HIV Drug Resistance Training
Module 15:
Specimen Management
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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
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Topics
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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
management
Why 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!
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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
management
What 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 and
Generating Pending List
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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
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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
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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
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SOP for specimen management
Related document and forms:
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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
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Importance of Specimen Management
Components of Specimen Management
Policies
Procedures
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