Shipper's Responsibility Guidelines for shipping biological substance CATEGORY B SUBSTANCES within the United States Guidelines for shipping biological substance CATEGORY A SUBSTANCES within the United States Guidelines for shipping biological substance CATEGORY B SUBSTANCES Internationally Guidelines for shipping biological substance CATEGORY A SUBSTANCES Internationally Shipping procedures - ADDITIONAL INFORMATION

Shipper’s Responsibility

The shipper is required to comply with the rules and guidelines for transport of medical specimens as set forth by the United States government, the government of the country of origin and international regulatory agencies.   Failure to follow instructions for packaging and shipping specimens can result in the delay, loss or destruction of your specimens. Quest Diagnostics Nichols Institute of Valencia will not be held responsible for any liability attributable to the shipper's improper actions for failure to comply with regulations.

1. Shipper must comply with any applicable regulations set forth by the countries of origin, transit and destination.   Violation of these regulations may be in breach of national laws and can be subject to civil or criminal penalties.
   
2. Shipper must properly identify, classify, package, mark, label and document contents of the shipment in accordance with the laws and regulations of the countries of origin, transit and destination.
   
3. Shipper must notify Quest Diagnostics Nichols Institute of Valencia of the shipping details for tracking purposes. Shipment details including tracking number and air carrier should be faxed to 661-799-5275.
   
4. Shipper must provide such information to his employees as will enable them to carry out their responsibilities with regard to the transport laws and regulations pertaining to the goods being shipped.
   
5. Shipper's personnel involved in the preparation of the packages for the transport of clinical specimens must have received training to enable them to carry out their responsibilities.   Personnel sending Biological Substances Category B specimens must know about the requirements to send Biological Substance Category B specimens.   Personnel who send Biological Substance Category A specimens must be trained in the shipment of Biological Substance Category A specimens.   Records of this training must be maintained and individuals recertified every 3 years.

Definition of Biological Substance Category A and Biological Substance Category B Substances
(1) Division 6.2 (Infectious substance) means a material known or reasonably expected to contain a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion), that can cause disease in humans or animals. An infectious substance must be assigned the identification number UN 2814, UN 2900, UN 3373, or UN 3291 as appropriate, and must be assigned to one of the following categories:

1. Category A: An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. An exposure occurs when an infectious substance is released outside of its protective packaging, resulting in physical contact with humans or animals. A Category A infectious substance must be assigned to identification number UN 2814 or UN 2900, as appropriate. Assignment to UN 2814 or UN 2900 must be based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgment concerning the individual circumstances of the source human or animal. A list of examples of category A infectious substances is attached.
Click here to see a list of Category A biological substances.



2. Category B: An infectious substance that is not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes Category B infectious substances transported for diagnostic or investigational purposes.
   
   

• Patient Name
• Sending Lab's Specimen identification #
• Type of Specimen
• Collection Date, Time and Initials
• Name of Sending Lab
• Physician Name (First, MI, Last)

• Leakproof primary receptacle
• Leakproof secondary packaging with biohazard labeling
• Either the primary or secondary package must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa
• Absorbent material (desiccant) placed between the primary receptacle and the secondary packaging.
• Sturdy outside packaging constructed of corrugated fiberboard (cardboard), wood, metal or plastic. Exterior package must be capable of passing a drop test of at least 1.2 meters, and must contain an "air eligible" requirement.
  

• Name and Address of Sending Lab
• Temperature of the Specimen(s)
• Indication of Quest Diagnostics Nichols Institute of Valencia as Receiver
• A count of the number of bags

If you are using DataPassportMD®, the packing slip is printed automatically. If you are using a Quest Diagnostics Nichols Institute of Valencia courier, the courier will complete the packing slip for you.

Quest Diagnostics Nichols Institute of Valencia Courier Instructions

1. Place all samples for a single patient in an individual specimen bag containing absorbent material.   Plastic specimen bags/absorbent are available from Quest Diagnostics Nichols Institute of Valencia.
   
   
2. Fold requisition in half and insert the requisition in the plastic bag so that the patient's name is displayed.



3. Use a plastic transport tube whenever possible.   Glass tubes are not acceptable for frozen samples.   Closures must be sufficiently tight to prevent leaking.   Stoppers or corks must be held securely in position with wire, adhesive tape or other positive means.   Packagings having necks with moulded screw-threads must have threaded-type caps having a resilient liner completely resistant to the contents.

