1 / 30

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.

oberon
Download Presentation

Quality Assurance Programmes for Laboratory Testing - An Overview

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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. 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

  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 4. QC 7. Re-evaluation 2. Batch Testing 8. Strategy development 5. Monitoring

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

  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. cutoff Frequency OD/Co 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 Seroconversion ARC/AIDS Asymptomatic Neutralising Antibody NAA viral load p24 Ag - Viraemia 4-5 weeks Up to 12 years 2-3 years

  13. 2. Pre-marketing Batch Testing • Usually by regulation • Usually by central laboratory • Other measures may be used “in-house”

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

  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. 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

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

  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. 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

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

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

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

  25. “Trouble- Shooting” Sorting out testing problems

  26. Personnel Assay Reported problems Sample Equipment Methods Trouble Shooting

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

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

More Related