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Based on observation, interview, and record review, the facility failed to comply with State law regarding reporting any occurrence, such as a disaster, or unusual occurrence which threatens the welfare, safety or health of the patients, personnel, or visitors as soon as reasonably practical to the local health officer and to the department. The facility had an inoperable chiller equipment that affected two of four Operating Rooms for 7 days and the facility did not report this occurrence to the department.

This deficient practice could have negative effects to the welfare, safety or health of the patients and personnel.

Findings:

On 4/12/23 at 1:40 p.m., an investigation was initiated regarding two Operating Rooms (OR) being out of temperature. The Chief Nursing Officer (CNO 1), Risk Management Director (RMD 1), Director of Surgical Services (DSS 1), and the facility Facility Maintenance Manager (FM 1) were informed of the visit.

The patient census was 156 and bed capacity is 273.

On 4/12/23, at 2:10 p.m., an interview was conducted with the FM 1 regarding the incident. The FM 1 stated on the morning of 4/6/23, the engineering staff were conducting their daily rounds and were taking room temperatures throughout the facility. The FM 1 also stated that at 5:30 am, when they entered OR 1 and OR 2, the engineer staff noticed that the air conditioning fans were not working in the two OR's. The engineering staff assessed the problem and determined that two of three chillers were inoperable (a chiller is a machine that removes heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water is used to cool and dehumidify air in large buildings, like a large hospital.). FM 1 stated, on 4/6/23 in the morning, he was notified and he informed CNO 1, RMD 1, and DSS 1 regarding the inoperable chillers. FM 1 stated the air conditioning company was called and the air conditioning company determined that a gear box for cooling tower 1 (a device that rotates a large fan to the two chillers) was inoperable and needed to be replaced. The facility committee approved the air conditioning company's bid, and a new gear box was ordered. FM 1 further stated that the engineering staff measures and record the room temperatures in the morning only once a day.

On 4/12/23, at 2:50 p.m., an interview was conducted with DSS 1 regarding the incident. DSS 1 stated that on 4/6/23, he was notified by the engineering staff that OR 1 and OR 2 air conditioning fans were not functioning properly. DSS 1 stated that the OR staff visually monitor the room temperatures routinely in all four OR before each surgery procedure, by checking the wall-mounted thermometers in each ORs. DSS also stated that OR 1 and OR 2 temperatures would slowly increase up to 73 degrees Fahrenheit (F). When OR 1 and OR 2 temperatures would increase, the OR staff would report it to DSS 1 and he would either re-schedule the surgery procedure or move it to OR 3 or OR 4. The OR staff would stop using OR 1 and OR 2 until the room temperatures would decrease below 73 degrees F. Then the OR staff would resume use of OR 1 and OR 2 for surgery. DSS 1 further stated that no surgeries procedures were stopped due to the increase hot temperatures in OR 1 and OR 2 temperatures.

On 4/12/23, at 3:55 p.m., an interview was conducted with the OR Registered Nurse (RN 1) working the 3:00 pm to 11:00 am shift. RN 1 stated that he worked on 4/6/23, 4/7/23, and 4/10/23 in OR 2 and remembered, "It felt warmer than normal," in the OR 2. RN 1 also stated that on 4/10/23, there was a surgical procedure "Around 5:00 p.m.," and the temperature was "Borderline hot." RN 1 further stated that he did not see the wall-mounted thermometer in OR 2 because his backside was facing the wall mounted thermometer, but remembered it was hot.

On 4/12/23, at 4:15 p.m., during an interview, OR surgical technician (ST 1) working the 3:00 p.m. to 11:00 a.m. shift stated that she worked on 4/6/23, 4/7/23, and 4/10/23 in OR 2 and remembers, "It felt very warm." ST 1 also stated that on 4/10/23, there was a surgical procedure "around 5:00 p.m." and heard the surgeon (MD 1) had complained that OR 2 was very hot. ST 1 further stated that she did not see the wall-mounted thermometer in OR 2 because her backside was facing the wall mounted thermometer but she did noticed MD 1 was sweating a lot. ST 1 stated that during the surgery, MD 1 stated out loud to the surgery staff that he wanted to stop the surgery procedure due to the hot room temperature in OR 2.

A review of the facility's Environmental Control Policy revised on 9/2022 which includes the OR temperature and humidity requirements, revealed that the OR room temperature should be between 68 to 73 degrees F, and the humidity should be between 35-60 percent (%).

On 4/13/2,3 at 11:30 a.m., a general observation tour was conducted with the FM 1 on the roof. It was noticed that 2 of 3 chillers from cooling tower 1 was not working.

A review of the facility's Sentinel Event Management policy approved on 3/2022, revealed that any potential sentinel event is to be reported immediately to the Risk Manager. The policy also revealed that the regulatory reporting requirements will be to include the "Department of Health Service".

A review of OR 2 schedule for 4/10/23 revealed that MD 1 was scheduled to conduct a Cervical (C 3) - C 4 anterior corpectomy (removal of the anterior segment plate on the upper back shoulder) surgery procedure on Patient 1, at 3:00 pm.

A review of the post-operative report in Patient 1's medical record dated 4/10/23, revealed that the C 3 - C 4 anterior corpectomy surgery was aborted. A further review of the post-operative report revealed that MD 1 stated, "During this time, the temperature in the room continued to rise and was unable to be controlled by engineering." At the end of the post-operative report revealed, "The anterior cervical plate was removed. At this point, the temperature climbed to 78.1 degrees F with 51% humidity. It was entirely unsafe to continue operating and so at this point, the operation was aborted."

On 4/13/23, at 4:30 p.m., during an interview with RMD 1 regarding this incident. RMD 1 stated that on the morning of 4/6/23, when the engineering staff reported that the air conditioning fans were not working in OR 1 and OR 2, RMD 1 felt it was not necessary to report this occurrence to the Department of Public Health. At the end of the interview, RMD 1 stated now that he looks back on the incident, the facility should have reported this incident as an unusual occurrence to the Department of Public Health.

On 4/14/23, at 3:30 p.m., an interview with the CNO 1 regarding the incident. CNO 1 stated she was informed by RMD 1 that the facility failed to report this unusual occurrence to Department of Public Health.

Based on observation, interview, and record review, the facility's Governing Body failed to assume full legal responsibility for implementing, and monitoring policies governing oversight for quality health care in a safe environment. The facility did not meet the condition for coverage in governing body and management by failing to:

1. Ensure a medical staff was designated to supervise and carry out a safety plan when facility's Operating Rooms (OR) temperature were not safe for four (4) of five (5) operating rooms (OR 1, OR 2, OR 3, and OR 4). The facility's two chillers (chiller 1 and chiller 2, a machine that removed heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water was used to cool and dehumidify air in large buildings, like a large hospital) and the gear box (the motor that provides powers to turn the fan blades) of the cooling tower 1 (a device that rotates a large fan to the two chillers) were not working (inoperable) to keep OR temperature within a safe range (68 degrees F to 73 degrees F) the five operating rooms (OR 1, OR 2, OR 3, OR 4, and OR 5) since 4/6/2023. (Refer A - 0049).

2. Ensure a surgery was safe to be performed with the fluctuating room temperature in Operating Room 2 (OR 2) for one (1) of thirty (30) sampled patient (Patient 1). Patient 1's surgery was performed in OR 2, on 4/10/23, and the OR 2's room temperature was not within range between 68 degrees Fahrenheit [F, unit of measurement for temperature] to 73 degrees F in accordance with the facility's policy and procedure (P&P). The facility's two chillers (chiller 1 and chiller 2, a machine that removed heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water was used to cool and dehumidify air in large buildings, like a large hospital) and the gear box of the cooling tower 1 (a device that rotates a large fan to the two chillers) were not working (inoperable) to keep OR 2 temperature within a safe range (68 degrees F to 73 degrees F) since 4/6/2023. (Refer to A - 0063).

