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Regulatory Aspects, Standards,and Guidelines

This lecture contains a variety of slides that address the following topics: OSHA Law, Standards, and Directives The OSHA Bloodborne Pathogens Standard Basic Overview of Bioterrorism Regulations Brief overview of the NIH rDNA Guidelines Tuberculosis Awareness Training Additional OSHA Standards that may be applicable to Biosafety and Laboratory Safety Overview of Medical Waste Rules Shipping/Transport of Regulated Biological Materials As provided there are “MORE SLIDES” than the standard lecture allows. The primary lecture objective was to provide a general awareness of OSHA (Occupational Safety and Health Administration), and review the Bloodborne Pathogens Standard (1910.1030). All other regulatory components can be maintained as supplemental slides. The HOMEWORK prior to the class was to provide students with a copy of the OSHA Bloodborne Pathogens Standard (accessible from www.osha.gov or www.absa.org under Biosafety Resources – Regulations…) the week prior to the lecture. Have them read the standard and highlight any features for use in an “in-class” exercise. When the Bloodborne Pathogens Standard slides are presented – there are three Scenarios provided related to the Standard. The Instructor may wish to HIDE the answers the follow the three Scenarios and then provide them to the class later or ask the students not to look ahead (simply distribute the course handouts to students after the exercise). Put up Scenario #1 on the Board and either: Divide the class into groups or one group and have them work together through their highlighted sections of the OSHA Bloodborne Pathogens Standard to find the answers. Give them 10 minutes per exercise to find the relative sections and highlight the requirements for the institution. OR If the class has a few “experts” have them call out the requirements and write them on a flip chart or chalkboard in the class. Either way, once the suggestions are exhausted or the group has finished (time is up) – have the class present their findings. At the end, show the summary responses to each scenario and discuss any other findings the class may have had. This is one way to “guide” the students through one comprehensive OSHA standard. The other standards and guidelines may be presented as part of other lectures. Tuberculosis Awareness can be presented in 30 – 60 minutes. Shipping/Transport of Biological Hazards can be presented in 45 minutes to 2 hours depending on the depth of the instructor. Medical Waste can be presented in 10 – 15 minutes as a cursory overview, or a representative from the institution responsible for the Biomedical Waste Program can provide a more detailed presentation of the program at the host institution and take the class on a brief field trip to see the program in action. An online Biomedical Waste Segregation Training Overview can be accessed online and shown to the class from the Yale OEHS website. (www.yale.edu/oehs). Once at this site, click on Biosafety, then once Biosafety is open, click on MoreInfo. This will open up a series of streaming video and powerpoint presentations that can be opened and shown to the class. The Biomedical Waste Program Overview is one of the interactive exercises that may be shown.

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