Quality in, quality out

Dec. 22, 2021
Assurance of sterility takes best tools and best practices

The Central Service/Sterile Processing & Distribution (CS/SPD) department is known for its fast-paced environment burdened by high employee turnover and intense pressure to reprocess instrument sets quickly but also in accordance with manufacturers’ instructions for use (IFU). All of this impacts the quality of processes and instrumentation, as Sharon Hadley, BSN, RN, CNOR, CSPDM, CHL, CFER, Principal Consultant, STERIS Instrument Processing Solutions, explains.

“Quality suffers due to lack of training for staff, increased complexity of instrumentation, time crunches (e.g., ORs pushing staff in both departments to perform turnovers faster), and lack of staff – both qualified and entry-level. Effective processes have given way to chaos in many SPDs. Leaders may attempt to perform process improvement, but in reality, they are just trying to keep up with demand in whatever way possible.”

Quality and sterility assurance in the CS/SPD department is only becoming more important as healthcare industry agencies and associations, health systems and hospitals themselves demand greater quality from all areas that impact patient care.

“More focus will be put on quality/sterility assurance and I believe that our Joint Commission surveyors, the Association for the Advancement of Medical Instrumentation (AAMI); as well as, our internal surveyors from areas like infection prevention will require higher levels of quality/sterility assurance standards be implemented,” said Mary K. Lane, MHA, CSPDM, CSPDS, CSPDT, MK Lane SPD Consulting.

Hadley, Lane and others offer myriad recommendations on assuring CS/SPD quality and sterility, from quick wins to longer-term strategies and approaches, and share their thoughts on the future state of sterile processing.

Staff education and training

The often “chaotic” nature of the CS/SPD environment, where technicians are forced to balance quality and safety with OR staff demands for quick instrument turnaround, can leave little time and resources for educational efforts, SPD experts say. Those in the field note how this can lead to technicians being thrown into the fire of the job without adequate training.

“SPD staff get rushed to meet quantity quotas that come from finance measures, some staff are still in the learning stage and are afraid to ask questions, others don’t have a good understanding/appreciation as to why quality/sterility assurance is critical to successful patient outcomes, and others lack attention to detail that is so very critical,” said Lane. “In addition, there is no consistency in color of the chemical indicators in SPD and this causes additional confusion for both SPD and the operating room (OR) staff.”

The development of a well-trained team with a high level of knowledge and skill and commitment to patient safety is absolutely necessary to improving CS/SPD quality and sterility, according to Seth Hendee, CRCST, CIS, CHL, CER, CSPDT, CFER, IAHCSMM Approved Instructor, Clinical Edu­cation Coor­dinator, SPD, Healthmark Industries. He points to current quality gaps between what technicians need to know and what many training programs teach them.

“In too many processing departments, trainees are routinely ‘trained’ while also being part of daily production,” Hendee noted. “The model is easy to understand considering the limited staff and space many SPD are restricted by, but this style of training rarely allows time for a key piece of information, the ‘why’ behind the process. Without this essential piece of the puzzle, techs may not understand the repercussions of taking short cuts or deviating from facility policy. Any long-lasting solution to this problem will have departments separating training from production and adding clinical knowledge of not only how but why we do what we do.”

Hadley says standardized training, using standard work instructions, is becoming a focus for CS/SPD departments.

“Leaders responsible for this department are reorganizing staff structure to allow for SPD-certified educators to be added to ensure staff are trained in an organized and standard manner as well as sustain what has been taught,” she commented.

Beyond the CS/SPD

It’s not just CS/SPD professionals who can benefit from enhanced education and training, explains Leslie Kronstedt, CRCST, CHL, CIS, President Elect of the Western Wisconsin Chapter of the International Association of Healthcare Central Service Materiel Management. (IAHCSMM).

“Knowledge is a powerful tool; it becomes apparent that there are gaps when some don’t know what quality/sterility assurance means or how to establish it within their departments,” said Kronstedt. “It becomes necessary to recognize that you may need to educate infection control, perioperative services, and risk management on handling different quality and sterility assurance events.”

