Sterilization and Disinfection Documentation

Guidelines:

• During accreditation reviews, surveyors from regulatory bodies (eg, The Joint Commission) examine processes that facility leaders have implemented for decontaminating and sterilizing instruments. The Joint Commission surveyors refer to standards and guidelines developed by the Association for the Advancement of Medical Instrumentation (AAMI) and AORN when inspecting instrument processing areas. In addition, surveyors refer to facility policies and manufacturer’s instructions to ensure that personnel are performing tasks correctly.
  • Provide comprehensive and intensive training for all staff assigned to reprocess semicritical and critical medical/surgical instruments
    • Hands-on training
    • Supervision of work until competency is documented for each reprocessing task
    • Competency testing at the beginning of employment and regularly thereafter
    • Review the written reprocessing instructions regularly to ensure they comply with the scientific literature and
      the manufacturers’ instructions
  • Written plan for routinely verifying and documenting that the facility’s cleaning equipment can properly clean instruments and devices after they are manually cleaned
  • Testing the cleaning effectiveness of mechanical cleaning equipment
    • Frequency of equipment testing per AAMI is every day the equipment is used
  • Documentation of staff onboarding and ongoing education and competency assessment

Considerations:

• Quality Control for Sterilized Items:
  • Sterilizer maintenance contract with records of service
  • System of process monitoring
  • Air-removal testing for prevacuum steam sterilizers (Bowie Dick, daily when in use)
  • Spore test on each sterilizer at least weekly and with every load with an implantable device
  • Visual inspection of packaging materials
  • Traceability of load contents

Nurse’s role:

• Maintain education and competency for sterilization and disinfection practices related to role
• Complete and maintain appropriate documentation for sterilization and disinfection per facility policy
  • Implantable items: Load #, expiration date, site, preparation, etc.
• Follow professional and regulatory standards
  • AORN Standards, Recommended Practices, and Guidelines
  • OSHA
  • Association for the Advancement of Medical Instrumentation (AAMI)
  • Association for Professionals in Infection Control
  • State and local regulations
  • The Joint Commission
• Knowledge of documentation requirements for sterilization, biological and chemical monitoring
  • Will cover in the example slide

Pitfalls:

• SPD leaders should:
  • Compare the reprocessing instructions provided by the instrument manufacturer and sterilizer manufacturer and resolve any conflicting recommendations through communication with both manufacturers
  • Review documentation for all required testing and follow up on any adverse events
  • Periodically review policies and procedures for sterilization
  • Ensure performance preventive maintenance on sterilizers by qualified personnel who are guided by the manufacturer’s IFU

Examples:

• For each sterilization cycle, record:
  • The type of sterilizer and cycle used
  • The load identification number
  • The load contents
  • The exposure parameters
    • Time, temperature
  • The operator’s name or initials
  • The results of mechanical, chemical, and biological monitoring
• Records of sterilization monitoring (mechanical, chemical, and biological) should be maintained long enough to comply with state and local regulations. The CDC does not maintain information on time limits for every state but provides an example of 3 years in its sterilization guidelines, which is the time frame used by The Joint Commission

Linchpins (Key Points):

• Maintain documentation for each sterilization cycle
• Maintain documentation for records of sterilization monitoring
• Maintain documentation for initial and ongoing education and competency for staff responsible for sterilization and disinfection
• Follow facility policies and procedures, state and local regulations, and manufacturer’s IFU