4 HUMAN-19 091686 092286 127 155 4

Table 17 Summary of Quality Control Data Relative T-Lymphocytes

Control Name

Begin Date

End Date

Mean ()

Standard Deviation

No o J servations

HUMAN-01 HUMAN-02 HUMAN-03 HUMAN-04 HUMAN-05 HUMAN-06 HUMAN-07 HUMAN-08 HUMAN-09 HUMAN-10 HUMAN-11 HUMAN-12 HUMAN-13 HUMAN-14 HUMAN-15 HUMAN-16 HUMAN-17 HUMAN-18 HUMAN-19

060385 060385 060385 060485 060485 060485 060585 060685 061385 061885 090385 090485 090585 091085 091285 071086 072986 090986 091686

090186 092586 091186 090486 081986 041086 070786 092386 080486 090986 051286 092386 090585 091885 071786 091686 092586 092286 092286

573 711 663 712 776 716 745 791 685 752 789 773 752 773 769 737 707 735 744

636 455 312 419 486 290 605 269 408 524 346 373 099 483 510 290 546 455 462

59 118

94 98

114 26 66 64 72 55 46 58

2 6

88 14 10 4 4

I r

l 241

Table 18 Summary of Quality Control Data Relative T4-Lymphocytes ----- Control Begin End Mean Standard No Name Date Date

bull-__-______ () Deviation Observatill 1S

HUMAN-01 060385 090186 386 511 59 HUMAN-02 060385 092586 534 375 118 HUMAN-03 060385 091186 437 376 94 HUMAN-04 060485 090486 482 358 98 HUMAN-05 060485 081986 531 401 114 HUMAN-06 060485 041086 440 334 27 HUMAN-07 060585 070786 419 629 66 HUMAN-08 060685 092386 503 454 64 HUMAN-09 061385 080486 456 353 72 HUMAN-10 061885 090986 511 421 55 HUMAN-11 090385 051286 582 340 46 HUMAN-12 090485 092386 443 356 58 HUMAN-13 090585 090585 590 269 2 HUMAN-14 091085 091885 551 200 6 HUMAN-15 091285 071786 525 406 88 HUMAN-16 071086 091686 347 290 14 HUMAN-17 072986 092586 537 295 10 HUMAN-18 090986 092286 527 300 4 HUMAN-19 091686 092286 547 738 4

Table 19 Summary of Quality Control Data Relative T8-Lymphocytes

Control Begin End Mean Standard No Name Date Date () Deviation Observatlc 115

HUMAN-01 060385 090186 310 273 59 HUMAN-02 060385 092586 291 204 118 HUMAN-03 060385 091186 218 188 94 HUMAN-04 060485 090486 314 211 98 HUMAN-05 060485 081986 288 189 114 HUMAN-06 060485 041086 321 145 27 HUMAN-07 060585 070786 387 473 66 HUMAN-08 060685 092386 349 429 64 HUMAN-09 061385 080486 256 166 71 HUMAN-10 061885 090986 234 193 55 HUMAN-11 090385 051286 220 156 46 HUMAN-12 090485 092386 293 341 58 HUMAN-13 090585 090585 178 064 2 HUMAN-14 091085 091885 208 136 6 HUMAN-15 091285 071786 258 248 88 HUMAN-16 071086 091686 442 113 14 HUMAN-17 072986 092586 216 371 10 HUMAN-18 090986 092286 244 104 4 HUMAN-19 091686 092286 254 236 4

242

Table 20 Summary of Quality Control Data T4(Ta Ratio -~- ---------~-------- ---~--~----~--~-laquo-------~~ bullbull

Control Begin End Mean Standard No Name Date Date (Ratio) Deviation ( I )servations

HUMAN-01 060385 090186 13 022 59 HUMAN-02 060385 092586 18 020 118 HUMAN-03 060385 091186 20 024 94 HUMAN-04 060485 090486 15 016 98 HUMAN-05 060485 081986 19 017 114 HUMAN-06 060485 041086 14 012 27 HUMAN-07 060585 070786 11 027 66 HUMAN-08 060685 092386 15 028 64 HUMAN-09 061385 080486 18 014 71 HUMAN-10 061885 090986 22 028 55 HUMAN-11 090385 051286 27 023 46 HUMAN-12 090485 092386 15 022 58 HUMAN-13 090585 090585 33 002 2 HUMAN-14 091085 091885 27 017 6 HUMAN-15 091285 071786 21 022 88 HUMAN-16 071086 091686 08 008 14 HUMAN-17 072986 092586 25 036 10 HUMAN-18 090986 092286 22 008 4 HUMAN-19 091686 092286 21 015 4

It

243

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 18 Summary of Quality Control Data Relative T4-Lymphocytes ----- Control Begin End Mean Standard No Name Date Date

bull-__-______ () Deviation Observatill 1S

HUMAN-01 060385 090186 386 511 59 HUMAN-02 060385 092586 534 375 118 HUMAN-03 060385 091186 437 376 94 HUMAN-04 060485 090486 482 358 98 HUMAN-05 060485 081986 531 401 114 HUMAN-06 060485 041086 440 334 27 HUMAN-07 060585 070786 419 629 66 HUMAN-08 060685 092386 503 454 64 HUMAN-09 061385 080486 456 353 72 HUMAN-10 061885 090986 511 421 55 HUMAN-11 090385 051286 582 340 46 HUMAN-12 090485 092386 443 356 58 HUMAN-13 090585 090585 590 269 2 HUMAN-14 091085 091885 551 200 6 HUMAN-15 091285 071786 525 406 88 HUMAN-16 071086 091686 347 290 14 HUMAN-17 072986 092586 537 295 10 HUMAN-18 090986 092286 527 300 4 HUMAN-19 091686 092286 547 738 4

