St Luke’s Regional Medical Center

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 44100 Based on ED log review, medical record review, EMS record review, recorded audio review, and staff interview, it was determined the hospital failed to ensure emergency services were provided in compliance with 42 CFR Part 489.24. Refer to A 2407 as it refers to hospital failure to ensure stabilizing treatment in a timely manner. Refer to A 2409 as it refers to hospital failure to ensure an appropriate transfer.”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 44100 Based on medical record review, policy review, EMS documentation, audio recording review, and staff interviews, it was determined the Hospital failed to provide necessary stabilizing treatment within its capabilities for 1 of 22 patients (Patient #17) with an Emergency Medical Condition (EMC) in accordance with 42 CFR §489.24 and whose medical records were reviewed. Findings include: A Policy titled, “EMTALA and Transfers into or out of [Hospital A system],” revised date 4/2/25, was reviewed. This policy stated, “If the MSE indicates that the person has an EMC, [Hospital A] will: 1. Provide necessary stabilizing treatment within the capabilities of staff and facilities routinely available, which may include consulting with on-call specialists or use of ancillary services.” A policy titled “Provision of Patient Care Plan for Emergency Services” revised date 12/23/24, was reviewed. The policy stated “Emergency Department triage, examination, treatment, stabilization, and coordination of disposition and follow up care for patients of all ages - newborn to geriatric experiencing any emergency medical condition, ... Service provided shall be integrated and coordinated throughout the facility. Processes to assure integration and coordination include, but are not limited to: A. Establishing multidisciplinary care-teams and committees to address patient care issues.” An Algorithm titled “Transfer Center Peds Trauma Algorithm”, revised date 10/02/25, was reviewed. The algorithm includes “Patient 15-17-year-olds Connect with [Hospital B] for consult/transfer. If [Hospital A system] provider requests to speak with [Hospital A system] peds trauma provide connection. Pts with complex, peds-specific needs may be accepted to [Hospital A system] case-by-case.” These policies were not followed. An example includes: Patient #17, a 16-year-old male, arrived at [Hospital A] ED on 03/01/2026 at 12:20 AM via EMS following a high-velocity snowboard accident. The EMS run sheet reported hypotension (BP 52/43) and “seizure-like activity.” The EMS run sheet documented provision of fluids and BP improvement. The EMS run sheet further documented a “Priority 1 trauma alert is called into [Hospital A] with Pt acuity, vitals, interventions ETA of l0 minutes approximate. Upon arrival, RN reports that they will not be leveling the trauma as initially recommended by lead paramedic.” [Hospital A] medical record for Patient #17 documented a BP on arrival at 12:21 of 96/48. CTs were ordered at 12:34 AM. At 01:17 AM, the ED physician was notified of critical CT results which included a subclavian artery injury with active extravasation and a large hemothorax with mediastinal shift. Review of Patient #17’s medical record, hospital on-call logs and staff interviews revealed the following failures in stabilizing treatment: 1.Diagnosis: CT Chest Abdomen Pelvis with IV Contrast was ordered at 12:34 AM, results were not provided until 1:17 AM. CT results identified a “right subclavian artery injury with active arterial contrast extravasation and a large hemothorax with mediastinal shift.” 2. Specialist Resource Availability: Review of the on-call logs for 03/01/2026 identified a Cardiothoracic (CT) Surgeon was available. Medical records and interviews showed this specialist was not contacted regarding Patient #17’s arterial injury until he was being moved to the gurney for transfer at approximately 01:50 AM. 3. Clinical Status and Delay: Between 01:17 AM and 01:50 AM, while Patient #17 was stable for much of the time, nursing care summary recorded the patient “actively decompensating” with a heart rate of 160, respirations of 43, unmeasurable blood pressure, and oxygen saturation of 85% at 1:50 AM. During this 33-minute interval, audio recordings of the transfer center confirmed the ED Physician was on the phone for 25 minutes discussing the case with Hospital B. 4. Internal Protocols: Facility A’s Pediatric Trauma algorithm (designated for ages 15-17 on a “case-by-case” basis) was not utilized. Observations of the physician work areas on 04/06/2026 showed this specific algorithm was not posted or available for staff reference. 5. Patient #17’s medical record showed that TXA, a medication used to control excessive bleeding, was administered at 1:43 AM, 26 minutes after the bleed was reported by CT and 87 minutes after arrival to the ED and only after the suggestion of Hospital B’s trauma physician. 