Kronstedt notes how each department owns its own piece of the quality/sterility assurance continuum, thinking about it in their own way. It ranges from the mechanical/ temperature gauges used during sterilization to measure time, temperature and pressure to chemical indicators (CI) and biological indicators (BI). With regards to sterile storage, quality/sterility assurance for perioperative means looking for holes, tears and moisture in wrapped sets, she explains.

“Many SPDs are using process improvement events to create effective and positive change,” said Hadley. “Working collaboratively with the OR and other customer departments to refine or completely revise existing processes can greatly impact efficiency and improve quality and customer and staff satisfaction.”

Detailed documentation

With internal and external surveyors applying more stringent quality/sterility assurance standards to their inspections of CS/SPD operations, Lane says CS/SPD professionals have to be more meticulous in their data collection to prove compliance at each stage of reprocessing. 

“This will likely require additional documenting from SPD staff and retention of additional record keeping,” she stated.

Kronstedt says data collection is required to manage both simple and complex processes in the CS/SPD. She notes how maintenance records must be kept from the time instruments arrive in the department to the time they are sterilized and stored.

“Every sterilization load will have data detailing the sterilization process if parameters have been met and accountability for who has handled the processes in place,” she said. “In the event of a recall, there must be a system in place for finding and reprocessing the items in question and who needs to be notified when such an event occurs. Even the room maintenance records must be maintained and recorded to ensure that temperature or humidity within the room doesn’t compromise sterility.”

According to Kronstedt, gaps in quality/sterility assurance occur when each hospital’s CS/SPD has its own unique methods of documenting this critical information.

“There is a lack of comprehensive national quality programming that makes policies and procedures universally handled identically,” she explains. “This allows gaps to infiltrate the system leading to a breakdown in patient safety. If anything has been identified in the healthcare system, the best way to prevent errors is to have continuity across the board. This removes doubts and creates standardization that is not going to vary from organization to organization.”

Don’t skip the basics

When educating CS/SPD staff and other stakeholders on ways to improve quality and safety and achieve and maintain the sterility of instrumentation, leaders shouldn’t skip the basics: Hand and instrument cleanliness. Both factors can help minimize the risk for healthcare acquired infections (HAIs), while maximizing the opportunity for high quality patient outcomes.

“Hand hygiene plays a critical role in all infection prevention efforts and is an important indicator of a facility’s commitment to patient safety and quality healthcare,” said Jaimee Rosenthal, Acute Healthcare Market Director, GOJO Industries. “In departments like CS/SPD, where there is a strong focus on safety, quality and risk-reduction, basic protocols for infection prevention can play an out-sized role. Ensuring staff are performing hand hygiene, with products that are designed for healthcare environments, prior to the start and at the completion of any task is important to reducing the potential for germs that may cause illness.”

When it comes to the quality and sterility of instruments, the following has often been referenced and is worth repeating: “An instrument can be clean without being sterile, but it can’t be sterile without being clean,” commented Noreen Costelloe, Director of Marketing, Ruhof Corporation.

“This statement supports the well-known fact that cleaning—the removal of organic and inorganic debris from an instrument or device should precede all disinfection and sterilization processes,” she said. “Failure to do so can interfere with microbial inactivation and can compromise the disinfection or sterilization process, placing patients at serious risk. Therefore, one key area that CS/SPD professionals must address as part of their quality assurance plan for sterilization is the monitoring of/and verification that instruments and devices have been properly cleaned.”

Costelloe points to how leading industry associations recommend verification testing of instrumentation, medical devices and endoscopes to ensure cleanliness has been achieved prior to sterilization.