Table 19 Summary of Quality Control Data Relative T8-Lymphocytes

Control Begin End Mean Standard No Name Date Date () Deviation Observatlc 115

HUMAN-01 060385 090186 310 273 59 HUMAN-02 060385 092586 291 204 118 HUMAN-03 060385 091186 218 188 94 HUMAN-04 060485 090486 314 211 98 HUMAN-05 060485 081986 288 189 114 HUMAN-06 060485 041086 321 145 27 HUMAN-07 060585 070786 387 473 66 HUMAN-08 060685 092386 349 429 64 HUMAN-09 061385 080486 256 166 71 HUMAN-10 061885 090986 234 193 55 HUMAN-11 090385 051286 220 156 46 HUMAN-12 090485 092386 293 341 58 HUMAN-13 090585 090585 178 064 2 HUMAN-14 091085 091885 208 136 6 HUMAN-15 091285 071786 258 248 88 HUMAN-16 071086 091686 442 113 14 HUMAN-17 072986 092586 216 371 10 HUMAN-18 090986 092286 244 104 4 HUMAN-19 091686 092286 254 236 4

242

Table 20 Summary of Quality Control Data T4(Ta Ratio -~- ---------~-------- ---~--~----~--~-laquo-------~~ bullbull

Control Begin End Mean Standard No Name Date Date (Ratio) Deviation ( I )servations

HUMAN-01 060385 090186 13 022 59 HUMAN-02 060385 092586 18 020 118 HUMAN-03 060385 091186 20 024 94 HUMAN-04 060485 090486 15 016 98 HUMAN-05 060485 081986 19 017 114 HUMAN-06 060485 041086 14 012 27 HUMAN-07 060585 070786 11 027 66 HUMAN-08 060685 092386 15 028 64 HUMAN-09 061385 080486 18 014 71 HUMAN-10 061885 090986 22 028 55 HUMAN-11 090385 051286 27 023 46 HUMAN-12 090485 092386 15 022 58 HUMAN-13 090585 090585 33 002 2 HUMAN-14 091085 091885 27 017 6 HUMAN-15 091285 071786 21 022 88 HUMAN-16 071086 091686 08 008 14 HUMAN-17 072986 092586 25 036 10 HUMAN-18 090986 092286 22 008 4 HUMAN-19 091686 092286 21 015 4

It

243

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 20 Summary of Quality Control Data T4(Ta Ratio -~- ---------~-------- ---~--~----~--~-laquo-------~~ bullbull

Control Begin End Mean Standard No Name Date Date (Ratio) Deviation ( I )servations

HUMAN-01 060385 090186 13 022 59 HUMAN-02 060385 092586 18 020 118 HUMAN-03 060385 091186 20 024 94 HUMAN-04 060485 090486 15 016 98 HUMAN-05 060485 081986 19 017 114 HUMAN-06 060485 041086 14 012 27 HUMAN-07 060585 070786 11 027 66 HUMAN-08 060685 092386 15 028 64 HUMAN-09 061385 080486 18 014 71 HUMAN-10 061885 090986 22 028 55 HUMAN-11 090385 051286 27 023 46 HUMAN-12 090485 092386 15 022 58 HUMAN-13 090585 090585 33 002 2 HUMAN-14 091085 091885 27 017 6 HUMAN-15 091285 071786 21 022 88 HUMAN-16 071086 091686 08 008 14 HUMAN-17 072986 092586 25 036 10 HUMAN-18 090986 092286 22 008 4 HUMAN-19 091686 092286 21 015 4

It

243

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 1 Monthly Mean Qualilty Control Values Prothrombin Time

22

20 B-----A-----lt--tr

~ 18 U W (fl

----shy 16 Z o b ltC 14 Il t-shyZ

t3 1 2 z o u

10

A_-AA---JAIr--AA--IAIr---AAr----cAA---fAIr----pA---A

8

6 -------~-------~----------------~

J85 J85 A85 S85 085 N85 085 J85 F85 M86 A85 M85 J85 J86 A86 585

MONTH AND YEAR

LEGEND CITROL-I=A CITRL-[J=B CITRL-IA=C ClTRUIA=D

Table 21 Summary of Quality Control Data Prothrombin Time

Control Lot Begin End Mean Standard Coefficient of No Nam_~ _______ ~(L_____lla_te____Da_e__ (~laquoc) Deviation Variation Observe tons

CITROL-I COL 1-286 060385 072486 119 017 146 84~ CITRL-II COL2-276 060385 072486 199 044 221 84~

CITRL-IA C0L1-313 072886 092586 128 012 092 10E CITRLlIA COL2-286 072886 092586 209 036 171 10E

244

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 2 Monthly Mean Quality Control Values o-Glucaric Acid

65-------------------------------------------------------------shy

55

z o b 35

~ b Z W U 25 Z o u

15

5~--~--------_--_r--~_--_--_r----_--_--_r----_--_--~

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGENDD-GLUCAR=A D-GLUC-2=B D-GLUC-3=C U-LYFH-2=D

Table 22 Summary of Quality Control Data o-Glucaric Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (fJgml) Deviation Variation ( Ibservations

DmiddotGLUCAR POOLmiddot85 060385 071785 493 597 1211 44 D-GLUC-2 POOL-85 071885 092085 443 523 1181 74 D-GLUC-3 POOL-85 092385 011686 336 584 1737 120 U-LYPH-2 07100-86 012086 092586 176 204 1159 246

245

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 3 Monthly Mean Quality Control Values Porphobilinogen

