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Based on intervention and record review, the hospital failed to follow its policy and procedure (P&P) titled, "Temperature and Humidity Control in Sensitive Areas" for five out of 36 Sensitive Areas (Operating Room [OR] Sterile Storage S, Neonatal Intensive Care Unit [NICU - area of the hospital where critically ill newborns receive care] 3, NICU 4, NICU 5, and Burn Intensive Care Unit [BICU - area of the hospital where critically ill patients suffering from burns receive care] equipment. This failure had the potential to negatively impact patient outcomes.

Findings:

During an interview on 7/22/24 at 10:28 a.m. with Director of Facilities (DOF- director of the department which ensures proper routine maintenance and repair of facility structures, systems and support areas to minimize downtime of facility/operations), DOF stated the hospital used an automated system to monitor temperature and humidity in certain rooms in the hospital. DOF stated the system allowed for remote assessment when any of the monitored rooms were out of the acceptable parameters.

During a concurrent interview and record review on 7/22/24 at 1:10 p.m. with Quality Patient Safety Program Manager (QPSPM) 3, the hospital's "Temp [temperature]/Humidity Compliance" logs, dated 7/5/24 to 7/18/24 were reviewed. The log indicated no compliance failures in this period. Requested "Temp/Humidity Compliance" logs (THCL) with last three failed readings.

During a concurrent interview and record review on 7/22/24 with DOF, "Temp/Humidity Compliance" logs dated 4/23/24, 6/6/24, and 7/11/24 were reviewed. DOF stated the monitored rooms/areas had acceptable temperature and humidity ranges.
The THCL dated 4/23/24 indicated "OR Sterile Storage S" had a temperature of 66.6 degrees F. The acceptable range for that room was listed as between 68 to 73 degrees F. A handwritten note at the bottom page of the log indicated a "lock box was installed." DOF stated lock boxes were installed to prevent staff from adjusting the temperature on the thermostats in the affected areas.
The THCL dated 6/6/24 indicated "NICU 3" had a relative humidity (RH- the amount of water vapor present in air expressed as a percentage) level of 62.8 %. The acceptable RH for that area was listed 30% to 60%.
The THCL dated 6/6/24 indicated "NICU 4" had a RH level of 60.7 %. The acceptable RH for that area was listed 30% to 60%.
The THCL dated 6/6/24 indicated "NICU 5" had a RH level of 61.2 %. The acceptable RH for that area was listed 30% to 60%. A handwritten note at the bottom page of the log indicated "Controls adjustment on AHU [air conditioning and heating unit] #2."
The THCL dated 7/11/24 indicated "BICU Equipment" had a temperature of 76.5 degrees F. The acceptable range for that room was listed as between 0 to 75 degrees F. A handwritten note at the bottom page of the log indicated "STAT relocated to correct problem.
Requested work orders generated for failures and director of affected departments notification.

During an interview on 7/23/24 at 2:52 p.m. with QPSPM 3. QPSPM 3 stated DOF was unable to find any requested workorders for THCL failures or director notifications.

During a review of the hospital P&P titled, ""Temperature and Humidity Control in Sensitive Areas," dated 1/26/22, the P&P indicated, "7. The building automation system can be used to monitor daily temperature and humidity levels in areas where the system is installed. . . b. If using building automation system: Facilities will monitor daily; any out of range values and corrective action will be as per policy below. . . 10. Preventative Maintenance (PM) Work Orders will be generated and documented by Facilities. . . In the event that the HVAC (heating, ventilation, and air conditioning) system fails, or any of the requirements are out of range, the following process is to occur: 2. When a reading of the building automation is found to be out of acceptable range, The [sic] Director of the affected area and the Director of Facilities or their designee(s) will be notified of the failure immediately. The notification, who was notified and the time, and the corrective action taken will be documented on the log in Facilities. . . The Infection Control Nurse will be notified by the director of the affected area(s) and given the identification of patients currently in the affected area(s) for follow-up."

