Sample Submission Step 3: Shipment
According to the latest available information, the following criteria are to be met when sending a specimen either through the U.S. Mail or via private courier services (Federal Express, Airborne, etc.). Read requirements on the Centers for Disease Control website.  Two containers are required: 

Primary Container

The labeled specimen must be packed in a securely sealed, crushproof, and liquid-tight (leak-proof) primary container. In most cases, the primary container will be either an evacuated glass tube, vial, jar or bottle with a screw-top cap.

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. It is also recommended that the tubes be placed in a capped plastic vial in case of freeze-related breakage.

Glass tubes are to be packed in one of two ways. They may either be individually placed in secondary containment tubes (see below), or they are to be 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 “Ziploc®” bag described below. Do not allow tubes to come in contact with each other to avoid breakage during shipping.

Opened Evacuated Tubes

Once a stopper has been removed, it cannot be replaced in a manner which will prevent leakage during shipment. If the tube has been previously opened, the contents are to be transferred to a screw-top or snap-top plastic tube, with a notation made on the Analysis Requisition as to the nature of the original evacuated tube, e.g. stopper color, and/or preservative.

Secondary Container

Each primary container is to be placed in a secondary container. In the case of glass or plastic tubes, the best secondary container is a plastic container (tube) with a larger diameter and a screw-top lid. For all other specimens, a “Ziploc®” bag is appropriate. The purpose of the secondary container is to preserve and protect the specimen(s) if the primary container cracks, to protect other specimens from possible contamination and to protect persons (postal service workers, laboratory staff, etc.) from exposure to potential hazardous substances/materials or biological fluids during their handling.

Absorbent Material

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.

Required Documents

Analysis Requisitions and other documents (i.e. histories, 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.

Interior Padding

Shock-absorbent material must be used if multiple specimens are being shipped. It should be adequate to prevent breakage during ordinary handling.

Cooling Agents

Specimens required to be submitted frozen are to be immediately frozen following collection and shipped in a Styrofoam® container completely filled with a sufficient volume of dry ice in order to preserve the specimens during the anticipated shipping time. Specimens which require refrigerated temperatures should be shipped with a minimum of one frozen cold-pack placed in the bottom of a Styrofoam® container and in close contact with the specimen(s). Overnight delivery is recommended for all specimen types. Samples shipped on Fridays should be marked for priority overnight and Saturday delivery.

Light Protection

Many drugs and other toxins can degrade in the presence of light, even when in a biological sample.  This can happen with both natural and artificial light.  NMS Labs makes efforts to assess drugs for their light stability as part of our extensive method validation procedure.  We require those analytes, which are light sensitive to be collected or stored in a light, protected container, and either amber glass or in a clear glass wrapped with aluminum foil.  This, and observing proper storage and shipping temperature helps ensure that the drug concentration present at the time of analysis reflects the concentration at the time the sample was collected, and assists with interpretation and patient care.

Outer Carrier Box

Each set of primary and secondary containers are to be placed in a crush-proof shipping container made of fiberboard or Styrofoam.

External Shipping Labeling

The outer container must be labeled and sealed to indicate that it contains potentially hazardous materials. Biohazard labels 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.

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