30-----------------------------------shy

25

3 E -shy020 i

z o f 15 lt 0 b Z r1 U 10 Z o u

05

00L-~---------~-_-_--~-_-_---~~-_-_-_--

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8E M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND PORPHOBG=A PORPHBG2=B PORPHBG3=C PORPHBG4=D PORPHBG5=E

Table 23 Summary of Quality Control Data Porphobilinogen

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (gml) Deviation Variation Observ I Ions ------__ ___--- --shyPORPHOBG POOL-85 060385 082685 13 028 2130 81 PORPHBG2 POOL-85 082685 121985 16 020 1214 13 ) PORPHBG3 POOL-85 010686 042486 14 016 1135 121 PORPHBG4 POOL-86 042886 081486 15 017 1120 91 PORPHBG5 POOL-86 081886 092586 18 024 1312 31

246

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 4 Monthly Mean Quality Control Values Total Porphyrin Screen

175-----------------~----------------------~------------------ -------

3 165 - o i

z o ~ 155 P b Z rpoundI U Z o U 145

135l-----------r--~----_--_r--_----_--_r--_----_--_--_r -----~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGENDPORSCR-l=A

Table 24 Summary of Quality Control Data Total Porphyrin Screen

Control Name

Lot Begin End Mean Standard Coefficient of No No Date Date (I-LgL) Deviation Variation I bservations

------------------------------------~~~-------------------------PORSCR-1 082185 092385 010986 1593 1166 732 110

247

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 5 Plot Mean Quality Control Values Coproporphyrin

550 -~

3500 ~ CJ i

z o E=ltP ~ Z rl U Z o U

450

400

I I

I 350 1 ~--------r

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 086

MONTH AND YEAR

LEGEND U-LYPH-2~A

Table 25 Summary of Quality Control Data Coproporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date -- -~- -------shy Date ()tgL) Deviation Variation Observat I inS

UmiddotLYPHmiddot2 07100 010686 092586 4541 3632 800 260

248

J In J J A __

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 26 Summary of Quality Control Data Uroporphyrin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (JlgL) Deviation Variation 0 servations --------------------------------~~~------------------------U-LYPH-2 07100 010686 092586 5070 3669 724 260

Figure 6 Monthly Mean Quality Control Values Uroporphyrin

600------------------------------------------------------------- ------~

3550

lJ t

z o b 500 Il E-lt Z

U Z o U 450

400~--~-------~--~----

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND U-LYPH-2~A

IU =

r r

249

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 7 Monthly Mean Quality Control Values Alanine Aminotransferase

575~---------------------------------------------------------

475

375

3275 ~

g 1 75 tt-B--HB---IB

z o 75T---------------------------------------------------------------shyE= ltt ~ 55 Z ~ 55 Z oU 45

35 A--_A--A

25

J85 J85 A85 S85 085 N85 085 J86 F85 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

jTable 27 Summary of Quality Control Data Alanine Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lUlL) Deviation Variation Observ lions

-bull--~---------shyCHMTRK-1 U1-8605B 060385 080885 304 125 410 13E CHMTRK-3 U3-8605B 060385 080885 1878 281 150 13E KODAK--1 32401-85 072985 021386 570 170 299 42L KODAK--2 34402-85 072985 021386 4851 1039 214 42L KODAK-1R 32401-86 021786 OS2286 551 218 395 21~

KODAK-2R 34402-86 021786 OS2286 4938 936 190 21~ KODAK-1 A 0235401 OS2686 092586 423 204 483 21~

KODAK-2A 0239402 OS2686 092586 4553 542 119 21 ~

250

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 8 Monthly Mean Quality Control Values Albumin

7

6 H

~5 ~

2shy~4 E= lt ~

~3 rxJ u Z 02 U

Bshy

A

D

B

~

0

B

e

9

C

0

C

D-g

C C

0

C

9---8shy

C C

9

C

-g

~

0 e---~

-~I

o J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86

----------------- A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 28 Summary of Quality Control Data Albumin

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (gdl) Deviation Variation Il bservatlons

CHMTRK-1 U1-8605B 060385 080885 25 005 202 136 CHMTRK-3 U3-86058 060385 080885 42 010 235 136 KODAK--1 32401-85 072985 050186 23 006 238 600 KODAK--2 34402-85 072985 050186 54 012 222 600 KODAK-1R 32401-86 050586 OS2286 22 005 215 36 KODAK-2R 34402-86 050586 OS2286 63 009 137 36 KODAK-1A 0235401 OS2686 092586 25 007 296 212 KODAK-2A 0239402 OS2686 092586 54 011 207 212

251

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 9 Monthly Mean Quality Control Values Alkaline Phosphatase

1100

1000

900

1 800 ~ = ~ 700

Z 0 E 600

ltt 0 500EshyZ ~ W

400U Z 0 U 300

200

G C C C c c c [ E EA--A A100

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=O

Table 29 Summary of Quality Control Data Alkaline Phosphatase

Control Lot Begin End Mean Standard Coefficient of No Name No Date ____-----shy Date (IUL) Deviation Variation Observli ions

CHMTRK-1 U1-86058 060385 080885 1103 664 602 13E CHMTRK-3 U3-86058 060385 080885 4354 1942 446 131 KODAK--1 32401-85 072985 021386 1411 480 340 42 KODAK--2 34402-85 072985 021386 9844 2503 254 42 KODAK-1R 32401-86 021786 OS2286 1341 566 422 21 KODAK-2R 34402-86 021786 OS2286 9441 2558 271 21 KODAK-1A 0235401 OS2686 092586 985 452 459 21 KODAK-2A 0239402 OS2686 092586 10119 2660 263 21

252

FFD

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 10 Monthly Mean Quaty Control Values Aspartate Aminotransferase

