HospitalInspections.org

Based on observation, interview and document review, the facility failed to ensure all scheduled medications stored in the Critical Access Hospital (CAH) were routinely reconciled to prevent potential diversion.

Findings include:

During observation of the CAH's pharmacy with the pharmacist (RPh)-A, on 8/21/19 at 3:07 p.m., RPh-A stated he was onsite at the CAH three partial days per week: Mondays, Wednesdays, and Fridays. RPh-A stated any pharmacy needs before or after he was onsite, would be filled by use of ePharmacy. RPh-A stated the charge nurse on duty had access to the pharmacy when he was unavailable and the charge nurse would hand off the key to the oncoming shift. During observation, the scheduled medications were co-mingled with other medication on the shelves. RPh-A stated nursing staff would frequently need access to the pharmacy after hours, would take needed medications, and would write down the name and amounts they had taken and identify the resident, then would exit the pharmacy. The RPh stated he would routinely review medications for reconciliation, but only reconciled those the nurses had signed out by ePharmacy. RPh-A confirmed he didn't have a system for reconciling the other scheduled medications until they were used which left the other accessible scheduled medications at risk for diversion. He stated while he reconciled the medications signed out, he only conducted a full reconciliation of all medications once per year, and conducted no spot checks to minimize the risks for diversion. RPh-A also stated he had recently switched to a new automated system for medications accessible on the nursing units, to ensure diversion would not occur, but had not yet implemented any such system for the pharmacy stock. RPh-A verified he made reports of any adverse events at the CAH's quarterly pharmacy committee meeting, and stated the potential for diversion of medications from the pharmacy had not been discussed as a concern.

Review of the 3/27/17, Minnesota Board of Pharmacy inspection report identified RPH-A was to keep a perpetual inventory and reconciliation of all controlled medications.

During interview with the administrator on 8/22/19, the administrator stated he was unaware of any current or potential diversion occurring, but agreed without an accurate/current reconciliation of all scheduled medications, there would be no way to easily identify potential diversion.

Although requested, no policy related to reconciliation of scheduled medications was provided at the time of survey.

Based on observation, interview and document review, Critical Assess Hospital (CAH) failed to appropriately reprocess/disinfect 1 of 1 cystoscope, 2 of 2 endoscopes and 2 of 2 colonoscopes, failed to monitor for potential infections, and failed to ensure staff disinfected water lines in accordance with manufacturer recommendations. The cumulative effect of these systemic problems resulted in the CAH's inability to ensure patient safety during scope procedures therefore, the CAH was unable to meet the Condition of Participation for Surgical Services at 42 CFR 485.639. In addition, the deficient practices resulted in an immediate jeopardy to patient safety for any patients who presented to the CAH for procedures using the scopes. .

The IJ began on 8/21/19 when it was determined the facility failed to ensure appropriate reprocessing/disinfection of scopes in accordance with manufacturers' storage and disinfection guidelines, and failed to identify lack of staff competency related to the reprocessing of the scopes. The IJ was identified on 8/21/19 and hospital administrative staff including the administrator and director of nursing (DON) were informed of the IJ at 3:20 p.m. on 8/21/19. The immediate jeopardy was removed on 8/22/19 at 1:00 p.m..

Findings include:

During interview and observation on 8/20/19 at 1:20 p.m., registered nurse (RN)-A stated she was one of two RNs who worked in the surgical suite. Further, RN-A stated the only surgical procedures the facility conducted were scope procedures which were performed three days per month with medical doctor (MD)-A and MD-B. RN-A stated her OR experience was from having assisted in the OR at a previous hospital prior to employment at this CAH. RN-A was unaware of training/experience RN-B had. RN-A stated neither she or RN-B were responsible to reprocess any of the 5 scopes they used during procedures. RN-A stated they had two nursing assistants (NA) who were taught how to disinfect the scopes by the previously employed surgical technician who had left employment from the CAH about 1 year ago. RN-A verified the manufacturer had not been contacted to educate staff how to disinfect and run the machines and scopes. RN-A verified 4 scopes (2 endoscopes and 2 colonoscopes) were hanging in a cabinet in the procedure room. However, the cystoscope was observed to be stored in the manufacturer's carrying case. RN-A stated she was unaware of any part of the disinfection system for the endoscopes, had never herself been trained to do the disinfection, nor was she aware of anyone having performed competency evaluations on the nursing assistant staff who were responsible for the scope disinfection.

During interview on 8/21/19 at 9:00 a.m. with NA-A identified she and NA-B were responsible for all scope cleaning and machine disinfection. NA-A confirmed she was trained by the surgical technician who left employment with the facility approximately 1 year ago. NA-A stated she had watched approximately three procedures and reprocessing, and had completed three with the surgical technician before doing them independently. NA-A said the surgical technician had deemed her to be competent with the scope disinfection process. She verified the manufacturer had never come to the facility to provide education, or to conduct any competency assessment. NA-A verbally walked through the process of scope disinfection and described the procedure for reprocessing the cystoscope to include:
1. It was removed from its original container prior to a procedure and reprocessed.
2. After use by the surgeon, the scope was reprocessed once more.
3. After disinfection in the Olympus machine, NA-A stated she was to remove the scope, pat dry and immediately place it back into the carrying case. NA-A stated there was no cabinet to hang the scope to allow it to appropriately dry because there was no room in the cupboard containing the other 4 scopes. NA-A also stated although she was responsible to reprocess the scopes, maintenance replaced all filters.

