The Pursuit of Excellence: A Fusion of Quality and Process in Endoscope Reprocessing
No one likes to be caught off guard by a last-minute accreditation audit or survey, especially when tensions are high, resources and staff are stretched thin, and potential contaminants are myriad. But facilities can get out ahead of surveys and reviews with a commitment to regular, practical steps and established protocols and routines that can make readiness and quality second nature. This readiness has never been more important to a facility’s reputation and accreditation, and to patient safety and care.
In 2017, The Joint Commission published an article stating that “from 2013–2016, immediate threat to life (ITL) declarations directly related to improperly sterilized or HLD equipment increased significantly. In 2016, 74% of all ITLs were related to improperly sterilized or HLD equipment.”1 More recently, in 2019, several patients filed a lawsuit against a hospital in Colorado, United States, when they allegedly developed surgical site infections after surgery. An investigation found that improperly cleaned and sterilized instruments had been sent to the operating room with debris and bioburden. According to the Centers for Disease Control and Prevention, the estimated cost for surgical site infections is estimated to be $1–10 billion per year, but the consequences are not just financial. In a tragic instance, patients were put at risk and some even died when they were exposed to lethal microorganisms from endoscopes that were not cleaned properly nor high-level disinfected (HLD) after colonoscopy procedures.2
The shame of it is, of course, that these complications and deaths are highly preventable, and with the right steps, collaboration, and cooperation, hospitals and facilities can ensure patient and physician safety and a smooth accreditation process.
The OSPECS Four “C” Model—Condition, Centralization, Competency, and Collaboration—is a blueprint for a successful and safe endoscope reprocessing area and can help a department leader break down the readiness and preparedness into smaller, more manageable steps that, when implemented correctly, become routine to the teams involved.
The Four “C” Model
- Condition: The design, or condition, of your endoscopy reprocessing area can streamline processes that enable throughput, prevent infection, and promote patient and employee safety. Not sure where to start? AAMI ST91 lays out specific guidelines to consider when designing the endoscopy reprocessing area, and federal and state guidelines lend guidance as well. Ventilation, HVAC systems, and the flow of instrumentation are of particular importance when designing any reprocessing area.
- Flow: An endoscopy cleaning room may house all of the steps in the decontamination process but the flow of contaminated instruments must be unidirectional—from decontamination to the clean area to the storage area — to prevent recontamination along the way. Ensure proper flow with an ordered process and clearly marked areas for manual cleaning, inspection, high-level disinfection, dispensing, and the like.
- Traffic control: Only authorized personnel should be allowed in the endoscope cleaning area and strict measures on attire and personal protective equipment (PPE) must be enforced to prevent the transfer of microorganisms from other areas of the facility into the processing area.
- Equipment: You’ve got your flow and traffic control down, but cleaning and high-level disinfection is nearly impossible without the right equipment. Crucial to endoscope reprocessing is a large sink that’s deep enough for complete immersion of the endoscope (this minimizes the risk of aerosolization) and wide enough for cleaning without coiling the scope too tightly. Also vital to the endoscopy area is the automated endoscope reprocessor, which must be set up, routinely cleaned, and run in accordance with the manufacturer’s instructions for use (IFU).
- Tools for cleaning and inspection: Facilities must fill their technician’s toolbox with the right cleaning brushes, air leak testers, magnifying glasses, residue detection systems, and more to ensure thorough and sterile instrument cleaning. Facilities must also train techs on the correct and best techniques to scour and decontaminate an endoscope’s many channels, long lumen, and, in some cases, complex elevator channels. As always, use the right size cleaning brushes for lumens and chemistries based on the endoscope’s IFU.
- Quality management: Set process improvement goals, establish benchmarks for outcomes, and implement an audit process to determine if benchmarks are being met. Collaborate with your team to develop the criteria for audit; a few good places to start are the accuracy of decontamination, compliance with established standards, and physician and patient satisfaction scores. Work with team members to design and post the most effective colorful charts and graphics that convey processes and procedures. These displays demonstrate to surveyors that a facility is committed to quality and always striving for improvement.
- Policies and procedures, protocols, and work instructions: Lay the groundwork for smooth processing and decontamination with well-outlined and up-to-date policies, procedures, protocols, and work instructions. Be sure to regularly review protocol with staff.
- Centralization: As the saying goes, if it’s everyone’s responsibility, it’s no one’s responsibility, and splitting endoscope reprocessing over multiple people or departments inhibits oversight and wastes resources. Appoint a specific person as the authority on endoscope reprocessing so that he or she may standardize processes and data capture, manage available equipment, keep staff up to date on new regulations, monitor quality, document information, and be the final word on the facility’s reprocessing area. This centralization is also a boon come audit time when surveyors look for consistency and standardization of processes.
- Competency: All staff education must be up to date. Validate and document all competencies for every critical task. Prepare a training agenda for the year to keep skills current and provide training when introducing new processes or equipment. If team members are certified, keep a copy of their active certification card and their continuing education progress on file. If someone is on a performance improvement plan, provide regular feedback and document progress.
- Collaboration: Partner with physicians, nurses, and reprocessing technicians to discuss quality issues and to establish plans for improvement. Cross-functional working groups can analyze existing processes, determine the root cause of the problem, and brainstorm solutions. Look for contributions from members of the OR, endo, SPD, infection control, physicians, technicians, and administrative leaders.
The OSPECS Four “C” Program is a blueprint for a successful endoscope reprocessing department and can minimize the time spent preparing for an accreditation survey. By reviewing the condition of the department, striving to centralize services, ensuring staff competencies are current, and collaborating with teams within the hospital, you’ll soon find yourself in a state of perpetual readiness.
- The Joint Commission, “Quick Safety 33: Improperly Sterilized or HLD Equipment—A Growing Problem,” Oakbrook Terrace, IL. Accessed September 25, 2020. https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/quick-safety/quick-safety-issue-33-improperly-sterilized-or-hld-equipment–a-growing-problem/improperly-sterilized-or-hld-equipment–a-growing-problem
- Centers for Disease Control and Prevention, “Health and Economic Impact of Surgical Site Infections Diagnosed after Hospital Discharge,” Atlanta, GA. Accessed September 29, 2020. https://wwwnc.cdc.gov/eid/article/9/2/02-0232_article
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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