600 g g g g g g ~ G

550 II H 41 +lII

500

lt 450

400 J 350

~ 300

~ 250 p ~ ~ 200 Ii1 U 150 Z

800 u

Ashy A60 G ~ C C C C C C C C E E E E [

40

20

0 J85 J85 A85 585 085 N85 D85 J86 FB6 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 30 Summary of Quaty Control Data Aspartate Aminotransferase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation o l servations

CHMTRK-1 U1-86058 060385 080885 615 372 604 136 CHMTRK-3 U3-86058 060385 080885 2243 851 380 136 KODAK--1 32401-85 072985 OS2286 530 221 416 636 KODAK--2 34402-85 072985 OS2286 5769 1171 203 636 KODAK-1A 0235401 OS2686 092586 547 218 399 212 KODAK-2A 0239402 OS2686 092586 5488 716 130 212

I

i

253

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 11 Monthly Mean Quality Control Values Total BIlirubin

18----------------------------------------------------------------shy

F 16

1-1--+-- ---1

~14 J Q

-shyCJ 12

~ ~ 10

E= lt ~ 8 E--lt Z (iI

U 6 Z 0 B BB-u

4

H -HE G G C C G G G C

A -A -A 0

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IB=E KODAK-2B=F KODAK-IC=H KODAK-2C=I

Table 31 Summary of Quality Control Data Total Bilirubin

Control Lot Begin End Mean Standard Coefficient of Nc Name No Date Date (mgdl) Deviation Variation Observ I lon6 CHMTRK-1 U1-8605B 060385 080885 08 006 757 131) CHMTRK-3 U3-8605B 060385 080885 47 016 342 131 KODAK--1 32401-85 072985 021386 16 004 273 4201 KODAK--2 34402-85 072985 021386 161 049 301 42middot KODAK-1B 0235401 070786 071586 25 006 252 211 KODAK-2B 0239402 070786 071586 165 041 250 211 KODAK-1C 717NEWSD 071786 092586 25 008 316 12 KODAK-2C 717NEWSD 071786 092586 154 023 152 12

254

_I

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 12 Monthly Mean Quality Control Values UnconJugated BJllrubln

13 G- o 0 0 0

12 H II II II 11

3 10 0 - 9 0

6 8

Z 0 7 E= p E-o

lt 6

z 5

U 4 0 Z

U 3

8 8 8 2 I

G G G G G G G e E E E

a J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-lA CHMTRK-3=B KODAK--lC KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1AI KODAK-2A=O

Table 32 Summary of Quality Control Data UnconJugated BJllrubln

Control Lot BegIn End Mean Standard Coefficient of No Name No Date Date (mgdl) DevIatIon Variation o t servatlons

CHMTRK-1 U1-86058 060385 080885 02 007 3294 136 CHMTRK-3 U3-86058 060385 080885 22 006 268 136 KODAK--1 32401-85 072985 021386 12 006 464 424 KODAK--2 34402-85 072985 021386 114 020 179 424 KODAK-1R 32401-86 021786 OS2286 13 004 314 212 KODAK-2R 34402-86 021786 OS2286 116 022 191 212 KODAK-1A 0235401 OS2686 092586 19 006 340 212 KODAK-2A 0239402 OS2686 092586 124 022 181 212

i i

t

l

255

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 13 Monthly Mean Quality Control Values Blood Urea Nitrogen

100-----------------------------------------------------------------shy

90

80 3 Ci - 70 o 6 60 z oE= 50 B--~Df____ __B

Pi ~ 40 W U Z o u

J8S J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=8 KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

j

1

Table 33 Summary of Quality Control Data Blood Urea Nitrogen

Control Lot Begin End Mean Standard Coefficient of Nil Name No Date Date (mgdl) Deviation Variation Obsel 1 tlons

CHMTRK-1 U1-8605B 060385 080885 128 024 188 1~ [ CHMTRK-3 U3-8605B 060385 080885 510 086 169 12[ KODAK--1 32401-85 072985 OS2286 220 037 168 61

KODAK--2 34402-85 072985 OS2286 808 133 164 63 KODAK-1A 0235401 OS2686 092586 239 043 182 21 KODAK-2A 0239402 OS2686 092586 846 130 154 21

256

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 14 Monthly Mean Quality Control Values Total Cholesterol

300~----------------------------------------------------------- ---

280

260

3 240 ~ ~ o 220

6 Z 200 o b 120 ltP E- 110 Z

tl100 AshyZ --~A~~A

8 90

80 G C C C C C C C c- c C

70

60 J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-I=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 34 Summary of Quality Control Data Total Cholesterol ~~_v~~____~__bull__m ___bull___

Control Name

Lot No

Begin Date

End Date

Mean (mgdl)

Standard Deviation

Coefficient of Variation

No I bservatlons

CHMTRK-1 U1-8605B 060385 080885 969 158 163 136 CHMTRK-3 U3-8605B 060385 080885 2153 447 208 136 KODAK--1 32401-85 072985 OS2286 767 140 183 636 KODAK--2 34402-85 072985 OS2286 2695 474 176 636 KODAK-1A 0235401 OS2686 092586 984 157 160 212 KODAK-2A 0239402 OS2686 092586 2888 437 151 212

257

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 15 Monthly Mean Quality Control Values High-Density Lipoprotein (HDL) Chores I erol

100

90

~-euro-BO

3 0 AA A~A A A A -A70 A~A-shyCJ

6 50 Z 0 E= 50 0 t-lt 40 B-- B 8 B B B Bz B 8 B B B 8ILl U Z 30 0 ~U

20

10

0 J85 JB5 A8S 585 085 N85 085 J85 F86 MB6 Ae6 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND SIGMA-HI=A SIGMA-LO=B SIGMAHIB=C SIGMALOB=D