The cumulative effect of these systemic practices resulted in the facility's inability to ensure the provision of quality health care in a safe environment that included the oversight, accountability for all the facility's activities, and total operations in the surgery services.

Based on observation, interview, and record review, the facility's Governing Body failed to ensure a medical staff was designated to supervise and carry out a safety plan when facility's Operating Rooms (OR) temperature were not safe for four (4) of five (5) operating rooms (OR 1, OR 2, OR 3, and OR 4). The facility's two chillers (chiller 1 and chiller 2, a machine that removed heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water was used to cool and dehumidify air in large buildings, like a large hospital) and the gear box (the motor that provides powers to turn the fan blades) of the cooling tower 1 (a device that rotates a large fan to the two chillers) were not working (inoperable) to keep OR temperature within a safe range (68 degrees F to 73 degrees F) for the five operating rooms (OR 1, OR 2, OR 3, OR 4, and OR 5) since 4/6/2023.

This deficient practice resulted to facility continued performing surgeries in the facility's Operating Rooms (OR 1, OR 2, OR 3, and OR 4) with fluctuating temperature range. This deficient practice had the potential to increase the chance of infection and possible serious complications of surgery for the surgery patients.

Findings:

On review of the facility OR census for surgery conducted, on 4/6/2023 to 4/13/2023, the facility conducted the following surgeries after 2 of the 3 chillers were out of broken. The patient OR census indicated the following cases were performed on either OR 1, OR 2, OR 3, and OR 4:

a. On 4/6/23, 15 surgery cases.
b. On 4/7/23, 16 surgery cases.
c. On 4/8/23, 6 (six) surgery cases.
d. On 4/9/23, none.
e. On 4/10/23, 11 surgery cases.
f. On 4/11/23, 18 surgery cases.
g. On 4/12/23, 9 (nine) surgery cases.
i. On 4/13/23, 16 surgery cases.

On 4/12/23 at 1:10 p.m., during an observation of the facility's five Operating Rooms, the wall mount temperature reading device inside the ORs indicated OR 1 temperature was 73.9 degrees F, OR 2 temperature was 74.7 degrees F, OR 3 temperature was 71.4 degrees F, OR 4 temperature was 67.6 degrees F, and OR 5 was used as storage for surgical equipments. OR 5 temperature was not recorded.

On 4/12/23 at 2:10 p.m., an interview was conducted with the Facility Maintenance Manager (FM 1) regarding the incident (the engineer staff noticed that the air conditioning fans were not working in the two OR's) on the morning of 4/6/23, FM 1 stated the engineering staffs were conducting their daily rounds and were taking room temperatures throughout the facility. The FM 1 stated that at 5:30 a.m., when they (engineering staffs) entered OR 1 and OR 2, the engineer staff noticed that the air conditioning fans were not working in the two OR's. The engineering staff assessed the problem and determined that two (chiller 1 and chiller 2) of three chillers were inoperable. FM 1 stated, on 4/6/23 morning, FM 1 was notified, and he informed the Chief Nursing Officer (CNO 1), Risk Management Director (RMD 1), and the Director of Surgical Services (DSS 1) regarding the facility problems with the chillers. FM 1 stated the air conditioning company was called and the air conditioning company determined that a gear box for cooling tower 1 (a device that rotates a large fan to the two chillers) was inoperable and needed to be replaced. The facility committee approved the air conditioning company's bid, and a new gear box was ordered (date ordered not provided). FM 1 further stated that the engineering staff measures and record the room temperatures in the morning only once a day.

On 4/12/2023, at 2:30 p.m., during an interview, the DSS 1 stated the facility continued to schedule surgery in all four Operation Rooms (OR 1, OR 2, OR 3, and OR 4) since 4/6/2023. The DSS 1 stated the OR's staff were not required to record temperature in the OR room prior to surgery since 4/6/2023. The DSS 1 explained that only the engineers would take a temperature in the ORs once a day in the morning. The DSS 1 stated he does not think anyone monitored the temperature in the Operating Rooms during the second shift (3 p.m. to 11 p.m.) and the third shift (11 p.m. to 7 a.m. shift) since 4/6/2023. DSS 1 stated after the facility's cooling tower 1 and the two chillers failed to keep the temperatures in the ORs within a safe range (68 degrees F to 73 degrees F), OR staffs (nurses and surgical technician) were never directed to record the ORs temperatures.

On 4/12/23 at 3 p.m., during an observation of the operation rooms, the wall mount temperature reading device inside the ORs indicated OR 1 temperature was 75 degrees F, OR 2 temperature was 75.9 degrees F, OR 3 temperature was 73.1 degrees F, and OR 4 temperature was 74.6 degrees F.

On 4/14/2023, at 5:35 p.m., during an interview, the Administrator 2 (ADM 2) stated the facility had no one party responsible for overseeing the problem of fluctuating temperatures in the OR rooms since 4/6/2023. ADM 2 stated it (oversight of temperature in the OR) was delegated to nursing staff and teams such as EOC (Environmental Care). ADM 2 stated the facility needed to develop a plan of correction when the OR temperatures continued to fluctuate.

A review of the facility's Surgery Manual titled, "Environmental Control," dated 2/2022, the surgery manual indicated, "Temperature in the operating room should be 68 degrees F to 73 degrees F."

A review of the facility's policy and procedure titled "Standard of Care-Surgery," dated 2/2022, indicated the standards of care for surgical patients include continuous development, implementation, and monitoring so as to attain goals in providing consistency and quality in the delivery of service.

A review of the facility's Infection Control Manual titled, "Preventing Surgical Site Infections," dated 2/2022, indicated operating room suite temperature and humidity levels must be maintained within established regulatory and scientific community ranges to provide a comfortable operational environment and prevent any potential long-term effects on supply integrity and/or microorganism growth within the OR environment.

Based on interview, and record review, the facility's Governing Body failed to established oversight of the Surgical Service department to:

Ensure a surgery was safe to be performed with the fluctuating room temperature in Operating Room 2 (OR 2) for one (1) of thirty (30) sampled patient (Patient 1). Patient 1's surgery was performed in OR 2, on 4/10/23, and the OR 2's room temperature was not within range between 68 degrees Fahrenheit [F, unit of measurement for temperature] to 73 degrees F in accordance with the facility's policy and procedure (P&P). The facility's two chillers (chiller 1 and chiller 2, a machine that removed heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water was used to cool and dehumidify air in large buildings, like a large hospital) and the gear box (the motor that provides powers to turn the fan blades) of the cooling tower 1 (a device that rotates a large fan to the two chillers) were not working (inoperable) to keep OR 2 temperature within a safe range (68 degrees F to 73 degrees F) since 4/6/2023.

This deficiency practice has resulted in Patient 1's surgery being interrupted and aborted (not completed) midway through the scheduled surgery procedure. The deficient practice increased Patient 1's potential risk of infection and possible serious complications of surgery.

Findings:

1. A review of Patient 1's History and Physical (H & P) record, dated 4/6/2023, indicates Patient 1's medical chief complaint was five days of neck pain due to cervical (part of the spine) spinal pain in the neck. The Patient 1's medical history includes neck cancer. Patient 1 had received chemotherapy (a type of cancer treatment that uses one or more anti-cancer drugs) and radiation therapy (a therapy using ionizing radiation [a therapy using high energy x-ray to destroy cell], generally provided as part of cancer treatment).

