Shipping infectious substances and diagnostic specimens Hazmat Training Shipping infectious substances and diagnostic specimens

Requirements for training Awareness Training Function Specific Training Safety Security

Hazardous Material Regulations This training is intended to meet the regulations set by The International Civil Aviation Organization (ICAO), International Air Transport Association (IATA), 49 Code of Federal Regulations (49 CFR) transport of dangerous goods , Clear Language Edition (Canadian TDGR), European Agreement concerning the international carriage of dangerous goods by ADR and regulations concerning the International Carriage of Dangerous Goods by Rail (RID)

Awareness Training Awareness Training

Purpose of the training Federal Hazardous Materials Transportation Law requires training of ALL Hazmat employees If you ship Diagnostic specimens you are considered a Hazmat employee Increase knowledge of Department of Transportation regulations Learn what each employees responsibility is regarding the transportation of Hazardous Materials.

Who is a Hazmat employee Any person who is employed by a Hazmat employer and directly affects hazardous materials transportation Safety including An owner-operator of a motor vehicle which transports hazardous materials A person including a self-employed person who Loads, unloads, or handles hazardous materials Tests, reconditions, repairs, modifies, marks or otherwise represents packaging as qualified for use in the transportation of hazardous materials Prepares hazardous materials for transportation Prepares hazardous materials paperwork Is responsible for safely transporting hazardous materials Operated a vehicle used to transport hazardous materials.

To Whom are the regulations applicable? Under IATA 1.2.1 and ICAO 1.1.2 this regulation applies to ANYONE WHO HANDLES, OFFERS FOR TRANSPORTATION, TRANSPORTS DANGEROUS GOODS OR CAUSES DANGEROUS GOODS TO BE TRANSPORTED

What are my responsibilities In any situation involving hazardous materials it is the responsibility of each person to make sure these materials are properly handled, stored, packaged and transported. It is the responsibility of all persons who handle or supervises hazardous materials to know that there are certain regulations about packaging, labeling, and marking that must be followed.

The Department of Transportation Hazardous Materials Regulations (HMR) provide a uniform set of procedures for the packaging, labeling, marking, loading, transporting, segregating and unloading of hazardous materials. The regulations spell out all of the procedures necessary for the safe transportation of hazardous materials

What are Hazardous Materials Any article or substance, solid, liquid or gas designated by the DOT which has Physical or chemical properties which could under normal or reasonable achievable conditions could pose a threat to people and/or livestock or pose recognized and measurable damage to health and safety. In international commerce, the term for “Hazardous Material” is “Dangerous Goods”

What are Dangerous Goods? Dangerous goods are classified into 9 classes. Class 1, EXPLOSIVE Class 2, GASSES Class 3, FLAMMABLE LIQUIDS (3.1) Flammable, (3.2) Combustible Class 4 -FLAMMABLE SOLIDS Class 5 -OXIDIZING SUBSTANCES Class 6 -TOXIC/INFECTIOUS (6.2) Infectious Substances Class 7 -RADIOACTIVE Class 8 -CORROSIVE Class 9 –MISCELLANEOUS (Dry Ice)

Training requirements All Hazmat employees are required by IATA 1.5 and IACO 1.4.2.2. to have an initial training then be recertified every 2 years. The records of your training including a certification which shows a test has been completed must be kept for at least 2 years. Develop and retain records for each employee during their employment and 90 days there after.

Shippers requirements As the shipper packing dangerous goods you need to make sure to Classify Identify Pack Mark Label Document

Classify Definition of 6.2 Division 6.2 includes substances which are infectious to humans and/or animals, genetically modified micro-organisms and organisms, biological produces, diagnostic specimens and clinical and medical waste as described in 3.6.2.1.1 to 3.6.2.1.5

What did that mean? The blood that we ship is considered by DOT to be a Diagnostic Sample/infectious Substances. Therefore it belongs in the Division 6.2 as a dangerous good

Biological products These are products derived from living organisms that are manufactured and distributed in accordance with the requirements of the National Governmental authorities. These include but are not limited to finished or unfinished products such as vaccines and diagnostic products

Diagnostic Specimens Any human or animal material including, but not limited to, Excreta, Secreta, Blood and its components, tissue and tissue fluids, being transported for diagnostic purposes or investigational purposes, but excluding live infected animals.