Table 35 Summary of Quality Control Data High-Density Lipoprotein Cholesterol

Control Lot Begin End Mean Standard Coefficient of No Name No Date Dale (mgdl) Deviation Variation Observ lions

SIGMA-HI 84F-6166 060385 062486 695 204 293 80C SIGMA-LO 84F-6167 060385 062486 378 109 288 80C SIGMAHIB 95F-6094 062686 092586 813 213 262 15E SIGMALOB 95F-6095 032686 092586 279 103 369 15E

I

258

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 16 Monthly Mean Quality Control Values Creatine Phosphokinase

1500--------------------------------------------------------- -------~

1400

1300

~ 1200 gt - 1100 z 0-- 8 )8middot El2 1000 r P 500r z W1 400u B- 8 -Br z ~ 0

U 300

G G G G G G G I 10 10 E 200 I IA A A

100

0 JBS JBS ABS SB5 085 N8S 085 J86 F86 MB6 AB6 MB6 JB6 JBE AB6 SB6

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IR=E KODAK-2R=H KODAK-IA= KODAK-2A=0

-

Table 36 Summary of Quality Control Data Creatine Phosphokinase

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation )bservations

136 CHMTRK-1 U1middot8605B 060385 080885 1561 487 312 CHMTRK-3 U3-8605B 060385 080885 3637 1419 390 136 KODAK--1 32401-85 072985 021386 2173 702 323 424 KODAK--2 34402-85 072985 021386 13468 3290 244 424 KODAK-1R 32401-86 021786 OS2286 2266 729 322 212 KODAK-2R 34402-86 021786 OS2286 14178 3635 256 212 KODAK-1A 0235401 OS2686 092586 1762 634 360 212 KODAK-2A 0239402 OS2686 092586 10417 3542 340 212

259

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 17 Monthly Mean Quality Control Values Serum Creatinine

