call-in information
DESCRIPTION
Call-In Information. Web meeting address: https://www.webmeeting.att.com Meeting number 8773361828 Access Code: 1666469 Join the audio portion at: 877-336-1828 Access code 1666469 (yes, they are the same) (the audio will not be able to be streamed through the computer). - PowerPoint PPT PresentationTRANSCRIPT
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Call-In Information
• Web meeting address: https://www.webmeeting.att.com – Meeting number 8773361828– Access Code: 1666469
• Join the audio portion at: – 877-336-1828– Access code 1666469 (yes, they are the same)
(the audio will not be able to be streamed through the computer)
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Michigan Regional Laboratory System
Laboratory In-service:Laboratory Director and Site
Coordinator Training
Jeffrey P. Massey, Dr.P.H., HCLD(ABB)Michigan Department of Community Health
Quality Manager517-335-8074
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Agenda
• Laboratory Quality Commandments• Guidelines for review of QC documentation• Good Laboratory Practice & Laboratory
Documentation• Responsibilities
– Lab Director– Clinical Consultant– Site Coordinator
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Laboratory Quality Commandments
Yes, they are carved in stone!
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I.I. Thou shall not perform
any clinical test for which thou
are not trained and checked
for competency.
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• . II. Thou shall not use any expired reagents or supplies to perform any clinical test, including quality control evaluations
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III.III. Thou shall not perform any patient test for which any of the Quality Control checks have failed.
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IV. Thou shall not perform any test in any manner except as specified in the written standard operating procedure or manufacturers product insert.
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Laboratory Quality Commandments
• There are no exceptions!
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Quality Assessmentanswers these questions
Does the procedure work the way it is supposed to work?
Does the data produced reflect a real condition in the client?
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Quality Control:Quality Assessment Component
• Intended to detect, reduce, and correct errors prior to the release of patient results.
• QC measures of precision or how well the measurement system reproduces the same result over time and accuracy or if that measurement is what is really present in the patient.
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Quality ControlIn practice, we have three parameters to evaluate:
1. The Instrument:• Does the instrument perform as expected*?
2. The Reagents:• Do the reagents perform as expected?
3. The Analyst:• Is the person performing the test correctly?
*within the parameters in the manufacturer’s insert as approved by the FDA
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Quality Control: Equipment
• What equipment preventative maintenance is indicated by the manufacturer?
• Has the indicated maintenance been performed:– on schedule?– and documented?
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Quality Control: Equipment
• Instrument Checks– Display shows what it is supposed to when
power is turned on.• Self check is ok?
– Instrument check device• Optics Cuvette• Calibration Cassette• Calibration strip, tag, stick
– Calibration checks are within expected range
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Quality Control: Reagents
• Guidelines apply to Test reagents and QC materials!
• Determine closed vial (or other container) expiration date specified by manufacturer.– Specific date (March 13, 2011 = March 13, 2011)– End of the month (June 2011 = June 30, 2011)
• Determine open vial expiration date– 30, 60 or 90 days after opening– Open vial expiration date CANNOT exceed the
closed vial expiration date
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Quality Control: Reagents
• Store according to manufacturer’s instructions– Protect from moisture and light– Bring to room temperature before opening
packet unless manufacturer says otherwise
• Open only what you need– Monitor/document room temperature if reagents
stored at room temp or test performed at room temp
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Quality Control: Reagents
• If any of your reagents are expired, then you can not perform the test for clinical purposes.
• Options:– Find some reagents that are not expired– Use your backup plan, or – Cancel your clinic!
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Quality ControlA Reagent Cardinal Rule
• NEVER, EVERNEVER, EVER use expired reagents to test clinical specimens.
• Expired reagents should be:– Discarded– Marked: Warning: EXPIRED. Use for
training only. Not for clinical use.
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Quality Control: Reagents• QC material has an established value (or range of
values) for the analyte being measured by the test. • QC frequency minimally must follow those
established by the lab director for non-waived tests or is stated in the manufacture’s insert for waived tests.