A review of patient 1's Intraoperative Record, dated 4/10/2023, indicated Patient 1 was scheduled for a surgical procedure called an anterior cervical corpectomy (a surgical procedure that involved removal of the damaged vertebra [each of the series of small bones forming the spine]. The second part of the surgery was the fusion (to connect two or more bones) of the spine to ensure the spinal column was stable. The record indicated during a spinal fusion, the surgeon would fill the space between the discs and vertebrae with an implant (an implant fills the available space, providing strength and stability to the spine). The record indicated surgery was terminated before the surgeon could fill the space. The second part of the surgery was not completed as the temperature in the OR 2 climbed to 78.1 degrees F. The surgeon (MD 1), indicated in the operative report that it (OR 2) was entirely unsafe to continue operating, the Patient 1's operation was aborted. The surgery started at 5:28 p.m., and the surgery ended at 7:12 p.m. (surgery total time of 1 hours and 44 minutes).

On 4/12/23 at 2:10 p.m., an interview was conducted with the Facility Maintenance Manager (FM 1) regarding the incident (the engineer staff noticed that the air conditioning fans were not working in the two OR's) on the morning of 4/6/23, FM 1 stated the engineering staffs were conducting their daily rounds and were taking room temperatures throughout the facility. The FM 1 stated on 4/6/2023 at 5:30 a.m., when they (engineering staffs) entered OR 1 and OR 2, the engineer staff noticed that the air conditioning fans were not working in the two OR's. FM 1 stated the engineering staff assessed the problem and determined that two (chiller 1 and chiller 2) of three chillers were inoperable. FM 1 stated, on 4/6/23 morning, FM 1 was notified and informed the Chief Nursing Officer (CNO 1), Risk Management Director (RMD 1), and Director of Surgical Services (DSS 1) regarding the facility problems with the chillers. FM 1 stated the air conditioning company was called, and the air conditioning company determined that a gear box for cooling tower 1 was inoperable and needed to be replaced. FM 1 further stated that the engineering staff measures and record the room temperatures in the morning only once a day.

On 4/12/2023, at 5:00 p.m., during an interview, Surgical Technician 1 (ST 1) stated she was present in the operating room (OR 2), on 4/10/2023 at 5:00 p.m., when the surgeon stated it (OR 2) was too hot to continue with the surgery. ST 1 stated, "The surgeon removes the plate (vertebral bone and intervertebral disc material) but did not insert the implanted plate in the space." ST 1 stated the surgeon was observed sweating profusely . ST 1 stated when the doctor removed his gown, the surgeon's gown had sweat. ST 1 stated the OR 2 temperature was definitely out of range and OR 2 temperature was over 75 degrees.

On 4/12/2023, at 5:15 p.m., during an interview, Registered Nurse 2 (RN 2) stated he was in the operating room when the surgeon complained that the OR was too hot. Stated the surgeon did not complete the surgery for the Patient 1.

On 4/13/2023 at 9 a.m., during a concurrent interview with DSS 1 and record review of Patient 1's Operative Report, on 4/13/2023 at 9 a.m., DSS 1 stated on 4/10/2023, the operating room temperature increased above 75 degrees F, and the surgery procedure for Patient 1 was aborted.

On 4/13/2023 at 9 a.m., during a concurrent interview with DSS 1 and record review of the facility's Infection Control Manual titled "Preventing Surgical Site Infections," dated 2/2022, DSS 1 stated and verified the facility's operating room suite temperature and humidity levels must be maintained within established regulatory and scientific community ranges to provide a comfortable operational environment and prevent any potential long-term effects on supply integrity and/or microorganism growth within the OR environment.

On 4/13/2023 at 10:30 a.m., during a concurrent interview with DSS 1 and record review of facility's operating rooms schedules, DSS 1 stated the operating rooms temperature (OR 1, OR 2, OR 3, and OR 4) has been fluctuating since the chillers were broken on 4/6/2023. DSS 1 stated the chillers had been broken for seven days. DSS 1 verified the facility continued to utilize all four operating rooms (OR 1, 2, 3, and 4) since 4/6/2023. DSS 1 verified that the facility continues to not require nursing staff to record temperatures during surgery.

On 4/13/2023, at 10:50 a.m., DSS 1 stated when the temperature increase, if the surgeon's sweat drips down to the patient, it (sweat drip on surgical area) puts the patient at risk for developing infection. DSS 1 stated the temperature in the four operating rooms (OR 1, OR 2, OR 3, OR 4) continue to fluctuate, and it (operating rooms) gets warmer after twelve p.m.

During a concurrent interview and record review of Patient 1's Operative Report, on 4/13/2023, at 10:59 p.m., with the Director of Surgical Services 1 (DSS 1), Patient 1's Operative Report, date of service on 4/10/2023 indicated Patient 1 was scheduled for removal of anterior segmental plate (a small plate [made of stainless steel and plastic] applied to the front of the spine) and anterior corpectomy. The operative record indicated, "The anterior segmental plate was removed. At that point, the temperature climbed 78.1 degrees F with humidity at 51 percent (normal range 20 percent to 60 percent). It was entirely unsafe to continue operating and so at this point, the operation was aborted. The drain (a soft, thin, sterile tube [catheter] placed into the spine) was placed in the operative space and the wound was closed." DDS 1 stated Patient 1's surgery was interrupted, on 4/10/2023 due to increase in temperature in OR 2. DDS 1 stated the surgeon did not complete the surgery, and the anterior cervical corpectomy was not performed as scheduled.

During an interview on 4/14/2023, at 5:35 p.m., with the Administrator 2 (ADM 2) stated there was no one party (staff) responsible for overseeing the problem of fluctuating temperatures in the OR rooms. ADM 2 stated it (oversight of temperature in OR) was delegated to staff and teams such as EOC (environmental care). ADM 2 stated the facility must develop a plan of correction when the OR temperature continues to fluctuate, and the governing body should oversee the situation (problem of fluctuating temperature in OR).

A review of the facility's Surgery Manual titled, "Environmental Control," dated 2/2022, the surgery manual indicated, "Temperature in the operating room should be 68 degrees F to 73 degrees F."

A review of the facility's P&P titled "Standard of Care-Surgery," dated 2/2022, indicated the standards of care for surgical patients include continuous development, implementation, and monitoring so as to attain goals in providing consistency and quality in the delivery of service.

Based on observation, interview, and record review, the facility failed to meet the condition of participation of QAPI (Quality Assessment & Performance Improvement) by failing to:

1. Sustain the facility's performance improvement activities and implement a plan (emergency plan) to ensure facility's Operation Room temperature maintained within range (68 degrees Fahrenheit [F, unit of measurement for temperature] to 75 degrees F and or 68 degrees to 73 degrees F) for four (4) of five operating rooms. The facility's two chillers (chiller 1 and chiller 2, a machine that removed heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water was used to cool and dehumidify air in large buildings, like a large hospital) and the gear box of the cooling tower 1 (a device that rotates a large fan to the two chillers) were not working (inoperable) since 4/6/2023. The facility continued to performed surgery from 4/6/2023 to 4/13/23 in the surgical operating rooms (OR 1, OR 2, OR 3, and OR 4), and the facility had two different policy and procedure for the operating rooms temperature range. The facility's policy and procedure for Environmental Control range was 68 degrees to 73 degrees F, and the facility's Preventing Surgical Site Infection was 68 degrees F to 75 degrees F. (Refer to A - 283).

2. Sustain the facility's performance improvement activities in the prevention of aborting a surgical procedure due to the surgical operation room (OR 2) was too hot to complete the surgery for one (1) of 30 sampled patients (Patient 1). On 4/10/2023, Patient 1's surgery was aborted (not completed) midway due to OR room was too hot (78 degrees F) to complete the surgery. (Refer to A - 286)

The cumulative effect of these systemic practices resulted in no opportunities for improvement or changes in activities to improve ineffective hospital processes.