If a test requires multiple samples at different temperatures (for example: one frozen sample and one sample at room temperature), place a copy of the requisition with each sample.   Write "Duplicate Requisition" on each copy of the Test Requisition Form.   Place a copy of computer-generated packing lists with specimens.

Air Courier Instructions (FedEx)

To prevent damage and insure specimen stability, samples should be packed for shipping as follows:

1. Secure the cap on the primary collection tube.
2. Place specimen in a Quest Diagnostics Nichols Institute of Valencia specimen bag containing absorbent material.
3. Package specimens in appropriate size container, such as Styrofoam cooler; include insulation material to prevent breakage.
4. Place ambient, refrigerated or frozen specimens in separate coolers and separate shipping boxes.
   1. Place ambient specimens in Styrofoam cooler. Place a shipping manifest (packing slip) on top of the specimens. Use paper towels or newspaper to insulate samples against breakage.
   2. Place a cold pack that has been frozen for more than 24 hours in a Styrofoam cooler. The cold pack should be taken from freezer and kept refrigerated for at least 3 hours before it is placed in cooler with refrigerated specimens; protect tubes from direct contact with the cold pack with newspaper or paper towels. Use additional paper towels or newspaper to insulate samples against breakage. Place a shipping manifest (packing slip) on top of the specimens
   3. If frozen samples (including tissue) are sent, please follow specific instructions listed under PACKING A SHIPPING COOLER FOR FROZEN SPECIMENS in the Shipping Procedures Appendix. (See Figure B).
5. Include a packing slip (available from our lab) in each box.
6. Seal container with strapping tape.
7. Place thick-walled Styrofoam container inside cardboard box and seal with strapping tape.
8. Fill out the air waybill completely, including the sender's and recipient's complete names, addresses and phone numbers.
   
9. The exterior box should be marked "Diagnostic specimens packed in accordance with IATA packing instruction 650." In addition a "Dry Ice" label should be placed on the package if it contains dry ice.
   
   

   Air Courier Delivery Address Quest Diagnostics Nichols Institute of Valencia 27027 Tourney Road Valencia, CA 91355-5386 Phone 800-421-7110, ext 2 Local 661-799-6543, ext 2 Fax 661-799-5275

   
   
10. Contact the overnight courier for specific instructions related to their service. Pick-up service is generally available Monday through Friday. If shipping on a Friday, be sure to check the "Saturday Delivery" box on the air waybill to insure next day delivery.

If ambient specimens are shipped at the same time as frozen specimens, place the ambient specimens in a second Styrofoam container and ship as a separate entity. If shipping via Federal Express, fax a copy of the air waybill to Quest Diagnostics Nichols Institute of Valencia at 661-799-5275. The package will be tracked during shipment to insure timely delivery.

• Specimen Labeling
• Packing Slips
• Specimen Shipping Location

Preparation/Shipping of Etiologic Agents

As the shipper, your Sendout Department is responsible for reviewing specimens to determine if they are considered infectious before sending to us or giving them to a Quest Diagnostics Nichols Institute of Valencia courier for shipment. It is important that your laboratory make the determination of whether a specimen is infectious based upon your knowledge of the specimen being sent.

Quest Diagnostics Nichols Institute of Valencia will supply you with the appropriate packaging materials and labels to ship Biological Substance Category A specimens via FedEx.   You should contact the Client Supply Department at 800-421-7110 ext 6690 to request packaging for the shipment of infectious specimens.   Specific Instructions on the use of this packaging will be included with the supplies.   All individuals shipping Biological Substance Category A specimens must be trained according to regulations contained in 49CFR 172.704.


GUIDELINES FOR SHIPPING BIOLOGICAL SUBSTANCE CATEGORY B SUBSTANCES Internationally

Follow the "Air Courier" instructions instructions for shipping Biological Substance Category B substances within the United States.   Follow any additional regulations set forth by the countries of origin, transit and destination.   Instructions for packaging frozen specimens are included in PACKING A SHIPPING COOLER FOR FROZEN SPECIMENS in the information that follows this Appendix.

The Quest Diagnostics Nichols Institute of Valencia Directory of Services lists acceptable specimen temperatures for individual assays and panels. For additional specimen stability information, contact Client Services at 800-421-4449 or 661-799-6543 for international clients.

