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Based on the Life Safety Code (LSC) survey. A Medicare-participating Critical Access Hospital (CAH), including all component parts or facilities of the CAH, must comply with the applicable LSC requirements.

Please refer to the life safety code deficiencies cited at: K0131, K0341, K0353, K0355, K0372, K0754, KO907, for additional information.

Based on observation, interview and document review, the Critical Access Hospital (CAH) was found to be out of compliance with the Condition of Surgical Services at 485.639. The CAH failed to ensure proper sanitation of surgical instruments for patients when they implemented use of flash sterilization on a routine basis rather than reserving flash sterilization for emergency use. The cumulative effect of this systemic problem resulted in the CAH's inability to ensure the provision of quality health care in a safe environment. Further, the facility failed to ensure appropriate staff competencies were completed for use of flash sterilization and the cleaning of endoscopes.

Findings include:

During initial tour on 8/14/18 at 9:30 a.m., in the surgical suite with registered nurse (RN)-A, a log book of flash sterilization procedures was observed. RN-A was unaware why some surgical instruments, used in routine operations and procedures had been flashed. The surgical technician role was assigned to licensed practical nurses (LPN). There were 3 LPNs who performed sterilization and cleaning of endoscopes, colonoscopes and the sterilization of all hospital surgical and medical equipment. None of the LPN's had been at work that day. All of the surgical LPN staff had been with the facility for at least 2 yrs. The surgical services director (SSD) was not onsite or available to be interviewed during the tour.

On 8/14/18, at 10:18 a.m. with LPN-B performing colonoscope cleaning and disinfection indicated she had been trained on the cleaning and disinfection process of the endoscopes, and did assist in sterilization of medical and surgical instruments. She indicated she had been in this role for approximately 8 years. LPN-B indicated competencies in flash sterilization, after staff had been initially trained, were performed by fellow LPNs. Those competencies had not been administered by the SSD or an RN staff member with direct authority.

Review of the flash sterilization log revealed the following:
(1) On 3/7/18, the rigid cytoscope was flashed 3 times, back to back, as staff had one rigid cytoscope and the obstetrics and gynecologist (OB/GYN) only liked to use that piece of equipment.
(2) On 3/22/18, podiatry instruments (skin hooks, a weitlander, and ragnells) were flashed for convenience and speedy turn-around.
(3) On 4/5/18, bone instruments were flashed that had been used in an orthopedic procedure. There was no mention what the bone instruments were.
(4) On 4/12/18, femoral pavels, orthopedic instruments used in total joint surgeries, had been flashed for convenience.
(5) On 4/18/18, an orthopedic screwdriver and handle was flashed as the pack was determined contaminated. There was no indication why the instruments were not processed through full sterilization.
(6) On 5/2/18, the rigid cytoscope was flashed 3 times, for back to back procedures.
(7) On 5/10/18, skin hooks, a weitlander, and ragnells had been flashed for a podiatry procedure. The facility had only 1 bone tray for minor procedures, and had to utilize flash sterilization for speedy turn-around.
(8) On 8/8/18, two tonsil and adenoidectomy (T&A) trays were flashed as the facility had 1 pack, and 2 patients scheduled for back to back surgeries.

On 8/14/18 at 10:35 a.m., LPN-A indicated flash sterilization was routinely used for orthopedic instruments, podiatry instruments, and cytoscopes (scope used in diagnostic bladder procedures) because the facility had not had enough equipment. LPN-A stated the lack of necessary equipment and/or speedy turn-around time led to surgical instruments being flashed for convenience. LPN-A indicated she was unsure if the appropriate use of flash sterilization was included in policies and procedures. She had been trained initially upon hire on flash sterilization, but was unaware of the last time she had any competencies performed by her supervisor or an RN. LPN-A stated the other LPNs performed competencies on each other, but could not remember when this last occurred.

Review of the training records for LPN-A, LPN-B, and LPN-C revealed LPN-A and LPN-C had competencies related to sterilization of surgical instruments performed last on 5/8/17. There was no documentation provided to show LPN-B had competencies performed on sterilization at that same time. Competencies for LPN-A and LPN-C for sterilization at that time were signed off by the SSD.

On 8/14/18, at 3:45 p.m. the infection control preventionist (ICP) indicated staff were reviewing surgical site infections (SSI)s related to podiatric surgeries. ICP indicated staff were monitoring the podiatrist for infections postoperatively since the beginning of the year 2018. ICP indicated she was not able to correlate those infections with a root cause, and had not reviewed the appropriate sterilization of the instruments used in the procedure as a possible root cause. ICP was unaware of the use of flash sterilization for the above-mentioned instruments had been performed, related to not enough instruments being available to physicians to perform multiple surgeries. ICP indicated instruments that were not cleaned and disinfected appropriately would put patients at risk for potential infections. She indicated she had no oversight or input of competencies by staff to ensure tasks were being performed appropriately. The ICP stated she would inform the safety committee on SSIs, but had not submitted the information to quality assurance performance improvement (QAPI). The ICP stated she was not a member of the QAPI committee and did not attend meetings.

