Baystate Medical Center

“RECIPIENT HOSPITAL RESPONSIBILITIES CFR(s): 489.24(f) A participating hospital that has specialized capabilities or facilities (including, but not limited to, facilities such as burn units, shock-trauma units, neonatal intensive care units, or (with respect to rural areas) regional referral centers, which, for purposes of this subpart, means hospitals meeting the requirements of referral centers found at §412.96 of this chapter) may not refuse to accept from a referring hospital within the boundaries of the United States an appropriate transfer of an individual who requires such specialized capabilities or facilities if the receiving hospital has the capacity to treat the individual. This requirement applies to any participating hospital with specialized capabilities, regardless of whether the hospital has a dedicated emergency department. This Standard is not met as evidenced by: 37556 Based on a review of audio recordings, medical records, policies, and staff interviews, the Hospital failed to follow the Emergency Medical Treatment and Labor Act (EMTALA) requirements, when on 5/10/25, despite having the capability and capacity, the Hospital refused a transfer request for Patient #1, who had a small bowel obstruction and history of Crohn ’ s Disease along with a suspected biliary malignancy, from a rural Critical Access Hospital (CAH) that did not have Gastroenterology Services or a working operating room due a mechanical failure of equipment. Findings include: Review of the Hospital’s Policy titled, Examination, Treatment and Transfer of Patients to other Facilities, dated 1/23/20, indicated the Hospital would, within its capabilities, provide, without discrimination, an appropriate medication screening exam to any individual who was seeking emergency medical care or who is being transferred in an unstable condition. The Policy defined capability as the physical space, equipment, supplies, and specialized services (such as surgery, psychiatry, obstetrics, intensive care, pediatrics, and trauma), including ancillary services available at the Hospital. The Policy further indicated that if the Hospital was believed to have violated any of the EMTALA regulations, the event should be reported to the Chairman of the Emergency Medicine Department for immediate review. Review of the Department of Public Health’s (DPH) Health Care Facility Reporting System (HCFRS), dated 5/12/25, included a report alleging that on 5/10/25, a rural CAH Emergency Department (ED) Physican contacted the Hospital to transfer Patient #1, who had a small bowel obstruction and history of Crohn’s Disease, along with a suspected biliary malignancy, as the Hospital did not have Gastroenterology Services to complete an evaluation or a functioning operating room due to an equipment failure. The Report alleged the Hospital declined to accept Patient #1 because he/she did not need surgery emergently. Review of DPH’s HCFRS, dated 5/15/25, included a report from the Hospital self reporting an EMTALA violation involving a transfer request for Patient #1 on 5/10/25. The Report indicated that two surgeons spoke with the transferring Hospital ED Physician regarding Patient #1’s case and although there was no identified need for surgery, Patient #1 could transfer to the Hospital for a full work up by internal medicine. The Report indicated the internal medicine group received incomplete information reported internally when a Hospitalist #1 refused Patient #1’s transfer request by the CAH. On 5/21/25, the Senior Director of Regulatory Affairs provided a review of audio recordings of the Hospitals Transfer Center phone conversations on 5/10/25, between Hospital staff members and the CAH staff members, who requested the transfer of Patient #1. The audio revealed the following: - 2:39 P.M.: The transferring Hospital’s ED Physician told staff (a General Surgeon and a Patient Placement Nurse Manager) that the CAH did not have the capability and capacity to care for Patient #1 and they requested transfer according to the EMTALA requirements as they are the closest. - 3:19 P.M.: The CAH’s ED Physician told staff (a Colorectal Surgeon and a Patient Placement Nurse Manager) that Patient #1 needed a more extensive work up and she was happy to speak with internal medicine as the CAH was unable to admit Patient #1 who needs further evaluation, and possibly treatment and/or surgery. - 4:07 P.M.: A Patient Placement Nurse told the CAH ED Physician that she spoke with the internal medicine group, who declined the transfer of Patient #1. The CAH ED Physician said she felt like the decline of Patient #1’s transfer was inappropriate as they were a Critical