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Rules and regulations

Examples include:

  • Local or state health authority
  • Local, state and federal building code requirements
  • Occupational Safety and Health Administration (OSHA)
  • Food and Drug Administration (FDA)
  • Environmental Protection Agency (EPA)

CMS requirements

  • CMS Conditions of Participation (CoPs) and/or Conditions for Coverage (CfCs)
  • CMS Survey and Certification letters
  • CMS Quality Safety & Oversight memoranda

Manufacture instructions

  • Reprocessing must be consistent with intended use (Spaulding Classification)
  • Manufacturers responsible for validating cleaning, disinfection and sterilization
  • Organizations must resolve any conflicts by contacting equipment and product manufacturers
  • Staff performing reprocessing must have access to instructions

Evidence based guidelines

  • Â鶹´«Ã½ requires:
    • NPSG.07.01.01, EP1: Hand hygiene guidelines from the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO)
    • IC.02.01.01, EP2: CDC Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings
    • IC.02.01.01, EP3: CDC Isolation Guidelines (may be adapted to health care setting)
  • EBGs cannot be less strict than regulations, CMS requirements* or IFUs
  • Unless required by regulation or standard, organizations may choose EBGs
  • When an EBG is voluntary, organizations may select relevant portions of the EBG to include
  • Examples of EBGs related to disinfection and sterilization:
    • CDC:
    • The American Academy of Ophthalmology (AAO):

consensus documents

Organizations may choose to consult consensus documents when a requirement is not already evident based on the hierarchy or if they wish to implement additional practices to ensure patient safety. Sources include:

  • Professional organizations
  • Expert panels

Examples of consensus documents related to disinfection and sterilization:

  • Association for the Advancement of Medical Instrumentation (AAMI):
  • American Dental Association (ADA):
  • ADA:

Be able to explain how your organization came to the correct conclusion for your organization following this hierarchical approach.

For more information, refer to the April 2019 issue of Perspectives.

Questions? Please contact the Standards Interpretation Group .

 

*The bullet points in this hierarchy are examples and are not all encompassing.
**For organizations that use Joint Commission accreditation for deemed status purposes or are required by state regulation or directive, CoPs and/or CfCs should be reviewed for applicable mandatory requirements.