quality assurance programmes for laboratory testing - an overview elizabeth m. dax national serology...

Quality Assurance Programmes for Laboratory Testing -

An Overview

Quality Assurance Programmes for Laboratory Testing -

An Overview

Elizabeth M. DaxElizabeth M. Dax

National Serology Reference National Serology Reference Laboratory, AustraliaLaboratory, Australia

www.www.nrlnrl..govgov..auau

Elizabeth M. DaxElizabeth M. Dax

National Serology Reference National Serology Reference Laboratory, AustraliaLaboratory, Australia

www.www.nrlnrl..govgov..auau

Quality AssuranceQuality Assurance

Is the series of procedures that ensure that a correct result is achieved in a standard,

reproducible and traceable manner.

Is the series of procedures that ensure that a correct result is achieved in a standard,

reproducible and traceable manner.

Quality Assurance SystemQuality Assurance System

Kit EvaluationKit EvaluationKit EvaluationKit Evaluation

Performance Monitoring


Strategy developmentStrategy development

Trouble shootingTrouble shooting

Tertiary Reference TestingTertiary Reference Testing

Specificity monitoringQuality ControlQAP(Batch testing)


QUALITY PERFORMANCEPERFORMANCEQUALITY PERFORMANCEPERFORMANCE

Pre-marketing Pre-marketing


Document Control/SOPsDocument Control/SOPs

Equipment maintenanceEquipment maintenance

QAPQAP

SafetySafety

TrainingTraining

Trouble ShootingTrouble Shooting

Specimen Collection

Specimen Collection

Specimen Processing

Specimen Processing

TestingTestingQCQC

Reporting Reporting Other Management ControlsOther Management Controls

Quality Assurance ProgrammeQuality Assurance ProgrammeQuality Assurance ProgrammeQuality Assurance Programme

1. Test Kit Evaluation

1. Test Kit Evaluation

whenwhen

what,

howwhat,

how

Pre-market Pre-market Post-market Post-market

7. Re-evaluation7. Re-evaluation4. QC4. QC

3. QAP3. QAP

8. Strategy development

8. Strategy development

5. Monitoring5. Monitoring2. Batch Testing

2. Batch Testing

6. Trouble shooting

6. Trouble shooting

NRL NRL Laboratories Laboratories Collaborative Collaborative who,

wherewho,

where

1. Evaluation (Re-evaluation)1. Evaluation (Re-evaluation)

ReasonsReasons

RequirementsRequirementsResources Resources

requiredrequired

ReasonsReasons

RequirementsRequirementsResources Resources

requiredrequired

Assess test, Assess test, baseline data for baseline data for QAQA

Evaluation panelsEvaluation panelsRegulations, serum Regulations, serum panels, storage panels, storage facilitiesfacilities

Assess test, Assess test, baseline data for baseline data for QAQA

Evaluation panelsEvaluation panelsRegulations, serum Regulations, serum panels, storage panels, storage facilitiesfacilities

EvaluationsEvaluations

An evaluation is the appropriate An evaluation is the appropriate assessment of the working assessment of the working performance of a test kit or performance of a test kit or

an assay an assay at a point in time.at a point in time.

An evaluation is the appropriate An evaluation is the appropriate assessment of the working assessment of the working performance of a test kit or performance of a test kit or

an assay an assay at a point in time.at a point in time.

7. Use the results7. Use the results 7. Use the results7. Use the results 6. Collate and analyse the data6. Collate and analyse the data 6. Collate and analyse the data6. Collate and analyse the data

5. Perform the testing5. Perform the testing5. Perform the testing5. Perform the testing

44. Select an evaluation panel. Select an evaluation panel44. Select an evaluation panel. Select an evaluation panel

3. Write evaluation protocol3. Write evaluation protocol3. Write evaluation protocol3. Write evaluation protocol

2. Examine the data2. Examine the data 2. Examine the data2. Examine the data

1. Gather information on the kit1. Gather information on the kit 1. Gather information on the kit1. Gather information on the kit

