New Standard Helping SPDs Implement Quality Management Systems

By Kelly M. Pyrek

Quality management systems (QMS) have infiltrated healthcare but their reach to the sterile processing department (SPD) has been slow or nonexistent. Damien Berg, sterile processing manager for St. Anthony Hospital & OrthoColorado Hospital and incoming president of the International Association of Healthcare Central Service Materiel Management (IAHCSMM) says a new standard from the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) could help bring QMS to the SPD.

ANSI/AAMI ST90: Processing of healthcare products-Quality management systems for processing in healthcare facilities specifies the minimum QMS requirements needed for a healthcare organization to effectively, efficiently and consistently process medical devices to prevent adverse patient events and non-manufacturer-related device failures. As the standard explains, "The adoption of a quality management system should be a strategic decision of an organization/department. The design and implementation of an organization’s quality management is influenced by varying needs, particular objectives, the products provided, the processes employed, and the size and structure of the organization."

“ST90 is the blueprint for a process that will ensure that sterile processing departments can maintain and deliver quality outcomes to our customers and patients,” says Berg, who is co-chair of the AAMI Quality Systems for Device Processing Working Group.

Fellow working group co-chair, Richard Schule, director of clinical education services at STERIS Corporation, notes, “It is my hope that ST90 provides the framework and structure for device processing areas within a healthcare facility to be more effective, efficient, and consistent in their device processing processes. I also hope ST90 provides technicians, supervisors, and department leadership with a systematic approach to take their department to the next level.”

The American Society for Quality (ASC) defines QMS as a formalized system that documents processes, procedures and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. ISO 9001, the international standard specifying requirements for quality management systems, is the most prominent approach to quality management systems.

ANSI/AAMI ST90 follows the format of ANSI/AAMI/ISO 13485, according to Schule, who also says ISO 9001 served as a foundational document for the working group that was developing ST90. "If you were to compare the two, there are similarities," he explains, "and ISO 13485 served as our template for ST90. We massaged ISO 13485 as a template to fit the world of device reprocessing, so it allowed us to avoid reinventing the wheel."

Schule says the diverse backgrounds and perspectives of the members of AAMI Quality Systems for Device Processing Working Group helped the team create a document that embraced as many viewpoints as possible. "One of the exciting challenges that Damien and I faced was the importance of balance on the AAMI working groups," Schule says. "ANSI required that AAMI show a balance of working group committee members, so we had representatives from manufacturers, end users and other stakeholders. Because we were developing a standard that was unknown among so many users, Damien and I needed to guide the conversations, and having taken my SPD into ISO certification 12 or 13 years ago, I had a very good appreciation for the challenges ahead of us. I think we made a very good attempt at balancing the input from the various stakeholders. When we started developing the standard, we broke into subcommittees and each subcommittee was handling a different section of the standard and that became interesting because of the varied interpretations among stakeholders. Manufacturers had a different interpretation because they were coming from ISO 13485, and the users were confused and challenged by some of the requirements of the new document, especially when you get into device design. If you had a subcommittee that was heavy on the user side, and a subcommittee that was heavy on the manufacturing side, you could see a difference in the way that the standard began to blossom. Subcommittee members with quality backgrounds were very helpful in explaining and educating about QMS, and when we started to go down a rabbit hole, we would take a time-out and refer to ISO 9001 and ISO 13485 for guidance."

Berg points to the unique opportunity that sterile processing departments have to embrace quality improvement and contribute to the dialogue with other healthcare stakeholders. "ST90 is going to start some much-needed conversations between sterile processing, the quality department and healthcare institution leadership," Berg says. "With this standard, we can speak the same language and get sterile processing on the same level playing field so that we are not just a service department, we are a quality department, too. This document will help us achieve that by assisting sterile processing professionals to truly understand what QMS is and how it fits into our everyday sterile processing lives and into the bigger picture of the hospital."

Schule says that all levels of the healthcare organization can benefit from the implementation of ST90.

For the processing technician, a QMS approach would result in a better understanding of what to do and how to do it; the ability to check work against requirements; the ability to adjust processes when results are not meeting requirements; a means of getting help to solve problems; opportunities to communicate problems in a nonthreatening manner by focusing on process issues; and an environment where the technician is not blamed for issues that can only be resolved by managers.

