IAHCSMM Chapter 5 Regulations and Standards Exam Review, Exams of Community Health

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IAHCSMM CHAPTER 5 REGULATIONS AND

STANDARDS Exam Review Questions and

Answers 100% Pass | Graded A+

David Mungai [Date] [Course title]

IAHCSMM CHAPTER 5 REGULATIONS

AND STANDARDS Exam Review

Questions and Answers 100% Pass |

Graded A+

A written law adopted by a legislative body that governs a city, county, state or country. - Answer>> Statute Rules issued by administrative agencies that have the force of law. - Answer>> Regulation A uniform method of defining basic parameters for processes, products, services and measurements. - Answer>> Standard A comparison benchmark that is mandated by a governing agency. Noncompliance with regulatory standards may lead to citations and legal penalties. - Answer>> Regulatory standards Guidelines or recommendations for best practices to provide better patient care. Industry, nonprofit organizations, trade associations and others develop these. - Answer>> Voluntary standards A method or technique that has consistently shown results superior to those achieved by other means. - Answer>> Best practice A safety information & adverse event reporting system that serves healthcare professional and the public by reporting serious problems suspected to be associated with the drugs & medical devices they prescribe, dispense or use. - Answer>> Medwatch

are those with requirements imposed by government agencies. These standards can yield legal penalties if not followed. - Answer>> REGULATORY STANDARDS are strongly suggested for better patient care, but are not mandated with legal consequences for non-compliance. - Answer>> VOLUNTARY STANDARDS are laws that must be followed. Statutes are created by legislative bodies or by the electorate. Regulations are rules issued by governmental administrative agencies. Violations of statutes and regulations may have legal penalties. - Answer>> REGULATIONS AND STATUTES

• Statutes & regulations must be followed and failure to comply with them may result in legal consequences to the healthcare facility;
• Regulations and voluntary standards may include workplace safety issues, which may help protect CS professionals from exposure to infectious agents and toxic substances; - Answer>> CS professionals are affected by statutes, regulations and voluntary standards, and they must be familiar w/ applicable regulations & statutes for the following reasons:
• By careful compliance with statutes, regulations and voluntary standards, patient safety is at its highest level of quality of care. - Answer>> * Regulations and voluntary standards may include disinfection and sterilization practices. These standards and regulations may be helpful in pre-purchase product evaluation. is the federal agency responsible for ensuring that foods, cosmetics, human/veterinary drugs, biological products, medical devices, and electronics products that emit radiation are safe & effective for public use, also functions within the Public Health

Service of the US DHS. FDA regulates the manufacture of all medical devices & requires pre-market clearance of new medical

• Answer>> FDA - U.S. Food and Drug Administration devices, also regulates the sterilants & high-level disinfectants (HLDs) used to process critical and semi-critical devices. Prior to marketing these chemicals, rigorous testing a broad range of microorganisms is required along with packaging materials, sterilizers & quality monitors, such as biological indicators, are regulated by the FDA. - Answer>> FDA - US Food and Drug Administration continued the level of regulation placed on any device depends upon how the FDA classifies that device: - Answer>> MEDICAL DEVICE CLASSIFICATION these include low-risk devices, such as most hand-held surgical instruments and ultrasonic cleaners. include registration and device listing, medical device reporting, and quality system regulation and labeling. Most Class 1 devices are exempt from a pre-market notification approval. - Answer>> Class 1 Devices these are devices considered to pose potential risks great enough to warrant a higher level of regulation. Class 11 devices include most types of sterilization equipment, biological/chemical indicators. Manufacturers are required to submit a pre-market notification application 510(k) before they can sell their these products. - Answer>> Class 11 Devices these are the most stringently regulated devices and include heart valves, pacemakers, and other life-sustaining devices. Manufacturers of new

Answer>> (EPA) U.S. ENVIRONMENTAL PROTECTION AGENCY