1. HIV Drug Resistance Training
Module 15:
Specimen Management
Present: In this module, we’ll talk about maintaining quality control from the time you receive the sample to the time you dispose of it.

2. A Systems Approach to Laboratory Quality
2005
A Systems Approach to Laboratory Quality
Organization
Personnel
Equipment
Stock Management
Quality Control
Data Management
Remind participants that specimen management is part of the systems approach to laboratory quality.
SOPs, Documents & Records
Occurrence Management
Assessment
Process
Improvement
Specimen Management
Safety & Waste Management
Module 10: Inventory

3. Topics Importance of Specimen Management
Components of Specimen Management
Policies and Procedures
Present an overview of the topics in this module:
First, we’ll talk about why this topic is so important.
Then, we’ll look at the different aspects for specimen management.
Finally, you’ll have a chance to discuss the policies and procedures your lab needs to develop to ensure quality specimen management.

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.
Present objectives for the module.

5. importance of specimen management
Why is specimen management important?
Transition to next section. Note that we will try to answer this question.

6. Specimen Management Means…
2005
Specimen Management Means…
Policies, procedures and infrastructure to support the safe handling and treatment of biological specimens
Module 10: Inventory

7. Specimen Management Leads to High Quality Testing
2005
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
Module 10: Inventory

8. components of specimen management
What is involved in specimen management?
In what parts of the process is it especially important to control quality?
Transition to next section. Note that we will try to answer these questions.

9. What can happen to a specimen?
2005
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?
Facilitate small group activity:
Ask participants to work in small groups.
Ask them to create a process flow diagram showing the various steps/procedures performed during the time the specimen is in the lab.
Ask them to identify “hot spots”—times when things could happen to specimens that would compromise safety or testing quality.
Allow 15 minutes.
Ask one group to report out, then ask other groups to add insights.
Module 10: Inventory

10. Specimen Management Involves…
2005
Specimen Management Involves…
Collecting Samples
Receiving
Evaluating Quality
Labeling
Pre-testing Storage and Generating Pending List
Communication and Turnaround Time
Inventory and Post-testing Storage
Disposal
Present: Specimen management involves…
Collecting specimen from patient
Receiving a specimen
Evaluating the quality of the received specimen
Labeling the specimen
Handling and storing the specimen before testing
Managing turnaround time
Storing the specimen (including freezer storage)
Disposing of the specimen
(Note: We already talked about DBS samples, and collecting samples is outside this training program, so we’ll focus on the other components.)
Module 10: Inventory

11. Receiving Specimens Inspect specimens upon receipt:
2005
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.
Review the guidelines on the slide.
Refer participants to the Data Clarification Form and Specimen Tracking Log in their Participant’s Guides and explain how each is used.
Module 10: Inventory

12. Specimen Quality Evaluation
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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.
Review the guidelines on the slide.
Module 10: Inventory

13. 2005
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.
Review the guidelines on the slide.
Module 10: Inventory

14. 2005
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
Review the guidelines on the slide.
Module 10: Inventory

15. Pre-testing Storage and Generating Pending List
2005
Pre-testing Storage and Generating 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).
Review the guidelines on the slide.
Module 10: Inventory

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 Form and document it.
How to label specimen storage location:
Freezer name/number
Shelf number
Box number/location
Example: H-2-5A5
Review the guidelines on the slide.
Refer participants to the Freezer Inventory Form and explain how it is used.

17. Disposing of the Specimens
2005
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
Review the guidelines on the slide.
Module 10: Inventory

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?
Transition to next section. Note that we will try to answer this question.

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.
Review the guidelines on the slide.

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
Facilitate a group discussion of the questions and ask each lab to create a list of policies they need to revise and policies they need to develop.

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
Refer participants to the sample SOP and related documents and forms.
Explain how they fit together.
Ask participants to discuss how each document might be used/modified.

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?
Ask participants to write their own answers to these questions in the blank space on their handouts.

23. Key Messages Specimen management ensures accurate genotyping results.
2005
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.
Module 10: Inventory

24. Summary Importance of Specimen Management
Components of Specimen Management
Policies
Procedures
Ask select participants to summarize, in one or two sentences, the key points they learned in this module.