For the middle manager or shift supervisor, using ST90 would lead to better control of processes; a higher level of consistency; the ability to manage using data rather than opinions; enhanced communication throughout the organization; clarity of responsibility and accountability; standardization of processes, reducing variability and making it easier to solve problems; and the establishment of continual improvement as a core value of the department

For senior leadership, the approach would provide greater clarity on departmental goals and objectives; an improved ability to understand and meet customer requirements in a consistent manner; and an alignment of employees and processes to meet organizational objectives.

"Quality must be embraced by everyone who touches a medical device or surgical instrument," Schule says. "It doesn't matter if you are a technician, nurse, surgical technologist or surgeon. There are parts of the quality system that the sterile processing technician may not know about, so their education, training and competency is extremely important piece of learning about quality. They must take some responsibility to maintain their education, attend those training sessions, do their due diligence during the competency observation process."

Berg encourages sterile processing personnel not to be intimidated by something as foreign-sounding as QMS. "I tell people not to be scared of something new, don't be afraid of a concept that seems outside of the box," he says. "In sterile processing we get extremely busy with our day-to-day operations and putting out fires, but that doesn't mean you don't have time to do quality management system work; it will actually help you at those times when things feel chaotic." Berg is being interviewed on a day when many personnel are out sick from the flu and points to this situation as an example of the need for continuous quality. "I am not immune from a day like today in my department where the wheels could come off the wagon, but they aren't. We are all about as stressed as we can be, but it doesn't change who you are or what you do, we all work together. For example, our QMS is helping us get through a day like today where 50 percent of my staff is down with the flu and if I didn't have good quality management systems in place to help the staff maneuver around challenges, we would fail."

Schule says it is vital to work in an environment that supports quality to begin with. "There must be an existing culture so that when something goes outside of the conformity of specifications, you are able to hit that red button and stop the process, like on the automotive line -- if something is not working, they stop that line," he explains. "Stopping that line costs money but if you don't, you are sending defects out the door."

To better understand the concepts of QMS, Schule alludes to the manufacturing acronym SIPOC, which stands for suppliers, inputs, process, outputs, and customers. "In manufacturing, there is a supplier that is providing whatever the materials are, you have an input, and then you have the process, and after that process is complete you now have an output and then you have a customer and in that manufacturing model, each one of us in sterile processing plays a role. One of the greatest things I think ST90 can do, hopefully, is be a foundation for the conversation we need to have with our professional clinical staff. We talk about point-of-use care, especially recently with flexible scopes; this POC care is placed on the clinician at the time of the procedure in the OR -- if you take care of your instruments properly during that time, that collaboration is part of quality systems thinking because everyone is a stakeholder in the process."

"I advise people to take small steps during QMS implementation, and remember that we are already focusing on quality performance in the majority of hospital SPDs, we may just not know it or connect these dots to an official quality system," Berg says. "I think many people are doing a lot of great quality-related tasks but these efforts are all over the place. Let's narrow our aim and focus by using ST90, and when we move on something, let's do it thoughtfully, methodically and purposefully. I think that if we take that approach, we'll get there."

“For those thinking it is going to be a lot of work to implement a QMS in their department-it will be, but anything worth doing correctly is not always easy,” Schule says. “Success can only be achieved with team effort and clear vision.”

That vision involves being able to determine return on investment (ROI) for the healthcare institution. "If personnel were to embrace quality and tried to understand what it means to their department or healthcare organization, it would mean identifying or reducing the number of defects, deficiencies or failures,"

Schule adds. "That correlates to medical device and instrument processing in a number of ways, such as the challenges of providing a sterile tray with all of the instruments functioning, prepared for use, everything on the count sheet meeting the customer's specifications and expectations. QMS can involve getting wrapped up into some of the measures that are akin to counting widgets; while that serves a purpose, I don't think the right questions are asked before measurements are taken. So, counting the number of devices we process is good from the simple perspective that people are trying to challenge themselves from a Six Sigma perspective. SPDs are probably between a 4 or a 5 Sigma when it relates to millions of devices that are reprocessed and that correlates with anywhere from 1,200 errors a year down to 200."

