packaging and shipping of infectious substances recertification 2012
DESCRIPTION
Packaging and Shipping of Infectious Substances Recertification 2012. Alabama Department of Public Health Bureau of Clinical Laboratories Jeannine Parker, Trainer. Objectives. Review additions and changes to the IATA and DOT regulations. - PowerPoint PPT PresentationTRANSCRIPT
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Alabama Department of Public HealthBureau of Clinical Laboratories
Jeannine Parker, Trainer
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ObjectivesReview additions and changes to the IATA and DOT
regulations.Review how to classify, mark, label, and document
Division 6.2 Hazardous Materials (Infectious Substances tagged UN 3373 and UN 2814).
Review the training requirements of DOT and IATA and how those requirements relate to anyone who packages and ships certain laboratory specimens.
Review the exceptions to the regulations and list when they can be used.
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General PhilosophyBefore any package of dangerous goods is offered for air
transport, the shipper must comply with certain requirements:Information must be provided so you can carry out your
responsibilities as a shipperOne must ensure that the article is not prohibited from air
transportBefore packaging and shipping, all relevant personnel must have
received training in accordance with their responsibilitiesAll dangerous goods are packed in compliance with the
regulations
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Training CurriculaGeneral Familiarization
Familiar with the general provisions of the regulationsFunction Specific Training
Detailed training in the requirements applicable to the function for which that person is responsible
Safety TrainingHazards presented by dangerous goods, safe handling, and
emergency response proceduresOSHA Training may substitute for this training
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Function Specific TrainingThis training is for Packaging and Shipping of Infectious
SubstancesNot gasolineNot oilNot explosivesNot gases
Just Infectious Substances
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Safety Training
IncludesSafe handling HazardsEmergency response in the event of an incident
Security TrainingAwareness of security risks associated with dangerous
goods transportation
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Training IATA 1.5 Training Requirements
1.5.0.2 Personnel identified in the categories specified… must be trained or training must be verified prior to the person performing any duty specified…
1.5.0.3 Recurrent training must be provided within 24 months of previous training to ensure knowledge is current.
1.5.0.4 A test must be provided following dangerous goods training to verify understanding of the regulations.
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Training, cont’dWho 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
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Training, cont’dEmployer’s Responsibilities
Provide training or verify employee was trainedTest was given and passedDocument the training
Hazmat Safety Security
Certify employee trained
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Training, cont’dRecordkeeping
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
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Regulators/RegulationsUnited Nations
UN Committee of Experts (UNCOE) writes the UN Recommendations on the Transport of Dangerous Goods Model Regulations.
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 the Safe Transport of Dangerous Goods by Air .
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Regulators/RegulationsInternational Air Transport Association (IATA)
Promulgates the Dangerous Goods Regulation (DGR), based on the Technical Instructions from ICAO, and is printed every January.
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)
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Regulators/RegulationsUS 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 mailPromulgates US Postal Regulations
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Shipper’s Responsibilities
You are ultimately responsible for the package from
beginning to end
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What are your Responsibilities?
ClassifyIdentifyPackMark & LabelDocument (if required)
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IATA Dangerous Goods RegulationApplicability – applicable to any dangerous good that will
travel by airLimitations – Forbidden/Hidden Dangerous Goods as well as
Exceptions for small quantities (none for Infectious Substances) and Limited Quantity Exceptions (no provisions for Infectious Substances), USG-01 Variation: comply with DOT regulations
Classification – Classifying the hazardous material Identification – Identifying the material as per Proper Shipping
Name and related Technical NamePacking – selecting the proper packaging and using it
according to manufacturer's instructions
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DOT RegulationsCFR Title 49 Transportation Parts 100-185 comprise the Hazardous Materials
Regulations (HMR)Governs the shipment of all dangerous goods that transit
through the US by any mode (rail, air, road, sea, etc.)HMR based on the UN Model Regulations
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ClassificationSo, just what are dangerous goods?IATA says:
“Articles or substances which are capable of posing a risk to health, safety, property, or the environment and which are shown in the list of dangerous goods in these regulations or which are classified according to these regulations”
IATA DGR 1.0
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ClassificationDOT says:
“a substance or material that the Secretary of Transportation has determined is capable of posing an unreasonable risk to health, safety, and property when transported in commerce, and has been designated as hazardous under section 5130 of Federal Hazardous Materials Transportation Law (49 U.S.C. 5130).” 49 CFR 105.5
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How do you Classify your Substance?
Definition of an Infectious SubstanceSubstances 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 3.6.2.1.1
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9 Hazard Classes1Explosives2Gasses3Flammable liquids4Flammable solids5Oxidizing
substances
6Toxic/Infectious7Radioactive8Corrosive9Miscellaneous
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Class 6 Toxic and Infectious SubstancesClass 6 is divided into two Divisions
6.1- Toxins/Poisons6.2- Infectious Substances
Division 6.2 is divided into two categoriesCategory A Infectious SubstancesCategory B Biological Substances
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Other Recognized CategoriesHuman Exempt
Specimens with minimal likelihood of a pathogenGenetically modified organisms and micro-organisms
(GMOs) Pathogenic GMO must be designated Category A or BNon-pathogenic GMO
Medical or clinical wastes
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DefinitionsCategory 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 NameInfectious substance, affecting humans
(Technical Name)
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DefinitionsCategory B – assigned UN 3373
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.