Based on observation, interview, and record review, the facility failed to sustain the facility's performance improvement activities and implement a plan (emergency plan) to ensure facility's Operation Room temperature maintained within range (68 degrees Fahrenheit [F, unit of measurement for temperature] to 75 degrees F and or 68 degrees to 73 degrees F) for four (4) of five operating rooms. The facility's two chillers (chiller 1 and chiller 2, a machine that removed heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water was used to cool and dehumidify air in large buildings, like a large hospital) and the gear box of the cooling tower 1 (a device that rotates a large fan to the two chillers) were not working (inoperable) since 4/6/2023. The facility continued to performed surgery from 4/6/2023 to 4/13/23 in the surgical operating rooms (OR 1, OR 2, OR 3, and OR 4), and the facility had two different policy and procedure for operating rooms temperature range. The facility's policy and procedure for Environmental Control range was 68 degrees to 73 degrees F, and the facility's and Preventing Surgical Site Infection was 68 degrees F to 75 degrees F.

This deficient practice resulted in surgical service and medical staff continuing performing surgeries in the facility's Operating Rooms (OR 1, OR 2, OR 3, and OR 4) with fluctuating temperature ranges and had the potential to increase the chance of infection and possible serious complications of surgery for the surgical patients operated on 4/6/2023 to 4/13/23.

Findings:

On review of the facility OR census for surgery conducted, on 4/6/2023 to 4/13/2023, the facility conducted the following surgeries after 2 of the 3 chillers were broken. The patient OR census indicated the following cases performed:

a. On 4/6/23, 15 surgery cases.
b. On 4/7/23, 16 surgery cases.
c. On 4/8/23, 6 (six) surgery cases.
d. On 4/9/23, none.
e. On 4/10/23, 11 surgery cases.
f. On 4/11/23, 19 surgery cases.
g. On 4/12/23, 11 surgery cases.
i. On 4/13/23, 16 surgery cases.

On 4/12/23 at 1:10 p.m., during an observation of the facility's five Operating Rooms, OR 1 temperature was 73.9 degrees F, OR 2 temperature was 74.7 degrees F, OR 3 temperature was 71.4 degrees F, OR 4 temperature was 67.6 degrees F, and OR 5 was used as storage.

On 4/12/23 at 2:10 p.m., an interview was conducted with the Facility Maintenance Manager (FM 1) regarding the incident on the morning of 4/6/23, FM 1 stated the engineering staffs were conducting their daily rounds and were taking room temperatures throughout the facility. The FM 1 stated that at 5:30 a.m., when they (engineering staffs) entered OR 1 and OR 2, the engineer staff noticed that the air conditioning fans were not working in the two OR's. The engineering staff assessed the problem and determined that two (chiller 1 and chiller 2) of three chillers were inoperable (a chiller was a machine that removes heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water is used to cool and dehumidify air in large buildings, like a large hospital.). FM 1 stated, on 4/6/23 morning, FM 1 was notified, and he informed the Chief Nursing Officer (CNO), Risk Management Director (RMD 1), and Director of Surgical Services (DSS 1) regarding the facility problems with the chillers. FM 1 stated the air conditioning company was called and the air conditioning company determined that a gear box for cooling tower 1 (a device that rotates a large fan to the two chillers) was inoperable and needed to be replaced. The facility committee approved the air conditioning company's bid, and a new gear box was ordered. FM 1 further stated that the engineering staff measures and record the room temperatures in the morning only once a day.

On 4/12/2023, at 2:30 p.m., during an interview, DSS 1 stated the facility continued to schedule surgery in all four Operation Rooms (OR 1, OR 2, OR 3, and OR 4) since 4/6/2023. DSS 1 stated the OR's staff were not required to record temperature in the OR room prior to surgery since 4/6/2023. DSS 1 explained that only the engineers would take a temperature in the ORs once a day in the morning. DSS 1 stated he does not think anyone monitored the temperature in the Operating Rooms during the second shift (3 p.m. to 11 p.m.) and the third shift (11 p.m. to 7 a.m. shift) since 4/6/2023. DSS 1 stated after the facility's cooling tower 1 and the two chillers failed to keep the temperatures in the ORs within a safe range (68 degrees F to 73 degrees F), OR staffs (nurses and surgical technician) were never directed to record the ORs temperatures during surgery.

On 4/12/23 at 3 p.m., during an observation of the operating rooms, OR 1 temperature was 75 degrees F, OR 2 temperature was 75.9 degrees F, OR 3 temperature was 73.1 degrees F, and OR 4 temperature was 74.6 degrees F.

On 4/13/2023 at 12:05 p.m., during a concurrent interview with Facility Maintenance Manager 1 (FM 1) and record review of the facility's Heating, Cooling, and Humidity log for the facility's operating rooms, FM 1 clarified the temperature range of the facility's operating rooms should be between 68 degrees F to 75 degrees F. FM 1 stated the temperature range recommended on the nursing department policy and procedure may be slightly different than the Facility's engineering department.

During an interview on 4/14/2023, at 5:35 p.m., with the Administrator 2 (ADM 2) stated there was no one party (staff) responsible for overseeing the problem of fluctuating temperatures in the OR rooms. ADM 2 stated it (oversight of temperature in OR) was delegated to staff and teams such as EOC (environmental care). ADM 2 stated the facility must develop a plan of correction when the OR temperature continues to fluctuate, and the governing body should oversee the situation (problem of fluctuating temperature in OR).

On 4/15/2023 at 5:30 p.m., during an interview and record review of the facility's committee meetings (4/6/2023 to 4/15/2023), ADM 2 stated there are no minutes or agendas recorded from the committee meetings regarding problems with keeping the operating room temperature at a safe range or regarding fixing the two broken chillers. ADM 2 was unable to identify a representative appointed by the governing body designated to supervise and carry out a safety plan. ADM 2 the facility must develop an emergency plan. ADM 2 stated need to formally appoint someone to oversee situations like this. "Any situation out of the norm deserves our attention and all the resources we have."

During a review of the facility's Surgery Manual titled, "Environmental Control, "dated 2/2022, the surgery manual indicated temperature in the operating room should be 68 degrees F to 73 degrees F.

A review of the facility's log titled, "Heating, Cooling, and Humidity," log dated from 4/1/23 to 4/12/23 the log indicates the temperature range in the operating room should be 68 degrees F to 75 degrees F.

During a review of the facility's Infection Control Manual titled, "Preventing Surgical Site Infection," dated 2/2023, the manual indicated temperature in the operating room should be 68 degrees F to 75 degrees F.

Based on interview and record review, failed to sustain the facility's performance improvement activities in the prevention of aborting a surgical procedure due to the surgical operation room (OR 2) was too hot to complete the surgery for one (1) of 30 sampled patients (Patient 1). On 4/10/2023, Patient 1's surgery was aborted (not completed) midway due to OR room was too hot (78.1 degrees Fahrenheit [F] , normal range 68 degrees F to 73 degrees F) to complete the Patient 1's surgery.

This deficiency practice has resulted in Patient 1's surgery being interrupted and aborted (not completed) midway through the scheduled surgery procedure. The deficient practice increased Patient 1's potential risk of infection and possible serious complications of surgery.

Findings:

A review of Patient 1's History and Physical (H & P) record, dated 4/6/2023, indicates Patient 1's medical chief complaint was five days of neck pain due to cervical (part of the spine) spinal pain in the neck. The Patient 1's medical history includes neck cancer. Patient 1 had received chemotherapy (a type of cancer treatment that uses one or more anti-cancer drugs) and radiation therapy [a therapy using high energy x-ray to destroy cell], generally provided as part of cancer treatment).

A review of patient 1's Intraoperative (during surgery) Record, dated 4/10/2023, indicated Patient 1 was scheduled for a surgical procedure called an anterior cervical corpectomy (a surgical procedure that involved removal of the damaged vertebra [each of the series of small bones forming the spine]. The second part of the surgery was the fusion (to connect two or more bones) of the spine to ensure the spinal column was stable. The record indicated during a spinal fusion, the surgeon would fill the space between the discs and vertebrae with an implant (an implant fills the available space, providing strength and stability to the spine). The record indicated surgery was terminated before the surgeon could fill the space. The second part of the surgery was not completed as the temperature in the OR 2 climbed to 78.1 degrees F. The surgeon (MD 1), indicated in the operative report that it (OR 2) was entirely unsafe to continue operating, the Patient 1's operation was aborted. The surgery started at 5:28 p.m., and the surgery ended at 7:12 p.m. (surgery total time of 1 hours and 44 minutes).