“The Association of periOperative Registered Nurses (AORN) recommends ATP as one of the valid qualitative tests that can be used to assess cleaning efficacy, stating further that such testing will allow the tracking and trending of performance as part of a quality program. The Association for Advancement of Medical Instruments (AAMI) also recommends rapid, easy to perform and sensitive verification testing such as ATP for the detection of organic residues on instrumentation while the Centers for Disease Control and Prevention (CDC) endorse the use of ATP testing as a method for evaluating environmental hygiene,” Costelloe cited.

As Costelloe explains, an ATP Con­tam­ina­tion System is a quick, easy to use and a reliable monitoring tool used to detect Adenosine Triphosphate (ATP), the universal energy molecule found in all animal, plant, bacterial, yeast and mold cells. In addition to its use in the CS/SPD, ATP can also be used to test non-critical surfaces throughout a healthcare facility.

“Product residues, particularly blood and bio burden, contain large amounts of ATP while microbial contamination contains ATP, but in smaller amounts,” she added. “An ATP Contamination Monitoring System measures the amount of contaminants present after cleaning and with integrated software enables data tracking to focus on process improvement efforts where they’re needed most.”

CS/SPD: 2022 and beyond

The COVID-19 pandemic has driven significant change in healthcare delivery over the past two years. The CS/SPD has not been immune to the impacts, as evidenced by the International Association of Healthcare Central Service Materiel Management’s (IAHCSMM) efforts to help enact hazard pay for sterile processors for their work during COVID-19 in 2020 and 2021.1

The fight continues for CS/SPD professionals to prove their critical role in patient care and safety to their health system and hospital leaders, on par with other clinical areas. Moving forward, Hadley says CS/SPD must become a focus to leadership in order for departments to secure the resources they need for quality and sterility assurance improvements, stating:

“Technology in SPD must match the technology in the OR. Facilities spend millions of dollars for the latest surgical technology but do not match that for managing the care of those instruments.”

“The spotlight is finally shining on the sterile processing department,” Hadley added. “Senior leaders are realizing the critical importance of this department and are willing to invest for success as never before. Technology in SPD must mirror that of the OR it makes little sense to invest millions on the latest surgical innovation if one can’t adequately care for the instruments used in those innovative procedures.”

Hendee envisions a future where CS/SPD technician training will be on par with the full classroom experience provided to other clinical professionals. He says this model has already begun, with stand-alone and interdepartmental tech training classes “popping up” around the country.

For example, the CS/SPD tech training program at Northside Hospital in Atlanta requires new CS/SPD technicians to attend several weeks of classes along with hands-on training. Hendee notes how this model of class time blended with hands-on experience is creating techs with a greater depth of knowledge and a high rate of passing the certification exam.

“For decades SPD staff have been seeking recognition for how technically challenging the role is,” Hendee said. “Unfortunately, with so many onboarding programs solely based in on-the-job training, the profession is often equated to a factory production line. If classes teaching the basics of asepsis, microbiology and other clinically relevant topics were part of every technician’s training, the tech would not only possess a greater understanding of their job, but others within the facility would see the true depth of skill needed to do the job well.

Kronstedt foresees a future where there is greater continuity in how CS/SPD quality/sterility assurance is documented, recorded and monitored, stating:

“With the advancements of technology, paper tracking will disappear and be replaced with digital,” she said. I hope technology will be so advanced that the sterilizers will detect wet loads. Our computer software will track room parameters and notify us when sterility has been compromised in sterile storage.”

“What will be the driving force behind all these advancements? Standardization,” Kronstedt added. “Much like the structure and repetition that creates patient safety in the rest of the healthcare setting, quality/sterility assurance will also receive its own overhaul of structure that will be the same no matter what facility you walk into, continuing the continuity of care that we have all come to depend.” 

1. IAHCSMM Hires Federal Lobbyist to Secure Hazard Pay for Sterile Processors, October 13, 2021, https://www.iahcsmm.org/iahcsmm-news/insights-iahcsmm-hires-federal-lobbyist-oct-2021.html

Original photo courtesy Bayhealth SPD, HPN's 2021 SPD of the Year, with affects added by generative AI.
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