packaging and shipping laboratory specimens
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Packaging and Shipping Laboratory Specimens. Training and Update Information on the IATA Regulation Changes 2010. Objectives. Understand the training requirements of DOT and IATA and how those requirements relate to anyone who packages and ships certain laboratory specimens. - PowerPoint PPT PresentationTRANSCRIPT
Packaging and Shipping Laboratory Specimens
Training and Update Information on the IATA
Regulation Changes2010
Objectives
Understand the training requirements of DOT and IATA and how those requirements relate to anyone who packages and ships certain laboratory specimens.
Identify the regulators and their respective regulations, and their roles within their respective jurisdictions.
Objectives, cont’d
Classify, mark, label, and document Division 6.2 Hazardous Materials (Infectious Substances tagged UN 3373 and UN 2814).
Have a working knowledge of the exceptions to the regulations and list when they can be used.
Who are the Regulators and What are their Regulations?
United Nations– UN Committee of Experts (UNCOE)
International Civil Aviation Organization (ICAO)– the specialized agency of the United Nations
whose mandate is to ensure the safe, efficient and orderly evolution of international civil aviation. They are responsible for the Technical Instructions for aviation.
Who are the Regulators and What are their Regulations?
International Air Transport Association (IATA)– Promulgates the Dangerous Goods Regulation
(DGR), based on the Technical Instructions from ICAO
– IATA is organized in a two-tier format Trade Association (technical, legal, financial, traffic
services and most agency matters) Tariff Coordination (passenger fares, cargo rates, and
related conditions and charges)
Regulators, cont’d
US Department of Transportation (DOT)– Regulates any hazardous material traveling on the roadways,
waterways, and railways of the US– Promulgates regulations to the Code of Federal Regulations (CFR)
CFR Title 49 (specific for DOT) US Postal Service (USPS)
– Regulates all mail– Promulgates US Postal Regulations– New interim rule issued Nov 6, 2006
Centers for Disease Control and Prevention (CDC)– Regulates any other area not covered by DOT or USPS– Promulgates regulations to the Code of Federal Regulations (CFR)
CFR Title 42
Class 6, Division 6.2Definitions - IATA
Infectious Substances– Substances which are known or are reasonably
expected to contain pathogens. Pathogens are micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals.
IATA DGR 3.6.2.1.1
If it meets the definition, it’s an A or B
Class 6, Division 6.2Definitions
Patient Specimen– Human or animal materials collected directly from
humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g., transwabs, culture media, and blood culture bottles).
Class 6, Division 6.2Definitions
Culture– An infectious substance containing a pathogen
that is intentionally propagated. Culture does not include a human or animal patient specimen.
Shippers’ Responsibilities
You are ultimately responsible for the package from beginning to end.
Shippers’ Responsibilities
Identify: is the material hazardous? Classify: what kind of hazardous material is it? Package:
– Use certified packaging unit for 6.2 – Put the unit together using appropriate Packing
Instructions (PI)
Shippers’ Responsibilities
Marking: Ensure all markings are proper Labeling: Ensure all labels are correct Document:
– Complete the Shipper’s Declaration, if required
Nine Classifications of Hazardous Materials (all regs)
1 Explosives2 Gasses3 Flammable liquids4 Flammable solids5 Oxidizing
substances
6 Toxic/Infectious7 Radioactive8 Corrosive9 Miscellaneous
Class 6
Class 6 is divided into two Divisions– 6.1- Toxins/Poisons– 6.2- Infectious Substances
Category A Infectious Substances Category B Infectious Substances
Category A Infectious Substances
Category A – assigned UN 2814– An infectious substance which is transported in a
form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals.
– Proper Shipping Name– Infectious substance, affecting humans
Category B, Biological Substances
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 UN 2814 or UN 2900, as appropriate.
IATA and USPS Exemption
Exempt Human Specimens– A patient specimen unlikely to cause disease in humans or
animals or for which there is only a minimal likelihood that pathogens are present
– Subject to IATA and USPS packaging and marking requirements as
Exempt Human Specimen
– DOT does not recognize this category
IATA Guidance Document
• Pg 7
Category A Table
Table 3.6.D, IATA DGR– 49 listed organisms under UN 2814, Infectious
Substances affecting humans– 14 listed organisms under UN 2900, Infectious
Substances affecting animals
The same list appears in the DOT and USPS regulations.
Class 6.2 Divisions
Classifying what you have:
– This is a professional judgment call. Knowing the patient’s medical condition and status will determine how one decides to classify a substance.
Exempt Packaging Requirements
Three Components A leak-proof primary receptacle A leak-proof secondary packaging An outer packaging of adequate strength…
For Liquids Enough absorbent material around the primary
receptacles to absorb the entire contents For multiple primary receptacles, enough
cushioning to prevent contact, rattling, and breakage
Packing
Triple Packaging Concept
– Primary– Secondary– Outer
packaging
Certified Packaging for Category A, Infectious Substances
UN 6.2 Packaging for Infectious Substances must meet certain requirements of the regulation– Test standards– Marking standards– Triple packaging system
Leak-proof primary Leak-proof secondary Certified outer packaging Whole package must be used as a unit
Package Markings Category A
Manufacturers must mark their packages with– United Nations symbol– Packaging and construction code– “Class 6.2”– Last two digits of the year of manufacture– Country of manufacture– Certifying agency marks
4G/Class 6.2/02USA/+AX1852
UN
IATA Packing Instruction 602 Category A
Inner packaging– Watertight primary receptacle– Watertight secondary packaging
– Must be able to withstand internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi)
– Must be capable of withstanding temperatures in the range of -40ºC to +55ºC
PI 602, cont’d
For liquid specimens, there must be sufficient absorbent material to absorb the entire contents of the primary receptacles should they break. For more than one primary, there must be cushioning between the receptacles.
