online self-study shipping of infectious substances and other biomedical materials annual update

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ONLINE SELF-STUDY Shipping of Infectious Substances and Other Biomedical Materials Annual Update Slide 2 Course Objectives The purpose of this program is to: ensure the safe handling of hazardous materials using good sensible practices. recognize hazardous materials and realize there are special requirements Comply with Federal and International regulations The basic goal for this training is to provide a framework for decisions Is material to be shipped a dangerous good, genetically modified, biological substance category B, or an exempt human specimen? Upon completion you will receive certification to ship hazardous materials Slide 3 Course Objectives This training will increase your awareness of safety and compliance issues. If you need more information or help with shipping your package you can e-mail the EHS Shipping Specialist. The training will cover the topics listed below. Classification, identification, and packaging are three of the most important topics covered.EHS Shipping Specialist Regulatory Oversight Dangerous Goods/Hazardous Materials Training Requirements Shippers & Operators Responsibilities Classification, Identification Packaging Shipping with dry ice and Overpacks Marking & labeling packages Shipping documentation Emergency Response Laboratory Security Accept or reject shipments by use of checklist Slide 4 What is a Dangerous Good/Hazardous Material? Federal Regulations: U.S. Dept. of Transportation (DOT) 49 CFR Other federal requirements: CDC, OSHA, USDA, Department of Commerce, International Traffic and Arms (ITAR) and Toxic Substance Control Act (TSCA) DOT regulations primarily cover ground transportation. DOT is the organization that has the authority to fine you for violations. Their authority extends well beyond US boundaries. Import permits from the CDC or USDA may be needed if you are importing human etiological organisms or plant or animal pathogens. Department of Commerce licenses may be needed to export organisms, genetic elements, chemicals, technology or other commodities. TSCA Certification may be needed to import or export certain chemicals.CDCUSDA International Regulations (Air shipments) International Civil Aviation Organization (ICAO) International Air Transport Association (IATA) Dangerous Goods Regulations (DGR) Internationally, the UN Committee of Experts (CoE) develops recommended procedures for the transport of all types of dangerous good except Radioactive material. The International Civil Aviation Organization (ICAO) uses the UN recommendations as the basis for developing the regulations for the safe transport of dangerous goods by air. IATA is the international trade organization that interprets ICAO regulations and provides the Dangerous Goods Regulations (DGR). The IATA regulations are more stringent than DOT. This training program follows the IATA regulations. IATA regulations are minimal requirements - your carrier can be more stringent. Slide 5 What is a Dangerous Good/Hazardous Material? Fines and Penalties "Violations contrary to the U.S. Code of Federal Regulations (CFR) 49, if substantiated, may result in the assessment of a civil penalty of up to $37,500 per violation, and deliberate violations may result in criminal prosecution of up to $500,000 and 5 years in prison." There has been an increase in the number of Federal Aviation Inspections (FAA) in response to the 1996 ValuJet crash, the September 11, 2001 attacks, and the UPS package bomb scare in November 2010. If you are receiving a HazMat package it is your responsibility to ensure the sender packages it correctly. Oxygen-generating canister like the ones on board the ValuJet flight 592 Slide 6 Definition Infectious Substance - Class 6.2 Definition: Infectious substances are substances known to contain, or reasonably expected to contain, pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsia, parasites, fungi) and other agents such as prions which can cause disease in humans or animals. Critical to the infectious substance definition is the ability to cause disease. - Note the reliance on your professional judgment when the words reasonably expected are used. Slide 7 Definition The IATA definition for infectious substances leaves out toxins. Toxins are placed in a separate category. They are treated like chemicals. Toxins from plant, animal or bacterial sources which do not contain any infectious substances or toxins that are not contained in substances which are infectious substances should be considered for classification in Division 6.1 and assignment to UN 3172 (for liquids) or UN 3462 (for solids). Contact EHS if you are shipping toxins as instructions for shipping toxins is not covered in this training module. Please be aware that many toxins (if shipped out of the US) are regulated by the Department of Commerce. There are significant fines associated with exporting toxins without a license Slide 8 Definition Biological products are those products derived from living organisms which are manufactured and distributed in accordance with the requirements of appropriate national authorities, which may have special licensing requirements, and are used either for prevention, treatment, or diagnosis of disease in humans or animals, or for development, experimental or investigational purposes related thereto. They include, but are not limited to, finished or unfinished products such as vaccines. Slide 9 Definition Cultures Laboratory stocks are the result of a process by which pathogens are intentionally propagated in order to generate high concentrations. This increases the risk of infection when exposure to them occurs. An example of this would be a patient sample of TB that has been cultured. Slide 10 Definition Patient Specimens Patient Specimens are human or animal materials, collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention. Slide 11 Classification of Infectious Substances The three proper shipping names for infectious substances are: Infectious substances, affecting humans, UN 2814 Infectious substances affecting animals, UN 2900 Biological Substances Category B, UN 3373 (This does not require a Dangerous Good Declaration to ship) Slide 12 Classification Category A Infectious Substances - an infectious substance which is transported in a form that when exposure occurs, is capable of causing permanent disability, life threatening or fatal disease in otherwise healthy humans or animals. Examples of substances that meet this criteria are located in this table: Table 3.6.D.Table 3.6.D NOTE: An exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans or animals. Slide 13 Classification of Infectious Substances Infectious substances meeting the Category A criteria which cause disease in humans or both in humans and animals must be assigned to UN 2814 (Infectious substance, affecting humans). Infectious substances which cause disease only in animals must be assigned to UN 2900 (Infectious substance, affecting animals). Slide 14 Classification of Infectious Substances Assignment to UN 2814 or UN 2900 must be based on the known medical history and symptoms of the source human or animal, endemic local conditions, or professional judgment concerning individual circumstances of the source human or animal. Example: a patient from a foreign country is admitted to the hospital. You think they may have Ebola. You will ship all body fluids as infectious substances (Category A) using all the applicable packaging and paperwork. Slide 15 Classification of Infectious Substances Category B, biological substance is an infectious substance which does no meet the criteria for inclusion in Category A. An example of a Category B biological substance would be a patient's body fluid infected with mycobacterium tuberculosis. A culture of this same organism would be a Category A infectious substance. You must use your professional judgment in deciding if an infectious substance is a Category A or Category B infectious substance. Contact EHS if you need assistance determining your classification. Slide 16 Classification of Infectious Substances Infectious substances in category B must be assigned to UN 3373 except those organisms on table 3.6.D - which must be assigned to UN 2814 or UN 2900.table 3.6.D The proper shipping name of UN 3373 is Biological Substance Category B. Slide 17 Classification of Infectious Substances Exemptions under Biological Substance Category B Substances which do not contain infectious substances or substances which are unlikely to cause disease in humans or animals are not subject to these Regulations unless they meet the criteria for inclusion in another class i.e. you add ethanol to the sample. Substances containing micro-organisms, which are non-pathogenic to humans or animals are not subject to these Regulations unless they meet the criteria for inclusion in another class. Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk are not subject to these Regulations unless they meet the criteria for inclusion in another class. Environmental samples (including food and water samples), which are not considered to pose a significant risk of infection are not subject to these Regulations, unless they meet the criteria for inclusion in another class. Dried blood spots, collected by applying a drop of blood onto absorbent material, or faecal occult blood screening tests and blood or blood components which have been collected for the purposes of transfusion or for the preparation of blood products to be used for transfusion or tra

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