• Record the results of QC materials at the time of testing.
• Do not proceed with patient testing if QC values are not acceptable
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Quality Control ”The job is not done until the paperwork is
complete”
• Quality Control Log Sheets– The frequency or interval for QC testing depends upon
the test: check your procedure manual for appropriate intervals
– Document instrument control checks• Make sure the machine works before you proceed to test the
reagents.
– Document results at the time you obtain the result – don’t rely on your memory by filling in the result later
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Quality Control Quality Control Log Sheets
• Document lot numbers and expiration dates (both open vial and closed vial expiration dates)
• Test both high and low level controls. (Positive and negative if pregnancy or urine dipstick).
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Reporting Results:Positive
• Be consistent in how positive results are documented
• Positive– P– Pos– Positive
– Do not use the Symbol “+”
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Reporting Results:Negative
• Be consistent in how negative results are documented:
• Negative– N– Neg– Negative
– Do not use the symbol “-”
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Reporting Results:Quantitative
• Use 1+, 2+, 3+, 4+
• Do not use +, ++, +++, ++++
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Quality Control Quality Control Log Sheets
• If the results for high and/or low controls were out of range, consult the Trouble Shooting Guide
• Record any corrective action(s) taken on the QC Log– Your surveyor will say, “If you didn’t record it
then I must assume that you didn’t do it”.
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Quality ControlHave a back up plan!
• If your instrument or reagents fail the quality control checks; You may not You may not use that procedure for clinical use that procedure for clinical testing testing until;– Corrective action has been taken and – The instrument and reagent checks pass
all quality control checks.
• There are no exceptions to this ruleThere are no exceptions to this rule.
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The Penalty for Reporting Results if there is a QC Failure ……
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Quality Control
• QC Logs need to be reviewed:– By the Site Coordinator on a regular basis
(monthly or quarterly)– By the Laboratory Director on a regular basis
• May review a representative sample rather than all records
– Your assigned Technical Consultant will review if requested (Enhanced Services Option)
• Corrective action is required if problems are identified
• QC Records need to be filed for 2 years in a manner that allows ready retrieval.
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Quality Control: Testing Personnel
• Qualifications– Moderately complex– PPM– Waived
• Training– Cover all phases of testing– Checklists helpful
• Documented Competency– Direct observation– Trouble shooting scenarios
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Quarterly Chart AuditAn Important Quality Assessment activity
• Required for non-waived testing, recommended for waived testing
• Quarterly Chart Audit.– Verify that the QC Logs are completed for each test
performed• Lot # & expiration date, QC within acceptable limits,
corrective action initiated as required
– Randomly select 3-5 clients for each test. Verify that laboratory data is accurately transcribed to their chart; QC was performed and acceptable on the day of testing, testing personnel was trained and competent on the day of testing.
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Quality Control
“Quality in never an accident. It is always the result of an intelligent effort. It is the will to produce a superior thing.”
John Ruskin
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Good Laboratory Practice
• Quality Records & Documentation: Characteristics of a Good Record– Overall appearance– Permanence (pen not pencil)– Initials vs. Signature on record– Timing– Completeness– Appropriate error correction
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Overall Appearance
• Include document control elements
• Keep forms simple
• Allow enough room for data entry
• Entries must be legible
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Characteristics of a Good Record:Overall appearance/permanence
• Legibility is essential• Write in permanent
ink– No pencil– No White Out
Is this Jan or Jun? Is this 2000 or 2006?
Is this 1 or 7?
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Quality RecordPermanence
• Always use:– Black or blue indelible ink
• DO NOT USE:– Markers, felt tip pens, gel pens, glitter
pens, pencil, liquid paper, White Out
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Characteristics of a Good Record:Timing
Room Completed
(Place a √)
Initials Date Date
105 √ JPM 4/16/10 4/15/10
106 √ JPM 4/16/10 4/15/10
Date completed: April 15, 2010
WRONG CORRECT
By waiting to record tasks, you may forget to fill out the documentation. A later date causes speculation.If it is not documented – the task was not done.
