This article is Part 2 of a two-part series.
In Part 1, we looked at why ultrasound probe reprocessing often falls outside the surveillance systems hospitals have built around reportable healthcare-associated infections, and how an outbreak associated with contaminated ultrasound gel was recognized only after an unusual cluster of infections prompted an investigation. Without that kind of surveillance in place, the absence of identified infections tells us little about whether the reprocessing process is functioning reliably. Part 2 looks at practical ways Infection Preventionists can gather that information.
Applying Process Surveillance to Probe Reprocessing
Infection Preventionists already use process surveillance extensively in other areas of practice. We observe hand hygiene because we do not want to wait for transmission to determine whether hand hygiene practices are reliable. We audit central line maintenance and urinary catheter practices because those observations provide information that infection rates alone cannot. Environmental rounds, isolation observations, sterilization and disinfection audits, and other routine activities serve much the same purpose. Ultrasound probe reprocessing can be evaluated in a similar way, although I do not think the answer is to create another large surveillance program for Infection Prevention. Most IP departments do not have the staffing to add a labor-intensive audit requiring dozens of observations or record reviews every month, and the amount of data collected is not necessarily what makes surveillance useful. A smaller amount of information collected intentionally may be enough to identify where a process deserves closer attention.
One of the best places to begin is with the information the organization already has. High-level disinfection processes generally require documentation, and depending on the system in use, those records may include the date and time of reprocessing, the probe or device being processed, the employee performing the process, and information related to the disinfection cycle. Clinical departments may also have procedure logs, competency records, equipment inventories, maintenance records, and other documentation that can help an IP understand the process without creating a separate data collection system. Rather than reviewing every HLD record, an IP department could periodically review a small sample with the department responsible for reprocessing. The purpose would be to determine whether the records are complete and whether there is sufficient traceability to reconstruct the process if an exposure investigation were ever necessary. If the sample demonstrates consistent performance, there may be little value in continuing to review records frequently. If gaps are identified, the organization has a reason to look more closely and determine whether the issue is isolated or reflects a larger process problem.
The same approach can be incorporated into rounding that is already occurring. An IP who is already in the emergency department, labor and delivery, ICU, or another procedural area does not necessarily need a separate ultrasound audit. Looking at the ultrasound equipment while in the department and occasionally asking staff to describe how the probes are used and what happens to a probe after use can provide useful information. Observing where clean and contaminated probes are kept, how they are transported, and whether staff understand when high-level disinfection is required can help identify areas that need further evaluation. These observations can be incorporated into existing rounding tools when appropriate rather than establishing an entirely separate surveillance activity.
Using Near Misses and a Risk-Based Approach
When resources are limited, such as staffing and time, the choice of what to measure becomes especially important. The measure should reflect the process the organization is trying to understand rather than becoming another data point collected because it is easy to count. This is also where near misses and process deviations can provide useful information. A torn probe cover, missing HLD record, incomplete cycle, incorrect cleaning process, unidentified probe status, or discovery that staff have been using a probe differently than expected does not mean that a patient acquired an infection. It does provide information about the reliability of the system. When these events are documented and reviewed over time, patterns may become apparent that would otherwise remain anecdotal.
Organizations can also use these events to determine when additional surveillance is warranted. A department that has demonstrated consistent practice may require only periodic review, while repeated documentation gaps or competency concerns may justify more frequent observation for a period of time. Once corrective actions have been implemented and the process has stabilized, the frequency can be reduced again. This type of risk-based approach is generally more manageable than establishing a permanent monthly audit for every location using ultrasound. The information collected through this process can be particularly helpful when Infection Prevention is trying to advocate for a change. IPs are often asked for data when recommending additional equipment, workflow changes, education, staffing, or changes to the physical environment. When ultrasound probe reprocessing is not represented on the organizational scorecard, it can be difficult to demonstrate the scope of a problem using traditional infection data.
Process data can provide that support. If a review identifies repeated gaps in traceability, delays in reprocessing, inconsistent competency, or difficulty maintaining separation between clean and contaminated devices, those findings give the organization something specific to evaluate. They also establish a baseline that can be used after an intervention. If a workflow changes or new technology is introduced, the same measures can be reviewed again to determine whether the change actually addressed the problem.
