Center for Improvement in Healthcare Quality Newsletter
March 2022

CIHQ-ARS Article

High Level Disinfection: Log Requirements

By: Cara Nissen
Accurate and thorough documentation of high-level disinfection (HLD) processes is essential for organizations to ensure quality and prevent the spread of infection related to procedures involving semi-critical devices. Detailed records allow epidemiological tracking, continuous supervision of personnel performance, and verification of adherence to policies, procedures, and regulations. American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ST58 includes specific recommendations regarding HLD record-keeping, which form the basis of this discussion.
According to ANSI/AAMI, for each high-level disinfection cycle, the following information should be recorded and maintained:
  • Means of identification of the items processed and date processed should be assigned to each load of a cycle, chamber, or soaking tray
  • Full traceability to the patient should be maintained by recording the load identifier on the patient chart or by recording the patient’s name or other identifier on the load record
  • Specific contents of the lot or load, including quantity, department, and a description of the item(s)
  • Patient’s name, medical record number, procedure, and physician, if applicable
  • HLD lot number, shelf-life date, date the original container of HLD was opened, use-life of the open container, date the product was activated or diluted, date that the activated, diluted, or ready-to-use solution was poured into a secondary container, and the reuse-life of the solution, if applicable
  • Exposure time and temperature
  • Date and time of cycle
  • Chemical concentration of the exposure phase of the high-level disinfection cycle, if applicable
  • Name or initials of the operator
  • Results of biological indicator (BI) or spore strip testing, if applicable
  • Results of solution test strip quality control testing, if applicable
  • Results of minimum recommended concentration (MRC) or minimum effective concentration (MEC) testing, and
  • Any reports of low MRC or MEC testing results (as indicated by solution test strips)
Check out the Resource Library on the Accreditation Resource Services (ARS) members webpage for the Cidex OPA Solution & Test Strip Quality Control & Instrument Log, which meets ANSI/AAMI recommendations. The sheet can also be adapted for use with other HLD soaking solutions (Revital-Ox Resert, Aldahol, etc.). Automatic endoscope reprocessor (AER) machines may store a record of each run, or even solution changes and lot numbers. Organizations need to carefully review reports to ensure all the required documentation elements are captured. An additional/ separate log may be needed. According to ANSI/AAMI recommendations, print outs should be maintained (not discarded) and signed off by staff.
Manufacturer instructions for use (IFU) for the particular HLD method and equipment being processed should be reviewed for additional expectations related to documentation. For example, sleep labs may need to track the number of times each individual mask is reprocessed if limited by the IFU.
A record of repairs and preventive maintenance should be kept for each HLD processor including filter changes. The department should work closely with clinical engineering to verify who is accountable for ongoing preventative maintenance at various intervals and determine where the records for such maintenance are stored. Manufacturer IFU should be followed for specific preventive maintenance requirements.
Any data on personnel exposure testing should be recorded and maintained.
All records related to HLD must be retained in the department or another designated storage area for a period not less than that specified by hospital policy for retention of records, established in conjunction with the facility’s risk management department (or legal counsel) and infection prevention and control committees.

Resources:

Chemical sterilization and high-level disinfection in health care facilities Developed by AAMI Approved 21 August 2013 and reaffirmed 9 September 2018 by American National Standards Institute Inc.