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CASING
SCIENTIFIC Email:
casing@prodigy.net Packaging
of Diagnostic Specimens for Local Transport1
Recent changes in laboratory certification standards of the College of
American Pathology have raised questions among health care organizations
concerning packaging requirements for local shipment of diagnostic specimens.
These changed standards encompass more than the packaging of specimens.
Recent CAP inspection questionnaires have included topics such as (1)
employee safety in the shipment of bio-hazardous materials, (2) thermal
protection of specimens, (3) internal controls, (4) training of transportation
personnel in the safe handling and shipment of biohazards, and (5) compliance
with all federal, State, and local rules and regulations pertaining to the
shipment of diagnostic specimens. The CAP questionnaires address
shipments from satellite or other off-campus facilities to central testing
laboratories in local areas and cover all specimen shipments received from all
external laboratories.
Issues such as control over specimens shipped and received, thermal
maintenance of specimens in storage and transit, and training are fairly
straightforward issues to resolve; the question of packaging of diagnostics
specimens is more complicated because of the division of regulations between
federal agencies. What we know
about the regulation of diagnostic specimens follows: (1)
specimens known to contain an Infectious Substance are regulated by the
federal Department of Transportation (“DOT”) in local and interstate
transportation under Title 49 CFR (UN 4G/Class 6.2 packaging is a requirement) (2)
Any shipments to your central facility that are known Infectious
Substances, should be packed, marked, and labeled in accordance with Title 49
CFR. (3)
diagnostic specimen shipments qualify as “biohazards” under the
U.S.Department of Labor’s Occupational Health & Safety Administration (“OSHA”)
universal precautions standard and are therefore regulated at the federal
level, (4)
None of the federal agency regulations mandate a packaging requirement
for local shipment of diagnostic specimens.
In view of these circumstances of regulation, we believe that a
reasonable course of action for low risk diagnostic specimens, is to follow the
OSHA universal precautions standard together with the CDC recommendations
for packaging of diagnostic specimens that are indicated on page 219 of the CDC Biosafety
in Microbiological and Biomedical Laboratories, 4th Edition. The
enclosed drawing is from the CDC “BMBL”:
http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4acf2.htm BMBL Appendix C - Figure 2Packing and Labeling of Clinical Specimens
The drawing located at the link above reflects the packaging scenario and
labeling suggested by the U.S. Centers for Disease Control (“CDC”) for
diagnostic specimen shipments. The
international biohazard symbol is required by OSHA, and the universal
precautions standard, administered by OSHA, is the primary federal
regulation related to local shipments of diagnostic specimens.
The illustration suggests: (1)
that specimens should be placed in a leak-proof primary container, (2) the
leak-proof primary container should be wrapped in absorbent and padding, (3) the
padded primary container should be placed in a leak-proof secondary container
(bag) with an absorbent between the primary and secondary containers.
Absorbent should be sufficient to absorb the entire contents of the
primary receptacle(s). This
standard would be reasonable for CAP inspection purposes.2
From other hospital packaging procedures we have seen, it may be a good
idea to review packaging procedures with the objective of strengthening your
system. Vials should be prevented
from colliding with each other in-transit, even if they are wrapped and placed
inside ice chests. Wrapping each
vial in a super absorbent sheet and additional padding, with insertion in a leak
proof bag, would meet the standard.
Strong outer boxes for ice chests are recommended with the appropriate
labeling: CDC “biohazard” and
OSHA “biohazard labels with orientation arrows affixed to the outer secondary
packaging are recommended, even if
the vials and other primary specimen containers are appropriately labeled with
the same biohazard warnings.
When you review the CAP inspection questionnaire, it is important to
remember that this is a general questionnaire and that the scope of questions
during an actual inspection could broaden.