Infectious Substances Infectious substances are substances known to contain or reasonably expected to contain pathogens (including bacteria, viruses, rickettsia, parasites, fungi)

? Infectious Substance An infectious substance is assigned either UN2814 or UN2900 depending on weather or not it is Animal or Human Diagnostic samples are assigned to UN3373, unless the patient has a disease that can be readily transmitted from one individual to another (Risk Group 4) Infectious substances are assigned to risk groups based on criteria established by the World Health Organization (WHO) Risk Group 1-No known risk to individual and the community Risk Group 2-Moderate risk to individual and low risk to the community Risk Group 3-High risk to individual and low community risk Risk Group 4- High risk to individual and high risk to community

Function Specific Training

Packing instructions All of the samples that we send are packed using the Packing Instructions 650 The Primary and Secondary containers must be watertight They must contain a sufficient quantity of absorbent material to absorb the entire contents of the package Either the primary or secondary package must pass a interior pressure test of 95kPa This is required for shipments of liquid diagnostic specimens. Each complete package must pass a drop test of 1.2meters without breaking. When using multiple primary containers. Each primary container must be separated.

Before any package or over-pack of dangerous goods is offered for air transport, the shipper must comply with the following specific responsibilities a shipper must provide such information to his employees as will enable them to carry out their responsibilities with regard to the transport of dangerous goods by air the shipper must ensure that the articles or substances are not prohibited for transportation by air

Before any package or over-pack of dangerous goods Continued the articles or substance must be properly identified , classified, marked, labeled, documented and in the condition for transport in accordance with these Regulations. Before a consignment of dangerous goods is offered for air transport, all relevant persons involved in its preparation must have received training to enable them to carry out their responsibilities. Where a shipper does not have trained staff the relevant persons may be interpreted as applying to those employed to act on the shippers behalf and undertake the shippers responsibilities in the preparation of the consignment, as shown in table 1.5A

IATA 650 Packing Instructions The packing of Diagnostic Specimens Under IATA shipping regulation 3.6.2.2.3

INSTRUCTIONS FOR PACKING BLOOD UN 3373 Diagnostic sample with no known serious human or animal diseases

Operators and ground handling agents Table 1.5A Aspects if transport of dangerous goods by air with which they should be familiar, as a minimum Shippers and packers Freight Forward Operators and ground handling agents Security Screeners 1 2 3 4 5 6 7 8 9 10 11 12 General Philosophy X Limitations General requirements for shippers Classification List of dangerous goods General packing requirements Packing instructions Labeling and marking Shipper’s declaration and other relevant documentation Acceptance procedures Recognition of undeclared dangerous goods Storage and loading procedures Pilots’ notification Provisions for passengers and crew Emergency procedures

Under IATA regulation 3.6.2.2.1, 3.6.2.2.2 and 3.6.2.2. All packages must be packed with a Primary container that is leak proof (the vacutainer) and a secondary container that is leak proof (zip lock specimen bag). Either the primary or the secondary containers must be 95kPa compliant (the Vacutainer is 95kPa).

Under IATA regulation 3.6.2.2.1, 3.6.2.2.2 and 3.6.2.2.3 Each glass primary container must be separated (Aqui-pak will meet both of these items) and there must be an adequate absorbent material that will absorbe all the liquid in the entire shipment

Primary and Secondary containers Primary containers are placed in the tube separator also used as the absorbent material They are then placed in the specimen bag with the requisition and sealed. These are placed in the box for transport

Sample in box with labels

List of contents There must be a List of Contents between the secondary and outer packaging (*List of contents must include the amount of liquid as well as the number of tubes in the box*).

List of Contents

Shippers name and Number In addition, a contact name and number must be clearly visible on the outer cardboard box.

Fed-Ex Air Bill The air-bill must be marked in the “Nature and Quantity of Goods” box with “DIAGNOSTIC SPECIMENS” and UN3373 (sticker placed on the Fed-Ex billable sticker)

Other information According to the regulations, we are not required to fill out a shippers declaration or a chain of custody form.

