HIV Drug Resistance Training

Module 15:
Specimen Management

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A Systems Approach to Laboratory Quality

Organization Personnel Equipment

Stock Data
Quality Control
Management Management

SOPs,
Occurrence
Documents & Assessment
Management
Records

Safety &
Process Specimen
Waste
Improvement Management
Management 2
 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
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!
 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

 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

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