Imagine walking through the door of a hospital’s sterile processing department (SPD) to find original AMSCO steam steriliz-ers and ultrasonic machines, 1956 GOMCO suction machines with the reusable bottles, and a “central supply” setup where the operating team washes contaminated instruments in the OR and the central supply staff puts them in the “oven.” The sterile processing department’s library is full of books and manuals from 1956, and its technique manual from the American Sterilizer Company is the 1969 edition.

Now imagine that it’s not 1970, but it is, in fact, the year 2020. And despite the technological leaps the field of sterile processing has made over the past 50 years, this real-life facility has remained stubbornly in the past, manually fashioning items we now view as disposable and sterilizing single-use tools that should be thrown away. Things changed at this facility only recently, and only when an extraordinary chief nursing leader spoke out and made the safety of her patients and her staff a priority.

This story, while shocking, is certainly not the only example of a lack of commitment to sterile processing and high-level disinfection (HLD) procedures at hospitals throughout the country. In 2019, the Joint Commission (TJC) reported that 70.9 percent of the hospitals surveyed were cited for failure to comply with the IC 02.02.01 standard: “The hospital reduces the risk of infections associated with medical equipment, devices, and supplies standard.” The Centers for Disease Control and Prevention (CDC) has reported that although there have been advancements in practices to prevent infection, surgical site infections (SSI) remain the most expensive hospital-acquired infection (HAI) in the U.S., costing the American people over $3 billion dollars per year, according to the CDC.

And patients are paying attention. In the 2020 survey by the ECRI Institute, ranked concerns about improperly cleaned, disinfected, or sterilized instruments as No. 5 on the top 10 list.

It doesn’t have to be this way. Hospital leaders can rest easy if they prioritize the SPD and recommit to the processes and procedures that make sterile processing and high-level disinfecting as quotidian as regular handwashing. They will likely save lives, and face, in doing so.


Hospital leaders must make an honest assessment of their institutions’ sterile processing deficiencies and failings and then decide if the hospital itself has the competency to bring about change. If the hospital cannot improve its sterile processing department and procedures on its own, leaders should seek out the help from an expert or experts who can manage and advise on the process. These experts will also collaborate with physicians, nurses, and reprocessing techs to encourage adoption of new processes and protocol.
At OSPECS Consulting, we use a four-step program to help facilities update and upgrade their SPD processes and protocol. The program, named PEER (Prepare, Examine, Educate, and Reform), helps facilities get to and stay in readiness mode. Remaining in continual readiness mode is not a simple task. It will require a constant assessment of the processes, policies, staff performance and the physical condition of the department. Sterile processing professionals must always be looking for the next improvement opportunity expecting the accreditation surveyor to enter the department in a moments time.

The PEER program steps are detailed below.

PREPARE. Leaders should constantly ask themselves and their teams, “What are the things we need to know and the things we need to do in order to become a place of ex-cellence?” After all, in hospitals, as in life, there is no better prevention than preparation. Sterile Processing Department leaders should be equipped with the most up-to-date manuals, regulatory standards, and manufacturers’ instructions for use (IFUs). Leaders must regularly review them, seek out new information from regulatory literature and peers, and improve hospital processes. Most important, leaders must make this information easily accessible to their teams, develop policies and procedures (P&P) that adhere to regulatory standards and IFUs, and monitor compliance. A Sterile Processing Department’s library should include:
● Regulatory agencies
● State Department of Health (DoH): Their regulations may mirror the Federal laws but may be more stringent. The DoH may conduct an unannounced survey.
● State Department of Transportation (DoT): Regulates the transport of contaminated waste. Healthcare leaders must review these guidelines especially if the facility is transporting contaminated instruments between hospital systems.
● Food and Drug Administration (FDA): Regulates manufacturers of medical devices, sterilants and high-level disinfectants. The FDA has systems to report any device related problems.
● Centers for Disease Control and Prevention (CDC): These guidelines are not regulatory but are relied on as guidance and compliance.
● Centers for Medicare & Medicaid Services Regulations and Guidance (CMS): Operates Medicare, Medicaid and administers the Health Insurance Portability and Account-ability Act (HIPPA) – this agency can perform announced and unannounced surveys. Failure to pass the CMS survey may cause the hospital to lose all federal funding.
● Professional voluntary standards
● ANSI/AAMI Standards: ST79:2017; ST91:2015; ST90:2017; ST58:2013; & ST41:2008 (R2018) – Recommend-ed standards for reprocessing surgical instruments, flexible endoscopes and sterilization in healthcare facilities. Some State DoH regulations include a statement recommending sterile processing to comply with these standards.
● SGNA Guidelines: Voluntary guidelines for processing GI flexible endoscopes.
● Educational resources and sterile processing technician accrediting agencies. Both agencies provide certification preparation materials and testing to credential sterile processing technicians and managers.
● International Association of Healthcare Central Service Materiel Management (IAHCSMM)
● Certification Board for Sterile Processing and Distribution (CBSPD)
● Accreditation Agencies – Hospitals must be accredited in order to receive Medicare and Medicaid payments. The most popular accrediting agencies are:
● The Joint Commission (TJC) – Surveys hospitals every 3 years and their standards revolve around continuously improving the quality of care and safety provided to patients.
● The JC guidance for SPD readiness – High-Level Disinfection (HLD) and Sterilization BoosterPak
● Det Norske Veritas (DNV-GL) – the accreditation survey is based on the integration of the CMS condition of participation standards International Standards Organization (ISO) 9001 Quality Management. DNV-GL also offers a sterile processing certification.
● American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) – accreditation for outpatient facilities.
There many other regulatory and voluntary agencies not discussed in this article that develop standards to help healthcare be a more efficient and safer environment for our patients. The sterile processing professional should be familiar with the guidelines that impact the functions of SPD and should incorporate them into the department’s policies and procedures.