Proper Shipping Name is Biological Substance, Category B
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Some Other DefinitionsPatient Specimen
are those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue swabs, body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention.
IATA 3.6.2.1.4
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Definitions
CulturesAre the result of a process by which pathogens are
intentionally propagated. This definition does not include patient specimens as defined in 3.6.2.1.4.
IATA 3.6.2.1.3
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Category A 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 NameInfectious substance, affecting humans
(Technical Name)
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Table 3.6.D
Table 3.6.D is not exhaustive. Infectious substances which do not appear in the Table but do meet the criteria for inclusion, must be assigned Category A.
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Category BUN 3373
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.
Proper Shipping Name is Biological Substance, Category B
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Exempt Human Specimen Category“Patient specimens for which there is minimal likelihood
that pathogens are present are not subject to these regulations if the specimen is packed in a packaging which will prevent any leakage and which is marker with the words “Exempt Human Specimen” or “Exempt Animal Specimen”, as appropriate. The packaging must meet the following conditions:
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Exempt Human SpecimensThe packaging must consist of three components:
A leak-proof primary receptacleA leak-proof secondary packagingAn outer packaging of adequate strength for its capacity,
mass, and intended use, and with at least one surface having minimum dimensions of 100 mm X 100 mm
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Exempt Human SpecimensFor liquids, absorbent material in sufficient quantity to
absorb the entire contents must be placed between the primary receptacles and the secondary packaging, so that, during transport, any release or leak of a liquid substance will not reach the outer packaging and will not compromise the integrity of the cushioning material
When multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them.
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Non-Regulated MaterialSubstances which do not contain infectious substances or
substances which are unlikely to cause disease in humans or animals
Substances which contain micro-organisms which are non-pathogenic to humans or animals
Substances in a form that any present pathogens have been neutralized or inactivated such that they not longer pose a threat
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Non-Regulated MaterialEnvironmental samples (including food and water
samples) which are not considered to pose a significant risk of infection
Dried blood spots collected by applying a drop of blood onto absorbent material, or fecal occult blood screening tests and blood or blood components which have been collected for the purpose of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation.
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DOT Motor Vehicle Exception“A Division 6.2 material, other than Category A Infectious
Substance, contained in a patient sample being transported for research, diagnosis, investigational activities, or disease treatment or prevention, or a biological product, when such materials are transported by a private or contract carrier in a motor vehicle used exclusively to transport such materials. Medical or clinical equipment and laboratory products may be transported aboard the same vehicle provided they are properly packaged and secured against exposure or contamination.” 49 CFR 173.143(b)(10)
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Dry Ice UN 1845Class 9 Miscellaneous
Packing Group III – low danger Three packing groups, from high (PG I) to low danger
Packing Groups so not apply to Infectious SubstancesPacking Instruction 954
Package must allow for the release of gas (CO2) Proper shipping name and weight in kilograms must appear on
the package
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IdentificationAssigning a Proper Shipping Name to a Dangerous GoodProper Shipping Name (PSN) for 6.2 Category A :
Infectious Substance, affecting humans Assigning a four digit ID number by the UN
UN 2814 (Cat A)UN 3373 (Cat B)UN 2900 (animals)UN 1845 (dry ice)Some DGs require a Technical Name, listed in parentheses,
after the PSN (Suspect Category A, Infectious Substance)
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Proper Packaging6.2 Packaging must
Be TestedMeet regulatory specificationsBe certifiedUsed as a unitBe marked with appropriate certification markings
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Proper PackagingTriple packaging concept
Primary receptacles must be leak-proofSecondary packaging must be leak-proof and meet the
regulation for pressure differentialOuter packaging must meet the regulations for
Leakage Sturdiness Rigidness markings
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Proper PackagingLeak-proof Primary Receptacle
Blood tubesUrine transport tubesMedia slantsMetal-crimped glass vialsMust be cushioned if more than one primary in a secondary
packageLiquid contents primaries must have sufficient absorbent
material to absorb the entire contents if the primary breaks during transport
Must have a positive means of securing the top, i.e., parafilm or tape
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Proper PackagingSecondary Packaging
Must be leak-proofMust be able to contain the contents of the primaries
Either Primary or Secondary must be able to withstand an internal pressure differential of 95 kPa in a temperature range of -40°C to 55°C.
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Proper PackagingOuter Package
Must meet the design type testing requirements Drop test of 9 m Puncture test of steel rod, weighing 7 kg, dropped from 1 m w/ intent to
rupture primary Water spray of 5 cm/hr for one hour before the drop test
Must be rigid and of adequate strength for its capacity, weight, and intended use
Must bear the UN Specification Mark4G/Class 6.2/02USA/+AX1852
Must be labeled properly
UN
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Proper PackagingEntire UN certified 6.2 package must be used as an entire
unitNo substitutions of secondary packagingShould not add or cover up the 6.2 labelName and telephone number of the Responsible Person
must appear on the outer packageSmallest dimensions at least 100 mm X 100 mm (4 inches)
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Proper PackagingCategory B
“packaging must be of good quality, strong enough to withstand the shocks and loadings normally encountered during transport…Packaging must be constructed and closed so as to prevent any loss of contents….”
