HIV Drug Resistance Training

1. HIV Drug Resistance Training Module 15: Specimen Management

2. A Systems Approach to Laboratory Quality Organization Personnel Equipment Stock Management Quality Control Data Management SOPs, Documents & Records Occurrence Management Assessment Process Improvement Specimen Management Safety & Waste Management

3. Topics • Importance of Specimen Management • Components of Specimen Management • Policies and Procedures

4. Objectives At the end of this module, you will be able to: • Describe the importance of specimen management. • Define the specimen management process for receipt, rejection, identification, transport, storage, inventory and disposal. • Identify policies and procedures needed to support specimen management.

5. importance of specimen management Why is specimen management important?

6. Specimen Management Means… Policies, procedures and infrastructure to support the safe handling and treatment of biological specimens

7. Specimen Management Leads to High Quality Testing Lab test results are only as good as the condition of the specimen allows Garbage in, garbage out! Ensures the result is connected to the right specimen and patient Ensure quality specimen management for accurate test results Lab safety

8. components of specimen management What is involved in specimen management? In what parts of the process is it especially important to control quality?

9. What can happen to a specimen? Map it out! Trace the path of a single specimen (plasma or DBS) from the time it enters your lab to the time you dispose of it. What happens to the specimen during that time? What could happen to the specimen to compromise lab safety or testing quality?

10. Specimen Management Involves…

11. Receiving Specimens • Inspect specimens upon receipt: • Treat shipping package and specimens as potentially infectious material. Open containers within a Biological Safety Cabinet. • Examine incoming specimens and paperwork. Document date and time received and receiver’s initials on Requisition Form. • Complete and submit Data Clarification Form if there are any discrepancies or problems with shipment. • Complete the Specimen Tracking Log by using the data from the electronic requisition form.

12. Specimen Quality Evaluation • Inspect specimen quality based on genotyping requirements • Plasma specimen—frozen and shipped with dry ice • Dried blood spots—shipped either at ambient temperature or frozen, based on the lab SOP • Check label • Compare specimen label to shipment paperwork • If discrepancies are noted, resolve the issue before testing.

13. Rejecting Samples • Reject specimens with incomplete identification on the requisition and/or specimen. Do not test these samples unless the information is clarified. • Reject specimens with evidence of contamination, leakage or spillage in transit. Report back to the client with the appropriate rejection message.   • Reject if insufficient volume for testing. • Reject specimens whose integrity/stability is questionable due to improper storage conditions during transportation.

14. Labeling specimens • Once all the samples have been inspected and met acceptance criteria, • Assign a unique lab specimen ID to each specimen • Place the label on each specimen

15. Pre-testing Storage andGenerating Pending List • Generate a pending list for specimens received. • Assign testing responsibility. • Communicate with requesting clients and determine turn around time (usually 2 wk-6 months depend on the quantity of the shipment).

16. Specimen Inventory and Post-Testing Storage • Store specimens in the appropriate freezers for at least 6 months post testing. (Special purpose specimens can be stored for up to 5 years.) • Record the storage location on the Freezer Inventory Formand document it. • How to label specimen storage location: • Freezer name/number • Shelf number • Box number/location • Example: H-2-5A5

17. Disposing of the Specimens • Establish policies on when and how to dispose stored specimens. • Usually maintain specimens in the laboratory a minimum of six months to allow for repeat testing or verification of data purposes. • If any specimens are discarded, update the information in the electronic/hard copy Specimen Tracking Log. • Discard Date • Discard By

18. Policies and Procedures What policies do we need to develop or enhance to ensure the quality control and safety of specimens used for genotyping?

19. Policies: Turnaround Time • Lab should have clear policy on turnaround time. • Turnaround time is one of the key factors that evaluate lab service quality to its clients. • Specify priority for genotyping specimen testing. • Usually patient specimens should be tested as soon as possible and return results with the minimal turnaround time.

20. Discussion • Think of your current lab policies related to specimen management. • What changes, if any, should be made to policies to ensure the quality of genotyping results? • Transcription errors • Mislabeling DBS card • From lab register to specimen transfer log • From reference lab to testing site • Inadequate specimens

21. Procedures and Forms • SOP for specimen management • Related document and forms: • Results Reporting Procedure • Shipping and Export Procedure • Occurrence Management Form • Customer Communication Form • Specimen Tracking Log • Drug Resistance Requisition Form • Data Clarification Form • Freezer Inventory Form • Examples of these forms in handout

22. Reflection • What does specimen management mean? • What are the different components of specimen management in the life cycle of the sample? • What work does your lab need to do in this area?

23. Key Messages • Specimen management ensures accurate genotyping results. • If needed, the original specimen can be easily traced and pulled out for retesting or verification purpose.

24. Summary • Importance of Specimen Management • Components of Specimen Management • Policies • Procedures