Access Hospital and did not have the staff (specialists or surgeons) or a working operating room to treat Patient #1 who had a complicated medical condition and needed a further medical workup. During an interview on 5/21/25 at 12:30 P.M., Hospitalist #1 said he refused the transfer request for Patient #1 on 5/10/25. Hospitalist #2 said he was not made aware that the CAH was unable to provide a gastrointestinal evaluation; additionally, he was unaware of the lesions found on a computed tomography (CT) scan when considering accepting Patient #1’s transfer request. Hospitalist # 2 said that if he would have known that additional information, he would have accepted the transfer request and admitted Patient #1 to internal medicine for further GI evaluation. During an interview on 5/20/25 at 1:05 P.M., The Senior Director of Patient Safety and the Senior Director of Regulatory Affairs said the Hospital completed an Internal Investigation and identified an EMTALA violation 5/10/25; additionally, staff did not follow Hospital Policy when they failed to internally escalate the reported EMATALA concerns made by the CAH ED Physician during Patient #1’s transfer request conversations. They said the Hospital had developed but not implemented system wide corrective actions in response to the event.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(8) Unless superseded by State law that is more restrictive-- (i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours: (A) 4 hours for adults 18 years of age or older; (B) 2 hours for children and adolescents 9 to 17 years of age; or (C) 1-hour for children under 9 years of age; This Standard is not met as evidenced by: 39257 Based on record review and interviews, the hospital failed, for two (Patient #1 and Patient #5) of ten patients sampled, to document provider restraint renewal orders every 4 hours in accordance with hospital policy. Findings Include: The policy titled “Restraints or Seclusion for Violent or Self-Destructive Behavior”, states under Section 1B, “The physician’s order for a physical restraint is time-limited to: 4 hours for adults.” Additionally, the policy states under Section 1C, “The physician or LIP (licensed independent practitioner) makes an in-person re-evaluation at least every 8 hours for patients 18 years old or older and every 4 hours for patients 17 and younger.” Additionally, the policy states under Section 2C. “Assessment and Care. The staff’s experience with the patient and the assessment of the patient’s risk for injury to self-determine the method of restraint. Assessment of the patient during restraint will be conducted by qualified staff, staff that has demonstrated competence in the application and monitoring of patients in restraint. The nurse will conduct the assessment of ongoing need for and response to the restraint every 15 minutes.” The surveyor interviewed the Risk Manager on 01/27/25 at 2:40 P.M. The Risk Manager said that all restraint periods of Patient #1 were reviewed. The Risk Manager said that it was identified that the initial four-point restraint order on Patient #1 in the Emergency Department (ED), on 01/01/2024 at 12:00 P.M. (Patient #1 hospital admission was from 01/01/24 until 04/12/24) was missing. Although an ED physician note indicated the physician was aware of Patient #1 being put in restraints, the actual restraint order was not placed/documented in Patient #1’s medical record. The surveyor interviewed the Risk Manager on 01/28/25. The Risk Manager said that during Patient #1’s inpatient stay on a unit from 01/06/24 until 01/10/24, Patient #1 was on violent, self-destructive restraints. Although it was identified that indications for the violent, self-destructive restraints were appropriate, the Risk Manager acknowledged that there were gaps (missing or lack of documentation) in provider assessment documentation, provider order renewals and nursing assessments. Medical record review of an active patient (Patient #5) on 02/03/25 at 2:00 P.M., indicated that there was missing restraint orders during the inpatient care of Patient #5. Patient #5 was on violent, self-destructive restraints while on the neurology intermediate care unit (nICU) from 01/28/25 at 12:17 A.M. until 01/29/25 at 7:21 P.M, (a period of approximately 43 hours). During that time, medical record review indicated a lack of documentation of physician restraint renewal orders, where orders were not being renewed every 4 hours in accordance with hospital policy. The first provider order renewal gap was between 01/28/25 at 12:35 A.M. and 01/28/25 at 12:21 P.M. (12 hour gap). The second provider order renewal gap was between 01/28/25 at 4:32 P.M. and 01/29/25 at 6:02 A.M. (a 14 hour gap). The surveyor interviewed the Patient Safety Coordinator (PSC) on 02/03/25 at 2:00 P.M. The PSC acknowledged that there was a 12 hour and 14 hour time period without a provider restraint renewal order in accordance with hospital policy while Patient #5 was on violent, self-destructive restraints on the nICU.