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Based on the manner and degree of the standard level deficiency, it was determined §482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance.

A-0749- The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observation, interviews, and document review the facility failed to implement a process to sterilize surgical instruments according to manufacturer's instructions and the national guidelines followed by the facility. Specifically, the facility failed to prevent the routine and non-emergent use of Immediate Use Steam Sterilization (IUSS) when sterilizing instruments. The facility also failed to ensure the manufacturer instructions validated the use of IUSS on a device prior to performing that sterilization method.

Based on observation, interviews, and document review the facility failed to implement a process to sterilize surgical instruments according to manufacturer's instructions and the national guidelines followed by the facility. Specifically, the facility failed to prevent the routine use of Immediate Use Steam Sterilization (IUSS) when sterilizing instruments. The facility also failed to ensure the manufacturer instructions validated the use of IUSS on a device prior to performing that sterilization method. The failure was identified in 5 out of 10 month samples of IUSS logs reviewed for 2020 (January, February, May, September, and October).

Findings include:

Facility Policy:

According to the facility's policy, Steam Sterilization in the Operating Room, staff should follow recommendations from the Association of periOperative Registered Nurses (AORN). The policy also read that sterilization will not be performed on instruments in the operating room (OR) on devices that have not been validated for the specific cycle employed.

The facility's 2020 Infection Prevention Risk Assessment and Plan With Evaluation of 2019 Goals read the facility supports clinical practices that are recommended by respected private and public professional organizations such as The Association of Operating Room Nurses (AORN) and the Centers for Disease Control and Prevention (CDC).

References:

The 2016 CDC Guideline for Disinfection and Sterilization in Healthcare Facilities read that flash sterilization, or IUSS, should not be used for reasons of convenience, or as an alternative to purchasing additional instrument sets, or to save time. 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.

The 2019 AORN, IUSS: How To Be Survey Ready, read the use of IUSS in the operating room (OR) should be used for emergent situations and situations where patient care items cannot be packaged, sterilized and stored before use.

According to the Stryker Orthopaedics manufacturer guidelines provided by the facility, the sterilization reference guide read that Stryker Orthopaedics does not recommend the use of 'flash' sterilization, or IUSS, for reusable instruments.

1. The facility failed to prevent the routine use of Immediate Use Steam Sterilization (IUSS) when sterilizing instruments and failed to follow the manufacturer instructions which did not recommend the use of IUSS on the instruments.

Observation

a. On 10/26/20 at approximately 2:30 p.m., observations were conducted in the sterile processing department (SPD) where instruments were reprocessed (the process of cleaning, disinfecting, and sterilizing contaminated surgical instruments). During the observation, the sterile processing department technician (Tech #5) stated the red and green tags observed in the department were used to indicate how soon an instrument had to be reprocessed. Tech #5 stated the green tags in particular were attached to surgical instrument sets to indicate they required an IUSS cycle. At the time of the observation, Tech #5 stated that IUSS was typically performed when the surgeon had more surgery cases scheduled than the available inventory of instrumentation needed for those cases.

Interviews

b. On 10/27/2020 at 1:28 p.m., an interview was conducted with the sterile processing department supervisor (Supervisor #1). Supervisor #1 stated the reason IUSS was done routinely was because there was not enough time available to perform a full sterilization cycle on instruments because too many procedures were scheduled within an inadequate timeframe. Supervisor #1 stated that there were many risks associated with IUSS, e.g., staff being rushed to complete IUSS, missing something during inspection of instruments, and all steps of the manual cleaning may not be done adequately. Supervisor #1 also stated IUSS should only be used for emergencies but the facility had regularly performed IUSS. Consequently, the staff used the shortened IUSS cycle to accommodate the number of surgeries scheduled.

c. On 10/27/2020 at 2:16 p.m. an interview was conducted with a scrub tech (ST #2) who stated IUSS was typically utilized due to a lack of available instrument sets for the amount of scheduled surgical cases for the day. ST #2 stated another factor which contributed to the frequent use of IUSS included a lack of time in between cases and staff needing to have instrumentation and the OR turned over for the next scheduled procedure. ST #2 stated that IUSS should be used as a last resort.