Based on observation, interview, and record review the hospital failed to ensure anesthesia (medicines to prevent pain during surgery) services were provided in accordance with Department of Surgery Rules and Regulations [DSRR], and the American Society of Anesthesiologists (ASA) guidelines when:

1. Anesthesia providers (physicians or Certified Registered Nurse Anesthetist [CRNA-advanced practice registered nurse] who administer anesthesia) did not consistently remain in operating rooms (OR) to monitor patients who were under the effects of anesthesia for one of one patients (Patient 2). This failure had the potential for anesthesia providers to be unaware of rapid changes in patient status during anesthesia and the potential for a negative outcome. (Refer to A-1001)

2. The hospital did not appoint a qualified Medical Staff member to provide oversight of all anesthesia administered throughout the hospital. This failure resulted the quality of anesthesia care not being monitored, and the potential for a negative outcome. (Refer A-1001)

2. Anesthesiologists did not follow current professional practice guidelines by the American Society of Anesthesiologists (ASA) when the pre - anesthesia (administration of gases or drugs before surgical operations to lessen awareness and/or pain) evaluation for two of three patients (Patient 11, Patient 14) did not include assessment of heart and lungs.
This failure had the potential to put patients at risk for harm or death.(Refer A-1003)

The cumulative effect of these systemic problems had the potential to negatively impact the safety of patients undergoing medical procedures utilizing anesthesia services.

Based on interview and record review, the hospital failed to ensure Anesthesia (medicines to prevent pain during surgery) Services followed the Department of Surgery Rules and Regulations [DSRR], and the American Society of Anesthesiologists (ASA) guidelines when:

1. Anesthesia providers (physicians or Certified Registered Nurse Anesthetist [CRNA-advanced practice registered nurse] who administer anesthesia) did not consistently remain in operating rooms (OR) to monitor patients who were under the effects of anesthesia for one of one patients (Patient 2).
This failure had the potential for anesthesia providers to be unaware of rapid changes in patient status during anesthesia and the potential for a negative outcome.

2. The hospital did not appoint a qualified Medical Staff member to provide oversight of all anesthesia administered throughout the hospital.
This failure resulted the quality of anesthesia care not being monitored, and the potential for a negative outcome.

Findings:

1. During an interview on 7/22/24 at 9:32 a.m. with Registered Nurse (RN) 3, RN 3 stated if the anesthesia provider left the OR during a surgery, while the patient was anesthetized, the anesthesia provider would ask the RN to stand by the anesthesia machine (monitors heart rate, blood pressure, oxygen levels, and contains equipment used to provide artificial breathing). RN 3 stated the nurse did not have to stand right next to the anesthesia machine but needed to be able to hear any alarms. RN 3 stated the anesthesia providers would leave the room to get intravenous (IV-through the vein) fluids or medications.

During an interview on 7/22/24 at 2:08 p.m. with RN 4, RN 4 stated if anesthesia providers "step out" of the operating room, they would ask the nurse to watch the monitor. RN 4 stated most of the time, the provider left the OR to get medication from the automated drug dispensing (ADD) machine in the core (cleanest area in operating room department, used for sterile supply storage, only staff wearing appropriate surgical attire are allowed in the core).

During an interview on 7/22/24 at 2:20 p.m. with Director of Perioperative Services (DPOS), DPOS stated the anesthesia providers follow the ASA guidelines. DPOS stated the anesthesia providers "should not" be leaving anesthetized patients in the operating rooms without another anesthesia provider present.

During an interview on 7/23/24 at 12:38 p.m. with Anesthesiologist (Anesth) 3, Anesth 3 stated he was the "Director of Anesthesiology." Anesth 3 stated anesthesia providers would sometimes leave the OR with a patient under anesthesia to get medication from the ADD in the core.


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During a concurrent interview and record review on 7/24/24, at 9:27 a.m. with RN 1 and DPOS, Patient 2's "Perioperative Record [PR]," dated 5/14/24 was reviewed. The "PR" indicated, Procedure right total knee replacement. Case Attendees: Certified Registered Nurse Anesthetist [CRNA] 1 time in operating room 8:45 a.m., time out of operating room 10:34 a.m. Anesthesia Type Regional Block (pain management for surgery that numbs part of body) with Sedation (medication to cause sleepiness, and relaxation). RN 1 stated anesthesia providers left the operating rooms with anesthetized patients to get fluids and reversal medications (drugs used to reverse the effects of anesthetics). RN 1 stated he did not monitor the patient for the anesthesia provider because it was not his role as a nurse. RN 1 stated he was unable to recall if CRNA 1 left the room or if CRNA 2 entered and left the room during Patient 2's procedure. RN 1 was unable to provide documentation which indicated CRNA 1 left the OR during Patient 2's procedure or that CRNA 1 entered and left the operating room during Patient 2's procedure. DPOS stated the anesthesia provider had no reason to leave the operating room to prepare for the next case. DPOS stated there were two teams to assist in setting up the rooms for each case.

