School of Medicine Nephropathology Laboratory: Shipping Diagnostic Specimens

Title

School of Medicine Nephropathology Laboratory: Shipping Diagnostic Specimens

I. Purpose

Proper packaging of diagnostic specimens is required for safe delivery to their desired destinations. In order for specimens to be received in the same condition they were sent, special packaging to prevent breakage, leakage, or loss is required. Specimens requiring rapid delivery will be sent by FedEx.

II. Transport Personnel

Transport personnel are trained in appropriate safety and packaging procedures and are certified every two years by taking the IATA/DOT TRAINING. Records of training can be found on the EH&S website, as well as in the Safety Training Log on the Supervisor’s computer.

III. Specimens

Human and animal materials are considered diagnostic specimens. They may include excreta, secreta, blood, tissue, and tissue fluids. In addition, diagnostic specimens are considered those not suspected of containing known infectious substances. Blood, urine, fluids, and other specimens known to contain infectious substances such as HIV, Hepatitis, and etc. will have additional shipping requirements not mentioned in this procedure.

IV. Materials

A. Acceptable Packaging Materials

1. Watertight Primary Container: must have positive closures such as screw-on, snap-on, or push-on lids that assure a leak proof seal. Reinforce screw caps with adhesive tape.
   1. Plastic Canister
   2. Glass/Plastic Jar
   3. Glass/Plastic Vial
2. Watertight Secondary Container: Enclose an itemized list of contents between the secondary packaging and the outer packaging.
   1. Plastic Canister
   2. Sealed Plastic Bag
   3. Sealed Styrofoam™ Container (1” thick minimum)
   4. Screw-Cap Can
3. Absorbent Material: Place absorbent material between the primary and secondary receptacle, making sure that multiple primary receptacles are individually wrapped to prevent contact. Use enough absorbent material to absorb the entire contents of all primary receptacles.
   1. Cellulose Wadding
   2. Cotton Balls
   3. Super Absorbent Packet
   4. Paper Towels
4. Sturdy Outer Packaging: Must consist of corrugated fiberboard, wood, metal or rigid plastic.
   1. Corrugated Fiberboard
   2. Wood
   3. Rigid Cooler
   4. Rigid Plastic Container
5. Additional Packaging That May Be Purchased From FedEx
   1. FedEx® Clinical Pak

B. Other Supplies

1. Shipping Address Labels
2. Biohazard Labels
3. UN 3373 “Diagnostic Specimens” Labels
4. Packing Tape
5. List of Package Contents

V. Procedure

1. Place the specimen in a watertight primary container as noted above. Plastic is preferred to glass as it will reduce the chances of breakage. Liquid specimens must not contain more than 500ml in volume and solid specimens must not contain more than 500g in weight.
2. Seal the lid of the container with tape or Parafilm®.
3. Label the specimen with name, birth date, date of collection, specimen type, and medical record or sample identification number.
4. Wrap the primary container in absorbent material. If multiple containers are to be shipped together, wrap each one individually before placing in the secondary container. Enough absorbent material should be used to absorb the entire contents in case leakage occurs.
5. Once the primary container is wrapped in absorbent material, place it inside the secondary container. If the secondary container is a bag, seal it completely. If it is a container with a lid, again seal it with tape or Parafilm®. The secondary container must not contain more than 4L of a liquid or 4Kg of a solid.
6. Place a biohazard label on the outside of the secondary container.
7. Make sure patient identification information is not visible to the outside.
8. Place a list of package contents.
9. Place the secondary container containing the specimen, the accompanying paperwork to be sent, and a brief list of package contents inside the sturdy outer packaging. This packaging should be a minimum of 7” x 4” x 2” in size. (If this size is not met, a FedEx® Clinical Pak should be obtained as an overwrap).

