Center for Improvement in Healthcare Quality Newsletter
November 2021

News You Can Use

November Compliance Tip of the Month

November’s tip of the month is focused on the standard/requirements regarding Disinfection & Sterilization Practices. Specifically, the high-level sterilization of hinged instruments such as hemostats, scissors, and needle holders.
When a surveyor is visiting any area of the hospital where there is storage of sterile instruments, he/she will look at instruments such as those described above to determine if the sterilization process was performed in their fully open position. This allows the instrument maximum exposure during the sterilization process. Organizations are often cited when it is unable to determine if they were fully open and subsequently got closed. The manufacturer’s instructions will indicate the need for this to be done. The regulations include the need for all manufacturer’s instructions for use (IFU’s) to be followed. Both the CMS and CIHQ standards/requirements have been included for reference.


IC-7: Disinfection & Sterilization Practices
The organization must assure that equipment, supplies, instrumentation, and surfaces are disinfected or sterilized appropriately.
  1. Sterilization must be performed in accordance with the CDC Guidelines for Sterilization and Disinfection in Healthcare Facilities, AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, and manufacturer’s instructions for the instrumentation and equipment used.


§482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs
The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program.
Interpretive Guidelines §482.42
Guidance is pending and will be updated in future release.
§482.42(a) Standard: Infection prevention and control program organization and policies.
The hospital must demonstrate that:
§482.42(a)(2) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings
Interpretive Guidelines §482.42(a)(2
Guidance is pending and will be updated in future release.
It is recommended that the organization have a policy/procedure that includes the process used to demonstrate compliance with all manufacturer instructions for use regarding the processing of hinged instruments. CIHQ as well as AAMI and AORN strongly recommend that a device be used to assure that they stay open such as instrument stringers, tip protectors or dual instrument guards.
ARS resources to assist with compliance:
Resource Library – Infection Control
  • 1183 Policy – Steam Sterilization
  • 1180 Tool – Audit for Sterilization of Supplies & Instruments
  • 1185 Tool – Competency Checklist for Staff Performing Steam Sterilization
Need access to manufacturer’s IFU’s CIHQ recognizes OneSource as a partner, and they do this electronically at a reasonable cost. You can find them listed in the CIHQ Partner section of the CIHQ website.