Specimen Guides - Collection & Transport
Focus Diagnostics provides guides for the collection and transport of Microbiology, Virology, and Molecular Diagnostics specimens.
Please use the links below to view each of the guides.
Specimen Bags
Specimen bags are provided by Focus Diagnostics to ensure the integrity and security of each specimen. Using these bags properly helps our laboratory deliver the highest quality results to our clients.
Unacceptable Specimens
- Needles: Focus will not accept, transport or test any specimen with a needle attached. In cases where syringes must be submitted, the syringe must be plastic and have a Luer Lock securely attached.
- Glass Tubes: Glass tubes should be avoided due to the increased risk of broken glass and biological contamination.
- Tissue Specimens: Focus will not process tissue specimens received dry. All tissue specimens must be submitted in sterile saline or other appropriate transport media.
- Animal Specimens: No animal specimens will be accepted for testing without prior approval by the Laboratory Director or Scientific Director.
- Unacceptable Ova and Parasite Samples: Focus will not accept specimens submitted for parasite exam and identification that are not contained in formalin or PVA.
- Improperly Labeled Specimens: Focus will not accept specimens submitted without patient identification (patient name or identification number).
Specimen Transport
All carriers are dependent on the shipper to determine the correct transport conditions category of the specimens being submitted. Use the following guidelines to assist in your decision.
Temperature Requirements
Specific temperature transport requirements are provided under each assay description in the test listing. Specimens should be transported at 2-8º C unless otherwise indicated.
Diagnostic Specimens
Any human material including, but not limited to excreta, secreta, blood and its components, tissue and tissue fluids being shipped for purposes of diagnosis. The following Diagnostic Shipping Guidelines (IATA Packing Instruction 650) are to be utilized:
- A watertight primary receptacle.
- A watertight secondary receptacle.
- An absorbent material placed between the primary receptacle and the secondary receptacle.
- A sturdy outside packaging constructed of corrugated fiberboard, wood, metal or plastic.
Infectious Substances
Substances known to contain, or reasonably expected to contain, pathogens. Pathogens are microorganisms (including bacteria, viruses, rickettsia, parasites, fungi) or recombinant micro-organisms (hybrid or mutant) that are known or reasonably expected to cause infectious disease in humans. The following Infectious Substance Shipping Guidelines (IATA Packing Instructions 602) are to be utilized:
- A watertight primary receptacle
- A watertight secondary receptacle
- Absorbent material, sufficient to absorb the entire contents of all primary receptacles
- All packaging must meet the requirements of Subsection 6.5 Performance Tests - Infectious Substances of IATA Dangerous Good Regulations (DGR).
- Affix an Infectious Substance label.
- Attach the Shipper’s Declaration of Dangerous Goods.
- In case of emergency biohazard spill, contact INFOTRAC at (800) 535-5035.
A number of helpful links to more detailed IATA information can be found in Summary of IATA Regulation. These are recommendations only; each laboratory is responsible for in implementing the procedures that comply with Federal Regulations.
Frozen (Dry Ice) Shipments
A minimum of 2lbs (1kg) of dry ice should be used depending on weather conditions. Be aware that dry ice is a dangerous good and must be declared by marking, labeling and documentation. If there are no other dangerous goods in a shipment with dry ice, a formal Shipper’s Declaration is not required. Refer to IATA packing instruction 904.
Summary of IATA Guidelines
Infectious Substance Regulation Update
The following information addresses recent changes to the Federal Regulations for shipping Infectious Substances, effective February 2003. The complete regulation can be found on the Internet at the following sites:
IATA (www.iata.org)
ICAO (www.icao.org)
CDC (www.cdc.gov)
Infectious substances are referenced under section 6.2 / UN 2814 or UN 2900. It is worth noting that some specimens previously required to ship as Infectious Substances have been reclassified as Diagnostic Specimens. If there is doubt as to whether or not a pathogen falls within this category it MUST be transported as an Infectious Substance.
Other specimens are clearly classified as Infectious Substances that can affect humans. For example:
Dengue virus (cultures only)
Hepatitis B virus (cultures only)
Herpes B virus (cultures only)
Human immunodeficiency virus (cultures only)
Chlamydia psittaci-avian strains (cultures only)
Proper Packaging of Dangerous Goods
Refer to IATA, section 12, instructions 602 and 650. Packaging must be tested, have a manufacture report available and bear UN specification mark. The shipping packages can be obtained from various vendors. The following vendor web sites are provided for your convenience; please note this is not an endorsement for a particular resource:
SAFTPACK, Inc. (www.saftpak.com)
All-Pak, Inc. (www.all-pak.com)
EXACT-PAK® (www.exaktpak.com)
The correct marking and labeling of dangerous goods is one of the most important parts of the process of shipping. Some of the information that must be shown on the package and documentation includes, but is not limited to:
- Technical name (name of what is being shipped)
- UN number
- Addresses of both the shipper and receiver
- Name and phone number of responsible person per IATA 7.1.5.1. (for emergency contact in case of spill, broken containers).
All the information on what and how to complete the forms is covered in detail at IATA training sessions.
A shipper's declaration must be completed for shipment of infectious substances. These are legal documents signed by the shipper. The document must be accurate, legible, neat and no spelling errors. Only the shipper may complete and sign the shipper's declaration. The courier or carrier is only a means of transporting the shipment from point A to point B, and are not responsible for these documents.
IATA requires that the person who packs/ships materials be a trained person. The following web sites, as well as others not listed, can provide information on training.
Each facility can send one person to be trained. This person is then "licensed" and can train others in his/her facility. Each packer/shipper must have training record on file. Certification is valid for 2 years. Each person must be re-trained and re-certified at the end of 2 years period.
It is important that each facility read and understand the entire regulation. We have attempted to summarize the most significant changes, but this is only an excerpt and cannot be used to determine compliance or suitability of shipping materials. Per federal regulations, it is the shipper's responsibility to determine the proper method for shipping specimens, and maintaining the documentation for proof of compliance.