During a concurrent interview and record review of Patient 1's Operative Report, on 4/13/2023, at 10:59 p.m., with the Director of Surgical Services 1 (DSS 1), Patient 1's Operative Report, date of service on 4/10/2023 indicated the patient was scheduled for removal of anterior segmental plate (a bilayer of cartilage and bone that separates spine) and anterior corpectomy. The operative record indicated, "The anterior segmental plate was removed. At that point, the temperature climbed 78.1 degrees with humidity at 51 percent. It was entirely unsafe to continue operating and so at this point, the operation was aborted. The drain was placed in the operative space and the wound was closed." DDS 1 verified Patient 1's surgery was interrupted on 4/10/2023 due to increase in temperature in OR 2. DDS 1 stated the surgeon did not complete the surgery, the anterior corpectomy was not performed as scheduled.

During an interview on 4/12/2023, at 5:00 p.m., Surgical Technician 1 (ST 1) stated she was present in the operating room (OR 2), on 4/10/2023 at 5:00 p.m., when the surgeon stated it is too hot to continue with the surgery. ST 1 stated, "The surgeon removes the plate (vertebral bone and intervertebral disc material) but did not insert the implanted plate in the space." ST 1 stated the surgeon was observed sweating profusely. ST 1 stated when the doctor removed his gown, the surgeon's gown had sweat. ST 1 stated the OR 2 temperature was definitely out of range and OR 2 temperature was over 75 degrees.

During an interview on 4/12/2023, at 5:15 p.m., Registered Nurse 2 (RN 2) stated he was in the operating room when the surgeon complained that the OR was too hot. RN 2 stated the surgeon did not complete the surgery for the Patient 1.

During an interview the Director of Pharmacy 1 (DP 1) and concurrent record review the anesthesia (medication use for sedation) storage temperature log, on 4/13/2023 at 10:30 a.m., DP 1 stated anesthesia medications were affected by high temperatures, which can affect their effectiveness. DP 1 stated on review of the anesthesia storage temperature log, indicated the temperature recommended for most anesthesia was between 68 degrees F and 77 degrees F.

During an interview and concurrent record review on 4/13/2023, at 10:50 a.m., the Director of Surgical Services 1 (DSS 1) stated when the temperature increases and if the surgeon sweat, the surgeon's sweat can drips down to the patient, it puts the patient at risk for developing infection.

During an interview on 4/14/2023, at 5:35 p.m., with the Administrator 2 (ADM 2) stated there was no one party (staff) responsible for overseeing the problem of fluctuating temperatures in the OR rooms. ADM 2 stated it (oversight of temperature in OR) was delegated to staff and teams such as EOC (environmental care). ADM 2 stated the facility must develop a plan of correction when the OR temperature continues to fluctuate, and the governing body should oversee the situation (problem of fluctuating temperature in OR).

During a concurrent interview and record review of facility Quality Assessment & Performance Improvement (QAPI) minutes, on 4/15/2023 at 5:30 p.m., ADM 2 stated there were no minutes or agendas recorded from the committee meetings regarding problems with keeping the operating room temperature at a safe range or regarding fixing the two broken chillers (to keep the facility temperature cool). ADM 2 was unable to identify a representative appointed by the governing body designated to supervise and carry out a safety plan. ADM 2 stated the facility must develop an emergency plan. ADM 2 stated the facility need to formally appoint someone to oversee situations like this and stated, "Any situation out of the norm deserves our attention and all the resources we have."

A review of the facility's Surgery Manual titled, "Environmental Control," dated 2/2022, the surgery manual indicated, "Temperature in the operating room should be 68 degrees F to 73 degrees F."

Based on observation, interview, and record review, the facility failed to maintain the safety of the patients at all times. The maintenance staff did not maintain two of the three facility chillers (a machine that removes heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment) in operable condition and good repair.

This deficient practice could have negative effects to the welfare, safety or health of the patients, personnel, or visitors.

Findings:

On 4/12/23, at 1:40 p.m., an investigation was initiated regarding two Operating Rooms (OR) being out of temperature. The Chief Nursing Officer (CNO 1), the Risk Management Director (RMD 1), the Director of Surgical Services (DSS 1), and the Facility Maintenance Manager (FM 1) were informed of the visit.

The patient census was 156 and the bed capacity is 273.

On 4/12/23, at 2:10 p.m., an interview was conducted with the FM 1 regarding the incident. The FM 1 stated on the morning of 4/6/23, the engineering staff were conducting their daily rounds and were taking room temperatures throughout the facility. The FM 1 also stated that at 5:30 am, when they entered OR 1 and OR 2, the engineer staff noticed that the air conditioning fans were not working in the two OR's. The engineering staff assessed the problem and determined that two of three chillers were inoperable (a chiller was a machine that removes heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water is used to cool and dehumidify air in large buildings, like a large hospital.). FM 1 stated, on 4/6/23 morning, FM 1 was notified and he informed CNO 1, RMD 1, and DSS 1 regarding the facility problems with the chillers. FM 1 stated the air conditioning company was called and the air conditioning company determined that a gear box for cooling tower 1 (a device that rotates a large fan to the two chillers) was inoperable and needed to be replaced. The facility committee approved the air conditioning company's bid, and a new gear box was ordered. FM 1 further stated that the engineering staff measures and record the room temperatures in the morning only once a day.

On 4/12/23, at 2:55 pm, an interview was conducted with DSS 1 regarding the incident. DSS 1 stated that on 4/6/23, he was notified by the engineering staff that OR 1 and OR 2 air conditioning fans were not functioning properly. DSS 1 stated that the OR staff visually monitor the room temperatures routinely in all four OR before each surgery procedure, by checking the wall-mounted thermometers in each ORs. DSS also stated that OR 1 and OR 2 temperatures would slowly increase up to 73 degrees Fahrenheit (F). FM 1 stated when OR 1 and OR 2 temperatures would increase, the OR staff would report it to DSS 1 and he would either re-schedule the surgery procedure or move it to OR 3 or OR 4. The OR staff would stop using OR 1 and OR 2 until the room temperatures would decrease below 73 degrees F. FM 1 stated then the OR staff would resume use of OR 1 and OR 2 for surgery. DSS 1 further stated that no surgeries procedures were stopped due to the increase hot temperatures in OR 1 and OR 2 temperatures.

On 4/12/23, at 3:55 pm, an interview was conducted with the OR Registered Nurse (RN 1) working the 3:00 pm to 11:00 pm shift. RN 1 stated that he worked on 4/6/23, 4/7/23, and 4/10/23 in OR 2 and remembered, "It felt warmer than normal" in the OR 2. RN 1 also stated that on 4/10/23, there was a surgical procedure "around 5:00 pm" and the temperature was "borderline hot". RN 1 further stated that he did not see the wall-mounted thermometer in OR 2 because his backside was facing the wall mounted thermometer, but remembered it was hot.

On 4/12/23, at 4:15 p.m., an interview was conducted with 3 pm to 11 pm OR surgical technician (ST 1) working the 3:00 pm to 11:00 pm shift. ST 1 stated that she worked on 4/6/23, 4/7/23, and 4/10/23 in OR 2 and remembers "it felt very warm". ST 1 also stated that on 4/10/23, there was a surgical procedure "around 5:00 pm" and heard the surgeon (MD 1) had complained that OR 2 was very hot. ST 1 further stated that she did not see the wall-mounted thermometer in OR 2 because her backside was facing the wall mounted thermometer but she did noticed MD 1 was sweating a lot. ST 1 stated that during the surgery, MD 1 stated out loud to the surgery staff that he wanted to stop the surgery procedure due to the hot room temperature in OR 2.

