Packing methods and shipping guidelines are important in assuring quality patient care and maintaining result integrity by providing for and achieving optimum environmental control during transit. In addition, for the safety of others, it is imperative specimens be classified for sorting into respective shipping groups.

PAML recognizes the importance of specimen integrity. The temperature at which specimens are held and or transported is a critical component of these requirements, and different packaging will be needed for frozen, refrigerated, and ambient temperatures. Additional steps may need to be taken in seasons/locations where extremes of heat or cold could affect specimen integrity. Basic infection control procedures must also be followed, including adherence to universal precautions protocols. OSHA requires all body fluids be considered potentially infectious by those who handle them and that appropriate engineering and work practice controls be implemented while handling the specimen. While the specimen(s) is in transport, it may be classified as Exempt Human Specimens, Biological Substance (Category B), or Infectious Substance (Category A).

Classification of Specimens

Exempt Human Specimens: NOT REGULATED; Patient specimens for which there is minimal likelihood that pathogens are present are not subject to these Regulations if the specimen is packed in a packaging which will prevent any leakage and which is marked with the words “Exempt Human Specimen”.

Category B, Biological Substances (650): UN3373; An infectious substance which does not meet the criteria for inclusion in Category A.

Category A, Infectious Substances (620): UN2814; An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life threatening or fatal disease in otherwise healthy humans.

* Some substances in Category B may be included in Category A only if they are in culture form. Cultures (laboratory stocks) are the result of a process by which pathogens are amplified or propagate in order to generate high concentrations, thereby increasing the risk of infection when exposure to them occurs.  This definition refers to cultures prepared for the intentional generation of pathogens and does not include cultures intended for biological and clinical purposes.

Key Points when shipping Category A (Infectious Substance UN2814)

Category A Shipments must never be shipped with non-Category A Specimens (Category B/Exempt). This will help avoid delaying non-Category A specimens.

Category A Shipments cannot move on commercial airlines, they must ship via FedEx or Ground (if local area). Note: Category A’s cannot be shipped FedEx First Overnight (FO), they must be shipped FedEx Priority 1 (P1).

The Shipper's Declaration requires up to 4 copies and must be completed by the sender, not the courier. The sender will need to keep 1 copy on file for 2 years, 3 copies must go with the package.

Select Appropriate Shipper's Declaration for your Shipment:

Known Category A – Frozen

Known Category A – Ambient or Refrigerated

Unknown Category A – Frozen

Unknown Category A – Ambient or Refrigerated