Bringing transparency to federal inspections
Tag No.: A0951
Based on record review, interview, observation, and policy review the provider failed to:
*Provide an adequate number of surgical instruments or schedule surgeries appropriately to prevent the use of immediate use sterilization between surgical procedures at one of one surgical center.
*Maintain warmed intravenous (IV) fluids below 104 degrees Fahrenheit (F) and blankets below 130 degrees F in one of one warming cabinet in one of one surgical center.
Findings include:
1. Review of the 1/11/23 through 4/26/23 "Flash [immediate use] Sterilization Log" documentation revealed:
*There had been 27 documented flash sterilizations during that time frame for the reason "turn" or "turn over".
*Examples of load contents for flash sterilization included myringotomy and tubes sets, arthroscopy sets, tonsils, and adenoid sets. Each set contained multiple surgical instruments used to perform surgeries.
Interview and review on 5/11/23 at 9:02 a.m. with the manager of surgical services D regarding the Flash Sterilization Log documentation revealed:
*Flash sterilization of surgical instruments was used infrequently and only emergently. *She was unsure about the extent the flash sterilization had been used.
*She had not reviewed the logs or observed the sterilization process between surgeries.
*Surgical instruments should have been sterilized using the normal sterilization method and not the shortened flash sterilization method.
Interview on 5/11/23 at 10:15 a.m. with surgical technician C revealed:
*He was one of four surgical technicians who performed sterilization of the surgical instruments.
*When there were more surgeries scheduled then the number of sets of surgical instruments, they would use flash sterilization between surgical procedures on those sets of instruments to shorten the sterilization time.
Review of the revised October 2018 Steam Sterilization (Immediate-Use Sterilization) policy revealed: "B. Policy: The use of immediate-use steam sterilization (IUSS) shall be kept to a minimum. It shall be utilized only when there is insufficient time to process by the preferred wrapped or container method. Immediate-use steam sterilization shall not be used as a substitute for insufficient instrument inventory."
2. Observation on 5/11/23 at 9:15a.m. of the blanket/fluid warming cabinet in the surgical center revealed:
*There were seven bags of IV fluids stored in the top warming cabinet.
*The temperature on the gauge for that cabinet was 110 degrees F.
*Testing of the ambient air temperature in the top cabinet revealed it ranged between 107 degrees F and 109 degrees F.
*While observing the warming cabinet the temperature went up to 120 degrees F and alarmed. (The fluid warming cabinet should not have exceeded 104 degrees F.)
*The bottom cabinet was full of blankets.
*The temperature on the gauge for the bottom cabinet was 153 degrees F.
*Testing of the ambient air temperature in the bottom cabinet revealed it was 139 degrees F. (The temperature of the blanket warmer should not have exceeded 130 degrees F.)
Review of the May 2023 Nurses Daily Checklist revealed:
*Temperatures for the top cabinet had been documented between 110 degrees F and 111 degrees F for eight of the eleven days reviewed. Two of the eleven days the facility was closed, and the temperatures were not tracked.
*Temperatures for the bottom cabinet had been documented between 152 degrees F and 153 degrees F for eight of the eleven days reviewed. Two of the eleven days the facility was closed, and the temperatures were not tracked.
*There were not temperatures recorded on 5/1/23.
Interview and review on 5/11/23 at 9:05 a.m. with surgical services registered nurse E regarding the May 2023 Nurses Daily Checklist revealed:
*Temperatures for the upper and lower cabinet of the warmer were documented daily by the nursing staff and the expectation was for those monitored temperatures to have been within the range identified at the bottom of the checklist.
-That range was "between 103- and 153-degrees F".
*She was unable to locate the provider's policy to validate the accuracy of the temperature range.
Interview and review on 5/11/23 at 9:15 a.m. with manger of surgical services D regarding the May 2023 Nurses Daily Checklist revealed:
*Confirmed there was a discrepancy between the temperature readings on the cabinet and the ambient temperature readings that had been taken above.
*Knew the temperatures documented on the Nurses Daily Checklist had not been within acceptable parameters if those temperatures documented were accurate.
*Expected nursing staff had been aware of the acceptable temperature parameters for both the upper and lower warming cabinet compartments, adhered to those parameters, and had reported to the plant operations (PO) any deviations of those temperatures.
*Was unable to locate the provider's policy for acceptable warming cabinet temperatures.
Interview on 5/11/23 at 12:05 p.m. with PO manager F revealed:
*PO was responsible for initially setting the temperature parameters for the upper and lower warming cabinet compartments according to the provider's policy.
-Temperatures that exceeded those parameters caused the cabinet to alarm alerting the nursing staff to a potential problem with the unit.
-PO was expected to have been notified by the nursing staff of any potential or actual concerns with the temperatures in the cabinet.
*The cabinet was cleaned by the PO department every six months, but the temperature calibration of the cabinet compartments was not a part of that maintenance.
*PO manager F was unaware of any potential or actual problems with the temperatures of the warming cabinet at the surgical center.
Review of the revised June 2022 Parenteral Solutions, Storage & Warming Of policy revealed: *"F. Solution warming cabinet temperatures are limited to less than or equal to 104 F and blanket warming cabinet temperatures to less than or equal to 130 F." *"J. All malfunctions of the cabinet alarms or out of temperature ranges are to be reported to Plant Operations."
*"K. If the cabinet thermometer exceeds the recommended administration temperature, the fluids in the cabinets