EXAMINE. Honest self-examination can shed light on deficiencies in sterilization and HLD and force a reckoning for an institution. At a loss for where to start? Check out CMS’s sur-veyors’ worksheets for straightforward guidance, or TJC’s HLD BoosterPk, which outlines the areas most likely to be assessed by inspectors and details corresponding regulations. DNV-GL’s Assessment Checklist ISO 9001:2015 makes easy work of following steps on the way to compliance. When in doubt, remember that a comprehensive examination for vulnerabilities should cover process workflow, quality management processes, competencies, recordkeeping, and flexible endoscope repro-cessing. Healthcare organiza-tions can engage a professional reprocessing expert to conduct a comprehensive review of reprocessing procedures.

EDUCATE. Many states now require SPD professionals to achieve certification in their field and submit continuing education credits on a yearly basis. That’s a good thing. Advances in surgical technology have introduced sophisticated and delicate instrumentation that require even more attention during processing and sterilization, so it is vital that SPD professionals stay up to date, understand, and adhere to guidelines and IFUs for processing these ever-advancing tools. It is critical to understand that before a technician is assigned to perform a task, they must be fully trained in all aspects of the process. Leaders must set the example by educating themselves and strictly adhering to protocol. They must also take notice of employees who are doing the right thing and praise accord-ingly, and address issues where they may arise.

REFORM. After care-ful preparation, honest examination, and thorough education, hospital leadership must enact the change they wish to see in their facilities. But they cannot do it alone. It is imperative that leaders propose change in collaboration with administrative leadership, operating room teams, infection control specialists, and sterile processing team members. These team members have a unique vantage point of a facility’s current operations and missteps and can offer on-the-ground insight that upper management cannot. Plus, these teams are the most affected by changes in process and protocol and may have to undo years of ingrained habits. Leaders should make these teams feel heard, incorporate feedback into new processes, and guide resistant team members through the change.

Sometimes, the end result of the PEER process is a complete overhaul of the SPD, and that’s okay. An SPD that provides the proper amount of space, equipment, and resources to deliver quality outcomes reduces the risk of infection in patients, decreases OR case delays due to instruments, and increases physician satisfaction. An improved SPD can also decrease error rates and reduce staffing-related problems. A well-organized SPD is the pinnacle of enhanced productivity.

Remember, the PEER model is more than just preparation for an accreditation survey. It’s the foundation for being a center of excellence and a model of sterile processing and high-level disinfecting compliance.

And for you? Well, knowing that your SPD is a well-oiled machine will help you have restful nights.

Mary Olivera, MHA, CRCST, CHL, FCS, has actively participated in the monitoring, surveying and training interde-partmental staff in the proper cleaning, decontamination and sterilization practices and has been highly committed to the standardization of interdepartmental processes. Currently, she is the president and CEO for OSPECS Consulting, LLC. a company dedicated to facilitating process re-engineering in healthcare organizations.

Original article printed in the Healthcare Hygiene Magazine, August 2020 issue.

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