I

10

G----D~--~D-~Damp---~D--D 9

3 Q 8 ~ o 6 7

Z o 6 b ~ 5 E--lt

~ 4~-B z o J U

2

~~~c~-trc---ampc-~c I-E--fE-----tE----IEi=---~a----+--jW-tr-- ---w--- -W1

oLr--~~--~middot---r--_----_--_r--_----_--_r--_----_--_r--_----r_

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A=I KODAK-2A=O

KODAK-1B=W KODAK-2B=X

Table 37 Summary of Quality Control Data Serum Creatinine

Control Lot Begin End Mean Standard No Name No Date Date (mgdl) Deviation Observe nons ---___----shy --_ CHMTRK-1 U1-8605B 060385 080885 06 017 13 CHMTRK-3 U3-8605B 060385 080885 37 034 13 KODAK--1 32401-85 072985 121985 09 008 32f KODAK--2 34402-85 072985 121985 95 020 32E KODAK-1R 32401-86 010686 OS2286 09 008 31 KODAK-2R 34402-86 010686 OS2286 104 021 31 KODAK-1A 0235401 OS2686 070186 09 009 6E KODAK-2A 0239402 OS2686 070186 95 014 6E KODAK-1B 0235401 070786 092586 09 010 14~

KODAK-2B 0239402 070786 092586 91 018 14~

260

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

middot Figure 18 Monthly Mean Quality Control Values Urine Creatinine

~ 325------------------------------------------------------------ -------

300

275

3 Q 250 - f+ - ---t+II--HHCJ e 225

5 200 E= ~ 175 E-lt Z rJ 150 U Z o 125 U

100 ------(A----A----I----APr------IA~-A E- E E

75 j 50l--------------------~----------~--~-----------r

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND U-LYFH-l=A U-LYFH-2=B ULYFH-IR=C ULYFH-2R=D ULYFH-IA=E ULYFH-2A=H

Table 38 Summary of Quality Control Data Urine Creatinine

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation ()bservations

436 U-LYPH-1 07000-85 060385 121985 947 399 422 U-LYPH-2 07100-85 060385 121985 2356 903 383 436 ULYPH-1R 07000-86 010686 070186 1063 437 411 380 ULYPH-2R 07100-86 010686 070186 2919 1106 379 380 ULYPH-1A 07000-86 070786 092586 907 304 336 144 ULYPH-2A 07100-86 070786 092586 2348 617 263 144

261

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 19 Monthly Mean Quality Control Values Gamma Glutamyl Transferase

750

S 650

350

B300 I+B--8B---tl

250

200

150

100

J85

G C

A A

C C C C C

585 085 N85 085 J86J85 A85

3 -

3 E= 0 EshyZ Jl UZ o U

--jpound E E II

F86 M86 A86 M86 J86 J86 A86 386

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1R=E KODAK-2R=H KODAK-1A= KODAK-2A=0

001950

850

262

-=

Table 39 Summary of Quality Control Data Gamma Glutamyl Transferase

Control Lot Begin End Mean Standard Coefficient of No Name No ---shy Date Date (IUL) Deviation Variation Observa 1 ons

CHMTRK-1 U1-86058 060385 080885 277 106 381 136 CHMTRK-3 U3-8605B 060385 080885 3021 657 218 136 KODAK--1 32401-85 072985 021386 821 208 253 424 KODAK--2 34402-85 072985 021386 8913 3174 356 424 KODAK-1R 32401-86 021786 OS2286 782 159 203 212 KODAK-2R 34402-86 021786 OS2286 9126 2422 265 212 KODAK-1A 0235401 OS2686 092586 800 168 210 216 KODAK-2A 0239402 OS2686 092586 9947 1984 199 216

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 20 Monthly Mean Quality Control Values Fasting Glucose

525

475

425 ~-~ 0 0 0 0 O----B--- D D D D 03 o 375

shy0 3 325

B B B ~ 275 ~ ~ 225 E-lt

~ 125 U Z o 100 U

E-shyE E EA75

i 6 e c c c c C C c c f

50

25 JB5 JB5 AB5 585 085 NB5 085 J86 FB6 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-1A=E KODAK-2A=H

Table 40 Summary of Quality Control Data Fasting Glucose

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation CI bservations

CHMTRK-1 U1-8605B 060385 080885 775 085 109 136 CHMTRK-3 U3-86058 060385 080885 2941 257 088 136 KODAK--1 32401-85 072985 OS2286 747 141 188 636 KODAK--2 34402-85 072985 OS2286 3975 687 173 636 KODAK-1A 0235401 OS2686 092586 813 130 160 212 KODAK-2A 0239402 OS2686 092586 4253 622 146 212

263

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

1

1

Figure 21 Monthly Mean Quality Control Values Lactic Dehydrogenase

j--------l8----B

1300 1 i

~ 1200 I - 11 00 ~

3 1000 b

~ A- Ab gOO zt3 800 Z o U 700

600 E E [

500

400 --I~------ ---- shy

J85 J85 A85 585 085 N85 085 J86 F86 M86 A8Elt M86 J86 J86 A86 bull86

MONTH AND YEAR

LEGEND CHMTRK-l~A CHMTRK-3=B KODAK--l~C KODAK--2=D KODAK-1R~E KODAK-2R=H KODAK-1A=I KODAK-2A=O

Table 41

Control

Summary of Quality Control Data Lactic Dehydrogenase

Lot Begin End Mean Standard Coefficient of No Name No Date Date

080885

(IUL)

9150

Deviation Variation Observal i ms

CHMTRK-1 U1-86058 060385 1297 142 136 CHMTRK-3 U3-86058 060385 080885 14610 2024 139 136 KODAK--1 32401-85 072985 021386 5690 1911 336 424 KODAK--2 34402-85 072985 021386 13687 3050 223 424 KODAK-1R 32401-86 021786 OS2286 5955 1325 223 212 KODAK-2R 34402-86 021786 OS2286 14018 2416 172 212 KODAK-1A 0235401 OS2686 092586 6905 947 137 212 KODAK-2A 0239402 OS2686 092586 14134 1850 131 212

264

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

265

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

1

266

Figure 23 Monthly Mean Quality Control Values Trlglycerldes

350 --H pound)0 00 0325 0 0 D 0 9----9

300 ~

J 275 0 shyCJ 250 e z 225 0 Ashy A A g 200 0 E-lt 175 Z iil U 150 Z 8 125

E E E E --E 100

G G G G G G G G G G C 75

50 J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B KODAK--l=C KODAK--2=D KODAK-IA=E KODAK-2A=H

Table 43

Control Name

CHMTRK-1

Summary o

Lot No

Ul-86058

f Quality C

Begin Date

060385

ontrol Data Trlglycer

End Date

080885

Mean (mgdl)

2094

ldes

Standard Deviation

265

Coefficient 01 Variation

127

0Obser I Eltlons

1 l3 CHMTRK-3 U3-86058 060385 080885 2893 359 124 1 l3 KODAK1 32401-85 072985 OS2286 920 186 203 6 J 3 KODAK--2 34402-85 072985 OS2286 3256 630 193 6 J3 KODAK-1A 0235401 OS2686 092586 1072 178 166 2 KODAK-2A 0239402 OS2686 092586 3416 474 139 2

