IAHCSMM CRCST 8th Edition - Chapter 5 Flashcards
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Questions and Answers

What is a statute?

  • Rules issued by administrative agencies
  • A written law adopted by a legislative body (correct)
  • Guidelines for best practices
  • A method that shows superior results
  • What is a regulation?

  • A uniform method for defining parameters
  • A method that shows superior results
  • Rules issued by administrative agencies (correct)
  • Guidelines for best practices
  • What is a standard?

  • A written law
  • A medical insurance program
  • Guidelines for best practices
  • A uniform method of defining parameters (correct)
  • What is a regulatory standard?

    <p>A comparison benchmark mandated by a governing agency</p> Signup and view all the answers

    Voluntary standards provide guidelines for best practices.

    <p>True</p> Signup and view all the answers

    What is MedWatch?

    <p>A safety information and adverse event reporting system for healthcare professionals and the public</p> Signup and view all the answers

    What are greenhouse gases?

    <p>Gases that absorb solar radiation</p> Signup and view all the answers

    Who does Medicare primarily serve?

    <p>People over 65 and disabled individuals</p> Signup and view all the answers

    What does HIPAA stand for?

    <p>Health Insurance Portability and Accountability Act</p> Signup and view all the answers

    Failure to receive accreditation from the Joint Commission can result in loss of Medicare payments.

    <p>True</p> Signup and view all the answers

    What does OSHA do?

    <p>Protects workers from illness and injury</p> Signup and view all the answers

    What is a Class II medical device?

    <p>Devices posing potential risks requiring a higher level of regulation</p> Signup and view all the answers

    Class III medical devices are identified as __________.

    <p>High Risk</p> Signup and view all the answers

    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.

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    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!

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