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Sterile Processing - Annual Risk Assessment

Updated: 16 hours ago

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Thought of the Week

Sterile processing departments need to regularly perform risk assessments to ensure high performance and quality outputs. Opportunities for failure come in many different forms. For example, equipment failures, utility failures, inventory failures, and staff failures, to list just a few. An ACA (Apparent Cause Analysis) is a great way to accomplish reviews of near misses. In contrast, an RCA (Root Cause Analysis) deals with the harm that has already occurred. Our focus is on completing annual risk assessments in the Sterile Processing Department (SPD) as a gap analysis approach.

What do I need to assess during sterile processing risk assessment?

Everything! I know that sounds impossible. It's not if you develop a gap analysis template. It does take time to complete, but not only will it reduce disruptions in your department it will also improve the quality and safety of the SPD department for your patients and your staff. This process is a top-down approach culminating from identifying the risk to assessing a risk classification. The areas of evaluation should at least include impact on the end users, key stakeholders, solutions, a risk classification, and provide a priority classification.

How do I assess everything?

Develop operational categories for the SPD department and pare down from there.


Education (category or sub-category)

  1. Are all staff processing medical instrumentation certified?

  2. Does all staff processing medical instrumentation receive in-service training for all new medical devices, cleaning equipment, and sterilizers?

  3. Does all staff processing medical instrumentation receive continuing education?

  4. Are competencies completed annually for the decontamination, assembly, and sterilization of medical instrumentation?

  5. Can all staff processing medical instrumentation demonstrate competence in their work responsibilities?

Using the example above, you may discover that one or more areas have a gap. Using that knowledge, you can develop the resources you need to close it. For example, the staff is failing a competency on a large scale. Let's say it is using the TEE reprocessing unit. The result may be to develop additional training and re-evaluate staff competencies for this process more often than annually. You may even decide to develop a core group of expert users in your department to help maintain the process. The solutions are boundless.

Risk assessment categories for SPD should include:

  • Staff Qualifications

  • Policies and Procedures

  • Facility Design

  • Infection Prevention

  • Decontamination Area

  • Processing/Assembly Area

  • Packaging/Sterility Maintenance

  • Sterilization (Steam, IUSS, and Low Temperature

  • High-Level Disinfection

  • Sterility Maintenance and Transportation of Sterile Products

  • Preventative Maintenance and Quality Control of Equipment

  • Continuous Improvement Processes

  • New Product Evaluation

  • Receiving of New Medical Devices/Supplies

Now, the hard work begins!

I have completed my gap analysis, spoken to my key stakeholders, developed solutions, categorized my risk levels, and adjusted the priorities. Where do I go from here? More likely, you have identified solutions for which you do not have current resources. If you don't have data to substantiate your assessment, you will need to develop some. Qualitative and quantitative data are important when building your story. Hospital Administrators are less likely to provide support for projects without data. A return on investment (ROI) is a necessary component of your story. Unlike capital equipment purchases which may have an ROI based on patient utilization, the ROI you will be supporting will be safety for your patients, staff, and possibly, the business if your risk involves compliance with CMS. The benefits of change also often have soft and hard cost implications. Suppose your assessment and change reduce delays in the OR, which saves money that is a hard cost saving. If your assessment and change reduce operational failures and risks, that is a soft cost saving. And if you are lucky enough to create change that reaps revenue and reduces risk, you have hit upon the holy grail.


Without completing an annual risk assessment, you have no road map for success. You are driving the car down an old country road in the dark with your headlights off. You know where the steering wheel is, the gas pedal, and the brake, but you can't see the turn up ahead. Save yourself, your staff, and your business by turning your headlights on so you can see the road. Take the information gained in your risk assessment and conquer your environment.

At Evolved Sterile Processing, our consultants have a greater focus on sterile processing. With our decades of experience, we will help you develop better processes and educational resources for your staff.


CDC Ambulatory Surgical Center (ASC) Infection Control Surveyor Worksheet Rev. 142

NJ Title 8 subchapter 43G

AAMI ST 79: 2017

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