Schule continues, "There are other key issues, such as, if I am having poor quality, what's the cost of that quality? How much money are we wasting on man-hours, consumable supplies and utilities? If we want to get some ROI on quality, are we measuring how much money we are wasting? SPD is a nonrevenue-generating department, so if we can get control of that, we can show some turnaround. We also must consider how we produce our products and/or services, what are the customer needs or behavior, and are we achieving customer satisfaction. Do we fully understand the expectations and the needs of the customer? The SPD can have a relationship with the operating room that is sometimes aggressive or hostile, and I don't like those kinds of conversations -- that's just professional etiquette. Understanding the customer's expectations and needs is essential and yet we have folks working in a support area that have never experienced what trauma surgery is about; unless you understand the criticality of having functioning devices that can mean someone's life, you will never bridge those gaps between the SPD and the OR. If you are reprocessing medical devices, take it upon yourself to not only maintain your education and competencies, but walk in the customer's shoes -- and if you can do that, it tells your customer you respect them enough to understand a little bit about what they do."

In October 2011, AAMI and the Food and Drug Administration (FDA) convened a Medical Device Reprocessing Summit through which stakeholders identified challenges to safe and proper reprocessing and set in motion the conversations needed to address clarion themes (see sidebar on page XX) that represented the most significant challenges and barriers. Almost seven years later, these issues persist and can undermine implementation of QMS from a labor and time perspective.

"Those clarion themes that emerged from that summit -- from going back to the basics, to having the right tools, to the awareness of the purchasing process, the necessary training and certification, and sharing lessons learned -- can be cross-referenced into quality systems," Schule says. "Everything returns to quality. If you have manufacturers deploying quality systems in their device design and development as well as their process of moving forward with an FDA 510(k) submission, it's hypocritical to some degree for a healthcare professional to hold a company responsible for quality out of the box for the equipment we buy and use yet they do not hold themselves accountable for the devices and services they provide the clinicians who are at the bedside or in the OR taking care of the patient. It is remarkable that today we are still having these conversations; if you review reports of outbreaks and adverse events, you can peel back that onion and for every one of those events, had they had a quality system in place, 9 out of 10 of those issues would not have occurred."
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AAMI/FDA Medical Device Reprocessing Summit Clarion Themes
1. Gain consensus on “how clean is clean” and on adequate cleaning validation protocols for reprocessing reusable medical devices.
2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
3. Pay early, iterative, and comprehensive attention to reprocessing requirements throughout the device design process.
4. Make human factors and work environment factors priorities when developing reprocessing requirements.
5. Improve information collection and sharing to broaden the use of best practices in reprocessing.
6. Improve reprocessing competencies by strengthening training, education and certification.
7. Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing
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Schule continues, "I used to tell folks over the last couple of years as this standard was being developed, if you are not disciplined in your own personal life to balance your checkbook or change the oil in your car, or prepare a list before going grocery shopping, you will have some difficulty in terms of quality systems in your department. As I thought about it more, it was the wrong thing to say. ST90 is opening the door for another role responsibility in our device processing areas, however, most managers and supervisors running these departments cannot take on another task to administratively run their department. They are overtaxed, they are understaffed in some cases, and it's going to take some discipline for them to carve out a portion of their day devoted to QMS. It's going to take X number of hours every day, week or month to start to build their quality systems in their department. Most SPDs are only doing about 55 percent of what's asked of them in ST90; some folks think that if they do BIs and CIs and sterility assurance, that's adequate as a quality system. We have an opportunity to dissect and digest the sections of the standard and teach our leaders that it opens the door to a new role and job description in sterile processing. Going back 12 or 13 years ago to my time at the Cleveland Clinic's SPD, I needed to have a point person or a champion that was going to help with our quality initiatives. The title of this role was a quality management representative (QMR). That individual bridged the gap between the departments, the quality manual, and the processes within the department. That role was 50 percent and the other half was serving as the educator of the department. So, when you examined preventive actions and corrections which is a portion of quality systems, and you spotted deficiencies and defects, you can educate on them immediately. Having a QMR to assist with quality initiatives and implementation will be a critical role. If you don't have the latitude to do this, then the manager or the supervisor takes on that role amongst all the other things they are trying to do and that will become a significant challenge."

Infection preventionists can assist SPD supervisors and managers through collaboration, Schule says. "Working together throughout the organization on supporting quality systems in device-processing areas is paramount for all stakeholders, and the IP is one of those key stakeholders," he says. "Their perfect place is in the audit process -- an audit should not be conducted by the individuals who have a stake in the process being audited. You should have another set of eyes that is outside of the department that can audit your procedures and processes. IPs have a great opportunity to collaborate with managers of SPDs to learn what ST90 is all about; they don't necessarily have to be an expert in the space to audit it, because if the checklists are constructed and in place, the audit process is straightforward. The IP is an integral part of the audit process and an institution's overall quality effort."