It’s no secret that a continuous quality improvement (CQI) program is a critical responsibility of managing the Central Sterile Supply Department (CSSD). The Joint Commission requires it, and AORN, AAMI, and IAHCSMM support it through published standards, recommendations, and guidelines. In fact, according to ANSI/AAMI ST79: 11.2.2, a “sterilization risk analysis should be part of the healthcare facility’s overall infection prevention and control risk analysis in accordance with accreditation agency requirements. It should be performed at least annually and should be reevaluated whenever significant changes occur”.1

Since every facility is different regarding the type of equipment, assets, layout, size, etc., CQI programs need to be customized to the facility. Additionally, there are many areas in sterile processing where quality monitoring is recommended practice:

Decontamination

  • Design of the decontamination area
  • Personnel
  • Handling of contaminated items at the point of use containment, and transport
  • Decontamination processes
  • Servicing and repair
  • Documentation of cleaning verification
  • Documentation of processing parameters

 

Rigid Sterilization Container Systems

  • Transfer of contaminated items to the decontamination area
  • Decontamination processes
  • Sterilizer loading and unloading
  • Matching the rigid sterilization container system and the sterilization cycle
  • Inspection of rigid sterilization container systems
  • The configuration of instrument sets
  • Sterility maintenance

 

Immediate-Use Steam Sterilization

  • Decontamination area
  • Work practices
  • Installation, care, and maintenance of sterilizers
  • Containment of contaminated items
  • Sterilization process
  • Aseptic handling and transfer2

With so many procedures and areas to monitor, combined with the need for customization, CQI programs can be challenging. Here are a few tips:

  1. In section 11.4 ANSI/AAMI ST79 does explain that effective risk analysis has three basic components - listed below. Breaking your CQI program down into these three categories is a great place to start:
  • Risk assessment – involves identifying the sources of sterilization failures, and estimating the likelihood and consequences of failures.
  • Risk management – entails determining which sterilization failures require management and implementing plans to monitor and control failures.
  • Risk communication – the plan for how recalls are communicated to all the stakeholders in the reprocessing loop, i.e. Central Sterile Supply Department staff, OR staff, Infection Prevention staff.3
  1. Engage staff members that are responsible for the daily functions in specific areas in the process. All staff needs to understand the importance of CQI monitoring, and playing a role in the process can help encourage ownership and commitment to the achievement of department goals. According to AAMI, “The single most important issue for those charged with implementing a CQI program is the accurate collection of data using the facility plan for documenting process monitoring and product performance (developed as part of the CQI program)”.4
  1. Utilize software tools to help with documentation versus maintaining paper records. While AAMI does not specify the use of software applications, they do recommend facilities use “a formal, documented system to log, investigate, and resolve complaints and/or product failures so they can be tracked over time.”5  

A perfect example of CQI software tool is CensiTrac’s Quality Management module. This module, which is included in the CensiTrac surgical asset management solution, provides any stakeholder involved in the reprocessing of instruments an electronic tool to document comments or images regarding the condition of trays, instruments or other assets. Then module reporting capabilities provide management insight into problem areas so that proactive improvements can be made. A 37-month project at Virginia Mason Medical Center relied on a quality monitoring approach that was developed to identify and categorize errors in sterile instrument processing through the use of a daily defect sheet.6 Capturing the information on the daily defect sheet electronically, using the Quality Management module can help ensure data collection is accurate and easily accessible for review and analysis.

The beauty of having a well-designed and well- executed CQI process is that as the process of improvement works, the workload of monitoring and documenting problems should reduce over time if your program is truly effective. So while developing a CQI program is not easy, the good news is that in this case, hard work on the front end really does pay off.

Citations:

1Association for the Advancement of Medical Instrumentation. Comprehensive guide to  steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013; 11.2.2, p. 139.

2Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013; 11.2.3 -11.2.5, pgs. 140-142.

3Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013; 11.2.2:138.

4Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013; 11.4:144.

5Blackmore C., Bishop R., Luker S., Williams B. Applying Lean Methods to Improve Quality and Safety in Surgical Sterile Instrument Reprocessing. The Joint Commission Journal on Quality and Patient Safety March 2013; 39:3:99-105. Accessed December 11, 2016. Available at: http://www.jointcommissionjournal.com/article/S1553-7250(13)39014-X/fulltext

 

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