quality in the clinical microbiology laboratory

8/6/2019 Quality in the Clinical Microbiology Laboratory

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Quality in The Clinical Microbiology Laboratory

Dr.F.Rashedmarandi

Reference laboratories of IranResearch center


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Total laboratory Quality Program

Total quality management( TQM)

Continuous quality Improvement ( CQ I) or Performance improvement ( PI)Quality Control ( QC)

Quality Assurance ( QA)


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TQM

TQM evolved as an activity to improve patients care by having the laboratory

monitor


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CQI and PI

CQ I and PI went a step further by seekingto improve patients care by placing the

emphasis on not making mistake on first place; CQ I and PI advocate continuous

training to guard against having to correct

deficiencies


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QC

QC is now associated with the internalactivities that insure diagnostic accuracy.

QA is associated with those externalactivities that ensure positive patient

outcome.


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Positive Patient outcome in the

Microbiology laboratoryReduced length of stay

Reduced cost of stayReduced turn-around time for diagnosis of

infectionChange to appropriate antimicrobial therapy

Customer ( physician or patients)satisfaction


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QC program

The laboratory director is primarilyresponsible for QC and QA programs.

However all laboratory personnel mustactively participate in both program


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The basic elements of QC

S pecimens collection and transport.Standard operating procedures ( SOPM) .

PersonnelProficiency testing

Performance checksAntimicrobial Susceptibility tests

Eminence of QC proceduresMaintence of QC stocks

Patients reports


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S PECIMEN COLLECTION AND

TRAN S PORT

The laboratory is responsible for providinginstructions for the proper collection and

transport of specimens . These instructionsshould be available to the clinical staff for

use when specimens collected


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W ritten collection instruction

Test selection criteriaPatients selection criteria

Timing of specimen collection (e.g.,Before antimicrobial are administration )

O ptimal specimen collection siteApproved specimen collection method

S pecimen transport medium


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S pecimen transport time and temperatureS pecimen holding instructions if it cannot be

transported immediately (e.g. hold at 4 C for 24hours )

Availability of test (on site or sent to referencelaboratory )

Hours test performed (daily or batch )Turn-around time

Result reporting procedures


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Information should be filled

Patient nameHospital or laboratory number

Ordering physicianWhether the patient receiving antimicrobial

therapySuspect agent or syndrome


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Criteria for unacceptable specimens

Unlabeled or mislabeled specimensUse of improper transport medium

Excessive transport timeImproper temperature during transport or storageImproper collection site for test request

S pecimen leakage out of transport container

Sera that are excessively hemolyzed ,lipemic, or contaminated with bacteria


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S tandard operating procedure

Manuel ( S

OPM)The S OPM is considered part of QC

The SOPM should define test program. performance , tolerance limits, reagent

preparation, required quality control ,resultreporting and references.

The SOPM should be written in N CCLS format and must be reviewed and signed

by the microbiology director.annually


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Sections of SOP

Title (name of procedure )Priniciple (reason for performing the test )Preferred specimen patient preparation

Transport container (need for anticoagulant, preservative, or holding medium )Transportation conditions (wet ice, room temperature ).

S pecimen storage in Laboratory (room temperature, 4 C, -20 C,- 10 C)Criteria for unacceptable specimen (delay in transport, leaking container, presence

of barium )S pecial safety precautions (tape plates for AF B or brucellae )

Reagents or media required and incubation conditionsExamination of cultures

Guidelines for identification and susceptibility testing by culture type (respiratory,urine, blood, stool )

Required quality controlmethods for reporting positive, negative, and unsatisfactory results

Technical notes, including possible sources of error and helpful hintsReferences


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available in the work The SPOM should be.It is the definitive laboratory referencearea

and is used often for questions relating to Any obsolete proceduresindividual test .

should be dated when removed from SPOM

and retained for at least 2 years.


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Personnel

It is laboratory director's responsibility to employfor the volume and sufficient qualified personnel

complexity of the work performed. Document competency and training twice a year

Continuing education program should be provided

All documentation should maintained in personnel file


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Proficiency Testing

Laboratories are required to participate in anexternal proficiency testing ( PT)

The laboratory must maintain an average score of 80%to maintain licensure in any subspecialty area.The laboratory's procedures, reagents, equipments

and personnel are all checked in the process.


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PT or External quality control

Provide laboratory management with an insightinto their performance

Improve both local and national standardsReveals unsuspected area of difficultyProvides an educational stimulate for

improvements

Acts as a check on the efficacy of internal qualitycontrol procedures

Demonstrates to colleagues and customers acommitment to quality


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Performance Checks

InstrumentEquipment logs should contain the

following informationInstrument name, serial number, and date

put useProcedure and periodicity( daily, weekly,

monthly ) for routine function check )


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Acceptable performance rangesInstrument function failure ,including

specific details of steps taken to correct the problems (corrective action )

Date and time of services requests and

responseDate of routine preventive maintence ( PM) which should follow manufactures

recommondations


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Maintenance records should be retained inthe laboratory for the life of instrument.

