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 Conditions of Participation (CoPs) and/or Conditions for Coverage (CfCs)
- CMS Survey and Certification letters
- CMS Quality Safety & Oversight memoranda
- 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
- The Joint Commission 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: Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)
- The American Academy of Ophthalmology (AAO): Guidelines for the Cleaning and Sterilization of Intraocular Surgical Instruments (2018)
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): https://store.aami.org/s/store
- American Dental Association (ADA): Infection Control and Sterilization
- ADA: Sterilization and Disinfection of Patient Care Items and Devices
Be able to explain how your organization came to the correct conclusion for your organization following this hierarchical approach.
*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.