During a concurrent interview and record review on 7/24/24 at 10 a.m. with CRNA 1, Patient 2's "Anesthesia Record (AR)" dated 5/14/24 was reviewed. The "AR" indicated. CRNA 1 was administering Propofol (highly lethal medication used as anesthesia) intravenous (IV, in the vein) infusion (method of continuously providing medication or fluids into the blood stream, requires close monitoring) to Patient 2. CRNA 1 stated he leaves the operating room, if the patient was stable, to obtain intravenous fluids or reversal medications. The "AR" indicated CRNA 2 provided a break for CRNA 1 from 9:37 a.m. until 9:56 a.m. CRNA 1 stated on 5/14/24 during Patient 2's surgery, he left Patient 2's room due to a personal issue and when he returned CRNA 2 was there. CRNA 1 stated he notified Anesth 3 but left before he was relieved by another anesthesia provider which left Patient 2 unmonitored. CRNA 1 was unable to provide documentation in Patient 2's medical record that he notified Anesth 3. CRNA 1 stated current national standards for anesthesiologists indicate anesthesia providers are not leave the operating room during a procedure unless there was an emergency situation with another patient.

During an interview on 7/29/24 at 12:18 p.m. with DPOS, DPOS stated anesthesia providers should not leave their patients in the operating room. DPOS stated it was not the role of the RN to monitor patients under anesthesia. DPOS stated if the anesthesia provider or RN needed an item during a surgery case, the RN was to call the supervisor or charge nurse to retrieve the item.

During a review of the hospital's "Department of Surgery Rules and Regulations [DSRR], dated 11/19/14, the DSRR indicated, "21. The anesthesiologist is not to leave the room in any case that requires anesthesia care. If the anesthesiologist leaves the room, the incident will be reported to the Chief of Service."

During a review of the American Society of Anesthesiologists Standards, Guidelines, and Statements, the Statements and Practice Parameters indicated:

"STANDARD I: Qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care.
1.1 Objective -Because of the rapid changes in patient status during anesthesia, qualified anesthesia personnel shall be continuously present to monitor the patient and provide anesthesia care. In the event there is a direct known hazard, e.g., radiation, to the anesthesia personnel which might require intermittent remote observation of the patient, some provision for monitoring the patient must be made. In the event that an emergency requires the temporary absence of the person primarily responsible for the anesthetic, the best judgment of the anesthesiologist will be exercised in comparing the emergency with the anesthetized patient's condition and in the selection of the person left responsible for the anesthetic during the temporary absence."

"STANDARD II: During all anesthetics, the patient's oxygenation, ventilation (exchange of air and carbon dioxide [waste product]) and circulation (blood flow) shall be continually evaluated."

2. Based on interview and record review on 7/29/24, at 3:25 p.m. with Anesth 4 and vice president chief operation officer (COO). The hospital's "DSRR Department of Surgery Anesthesia Section" dated 6/2018, was reviewed. The DSRR anesthesia section indicated, "Structure and Qualifications A. The anesthesia service of [hospital name] shall be directed by a specialist in anesthesiology who is a member of the active medical staff. He/She shall be chairperson the Anesthesia Section of the Department of Surgery." COO stated the Hospital's Department of Surgery Rules and Regulations, Department of Surgery Anesthesia Section were outdated. COO stated the Anesthesia department did not have a section chair as a requirement in the current DSRR Anesthesia Section. COO stated the contracted anesthesia group had a Medical Staff member (Anesth 4) who acted as the Medical Director of anesthesia. Anesth 4 stated he was the Medical Director of the anesthesia services but only for the private contracted group of anesthesiologists and CRNAs. Anesth 4 stated he did not attend surgery supervisory committee. Anesth 4 stated he was not the chair of the anesthesia section and was not Medical Director of any other aspects of anesthesia provision in the hospital.