The CAP sample questionnaire deals with local shipments from other
collection stations or hospitals, and it may be important to see this queuing of
specimens in terms of how your packaging affect the safety and accreditation
programs of outside laboratories
that receive and test specimens from your facility. U.S. Regulations & Regulatory Proposals: On January 22, 2001, the U.S. Department of Transportation published a proposal to regulate diagnostic specimen shipments in the Federal Register. This proposal coincides with a similar proposal from the U.S. Centers for Disease Control in Atlanta that was published on October 28, 1999. The U.S. DOT
regulatory proposal suggests that in special circumstances, surface specimen
shipments will be given certain exceptions from federal transportation
regulation, with the main thrust of new regulation directed at diagnostic
specimen shipments by air. Specimens
that are transported by a surface common carrier will have to be packaged very
similarly to the CDC recommendations described in this summary, with an
additional performance requirement of a 1.2 meter drop test. DOT proposes that both ground and
air shipments of Infectious Substances will be further regulated.
The proposed regulations address issues such as the classification of
Infectious Substances according to World Health Organization risk groups, new
classifications for Infectious Substances requiring special tracking and
notification of CDC, and substantial new regulation of diagnostic specimens
shipped by air. The proposed
packaging of diagnostic specimen shipments, for specimens transported by
commercial air carriers, is identical to the International Air Transport
Association (“IATA”) Packing Instruction 650 published in the IATA Dangerous
Goods Regulations. In the event of U.S. Department of Transportation regulation of diagnostic specimens shipments, OSHA will continue to be the primary federal regulatory agency concerned with administering U.S. regulations that govern employee safety.
The U.S. Centers for Disease Control and the National Institutes of
Health are the public health authorities in the United States. Adoption of their recommendations in the packaging of
diagnostic specimens for local transport would be additional protection in terms
of (a) liability claims for damages in civil lawsuits3 and (b)
inspections or investigations by OSHA. OSHA, DOT, & CDC, are
“fellow servants” of the U.S. government.
While these agencies cannot enforce each other’s regulations, there is
mutual respect at an official level for each agency’s regulatory expertise,
and the agencies often advise each other, sharing expertise and
scientific-engineering knowledge, before issuing new regulatory proposals. In the absence of a mandatory packaging standard for
diagnostic specimens, we believe the CDC BMBL, 4th edition is a
standard that would be the best authoritative approach to meet the new
accreditation standards of the College of American Pathology, the regulatory
standards of OSHA, and the legal standards of the civil courts. Finally, if any State or local authorities have issued written regulations concerning packaging for shipment of diagnostic specimens, these regulations should be considered together with the OSHA universal precautions standard. Notes:__________________________________________________________________ 1 The views expressed here are solely those of CASING SCIENTIFIC. 2 The life cycle of a clinical specimen and its legal-regulatory status follows a basic rule: a diagnostic specimen is legally defined as a specimen as long as it is maintained or transported for clinical studies or clinical research. Any transport of a diagnostic specimen that continues to have clinical value follows a packaging standard for shipment of clinical specimens, such as the CDC recommended triple-packaging illustrated in the enclosed schematic drawing. In the United States, when a diagnostic specimen is ready to be discarded as a waste material, it must be packaged as a hazardous material according to U.S. Department of Transportation regulations for regulated medical waste. These packing, marking, and labeling standards originated with OSHA and were later adopted by DOT in 1996. DOT established the package performance standards and required UN 3219 labeling of each package. At the stage where the specimen is being utilized for clinical studies, OSHA is the only regulatory agency with enforcement authority over specimen packaging, handling, and transport; at the stage where a specimen is defined as regulated medical waste material, it is regulated by OSHA and by DOT, and the packaging stipulated by both agencies for (waste) specimen shipments and other regulated medical waste is basically identical, if the health care organization issues shipments of regulated medical waste using the public streets and highways. The standard for specimen transport as a waste material is a bag containing the waste material together with sufficient absorbent material, over-packed in a box with the OSHA biohazard symbols, markings, and labeling; the CDC standard for a specimen as a clinical material, involves a specimen, wrapped in absorbent and padding material, inserted in a bag, and further over-packed in a box with appropriate labeling and marking. 3 For information
on recent litigation connected with specimen transport and employee exposure to
Infectious Substances, please feel free to call us.
Our telephone numbers are enclosed below. If
you need assistance in addressing these new CAP requirements, please call us at
your convenience! _________________________________________________________________________________________________ Casing Scientific –
P.O. Box 820369 Dallas, Texas 75382
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