Evaluation

Evaluation

Process

ProcessEvaluation

Evaluation

Process

Process

Distributions of +ve & -ve samples in a “perfect” assay

Distributions of +ve & -ve samples in a “perfect” assay

cutoffcutoff

OD/CoOD/Co

Fre

qu

ency

Fre

qu

ency

cutoffcutoff

OD/CoOD/Co

Fre

qu

ency

Fre

qu

ency

Distributions of +ve & -ve Samples in a Serological Assay




cutoffcutoffcutoffcutoff

OD/CoOD/CoOD/CoOD/Co

Fre

qu

ency

Fre

qu

ency

Fre

qu

ency

Fre

qu

ency OTHER FACTORSOTHER FACTORS

(unrelated to antibody)(unrelated to antibody)

•High IgMHigh IgM

•Rheumatoid factorRheumatoid factor

•Sample related factors Sample related factors

•Physical disruptionPhysical disruption

OTHER FACTORSOTHER FACTORS

(unrelated to antibody)(unrelated to antibody)

•High IgMHigh IgM

•Rheumatoid factorRheumatoid factor

•Sample related factors Sample related factors

•Physical disruptionPhysical disruption

PathogenesisPathogenesis

Seroconversion Seroconversion

Seroconversion Seroconversion

AsymptomaticAsymptomaticAsymptomaticAsymptomaticARC/AIDSARC/AIDSARC/AIDSARC/AIDS

4-5 weeks4-5 weeks4-5 weeks4-5 weeks Up to 12 yearsUp to 12 yearsUp to 12 yearsUp to 12 years 2-3 years2-3 years2-3 years2-3 years

Neutralising Neutralising AntibodyAntibodyNeutralising Neutralising AntibodyAntibody

p24 Ag - Viraemiap24 Ag - Viraemiap24 Ag - Viraemiap24 Ag - Viraemia

NAA viral loadNAA viral load

2. Pre-marketing Batch Testing2. Pre-marketing Batch Testing

Usually by regulationUsually by regulation Usually by central laboratoryUsually by central laboratory Other measures may be used “in-Other measures may be used “in-

house”house”

Usually by regulationUsually by regulation Usually by central laboratoryUsually by central laboratory Other measures may be used “in-Other measures may be used “in-

house”house”

3. Quality Assessment Programme3. Quality Assessment Programme

ReasonsReasons

RequirementsRequirements

Resources Resources requiredrequired

ReasonsReasons



Assess laboratory Assess laboratory processesprocesses

QAP panels, data QAP panels, data processing,questionnairesprocessing,questionnaires

Materials, QA coordinationMaterials, QA coordination

Assess laboratory Assess laboratory processesprocesses

QAP panels, data QAP panels, data processing,questionnairesprocessing,questionnaires

Materials, QA coordinationMaterials, QA coordination

Quality Assessment(also known as proficiency testing)

Quality Assessment(also known as proficiency testing)

Method by which the quality of results generated by a particular

laboratory is determined.

Method by which the quality of results generated by a particular

laboratory is determined.

Quality Assessment ProgrammeQuality Assessment ProgrammeQuality Assessment ProgrammeQuality Assessment Programme

Definition: Definition: Method by which the entire testing Method by which the entire testing

process including the quality of results process including the quality of results generated by a particular laboratory is generated by a particular laboratory is assessed.assessed.

Definition: Definition: Method by which the entire testing Method by which the entire testing

process including the quality of results process including the quality of results generated by a particular laboratory is generated by a particular laboratory is assessed.assessed.

1A. Questionnaire1A. Questionnaire

1B. New Participants1B. New Participants

2. Preparation of Panels2. Preparation of Panels2. Preparation of Panels2. Preparation of Panels

3. Panel Distribution3. Panel Distribution3. Panel Distribution3. Panel Distribution

4. Data Collection4. Data Collection4. Data Collection4. Data Collection

5. Preliminary report 5. Preliminary report 5. Preliminary report 5. Preliminary report

6. Data Analysis 6. Data Analysis 6. Data Analysis 6. Data Analysis

7. Final report7. Final report7. Final report7. Final report

QAP Process

QAP Process

QAP Process

QAP Process

Quality Assurance Programme Element: Performance Monitoring

Quality Assurance Programme Element: Performance MonitoringReasonsReasons



ReasonsReasons



Check performance in Check performance in use, check batchesuse, check batches

QC, data collection , QC, data collection , batch testingbatch testing

Communication, Communication, infrastructure (Lab infrastructure (Lab network)network)




4. Quality Control Programme4. Quality Control Programme

Measures that are used to ensure Measures that are used to ensure that that a test a test is working to the is working to the

highest standard.highest standard.

