LABORATORY OF PATHOLOGY ONLINE POLICY MANUAL

PACKAGING AND SHIPPING LABORATORY SPECIMENS TO OUTSIDE LOCATIONS

All shipments must comply with all applicable local, state, and federal laws governing packing, labeling, and transportation. Either Fed EX or U.S. Mail may be used to ship non-infectious diagnostic material to domestic locations. Blood, urine, fluids and other liquid diagnostic specimens must be shipped via FedEx. All other specimens (e.g., international shipments, infectious substances, toxic materials, dry ice, carbon dioxide, liquid nitrogen, formaldehyde, and hazardous material), including a clinical specimen that is known or reasonably believed to contain an infectious substance (etiologic agent), must be sent through the Freight Forwarding Section in Building 13.

Marking and Labeling

All markings must be visible on the package or overpacks and not located with other package markings that could substantially reduce their effectiveness. All markings must be written (or affixed) in English and be plain, durable, visible, legible, and weather proof.

Federal Express Small Package Delivery (Including non-infectious diagnostic material)

Call the Freight Forwarding Section on 496-5921 to establish a NIH Federal Express account number to ensure that you will receive the discounted contract rates. Call FedEx at 1-800-463-3339 to schedule a pickup or establish routine pickups. On the Federal Express USA Airbill only select "FedEx Priority Overnight" for next business day delivery service or "FedEx 2Day" for second business day delivery service. For shipments to Puerto Rico use the FedEx International Air Waybill. Select only "FedEx International Priority" for next business day service or "FedEx International Economy" for second business day service. FedEx will permit shipments of diagnostic materials to international locations, however; the shipper should call 1-800-463-3339 in advance to determine if there are any restrictions for the final destination and coordinate the shipment through the Freight Forwarding Section, if necessary.

Federal Express Domestic Non-infectious Diagnostic Material that is not shipped with carbon dioxide, solid (dry ice) or liquid nitrogen.

By definition, a diagnostic specimen is any human or animal material, including excreta, secreta, blood, and its components, tissue, and tissue fluids being transported for diagnostic or investigational purposes, but excluding live infected humans or animals.

If a specimen must be shipped in formaldehyde or with carbon dioxide, solid (dry ice) or liquid nitrogen contact the Freight Forwarding Section at 496-5921. These chemicals are hazardous and must be shippped as such.

If a specimen is infectious or suspected of containing pathogens which can be readily transmitted from one individual to another, directly or indirectly, and for which effective treatment and preventative measure are not usually available, as determined by medical staff, contact the Freight Forwarding Section at 496-5921.

Non-infectious (e.g., fixed) Diagnostic specimens must be packed in triple packaging, consisting of:

• A primary receptacle (e.g., block or slide box).
• For solids, the primary receptacle must be sift-proof with a capacity of not more than 500g (1.1 pounds).
• For liquids, the primary receptacle must be leak proof with a volume not to exceed 500 ml (16.9 ounces). For liquids, absorbent material must be used in sufficient quantity to absorb the entire contents of the primary receptacles.
• If several fragile primary receptacles are placed in a single secondary container, they must be individually wrapped or separated to prevent contact between them.
• If screw caps are used these must be reinforced with adhesive tape.
• If shipping lyophilized substances, the primary receptacle must be either flame-sealed glass ampoules or rubber-stoppered glass vials.
• A secondary leak-proof package must be used which is in compliance with IATA package insert 650. Several flexible secondary containers may be used and may be purchased through multiple vendors, some options are listed below:
• Saf-T-Pak Products www.chem-tran.com
• STP-700 6.5 x 6.75” Tyvek envelope $ 1.64 each
• STP-710 9.5 x 7.5” Tyvek envelope $ 1.99 each
• STP-740 12 x 14” Tyvek envelope $ 4.54 each
• Other products are available at:
• Cargo Pak www.cargopak.com
• Dangerous Goods Supplies www.dgsupplies.com
• Exakt-Pak Diagnostics www.exaktpak.com
• JIT Certified, Inc. www.jitcertified.com
• Polyfoam Packers www.polyfoam.com
• If several fragile primary receptacles are placed in a single secondary container, they must be individually wrapped or separated to prevent contact between them. For liquid shipments, absorbent material must be placed between the primary receptacle and secondary packaging.
• Write the words “DIAGNOSTIC SPECIMEN” on the secondary package.
• An itemized list of contents must be enclosed between the secondary packaging and the outer packaging.
• If wet ice, or prefrozen packs are used, place them outside the secondary packaging or alternatively in an overpack with one or more completed packages. Interior support must be provided to secure the secondary package in the original position after the ice has melted. If ice is used the packaging must be leak proof.