6. Patient #17’s medical record documented his oxygen saturation dropped to 85% with respirations of 43 and no obtainable blood pressure at 01:50 AM. Patient #17 was transported to Hospital B, leaving Hospital A at 2:06 AM. Two units of blood were ordered and administered during transport to Hospital B. Patient #17 arrived at Hospital B at 2:18 AM. Hospital B’s medical record for Patient #17 documented chest tube placement at 2:20 AM and massive transfusion protocol initiated with a total of 19 units administered. Patient #17 coded several times in the ED and required resuscitative CPR and administration of rescue medications. Patient #17 required a sternotomy prior to being taken into surgery at 3:17 AM. Patient #17 died on 3/3/26. The lead pediatric trauma nurse was interviewed on 4/6/26, beginning at 2:30 PM. The nurse confirmed that there is a caveat for 15-17 [the trauma team] is happy to consult but it is initiated by the ED provider. The On-Call Cardiothoracic Surgeon was interviewed on 04/06/2026 beginning at 4:00 PM. The CT surgeon confirmed he was only notified of the patient’s status when the patient was “already being moved to the gurney for transfer.” The CT surgeon, “If I had been contacted earlier, I might have considered whether there was anything we could do locally, but mobilizing a surgical team here would likely have taken 45 minutes to an hour, which could have caused further delay.” The ED physician was interviewed on 04/05/2026, beginning at 3:30 PM. The ED Physician stated, “It has been very clear in my practice that patients 14 years and younger are managed in-house, and those 15 and older are sent to [Hospital B].” When asked about the Hospital’s Pediatric Trauma algorithm (allowing for 15-17-year-olds), the physician stated he “had never seen this algorithm.” Patient #17 did not depart Hospital A until 02:06 AM, one hour and fifty minutes after arrival. Hospital A failed to utilize its available on-call surgical resources and specialized pediatric trauma capabilities to provide stabilizing treatment for a life-threatening vascular injury, which resulted in a critical delay in care and a fatal outcome. Hospital A failed to utilize its available resources and capabilities to provide stabilizing treatment.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 44100 Based on medical record review, policy review, EMS documentation, audio recording review, and staff interviews, it was determined the Hospital failed to provide an appropriate transfer for 1 of 22 patients (Patient #17) with an Emergency Medical Condition (EMC) in accordance with 42 CFR §489.24 and whose medical records were reviewed. Findings include: A Policy titled, “EMTALA and Transfers into or out of St. Lukes Health System Facilities,” last updated 4/2/25, was reviewed. This policy stated, “If the MSE indicates that the person has an EMC, St. Luke’s will: 1. Provide necessary stabilizing treatment within the capabilities of staff and facilities routinely available, which may include consulting with on-call specialists or use of ancillary services.” It was unclear if this policy was followed. Example includes: Patient #17, a 16-year-old male, arrived at the ED on 03/01/2026 at 00:20 AM via EMS following a high-velocity snowboard accident. The EMS run sheet reported hypotension (BP 52/43) and “seizure-like activity.” The EMS run sheet documented provision of fluids and BP improved. The EMS run sheet further documented a “Priority 1 trauma alert is called into [Hospital A] with Pt acuity, vitals, interventions ETA of l0 minutes approximate. Upon arrival, RN reports that they will not be leveling the trauma as initially recommended by lead paramedic.” Under EMTALA guidelines, an appropriate transfer of an unstable individual requires the transfer be affected through qualified personnel and transportation equipment, and that the transferring hospital minimizes the risks to the individual’s health. The Hospital failed to meet these requirements as evidenced by the following: 1. Unnecessary Delays in Effecting Transfer: Despite the findings and notification to the ED physician of an active arterial bleed at 01:17 AM, Patient #17 did not depart Hospital A until 02:06 AM (49 minutes after the life-threatening findings were confirmed). 2. The ED physician engaged in a 25-30 minute phone conversation with Hospital B regarding procedures (chest tube insertion, administration of TXA) while the patient was declining into acute respiratory distress and exhibiting seizure-like activity. TXA was administered at 1:43 AM (26 minutes after diagnosis of bleed) after suggestion from Hospital B trauma provider during consult phone conversation. 3. Inadequate Monitoring and Intervention Prior to Departure: Patient #17’s medical record documented his oxygen saturation dropped to 85% with respirations of 43 and no obtainable blood pressure at 01:50 AM. Per medical record and EMS run record, Patient #17 was then transported to Hospital B at 2:06 AM. Additional TXA was administered at 1:53 AM but no additional interventions were documented in the medical record. While enroute to Hospital B, Patient #17 received 2 units of blood. 4. Transfer Center Audio Recordings: A review of recordings between 01:17 AM and 01:50 AM confirmed significant confusion regarding the patient’s stability. The ED physician was heard stating, “the patient has now started to become unstable... things are happening very quickly now,” yet the patient remained at Hospital A for another 15 minutes following this statement. 5. Patient #17’s medical record included an RN care summary at 02:07 AM (post-transfer) which documented the patient was “actively decompensating and agitated, unable to obtain blood pressure” at the time the transport team arrived. Patient #17 arrived at Hospital B at 2:18 AM. Hospital B’s medical record for Patient #17 documented chest tube placement at 2:20 AM and massive transfusion protocol initiated with a total of 19 units administered. Patient #17 coded several times in the ED and required resuscitative CPR and administration of rescue medications. Patient #17 required a sternotomy prior to being taken into surgery at 3:17 AM. Patient #17 died on 3/3/26. The ED physician was interviewed on 4/6/26 beginning at 3:30 PM and was asked about the 25-minute delay on the phone while Patient #17 was unstable. The ED physician stated, “Part of that time included the