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 39257 Based on record review and interviews, the hospital failed, for one (Patient #5) of ten patients sampled, to conduct and/or document the necessary monitoring required for a patient (Patient #5) on violent self-destructive restraints, in accordance with hospital policy. Findings Include: The policy titled, “Restraints or Seclusion for Violent or Self-Destructive Behavior”, last revised 05/2023, under section 2C, Assessment of Care states, “Assessment of the patient during restraint will be conducted by qualified staff, staff that has demonstrated competence in the application and monitoring of patients in restraint. The nurse will conduct the assessment of ongoing need for and response to the restraint every 15 minutes.” Medical record review of Patient #5 on 02/03/25 at 2:00 P.M. indicated that there were lapses in documentation of Patient #5’s every 15 minute patient checks, in accordance with hospital policy, during Patient #5’s restraint episode(s) period. Medical record review of Patient #5 on 02/03/25 at 2:00 P.M. indicated that Patient #5 transferred from the Emergency Department (ED) to the Neurology Intermediate Care Unit (nICU) on 01/28/25 at 12:17 A.M. and was on violent self-destructive restraint orders until 01/29/2025 at 7:21 P.M, (a period of approximately 43 hours). Medical record review of Patient #5 indicated that the form (the surveyor received this form on 01/29/25) for documenting the every 15 minute checks, titled “Behavioral Restraint Patient Observation, Baystate Health System-Non-Behavioral Units, Mental Status Observation q15 minutes,” (BRPO) was lacking the date of when the 15 minute checks were performed. Additionally, the form indicated 15 minute checks from a time period of 10:41 A.M. until 1:45 P.M, roughly 3 hours of every 15 minute checks documentation despite a total time period of 43 hours of Patient #5 on violent self-destructive restraints in the nICU (from 01/28/25 at 12:17 A.M. until 01/29/2025 at 7:21 P.M). The surveyor interviewed the Patient Safety Coordinator (PSC) on 02/03/2025 at 2:00 P.M. The PSC confirmed that there were no other BRPO forms in Patient #5’s medical record for the 43 hour period that Patient #5 was on violent self-destructive restraint orders in the nICU. The PSC said that only the undated BRPO indicating roughly three hours of 15 minute checks, was the only BRPO form that could be located. The PSC said it was required that hospital staff must fill out a BRPO form for every patient that is on violent, self-destructive restraint orders.”

“DELIVERY OF ANESTHESIA SERVICES CFR(s): 482.52(b) Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of pre-anesthesia and post-anesthesia responsibilities. The policies must ensure that the following are provided for each patient: This Standard is not met as evidenced by: 39257 Based on interviews the hospital failed for one (patient #4) of ten patients sampled, to appropriately deliver anesthesia services consistent with recognized standards for anesthesia care. Findings Include: The hospital report, submitted to the to the Department of Public Health (DPH) on 02/17/2024, reported that Patient #4 presented to the hospital for a lithotripsy procedure (a medical procedure used to break up and remove stones (such as kidney stones) in the urinary tract) in the Operating Room (OR). Once the procedure was completed, Patient #4 was being awakened from anesthesia and became hypoxic (low oxygen levels in the body’s tissues) and a code blue was called. The patient was noted to be pulseless, and anesthesia commenced cardiopulmonary resuscitation (CPR). Massive aspiration (breathing foreign objects into the lungs) of gastric (stomach) contents was noted. Despite all efforts of the team, and after discussion with Patient #4’s wife, it was decided to stop CPR, and Patient #4 was declared deceased. The surveyor interviewed the Chair of Anesthesia (CoA) on 02/03/2025 at 10:00 A.M. and again at 3:00 P.M. The CoA said that Patient #4 was ordered for supplemental oxygen during Patient #4’s lithotripsy procedure. The CoA said that there was one concern after the CoA reviewed the anesthesia record and after a conversation between the CoA and the attending anesthesiologist for Patient #4 (Anesthesiologist #1) regarding Patient #4’s anesthesia