Shipping Instructions for Clinical Samples
3701 Welsh Road
Willow Grove, PA 19090
Overnight delivery is recommended for all specimen types. Samples shipped on Fridays should be marked for priority overnight and Saturday delivery. According to the latest available information, the following criteria are to be met when sending a Category B specimen via private courier services (Federal Express, Airborne, etc.). For further information regarding Exempt Human specimens or Category A specimens, refer to the Center for Disease Control and Prevention (Click Here) and the Packaging Division Materials Guide (Click Here). Two containers are required for Category B biological specimens:
The labeled primary specimen container must be securely sealed, crushproof, and liquid-tight (leak-proof). In most cases, the primary container will be a stoppered tube, or screw-top bottle. Affix a biohazard symbol to the primary container.
Many drugs and other toxins can degrade in the presence of light, with both natural and artificial light. We require those analytes, which are light sensitive to be collected and stored in either amber glass or wrapped with aluminum foil.
Shipping Glass Test Tubes
We recommend the following procedures when shipping glass tubes. DO NOT FREEZE SPECIMENS IN GLASS TEST TUBES. If glass test tubes must be frozen, they must be placed at a shallow angle slant during freezing to avoid cracking the tube. Glass tubes may be individually placed in secondary containment tubes or placed in a protective foam box. If a foam box is used, the box is to be placed in a secondary leak-proof container such as a plastic zipper bag described below. Do not allow tubes to come in contact with each other to avoid breakage during shipping.
Each primary container is to be placed in a secondary container. The secondary container must contain enough absorbent material to absorb the entire liquid contents of the primary container if it should break in transit. All shipping containers must be packaged to fully contain leakage/spillage in accordance with applicable federal laws.
Specimens which require refrigerated temperatures should be shipped with a minimum of two frozen gel packs placed in the bottom of a foam container and in close contact with the specimen(s). Specimens requiring frozen transport are to be immediately frozen following collection and shipped in a foam container completely filled with a sufficient volume of dry ice in order to preserve the specimens during the anticipated shipping time. Include appropriate hazardous materials labeling on the outer box if dry ice is used.
Analysis Requisitions and other documents (i.e. manifest, chain of custody forms, etc.) are to be placed in a separate pouch or separate sealed plastic bag and must be shipped in the same box containing the specimens.
External Shipping Labeling
The outer container must be labeled and sealed to indicate that it contains potentially hazardous materials. Labels to identify Exempt Human Specimen or UN3373 specimens must be affixed to the outer container. If dry ice is used this must be noted as dangerous goods on the outer box. Compliance with U.S. Postal and/or commercial carrier requirements is necessary.
Shipping Requirements for Study Specimens
In general, study specimens should be shipped in accordance with the analytical requirements (e.g., frozen, light-protected) and following the guidelines for other specimens listed above. The specimens comprising a batch should be boxed together with the specimen analysis requisitions and other pertinent paperwork. These documents should be contained in a liquid-tight plastic bag or envelope. The shipment should be sent to NMS Labs to the attention of special studies. If a chain of custody protocol needs to be followed contact NMS Labs for details.
International Shipment of Specimens
The shipment of human diagnostic specimens internationally is regulated by the CDC import program. Normal human biological samples that are not known to contain infectious agents (e.g. Ebola, HIV, HBV/HCV) can be shipped through customs by the sender with a certification statement letter only (see below). If there is any knowledge that the samples may contain an infectious agent, then the paperwork from the shipper must list the potential infectious agents and each shipment MUST contain a CDC permit copy listing the name of the person at NMS Labs who will be receiving the shipment. DO NOT send both documents in a single shipment.
The Centers for Disease Control and Prevention (CDC) requires whoever is responsible for the shipment (e.g., sender or recipient) to provide one of the following documents in each shipment of biological samples:
- CDC/Import Permit Program Permit (IPP) OR
- A Certification Statement
The Import Permit must include the NMS Labs contact name that will be listed on the shipment paperwork (e.g. Jane Smith is listed as the Permittee but if her name is not listed on the paperwork for each shipment the NMS contact name must be added to the permit. See QA for processing each request.) The lead-time to obtain a permit is approximately 2+ weeks.
The Certification Statement must include a statement on official letterhead signed by the sender and clearly providing:
1. An accurate and detailed description of the material;
2. A statement that this material
- is not known or suspected to contain infectious biological agents, infectious substances, or vectors OR
- has been rendered noninfectious and describes the method(s) used to render the shipment noninfectious; and
3. Verification that it has been packaged, labeled, and transported in accordance with all applicable regulations.
The Certification Statement must originate from a medical establishment, licensed physician, government agency or research institute.
Shipments must not be leaking. Please refer to the Department of Transportation (DOT) and International Air Transport Association (IATA) regulations for packaging and shipping.