Quality Assurance Programmes for Laboratory Testing - An Overview - PowerPoint PPT Presentation

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Quality Assurance Programmes for Laboratory Testing - An Overview

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Title: Quality Assurance Programmes for Laboratory Testing - An Overview


1
Quality Assurance Programmes for Laboratory
Testing -An Overview
  • Elizabeth M. Dax
  • National Serology Reference Laboratory, Australia
  • www.nrl.gov.au

2
Quality Assurance
  • Is the series of procedures that ensure that a
    correct result is achieved in a standard,
    reproducible and traceable manner.

3
Quality Assurance System
Kit Evaluation
Performance Monitoring
Specificity monitoringQuality ControlQAP(Batch
testing)
QUALITY PERFORMANCE
QUALITY PERFORMANCE
Pre-marketing
4
Equipment maintenance
Specimen Collection
QAP
Safety
Specimen Processing
Training
Testing
QC
Trouble Shooting
Document Control/SOPs
Reporting
Other Management Controls
5
Quality Assurance Programme
when
Pre-market
Post-market
who, where
NRL
Laboratories
Collaborative
6. Trouble shooting
3. QAP
1. Test Kit Evaluation
what,how
7. Re-evaluation
4. QC
2. Batch Testing
8. Strategy development
5. Monitoring
6
1. Evaluation (Re-evaluation)
  • Reasons
  • Requirements
  • Resources required
  • Assess test, baseline data for QA
  • Evaluation panels
  • Regulations, serum panels, storage facilities

7
Evaluations
  • An evaluation is the appropriate assessment of
    the working performance of a test kit or
  • an assay at a point in time.

8
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
9
Distributions of ve -ve samples in a perfect
assay
10
Distributions of ve -ve Samples in a
Serological Assay

cutoff
Frequency
OD/Co
11
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
12
Pathogenesis
13
2. Pre-marketing Batch Testing
  • Usually by regulation
  • Usually by central laboratory
  • Other measures may be used in-house

14
3. Quality Assessment Programme
  • Assess laboratory processes
  • QAP panels, data processing,questionnaires
  • Materials, QA coordination
  • Reasons
  • Requirements
  • Resources required

15
Quality Assessment(also known as proficiency
testing)
  • Method by which the quality of results generated
    by a particular laboratory is determined.

16
Quality Assessment Programme
  • Definition
  • Method by which the entire testing process
    including the quality of results generated by a
    particular laboratory is assessed.

17
QAP Process
18
Quality Assurance Programme Element Performance
Monitoring
  • Reasons
  • Requirements
  • Resources required
  • Check performance in use, check batches
  • QC, data collection , batch testing
  • Communication, infrastructure (Lab network)

19
4. Quality Control Programme
  • Measures that are used to ensure that a test is
    working to the highest standard.

20
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
21
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
22
5. Performance Monitoring
  • Reasons
  • Requirements
  • Resources required
  • Check performance in use, check batches
  • QC, data collection , batch testing
  • Communication, infrastructure (Lab network)

23
Monitoring Assay Performance--ongoing evaluation
of assay performance
  • Monitoring specificity
  • Monitoring sensitivity

24
6. Trouble shooting
  • Reasons
  • Requirements
  • Resources required
  • Prevention of problems
  • Panels, testing
  • Quality control program, regulations

25
Trouble- Shooting
  • Sorting out testing problems

26
Trouble Shooting
27
8. Strategy development
  • Reasons
  • Requirements
  • Resources required
  • Assure testing is accurate efficient
  • Testing samples, collecting data
  • Data collection and analysis skills

28
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.

29
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

30
Quality Assurance System
Kit Evaluation
Performance Monitoring
Specificity monitoringQuality ControlQAP(Batch
testing)
QUALITY PERFORMANCE
Pre-marketing
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