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Biosafety in the Laboratory Prudent Practices for Handling and Disposal of Infectious Materials (1989) / Chapter Skim
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Appendix G: Regulation and Accreditation
Pages 208-211

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From page 208...
... Licensure The process by which an agency or government grants permission to persons or facilities meeting predetermined qualifications, to engage in a given occupation, use a particular title, or perform specified functions. Certification The process by which a nongovemment agency or association grants recognition to a person who has met certain predetermined qualifications specified by that agency or association.
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From page 209...
... The Resource Conservation and Recovery Act of 1976, as amended, requires EPA to develop and evaluate environmentally sound methods for management of hazardous waste, including infectious waste. In May 1986, the EPA published its Guidefor Infectious Waste Management (National Technical Information Service Publication No.
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From page 210...
... The FDA issues regulations pertaining to the safety, efficacy, and labeling of drugs and medical devices, including diagnostic reagents and laboratory equipment, under the provisions of the Food, Drug, and Cosmetic Act, as amended, and of biological products under the provisions of the Public Health Service Act. The Office of Medical Devices in the Center for Devices and Radiological Health (CDRH)
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From page 211...
... By overseeing both Medicare and Medicaid programs and related medical care quality control, the HCFA has a direct relationship with hospital laboratory services and indirectly influences safety concems. HCFA currently has the responsibility for licensing and inspecting clinical laboratories, which are subject to the Clinical Laboratory Improvement Act of 1967.
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