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Ii pound

Table 44 Summary of Quality Control Data 8-Amlnolevullnlc Acid

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation I) bservations

OELTAALA POOLmiddot85 060385 082985 42 039 933 92 O-ALA--2 POOL-85 090385 013086 330 380 1152 156 O-ALA--3 POOL-86 020386 060586 202 210 1043 134 O-ALA--4 POOL-86 060986 071786 190 138 727 36 O-ALA--5 POOL-86 072186 092586 136 167 1229 60

~

l

~

267

Figure 24 Monthly Mean Quality Control Values 8-Amlnolevulinic Acid

50

45

40

-

0E0

t

Z0

3 -- 35 CJ

Q

i - 30

25

Z

U

~ 20 LI

15 E- E E U

10

5 A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND DELTAALA=A D-ALA--2=B D-ALA--3=C D-ALA--4=D D-ALA--5=E

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 25 Monthly Mean Quality Control Values Glycerol Blank

26

24

22

203 Cl

18cJ

316

Z o 14 b r21L b B--shyZ 10 W U Z 8 0 U 6

A A A A A A A ~ E E 4

2

J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 86

MONTH AND YEAR

LEGEND CHMTRK-l=A CHMTRK-3=B CHMTK-IR=C CHMTK-3R=D CHMTRK1B=E CHMTRK3B=H CHMTRK1C=1 CHMTRK3C=0

Table 45 Summary of Quality Control Data Glycerol Blank

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observati ll15

CHMTRK-1 U1-86058 060385 010986 48 035 731 448 CHMTRK-3 U3-86058 060385 010986 106 032 299 448 CHMTK-1R U1-8605B 011386 021386 51 016 318 80 CHMTK-3R U3-8605B 011386 021386 113 022 194 80 CHMTRK1B U1-8605B 021786 042886 48 014 297 164 CHMTRK38 U3-8605B 021786 042886 106 021 197 164 CHMTRK1C U1-8703B 042986 092586 116 029 253 260 CHMTRK3C U3-87038 04986 092586 243 064 265 260

1

268

I

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 46 Summary of Quality Control Data Cortisol (Morning) --_ _-_-- shyControl Lot Begin End Mean Standard Coefficient of No Name No Date Date (~gdl) Deviation Variation at gtservations

LYPHO--1 01001-85 060385 091985 26 022 839 114 LYPHO--2 01002-85 060385 092586 177 100 566 476 LYPHO--3 01003-85 092385 092586 283 164 579 362

Figure 26 Monthly Mean Quality Control Values Cortisol (Morning)

40r-shy

35 1 3 30Q ---B----c ~ ~ c C C 0~25 Z 0 f 20 ~ rl ~B B B B--8 8 B B 8 B e------B 8 --B-------B b Z 15 rLI U Z

u 0 10

5

A A A A

0 J85 J85 A85 585 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 ~86 586

MONTH AND YEAR

LEGEND LYPHO--l~A LYPHO--2=B LYPHO--3~C

r

I t

r

~ I ~

I t r

t

l LLiIIil]

shy

269

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

I I

I 1

j

Table 47 Summary of Quality Control Data T3 Uptake

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date () Deviation Variation Observal I )ns

LYPHO--1 01001-85 060385 092586 269 069 257 476 LYPHO--3 01003-85 060385 092586 414 093 226 476

Figure 27 Monthly Mean Quality Control Values T3 Uptake

46

44

E= 42 B B B 8 ---B---e z B~8 B B 8 8 8 ---8 U 40 il

e- 38

Z S 36 1shy ~ 30 Z

U 28 J -AZ -A --A0 JgtU 26 IAshy

24

22 J85 J85 A85 S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--l=A LYPHO--3=B

270

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 48 Summary of Quality Control Data Thyroid-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mIUL) Deviation Variation bservations --------------------------------~~--~---------------------LYPHO--2 01002-85 0610385 092586 138 062 447 480 LYPHO--3 01003-85 060385 092586 341 118 347 480

Figure 28 Monthly Mean Quality Control Values Thyroid-Stimulating Hormone

40

38

36

-1 B B - 34 J

~32 Z o 30 E= ~ 20 EshyZ ~ 18 U Z o 16 U

-A14 A--- A

12

10 J85 J85 A85 585 085 N8S D8S J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

I t 4 i

]

f I

11

271

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

1 l

I 1l i

1 i J i j l

l

Table 49 Summary of Quality Control Data Thyroxlne-T4

Control Lot Begin End Mean Standard Coefficient of Nu Name No Date Date (flgdl) Deviation Variation Obsen1 lions

LYPHO--2 01002-85 060385 092586 68 037 551 48 LYPHO--3 01003-85 060385 092586 144 063 435 4E

Figure 29 Monthly Mean Quality Control Values Thyroxlne-T4

18i

16

~ B B B B -B B B B B B B -8~ 3 14

a - CJ 12 i

S 10

~ ~ 8 t-lt

A-- A A A A~A A A A A A A --AZ A AIiJ u 6 Z 0 i U 4

2

0 -J I

J85 J85 A8S S85 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

272

iii 1l mil

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 30 Monthly Mean Quality Control Values Dehydroepiandrosterone-S04

220------------------------------------------------------------- -------~

200

180 3 Q ~ 160 (] i ~140 Z o b 120 lt ~ ~ 100+------------------------------------------------------------- ------~

rLI U Z 50 o U

40

30

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND LYFHO--2=A LYFHODIL=B LYFHO-2A=C LYFHODLA=D LYPHO-2B=E LYPHODLB=i

------~-----bullbull--bull_- _shy

Table 50 Summary of Quality Control Data Dehydroepiandrosterone-S04

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (lLgdl) Deviation Variation )bservations

LYPHO--2 01002-85 060385 030686 1800 1852 1029 292 LYPHODIL 01004-85 060385 030686 404 467 1155 292 LYPHO-2A 01002middot86 031086 072986 1638 1222 746 140 LYPHODLA 01004-86 031086 072986 438 391 893 140 LYPHO-2B 01002-86 073186 092586 1699 1769 1041 50 LYPHODLB 01004-86 073186 092586 380 335 882 50

273

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 31 Monthly Mean Quality Control Values Follicle-Stimulating Hormone

100 I

90 I -amp- B 8 --B---_--g 80

3 - J 70 ~

Z 0 60 r= ltr 0

50 Z b

~ U 40Z 0 A----A

1 ---A u

20

10 J85 J8S A85 585 G3S N8S 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHO--3~B

Table 51 Summary of Quality Control Data Follicle-Stimulating Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (I UlL) Deviation Variation Observe lions