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Proper PackagingCategory B
Must use the triple packaging conceptPrimaries must be leak-proof cushioned such that breakage cannot occurPrimaries that contain liquid must have sufficient absorbent material to
absorb the entire contents of the primariesPositive means of securing the top, i.e., parafilm or tape
Secondary packaging must be leak-proofSecondary must meet the pressure differential requirement Unit must withstand a drop test of at least 1.2 m
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Proper Packaging
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Packing Instructions (PI)Category A PI 620
Triple packaging conceptPrimary receptacles must be leak-proofSecondary packaging must be leak-proof and meet the
regulation for pressure differentialItemized List of Contents must be included between
secondary and outer packaging Proper Shipping Name or Suspect Category A Infectious
Substance Number of vials/tubes/etc. included
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Packing Instructions (PI)Category A PI 620, cont’d
Outer packaging must meet the regulationsUnit packaging must be used as a unit. Fragile primaries
must have cushioning and/or absorbent material (or both if liquid) and the absorbent material must be sufficient to absorb all the contents of the primaries if they break
Must not pack other materials in with Category A
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Category A, 6.2 Packaging
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Packing Instructions (PI)Category B PI 650
Triple packaging requiredPrimary receptacles must be leak-proof
Primary receptacle must be packed in secondary packaging …so that they cannot break, be punctured, or leak
Secondary packaging must be leak-proof and meet the regulation for pressure differential Itemized list on contents between primary & secondary
Proper Shipping Name Number of vials/tubes/etc. included
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Packing Instructions (PI)Category B PI 650, cont’d
Leakage from a primary cannot compromise the integrity of the cushioning material or the outer package
Fragile primaries must have cushioning and/or absorbent material (or both if liquid) and the absorbent material must be sufficient to absorb all the contents of the primaries if they break
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Category B Biological Substance
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Dry Ice PI 954 Dry ice must be placed outside the secondary but in the
outer packageSupport other than the dry ice must be provided for the
secondary packagePackaging must be designed and constructed to permit
the release of CO2 gas to prevent a build-up of pressureUse a styrofoam-lined cardboard box for dry ice
shipments
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Quantity LimitsCategory A
50 ml/kg quantity limit on passenger airplanes
Category BA single primary receptacle is limited to 1 L
and the entire package must not exceed 4 L
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Marking and LabelingPackages are marked and labeled to give information
about the contents, the hazard within, and any special handling requirements.
All markings and labels should be placed so they do not cover any other markings and labels.
Difference between a mark and a label
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Marking and LabelingMarking
Name and address of shipper (Phone # is recommended)Name and address of the consignee (Phone # is
recommended)Name and telephone number of the Responsible Person
(required for Cat A and recommended for Cat B)Proper Shipping Name but no technical nameUN ID numberQuantity of DG (required for Cat A and Dry Ice)
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Marking and LabelingCategory A Label Category B Marking
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Handling LabelsOrientation Labels Cargo Aircraft Only Label
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Dry Ice Markings and LabelsDry Ice Hazard Label Dry Ice Marking for Package
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Labels and MarkingsCategory A Category B
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DocumentationShipper’s Declaration of Dangerous Goods
Air Waybill
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DocumentationShipper’s Declaration of Dangerous Goods
Use the correct form in the correct mannerEnsure information is accurate, easy to ID, legible and
durableEnsure form is properly signedEnsure the shipment has been prepared according to the
regulations
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DocumentationShipper’s Declaration of Dangerous Goods
Must be in color (red & black, or red on white)Must be in EnglishMust be letter sizeMust produce three copies, FedEx requires four
One for your records Two for carrier’s records One stays with the package
FedEx requires it to be typed or computer-generated, using their software
Under Additional Handling Information, the Responsible Person’s name and telephone number must be included
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Air WaybillHandling Information Section
“For Un 3373, it is only necessary to show the text…… and the number of packages.”
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Safety TrainingHazards presented by dangerous goods, safe handling, and emergency response procedures
HazardsInhalationIngestionContact
Safe HandlingPPESpill Clean-upDisposal
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Emergency Response“Information that can used in the event of an incident..”Emergency Response Guidebook
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Security AwarenessSecurity awareness training should address:
Nature of security risks Theft, loss, or release
Recognition of security risks How, when, or where along the chain of transport (or transport
within your facility) can the event occur?Methods to address and reduce the risks identified
How does one secure a package?Actions to be taken in the event of a security breach
Who do you call, what do you do when a breach has been discovered?
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Security PlanShould have a written Security PlanPlan 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
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TESTApply the appropriate,
proper labels and markings to the boxes and complete any required paperwork.