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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 Presentation

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  • Packaging and Shipping Laboratory SpecimensTraining and Update Information on the IATA Regulation Changes2010

  • ObjectivesUnderstand 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, contdClassify, 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 NationsUN 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 ICAOIATA is organized in a two-tier formatTrade Association (technical, legal, financial, traffic services and most agency matters) Tariff Coordination (passenger fares, cargo rates, and related conditions and charges)

  • Regulators, contdUS Department of Transportation (DOT)Regulates any hazardous material traveling on the roadways, waterways, and railways of the USPromulgates regulations to the Code of Federal Regulations (CFR) CFR Title 49 (specific for DOT)US Postal Service (USPS)Regulates all mailPromulgates US Postal RegulationsNew interim rule issued Nov 6, 2006 Centers for Disease Control and Prevention (CDC)Regulates any other area not covered by DOT or USPSPromulgates regulations to the Code of Federal Regulations (CFR) CFR Title 42

  • Class 6, Division 6.2Definitions - IATAInfectious SubstancesSubstances 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, its an A or B

  • Class 6, Division 6.2Definitions Patient SpecimenHuman 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

    CultureAn 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 properLabeling: Ensure all labels are correctDocument: Complete the Shippers Declaration, if required

  • Nine Classifications of Hazardous Materials (all regs)

    1Explosives2Gasses3Flammable liquids4Flammable solids5Oxidizing substances

    6Toxic/Infectious7Radioactive8Corrosive9Miscellaneous

  • Class 6 Class 6 is divided into two Divisions6.1- Toxins/Poisons6.2- Infectious SubstancesCategory A Infectious SubstancesCategory B Infectious Substances

  • Category A Infectious SubstancesCategory A assigned UN 2814An 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 ExemptionExempt Human SpecimensA patient specimen unlikely to cause disease in humans or animals or for which there is only a minimal likelihood that pathogens are presentSubject to IATA and USPS packaging and marking requirements asExempt Human Specimen

    DOT does not recognize this category

  • IATA Guidance DocumentPg 7

  • Category A Table

    Table 3.6.D, IATA DGR49 listed organisms under UN 2814, Infectious Substances affecting humans14 listed organisms under UN 2900, Infectious Substances affecting animals

    The same list appears in the DOT and USPS regulations.

  • Class 6.2 DivisionsClassifying what you have:This is a professional judgment call. Knowing the patients medical condition and status will determine how one decides to classify a substance.

  • Exempt Packaging RequirementsThree ComponentsA leak-proof primary receptacleA leak-proof secondary packagingAn outer packaging of adequate strengthFor LiquidsEnough absorbent material around the primary receptacles to absorb the entire contentsFor multiple primary receptacles, enough cushioning to prevent contact, rattling, and breakage

  • PackingTriple Packaging ConceptPrimarySecondaryOuter packaging

  • Certified Packaging for Category A, Infectious Substances

    UN 6.2 Packaging for Infectious Substances must meet certain requirements of the regulationTest standardsMarking standardsTriple packaging systemLeak-proof primaryLeak-proof secondaryCertified outer packaging Whole package must be used as a unit

  • Package Markings Category AManufacturers must mark their packages withUnited Nations symbolPackaging and construction codeClass 6.2Last two digits of the year of manufactureCountry of manufactureCertifying agency marks4G/Class 6.2/02USA/+AX1852

    UN

  • IATA Packing Instruction 602 Category AInner packagingWatertight primary receptacleWatertight 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 -40C to +55C

  • PI 602, contdFor 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, contdRigid 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 LabelClass 9 label, if dry ice is usedOrientation arrows Consignee name and addressShipper name, address, phone numberName 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 SubstancesTriple Packaging concept with some changesCertified packaging is NOT requiredNew marking, UN 3373No Declaration of Dangerous Goods required

    Biological Substance

  • IATA PI 650 Good quality packaging, strong enough to withstand normal shocks and loadingsTriple packaging conceptWater-proof primary and secondary receptaclesRigid 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, contFor liquid substancesQuantity limit of 1L / primary receptacle, 4 L / outer packagePrimary and secondary must be able to withstand, without leaking, internal pressure of 95 kPa in the range of -40C to +55C.Absorbent material between primary and secondary, sufficient to absorb entire contents of primary

  • IATA PI 650, contFor solid substancesPrimary and secondary must be sift-proofQuantity limit of 1 kg / primary receptacle, 4 kg / outer packageCushioning between primaries if more than one

  • MarkingsNew diamond with UN number, UN 3373Proper shipping name must be adjacent to the diamond marking

    Biological SubstanceIATA PI 650, contItemized 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 650On the package:Name & address of shipperName & address of consigneeName & telepho

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