During interview on 8/21/19 at 12:24 p.m., the Olympus manufacturer representative (O)-A was informed of the process NA-A had described for reprocessing the cystoscope. O-A stated the facility was not reprocessing the cystoscope correctly, because it should not be placed in the carrying case after each procedure. O-A also stated the water supply system was suppose to be disinfected after each filter change monthly. The O-A stated, "If at any time the water supply is not disinfected, reprocessing of any scope would not be correct because the risk of microorganisms overgrowth was high without appropriate disinfection." O-A stated the company had their own complaint process and recognized the issues with the CAH's processes as a significant breech of infection control, so Olympus would be sending representatives to inspect the reprocessing system, perform competencies on staff, and ensure scopes are hung appropriately.

Review of the current manufacturer's instruction manual for the Olympus Cysto Nephro Videoscope manual page 115, included: immediately after reprocessing, staff should hang the scope in the storage cabinet for drying. The directions indicated staff were to ensure scopes were in the cabinet to dry because the carrying case could not be cleaned, disinfected or sterilized. If a scope was not cleaned, disinfected or sterilized, it could pose an infection control risk.

Review of the current Olympus Reprocessor OER-Pro Operation manual identified disinfection of the water supply piping was to occur at least monthly, and or after each filter change. The manual indicated disinfection of the water supply piping after replacing the water filter was important to prevent the growth of water-borne microorganisms. The manual indicated failure to perform this operation could result in contamination of the device's piping and prevent effective reprocessing of the scope.

During further interview on 8/21/19 at 10:00 a.m., NA-A stated she had never accessed the manufacturer manuals before and had never performed any disinfection of the water supply system. NA-A stated it was her understanding maintenance would handle that when replacing the filter. NA-A also verified she was unaware the cystoscope was not to be stored in its carrying case.

Review of the surgery schedule book from 8/28/18 through 8/14/19, identified 92 scope procedures had been performed at the facility.

During interview on 8/21/19 at 10:15 a.m., the infection control coordinator (ICC) stated she was unaware of the process for appropriate use of the Olympus reprocessor or appropriate cleaning and disinfecting of the scopes. The ICC stated she had not performed any oversight of surgical processes since the facility had discontinued doing major surgeries about 1 year ago. The ICC verified the facility had lost their former surgical technician due to low OR case numbers. Further the ICC stated she had not performed any IC audits, tracked no patients for identification of potential procedure related infections, and had not conducted any audits of scope reprocessing. The ICC agreed she should increase oversight of the surgical department to verify appropriate techniques and competency of staff. She also stated MD-A and MD-B saw patients in their clinic offices across the state line, so she was not always aware of the patients' statuses post procedure, so she would be unaware if any complications arose from procedures performed at the facility.

During interview on 8/21/19 at 10:35 a.m., the maintenance supervisor stated neither he or his department staff were aware they should have disinfected the water supply system. The maintenance supervisor stated he thought that was the responsibility of the NAs who disinfected the scopes.

During interview on 8/21/19 at 10:55 a.m., MD-B stated he was unaware the facilty was not disinfecting or storing the scopes appropriately in accordance with manufacturer guidelines. MD-B also stated he was unaware if any of his patients had developed infections following their scope procedures. MD-B stated, "This is really concerning," and stated effective immediately, he would be suspending all scope procedures at the facility pending an investigation.

During interview on 8/21/19 at 2:50 p.m. the director of nursing (DON) stated he was unaware how scopes were to be reprocessed or stored, or what maintenance was to be performed on the machine and water supply. The DON verified he had not provided oversight, or monitored competencies of the NAs doing the reprocessing of scopes. He also stated he was unaware of the manufacturer ever having provided oversight with the machine or scopes to educate and ensure staff were deemed competent.

Interview with the interim medical director-C identified he was filling in for the CAH's medical director who was a patient in a hospital at the time of the survey. Medical Director-C was unaware of the lack of IC measures and monitoring of procedures performed in the OR. He agreed staff needed education on IC to ensure there was no potential for infection to patients. Medical Director-C verified surgical infections were not discussed in Quality Assurance Performance Improvement (QAPI). He agreed all staff who worked or oversaw the OR needed to be appropriately trained and competencies performed routinely to ensure appropriate disinfection and auditing occurred stating, "We will fix it."

During interview with MD-A on 8/21/19 at 3:48 p.m., MD-A stated he was unaware the facilty had not been storing, or disinfecting the scopes appropriately according to manufacturer guidelines. MD-A also stated he was unaware if any of his patients had contracted an infection after the procedures. MD-A stated he would contact the facility and advise them he would be immediately suspending all scope procedures until an investigation and correction of the above concerns could be completed. MD-A was concerned with high potential for infections related to inappropriate reprocessing.

Review of the revised January 2014 Infection Prevention and Control Program policy, indicated it was the clinical manager's responsibility to enforce IC practices were implemented and appropriately overseen. The policy also indicated staff physicians were responsible to perform surveillance on the patients who develop symptoms of infection and report to the IC committee. There was no mention how outreach provider physicians or surgeons were to implement IC surveillance related to scope procedures or how surveillance would be included in the IC program.

Review of the current Medical Bylaws made no mention of staff competency or how outreach providers were to assist in surveillance of infection for procedures performed in the OR suite.

The facility had no policy regarding the reprocessing of endoscopes or maintenance of the scope system.

RN-B was on medical leave at the present time and would be unavailable for interview.

The IJ began on 8/21/19, was removed on 8/22/19 at 1:00 p.m., when it could be verified through interview and document review, the facility had taken steps to remove the immediate situation by discontinuing all scope procedures until staff competency could be verified, and infection control monitoring processes could be implemented related to scope storage and machine disinfection in accordance with manufacturer guidelines.