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

Download IAHCSMM Regulations and Standards: Chapter 5 Exam Review and more Exams Community Health in PDF only on Docsity!

IAHCSMM Regulations and Standards

Chapter 5 Exam Review Questions and

Answers 100% Pass | Graded A+

David Mungai [Date] [Course title]

IAHCSMM Regulations and Standards

Chapter 5 Exam Review Questions and

Answers 100% Pass | Graded A+

A safety information and adverse event reporting system. Serves healthcare professionals and public by reporting serious problems suspected to be associated with the drugs and medical devices they prescribe, dispense or use. The FDA MedWatch program is designed for the voluntary reporting of device-related problems. - Answer>> MedWatch High Risk. Reasonable chance product will cause serious health problems or death. - Answer>> Recall - Class I Less Serious Risk. Possible that product will cause a temporary or medically reversible adverse health problem, or remote chance the device will cause a serious health problem. - Answer>> Recall

• Class II Low Risk. Product not likely to cause adverse health consequences. - Answer>> Recall - Class III Food and Drug Administration. Federal agency responsible for ensuring that foods, cosmetics, human and veterinary drugs, biological products, medical devices and electronic products that emit radiation are safe and effective for public use. Requires manufacturers to provide IFU with products. - Answer>> FDA Centers for Disease Control. Federal agency organized within U.S. Department for Health and Human Services. Works to promote health and quality of life by preventing and controlling disease, injury and disability, and by responding to health emergencies. - Answer>> CDC

surveys of hospitals, long-term care facilities, ambulatory surgery centers and laboratories. - Answer>> CMS A federal medical insurance program that primarily serves those over age 65 years of age (regardless of income), and people under 65 with certain disabilities and people of all ages with end stage renal disease. - Answer>> Medicare A federal and state assistance program that pays covered medical expenses for low-income individuals. It is run by state and local governments within federal guidelines. - Answer>> Medicaid Health Insurance Portability and Accountability Act. Provides federal protections for individually identifiable health information held by covered entities and their business associates, and gives patients an array of rights with respect to that information. - Answer>> HIPPA Voluntary guidelines representing a consensus of AAMI members that are intended for use by healthcare facilities and manufacturers to help ensure that medical instrumentation is safe for patient use. - Answer>> Standards (AAMI) Technical Information Reports. Reports developed by experts in the field that contain valuable information needed by the healthcare industry. TIRs have not undergone the formal approval system that standards are submitted to and may need further evaluation by experts. TIR may be revised or withdrawn at any time because they address a rapidly evolving field or technology. - Answer>> TIRs Association for Advancement of Medical Instrumentation. Nonprofit voluntary consensus organization comprised of

healthcare professionals. With an interest in development, management and use of safe and effective medical technology. FYI: The ANSI/AAMI ST79 document quickly became one of the most widely used documents in Central Service. Many sections of this document address processes that affect all types of sterilization, such as cleaning, packaging, indicators, product verification, education, and departmental workflow and design. - Answer>> AAMI American National Standards Institute. Enhances global competitiveness of U.S. business and the American quality of life by promoting and facilitating voluntary consensus standards and ensuring their integrity. ANSI does not develop American standards; however, it provides a neutral arena for interested parties to work toward agreement. FYI: ANSI is the sole representative to the International Standards Organization (ISO). - Answer>> ANSI The Association of periOperative Registered Nurses. Not a regulatory agency. Comprised of perioperative nurses and others who are dedicated to providing optimal care to the surgical patient. AORN members develop nationally-recognized, evidence-based standards, recommended practices, and guidelines. FYI: AORN's Guidelines for Perioperative Practice contains sections devoted to topics directly affecting the Central Service department. These topics include cleaning, disinfection, packaging, endoscope processing and sterilization. - Answer>> AORN The Association for Professionals in Infection Control and Epidemiology. Voluntary international organization. Works to prevent HAIs in healthcare facilities.

Service technicians who work with purified water or sterilizing water for irrigation. - Answer>> USP-NF World Health Organization. An agency of the United Nations. Its major task is to combat disease, especially key infectious diseases, and to promote the general health of people worldwide. FYI: Staff members coordinate efforts to monitor outbreaks of infectious diseases, such as Severe Acute Respiratory Syndrome (SARS), malaria, Acquired Immune Deficiency Syndrome (AIDS), and Creutzfeldt-Jakob Disease (CJD). - Answer>> WHO Society of Gastroenterology Nurses and Associates. Nonprofit organization of nurses and associates dedicated to the safe and effective practice of gastroenterology and endoscopy nursing. FYI: Collects information and establishes standards and guidelines relating to the processing of flexible endoscopes. - Answer>> SGNA Canadian Standards Organization. Nonprofit organization that develops standards for industry, government and healthcare for all Canadian provinces. FYI: Has developed many standards for the processing of surgical instrumentation. - Answer>> CSA European Committee for Standardization. Sets standards for Europe in much of the same way that AAMI sets standards for the U.S. FYI: U.S. companies that set standards for instrument processing in Europe must follow CEN standards for products sold in member U.S. countries. - Answer>> CEN 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. Non compliance 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 These include low-risk devices, such as most hand held surgical instruments and ultrasonic cleaners. - Answer>> Medical Device Classification - Class I Devices These are considered to pose potential risks great enough to warrant a higher level of regulation. Include most types of sterilization equipment, and biological and chemical indicators. - Answer>> Medical Device Classification - Class II Devices These are the most stringently regulated. Include heart valves, pacemakers and other life sustaining devices. - Answer>> Medical Device Classification - Class III Devices