Center for Improvement in Healthcare Quality Newsletter
February 2022

CIHQ-ARS Article

The Power of Targeted Self-Audits

Tune-ups for Sterile Processing Departments

An article furnished by RL Datix/OneSource
The Sterile Processing department is a crucial area responsible for reprocessing medical devices. It involves highly trained technicians performing diverse processes, many of which derive directly from an instrument manufacturer's instructions for use (IFU). The remaining processes are developed within the department utilizing up-to-date standards and best practices.
Sterile processing teams often struggle to meet the daily demand of a busy operating room schedule, without leaving much time to develop or maintain quality processes in real-time. Without the time or resources to innovate and push forward, departments can stagnate in improving quality of care metrics.
Incorporating real-time self-audits or assessments support CIHQ’s purpose statements.
For Sterile Processing leadership, Instructions for Use (IFUs) and organizational policies and procedures offer quick and tangible takeaways to start a self-audit process in your organization.


IFUs are of critical importance and a key area to audit. It is ripe for not only review but ongoing maintenance. IFUs are instructions directly from the manufacturer that tell technicians how to clean, process, and sterilize the medical devices.
Current standards (ANSI/AAMI ST79:2017 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities (Contains Amendments). This standard indicates that the IFU's be updated, readily available, in clean and legible condition, and they should cover ALL medical devices, including equipment. The Sterile Processing Department has a lot of equipment such as washers, sterilizers, sonics, etc. that are often overlooked and not included when considering the IFU library. We must make sure all of these are included in the library.
Some audit questions to consider:
  • Do we have IFUs for all equipment used in the department?
  • Are they using them?
  • Do they know how to access them?
  • How well do staff follow them through direct observation?
  • Do staff have the tools and implements available indicated in the IFU?
  • Where is the library? Binders? Scanned into network PC'’s or is it an online service?
Once the IFU Library meets the standard, we can audit their use by the staff through direct observation.

Existing policies and procedures:

Policies and procedures are the backbones of the department and require annual maintenance, at a minimum. When accreditation bodies visit the Sterile Processing, they are ensuring current standards and any policy procedures that are written are consistently followed.
Some audit questions to consider:
  • Are they current and updated appropriately?
  • Are they accessible for all staff? Where do they reside? Binders, network drives, or an online service?
  • Are they consistent across the organization and the system?
  • Are they being followed in day-to-day practice?
Policies and Procedures can be reviewed, updated, and benchmarked against how the staff adheres to them in actual practice. Consider involving key staff members in the review and update process as they are the experts performing these tasks and can provide valuable feedback.
An honest assessment of people and processes can not only get you back on track but also drive quality improvements. Visibility into documented policies and procedures allows teams to observe how they are translated and followed in actual practice. Best practice is to include audits as an element of a sterile processing departments' ongoing quality improvement program best practice is to include audits as one element that should be part of a department's ongoing quality improvement program as outlined in the latest ANSI/AAMI standards. (ANSI/AAMI ST90:2017 Processing of Health Care Products - Quality Management Systems for Processing in Health Care Facilities).
Developing and maintaining a quality system within Sterile Processing is challenging. Yet, in today's world, there are software systems that can assist in getting these processes up to speed and make them part of a quality management system that detects errors and brings ongoing improvements.
Unfortunately for many Sterile processing departments, their first exposure to tools that measure and improve quality is when an “official” accreditation survey occurs. It comes as a negative because they may not meet standards. They then are given the opportunity, time, resources, and expertise of what is wrong.
In helping our members and customers, we achieve our purpose and mission and give them a real, doable starting point to begin the journey towards quality. RLDatix offers solutions for managing manufacturer's documents, organizational policies and procedures, and accreditation & regulatory activities including auditing and rounding. Contact us to learn how RLDatix can help drive your self-audit and infection prevention processes.

Author Bio:

David Jagrosse serves as a partner and speaker for RLDatix and oneSOURCE.


ANSI/AAMI ST79:2017 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities (Contains Amendments). ANSI/AAMI ST90:2017 Processing Of Health Care Products - Quality Management Systems For Processing In Health Care Facilities. Sterile Processing in Healthcare Facilities Preparing for Accreditation Surveys 3rd edition Rose Seavey AAMI Bookstore