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HIV Drug Resistance Training

Module 15:

Specimen Management

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A Systems Approach to Laboratory Quality

Organization

Stock Management

SOPs, Documents & Records

Process Improvemen

t

Personnel

Quality Control

Occurrence Management

Specimen Management

Equipment

Data Management

Assessment

Safety & Waste

Management

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Topics

Importance of Specimen Management Components of Specimen Management Policies and Procedures

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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.

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importance of specimen managementWhy is specimen management important?

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Specimen Management Means…

Policies, procedures and infrastructure to

support the safe handling and treatment of

biological specimens

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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

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

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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?

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Specimen Management Involves…

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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.

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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.

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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.

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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

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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).

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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

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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

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Policies and Procedures

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

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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.

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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

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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

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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?

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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.

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Summary

Importance of Specimen Management Components of Specimen Management Policies Procedures