Most reprocessing audit gaps trace back to training, turnover and leadership

The Joint Commission's Office of Quality Monitoring compiled a list of findings from organizations that missed standard IC.02.02.01, the requirement to reduce infection risk from medical equipment, devices and supplies, according to a 2017 Infection Control Today article by infection prevention consultant Chuck Hughes. Most of the items on that list are about people and management rather than machines.

Hughes drew on more than 25 years of auditing surgical, dental and endoscopic reprocessing. The findings he relayed from the accreditor: staff believing the risk of passing pathogens to patients is low, staff lacking training, no access to evidence-based guidelines, no leadership support, turnover that pushes sterilization down the priority list, no safety culture that encourages reporting, shortcuts, timeframes not followed, nobody assigned to own the process, and facility design or space that gets in the way.

Count them. At least eight of the ten are about people, priorities and management. Only the last one is a building problem, and even that is a capital planning decision someone made. For the sterile processing manager building next quarter's internal audit, that is a strong argument for weighting competency files and a named process owner as heavily as biological indicator logs.

The 72-hour clock that follows a survey finding

Hughes wrote that Joint Commission surveyors were increasingly citing non-compliance with IC.02.02.01, and that many immediate threat to life findings in 2013 traced directly to improperly sterilized or high-level disinfected equipment. When a surveyor makes such a finding, Infection Control Today reported, the organization receives a preliminary denial of accreditation and has 72 hours to either eliminate the threat or implement emergency interventions, with 23 days as the outer limit to eliminate it entirely.

The corrective actions Hughes listed are the useful part for planning. Reprocessing every instrument involved in the breach. Evaluating staff competency and retraining. And implementing an equipment tracking process that traces items used back to the patient.

Cleaning is the step most worth checking, and scopes are a different problem

Michelle Alfa's 2019 State of the Science review in the American Journal of Infection Control described a shift over the preceding decade toward a quality management systems approach to reprocessing. Under that model, device manufacturers must supply validated cleaning instructions that are feasible in a real hospital, and reprocessing staff must monitor cleaning on an ongoing basis. The review's central warning is blunt: inadequate cleaning can cause sterilization or high-level disinfection to fail.

The evidence Alfa compiled explains why gastrointestinal flexible endoscopes get their own attention in the review, set apart from other used surgical instruments.

The AJIC review reported that endoscopes may carry up to 10^7 CFU/cm2 of bacteria after patient use, while patient-used surgical instruments were reported at 10^2 CFU/cm2 or less.

CDC epidemiologists Matthew Stuckey and Isaac Benowitz, writing in Prevention Strategist in 2019, listed the problems they see most often: failure to follow standards, guidelines and manufacturer instructions for use; not understanding how to monitor and interpret quality indicators such as sterilization parameters and controls; and device designs, some duodenoscopes among them, that are simply hard to reprocess. The second item is worth a pause. A department can run every indicator correctly and still fail an audit if nobody can explain what a result means.

What a step-by-step audit tool actually surfaces

A 2020 study in BMC Health Services Research shows what a structured tool produces at scale. Researchers built an audit instrument for medical device reprocessing and steam sterilization and applied it to 189 reprocessing cycles across 13 primary and secondary care public hospitals in Nepal, scoring percentage compliance for each standard practice.

Mean compliance came to 25.9%, with a 95% confidence interval of 21.0% to 30.8%. Individual hospitals ranged from 14.7% to 46.0%, and lower levels of care scored significantly lower (p < 0.01). The hospitals did better on cleaning used devices and on transporting and storing sterilized ones than on the steps in between.

The setting is a long way from a US academic medical center, and the absolute figures should not be read across. The method should. Scoring each step separately is what told the researchers where the gaps clustered, and it is the same logic a sterile processing director can apply to a department that already 'passes' on the whole: the per-step number is where the training hours go.

Infection prevention and sterile processing auditing each other

Hughes credited the Joint Commission and the CDC with reinforcing his efforts to get facilities aligned with AAMI, AORN and SGNA guidance. Healthcare Purchasing News took up the internal version of that alignment in a 2021 feature on how infection prevention and sterile processing can support one another.

Linda Homan of Ecolab Healthcare told the publication that infection preventionists bring deep knowledge of how infections spread and are prevented, while sterile processing staff bring deep knowledge of the specific steps that make instruments sterile, and that each needs the other's expertise. Janet Pate of The Ruhof Corporation described the practical obstacle: infection prevention teams are consumed by surgical site infection, catheter-associated urinary tract infection, central line infection and antibiotic stewardship work, and sterile processing teams are consumed by guideline compliance and precleaning, so neither has slack to observe the other.

Marc-Oliver Wright of PDI pointed HPN to the specific skill worth transferring. Quality review, data collection, trending and tracking of process and outcome measures are core infection prevention skills that map directly onto sterile processing, while SPD brings fluency in high-volume precision work and IP brings an appreciation of human factors engineering. In Wright's words, SPD and IP share a lot of common fundamentals, and a mentoring relationship can be supported throughout the partnership.

Credentialing is the other lever HPN flagged. Sterile processing certification is available through the International Association of Healthcare Central Service Materiel Management (IAHCSMM) and through the Certification Board for Sterile Processing and Distribution, and the publication reported that five states required SPD staff to be certified at the time. Infection preventionists certify through APIC. HPN noted that advocacy for certification rests on the understanding that credentialing leads to improved patient outcomes.

Three rows to add to the next internal reprocessing audit

• A dedicated staff person to oversee sterilization and high-level disinfection; according to Infection Control Today, the Joint Commission's findings include having no dedicated staff person to oversee that work.
• Separate cleaning verification metrics for flexible endoscopes and for surgical instrument sets, reflecting the 10^7 versus 10^2 CFU/cm2 starting loads in the AJIC review.
• Per-step compliance scores rather than a single pass/fail, following the BMC Health Services Research method, with infection prevention running the trending as Wright suggested to HPN.

Mean compliance for individual hospitals in the Nepal audit ranged from 14.7% to 46.0%, according to BMC Health Services Research. The open question for any sterile processing department that has never scored itself step by step is simply what its own number would be.