GUIDELINES FOR SHIPPING BIOLOGICAL SUBSTANCE CATEGORY A SUBSTANCES Internationally

Biological Substance Category A specimens must be packaged and shipped in boxes approved by the United Nations (UN) and labeled according to requirements detailed below.   We recommend the purchase of UN-approved boxes from your local packaging supplier. Your freight forwarder may be able to help in locating these suppliers.   In the event these are not available, you should confirm with your shipping company that all IATA regulations for shipment of Biological Substance Category A substances have been met.

A Shipper’s Declaration for Dangerous Goods Form must accompany all shipments of Biological Substance Category A substances. See GUIDELINES FOR SHIPPER'S DECLARATION FOR DANGEROUS GOODS.

For Biological Substance Category A   Specimens, follow the "Air Courier" instructions for shipping specimens within the United States as regards labeling and packaging specimen tubes.   For Category A Specimens, follow instructions supplied with packaging material.

Instructions for packaging frozen specimens are included in PACKING A SHIPPING COOLER FOR FROZEN SPECIMENS in the Appendix. Frozen specimens are advisable for international shipment unless contraindicated. Our Directory of Services lists acceptable specimen temperatures for individual assays and panels.

For additional specimen stability information, contact Client Services at 800-421-4449 or 661-799-6543 for international clients.

1. Seal box carefully with security tape.
2. Apply shipping label with the following information:
   • Return Address
   • Shipping Destination:  
     
     Quest Diagnostics Nichols Institute of Valencia
     27027 Tourney Road
     Valencia, CA 91355
     U.S.A.
     Attn: Accessioning
     
     
3. Apply “Dry Ice” Labels. (If required, see Figure C).
4. Apply yellow “0 degrees Celsius” label to the cardboard shipping box. (If required, see Figure E).
5. Tape a “Centers for Disease Control” label (See Figure F) to the outside of your shipping box. It should include our Permit No. 2005-01-123 and the expiration date 1/25/2006.
   The permit and label inform the U.S. Customs Service and the U.S. Division of Quarantine of the package contents and facilitate package movement through U.S. Customs. Any shipping boxes arriving without the CDC permit will be held in Customs until proof of permit is received. This delay could result in loss of specimen integrity for testing.
6. Complete a "Shipper's Declaration for Dangerous Goods" (See Figure D) form as per the GUIDELINES FOR COMPLETING "SHIPPER'S DECLARATION FOR DANGEROUS GOODS" in the Appendix following this section. Give the form to the transportation company when making a shipment. Apply "Infectious Specimen" labels as required.
   
7. A pro forma invoice is also required (See Figure G). (See Instructions for pro forma INVOICE in the Appendix). An original signed copy and a photocopy must be attached to the air waybill. An additional copy should be placed on the side of the box.
8. Ship package(s) prepaid via priority services (next flight out) with your Carrier.
9. When you ship the package(s), either fax our Distribution Services Department (661-799-5275) a copy of your pro forma invoice and the international air waybill or leave a voicemail message (661-799-6543, option 2) to notify our lab to expect an incoming shipment. You should provide the following information:
   • Client Name and Account #
   • Number of Boxes Being Shipped
   • Number of Specimens: ambient, refrigerated, frozen
   • Shipment Details:
     1. Shipping Company (e.g., FedEx, DHL)
     2. If Airline Carrier, then supply name, flight number and estimated time of arrival
     3. Air Waybill number of the shipment
     4. Date of shipment

SHIPPING PROCEDURES   - ADDITIONAL INFORMATION

PACKING A SHIPPING COOLER FOR FROZEN SPECIMENS

1. Put a layer of dry ice (half the total quantity) on the bottom of the cooler.
   NOTE: 2 kg of dry ice will last 20 hours. One solid piece lasts longer than several smaller pieces. Federal Express shipments should contain at least 5 kg of dry ice.
   
2. Place Quest Diagnostics Nichols Institute of Valencia specimen bag with specimens on top of dry ice.
3. Place the remainder of the dry ice on top of the specimens.
4. Fill excess space with paper towels or newspaper on top of the dry ice to serve as insulation.
5. Place shipping manifest on top of the insulation material.
6. Close the lid of the cooler and tape with clear shipping tape around 3 sides of the cooler. Leave the fourth side unsealed to allow dry ice gases (carbon dioxide) to escape.
7. Place the cooler in an appropriate shipping box, making sure to leave one side unsealed for dry ice gases to escape out of the shipping box.

