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A How-To Guide for Quality Processes
Like the infamous line about a totally different topic, most of us know quality when we see it. But in a medical or hospital setting, the word takes on an elevated meaning and can spell the difference between life and death. Quality in medicine is the degree to which healthcare services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. At baseline, the desired health outcome is that our patients get better, or at the very least, suffer less from pain. And while a commitment to quality cannot guarantee that all patients will be cured of what ails them, it can give them their best shot while protecting a facility from issues (read: lawsuits or other complications) stemming from poor adherence to quality.

The push for process quality in industry began in earnest in the 1950s when Dr. Edward Deming, an engineer, statistician, and management consultant, worked with business leaders in Japan to use statistical process control, systems thinking, and human psychology, among other things, to revive Japan’s postwar economy. He taught managers and teams methods for improving how they worked together, proving that collaboration and communication were keys to quality outcomes for both the teams and their customers.1 His Plan-Do-Study-Act process, commonly known as Deming’s PDSA cycle, offers a blueprint for instituting procedural changes and promotes the continuation of process improvements.2

Over the next series of articles, we will review the PDSA Cycle, how it relates to continual quality process improvement in the sterile processing department (SPD), and why we should be implementing a quality process in the first place.

Why do we need a continual quality improvement process?

A continual quality improvement (CQI) process is the clearest message a department’s leaders can send to patients, doctors, and staff that says “what we do here, and how we take care of you, matters to us.” A CQI gets to the root of recurring problems and complaints and can prompt a series of smaller, more incremental changes that are easier for teams to take on, and whose effects are easier to measure and manage.

We often hear from our SPDs that the top reasons for not having an established CQI program are that it takes too much time and too much effort to collect data and manually keep records. We have no doubt that these stressors weigh heavily on leadership, especially if they’re faced with a lack of their own CQI training, staffing shortages, or inadequate technology. But if we step back from the day-to-day work, we find that there’s no other option. A CQI in the SPD is key to increasing customer satisfaction, reducing the costs of services as it relates to rework, and minimizing complaints from an SPD’s main customer, the operating room.

Before launching into a CQI program, SPD leaders should endeavor to brush up on the most current skills and knowledge of their area, take care to encourage active participation from their employees in any process improvements, and solicit input and collaboration from other departments that will be affected by changes.

The PDSA Cycle
We can use Deming’s PDSA Cycle to implement a CQI that’s both measurable and effective by first drafting a plan of what needs to be improved. Work with team members or others who will be affected by procedural changes to get a clear picture of what needs to be accomplished and what’s possible with the team you have in place. Then, follow Deming’s wisdom to your eventual desired outcome.

  • Plan: Define the problem and investigate the root cause. Where does your process issue start? Who is most affected? Create a cause and effect diagram and map the process to assess what factors are influencing the root cause of the problem. This process works best when you assemble a team of process participants who can be up-front about issues and who can collaborate on solutions. When solving issues related to the SPD, this may include SPD technicians, OR surgical techs, the SPD educator, and others.

  • Do: Get to work brainstorming potential solutions and write ideas on a white board so everyone in the room can see all suggestions and weigh in. Analyze the advantages and disadvantages of potential solutions and let each department offer their own perspectives. Put each suggestion through the wringer: What would it take to implement this solution? Do we need a budget? Which solution will allow the process to be successful? What are the criteria and key performance indicators needed to implement the solution? Who will take part in the implementation process? How long will it take to complete the implementation? Can we do a test phase of the solution? At the end, the team should choose the best and most beneficial solution to the problem.

  • Study: Once you have selected a potential process to solve the problem and completed a test phase, analyze the outcome of the test. Was this solution effective? If so, why? If not, why not? Go back to the drawing board to make changes to the original, if imperfect, solution. Repeat steps one (Plan) and two (Do) until the team feels that the current iteration of the solution is the best answer to resolve the problem.

  • Act: If you’ve reached the A in PDSA, congratulations! It means that you’ve correctly identified the root cause of the problem, effectively devised and tested solutions, and can now implement the best solution for the problem. It also means that you’ll be able to prevent the same issue from recurring and monitor progress on the new process.

SPD leaders should always strive for continual process improvement; therefore, the cycle should be repeated to identify new opportunities for improvement.

Benefits of implementing a quality process
The benefits of a CQI go beyond employee empowerment and process improvement. A CQI in the SPD can help minimize patient complications from sterilization missteps and also:

  • Standardize processes: Everyone performs the tasks the same way without shortcuts or deficiencies, and everyone is held to the same clearly established standard.

  • Reduce waste and rework: Fewer instrument trays must go back for recleaning, reassembly, or resterilization because all are passing the quality audit test. The department becomes more productive and only necessary tasks are performed.
  • Foster teamwork: Understanding how one department’s work affects another department’s day-to-day is key to building empathy, collaboration, and teamwork among groups. Understanding another department’s unique pressures and time constraints allows for a little more breathing room for everyone.

  • Improve patient safety outcomes: Whether you’re in the SPD or the OR, the goal is always the same: better, safer outcomes in surgical procedures. Patients trust that anyone involved in their procedures is doing what they can to contribute to these outcomes and it’s on hospital teams to step up.

  • Increase customer satisfaction: By making your customer, the OR, a part of the quality process, you’ll be doing what you can to increase customer satisfaction and reduce stress for all involved.

It is proven that Dr. Deming’s philosophy of teamwork and collaboration can change the outcome of the process and the product quality. Like most things in life, it’s most difficult to just start. But with a carefully laid out plan and the participation of all stakeholders, it’s possible to institute a successful and manageable CQI.

When in doubt, remember that as Dr. W. Edwards Deming said, “It would be better if everyone worked together as a system, with the aim for everybody to win.”3


  1. The W. Edwards Deming Institute. Accessed October 15, 2020. https://deming.org/deming-the-man/
  2. The W. Edwards Deming Institute. Accessed October 15, 2020. https://deming.org/explore/pdsa/
  3. The W. Edwards Deming Institute. Accessed October 15, 2020. https://deming.org/deming-institute-podcast-deming-guide-to-layoffs/

Mary Olivera, MHA, CRCST, CHL, FCS has over 30 years of experience in numerous roles in healthcare sterile processing, distribution, and materials management. Ms. Olivera participates in monitoring, surveying, and training interdepartmental staff in the proper cleaning, decontamination, and sterilization practices, and has been highly committed to the standardization of interdepartmental processes. A regular recruit on expert panels regarding sterile processing and a past president of the New York State Central Service organization, she continues to play a major role in promoting higher educational requirements for central service professionals to increase patient safety.

Ms. Olivera brings to the table extensive knowledge of Joint Commission, DNV-GL, AAMI, OSHA, CDC, and DoH regulations. She specializes in budgeting, change management, inventory management, process re-engineering, program and project management, vendor relationships, quality control, Six Sigma, supply chain, and total quality management.

Ms. Olivera is an educator and has published numerous articles related to sterile processing, surgical services, process improvement, and guides to achieve successful accreditation surveys.

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