List of contents of the secondary package must be included between the secondary package and the outer package and must include proper shipping name and technical name (eg.-Suspected Category A Infectious Substance).
PI 602, cont’d
Rigid outer packaging must meet requirements
All packages containing infectious substances must be marked with the NAME and TELEPHONE NUMBER of the Responsible Person.
Package Labels Category A
Infectious Substance Label– Class 9 label, if dry ice is used
Orientation arrows Consignee name and address Shipper name, address, phone number
– Name and number of responsible person Proper Shipping Name, UN number, quantity
A note about the 24-hr Emergency Response Number-
“This 24-hr number must monitored at all times the Hazardous Material is in transit. It must be monitored by a person who is knowledgeable of the hazards and characteristics of the Hazardous Material, have comprehensive emergency response and accident litigation information or immediate access to someone who possesses such knowledge and information.”
Documentation
http://www.fedex.com/us/services/pdf/ShippersDecColumnsColorPrinter.pdf?link=4
Packaging for Category BBiological Substances
Triple Packaging concept with some changes
– Certified packaging is NOT required
New marking,
UN 3373– No Declaration of
Dangerous Goods required
UN3373
Biological Substance
IATA PI 650
Good quality packaging, strong enough to withstand normal shocks and loadings…
Triple packaging concept– Water-proof primary and secondary receptacles– Rigid outer packaging, at least one surface must
be 100 mm X100 mm (~4 in)– Primaries must be packed so that they should not
touch, break, or leak, and if they do, the cushioning or outer package is not compromised
IATA PI 650, con’t
For liquid substances– Quantity limit of 1L / primary receptacle,
4 L / outer package– Primary and secondary must be able to withstand,
without leaking, internal pressure of 95 kPa in the range of -40°C to +55°C.
– Absorbent material between primary and secondary, sufficient to absorb entire contents of primary
IATA PI 650, con’t
For solid substances– Primary and secondary must be sift-proof– Quantity limit of 1 kg / primary receptacle,
4 kg / outer package– Cushioning between primaries if more than one
MarkingsNew diamond with UN number, UN 3373Proper shipping name must be adjacent to the diamond marking
Biological Substance
IATA PI 650, con’t
UN3373
Itemized list of contents between secondary and outer packaging
Completed package must be able to withstand the drop test at 1.2 m. (3.9 ft.)
2010 Changes to PI 650
On the package:– Name & address of shipper– Name & address of consignee– Name & telephone number of responsible person (or on
the airway bill)– UN 3373 Marking with Proper Shipping Name, Biological
Substance, Category B On the waybill
– UN 3373 Biological Substance, Category B– Number of packages
IATA Packaging for Category B Infectious Substances
Quantity Limits for Infectious Substances
Category A, Infectious Substances– 50 ml or 50 g
Category B, Infectious Substances– 4 L or 4 kg
Shippers’ Responsibilities
You are ultimately responsible for the package from beginning to end.
Dry Ice on 6.2 Cat A
Use Class 9, Miscellaneous Hazard label
List Dry Ice on Declaration
– In Proper Shipping Name column
– Quantity in kilograms
Support inner packages Allow for escape of CO2
Air Waybill
Air Waybill: Box 6 Special Handling
Training
…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 as detailed in Subsection 1.5
IATA DGR 1.3.2.D
Training
Employer’s Responsibilities– Provide training or verify employee was trained– Test was given and passed– Document the training
Hazmat Safety Security
– Certify employee trained
Training: Who Needs To Be Trained?
Any persons who:– Packages a hazardous material
6.2 materials Dry ice
– Prepares materials or documentation Classifies, documents a 6.2 material
– Transports a hazardous material Courier in a motor vehicle (exceptions) Air plane Vessel
Training
Training shall include the following:– General awareness/familiarization of the
regulation– Function-specific training– Safety training
Emergency response Protective measures Proper procedures for handling hazardous material
– Security Awareness
Training, cont’d
Initial and Recurrent – Trained within 90 days of employment– Retrained every two years for IATA, every
three years for DOT– Training from a previous employer can be
transferred to new job
Training, cont’d
Recordkeeping– Record of Training
Employee name Most recent date trained Description of training Description of training materials/where kept Name and address of trainer
– Record of training kept as long as employed
Safety Training
Emergency Response– “Information that can used in the event of an
incident..” Basic description and technical name
– Proper shipping name on the Shipper’s Declaration Immediate hazards to health
– Inhalation or contact with substance may cause infection, disease, or death
Risk of fire or explosion– Some of these materials may burn, but none ignite easily
Safety Training
Emergency Response, cont Immediate precautions to be taken in the event of an
accident or incident– Don’t touch it, breathe it, or step in it– Do not touch spilled material or containers unless wearing
appropriate personal protective equipment/clothing– Don appropriate PPE
Respirators, gloves, coats, masks, etc
Safety Training
Emergency Response, cont Initial methods for handling spills or leaks
– Absorb spill with earth, sand, or other non-combustible material
– Cover spilled area or damaged container with damp toweling and keep wet with liquid bleach or other disinfectant
Safety Training
Emergency Response, cont
Preliminary first aid– Move victim to a safe, isolated area– Call 911 or emergency medical service– Remove and isolate contaminated clothing and shoes– Flush skin or eyes with running water for at least 20 min if
you are contaminated
Security Awareness
Should have a written Security Plan Plan should include:
– Assessment of transportation security risks Personnel security Unauthorized access En route security
– Copies made available to employees and revised and updated as needed 49 CFR Part 172, Subpart I
Summary
Packaging and Shipping
Questions?
Test
Apply the appropriate, proper labels and markings to the boxes and complete any required paperwork.
Lower Falls