Mark the net weight of the dry ice on the "Dry Ice" label (See Figure C) and affix it to the outside of the package near the shipping label. Additional "Dry Ice" labels should be applied to each side of the box.

INSTRUCTIONS FOR pro forma INVOICE (See Figure G )

The pro forma invoice is intended to help expedite your shipment through the U.S. Customs Service. A signed original and at least two copies should accompany the shipment. On your company's letterhead, include the following information:

1. Shipper Information
   • Company Name
   • Address and Country of origin
2. Description of Contents
   • "Non-Infectious (or Infectious) Human Blood (or other specimen)"
   • "Not for Commercial Use"
   • "For Diagnostic Purposes Only"
3. Quantity – total number of cartons
4. Declared Value – this is for tariff purposes only.
   To avoid incurring additional tariff charges, a declaration of $1 should be made.
5. Weight of Shipment – total weight of shipment, including dry ice if applicable
6. Letter to Department of Health, country of origin - may be required
   Please check your country's export regulations to determine if required and approved format.
   

When you ship the package(s), either fax our Distribution Services Department (661-799-5275) a copy of your pro forma invoice and the international air waybill or leave a voicemail message (661-799-6543, option 2) to notify our lab to expect an incoming shipment. You must provide the following information:

• Client Name and Account #
• Number of Boxes Being Shipped
• Number of Specimens: ambient, refrigerated, frozen
• Shipment Details:
  1. Shipping Company (e.g., FedEx, D.H.L.)
  2. If Airline Carrier, then supply name, flight number and estimated time of arrival
  3. Air Waybill number of the shipment
  4. Date of shipment

GUIDELINES FOR COMPLETING "SHIPPER'S DECLARATION FOR DANGEROUS GOODS" (See Figure D)

The instructions below are specific to shipping infectious substances to Quest Diagnostics Nichols Institute of Valencia. For complete details, see the current IATA Dangerous Goods Regulations. You must complete the form legibly in triplicate. Each copy must have the red border on each side.

1. Enter name and address of SHIPPER
2. Enter name and address of CONSIGNEE
   
   

   Quest Diagnostics Nichols Institute of Valencia 27027 Tourney Road Valencia, CA 91355 U.S.A. Attn: Accessionin

   
   
3. Enter PAGE OF PAGES, page number and total number of pages (e.g., page 1 of 2)
4. Delete "Cargo Aircraft Only" under TRANSPORT
5. Delete "Radioactive" under SHIPMENT TYPE
6. List the PROPER SHIPPING NAME and, if applicable, list the technical name in parenthesis
7. List the CLASS OR DIVISION number and, if applicable, compatibility group
   • Infectious Substance: 6.2
   • Dry Ice: 9
8. List the UN or ID NUMBER, being sure to include the prefix UN or ID
   • Infectious Substance: UN2814
   • Dry Ice: UN 1845
9. List the appropriate PACKING GROUP, if applicable
   • Dry Ice: III
10. Leave SUBSIDIARY RISK blank
11. List the QUANTITY (number of cartons and the net quantity in each package) AND TYPE OF PACKAGING (e.g., 1 fiberboard box × 2 kg)
12. Enter the PACKING INSTRUCTIONS number
    • Infectious Substances: 602
    • Dry Ice: 904
13. For ADDITIONAL HANDLING INFO, enter "Notify Consignee upon arrival"
14. Leave AUTHORIZATION blank
15. Enter EMERGENCY TELEPHONE NUMBER for Shipper – your number
16. Enter EMERGENCY TELEPHONE NUMBER for Receiver – 800-421-7110
17. Enter NAME/TITLE OF SIGNATORY – your name and title
18. Enter PLACE (city) AND DATE of shipment origin
19. Enter your SIGNATURE – it must be a complete signature

Figures

Figure A: International Shipping Details Form Figure B: Packing Procedures for Specimens on Dry Ice Figure C: Placement of Dry Ice Label on Shipping Box Figure D: Shipper's Declaration for Dangerous Goods Form Figure E: Other Appropriate Labels on Shipping Box Figure F: CDC Permit Label Figure G: Pro Forma Invoice