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Quality Records and Documentation: Completeness of Record
• Decimals
• Not applicable (N/A)
• Not in Use / Test Not Performed
• Expression of dates
• Arrows/ditto marks
• Initials vs. Signature
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Completeness of RecordNot Applicable (N/A)
• When completing a form, indicate the spaces or blanks that do not require a response.
• Record “NA” in spaces or blanks that do not apply to the situation. Do not leave spaces blank
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Completeness of RecordNot Applicable (N/A)
Room Completed
(Place a √)
Date Initials
105 √ 4/16/10 JPM
106
Blanks look as though operator forgot to complete the entry
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Completeness of RecordNot Applicable (N/A)
Room Completed
(Place a √)
Date Initials
105 √ 4/16/10 JPM
106 N/A 4/16/10 JPM
Fill in any entry spaces that are not to be completed with “N/A”
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Completeness of RecordNot in Use or Test Not Performed
• When an instrument is not used that day, enter “Not in Use” in the appropriate space. Include your initials and the date where needed.
• When a Test was not performed, enter “TNP” in the appropriate space, and include your initials and the date where needed.
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Completeness of RecordsExpression of Dates
• All dates should be entered as month, day, year– Examples
• April 16, 2010• Apr 16, 2010• 4/16/10• 04/16/2010
• The year must be recorded on all forms
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Correction of Erroneous Entries
• DO Not:– Use “White Out” (e.g., Liquid Paper)– Use erasors– Obliterate – Write over– Tape over
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Appropriate Error Correction:Obliteration
• Do Not Obliterate an Entry
– What would a reviewer think?– Site Coordinator– Laboratory Director– Surveyor
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Appropriate Error CorrectionWrite Over
• Do Not write over incorrect entries
• Again – what would a reviewer think??
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Procedure for correcting erroneous entries
• 1. Incorrect Result
• 2. Draw a single line through incorrect entry
• 3. Write correct result next to incorrect entry
• 4. Initial and date the correction
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Laboratory Director: Primary Responsibilities
(both Waived & Non-Waived Labs)
• Has ultimate responsibility for ALL testing
• Must ensure quality laboratory services
• Assign in writing the duties/responsibilities for each person involved in all phases of the testing process
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Responsibilities of Lab Director:Waived Laboratory
• Ensure testing is performed EXACTLY as stated by the manufacturer (including QC)
• Ensure that laboratory staff follow good laboratory practice
• Permit announced or unannounced inspections
• Maintain current CLIA certification
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Laboratory Director Responsibilities (for moderate complexity testing)
• Ensure safe working environment• Ensure tests chosen provide quality of
results required for client care• Ensure enrollment in PT program• Ensure Quality Control & Quality
Assessment programs are established & maintained
• Ensure corrective action is taken & documented
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Laboratory Director Responsibilities (cont.)
• Ensure test results only reported when test is functioning properly
• Ensure reports of test results include information for interpretation
• Ensure consultation of test results
• Ensure the lab employs sufficient number of testing staff
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Laboratory Director Responsibilities (cont.)
• Ensure testing staff are trained and competent
• Ensure procedure manual is available (review and sign on annual basis)
• Specify in writing the responsibilities of each consultant and testing staff
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Responsibilities That CAN Be Delegated
• Selection of test menu
• Enrollment in PT program
• Maintenance of QC/QA program
• Corrective action program
• Training and Competency of staff
• Make procedure manual available to staff
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Responsibilities that CAN be Delegated to Clinical Consultant
• Interpretation of test results
• Consultation available to clients concerning quality of test results
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Responsibilities that CANNOT be delegated by Lab Director
• Ensure safe working environment
• Ensure proper size of testing staff
• Ensure overall quality of test results
• Ensure annual review and signature of test procedures
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Questions?
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Questions???