During a review of the hospital's "DSRR", dated 11/19/14, the DSSR indicated, "DEPARTMENT CHAIR . . .XII SECTION CHIEF Each section shall have a chief who shall be a member of the Active Medical Staff and a member of the section which he or she is the head. . .XIII. SELECTION Each section chief shall be selected by the section in question."

During an observation, interview, and record review the facility failed to ensure the anesthesiologists (physicians or Certified Registered Nurse Anesthetist [CRNA-advanced practice registered nurse] who administer medication to prevent pain during surgery) followed current professional practice guidelines by the American Society of Anesthesiologists (ASA) when the preanesthesia evaluation for two of three patients (Patient 11, and Patient 14) did not include assessment of heart and lungs. This failure had the potential to put patients at risk for harm or death.

Findings:

During an observation on 7/22/24 at 8:40 a.m. in the preoperative (before surgical procedure) holding area, Anesthesiologist (Anesth) 2, conducted Patient 14's preanesthesia (before anesthesia) evaluation. Anesth 2 did not listen to Patient 14's lungs or heart.

During an interview on 7/22/24 at 8:49 a.m. with Anesth 2, Anesth 2 stated he did not listen to Patient 14's heart and lung sounds. Anesth 2 stated the surgeon completed the history and physical examination prior to surgery and he reviewed the surgeon's findings and used the information for his preanesthesia evaluation.

During concurrent interview and record review on 7/22/24 at 9:08 a.m. with Quality Program Specialist Program Manager (QPSPM) 2, Patient 14's "Anesthesia Physician Note [APN]" dated 7/22/24 was reviewed. The "APN" indicated, "Preanesthesia Evaluation NEW. . . Pre Anesthesia Evaluation. . .Respiratory: Lungs are clear to auscultation (listen/hearing) Cardiovascular: Normal rate, Regular rhythm." QPSPM verified Anesth 2 documented that he ausculatated Patient 14's heart and lungs on the pre anesthesia evaluation.

During a review of Patient 14's "APN" dated 7/22/24, the "APN" indicated Preanesthesia Evaluation NEW. . .Active Problems included "diabetes, end stage renal [kidney] disease on hemodialysis [treatment to filter toxins from blood]. . .Tobacco Use: Former smoker. . .Quit 7 years ago. . .Assessment and Plan. . .Anesthetic technique: General anesthesia.

During an observation on 7/22/24 at 1:28 p.m. in preoperative holding area, Anesth 1, conducted Patient 11's pre anesthesia evaluation. Anesth 1 did not listen to Patient 11's heart or lungs.

During an interview on 7/22/24 at 1:30 p.m. with Anesth 1, Anesth 1 stated he did not listen to Patient 11's heart or lungs. Anesth 1 stated a preanesthesia evaluation was a focused examination and did not require listening to the heart and lungs on every patient. Anesth 1 stated if the patient had medical concerns such as asthma he would listen to the patient's lungs.

During an interview on 7/22/24 at 8:49 a.m. with Anesth 3, Anesth 3 stated anesthesiologists were not required to listen to heart and lungs during the pre anesthesia evaluation. Anesth 3 stated the anesthesiologists were to look at the patient's history and physical and other medical information during their evaluation. Anesth 3 stated if the anesthesiologist did not listen to the patient's heart and lung sounds, the anesthesiologist should not document they listened to the patient's heart and lung sounds.

During a review Patient 11's "APN" dated 7/24/24 was reviewed. The "APN" indicated, "General: Pre Anesthesia Evaluation. . .Physical Examination. . .Heart: Regular rate and rhythm Lungs: clear to auscultation. . .Anesthesia: General."

During a review of "Practice Advisory for Preanesthesia Evaluation An Updated Report by the American Society of Anesthesiologists Task Force on Preanesthesia Evaluation [preanesthesia report]," dated 2012 the "preanesthesia report" indicated, At a minimum, a focused preanesthesia physical examination should include an assessment of the airway, lungs, and heart, with documentation of vital signs."

During a review of American Society of Anesthesiologists "Statement on Documentation of Anesthesia Care, [ASA statement]," dated 10/18/23, the "ASA statement" indicated, "Accurate and thorough documentation is an essential element of high quality and safe medical care and accordingly a basic responsibility of physician anesthesiologists."