Specimen Management - DAIDS Learning Portal

Report
Specimen Transport
and Management
Version 5.0, August 2012
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National
Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services,
under contract No. HHSN272201200009C, entitled NIAID HIV and Other Infectious Diseases Clinical Research
Support Services (CRSS).
Objectives





2
Discuss the importance of adequate collection, handling,
and transport of specimens
Discuss specimen flow and chain of custody
List the criteria for specimen rejection
Explain the importance of prompt clinic notification
regarding specimen quality and panic values
Discuss the importance of maintenance of optimal
conditions during specimen storage and shipment
Pre-Assessment Question #1
The following ‘order of draw’ should be followed when
performing a venipuncture:
A. Blood culture, Prothrombin Index/Partial Thromboplastin
Time (PI/PTT), chemistry (plain tube), Complete Blood
Count (CBC) Ethylenediaminetetraacetic Acid (EDTA),
glucose (Oxalate/Fluoride)
B. PI/PTT, blood culture, glucose (Oxalate/Fluoride), CBC
(EDTA), chemistry (plain tube)
C. Blood culture, chemistry (plain tube), glucose
(Oxalate/Fluoride), CBC (EDTA), PI/PTT
D. Chemistry (plain tube), blood culture, PI/PTT, CBC
(EDTA), glucose (Oxalate/Fluoride)
3
Pre-Assessment Question #2
Is it important to record the identity of the phlebotomist who
collected participant information on the requisition form?
A. Yes
B. No
4
Pre-Assessment Question #3
Which of the following are reasons to reject a specimen?
A.
B.
C.
D.
E.
F.
5
The wrong tube was used to collect the specimen
The specimen is not labeled or is labeled incorrectly
The request form includes adequate information
A and B only
B and C only
None of the above
Pre-Assessment Question #4
Notification records should include which of the following:
A. Identification (ID) of person making the contact
B. Date and time of contact
C. A description of the problems when accomplishing the
task
D. B and C only
E. All of the above
6
Pre-Assessment Question #5
Before shipping samples, which of the following tasks must
be ensured:
A. Number of specimens in box corresponds to the
number listed on the shipping manifest
B. ID numbers on the specimen tubes match those on the
shipping manifest
C. Shipping date matches the study protocol
D. A and B only
E. B and C only
F. All of the above
7
What Would You Do?
Fred opens a specimen transport container and prepares to
receive a packet of Sodium Heparin tubes for Peripheral
Blood Mononuclear Cells (PBMC) processing. He notes
from the requisition form that the specimens were collected
four days earlier.


8
What action should he take?
How can this be prevented from recurring in the future?
Specimen Quality
What is Specimen Integrity?
9
Specimen Quality (cont'd)
The reliability and
accuracy of all laboratory
test results depends on
the quality of the
specimen submitted
10
Specimen Quality (cont'd)
Labeled
Collected
The specimens should be
properly:
Handled
11
Transported
to the
laboratory
Specimen Collection and Transport
Inadequate collection and improper transport of specimens
result in:
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


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12
Inaccurate and invalid results
Results delay
Participant discomfort
Increased costs
Misdiagnosis, incorrect treatment
Reduced quality of care
Specimen Management
Collection
Labeling
Specimen:
Transport
Receipt
Referral
Processing
Storage
Disposal
Shipping
13
Specimen Collection SOP
Contents:
Venipuncture
guidelines
Specimen
labeling
Order
of draw
Standard labeling practices must be
implemented and enforced with all users of
the laboratory services.
All specimen tubes must be properly
identified with the Patient Identifications (PID).
14
Order of Draw
The order in which vacuum
tubes are drawn during
venipuncture can affect the
specimen quality
Additives from one tube may
contaminate the next tube
15
Order of Draw (cont’d)
1
Clinical and
Laboratory
Standards Institute
(CLSI) recommends
the following order
of draw
6
16
Sterile tubes for culture
Sodium Citrate
3
Serum tubes with or without clot
activator/gel
Heparin
5
EDTA
Oxalate/Fluoride tubes
Specimen Labeling
Laboratory should enforce
proper specimen labeling practices
17
Specimen Handling
Documented guidelines for use by the clinic staff:



18
Sample preparation
Sample transport
Specimen rejection criteria
Collection Forms
Requisition
Forms
Specimen
Tracking
Forms
19
Requisition Form
1st Section: Laboratory, Study ID
 Testing Laboratory
 Study ID
20
Requisition Form (cont’d)
2nd Section: Demographics




21
PID Number
Initials (Optional)
Gender
Date of Birth
Requisition Form (cont’d)
3rd Section: Visit Details



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22
Specimen Collection Date
Specimen Collection Time
Visit
Phlebotomist
Requisition Form (cont’d)
4th Section: Collection
 Tube quantity and type
 Visit specific investigations
listed
 Collection instructions
23
Requisition Form (cont’d)
5th Section: Specimen Receipt
 Specimen receipt
confirmation
 Receipt comments
24
Specimen Transport
Documented procedures required to address:
Biohazard labeling requirements of transport
containers
Specimen transport from offsite facilities
Specimen transport within the facility
25
Standard Precautions
All specimens should be treated as
potentially hazardous!
26
Specimen Receipt
27
Verification of
specimen
details
Assessment of
quality and
volume
Specimen
receipt date
and time
Identity of the
receiving
personnel
Specimen Rejection Criteria
Unlabeled specimen
Mislabeled/incompletely labeled specimen
Inadequate information on request form
Specimen collected in a wrong tube
Insufficient or clotted specimen
Specimens received past assay stability
28
Specimen Rejection Requires
29

Prompt notification of rejected
specimens to the clinic

Documentation of notification

Cumulative review of notification
records to be discussed at study team
meetings
Clarification/Notification Form
30
Data Clarification/Notification Form
31
Skill Check
You are about to perform an Human Immunodeficiency Virus
(HIV) enzyme-linked immunosorbent assay (EIA) run on 24
specimens. Upon recording the PIDs on the plate template, you
notice two specimens that have the same PID. How would you
proceed?
A. Consult with the supervisor; discard the two specimens;
notify study clinic
B. Abandon the whole run and seek clarification before proceeding
C. Consult with the supervisor; proceed with testing; if both
negative or positive, report results
D. All of the above
E. None of the above
32
Specimen Referral
Shipping manifests
Analyte stability
Specimen audit trail
33
Skill Check
A Section Supervisor notes that the potassium value generated
by the analyzer is 9.2 mmol/l (reference range 3.1 – 5.0).
Select the most appropriate steps that should be taken.
A. Release the results
B. Verify that quality control (QC) and calibration are
acceptable before releasing the results
C. Verify QC and calibration; notify the clinic and document
notification before releasing the results
D. Check the specimen for hemolysis; verify QC and
calibration; notify the clinic; and document notification
before releasing the results
34
Specimen Chain of Custody
Audit trail information includes
35
Critical Values
Definition
Results that require prompt and rapid clinical
attention to avert significant study
participant/patient morbidity or mortality
Values should be defined by the Laboratory
Director, in consultation with clinicians served
Policy/procedure for immediate contact of key
study personnel
36
Critical Values (cont'd)
Date and time of notification
Notification
records should
include:
ID of personnel making the
contact
Person notified and
message relayed
Problems encountered with
accomplishing the task
37
Critical Values (cont'd)
An emergency telephone
contact list for the key study
personnel
The laboratory should implement a
policy that personnel receiving verbal
or phone orders must read back the
entire order to verify accuracy of
transcription
38
Skill Check
The only sample for the day from the study clinic (30-minute
drive away) is received at the Central Laboratory for CBC
testing on a Friday afternoon. A PID number mismatch is
noted between the request form and the specimen label
although it appears that one digit seems to have been
omitted on the specimen label. The clinic closes early on
Fridays. Per the Laboratory Standard Operating Procedure
(SOP), specimens with PID mismatches should be rejected.
39
Skill Check
What should the laboratory personnel do?
A. Assume that this was a transcription error and process
the sample
B. Reject the sample as per SOP instruction
C. Process the sample and withhold release of results
until the issue is resolved
D. Place the specimen in the refrigerator for resolution of
the query the following week
40
Specimen Retention
Protocol-specific procedures

Which specimens?

