Professional Documents
Culture Documents
Disclaimer
This training is provided as a service to Mayo Medical Laboratories clients and
couriers. It is limited to shipping of medical specimens for diagnostic
testing, including Category A Infectious Substances and Category B
Biological Substances. Although we strive to ensure that the information is
current and accurate, we remind you that it is the employers responsibility
to perform and verify the training of their employees.
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clients and couriers should use this training. Non-Mayo Medical Laboratories clients
and couriers are encouraged to use one of the many commercial vendors
specializing in IATA and DOT training
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Our presenter for this training is Ranee Rasmussen, Quality Assurance Assistant in
the Laboratory Compliance Unit in the Department of Laboratory Medicine and
Pathology at Mayo Clinic in Rochester, Minnesota.
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Legally, anyone who is involved with shipping dangerous goods must follow the
regulations.
Its imperative to follow the regulations and to follow them correctly. If they are,
your specimen will not leak or be crushed in transit.
The U.S. government can assess substantial penalties for violations of these
regulations.
Keep in mind that there are numerous regulations that change all the time. One
person cannot understand or remember all the regulations, so dont be afraid to
ask or call someone if you are unsure.
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Its the responsibility of the sendout staff to follow regulations, and its the
employers responsibility to train the individual to follow the regulations.
The IATA Dangerous Goods Regulations and the 49 CFR guidelines can help
you prepare a specimen for shipment.
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First, Dangerous goods must be classified into the correct hazard class:
For training purposes, you should know all 9 hazard classes exist. But
generally, you will only use 2 of these hazard classes.
Infectious substances fall under Class 6, Division 6.2. Dry ice falls
under Class 9, Miscellaneous.
When preparing a specimen for shipping, you must know the hazard
class to complete the packaging and documentation correctly.
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In addition to the 9 hazard classes most hazardous substances are further assigned
to a packing Group
The 3 packing groups indicate the degree of hazard the substance presents.
For training purposes, you should know the packing groups exist, however when
shipping medical specimens you will not need to refer to a packing group, as
neither 6.2 Infectious substances, nor Biological Substance Category B are
assigned to a packing group.
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Category A, Infectious
Category B, Biological Substance
Rules for packaging and shipping are determined by how an infectious
substance is categorized
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The regulations for possessing, using, or transferring Select Agents from, to, or
within the United States are found in 42CFR, Parts 73.0 through 73.21. Most
diagnostic testing laboratories would not be involved with these agents and
toxins. Thus, it is beyond the scope of this presentation to cover this material.
Please refer to the Centers for Disease Control website: www.cdc.gov for more
information.
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IATA paragraph 3.6.2.2.3.5 classifies patient specimens for which there is minimal
likelihood that pathogens are present as Exempt Human Specimens. Examples
include:
Pregnancy tests
The classification of Exempt Human Specimen applies only to shipments by aircraft.
The US Department of Transportation considers these samples to be outside of their
regulations and thus does not assign them a classification at all.
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Cultures:
Cultures are the result of a process by which pathogens are intentionally
amplified or propagated in order to generate high concentrations. As such,
the risk of infection is increased if exposure occurs. This definition does not
include cultures intended for diagnostic and clinical purposes.
Cultures can be classified as Category A, Infectious or Category B, Biological
Substance:
Any culture intended for the intentional generation of pathogens as well as
any culture shipped for identification purposes must be shipped as Category
A, Infectious.
Cultures can be shipped as Category B, Biological if they arent intended for
the intentional generation of pathogens and are not found in the Category A
list in the IATA regulations.
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Instructions for shipping by air are found in the yellow pages of the IATA
regulations.
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Packing Instruction 620 for Category A, Infectious substances requires UNcertified packaging:
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It must fit in a box with a smallest external dimension no less than 100
mm (4 inches).
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Use the UN-certified number, UN2814, as well as the name and address of
the shipper and consignee.
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When shipping Category A, Infectious substances, you must use the proper
label:
You must always use the 6.2 Infectious Substance label, as shown on
the left.