S pecific guidelines regarding periodicity of testing for autoclaves, biological softy

cabinets ,centrifuges ,incubators,

microscope, refrigerators ,freezers, water bathes , heat blocks and other microbiologylaboratory can be found in reference books


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Commercially Prepared Culture

MediaThe N CCLS subcommittee on media

quality control collected data over several`years regarding the incidence of QC failure

of commonly used microbiology mediaBased on its finding the subcomm ittee

published a list of media that did not requireretesting in the user's laboratory if

purchased from a manufactures who follow NCCLS guidelines


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The laboratory must inspect each shipment for Cracked media

Excessive bubblesClarity

HemolysisFreezing

Unequal fillingVisible contamination


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U ser-Prepared and Nonexempt

,commercially prepared MediaQC forms for user-prepared media should

contain:The amount of prepared

The source of each ingredientThe lot number

Sterliza5tion methods


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The preparation dateThe expiration date ( Usually 1 month for

agar plate and 6 month for tube media )The name of prepare

All user prepared colures media also shouldchecked for:


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Proper color Depth

SmoothnessHemolysis

Excessive bubblesContamination


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S terility Check

A representative sample of the lot should betest for sterility;5%of any lot is tested when

a batch of 100 or fewer unit is received and maximum of 10 units are tested in large

batches.

Sterility is routinely checked by incubatingthe medium for 48 hours at the temperatureat which it will be used.


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Performance testing

When medium dose need to quality controlled because it was prepared in house (in the

laboratory ) or because it is complex, several basicrules must be followed :

All media must be tested before useEach medium must be tested with organisms

expected to give positive reaction as well as withyorganism expected either not to grow or produce a

negative reaction


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The medium should be tested for sterility and PHThe organisms selected for QC should represent the mostfastidious organisms for which the medium was designed

Testing technique should be different for primary platingmedia that for biochemical or subculture media. Primary

plating media should be tested with dilute suspensions of organisms, whereas biochemical media can be tested with

undiluted organisms

QC testing should be performed according to N CCLS recommendationExpiration date must be established


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Media failure log

Date 2/14/98Media TMS slants

Lot# In house preparation 2/13/98

Expiration date 6 month from preparationQuantity 2 racksFailure failure to give proper

reaction with S .epidermidis ,s.aureus and other coag-neg S

Action taken Qc repeated with S.epidermidis failedMemo sent to all techs and all tubes discarded

.New TMS preparedTechnologist MAR


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U se of S tock Cultures

To operate a quality control program, stock culture must be maintained by all

laboratories . They are available from manysources.

Commercial sources

Proficiency testingPatients isolates

American Type Culture Collection (A TCC)


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When quality control testing appears havefailed, it is usually the stock culture rather

than the test itself that has failed. Organismsmay mutate with repeated sub culturing. for

best results ,a stock culture should be grown

in a large volume of broth ,then dividedamong enough small freezer vials to last ayear


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With this technique a new vial can be removedfrom the freezer weekly so that organism do not

have to be continually subcultured .An organismmay need to be subcultured twice after thawing toreturn it to a healthy state. Media selection for

freezing is at the discretion of individuallaboratories but should not contain sugar. If

organism utilize sugar while being maintained ,theacid products that result may kill organism with

time.


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Popular Media for S tock Cultures

Schaeler broth with glycerolChopped meat (anaerobes )

Tryptic S oy agar deeps (at roomtemperature)

Cystein-tryptic agar ( CTA) withoutcarbohydrates


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Nonfastidious (rapidly growing ), aerobic bacterialorganisms can be saved up to 1 years on TSA

slants . Long term storage of aerobes or anaerobescan be accomplished either by lyophilizartion

(freeze drying ) or freezing ,at -70 C.Frozen ,nofastidious organism should be thawed ,reisolatedand refrozen every 5 years; fastidious organisms

should be thawed reisolated ,and refrozen every 3years. Stock isolated may be maintained by

freezing them in 10% skim milk , Trypticase SoyBroth ( TSB) with 15% glycerol .


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S tain and Reagents

Containers of stains and reagents should belabeled as to contents, concentration

,storage requirements, date prepared (or received ) date placed in service ,expirationdate, source (commercial manufacture or user prepared ) and lot number .All stainsand reagents should be stored according

manufacture's recommendations and testedwith positive and negative controls before

use.


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All stain Hippurate Instrument failureBacitracin Nitrate inoculum

B-lactamase O ptochin TemperatureCAMP PY R Moisture

Catalase Typing se Difficulty inCoagulase VP determining

FeCl3 X and V strips endpointGelatin Cation content

Germ tube Thymidin


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Antisera

received, conditiondate,lot number Thereceived ,and expiration date must be

recorded for all shipments of antisera.Inaddition ,the antisera should be dated when

opened .New lots must be tested

concurrently with previous lots, and testingmust include positive and negative controls.


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Maintence of QC records

All QC results should be recorded on anshould beCorrective action.QC formappropriate

aor temperature is adjusted noted on this form .If , the new reading withinbiochemical test repeated

the tolerance limits should be listed. In manyand initials allreviewslaboratories the supervisor

and the director then reviews eachweeklyformsQC records should be maintained for monthly.one

except those on equipment ,whichyears2at leastlife of instrument must be saved for the


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Patient Report

systemThe laboratory should established a for supervisory of all laboratory reports.

checking theThis review should involveto verify that the correct specimens workup

conclusion were drawn and no clerical

errors were made in reporting results.Reports should be given only given onlyauthorized by law to receive them.


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panic Clinician should be notified aboutimmediately. Panic values are values

potential-threatening results, for example positive Gram stain for CSF or a positive

All patients records should be blood culture.

years.2maintained for least

quality in the clinical microbiology laboratory

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