How do we store?

How long do we store?
Policy for disposal of biohazardous waste
41
Specimen Storage
Research samples are
an invaluable resource
42
Specimen Storage (cont'd)
Research Laboratories should invest in dedicated
sample storage facilities
Round the clock monitoring of storage conditions to
ensure that the integrity of samples is maintained
Fully documented disaster recovery
procedures should be implemented
43
Specimen Storage (cont'd)
Repositories
Sample
repositories
should be
created by
suitably
storing the
samples
44
Relevant
records for
repositories
should be
traceable and
accessible
Specimen
aliquots must
be properly
labeled before
storage
Specimen Shipping
Proper organization, packaging,
shipping, and handling of
specimens ensure specimen
integrity, while maintaining
timely and safe transfer of
specimens
All federal and in country
Transportation of Dangerous
Goods Regulations must be met
for the transportation of specimens
45
Specimen Shipping (cont'd)
Before dispatch of samples, ensure that
the shipping manifest:
46

Matches the number of specimens in the box

Matches the ID numbers on specimen tubes

Contains the necessary data for each PID

Includes the shipping date and other laboratory
information (e.g., name and address)
Specimen Shipping (cont'd)
Certification
Personnel who
ship specimens
must have
International Air
Transport
Association
(IATA)
dangerous
goods training
47
Training
must be
renewed
every
two years
Certification
must be
on file and
available for
inspection
What Would You Do?
Fred opens a specimen transport container and prepares to
receive a packet of Sodium Heparin tubes for PBMC
processing. He notes from the requisition form that the
specimens were collected four days earlier.


48
What action should he take?
How can this be prevented from recurring in the future?
Post-Assessment Question #1
The following ‘order of draw’ should be followed when
performing a venipuncture:
A. Blood culture, PI/PTT, chemistry (plain tube), CBC
(EDTA), glucose (Oxalate/Fluoride)
B. PI/PTT, blood culture, glucose (Oxalate/Fluoride), CBC
(EDTA), chemistry (plain tube)
C. Blood culture, chemistry (plain tube), glucose
(Oxalate/Fluoride), CBC (EDTA), PI/PTT
D. Chemistry (plain tube), blood culture, PI/PTT, CBC
(EDTA), glucose (Oxalate/Fluoride)
49
Post-Assessment Question #2
Is it important to record the identity of the phlebotomist who
collected participant information on the requisition form?
A. Yes
B. No
50
Post-Assessment Question #3
Which of the following are reasons to reject a specimen?
A.
B.
C.
D.
E.
F.
51
The wrong tube was used to collect the specimen
The specimen is not labeled or is labeled incorrectly
The request form includes adequate information
A and B only
B and C only
None of the above
Post-Assessment Question #4
Notification records should include which of the following:
A. ID of person making the contact
B. Date and time of contact
C. A description of the problems when accomplishing the
task
D. B and C only
E. All of the above
52
Post-Assessment Question #5
Before shipping samples, which of the following tasks must
be ensured:
A. Number of specimens in box corresponds to the
number listed on the shipping manifest
B. ID numbers on the specimen tubes match those on the
shipping manifest
C. Shipping date matches the study protocol
D. A and B only
E. B and C only
F. All of the above
53
References

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54
Guideline H18-A3: Procedures for the Handling
and Processing of Blood Specimens
www.legacyhealth.org
www.csmc.edu
www.uhl.uiowa.edu
www.vh.org
Wrap Up
55

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