Title: Quality Assurance Programmes for Laboratory Testing - An Overview
1Quality Assurance Programmes for Laboratory
Testing -An Overview
- Elizabeth M. Dax
- National Serology Reference Laboratory, Australia
- www.nrl.gov.au
2Quality Assurance
- Is the series of procedures that ensure that a
correct result is achieved in a standard,
reproducible and traceable manner.
3Quality Assurance System
Kit Evaluation
Performance Monitoring
Specificity monitoringQuality ControlQAP(Batch
testing)
QUALITY PERFORMANCE
QUALITY PERFORMANCE
Pre-marketing
4Equipment maintenance
Specimen Collection
QAP
Safety
Specimen Processing
Training
Testing
QC
Trouble Shooting
Document Control/SOPs
Reporting
Other Management Controls
5Quality 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
61. Evaluation (Re-evaluation)
- Reasons
- Requirements
- Resources required
- Assess test, baseline data for QA
- Evaluation panels
- Regulations, serum panels, storage facilities
7Evaluations
- 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
9Distributions of ve -ve samples in a perfect
assay
10Distributions of ve -ve Samples in a
Serological Assay
cutoff
Frequency
OD/Co
11Distributions 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
12Pathogenesis
132. Pre-marketing Batch Testing
- Usually by regulation
- Usually by central laboratory
- Other measures may be used in-house
143. Quality Assessment Programme
- Assess laboratory processes
- QAP panels, data processing,questionnaires
- Materials, QA coordination
- Reasons
- Requirements
- Resources required
15Quality Assessment(also known as proficiency
testing)
- Method by which the quality of results generated
by a particular laboratory is determined.
16Quality Assessment Programme
- Definition
- Method by which the entire testing process
including the quality of results generated by a
particular laboratory is assessed.
17QAP Process
18Quality Assurance Programme Element Performance
Monitoring
- Reasons
- Requirements
- Resources required
- Check performance in use, check batches
- QC, data collection , batch testing
- Communication, infrastructure (Lab network)
194. Quality Control Programme
- Measures that are used to ensure that a test is
working to the highest standard.
201. 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
21NRL 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
225. Performance Monitoring
- Reasons
- Requirements
- Resources required
- Check performance in use, check batches
- QC, data collection , batch testing
- Communication, infrastructure (Lab network)
23Monitoring Assay Performance--ongoing evaluation
of assay performance
- Monitoring specificity
- Monitoring sensitivity
246. Trouble shooting
- Reasons
- Requirements
- Resources required
- Prevention of problems
- Panels, testing
- Quality control program, regulations
25Trouble- Shooting
- Sorting out testing problems
26Trouble Shooting
278. Strategy development
- Reasons
- Requirements
- Resources required
- Assure testing is accurate efficient
- Testing samples, collecting data
- Data collection and analysis skills
28Strategy Development
- A strategy is a series of scientifically verified
testing steps using a combination of assays that
are employed to reach the correct diagnosis.
29Strategy 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
30Quality Assurance System
Kit Evaluation
Performance Monitoring
Specificity monitoringQuality ControlQAP(Batch
testing)
QUALITY PERFORMANCE
Pre-marketing