A review of the facility's Environmental Control Policy revised on 9/2022 which includes the OR temperature and humidity requirements, revealed that the OR room temperature should be between 68 to 73 degrees F, and the humidity should be between 35-60 percent (%).

On 4/13/23, at 11:30 a.m., a general observation tour was conducted with the FM 1 on the roof. It was noticed that 2 of 3 chillers from cooling tower 1 was not working.

A review of OR 2 schedule for 4/10/23 revealed that MD 1 was scheduled to conduct a Cervical 3 (C 3) - C 4 anterior corpectomy (removal of the anterior segment plate on the upper back shoulder) surgery procedure on Patient 1 at 3:00 pm.

A review of the post-operative report in Patient 1's medical record dated 4/10/23, revealed that the C 3 - C 4 anterior corpectomy surgery was aborted. A further review of the post-operative report revealed that MD 1 stated, "During this time, the temperature in the room continued to rise and was unable to be controlled by engineering." At the end of the post-operative report revealed, "The anterior cervical plate was removed. At this point, the temperature climbed to 78.1 degrees F with 51% humidity. It was entirely unsafe to continue operating and so at this point, the operation was aborted."

On 4/14/23, at 3:30 p.m., an interview with the CNO 1 regarding the incident. CNO 1 stated she was informed by RMD 1 that the facility failed to report this unusual occurrence to Department of Public Health.

Based on observation, interview, and record review, the facility failed to implement facility's infection control practices when:

1. Patient 2 and Patient 3's peripheral intravenous (IV, a small, short plastic catheter that is placed through the skin into a vein, usually in the hand, elbow, or foot, but occasionally in the scalp where medication are administered) access site were not labeled (date, time, and initials of the person who started IV) as indicated by the facility's IV Therapy policy and procedure manual.

2. Assessment (patency [open] and signs of infection [redness and/or inflammation]) and labeled (date of dressing change) of a dialysis access site (the surgical site created to reach the blood for hemodialysis, which is the process of removing excess fluid and waste from the body) was not done according to facility's policy and procedure for central line (an IV line that goes into a large blood vessel near the center of the body) for one (1) of the thirty (30) sampled patients (Patient 1). Patient 1 had a dialysis access site via the right internal jugular catheter (a catheter inserted into the large vein located on the neck area).

This deficient practice had the potential to put patients at risk for infection to develop at the IV site for Patient 2 and Patient 3, and dialysis access site used for for Patient 1.

Findings:

1. a. A review of Patient 2's admission record, dated 4/12/2023, indicated Patient 2 was admitted to the facility on 4/12/2023 with the diagnosis of cerebral infarction (stroke, which occurs as a result of disrupted blood flow to the brain due to problems with the blood vessels that supply it) and lactic acidosis (occurs when acid is too high).

During a review of Patient 2's "History and Physical" (H&P), dated 4/12/2023, indicated Patient 1's medical history also included hypertension (high blood pressure). The H&P indicates the treatment plan includes control of blood pressure and consultation with an infectious disease specialist for treatment of lactic acidosis.

During an observation and concurrent interview with Registered Nurse 2, on 4/13/2023, at 12:18 p.m., Patient 2's IV catheter to the right arm was observed, and the IV catheter site had no label indicating insertion date, time, or initials of the nurse, who inserted the IV catheter. RN 2 verified that the IV site had no label indicating the insertion date, time, or initials (nurse who inserted the IV catheter) label on Patient 2. RN 2 stated that part of nursing assessment was to check the IV catheter site. RN 2 stated checking the IV site include checking for the date of catheter insertion and the initials of the person who inserted the catheter. RN 2 stated following the process (checking the IV site) was to ensure the safety of the patient, the patency of the administration set and site, and infection control prevention for cross-contamination (the transfer of harmful bacteria from one substance or object to another) and bacterial growth.

b. A review of Patient 3's admission record, dated 4/13/2023, indicated Patient 3 was admitted to the facility on 4/13/2023 for shortness of breath.

A review of Patient 3's History and Physical (H&P), dated 4/13/2023, indicated Patient 3's medical history included diagnoses of chronic respiratory failure (a condition that occurs when the lungs cannot get enough oxygen into the blood), congestive heart failure (CHF, which is when the heart has stopped working less efficiently and the heart can't pump enough blood to keep pace with the body's needs), and pneumonia (an infection of one or both of the lungs caused by bacteria, viruses, fungi, or chemical irritants). The H&P indicates Zosyn (an antibiotic medication) was administered for the treatment of pneumonia.

During an observation and concurrent interview with Charge Nurse 2 (CN 2) on 4/13/2023, at 1:10 p.m., Patient 3's IV tubing set and IV catheter site to the left arm were found without a label indicating the date, time, and initials of the nurse who inserted the IV. CN 2 verified that the IV tubing and the IV piggyback (IVPB, secondary IV tubing connected to the primary tubing to administer medication to the vein) had not been labeled. CN 2 stated it was crucial to write down the date, time, and RN's initials, who inserted the IV. CN 2 stated that tubing must be replaced, and the IV catheter needs to be changed every 72 hours in order to prevent infection and infiltration (when the IV fluid or medication accidentally leaks into the surrounding tissues outside the intended vein. CN 2 stated Patient 2's antibiotic (Zosyn) was given IV. CN 2 stated when IV medication was given when an IV was infiltrated, the medication can leak into the tissue and cause permanent tissue damage and tissue necrosis (tissue death).

A review of the facility's Policy and Procedure Manual on Intravenous (IV) Therapy Guidelines, last reviewed on 3/2022, indicated the standards of care to ensure patient safety by correctly administering IV solutions were to change the peripheral IV tubing and sites every 96 hours and as needed. The guidelines included routine IV administration sets that included IV Piggyback (IVPB) tubing to be changed every 96 hours intervals. The guidelines indicated peripheral IV dressing change included writing initials (initial of person performing dressing change), date, and time on label and attaching to the dressing.

2. A review of Patient 1's admission record, dated 4/6/2023, indicated Patient 1 was admitted to the facility, on 4/6/2023, with diagnosis of cord compression (a condition that puts pressure on the spinal cord [a long, tube-like band of tissue that carries nerve tissues]).

A review of Patient 1's History and Physical (H&P), dated 4/6/2023, indicated Patient 1's medical history also included diagnosis of end-stage renal disease (a medical condition in which a person's kidneys cease functioning). Patient 1 was receiving dialysis via the right internal jugular catheter.

During a concurrent observation and interview with RN 4, on 4/14/2023, at 12:30 p.m., Patient 1's right IJ catheter site observed without a label of the date when the dressing was changed. RN 4 stated she forgot to check the date of the dressing on the right IJ catheter site. RN 4 stated the dressing on the right IJ catheter site should have a date. RN 4 stated it (the date on the right IJ catheter site) will indicate when the dressing must be changed.

During a concurrent interview with Registered Nurse, Informatics (RN I) and record review of Patient 1's Flow Sheets (electronic nursing documents that shows the assessment and intervention that was completed or not completed) on 4/15/19 at 2:40 p.m., RN I verified that Patient 1's Flow Sheet, dated 4/6/2022 to 4/14/2023, indicated no documentation of assessment of Patient 1's right IJ catheter (Patient's 1 dialysis access site) from nursing staff.