during the operation/procedure. The CoA said that the method of how Anesthesiologist #1 applied the supplemental oxygen to the patient was not in accordance with standard practice, not in accordance with hospital policy, and not typically how oxygen is given to a patient who requires supplemental oxygen during an operation/procedure. The CoA said that Anesthesiologist #1 created his/her own makeshift adapter when connecting Patient #4 to the anesthesia machine. It was Anesthesiologist #1’s own method to deliver oxygen to Patient #4 as Patient #4 was more than six feet away from the anesthesia machine (due to the type of procedure, amount of equipment involved, patient distance from the anesthesia machine was farther relative to other procedures). The CoA said that the standard practice would have been to retrieve readily available, commercially manufactured equipment called extension tubing, that would allow for Patient #4 to be connected to the anesthesia machine despite Patient #4 being placed more than six feet from the anesthesia machine. The CoA added that Anesthesiologist #1’s makeshift adapter was a deviation from that standard practice. The CoA said that Anesthesiologist #1 created this makeshift adapter by cutting an endotracheal (ET) tube, and taking part of that ET tube to connect to the anesthesia circuit tubing. The CoA said that this makeshift adapter was not a manufacturer produced adapter. The CoA said that the standard practice would have been to use extension tubing. When the CoA inquired with Anesthesiologist #1 why Anesthesiologist #1 did not use extension tubing, Anesthesiologist #1 claimed that Anesthesiologist #1 did not have the extension tubing available. The CoA said that extension tubing is readily available and added that even if extension tubing was not in Patient #4’s OR at the time of preparation for Patient #4’s procedure, Anesthesiologist #1 could have asked an anesthesia technician to deliver extension tubing to Anesthesiologist #1. The CoA said that the circuit (also known as a circle circuit) created by Anesthesiologist #1’s version of delivering oxygen to Patient #4 involves a valve. If the valve is open, then there is no pressure in the circuit. This circuit system requires pressure if oxygen is to get delivered to the face mask and ultimately to the patient. The CoA said that Anesthesiologist #1 could not explain to the CoA whether that valve was open or closed, (an open valve meaning no pressure in the circuit system, which would mean oxygen delivery to the patient may be compromised and/or not being delivered to the patient). The CoA said that Patient #4 was induced (induction phase of anesthesia which is the beginning phase of general anesthesia when the patient starts to be sedated) at 10:14 A.M. At that time, the measured oxygen to Patient #4 was ranging 21 to 23%. The CoA said that standard room air oxygen concentration is 21%. However, the CoA said that based on Patient #4’s profile (being that Patient #4 was undergoing a procedure receiving general anesthesia and would be subject to intravenous (IV) sedation) it is typical that when giving supplemental oxygen, the oxygen concentration delivery should be upwards to the 50 to 60% range. However, the CoA said that the highest inspired oxygen concentration at the face mask up until 10:30 A.M. was 26%, far below the 50 to 60 % ideal range. The CoA said that the oxygen saturation of Patient #4 from 10:15 A.M. until 10:30 A.M. was ranging from the mid-70’s to the mid-80’s with a low point of 76, indicating Patient #4’s body was deficient of oxygen or oxygen deprived, for approximately 15 minutes (standard oxygen saturation ranges 95 to 100%). The CoA said that at approximately 10:30 A.M. Anesthesiologist #1 switched Patient #4 to a different oxygen mask that was directly connected to the anesthesia machine. The measured oxygen concentration at 10:30 A.M. at the face mask was now approaching 100%. The surveyor inquired with the CoA whether or not an autopsy was performed on Patient #4 and if so, did the CoA have a chance to review the autopsy report. The CoA said that the CoA did not look at any autopsy results, but the CoA added that the CoA believed it was the hypoxic arrest that contributed to the death of Patient #4. The surveyor asked the CoA if there was any education and/or training to anesthesia staff regarding the inappropriate practice of creating a makeshift adapter as a substitution for retrieving extension tubing for the purposes of providing supplemental oxygen when a patient is placed relatively far from the anesthesia machine. The CoA could not recall any education and/or training to the anesthesia staff.”