Measures that are used to ensure Measures that are used to ensure that that a test a test is working to the is working to the

highest standard.highest standard.

Process for the use

Process for the use

of Quality Controls

of Quality Controls

Process for the use

Process for the use

of Quality Controls

of Quality Controls

1. QC Sample1. QC Sample

2. Determine Acceptable Ranges2. Determine Acceptable Ranges

3. Include in all test runs3. Include in all test runs

4. Data Collection4. Data Collection

5. Data Analysis5. Data Analysis

6. Accept or Reject Run6. Accept or Reject Run

7. If Variation Identified Investigate

7. If Variation Identified Investigate

NRL QC DataNRL QC Data

0

1

2

3

4

5

Mean -2SD

15/8/9715/8/97

date date

Mean Mean +2SD+2SD

MeanMean

10/3/9810/3/98

Invalid Kit Invalid Kit ControlsControls

Invalid QC Invalid QC samplesample

Batch 2

Batch 2Batch 3

Batch 3

Batch 1Batch 1

5. Performance Monitoring5. Performance Monitoring

ReasonsReasons



ReasonsReasons









Monitoring Assay Performance--ongoing evaluation of assay

performance

Monitoring Assay Performance--ongoing evaluation of assay

performance

Monitoring specificityMonitoring specificity Monitoring sensitivityMonitoring sensitivity

Monitoring specificityMonitoring specificity Monitoring sensitivityMonitoring sensitivity

6. Trouble shooting6. Trouble shooting

ReasonsReasons

RequirementsRequirements Resources Resources

requiredrequired

ReasonsReasons

RequirementsRequirements Resources Resources

requiredrequired

Prevention of Prevention of problemsproblems

Panels, testingPanels, testing Quality control Quality control

program, regulationsprogram, regulations

Prevention of Prevention of problemsproblems

Panels, testingPanels, testing Quality control Quality control

program, regulationsprogram, regulations

“Trouble- Shooting”“Trouble- Shooting”

Sorting out testing problemsSorting out testing problemsSorting out testing problemsSorting out testing problems

Reported

problemsReported

problems

Sample Equipment Methods

Sample Equipment Methods

Personnel Assay

Personnel Assay

Trouble ShootingTrouble Shooting

8. Strategy development 8. Strategy development

ReasonsReasons



ReasonsReasons



Assure testing is Assure testing is accurate & efficientaccurate & efficient

Testing samples, Testing samples, collecting datacollecting data

Data collection and Data collection and analysis skillsanalysis skills

Assure testing is Assure testing is accurate & efficientaccurate & efficient

Testing samples, Testing samples, collecting datacollecting data

Data collection and Data collection and analysis skillsanalysis skills

Strategy DevelopmentStrategy Development

A strategy is a series of scientifically verified A strategy is a series of scientifically verified testing steps using a combination of assays that testing steps using a combination of assays that

are employed to reach the correct diagnosis.are employed to reach the correct diagnosis.

A strategy is a series of scientifically verified A strategy is a series of scientifically verified testing steps using a combination of assays that testing steps using a combination of assays that

are employed to reach the correct diagnosis.are employed to reach the correct diagnosis.

Strategy DevelopmentStrategy Development

Understanding the predictive values Understanding the predictive values of the testsof the tests

Obtaining the appropriate dataObtaining the appropriate data Multivariant analyses of the data to Multivariant analyses of the data to

assess the predictive value of test assess the predictive value of test combinations used in sequencecombinations used in sequence

Understanding the predictive values Understanding the predictive values of the testsof the tests

Obtaining the appropriate dataObtaining the appropriate data Multivariant analyses of the data to Multivariant analyses of the data to

assess the predictive value of test assess the predictive value of test combinations used in sequencecombinations used in sequence

Quality Assurance SystemQuality Assurance System

Kit EvaluationKit EvaluationKit EvaluationKit Evaluation



Strategy developmentStrategy development

Trouble shootingTrouble shooting

Tertiary Reference TestingTertiary Reference Testing




Pre-marketing Pre-marketing

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