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24 STEVENS STREET

NORWALK, CT 06856

GOVERNING BODY

Tag No.: A0043

Based on tour of the facility, review of operating room patient procedure schedules, review of facility documentation, review of clinical records, review of policies, and interviews, the facility failed to ensure operational plans were effectively communicated after a planned water shut down was conducted in the hospital which resulted in the conduction of non-emergent surgical procedures in operating rooms with suboptimal environmental temperatures. The finding includes:

Review of the Hospital's Incident action plan identified that in order to make an urgent repair to a domestic water main there would be a planned water shutdown on Sunday September 25, 2022, 5:00 PM to Monday September 26, at 5:00 AM. The action plan identified that the operating rooms would be utilized for emergent cases and that non-emergent and urgent cases would be scheduled for after the shutdown.

A review of the list of scheduled surgeries dated 9/26/22 identified ten surgical procedures were conducted at the facility on 9/26/22 between 7:30 AM and 10:23 PM. Further review of the list of surgeries identified four surgical procedures were conducted in operating rooms #2 and #6 between 7:30 AM and 2:37 PM on 9/26/22.

Review of the temperature and Humidity logs identified: Operating Room (OR) #2 had relative humidity readings (RH) greater than 60 percent (%) from 10:00 PM on 9/25/22 to 1:30 AM on 9/26/22 (3.5 hours) and environmental temperatures over 75 degrees Fahrenheit from 3:00 AM on 9/26/27 to 12:00 AM on 9/27/22 (21 hours).

OR #6 had RH readings greater than 60% at 10:00 PM on 9/25/22 to 12:30 AM on 9/26/22 (2.5 hours) and environmental temperatures over 75% at 2:00 AM on 9/26/22 to 1:00 AM on 9/27/22 (23 hours).

According to The American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) the normal humidity in the OR should be between 20-60 % and normal temperature should be between 68-75 degrees Fahrenheit.

Review of Patient #1's clinical record identified Patient #1 underwent an elective surgical procedure in operating room #2 at the facility between 7:30 AM and 10:14 AM on 9/26/22. Review of the operating room temperature log identified Operating room #2 temperatures were documented as 77.3 to 80.7 degrees Fahrenheit during time of procedure.

Review of Patient #2's clinical records identified Patient #2 underwent an elective surgical procedure in operating room #2 at the facility on 9/26/22 from 11:00 AM - 2:37 PM. Review of the operating room temperature log identified temperatures in the operating room ranged from 80.4- 86.1 degrees Fahrenheit from 11:00 AM to 2:37 PM on 9/26/22.

Review of Patient #3 clinical record identified Patient #3 underwent an elective surgical procedure in operating room #6 at the facility on 9/26/22 from 9:47 AM - 10:24 AM. Review of the operating room temperature log for OR #6 identified temperatures of 83 degrees during time of procedure.

An interview with Manager #1 (Engineering) on 9/29/22 at 11:10 AM identified a hot and cold -water leak located close to the electrical infrastructure was identified in the basement of the facility. Manager #1 indicated shut down of the water for repair was initiated on 9/25/22 at 5:00 PM and unanticipated issues occurred at approximately 4:45 AM on 9/26/22 when the chiller plant went down during the refilling process.

Interview with Manager #3 (Infection control) on 9/29/22 at 12:25 PM identified the operating rooms were more concerned about humidity than environmental temperatures. Manager #3 indicated regulation of environmental temperatures were more for the comfort of staff and staff not sweating into the sterile field. Manager #3 identified that warmer temperatures are conducive to the growth of organisms.

An interview with the Quality Director on 9/29/22 at 2:10 PM identified that Director #1 (Perioperative services) and MD #1 (chair of surgery) were responsible for making the decisions on whether to resume surgeries. The Quality Director indicated that it was the practice that the engineering department communicated with the operating room management on any issues or concerns. The Quality Director indicated that in this case the Chief of Surgery and the Director of Perioperative Services would make decisions on when to resume surgical procedures.