During a concurrent interview with RN 4 and record review of Patient 1's medical records, on 4/15/2023 at 3:45 p.m., RN 4 stated she did not have a chance to document the dialysis catheter. RN 4 stated the physician's progress notes indicated had a right IJ (internal jugular) catheter. RN 4 stated she could not locate any nursing documented assessment for Patient 1's right IJ catheter by nursing staff. RN 4 stated it (documenting assessment) was important to assess the dialysis catheter site at least every four hours to prevent complications like bleeding and infection. RN 4 stated the hospitals policy indicates nursing staff were supposed to assess dialysis access sites every four hours. RN 4 stated IV lines and IV sites were supposed to be part of the registered nurse's assessment.

During a concurrent interview with Registered Nurse Informatic 2 (RNI 2)and record review of facility's Preventing Central Venous Catheter (a central line is a tube that doctors place in a large vein in the neck, chest, groin, or arm to give fluids, blood, or medications or to do medical tests or used for treatment) - Associated Bloodstream Infection for one -Associated Bloodstream Infection, dated 3/2019, on 4/15/2023 at 4:00 p.m., RNI 2 stated the nursing staff must assess and document the condition of the catheter site. RNI 2 stated the facility's IV Therapy manual indicated how often the nurse should assess the central catheter. RNI 2 stated registered nurses were required to assess the dialysis access site, at a minimum, every shift, as verified by RNI 2.

A review of the facility's Patient Care Service Manual titled "IV Therapy," dated 3/2022, indicated to ensure patient safety, nursing staff, "Document on the Patient Progress Flow Sheet the condition of the IV site every shift and any changes."

Based on observation, interview, and record review, the facility failed to:

1. Ensure that the Operating Room 2 (OR 2) was safe to conduct surgery for one of thirty sampled patients (Patient 1). Patient 1's surgery was performed in OR 2, on 4/10/23, and the OR 2's room temperature was not within range between 68 degrees Fahrenheit [F] to 73 degrees F in accordance with the facility's policy and procedure (P&P). The facility's two chillers (chiller 1 and chiller 2, a machine that removed heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water was used to cool and dehumidify air in large buildings, like a large hospital) and the gear box of the cooling tower 1 (a device that rotates a large fan to the two chillers) were not working (inoperable) to keep temperature within a safe range (68 degrees F to 73 degrees F) since 4/6/2023 in OR 2. (Refer to A - 951).

2. Ensure the facility's operating rooms were safe to continue performing surgery when the facility's two chillers (chiller 1 and chiller 2, a machine that removed heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water was used to cool and dehumidify air in large buildings, like a large hospital) and the gear box of the cooling tower 1 (a device that rotates a large fan to the two chillers) were not working (inoperable) to keep temperature within a safe range (68 degrees F to 73 degrees F) in five (5) of the five operating rooms (OR 1, OR 2, OR 3, OR 4, and OR 5) since 4/6/2023.

These systemic deficient practices resulted in the failure of the facility to deliver surgical services that safeguard the health of the patients.

Based on observation, interview and record review, the facility failed to:

1. Ensure that the Operating Room 2 (OR 2) was safe to conduct surgery for one of thirty sampled patients (Patient 1). Patient 1's surgery was performed in OR 2, on 4/10/23, and the OR 2's room temperature was not within range between 68 degrees Fahrenheit [F] to 73 degrees F in accordance with the facility's policy and procedure (P&P). The facility's two chillers (chiller 1 and chiller 2, a machine that removed heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water was used to cool and dehumidify air in large buildings, like a large hospital) and the gear box of the cooling tower 1 (a device that rotates a large fan to the two chillers) were not working (inoperable) to keep temperature within a safe range (68 degrees F to 73 degrees F) since 4/6/2023 in OR 2.

This deficiency practice resulted in Patient 1's surgery being interrupted and aborted (not completed) midway through the scheduled surgery procedure. The deficient practice increased Patient 1's potential risk of infection and possible serious complications of surgery.

2. Ensure the facility's operating rooms were safe to continue performing surgery when the facility's two chillers (chiller 1 and chiller 2, a machine that removed heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water was used to cool and dehumidify air in large buildings, like a large hospital) and the gear box of the cooling tower 1 (a device that rotates a large fan to the two chillers) were not working (inoperable) to keep temperature within a safe range (68 degrees F to 73 degrees F) in five (5) of the five operating rooms (OR 1, OR 2, OR 3, OR 4, and OR 5) since 4/6/2023.

The deficient practice increased surgery patients' potential risk of infection and possible serious complications of surgery.

On 4/13/2023, at 7:20 p.m., the survey team called an immediate jeopardy (IJ), a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient, in the presence of the Chief Nurse Officer (CNO). The facility failed to maintain the facility's operating rooms (four of the five) within the normal range (68 degrees F to 73 degrees F) according to facility policy and procedure. As a result, Patient 1's medical record, titled Operative Report, indicates surgery was aborted on 4/10/2023 due to an unsafe operating room temperature of 78.1 F. The operating rooms were outside of the acceptable temperature range (68 degrees F to 73 degrees F). OR room environment outside the acceptable temperature range (68 degrees F to 73 degrees F) had the potential to cause high-risk for infection and possible complication of surgery for Patient 1 and the other surgery patients.

On 4/15/2023, at 5:55 p.m., during an onsite visit, the IJ was removed in the presence of the Chief Executive Officer (CEO), CNO, Director of Quality and Risk (QAR), and the Associate Chief Nurse Officer (ACNO) after the facility submitted an acceptable IJ Removal Plan (interventions to correct the deficient practices). The elements of the IJ removal Plan were verified and confirmed through observation, interviews, and record reviews. Facility's IJ removal plan to ensure all OR room temperature and humidity stay within range, (68 degrees F to 73 degrees F), were as follows:

1. Surgeries will be canceled until temperature and humidity of the OR are within safe range.

2. A policy and procedure for when to cancel surgeries will be created

3. Staff will be educated on this new process starting Monday, 4/17/2023 until all staff have been in-serviced by 5/15/2023. The Facility Department will continue to check and monitor daily temperatures and humidity.

4. If temperature in the OR, during regular business hours, OR staff will call the Engineering Department directly. During afterhours staff will call the operator and operator will notify the Engineer on duty. These calls will be logged.

5. The OR staff will monitor temperature and humidity and document in a manual log before a patient is brought in for surgery.

6. The Intraoperative Record in CPSI (Cloud-Based Healthcare Product Electronic Health Record [EHR]) has been modified to include "Start OR temp in Fahrenheit" and "End OR temp." Staff will be educated on new process by 5/15/2023.

7. To ensure timely identification of equipment malfunction and related resolution to these issues, engineering staff will monitor the cooling tower temperature (designed to remove heat from a building or facility by spraying water down through the tower to exchange heat into the inside of the building) three times a day, log, and sign in logbook starting Monday, 4/17/2023.

Findings:

1. A review of Patient 1's History and Physical (H & P) record, dated 4/6/2023, indicates Patient 1's medical chief complaint was five days of neck pain due to cervical (part of the spine) spinal pain in the neck. The Patient 1's medical history includes neck cancer. Patient 1 had received chemotherapy (a type of cancer treatment that uses one or more anti-cancer drugs) and radiation therapy (a therapy using ionizing radiation [a therapy using high energy x-ray to destroy cell], generally provided as part of cancer treatment).

A review of patient 1's Intraoperative Record, dated 4/10/2023, indicated Patient 1 was scheduled for a surgical procedure called an anterior cervical corpectomy (a surgical procedure that involved removal of the damaged vertebra [each of the series of small bones forming the spine]. The second part of the surgery was the fusion (to connect two or more bones) of the spine to ensure the spinal column was stable. The record indicated during a spinal fusion, the surgeon would fill the space between the discs and vertebrae with an implant (an implant fills the available space, providing strength and stability to the spine). The record indicated surgery was terminated before the surgeon could fill the space. The second part of the surgery was not completed as the temperature in the OR 2 climbed to 78.1 degrees F. The surgeon (MD 1), indicated in the operative report that it (OR 2) was entirely unsafe to continue operating, the Patient 1's operation was aborted. The surgery started at 5:28 p.m., and the surgery ended at 7:12 p.m. (surgery total time of 1 hours and 44 minutes).