d. On 10/27/2020 at 4:17 p.m. an interview was conducted with the operating room registered nurse (RN #3). RN #3 stated IUSS was frequently performed when surgical cases were scheduled too closely together which did not allow enough time for a full sterilization cycle. According to the interview, the operating room assistant was responsible for performing the IUSS cycle on surgical instrument trays/sets in the OR sterilizers. RN #3 stated the OR Aides routinely performed IUSS on those surgical sets/trays identified as low inventory to meet the scheduled caseload for the day.

e. On 10/28/2020 at 10:55 a.m., an interview was conducted with the OR assistant (assistant #6). Assistant #6 stated he was trained to prioritize instruments for IUSS which were to be used in surgeries later in the shift and would not have time to be sterilized with the regular full cycle. Assistant #6 stated the process was in place due to a limited supply of needed surgical instruments. Assistant #6 also stated surgical instruments were sometimes already tagged for IUSS before entering the OR so the scrub technician would know which instrument should be processed via IUSS after the surgery was completed for the next surgical case.

f. On 10/29/2020 at 10:03 a.m. an interview was conducted with Infection Prevention Manager (Manager #7). Manager #7 stated that the use of IUSS was not the full sterilization process, but a shortened cycle in case of emergency situations. Manager #7 stated that IUSS was a shortened sterilization process and the facility had a goal to use IUSS in fewer than 5% of the total sterilization cycles performed. According to the interview, the facility had not met their goal of 5% and that barriers included a high turnover rate among staff including leadership within the sterile processing department. Manager #7 stated the sterile process department was expected to reprocess instruments according to national guidelines, to include AORN.

g. On 10/29/2020 at 10:54 a.m. an interview was conducted with the sterile processing department manager (Manager #4). Manager #4 stated the OR staff used IUSS frequently and not for emergent reasons. Reasons identified in the interview for the frequent utilization of IUSS included a lack of surgical instrumentation, closely scheduled surgical procedures, and a lack of staff training related to the appropriate and inappropriate uses of IUSS. Manager #4 stated the national guidelines applicable to the SPD department, such as AORN, did not recommend the frequent or non-emergent use of IUSS. Manager #4 stated the routine use of IUSS was a risk for patient safety because steps could be missed during the process, which would increase the risk of bioburden or contaminants left on the instrument after sterilization and could increase the potential for infections.

Document review

h. Review of the documented monthly percentages of IUSS for surgical instrumentation indicated that January 2020 had a rate of 15%, February 2020 had a rate of 20%, May 2020 had a rate of 18%, August 2020 had a rate of 5.7%, and September had a rate of 11%. The monthly values were all identified as above the facility's IUSS percentage goal of 0-5%.

i. Document review was conducted of the Clinical Situations for IUSS, which numbered reasons from #1-#5. A #1 meant an instrument or set underwent IUSS because it was a high demand instrument and needed for multiple procedures. Additionally, according to an interview with RN #3, a #1 documented on the IUSS log meant the facility did not have enough of the instruments to meet the needs of their case schedule.

j. Document review was conducted of the facility's monthly IUSS logs. The logs provided information regarding the IUSS sterilization parameters and the reason IUSS was used for that particular surgical instrument or set.

k. Review of the logs revealed that in a sample of 14 days from October 2020, the IUSS sterilizers located in the OR were used a total of 41 times. Of those 41 times used, 16 uses were documented with the number "1" as the reason for the utilization of IUSS on the instrument or set. On several of the sterilization documents, further detail was handwritten including statements such as, "used in previous case," "Need for next," "tray already used today," "None sterilized," and "not enough trays."

i. A review of the logs revealed similar documentation from other months to include:

- September 2020 IUSS logs indicated from a 14 day sample the OR IUSS sterilizer was documented as used 28 times, with 7 of those times being documented as #1 - "high demand."

- May 2020 IUSS log revealed from a 7 day sample, the OR sterilizers were used 11 times, with 5 times being documented for the reason of "high demand" instrument.

- February 2020 IUSS log indicated from a 14 day sample reviewed that the OR sterilizer was used 22 times with 10 times being documented for the reason of "high demand."

- January 2020 IUSS log indicated from a 14 day sample reviewed that the OR sterilizer was used 70 times with 40 times being documented for the reason of "high demand."

ii. Review of the IUSS log dated 1/23/20 found handwritten documentation revealed a Stryker Orthopaedics instrument underwent IUSS with #1 written on the sterilizer receipt. However, according to the Stryker Orthopaedic instruction for use (IFU) provided by the facility, it read that "flash" sterilization, or IUSS, was not recommended for the manufacturer's reusable surgical instruments.