• Outer packaging (FedEx Clinical Pak): The FedEx Clinical Pak is a new product available February 2003. You may still use the Diagnostic Specimen Pak, but this product was discontinued and replaced by the FedEx Clinical Pak. The Diagnostic Specimen Pak may be may be ordered by calling FedEx at 1800-633-7019.
• On the Air Bill, in section 2 or somewhere visible on the document, write “DIAGNOSTIC SPECIMEN, PACKAGED IN COMPLIANCE WITH IATA PACKAGE INSERT 650”. When properly packed, the FedEx package will in IATA compliance:
  • Capable of successfully passing a drop test at a drop height of 1.2 meters (3.9 feet) and the outer packaging may not exceed 4 kg (8.8 pounds) capacity.
  • For shipments by aircraft, the primary receptacle or the seconday packaging must be capable of withstanding without leakage an internal pressure producing a pressure differential of 95 kPa (0.95 bar, 14 psi).

Domestic U.S. Postal Service

Do not use U.S. Postal Service to mail specimens to military or Veterans Administration (VA) hospitals. These hospitals may irradiate mail and have reported delays in shipments and damage to specimens such as melted blocks and/or burned slides. Use the U.S. Postal Service only for domestic shipping locations; use Fed Ex and Freight Forwarding for international shipments.

You may ship clinical specimens that are not infectious using the US Postal Service. Any human materials, known or reasonably believed to not contain an infectious substance, that have been collected and are being shipped for the purpose of diagnosis are defined as “Clinical (diagnostic) specimens.” Glass slides or cover slips that were in contact with an infectious agent are defined as “sharps.” Please contact the Freight Forwarding section if you are shipping slides prepared from potentially infectious material, biological products, or other medical devices.

A sender’s declaration of dangerous goods is not required for Clinical Specimens, however, specific quantity limits and packaging conditions are specified below:

• Mailpieces must be marked on the address side as “Clinical Specimen –(specify type); e.g., “Clinical Specimen-Blood Sample,” “Clinical Specimen-Tissue Block”, “Clinical Specimen-Slides (non-infectious), etc.
• The outer packaging of shipments of “Clinical (diagnostic) specimens” may bear the international biohazard symbol (below) on the address side. This label has a flourescent orange or red background. The symbol and text are black.

• Sufficient shock-resistant material to withstand shock and pressure changes and absorbent material must surround the primary receptacle, or be otherwise configured to take up the content in case of leakage. The primary receptacle and the absorbent cushioning must be enclosed in a secondary packaging having a leakproof barrier that can prevent failure of the secondary packaging should there be leakage of the primary receptacle during shipment. The secondary packaging may serve as the out packaging if the specimen is less than 50 ml.
• If the specimen exceeds 50ml, a single primary receptacle must not contain more than 1,000 ml of specimen; two or more primary receptacles whose combined volume does not exceed 1,000 ml may be enclosed in a single secondary package.
• If the specimen exceeds 50ml, the secondary package must be enclosed in a fiberboard box or container of equivalent strength.
• Ship specimens Priority Mail or First-Class Mail, using Certified Mail Receipt, (green PS Form 3800) and Domestic Return (green PS Form 3811). Certified mail service provides the sender with a mailing receipt. Return receipt service provides a mailer with evidence of delivery (to whom the mail was delivered and the date of delivery). A return receipt also supplies the recipient's actual delivery address if it is different from the address used by the sender. Follow the instructions on the USPS forms.

Radioactive Specimens

Radioactive tissues are not processed and embedded in paraffin blocks unless radiation is below background level; therefore, no additional precautions are required. Call Radiation Safety at 301-496-3277 if additional information is required.

Freight Forwarding Section