Regulations and Standards IAHCSMM - Ch 5

Regulatory standards

A comparison benchmark that is mandated by a governing agency. Non compliance with regulatory standards may lead to citations and legal penalties.

Medicaid

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.

Medicare

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.

Best practice

A method or technique that has consistently shown results superior to those achieved by other means.

MedWatch

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.

Standard

A uniform method of defining basic parameters for processes, products, services and measurements.

Statute

A written law adopted by a legislative body that governs a city, county, state or country.

ANSI

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).

Greenhouse Gases

Any of the gases that absorb solar radiation are responsible for the greenhouse effect, including carbon dioxide, methane, oaone and fluorocarbons.

AAMI

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.

CSA

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.

CDC

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.

CEN

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.

FDA

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.

Voluntary standards

Guidelines or recommendations for best practices to provide better patient care. Industry, nonprofit organizations, trade associations and others develop these.

HIPPA

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.

Recall - Class I

High Risk. Reasonable chance product will cause serious health problems or death.

Recall - Class II

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.

Recall - Class III

Low Risk. Product not likely to cause adverse health consequences.

NFPA

National Fire Protection Association. International organization that works to reduce the burden of fire and other hazards around the world. FYI: NFPA is important to Central Service technicians because of the fire and safety standards used for the buildings in which they work. NFPA standards address the fire burden of all disposable packaged items, such as surgical drapes and gauze sponges, stored and used within the facility ; the fire standards for patient drapes utilized in the OR (operating room); and wrappers utilized in the Central Service processing area.

OSHA

Occupational Safety and Health Administration. Operates under U.S. Department of Labor. Its primary role and responsibility is to protect workers from occupationally-caused illnesses and injuries. FYI: Representatives may enter facility for a specific reason; however, once inside the facility, they have the right and obligation to investigate any violation in any department they may find.

Regulation

Rules issued by administrative agencies that have the force of law.

SGNA

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.

TIRs

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.

APIC

The Association for Professionals in Infection Control and Epidemiology. Voluntary international organization. Works to prevent HAIs in healthcare facilities. FYI: APIC members work in conjunction with other agencies, such as the CDC, to adopt standards for infection/disease prevention.

AORN

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.

CMS

The Centers for Medicare and Medicaid Services. Responsible for the operation of Medicare, Medicaid and the State Children's Health Insurance Program. FYI: CMS is also one of the agencies that administers the standards of the Health Insurance Portability and Accountability Act (HIPAA). Also, performs both announced and unannounced surveys of hospitals, long-term care facilities, ambulatory surgery centers and laboratories.

ISO

The International Standards Organization. Non-government organization. ISO standards are voluntary and the organization had no legal enforcement authority: however, many ISO standards have been adopted by some countries or are referred to in legislation, which makes them regulatory in these jurisdictions.

TJC

The Joint Commission. Private, independent, non-profit organization that develops standards for healthcare facilities. Conducts on-sight, unannounced, surveys every 3 years. Failure to comply with standards as evaluated through the TJC survey process may result in loss of accreditation by federal and state governments.

USP-NF

The United States Pharmacopoeia-National Formulary. Creates and revises standards for the purity of medicines, drug, substances and dietary supplements. FYI: Standards are set for packaging, labeling, bacteriological purity, pH and mineral content. The USP is important to Central Service technicians who work with purified water or sterilizing water for irrigation.

Medical Device Classification - Class II 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.

Medical Device Classification - Class III Devices

These are the most stringently regulated. Include heart valves, pacemakers and other life sustaining devices.

Medical Device Classification - Class I Devices

These include low-risk devices, such as most hand held surgical instruments and ultrasonic cleaners.

DOT

U.S. Department of Transportation. Federal agency dedicated to ensuring a fast, safe and efficient transportation system. Laws include those concerning the transportation of minimally processed instrumentation for repair, reprocessing and the transportation of hazardous and radioactive wastes. FYI: DOT regulations must be followed when CS departments transport soiled instrumentation between healthcare and repair facilities, including proper biohazard labeling and containment.

EPA

U.S. Environmental Protection Agency. Regulatory agency. Protects human health and environment by writing and enforcing regulations based on laws passed by Congress. Responsible for minimizing greenhouse gasses and toxic emissions, regulating the reuse of solid wastes, controlling indoor air pollution, and developing and enforcing pesticide regulations.

Standards (AAMI)

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.

WHO

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).