On 4/12/23 at 2:10 p.m., an interview was conducted with the Facility Maintenance Manager (FM 1) regarding the incident on the morning of 4/6/23, FM 1 stated the engineering staffs were conducting their daily rounds and were taking room temperatures throughout the facility. The FM 1 stated at 5:30 a.m., when they (engineering staffs) entered OR 1 and OR 2, the engineer staff noticed that the air conditioning fans were not working in the two OR's. FM 1 stated the engineering staff assessed the problem and determined that two (chiller 1 and chiller 2) of three chillers were inoperable. FM 1 stated, on 4/6/23 morning, FM 1 was notified and informed the Chief Nursing Officer (CNO 1), Risk Management Director (RMD 1), and Director of Surgical Services (DSS 1) regarding the facility problems with the chillers. FM 1 stated the air conditioning company was called, and the air conditioning company determined that a gear box for cooling tower 1 was inoperable and needed to be replaced. FM 1 further stated that the engineering staff measures and record the room temperatures in the morning only once a day.

On 4/12/2023, at 5:00 p.m., during an interview, Surgical Technician 1 (ST 1) stated she was present in the operating room (OR 2), on 4/10/2023 at 5:00 p.m., when the surgeon stated it (OR 2) was too hot to continue with the surgery. ST 1 stated, "The surgeon removes the plate (vertebral bone and intervertebral disc material) but did not insert the implanted plate in the space." ST 1 stated the surgeon was observed sweating profusely . ST 1 stated when the doctor removed his gown, the surgeon's gown had sweat. ST 1 stated the OR 2 temperature was definitely out of range and OR 2 temperature was over 75 degrees.

During an interview on 4/12/2023, at 5:15 p.m., Registered Nurse 2 (RN 2) stated, on 4/10/2023, he was in the operating room when the surgeon complained that the OR was too hot. Stated the surgeon did not complete the surgery for the Patient 1.

During an interview and concurrent record review on 4/13/2023, at 10:50 a.m., the Director of Surgical Services 1 (DSS 1) stated when the temperature increase, if the surgeon's sweat drips down to the patient, it puts the patient at risk for developing infection. DSS 1 stated the facility continue to have all four-operating room (OR) open (including OR two) for surgical procedure. DSS 1 stated the temperature in the four operating rooms (OR 1, OR 2, OR 3, OR 4) continue to fluctuate. DSS 1 stated it (operation rooms) gets warmer after twelve p.m.

On 4/13/2023, at 10:59 p.m., during a concurrent interview and record review of Patient 1's Operative Report, DSS 1, stated the Patient 1 was scheduled for removal of anterior segmental plate (a small plate [made of stainless steel and plastic] applied to the front of the spine) and anterior corpectomy. The operative record indicated, "The anterior segmental plate was removed. At that point, the temperature climbed 78.1 degrees F with humidity at 51 percent (normal range 20 percent to 60 percent). It was entirely unsafe to continue operating and so at this point, the operation was aborted. The drain (a soft, thin, sterile tube [catheter] placed into the spine) was placed in the operative space and the wound was closed." DDS 1 stated Patient 1's surgery was interrupted, on 4/10/2023 due to increase in temperature in OR 2. DDS 1 stated the surgeon did not complete the surgery, and the anterior cervical corpectomy was not performed as scheduled.

2. On review of the facility ORs' census for surgery conducted, on 4/6/2023 to 4/13/2023, the facility conducted the following surgeries after two (chiller 1 and chiller 2) of the 3 chillers were broken. The patient OR census indicated the following cases performed:

a. On 4/6/23, 15 surgery cases.
b. On 4/7/23, 16 surgery cases.
c. On 4/8/23, 6 (six) surgery cases.
d. On 4/9/23, none.
e. On 4/10/23, 11 surgery cases.
f. On 4/11/23, 19 surgery cases.
g. On 4/12/23, 11 surgery cases.
i. On 4/13/23, 16 surgery cases.

On 4/12/23 at 1:10 p.m., during an observation of the facility's five Operating Rooms, OR 1 temperature was 73.9 degrees F, OR 2 temperature was 74.7 degrees F, OR 3 temperature was 71.4 degrees F, OR 4 temperature was 67.6 degrees F, and OR 5 was used as storage for surgical equipments.

On 4/12/23 at 2:10 pm, an interview was conducted with the Facility Maintenance Manager (FM 1) regarding the incident on the morning of 4/6/23, FM 1 stated the engineering staffs were conducting their daily rounds and were taking room temperatures throughout the facility. The FM 1 stated that at 5:30 a.m., when they (engineering staffs) entered OR 1 and OR 2, the engineer staff noticed that the air conditioning fans were not working in the two OR's. The engineering staff assessed the problem and determined that two (chiller 1 and chiller 2) of three chillers were inoperable (a chiller was a machine that removes heat from a liquid coolant via an absorption refrigeration cycles. The liquid can be circulated through a heat exchanger to cool equipment. The chiller water is used to cool and dehumidify air in large buildings, like a large hospital.). FM 1 stated, on 4/6/23 morning, FM 1 was notified and he informed CNO 1, Risk Management Director (RMD 1), and DSS 1 regarding the facility problems with the chillers. FM 1 stated the air conditioning company was called and the air conditioning company determined that a gear box for cooling tower 1 (a device that rotates a large fan to the two chillers) was inoperable and needed to be replaced. The facility committee approved the air conditioning company's bid, and a new gear box was ordered. FM 1 further stated that the engineering staff measures and record the room temperatures in the morning only once a day.

During an interview on 4/12/2023, at 2:30 p.m., with the Director of Surgical Service 1 (DSS 1), DSS 1 stated the facility continued to schedule surgery in all four Operation Rooms (OR 1, OR 2, OR 3, and OR 4) since 4/6/2023. DSS 1 stated the OR's staff were not required to record temperature in the OR room prior to surgery since 4/6/2023. DSS 1 explained that only the engineers would take a temperature in the ORs once a day in the morning. DSS 1 stated he does not think anyone monitored the temperature in the Operating Rooms during the second shift (3 p.m. to 11 p.m.) and the third shift (11 p.m. to 7 a.m. shift) since 4/6/2023. DSS 1 stated after the facility's cooling tower 1 and the two chillers failed to keep the temperatures in the ORs within a safe range (68 degrees F to 73 degrees F), OR staffs (nurses and surgical technician) were never directed to record the ORs temperatures.

On 4/12/23 at 3 p.m., during an observation of the operation rooms, OR 1 temperature was 75 degrees F, OR 2 temperature was 75.9 degrees F, OR 3 temperature was 73.1 degrees F, and OR 4 temperature was 74.6 degrees F.

On 4/14/2023, at 5:35 p.m., during an interview, the Administrator 2 (ADM 2) stated the facility had no one party responsible for overseeing the problem of fluctuating temperatures in the OR rooms since 4/6/2023. ADM 2 stated it (oversight of temperature in the OR) was delegated to nursing staff and teams such as EOC (Environmental Care). ADM 2 stated the facility needed to develop a plan of correction when the OR temperatures continued to fluctuate.

A review of the facility's Surgery Manual titled, "Environmental Control," dated 2/2022, the surgery manual indicated, "Temperature in the operating room should be 68 degrees F to 73 degrees F."

A review of the facility's P&P titled "Standard of Care-Surgery," dated 2/2022, indicated the standards of care for surgical patients include continuous development, implementation, and monitoring so as to attain goals in providing consistency and quality in the delivery of service.

A review of the facility's Infection Control Manual titled, "Preventing Surgical Site Infections," dated 2/2022, indicates the operating room temperature must be maintained within established regulatory and scientific community ranges to provide comfortable operational environment and prevent any microorganism's growth within the operating room.