----------~--~------------------------LYPHO--2 01002-85 060385 092586 345 214 621 481 LYPHO--3 01003-85 060385 092586 838 591 706 481

274

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 52 Summary of Quality Control Data Luteinizing Hormone

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (IUL) Deviation Variation bservationsI

LYPHO--2 01002-85 060385 092586 820 550 670 484 LYPHO--3 01003-85 060385 092586 1441 1054 732 484

Figure 32 Monthly Mean Quality Control Values Luteinizing Hormone

160------------------------------------------------------------- ------~

150

140

3 - 130 g Z 120 o ~ 110 0 E-lt ~ 100 U

5 90

U 80 ~-~~---kA--~A~~--~A--~Ar-~A~---~A~~A~--~A---A~-~

70

60l--~----------_----_--~--~----r_--~--_----~--_--_r ------~

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J8E A86 586

MONTH AND YEAR

LEGEND LYPHO--2=A LYPHO--3=B

l r

I 275

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 53 Summary of Quality Control Data Testosterone

Control Name

Lot No

Begin Date

End Date

Mean (ngdl)

Standard Deviation

Coefficient of Variation

No Observal i )ns

LYPHOmiddotmiddot2 LYPHODIL LYPHO-2A LYPHODLA

01002middot85 01004-85 01002-86 01004-86

060385 060385 040986 040986

040886 040886 092586 092586

4951 1821 6256 2994

2796 1769 2844 1345

565 972 455 449

338 338 154 154

Figure 33 Monthly Mean Quality Control Values Testosterone

600

550

3 ~ 500

o 3 450

Z o 400 b ~ 350 b

~ 300 U

23 250 U

200

s---e------Bshy150

1 0 0 ------- -------------

J85 J85 A85 585 085 N85 085 J86 F86 M86 A86 M86 J86 J86 A86 586

MONTH AND YEAR

LEGEND LYPHO--2~A LYPHOD[L~B LYPHO-2A~C L~PHODLA=D

shy

276

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 34 Monthly Mean Quality Control Values Immunoglobulin A (lgA)

550 -~~~-~--

500

450

3 -E 400

CJ

6 350

Z o 300

E= C2 250 Eshy

~ 200 U

5 150 U

100

50

c~

A

B G---1Dr---D~--~D--~D

f--- ---+----1

~ ~ ~ ~ ~ ~ ~ ~ I E E~

------JoLr~-~---~-----------~-------------------------

JI I S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HGHPOOL~E NORMPOOL=H NORPOOLB=

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 A86

Table 54 Summary of Quality Control Data Immunoglobulin A

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation )bservations

18 ELEV POOL-85 060385 061785 4446 3625 815 NORM POOL-85 060385 061785 2457 1580 643 18 H-NORPAR 218558 061885 100985 5246 2034 388 120 N-NORPAR 55A220 061885 100985 2158 747 346 120 HIGHPOOL POOL-85 101085 092586 931 325 349 344 NORM POOL POOL-85 101085 061986 1039 354 341 260 NORPOOL8 POOL-86 062386 092586 1689 405 240 84

277

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 35 Monthly Mean Quality Control Values Immunoglobulin G (lgG)

2400-----shy0~--------------------------------------middot---------------------

2200 ~- ~

2000 3E 1800

ecJ 1600

z o 1400 E= B g1200 ~-I)-----j+---9--D0 0

~ 1000

8 U

E E E E E E -E E t ~ t t800

U H H H II H II H H

600

400

200~--~--~r_--~----_r--_--~----r_--_-_--~----~--~--_-

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A56 M86 J86 J86 A86 S86

MONTH AND YEAR

LEGEND ELEV~A NORM=B H-NORPAR=C N-NORPAR=D HlGHPOOL=E NORMPOOL=H NORPOOLB=

Table 55 Summary of Quality Control Data Immunoglobulin G

Control Lot BegIn End Mean Standard CoefficIent of No Name No Date Date (mgdl) DevIation VarIatIon Observatlo 1 S

ELEV POOL-85 060385 061785 21598 9350 433 18 NORM POOL-85 060385 061785 13107 10797 824 18 H-NORPAR 218558 061885 100985 22698 12070 532 120 N-NORPAR 55A220 061885 100985 11713 5047 431 120 HIGHPOOL POOL-85 101085 092586 7957 2998 377 344 NORMPOOL POOL-85 101085 061986 6513 2613 401 260 NORPOOLB POOL-86 062386 092586 8797 2532 288 84

278

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Figure 36 Monthly Mean Quality Control Values Immunoglobulin M (lgM)

6500--------------------------------------------------------- ------~

6000

55003 Ci --shy~ 5000 ~

5 1000

E= -lt Ae 250 b Z CiJ 200u C Cz C CG0 u 150

B D 0 0 0

100 Gshy

H H II II H II 14--1- -l

50~--_--_----r_--~--_r--_r--_----r_--_--_--_r--_--_ -----~

J85 J85 A85 S85 085 N85 D85 J86 F86 M86 A86 M86 J86 Je A86 S86

MONTH AND YEAR

LEGEND ELEV=A NORM=B H-NORPAR=C N-NORPAR=D HIGHPOOL=E NORMPOOL=H NORPOOLB=i

Table 56 Summary of Quality Control Data Immunoglobulin M _~___~_ltgtmiddot~middotmiddotmiddotmiddotmiddotV_

Control Lot Begin End Mean Standard Coefficient of No Name No Date Date (mgdl) Deviation Variation Observations

ELEV POOL-85 060385 061785 2604 3489 1340 18 NORM POOL-85 060385 061785 1325 1108 837 18 H-NORPAR 218558 061885 1010985 1803 663 368 120 N-NORPAR 55A220 061885 100985 1202 394 328 120 HIGHPOOL POOL-85 101085 092586 59151 29279 495 346 NORM POOL POOL-85 101085 061986 931 298 320 262 NORPOOL8 POOL-86 062386 092586 977 355 363 84

279

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m

Table 57 Summary of Quality Control Data Semen Analysis

Control Standard Coefficient of No of Sperm Measure No Control Name Mean Deviation Variation Observatio s

Concentration million cellsml

Motile cells

Mean linear velocity jJmsec

Normal shaped cells

1001 1002 1003 1001 1002 1003 1001 1002 1003 2001

LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL LOW-CONTROL MID-CONTROL HIGH-CONTROL NOR-CONTROL

167 621

1347 506 535 803 542 532 308 727

111 382 559 485 544 304 349 417 144 811

662 615 415 959

1017 378 645 784 467

1115

20 20 18 20 20 18 20 20 18 92

Mean cell area jJm 2 2001 NOR-CONTROL 84 053 635 92

Mean cell perimeter jJm 2001 NOR-CONTROL 115 042 362 92

Mean lengthwidth ratio 2001 NOR-CONTROL 15 004 274 92

Mean major axis length jJm 2001 NOR-CONTROL 40 014 354 92

bull1

280

m