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Quality Assurance Programmes for Laboratory Testing - An Overview . Elizabeth M. Dax National Serology Reference Laboratory, Australia www.nrl.gov.au. Quality Assurance.

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Quality Assurance Programmes for Laboratory Testing -An Overview

Elizabeth M. Dax

National Serology Reference Laboratory, Australia

www.nrl.gov.au


Quality Assurance

Is the series of procedures that ensure that a correct result is achieved in a standard, reproducible and traceable manner.


Strategy development

Trouble shooting

Tertiary Reference Testing

Quality Assurance System

Kit Evaluation

Performance Monitoring

Specificity monitoringQuality ControlQAP(Batch testing)

QUALITY PERFORMANCE

QUALITY PERFORMANCE

Pre-marketing


Equipment maintenance

Specimen Collection

QAP

Safety

Specimen Processing

Training

Testing

QC

Trouble Shooting

Document Control/SOPs

Reporting

Other Management Controls


Quality Assurance Programme

when

Pre-market

Post-market

who, where

NRL

Laboratories

Collaborative

6. Trouble shooting

3. QAP

1. Test Kit

Evaluation

what,how

4. QC

7. Re-evaluation

2. Batch Testing

8. Strategy development

5. Monitoring


Reasons

Requirements

Resources required

Assess test, baseline data for QA

Evaluation panels

Regulations, serum panels, storage facilities

1.Evaluation (Re-evaluation)


Evaluations

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

an assay at a point in time.


1. Gather information on the kit

2. Examine the data

EvaluationProcess

3. Write evaluation protocol

4. Select an evaluation panel

5. Perform the testing

6. Collate and analyse the data

7. Use the results


cutoff

Frequency

OD/Co

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


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

cutoff

Frequency

OD/Co


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

  • OTHER FACTORS

  • (unrelated to antibody)

    • High IgM

    • Rheumatoid factor

    • Sample related factors

    • Physical disruption

cutoff

Frequency

OD/Co


Pathogenesis

Seroconversion

ARC/AIDS

Asymptomatic

Neutralising Antibody

NAA viral load

p24 Ag - Viraemia

4-5 weeks

Up to 12 years

2-3 years


2. Pre-marketing Batch Testing

  • Usually by regulation

  • Usually by central laboratory

  • Other measures may be used “in-house”


Reasons

Requirements

Resources required

Assess laboratory processes

QAP panels, data processing,questionnaires

Materials, QA coordination

3. Quality Assessment Programme


Quality Assessment(also known as proficiency testing)

Method by which the quality of results generated by a particular laboratory is determined.


Quality Assessment Programme

  • Definition:

    • Method by which the entire testing process including the quality of results generated by a particular laboratory is assessed.


1A. Questionnaire

1B. New Participants

2. Preparation of Panels

3. Panel Distribution

4. Data Collection

5. Preliminary report

6. Data Analysis

7. Final report

QAP Process


Reasons

Requirements

Resources required

Check performance in use, check batches

QC, data collection , batch testing

Communication, infrastructure (Lab network)

Quality Assurance ProgrammeElement: Performance Monitoring


4. Quality Control Programme

Measures that are used to ensure that a test is working to the highest standard.


1. QC Sample

2. Determine Acceptable Ranges

Process for the use of Quality Controls

3. Include in all test runs

4. Data Collection

5. Data Analysis

6. Accept or Reject Run

7. If Variation Identified

 Investigate


5

4

3

2

1

0

NRL QC Data

Batch 2

Batch 3

Batch 1

Mean +2SD

Mean

Mean -2SD

Invalid QC sample

15/8/97

10/3/98

date

Invalid Kit Controls


Reasons

Requirements

Resources required

Check performance in use, check batches

QC, data collection , batch testing

Communication, infrastructure (Lab network)

5. Performance Monitoring


Monitoring Assay Performance--ongoing evaluation of assay performance

  • Monitoring specificity

  • Monitoring sensitivity


Reasons

Requirements

Resources required

Prevention of problems

Panels, testing

Quality control program, regulations

6. Trouble shooting


“Trouble- Shooting”

Sorting out testing problems


Personnel Assay

Reported problems

Sample Equipment Methods

Trouble Shooting


Reasons

Requirements

Resources required

Assure testing is accurate & efficient

Testing samples, collecting data

Data collection and analysis skills

8. Strategy development


Strategy Development

A strategy is a series of scientifically verified testing steps using a combination of assays that are employed to reach the correct diagnosis.


Strategy Development

  • Understanding the predictive values of the tests

  • Obtaining the appropriate data

  • Multivariant analyses of the data to assess the predictive value of test combinations used in sequence


Strategy development

Trouble shooting

Tertiary Reference Testing

Quality Assurance System

Kit Evaluation

Performance Monitoring

Specificity monitoringQuality ControlQAP(Batch testing)

QUALITY PERFORMANCE

Pre-marketing


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