3.6.2.2.1 Category A: An infectious substance which is transported in a form that, when exposed to it occurs, is capable of causing permanent disability, life threatening or fatal disease to humans or animals. These must be assigned to UN2900 or UN2814 as appropriate. NOTE: UN2814 is Infectious substance, affecting humans. UN2900 is infectious substance, affecting animals.

3.6.2.2.2 Category B: An infectious substance which does not meet the criteria for inclusion in Category A; infectious substances in Category B must be assigned to UN 3373 except that cultures, as defined in 3.6.2.1.3 must be assigned to UN2814 or UN2900, as appropriate. NOTE: the proper shipping name of UN3373 is Diagnostic specimens or clinical specimens.

3.6.2.2.3 Human or animal material including, but not limited to, excreta, secreta, blood and its components, tissue, and tissue fluids, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment or prevention, see UN 3373 and Special Provision A141.

Special Provision A141 A141 This entry applies to human or animal material including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluids, and body parts being transported for purpose such as research, diagnosis, investigational activities, disease treatment or prevention.

So to pack blood… The primary container is the Vacutainer that the blood is drawn in. Documentation from B&D that the vacutainers have passed a laboratory test and are 95kPa compliant is available. The secondary container is the specimen bag. The tubes are separated with the Aqua-pack tube separators within the secondary container. The tube separators serve as the absorbent pad and is more than adequate to absorb 40ml of blood.

Markings on packages Each package must be marked appropriately Substances which do not contain infectious substances or that are unlikely to cause disease in humans or animals are exempt from these regulations. It is a Division 6.2 under secution 6.3.2.2.3.1diagnostic sample Samples with a minimial likelihood to contain pathogens and are packed in a way to prevent liakage and or breakage and are marked with the words “exempt human diagnostic specimen’ Our samples belong to the UN 3373 All packages that we ship will be packed per the IATA Packing Instructions 650 (PI 650)and must be marked according to the PI 650.

As the Shipper It is the shippers responsibility to make sure that the package is packed correctly to prevent leaks and breakage It is the shippers responsibility to have the package labeled correctly with the correct hazards and notification information if necessary

How to ship safely Ask yourself a few questions… Does this sample contain a known pathogen? If yes use PI 602 Is it reasonably expected to contain a pathogen? Is this sample capable of spreading disease if exposure occurs? Is it a biological product known to contain a pathogens in risk group 2,3,or 4? Is this sample from a source patient or animal that may have a disease that can be readily transmitted and for which preventative measures are not usually available? If yes use 602 Is the sample a diagnostic sample for investigational purposes? If yes use PI 650 Is it blood collected for blood transfusions or preparation of blood products? Not restricted PI 650 recommended Is it a tissue or organ intended for transplant?

Overview CLASSIFY IDENTIFY PACK MARK LABLE DOCUMENT

Safety

Emergency Response Because our samples are not considered to be infectious the best response is to follow the Blood borne pathogen guidelines. Wear gloves Use absorbent material designed to pick up blood Do not use hands to pick up broken glass

As the Shipper It is the shippers responsibility to make sure that the package is packed correctly to prevent leaks and breakage It is the shippers responsibility to have the package labeled correctly with the correct hazards and notification information if necessary.

Security

Security Don’t allow visitors to be in the area where your package is being packed Be sure to label the package appropriately Be aware of packages that arrive to the facility do not accept any packages that you were not expecting.

DOT security Make sure that the vehicle that is transporting the hazardous material is secure at all time Keep access to the vehicle limited to persons who have proper authority and a need to know. Keep access to areas where there are Hazardous materials secure from all unauthorized people.

CARRIER SECURITY Perform background checks on all new hires Always carry identification Hazmat training for all employees handling Hazmat Inspection of all vehicles that carry Hazmat Follow tracking process Do you have available contact numbers

People receiving dangerous goods Proper unpacking Maintain proper documentation Maintain MSDS (Material Data Safety Sheets) on all dangerous goods Reporting of all suspicious items Facility is secure from all non-employees