by Adam Okada

Introduction – Why Perform Quality Audits?

One of my favorite Sterile Processing educators used to say, “Sterile Processing is a quality assurance department more than anything else”.   Having spent 15 years in the industry, I completely agree with that statement.  There are quality assurance inspection steps that should be performed at all steps of the process, including: instrument cleaning, decontamination, disinfection, preparation, packaging, sterilization, and storage.  Every Sterile Processing professional knows that quality is of the utmost importance for sterile processing and patient safety.  A detailed audit program is vital to the success of any quality assurance program, so in this article we’re going to explore the intricacies of the Sterile Processing audit form.  What inspection steps should be included, and how do we measure quality?

What is Quality?

One of the first questions that must be answered before creating a Sterile Processing audit form and audit program is, “How does our facility define quality?”.

A common answer to this question is to define quality according to our customers, the Operating Room (O.R.).  O.R. staff typically like to have consistency with their products.  If a tray is always clean, always complete, and always neat, then the O.R. staff doesn’t think about the effort on the SPD side, and that’s a good thing.  But any variation in that consistency (items soiled in the tray, items that are missing, extra instruments, etc), and the OR considers the tray a “failure” in terms of customer service.  Remember the acronym F.A.N. when assembling trays:  Trays should be Functional, Accurate, and Neat in order to achieve positive reviews from the O.R..  Again, consistency of the product is the end goal here.

So, with a goal of consistency in mind for our quality audits, let’s set forth with creating an audit form that really works.

How to Create an Audit Form

For the purposes of simplification, let’s assume you need to create a Sterile Processing audit form for Tray Assembly in the Prep/Pack area.  Make sure to include all steps that are vital to the process on your audit form.

First, let’s examine how the internal integrity of the set (how the set is assembled):

• Is the internal chemical indicator present and visible?
• Is count sheet filled out completely/accurately?
• Does instrument quantity match count sheet?
• Are all instruments functional?
• Are all instruments visibly clean?
• Are appropriate items disassembled correctly?
• Is the tray free of debris (old indicators, etc.) or moisture?

If any item on this list is deficient, then the set will be an audit failure.  Again, the goal is to create consistently excellent products that the operating rooms can count on time and time again.

Now let’s examine the external integrity of the set (for after sterilization):

• If sterilization wrap is used, is the wrapper free of holes and tears?
• Does tray have lot label attached?
• Is tray labeled appropriately?
• Has sterilization indicator tape turned completely?
• Is tray appropriately wrapped, per hospital guidelines?
• *IMPLANT ONLY: If tray contains implants, are the biological results available for verification?

Again, if any item on the audit list is deficient, then the set is an overall audit failure.

Make sure to create a printable form in Word, Excel, or any word processing program so you have the same audit sheet for every tray.

SPD Staff Buy-In

Now that you’ve set up the nuts and bolts of your audit form, it’s time to bring it to the SPD staff.  And believe me, this is the hardest step of all.  SPD staff are notorious for reacting negatively to any type of audit program because they see them as, “trying to get them in trouble”.

To avoid this attitude, make sure that you present your new audit program as a quality assurance measure.

I like to utilize this list when presenting the idea of audits to Sterile Processing Department staff:

1. We want this department to be viewed as a high-quality, high-functioning department.
2. To provide a high quality of service to the Operating Rooms, we need to provide consistency with our products.  Remember the acronym F.A.N. when assembling trays.  Trays should be:
   • Functional
   • Accurate
   • Neat
3. In order to ensure we are providing that consistency of products to our customers, we are instituting an audit program to verify that every set that goes to the O.R. is:
   • Functional
   • Accurate
   • Neat

Make sure staff sees this as an improvement opportunity and not as a punitive system.  Yes, you will need to bring negative or “failed” audits to the technician who made the error.  But don’t assign a negative value to the audits.  Instead make a reward system for techs who go 30, 60, or 90 days without a single error.

Your goal with the staff is to show them that you are valuing quality over quantity and will reward those are putting out consistently excellent quality products.

And make sure you follow-through with any rewards program!

Tracking Data

Once your audit system is live, make sure you have a consistent number of sets or trays that will be audited weekly.  I would do no more than 5 per week for each individual performing the audits.  Leads, Supervisors, Educators, etc can all perform the audits, but all have multiple other duties within the department, so you don’t want to overload them with audits all at once.

Make sure that once they turn in their audits to you, that you have a way to enter and track the data.  I typically use Excel for tracking, but any system can work.  Make sure you enter all pertinent data, list the total number of trays audited, and then the number of “failed” audits.  Within the “failed” audits, you should also be listing the specific errors that are made so you can find trends and commonalities that you can address as a leader.

NOTE:  One way that I like to perform these audits is in an electronic tracking system.  Sometimes your SPD tracking system will allow you to enter audits through the system (which is ideal), but even if they don’t, you can always use a setup such as Microsoft Forms or Google Forms for creating the audits and tracking the results.  Either setup will save you a ton of time in compiling your data at the end of the month!

Make sure you have monthly audit results posted in the department and use these results to show the O.R. about your quality improvement program!

In Conclusion

Creating a sterile processing audit form and setting up an audit program can be a daunting task, but I can guarantee that the results will be worth it and your patients will be safer.  Each department and facility should be striving for that elusive 100% accuracy of trays, and 0% surgical site infections.  And tracking the quality of your process to ensure consistency is vital to continuous improvement and maintaining a high level of excellence within your department.