IAHCSMM CRCST 8th Edition - Chapter 5 Flashcards

Study Notes

Key Terms and Definitions

Statute: A written law enacted by a legislative body governing various jurisdictions.
Regulation: Rules created by administrative agencies that have legal authority.
Standard: A method for defining fundamental parameters across processes, products, and services.
Regulatory Standard: A mandated benchmark set by governing bodies; noncompliance can lead to penalties.
Voluntary Standards: Best practice guidelines developed by various organizations to enhance patient care.
Best Practice: Techniques proven to deliver superior results compared to alternative methods.

Safety and Health Monitoring

MedWatch: A system for reporting serious problems related to drugs and medical devices for healthcare professionals and the public.
EPA (Environmental Protection Agency): Enforces laws for cleaner environmental conditions, including chemical labeling for disinfectants.
OSHA (Occupational Safety and Health Administration): Protects workers from health hazards and can intervene without specific regulations.

Health Insurance Programs

Medicare: Federal program providing medical insurance primarily for individuals over 65 and certain disabled persons.
Medicaid: Joint federal-state program covering medical expenses for low-income individuals under federal guidelines.

Health Information Standards

HIPAA (Health Insurance Portability and Accountability Act): Provides privacy protections for individually identifiable health information and patient rights.
AAMI Standards: Voluntary guidelines developed for healthcare facilities to ensure safety in medical instrumentation.

Regulatory Bodies and Organizations

SGNA (Society of Gastroenterology Nurses and Associates): Sets standards for processing flexible endoscopes.
WHO (World Health Organization): Enhances international health cooperation and improvements.
AORN (Association of periOperative Registered Nurses): Establishes recognized standards for the perioperative environment.
CDC (Centers for Disease Control and Prevention): Focuses on health promotion, disease prevention, and control strategies.

Medical Device Regulations

FDA (U.S. Food and Drug Administration): Oversees medical device market requirements, including safety and efficacy standards, and manages MedWatch.
Class I, II, III Medical Devices: Classification system based on the risk:
- Class I: Low-risk devices like surgical instruments.
- Class II: Moderate-risk requiring premarket notifications (e.g., sterilization indicators).
- Class III: High-risk devices needing rigorous premarket approval (e.g., heart valves).
Medical Device Reporting: Required reporting of suspected device-related deaths.

Recall Classifications

Class I Recall: High risk, potential for serious health problems or death.
Class II Recall: Moderate risk, possible temporary health issues.
Class III Recall: Low risk, unlikely to cause health issues.

Other Relevant Organizations

APIC (Association for Professionals in Infection Control): Dedicated to infection control and prevention.
DOT (Department of Transportation): Regulates and enforces medical waste transportation laws.
ANSI (American National Standards Institute): Enhances standards promoting global competitiveness and life quality.
USP-NFR (United States Pharmacopeia - National Formulary): Develops water processing standards for irrigation.

Miscellaneous

TIRs (Technical Information Reports): Provide valuable, non-approved information for the healthcare industry, subject to revision.
SUD: Acronym for Single-Use Device Reprocessor, highlighting regulations on device reuse.

Miscellaneous Regulations

Noncompliance with regulatory standards can lead to legal consequences.
Failure to gain Joint Commission accreditation risks losing Medicare and Medicaid payments.
Best practices for sterilization and endoscope processing are provided by AAMI and SGNA, respectively.

Description

Test your knowledge with these flashcards covering Chapter 5 of the IAHCSMM CRCST 8th Edition. Learn important terms such as statute, regulation, and standard that are essential for understanding healthcare compliance. Perfect for students and professionals in the field!