Author: Sam Harrison, CRCST | Clinical Analyst

When it comes to sterile processing departments, quality assurance (QA) is a gamechanger for successful processes and procedures. Complete and accurate documentation is critical to the success of SPDs, and a thorough QA process not only makes sure that documentation requirements are met, but it also ensures compliance from both employees, as well as compliance from regulatory agencies standards and recommendations, facilitates consistency and uniformity of the various sterilization processes, and maximizes patient safety.

How does a QA process accomplish all of these things? Read on to find out.

Meet Documentation Requirements

During state surveys, the Joint Commission often requests sterilization records to ensure compliance and accuracy within the department. The Association for the Advancement of Medical Instrumentation (AAMI)—in ST79 section 13.3.3 a-h—requires the following criteria be documented for each sterilization cycle:

  1. Load number
  2. The specific content of the lot or load (including quantity, department, and a specific description of the items)
  3. Exposure time and temperature
  4. Operator identification
  5. Biological testing results (if applicable)
  6. Bowie-Dick testing results (if applicable)
  7. The response of the chemical integrator (CI) placed in the process challenge device (PCD) (if applicable)
  8. Any report of inconclusive or nonresponsive CIs found later in the processed devices

A QA process can ensure that the applicable criteria are documented by having each sterilization record checked.

Ensure Employee Compliance and Process Uniformity

Facilities can integrate a QA process in a number of ways. Some hospitals will have a designated person review the records at the end of each shift, while other hospitals will have a designated person review the previous day’s records each day. What’s important is that there is at least one designated person who consistently reviews records for accuracy and then follows up with the appropriate individuals whenever there are any discrepancies.

Following up with staff is vital to make staff aware of their mistakes so they won’t repeat them in the future. This improves employee compliance, while also making the documentation more accurate and consistent. Consistency throughout the department is key to ensure that all processes are completed in the same way regardless of who’s working.

Maximize Patient Safety

This is the most important reason to implement a QA process. If QA checks are performed frequently (daily or at the end of each shift), you can address and correct any errors or discrepancies before they lead to negative outcomes. For example, a QA check could find that an implant tray was run without a biological, enabling you to recall the tray before it’s used.

Bonus: Smooth-Running SPDs

A side benefit often found in facilities with strong QA procedures is the organization, efficiency, and competency of the department’s staff. Errors are corrected before they become habits. Technicians may be more mindful of the accuracy of their work because they know it’s being checked. Having a consistent, thorough QA check doesn’t lead to micromanagement, but rather to a culture of competence.

How Censis Supports QA

If you use our surgical tracking system CensiTrac to document sterile loads, you already have a great tool that keeps a sterilization record, simplifying the QA process. All sterilization information is stored in the same database, where you can search and manipulate the data for QA checks and other needs. With only a few clicks, you can find any incomplete areas of sterilization documentation, which you can then correct through your QA process.


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