Quality Assurance Programmes for Laboratory Testing An Overview

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.

Quality Assurance System Kit Evaluation Performance Monitoring Specificity monitoring Quality Control QAP (Batch testing) Strategy development Trouble shooting Tertiary Reference Testing QUALITY PERFORMANCE Pre-marketing

Specimen Collection Equipment maintenance QAP Specimen Processing Safety Training QC Testing Trouble Shooting Document Control/SOPs Reporting Other Management Controls

Quality Assurance Programme en h w Pre-market o, e h r NRL w e h w 1. Test Kit , Evaluation at h w w o 2. Batch h Testing Post-market Laboratories Collaborative 3. QAP 6. Trouble shooting 4. QC 7. Re-evaluation 5. Monitoring 8. Strategy development

1. Evaluation (Re-evaluation) l. Reasons l. Assess l. Requirements l. Evaluation l. Resources l. Regulations, required test, baseline data for QA panels serum panels, storage facilities

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

2. Examine the data 3. Write evaluation protocol n on ttiio ua ua all ess a ess Ev oc Pr Pr 1. Gather information on the kit 4. Select an evaluation panel 5. Perform the testing 6. Collate and analyse the data 7. Use the results

Frequency Distributions of +ve & -ve samples in a “perfect” assay cutoff OD/Co

Frequency Distributions of +ve & -ve Samples in a Serological Assay cutoff OD/Co

Frequency Distributions of +ve & -ve Samples in a Serological Assay cutoff OTHER FACTORS (unrelated to antibody) • High Ig. M • Rheumatoid factor • Sample related factors • Physical disruption OD/Co

Pathogenesis Seroconversion ARC/AIDS Asymptomatic Neutralising Antibody NAA viral load p 24 Ag - Viraemia 4 -5 weeks Up to 12 years 2 -3 years

2. Pre-marketing Batch Testing Usually by regulation l Usually by central laboratory l Other measures may be used “inhouse” l

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

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

Quality Assessment Programme l Definition: ØMethod by which the entire testing process including the quality of results generated by a particular laboratory is assessed.

1 A. Questionnaire 2. Preparation of Panels AP AP Q Q 1 B. New Participants 4. Data Collection s s es es oc oc Pr Pr 3. Panel Distribution 5. Preliminary report 6. Data Analysis 7. Final report

Quality Assurance Programme Element: Performance Monitoring l. Reasons l Check l. Requirements l QC, l. Resources l Communication, required performance in use, check batches data collection , batch testing infrastructure (Lab network)

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

e se us s eu s he oll th tro r t tr or n fo on Co sf C s es ty es iity oc all Pr Qu of of 1. QC Sample 2. Determine Acceptable Ranges 3. Include in all test runs 4. Data Collection 5. Data Analysis 6. Accept or Reject Run 7. If Variation Identified Investigate

NRL QC Data h 1 atc B h 2 atc B 5 Mean +2 SD 4 3 Mean 2 SD Invalid QC sample 1 0 h 3 atc B 15/8/97 10/3/98 date Invalid Kit Controls

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

Monitoring Assay Performance-ongoing evaluation of assay performance Monitoring specificity l Monitoring sensitivity l

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

“Trouble- Shooting” Sorting out testing problems

Trouble Shooting nel on say As ers P ent pm S ple am qui E rted epo ms R ble pro ods eth M

8. Strategy development l Reasons l Assure l Requirements l Testing l Resources required l Data testing is accurate & efficient samples, collecting data collection and analysis skills

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 l Obtaining the appropriate data l Multivariant analyses of the data to assess the predictive value of test combinations used in sequence l

Quality Assurance System Kit Evaluation Performance Monitoring Specificity monitoring Quality Control QAP (Batch testing) Strategy development Trouble shooting Tertiary Reference Testing QUALITY PERFORMANCE Pre-marketing