VI. Diagnostic specimens will be labeled according to their potential of containing pathogens with markings as follows:

1. “Category B” substances are “Diagnostic” or “clinical specimens” or “Biological substances," which are known or are reasonably expected to contain pathogens and are shipped for diagnostic or investigational purposes. Pathogens are defined as micro-organisms and other agents which can cause disease in humans or animals. Such pathogens are divided in two categories – A and B.
2. Human or animal specimens which do not contain pathogens in Category A fall into Category B; and must be assigned to UN 3373 “Biological substance, Category B.”
3. Exempt Human or Exempt Animal specimens are specimens taken directly from a human or animal subject and transported for research, diagnosis, investigational activities, or disease treatment or prevention and have a minimal likelihood of containing pathogens. If a patient has no signs of disease and you have no reason to believe he is sick, then any bodily fluid or tissue sample from this patient is considered an Exempt Human Specimen.
   1. Patient specimens include excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media. Professional judgment is critical in determining the probability of pathogens being present in a specimen. The judgment should be based on the medical history of the source, symptoms and circumstances of the source, and endemic conditions of the local area.
   2. Packaging Exempt Human and Animal Specimens: Exempt human and animal specimens are packed according to the basic triple packing method:
      1. A leak proof primary receptacle
      2. A leak proof secondary receptacle
      3. A rigid outer container
   3. Labeling Exempt Human and Animal Specimens: The outer package must be marked with the words “EXEMPT HUMAN SPECIMEN” or “EXEMPT ANIMAL SPECIMEN”
   4. Documenting Exempt Human and Animal Specimens: No Declaration for Dangerous Goods is needed as this classification is not considered a dangerous good. You will list the items on the air waybill by their technical name. For example: Human blood samples.
4. Small amounts of some dangerous goods can be shipped under the Excepted Quantity rule. Hazardous biological materials do not have an Excepted Quantity exemption.
   1. If your material fits within the limits of its EQ allotment, then it can be shipped using an excepted quantities label instead of hazard labels and will not require a dangerous goods declaration for that material. You will need to write the class of your dangerous good underneath the symbol on the below label. You will also add the shipper or consignee name and address to this label if it is not already marked on the package. The “Nature and Quantity of Goods” information on the air waybill should include the phrase “Dangerous Goods in Excepted Quantities."
   2. For specimens suspected of containing pathogens, a diamond containing “UN3373” and the words “Biological Substance Category B” should be placed on the outer packaging.
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
       
   3. Specimens for which there is minimal likelihood of having pathogens present are labeled with the words “Exempt Human Specimens” on the outer packaging.
   4. Consult the UNC Environment, Health and Safety Office with further questions.
   5. If you send packages with FedEx that require the dangerous goods declaration you can either have EHS generate this document for you or contact dcvick@ehs.unc.edu for information on how to obtain the approved software.
   6. Excepted Quantities: Excepted quantity packages must be tested for durability and have documentation that the package has passed the required drop and load tests. See the Excepted Quantity Package Test document for details.
5. Seal the outer packaging with packing tape. Place the completed mailing address label on the outside of the package. A biohazard label should also be placed on the outside of the package if it is not enclosed in a FedEx® Clinical Pak.
6. When the package is ready, call FedEx for pickup.

VII. Comments/Limitations

1. Other categories of infectious substances, diagnostic specimens requiring refrigeration and packages shipped on dry ice require additional shipping requirements and will be handled differently than the diagnostic specimens this procedure pertains to. See applicable government and IATA regulations before shipping.
2. FedEx will not accept diagnostic specimens packaged in the FedEx® Envelope, FedEx® Tube, FedEx® Pak or any FedEx® Box.
3. Packages smaller than 7” x 4” x 2” in size should not be sent without some sort of overwrap or larger packaging to enclose it. This will help to prevent the “loss” of small packages during shipping. FedEx® Clinical Paks are available in two sizes and can be obtained prior to shipping.

VIII. References

1. FedEx Packaging UN 3373 Shipments 11/17
2. FedEx Pointers on Shipping: Clinical Samples, Diagnostic Specimens and Environmental Test Samples

IX. History

Created: 11/19/01 LKC

Replaces: N/A

Revisions:

• 7/2/18 LHR
• 8/7/12 LHR
• 2/21/11 LHR
• 2/23/07 LKC
• 5/9/06 LKC
• 3/2/05 LKC
• 4/28/03 LKC