Shipping Regulations

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SHIPPER'S RESPONSIBILITY 

The shipper is responsible for compliance with applicable regulations and guidelines for transport of medical specimens as set forth by the United States Department of Transportation (DOT), the International Air Transport Association (IATA), and other applicable laws and courier requirements.


For your reference we have included a list of the resources regarding shipping requirements:

  • DOT- Department of Transportation
  • ICAO- International Civil Aviation Administration
  • IATA- International Air Transport Association
  • CDC- Center for Disease Control
  • TSA- Transportation Safety Administration
  • FDA- Food and Drug Administration
  • OSHA- Occupational Safety and Health Association


The shipper is responsible for compliance with all packaging requirements. To insure the most rapid turnaround times and to preserve the integrity of the specimen, clients should follow the guidelines listed below. If you have questions regarding shipping or ordering a test, please call Viracor Eurofins at 1-800-305-5198 or 1-816-347-0113.


SPECIMEN LABELING 

All specimens must be labeled with the patient's name and collection date. A specimen that must be processed within a specific time frame must also include the time of collection. The specimen will not be accepted for testing if it is not labeled with the appropriate identifying information. 


A Viracor Euorfins Test Requisition Form or a Specimen Manifest (Retriever or Laboratory Link clients) must accompany the specimen(s).


ABBREVIATED GUIDELINES FOR SHIPPING DIAGNOSTIC SPECIMENS


See below for detailed shipping instructions.


Diagnostic specimens must be packaged in the following manner:

  1. Primary receptacle - The specimen must be placed into a tightly sealed container such as a blood tube or screw-top tube. 
  2. This primary receptacle must be placed in a zip-lock bag with an absorbent material in sufficient quantity that the entire volume of specimen would be absorbed should breakage of the primary receptacle occur. NOTE: If more than 1 specimen is to be shipped in the same container, it is critical that each specimen be placed in an individual zip-lock bag (each with its own absorbent material) to prevent cross contamination in case of leakage or breakage.
  3. Place the zip-lock bag containing the specimen into a secondary container, which usually consists of a styrofoam container.
  4. The styrofoam container is then placed into a rigid outer packaging consisting of a cardboard box, metal, or rigid plastic container.
  5. The completed Test Requisition Form should be placed inside the rigid outer packaging to prevent loss. 
  6. The packaged specimen is now placed into an outer packaging bag. Each shipping company has bags available that are specially designed for shipping diagnostic specimens.
  7. The outermost container must have the clearly visible mark (as shown below in Figure 1).
  8. Fill out the shipping label completely, including a complete return address with phone number.
  9. The specimen should be shipped by FedEx Priority Overnight® to the following address:


Viracor Eurofins
1001 NW Technology Drive
Lee's Summit, MO 64086


ADDITIONAL IMPORTANT POINTS TO NOTE 

Primary receptacles (blood tube or urine screw-top tube) must be leakproof with a volumetric capacity of not more than 16.9 ounces. 


Primary receptacles must be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured, or leak their contents into the secondary packaging.


The complete package must be capable of withstanding a 4' drop test outlined in IATA 6.6.1.

The outer packaging must be clearly marked with the words "Diagnostic Specimen". The outer packaging must not exceed 8.8 pounds capacity.

The primary receptacle or the secondary receptacle must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 0.95 bar, 14 psi.


Figure 1.


DETAILED GUIDELINES FOR SHIPPING DIAGNOSTIC SPECIMENS
 

The packagings must be of good quality, strong enough to withstand the shocks and loadings normally encountered during transport. Packagings must be constructed and closed so as to prevent any loss of contents that might be caused under normal conditions of transport, by vibration, or by changes in temperature, humidity or pressure.

The packaging must consist of 4 components:

  • A watertight  primary receptacle(s) - specimen container such as blood tube or urine screw-top tub
  • A watertight secondary packaging - sealed plastic bag or foam container sealed with tape suitable to prevent leakage
  • An absorbent material - enough material to absord the entire contents of all primary receptacles
  • A rigid outer packaging - outer package of corrugated fiberboard, wood, metal or plastic


If one surface of the rigid outer packaging is less than the minimum of 4" X 4", a flexible overwrap from a shipping carrier may be used to meet the size requirements for appropriate labeling of biologic substances.


Primary receptacles must be packed in secondary packagings in such a way that, under normal conditions of transport, they cannot break, be punctured or leak their contents into the secondary packaging. Secondary packagings must be secured in outer packagings with suitable cushioning material. Any leakage of the contents must not compromise the integrity of the cushioning material or of the outer packaging. 


Packages must be prepared as follows: 

For liquid substances: 

  • The primary receptacle(s) must be leakproof and must not contain more than 500mL.
  • The secondary packaging must be leakproof.
  • Absorbent material must be placed between the primary receptacle and the secondary packaging. The absorbent material, such as cotton wool, must be in sufficient quantity to absorb the entire contents of the primary receptacle(s) so that any release of the liquid substance will not compromise the integrity of the cushioning material or of the outer packaging.
  • The primary receptacle or the secondary packaging must be capable of withstanding, without leakage, an internal pressure of 95 kPa in the range of -40°C to 55°C (-40°F to 130°F).
  • The outer packaging must not contain more than 4 L (approximately 1 gallon). This quantity excludes ice, dry ice or liquid nitrogen when used to keep specimens cold. 

For solid substances:

  • The primary receptacle(s) must be shiftproof and must not exceed the outer packaging weight limit.
  • The secondary packaging must be shiftproof.
  • The outer packaging must not contain more than 4 Kg (approximately 8 lbs). This quantity excludes ice, dry ice or liquid nitrogen when used to keep specimens cold.
  • If there is any doubt as to whether or not residual liquid may be present in the primary receptacle during transport, then a packaging suitable for liquids, including absorbent materials, must be used.

An itemized list of contents must be enclosed between the secondary packaging and the outer packaging. At least one surface of the outer packaging must have a minimum dimension of 100 mm x 100 mm (4 in x 4 in).

The completed package must be capable of successfully passing a drop test with the height of the drop must not be less than 1.2 m (approximately 4 ft). Following the appropriate drop sequence, there must be no leakage from the primary receptacle(s) which must remain protected by absorbent material, when required, in the secondary packaging.

LABELING OF DIAGNOSTIC SPECIMENS


For transport, the mark illustrated above (Figure 1) must be displayed on the external surface of the outer packaging on a background of a contrasting color and must be clearly visible and legible. The mark must be in the form of a square set at an angle of 45° (diamond-shaped) with each side having a length of at least 50 mm (2 in), the width of the line must be at least 2 mm, and the letters and numbers must be at least 6 mm high. The proper shipping name "Biological Substance, Category B" in letters at least 6 mm high must be marked on the outer packaging adjacent to the diamond-shaped mark.


• The name and address of the shipper and of the consignee must be provided on each package.
• The name and telephone number of a person responsible must be provided on the shipping air waybill or on the package.

 
SHIPMENT TO VIRACOR EUROFINS


Ship specimens FedEx Priority Overnight® to:


Viracor Eurofins
1001 NW Technology Drive
Lee's Summit, MO 64086