Interview with Director #1 (Peri-operative services) on 9/29/22 at 2:20 PM identified she was in communication with Manager #3 (Infection Prevention) on 9/25/22 at 11:30 PM and received communication through the engineering department that temperatures in the operating rooms were out of normal ranges. Director #1 indicated that on 9/26/22 at 4:45 AM Scrub Technician #1 reported that he received a call from the engineering department stating that the system was functioning. Director #1 indicated she misinterpreted this communication to mean that permission was given to use the operating rooms for surgical procedures.

In an interview with Scrub Technician #1 on 10/3/22 at 10:30 AM, Scrub Tech #1 indicated he worked on the 11:00 PM shift on 11/25/22 and completed rounds to all the operating rooms at approximately 11:30 PM. Scrub Technician #1 stated the operating rooms were extremely hot. Scrub Tech #1 indicated he was told by the engineering department at about 4:45 AM on 9/26/22 that he was able to open the operating rooms as the temperatures were regulated. Scrub Tech #1 indicated he proceeded to terminally clean the operating rooms. Scrub Tech #1 stated he spoke with Director #1 (Perioperative Services) at approximately 5:30 AM on 9/26/22 and informed Director #1 that he spoke with engineering and that the operating rooms were ready to go.

Interview with Scrub Tech #2 on 10/3/22 at 11:20 AM identified that on 9/26/22 during a surgical procedure in OR #2 the circulating nurse indicated she was hot and asked whether other staff were hot as well. Scrub Tech #2 indicated that staff requested to turn the temperatures down in the operating room. Scrub Technician #2 indicated she did not observe staff perspiring.

An interview with the Chief Nursing officer (CNO) and Vice President of Medical affairs on 10/7/22 at 10:45 AM identified the facility opened a command center on 9/26/22 at 6:30 AM to determine if entire hospital would be fully operational as the water pressures were not back within normal capacity after the water shut down of 9/25/22. The CNO indicated that the participants of the command center included: The President, CNO, Safety officer, Public Relations, Operations Chief, and Director of the Operating rooms. The CNO indicated that at 6:30 AM on 9/26/22 the Engineering department communicated to the group that the chillers were not functioning, and the water pressure was not back to normal levels. The CNO indicated that there was communication in the group that 3 operating rooms (5, 7, and 8) were within the acceptable temperature and humidity range. The CNO indicated that herself and other members of the command center group were unaware that surgery procedures were initiated at 7:30 AM on 6/26/22 in Operating rooms that were not identified as being within normal temperatures. The CNO identified the issue was due to the absence of closed loop communication. The CNO identified that the plan was communicated with members of the Command center but was not heard by all in the same manner. The CNO indicated the rooms not identified as within normal temperatures should not have been used for surgical procedures until cleared.

An interview with the Quality Manager on 10/7/22 at 11:00 AM identified that the Hospital was working on a system by which the temperature and humidity of the operating rooms were documented prior to the start of each case.

Although suboptimal temperatures in the operating rooms was communicated to Manager #3 (Infection control) and Director #1 (Perioperative services) on 9/25/22 at 11:30 PM, the decision to use only the operating rooms that were within normal temperature ranges (OR #'s 5, 7, 8) on 6/26/22 at 6:30 AM was not clearly communicated by the Command center resulting in the conduction of surgical procedures in operating rooms with suboptimal environments

Review of the Temperature, Humidity and Ventilation in the Operating room and Procedural areas policy directed, Temperature and humidity is monitored daily by facilities personnel. The policy directed that if an operating or procedure room temperature reading is out of range facilities personnel will verify the reading and attempt corrective action with documentation of same. Under certain circumstances temperature may be adjusted based on a request by the surgeon an at- risk assessment must be completed and approved prior to making any changes and the facilities team must be notified when the procedure is done to ensure rooms are returned to recommended temperature levels. Considerations for adjustments to temperature include clinical needs of the patient or the procedure such as pediatric patients or patients requiring intentional hypothermia or excessive perspiration.

Review of the Bylaws of the Hospital's Association revised 4.28.22, Article 111 3.1 (ii) directed the Board shall have the authority to Maintain professional standards and oversee the quality of care provided at and by the Corporation.