Download Specimen submission

Quick Tip: Specimen Collection & Shipping
The collection and shipment of specimens is common in research protocols. Specimens are
collected & evaluated to verify eligibility, for laboratory tests (sent to a central laboratory) as well as
pharmacodynamics (PD) and pharmacokinetic (PK) testing. The clinical trial nurse needs to be
aware of the guidelines and regulations that surround the collection, processing & shipping of
diagnostic (clinical) specimens.
Collection:

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Consent must be signed prior to any study procedure. This includes laboratory tests, if they are
for research only, and not part of standard of care.
Gather appropriate tubes.
Tube
Red
Blue
Green
Lavender
Grey
Yellow
Green &
Red tiger
top
Black and
Blue Tiger
top
SST (black
& Red
Tiger top)
Contents
Use
No preservatives or anticoagulants
Sodium citrate as anticoagulant
Sodium heparin as preservative
Sodium or potassium EDTA as
anticoagulant
Potassium Oxalate/Sodium
Fluoride
ACD Solution
Sodium Heparin Gel and Density
Gradient Media (CPT)
Serum or clotted whole blood; chemistries
Clotting studies
Plasma collection
Hematology studies
Sodium Citrate Gel and Density
Gradient Media (CPT)
Separates mononuclear cells.
No anticoagulants or preservatives;
contains silicon barrier gel for
separation of serum
Serum, gel creates a physical barrier
between the serum and the clot; DO NOT
use SST for serum drug levels (gel barrier
will bind to drugs giving falsely low levels).
Alcohol testing, lactate levels & glucose.
Used for tissue typing, maintains cell viability.
Separates granular cells from nuclear cells.

Utilize a different IV line for drawing PK & PD samples than was used for drug administration.
o If this is not possible the line should be flushed with approximately 30 cc of normal saline,
followed by withdrawing 30 cc to discard, (consult the protocol and institutional policy).

Order of tubes (if not otherwise specified by the protocol)
o First: Sterile (Blood Cultures)
o Second: No preservatives (Red)
o Third: Coagulation Studies (Blue)
o Last: Additives (Green, Grey, Lavender)

Prevention of Hemolyzed Specimen (Red blood cell membrane rupture)
o The tourniquet should not be left on for longer than 2 minutes.
o Do not use too small of a needle gauge.
o Do not force blood through the needle into the tube, or force clotted blood into the tube.
o Do not shake the tube to vigorously, gently invert the tube.
o Do not draw blood from a hematoma.
o Do not pull back on the plunger to forcefully.

Label the tube(s) with the patient’s initials & Study ID# as well as the date & time of draw.
Developed: 3/2/07
Revised: 1/16/08, 2/7/14, 9/4/14
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Processing:
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Specimens should be processed by trained personnel that are covered under the laboratories
Clinical Laboratory Improvement Amendment (CLIA) accreditation & OSHA Polices (29 CFR
Part 1910.1030). Specimens should not be processed in a centrifuge or an area that is not
covered by a CLIA.
The centrifuge is set for the correct temperature, revolutions/min & duration as specified in the
protocol. Centrifuges should be recalibrated at least annually.
Plasma or serum is the straw colored liquid at the top after centrifugation.
Plasma or serum is removed using a pipette & transferred to labeled cryotubes (plastic tubes
with a screw top).
Specimens are stored per protocol guidelines (e.g. ambient, -20 C or -70C)
Specimen Blocks:


Check with your institution as some institutions will not allow blocks to be released but may allow
slides.
Verify with the sponsor if slides will be an acceptable alternative prior to agreeing to do the study.
Shipping:
 “Any person that transports or causes to be transported or shipped, a hazardous material . . .

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shall be subject to & comply with all provisions of the Federal Hazardous Material Transport law”,
49 CFR 171(b).
All employees must be trained within 90 days after employment, 49 CFR 172. Retraining is every
three years (Department of Transportation) or every 2 years (International Air Transportation
Association).
o General awareness training
o Functional specific training
o Safety training (subpart G)
o Security Awareness (subpart I)
Employees should be trained at their respective institution by completing a program that has
been approved by their safety department or compliance officer. Check with the laboratory at
your institution as to what training is required & approved at your site.
General Shipping Rules (49 CFR)
o All dangerous goods are assigned a specific UN number.
 Infectious substance known to cause harm to humans UN2814
 Infectious substance known to cause harm to animals UN2900
 Biologic Substances, Category B UN 3373 (Infectious substance, or diagnostic
specimen known to be infected with a substance that is not dangerous to humans or
animals)
 Caron Dioxide, solid or Dry Ice UN 1845
 Routine Laboratory specimens, known not to contain any infectious substance are not
subject to the Division 6.2 regulations for shipping of dangerous goods.
o Boxes must meet certain standards
 Drop test (49 CFR 178.603-609) 30 feet (9meters)
 May not exceed 4 L (1 Gallon for liquids)
 May not exceed 4 kg (8.8 lbs) for solids
 Capable of withstanding without leakage an internal pressure producing a pressure
differential of 95kPA or less.
Developed: 3/2/07
Revised: 1/16/08, 2/7/14, 9/4/14
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Packaging for exempt human specimens
 Packaging must meet the following conditions:
 Primary receptacle: (e.g. the lab tube)
o Leak proof, pressure proof @ 95 kPA, individually wrapped or separated to
prevent contact.
 Secondary receptacle: (the plastic bag)
o Leak proof, pressure proofs @ 95kPA
o Absorbent material in sufficient quantity to absorb the entire contents must be
placed between the primary receptacle(s) and the secondary packaging so
that, during transport, any release or leak of a liquid substance will not reach
the outer packaging and will not compromise the integrity of the cushioning
material.
o Must be at least 4 inches in the smallest dimension.
 Outer Packaging:
o Must be of adequate strength for its capacity, mass and intended use.
o Leakproof
o If the specimen does not contain infectious substances, then the package
must be marked with the words, “Exempt Human Specimen.” There is no
dimensional requirement on this marking. But must be on a visible part of the
outer packaging.
o Dry ice considerations:
 Must be placed in an overpak.
 Must allow the release of CO2 if Dry Ice is used
 Must mark the net weight on outside of packaging
 A miscellaneous Dangerous Goods label must be on the package.
o

One surface must be at least 100 mm (4” X4”).
Shipping papers/Specimen submission forms etc. are enclosed between the
secondary container and the outer packaging.
References:
International Air Transport Association. (2014) Dangerous Goods Regulations Manual, Section 3.
U.S. Food & Drug Administration (2010). Code of Federal Regulations (Title 29 CFR, Volume 6, Part
1910.1030). Washington, DC: U.S. Government Printing Office.
Developed: 3/2/07
Revised: 1/16/08, 2/7/14, 9/4/14
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U.S. Food & Drug Administration (2014). Code of Federal Regulations (Title 49 CFR, Volume 2, Part
171 - 177). Retrieved from: http://www.ecfr.gov/cgi-bin/textidx?SID=016fe28750512d7584644cf9f3b0f45a&c=ecfr&tpl=/ecfrbrowse/Title49/49cfrv2_02.tp
l
Developed: 3/2/07
Revised: 1/16/08, 2/7/14, 9/4/14
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