Why Traceability Matters During an Investigation
The value of having these systems in place becomes particularly apparent when a reprocessing failure or potential exposure is discovered. At that point, Infection Prevention may need to determine which patients were exposed, which probe was involved, how the device was reprocessed, whether the required process was completed, and which patients subsequently underwent procedures using the same device. Depending on the circumstances, the investigation may also include probe covers, ultrasound gel, disinfectants, reprocessing equipment, and staff involved in the process.
An earlier outbreak involving patients undergoing cardiovascular surgery illustrates how broad that investigation may need to be. During December 2011 and January 2012, investigators in Michigan identified 16 cardiovascular surgery patients with Pseudomonas aeruginosa respiratory tract colonization or infection.1 Seven met NHSN criteria for infection, including two patients with pneumonia and five with tracheobronchitis, while another nine were colonized. All of the affected patients had undergone transesophageal echocardiography as part of their surgical care, making the TEE equipment one of the potential sources considered during the investigation.
Investigators evaluated the TEE probes, storage tubes, work surfaces, reprocessing procedures, and other potential exposures. Cultures of the probes and environment were negative, and investigators ultimately identified contaminated ultrasound transmission gel as the source rather than the TEE probes themselves. The investigation is particularly relevant when thinking about traceability because the source was not apparent when the first infections were identified. The fact that patients shared a procedure involving TEE was one piece of information investigators needed in order to evaluate the possible routes of transmission.
When traceability has been incorporated into routine practice, much of the information needed during this type of investigation may already be available. When it has not, the investigation can depend on procedure schedules, equipment records, staff recollection, and documentation that was never designed to be connected. This can significantly affect how confidently an organization can define the potentially exposed population and determine what follow-up is necessary. For this reason, I tend to think of reprocessing documentation as more than proof that a task was completed. It is part of the information an organization may someday need to understand an exposure. Evaluating whether that information is complete and retrievable is therefore a reasonable component of infection prevention oversight even when there is no CMS measure or NHSN definition specifically directing us to do so.
Conclusion
The attention hospitals give to CLABSI, CAUTI, surgical site infections, MRSA bacteremia, C. difficile infection, and other reportable healthcare-associated infections is appropriate. These infections cause significant patient harm, and the surveillance systems surrounding them have provided healthcare organizations with consistent ways to measure performance and evaluate prevention efforts. They have also demonstrated the practical value of having reliable data when trying to understand whether a process is improving. Ultrasound probe reprocessing does not have the same surveillance infrastructure, and for most facilities it would not be practical or necessary to build one that resembles NHSN. What is reasonable is for Infection Prevention to understand where ultrasound probes are being used, how higher-risk probes are reprocessed, what documentation already exists, and whether there is enough information available to recognize a recurring problem or respond effectively if an exposure occurs.
A Low-Burden Approach to Probe Reprocessing Surveillance
For an IP department with limited staffing, that may involve:
- Reviewing a small sample of existing records a few times a year
- Adding several observations to rounds that are already taking place
- Asking the departments performing HLD to monitor their own competency and documentation
- Establishing circumstances that prompt Infection Prevention to take a closer look
None of those activities requires continuous surveillance, and they can be adjusted based on what the organization finds.
We spend a great deal of time in infection prevention working with the measures we are required to report, and those responsibilities will continue to occupy a significant portion of our surveillance programs. At the same time, there are processes occurring throughout healthcare that may never appear on a CMS report or facility scorecard but still warrant our attention. Finding practical ways to gather information about those processes gives us a better opportunity to identify weaknesses while they are still process problems, support improvements with local data, and have the information we need if we are ever asked to investigate what happened.
Have questions about surveillance or reprocessing of your ultrasound or TEE probes? The CS Medical team is here to help you evaluate your high-level disinfection process, strengthen documentation and traceability, and support your staff education. Contact CS Medical's Medical Affairs Manager and Infection Preventionist Jill Holdsworth or explore more articles on IP Insights.
References
- Chittick P, Russo V, Sims M, et al. Pseudomonas aeruginosa respiratory tract infections associated with contaminated ultrasound gel used for transesophageal echocardiography—Michigan, December 2011–January 2012. MMWR Morb Mortal Wkly Rep. 2012;61(15):262-264