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Ensure the box is marked with the diamond-shaped mark, shown on the
slide. The mark must be at least 2 X 2 and include the marking UN3373.
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If your vials are glass, you must wrap them in bubble wrap or rubber
band them together so that they do not break in transit.
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If your vials are glass, you must wrap them in bubble wrap or rubber
band them together so that they do not break in transit.
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When shipping Category B, Biological substances, you must use the proper
markings and labels:
You must always use the UN3373 marking, as shown on the left. Place the
mark next to the words Biological Substance, Category B.
If your specimen needs to be shipped on dry ice, use a dry ice label. This label
must include the weight of the dry ice, marked in kilograms.
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This slide shows an example of a box marked with the proper shipping name,
Biological Substance, Category B next to the UN3373 marking.
These are the only markings required for air or ground shipments.
If the specimen is liquid, your boxes needs to display orientation labels
on opposite sides. Since most of our shipments contain liquid, our
boxes are preprinted with these arrows.
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culture shipments.
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Place a blue C label on the bag and Styro containing the Category
B culture, as well as on the outside of the box.
If you have a courier pickup, they will take care of labeling the Styro
and box.
Mayo Medical Laboratories requests that you put the blue C label
on the outside of the bag.
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For details, contact the USPS for their Dangerous Goods regulations.
They can also refer you to their hazmat expert if necessary.
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If you operate your own private courier system or contract with a dedicated
contract courier:
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To ship legally and safely, it is important to identify the substance you are
shipping. To identify your substance correctly on your package and paperwork:
You must use the proper shipping name when shipping. The proper
shipping name is a standard name used to identify the article or substance
on the outside of the package and on the Shippers Declaration Form.
In the case of an infectious substance, you must know the technical name
of the substance as well. The technical name is a recognized chemical
namecurrently used in scientific and technical handbooks, texts, journals
which must accompany the proper shipping name when indicated in the
IATA or DOT regulations.
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Dangerous Goods regulations in both 49 CFR and IATA indicate when a substance
requires a technical name:
In IATA, substances followed by a bold star (*) need a technical name included
in the documentation.
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When shipping Category A, Infectious substances, a Shippers Declaration for Dangerous Goods is
required:
The Shippers Declaration describes the contents of the consignment. By signing the shippers
declaration, the shipper declares the consignment is classified, packaged, marked, and labeled
according to international and national government regulations.
If this form is filled out incorrectly in any way, your shipment will be rejected. At least two copies of the
declaration must be given to the airline.
You must retain a copy of the Shippers Declaration for two years.
Cargo aircraft only must be crossed (Xd) out if you have 50 mL or 50 grams or less of an
infectious substance.
The airport of departure and the airport of destination must be filled in.
The word radioactive must be crossed (Xd) out, leaving non-radioactive showing.
The proper shipping name must be listed exactly the same as in the IATA regulations.
The class or division must be filled in, such as 6.2, as well as the UN number.
Under the quantity and type of packaging, you must fill in the quantity of the infectious substance
and the number and type of packaging.
An emergency contact number must be listed on the paperwork. This must be a 24-hour
emergency response number that is monitored at all times by a person knowledgeable about the
dangers or characteristics of substance being transported. Minimally, this person must have
immediate access to a person who possesses such knowledge.
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The name and title of the shipper, as well as the date must be filled in.
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If you are audited by the FAA, your training records are typically
evaluated first.
Training must be repeated every 2 years per IATA, every 3 years per 49
CFR
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A test that ensures the employee can perform the assigned duties in
compliance with the regulations is required. No specific format must
be used, however. Training and testing may be accomplished in a
variety of waysperformance, written, verbal, or a combination. Once
the test is completed, a copy of the certification issued must be
retained.
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Security Awareness Training is required for all employees who ship dangerous
goods:
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If you have questions about transporting your specimen, contact the Mayo
Clinic Laboratory Compliance Unit by phone or email.
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