On 8/15/18, at 2:00 p.m. surgical services director (SSD) indicated she had signed off on LPN-A and LPN-C competencies. SSD indicated she had no training in the appropriate sterilization process for use in medical/surgical instruments and was unaware of appropriate cleaning and disinfection technique used by staff during sterilization and scope cleaning. SSD stated she had not been trained on sterilization techniques. She agreed not knowing appropriate technique herself regarding sterilization or scope cleaning would not be an effective way of deeming her staff competent to complete tasks according to the task policy and procedure. The SSD stated she had no involvement with SSI's, as that role fell to the ICP, nor was she part of the QAPI meetings.

Review of the Safety Committee Meeting minutes, dated 1/2/18 and 3/6/18 revealed the following:

-infection control information brought to the committee was regarding appropriate handwashing in the facility. A risk assessment was discussed and areas for improvement were noted of:
(1) Hand hygiene.
(2) Improving personal protective equipment.
(3) Improving [environmental] cleaning in the hospital.
(4) Construction.
(5) Water management.
(6) Environmental rounding for medication.

The minutes did not address the facility's SSI's the ICP was monitoring, surveillance of infections, known podiatry infections, or audits of competencies or practices performed in the facility.

Review of the undated SSI graph revealed, "From January, 2017 to March, 2018, [the podiatrist] had performed 15 surgical procedures. Of those 15 procedures, 4 resulted in SSI, resulting in a 26% infection rate."

Review of the OAHS [Ortonville Area Health Systems] Quality Committee meeting (QAPI) minutes, dated 7/26/18, revealed the SSD and ICP were not part of the QAPI team. The minutes did not address any current infection control concerns related to the known podiatry surgical site infections reports, or any surgical department issues or concerns. It was noted the QAPI intended to add infection control as part of the agenda moving forward, beginning in October 2018.

Review of the Immediate Sterilization policy, 5/10/18, indicated immediate use sterilization was to be used in emergent situations and according to manufacturer's instructions. The SSD must verify all staff understand the proper method of immediate sterilization.

Review of the current Centers for Disease Control Flash Sterilization Guidelines, https://www.cdc.gov/hicpac/Disinfection_Sterilization/dS_includes/13_02ds_FlashSterilization.html, indicated "Flash sterilization is a modification of conventional steam sterilization in which the flashed item is placed in an open tray or is placed in a specially designed, covered, rigid container to allow for rapid penetration of steam. Historically, it is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal. Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time817. Because of the potential for serious infections, flash sterilization is not recommended for implantable devices (i.e., devices placed into a surgically or naturally formed cavity of the human body)."

34088

Based on interview and document review, the critical access hospital (CAH) failed to ensure quality assurance/performance improvement (QAPI) projects were current, comprehensive and incorporated into the CAH's QAPI program for the following departments; central sterile reprocessing (CSR,) and services provided through agreement/arrangement or contracted services which included organ procurement organization (OPO). This had the potential to affect all patients receiving services from the CAH.


Findings include:

CSR:

Review of the OAHS [Ortonville Area Health Systems] Quality Committee meeting (QAPI) minutes, dated 7/26/18, revealed the SSD and ICP were not part of the QAPI team. The minutes did not address any current infection control concerns related to the known podiatry surgical site infections reports, or any surgical department issues or concerns. It was noted the QAPI intended to add infection control as part of the agenda moving forward, beginning in October 2018.

Review of the undated SSI graph revealed, "From January, 2017 to March, 2018, [the podiatrist] had performed 15 surgical procedures. Of those 15 procedures, 4 resulted in SSI, resulting in a 26% infection rate."

During an interview on 8/16/18, at 8:35 a.m. the director of quality (QA)-A stated she was unaware of any QAPI projects from the CSR department. She confirmed the hospital wide QAPI program did not include any current QAPI projects for CSR.

Contracted Services:

During an interview on 8/16/18, at 8:45 a.m. the QA-A confirmed the hospital wide QAPI program did not include any current QAPI projects for OPO.

The CAH QAPI plan approved 1/17/18, revealed the purpose of the QAPI plan was to be an ongoing facility-wide program to ensure provision of outstanding patient centered care and services, continuously improve care an services through improvement of processes, procedures, methods and systems. The plan identified it was the CAH's goal to evaluate all services, including contracted services, involved in the deliver of care through an annual evaluation of the QAPI plan.