transport team being at the bedside while the patient’s condition changed. He was stable when I made the initial call, but when he became unstable, I felt it was important to notify the receiving team so they would be prepared.” ED physician additionally stated “Things were moving very quickly... when I heard their trauma surgeon consulting vascular and then cardiothoracic surgery, I recognized the complexity... That was also part of the reason I did not involve our pediatric trauma team.” The On-Call Cardiothoracic Surgeon was interviewed on 04/06/2026 beginning at 4:00 PM. The CT surgeon confirmed, “I was not contacted until the patient was already being prepared for transfer. By that time, I was told the patient was on the gurney and the transport team was present. If I had been contacted earlier, I might have considered whether there was anything we could do locally, but mobilizing a surgical team here would likely have taken 45 minutes to an hour, which could have caused further delay.” The Hospital failed to affect a timely and appropriate transfer.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 44100 Based on medical record review, policy review , grievance review, and staff interviews, it was determined the hospital failed to ensure care in a safe setting for 1 of 10 patients (Patient # 14 ) whose records were reviewed and were seen in the ED. This had the poteintial to affect all patients seen in the ED. Findings include: A hospital policy titled, “Safe Patient Handling and Mobility (SPHM), PE031 SLHS,” last revised 1/29/24, was reviewed. The policy stated, “Assessment for Safe Patient Handling and Mobility (SPHM): performed by a licensed clinician to examine and evaluate the physicial, mental, cognitive, medical, and/or environmental conditions of a healthcare recipient to determine appropriate SPHM methods, technology, and equipment or assistive devices used during patient care.” The policy also stated, under compliance, “Healthcare workers will use best practice methods for patient handling and mobility tasks including the use of mechanical lifting devices and/or other approved safe patient handling aids and techniques for patient handling and mobility tasks.” The policy also stated, under SPHM Injury Prevention: “Examples of controls for patient handling injury prevention: 1. Eliminiate: Remove the hazard by not manually lifting patient.” This policy was not followed. A hospital policy titled, “Patient Rights and Responsibilities Policy, PA014 SLHS, last revised 8/27/25, was reviewed. The policy stated, “All patients of [hospital] have the following rights:...Respect, consideration and dignity...to be actively involved in consenting to treatment and in development and implementing of their plan of care.” This policy was not followed. Example includes: Patient #14 was a 66 year old female who presented with her caregiver to the ED on 7/24/25 with a chief complaint of increased pain due to parasites. Patient #14 had comorbidities which included quadriplegia and autonomic dysreflexia. Patient #14 had a CT abdomen and pelvis with unremarkable results. Patient was discharged to home with specific instructions to return with worsening symptoms. Patient and caregiver requested a hoyer lift to assist with transfer from gurney to wheelchair upon discharge. Patient was informed there was no hoyer lift available in the ED. A nurse apprentice attempted to transfer patient from gurney to wheelchair at which time patient slid onto the floor. The nurse apprentice picked up patient #14 from the floor and put patient into her wheelchair. The nurse apprentice was interviewed on 9/9/25 beginning at 1:20 PM. He stated he was familiar with Patient #14. He was asked if Patient #14 requested a hoyer lift when she was discharged. He stated that she did, but that they rarely use hoyer lifts as there are none in the ED. He could call for transport to assist but that “he has lifted thousands of patients himself.” He was asked if Patient #14 complained of pain after the fall and he stated that she did not complain of pain any greater than when she came in and that she and her caregiver were “just in a hurry to get out of there.” The ED nurse manager was interviewed on 9/9/25 beginning at 1:20 PM. She stated that the nurse apprentice did notify her of the incident after the occurrence. When asked about using a hoyer lift, she stated they were rarely used in the ED. When asked if a hoyer lift could be used in the ED, she stated that yes, they could call transport to bring a hoyer lift down to the ED. She stated that they have lift sheets and manpower to typically transfer patients. Patient #14 returned to the ED at a sister hospital the following day, 7/25/25, with a complaint of bilateral leg pain after she was dropped in the ED on 7/24/25. X-Rays of bilateral legs and ankles were completed and showed no indication of fractures. She was discharged with instructions to return to the ED with further concerns. Patient #14 was brought in by ambulance on 7/26/25 to the ED again. Patient #14 complained of pain to her pelvis after the fall in the ED on 7/24/25. A CT pelvis was completed with no indications of further fractures or injuries. Patient #14 was returned home via nonemergency medical transport. Patient #14 again requested a hoyer lift to assist with transfer from gurney to medical transport gurney but was told none was available. Patient #14 was successfully transferred with a 4 person assist and transported to home. The hospital failed to ensure all patients were cared for in a safe environment and also failed to ensure Patient #14 was treated with respect and dignity and allowed to be actively involved in her plan of care.”