By Kim Smiley

In late 2004, a healthcare system in North Carolina realized that it had been using elevator hydraulic fluid instead of cleaning detergent when cleaning its surgical tools.  Before the problem was realized, the improperly cleaned tools were used on 3,650 patients.  An analysis by infection control, material and toxicology experts determined that the sterilization process of the tools was not affected and that trace metals left on the tools from the hydraulic fluid were in too small of amounts to cause risk to patients.  Nonetheless, the potential for these safety risks is an impact to the patient safety goal.  Additionally, the fact that improperly cleaned tools were used on patients is an impact to the patient services goal.  Lastly, the re-cleaning and sterilization required for the tools is an impact to the labor goal.

This incident can be examined in a Cause Map or visual root cause analysis. The first step is to define the problem with respect to the impacts to the organization’s goals, as described above.  The second step is to begin with the impacted goals and ask “why” questions to diagram the cause-and-effect relationships that led to the incident.  In this case, improperly cleaned tools were used on patients because the tools were cleaned with hydraulic fluid and the tools were used on patients.  The tools were used on patients because it was not immediately obvious that they had been improperly cleaned.  The tools did retain an oily feel; however, the tools are lubricated as part of the cleaning and sterilization process to avoid rust and ensure proper operation and so may retain an oily feel.

The tools were cleaned with hydraulic cleaning fluid because the hydraulic fluid was stored in the cleaning detergent containers and delivered to system hospitals.  The containers were filled with elevator hydraulic fluid by an elevator maintenance company and left where they were picked up by the cleaning detergent provider.  The provider did not realize that the containers had been tampered with (as they were not relabeled and either had no indication of tampering or were not inspected for tampering) and so delivered them to the hospitals for use.

Once the problem was realized, the affected tools were re-cleaned and sterilized and the detergent replaced.  Follow-up monitoring was performed and appointments offered to the affected patients, despite determination that the sterilization process was not affected and that the trace metals were not in sufficient amounts to affect patient safety.  Employees were trained in container management and a process was added to verify the status of containers delivered to and used in the hospital.  Additionally, a process to determine when product integrity has been compromised.  An external review by the Centers for Medicaid and Medicare Services has certified that the impacted hospitals are in compliance with standards based on these implemented corrective actions.

To view the Outline, Cause Map and implemented solutions, please click “Download PDF” above.  Or click here to read information provided by the affected healthcare system.