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A comprehensive review of the key regulatory standards, voluntary standards, and governing agencies related to healthcare regulations and compliance. It covers topics such as the fda's classification of medical devices, the role of the cdc, epa, osha, and cms, as well as various industry organizations like aami, ansi, aorn, and sgna that develop voluntary guidelines and standards. The document aims to prepare students for the iahcsmm healthcare regulations and compliance chapter 15 exam, ensuring they have a thorough understanding of the regulatory landscape and can confidently navigate the complex web of healthcare regulations. With detailed explanations of key concepts, sample questions, and a focus on 100% pass rate, this document serves as a valuable study resource for healthcare professionals seeking to enhance their knowledge and compliance in the field.
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David Mungai [Date] [Course title]
Regulatory Standards - Answer>> a comparison benchmark that is mandated by a governing agency. noncompliance may lead to citations and legal penalties Voluntary Standards - Answer>> Guidelines or recommendations for best practices to provide better patient care. but not mandated with legal consequences for non-compliance statute - Answer>> a written law passed by a legislative body regulation - Answer>> rules issued by administrative agencies that have the force of law FDA (Food and Drug Administration) - Answer>> Federal agency that ensures food, cosmetics and medical devices are safe to use FDA also regulates - Answer>> manufractor of all medical devices before being released regulates sterilent and high-level disinfectants BI, packing materials, sterilizers and quality monitor Class 1 device - Answer>> low risk devices. Most hand-held surgical instruments, and ultrasonic cleaners. Subject to general controls which include registration and device listing, device reporting, and quality regulation and labeling. exempt from PMA and 510k
DOT (Department of Transportation) _____ and_____ organizations for statue violations - Answer>> inspect and cites EPA (Environmental Protection Agency) - Answer>> a regulatory agency Federal created in 1970 to minimize greenhouse gases and toxic emission, air pollution EPA (Environmental Protection Agency) administers two acts that are important to CS techs_____ - Answer>> FIFRA ( federal insectide, fungicide and rodenticide act clean air act amendments Every disinfectant and sanitizer manufracturer must obtain___ - Answer>> an EPA registration # for every covered product OSHA (Occupational Safety and Health Administration) - Answer>> created in 1971 operates under U.S department of labor protect workers from occupationally-caused illness and injuries General duty of OSHA - Answer>> OSHA may intervene in a matter of worker protection even if there isn't specific regulation that cover the situation CMS (Centers for Medicare and Medicaid Services) - Answer>> operates under U.s department of health and human services administers HIPPA ( health insurance portability and accountability act ) HAI ( healthcare-associated infection) - Answer>> If patient in the hospital for work related, means less operating funds for the facility less funding for instruments and equipment
State Regulatory Agencies - Answer>> DHS ( department health services) DOT ( department of transportation) EPA ( environmental protection agency) AAMI (Association for the Advancement of Medical Instrumentation) - Answer>> -voluntary guidelines representing a consenus of AAMi members to check instruments are safe to use -founded in 1967 is nonprofit voluntary consensus organ. TIRs ( technical information reports ) - Answer>> reports developed by experts valuable info that is needed by healthcare industries ANSI (American National Standards Institute) - Answer>> 1918 voluntary similar to AAMI AORN ( association of perioperative registered nurses ) - Answer>> nationally-organized, evidence based standards, recommended practices cleaning, disinfection and packaging, endoscopy National Fire Protection Association (NFPA) - Answer>> reduce the burden of fire and other hazards around the world USP/NF US pharmacopoeia/National Formulary - Answer>> creates and revises standards for the purity of medicine, drug substance and dietary suppliment SGNA (Society of Gastroenterology Nurses and Associates) - Answer>> non profit orga that safe practive of endoscope and gastroenterology