Allen County Regional Hospital

“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: 47233 Based on document review, record review, policy review and interview the Critical Access Hospital (CAH) failed to ensure the emergency medical treatment and labor act (EMTALA) requirements were met by failing to perform a medical screening exam (MSE), as requested, in a timely manner for a patient who presented to the emergency department seeking emergency medical care. Failure to perform a timely MSE places patients at risk for harm and injury up to an including death. Findings Include: Review of a document titled, “Medical Staff Rules and Regulations Allen County Regional Hospital” adopted on 05/26/2021 ... showed, “ ...All Active Medical Staff Members and other health care providers who possess appropriate education, training, experience, and clinical privileges including Physicians, Advanced Nurse Practitioners, and Emergency Department registered nurses with an appropriate position description may perform initial medical screening examinations of patients presenting to the Hospital in an emergency condition ... For the purposes of Emergency Department procedures, the term “Qualified Medical Professional” includes Physicians, Physician Assistants (PAs), and Advanced Practice Registered Nurses (APRNs). Qualified Medical Professionals are authorized to perform medical screening examinations and stabilizing treatment for patients in the Emergency Department as authorized under their scope of practice ...” Review of a document titled, “Medical Staff Bylaws of Saint Luke’s Hospital of Allen County, Inc.” approved by medical staff on 05/18/21 ...showed, “ ...RESPONSIBILITIES: Active Staff Members shall satisfy all the functions and responsibilities of appointment to the Active Staff, including: ...(b) providing emergency stabilization and continuity of care for unassigned patients as assigned by the President ...(l) complying with these Bylaws and the Rules and Regulations of the Medical Staff ... GENERAL DUTIES/ASSIGNMENT: Provision shall be made, either through assignment to Medical Staff committees or to interdisciplinary Hospital committees, or by participation on Board committees, for the effective performance of the Medical Staff functions described in Section 5.D.2 and all other Medical Staff functions required by these Bylaws, and of such other Medical Staff functions as the Executive Committee or the Board shall reasonably request. Such functions shall include, but not be limited to: ... providing ongoing evaluation of compliance with the provisions of the Emergency Medical Treatment and Active Labor Act (EMTALA) ...” Review of policy titled, “Patient Transfers and Emergency Medical Treatment and Labor Act (EMTALA), GA-063” revised 9/21/2022 showed, “ ...POLICY All persons receive an appropriate medical screening examination within Hospital’s capability to determine whether or not an emergency medical condition exists. If an emergency medical condition is found to exist, the Hospital will stabilize or transfer the patient in accordance with EMTALA ... Campus: Means the physical area immediately adjacent to the main Hospital building, any areas that are not strictly contiguous to the main Hospital buildings but are located within 250 yards of the main buildings, and any remote, off-campus, provider-based locations of the Hospital that are held out to the public as a place that provides emergency or labor and delivery services ... Comes to the Emergency Department: Means the individual (not yet a patient): A. Presents at the Hospital’s Emergency Department or on Hospital Property and examination or treatment for a medical condition is requested or it can reasonably be inferred that the individual needs examination or treatment for a medical condition; or B. Is in an ambulance on Hospital Property for presentation for examination and treatment for a medical condition at Hospital’s Emergency Department... ... B. The Location in Which the Medical Screening Examination Should Be Performed 1. If an individual arrives at the Hospital and is not in the Emergency Department, but is on Hospital Property and requests emergency care, he or she is entitled to an MSE. The MSE and other emergency services need not be provided in a location specifically identified as the Emergency Department ... The CAH failed to perform a timely MSE to determine if an emergency medical condition (EMC) existed for 1 of 20 patients (Patient 1) who presented to the emergency department (ED) seeking emergency medical care. (Refer to tag C2406)”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) and 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 47233 Based on record review, policy review, document review and interview the Critical Access Hospital (CAH) failed to perform a medical screening examination (MSE), as requested, in a timely manner to determine if an emergency medical condition (EMC) existed for 1 of 20 patients (Patient 1) who presented to the emergency department (ED) seeking emergency medical care. The CAH’s failure to perform a timely MSE has the potential to place patients at risk for adverse outcomes up to and including death. Findings Include: Patient 1 Review of a document titled, “V3.5 Prehospital Care Report” showed, [Patient 1] a 66-year-old male involved in a Motor Vehicle Accident (MVA) on 03/21/24 at 2:48 PM. Review of a document titled, “V3.5 Prehospital Care Report” showed, “ ...ACRH [Allen County Regional Hospital] was notified by 212 at 15:19 [3:19 PM] and report attempted. Advised to meet [helicopter]outside. ACRH again notified by 214 at 15:25 [3:25 PM] on arrival that [helicopter] had not arrived yet and we needed to come into ACRH as patient unstable, Door was lifted and we were allowed into bay ... 1525 [3:25 PM] Called ACRH ER and spoke to ER Nurse [Staff C, RN]. Asked [Staff C] to open the bay door as we were in the backup truck and did not have remote. [Staff C] Informed me she was informed the patient was not coming inside. I informed [Staff C] the patient was not stable and the helicopter had not yet arrived. She opened the door. She again said she was informed the patient was not coming inside. I asked her to send the doctor out to us, she said he was not coming. At that time, I could see and hear the helicopter coming. I rushed to the helo [sic] pad to inform [Staff K, EMT] of what was going on. He ran to assist us In bay. Pt started deteriorating more and after some life saving efforts, [Staff K] went into ER. We then were able to move patient into ER trauma room 2 ...” During an interview on 03/27/24 at 8:06 PM Staff C, RN stated that, there was a page that went out that the[Ambulance Service] was requesting Allen County assistance to meet at the Helicopter Pad. Staff C stated that she educated the nurses that the hospital is not allowed to take report unless the patient is coming in to be stabilized. A few minutes went by and [Ambulance Service] called and stated there were already at the ambulance bay, Staff C stated, “I told EMS [Emergency Medical Staff] that they couldn’t come in unless they were bringing me the patient, EMS hung up on me so I opened the big bay door. They came in, I met them at the glass sliding door. I attempted to tell them again I couldn’t take the patient if they wanted the helicopter team to take over. In the process of educating EMS, I told them if I come out there, we have to take the patient and stabilize or send with the helicopter team. EMS walked off and stated they would wait for helicopter crew since they had landed. The helicopter crew assessed patient and decided the patient was too unstable to transfer and they needed to stabilize. One of the helicopter crew notified me that they were bringing the patient in to stabilize. The patient was coding as they were bringing him in.” Review of Patient 1’s medical record showed, a 66-year-old male, was brought into the Emergency Department (ED) on 03/21/24 at 3:52 PM, 27 minutes after the patient arrived at the CAH’s ambulance bay, via EMS. Patient 1 arrived in critical condition with a chief complaint of MVA and cardiac arrest. Review of Patient 1’s record including a document titled, “ED Care Timeline” dated 03/21/24 at 3:52 PM, showed event “Code Start” Staff B, RN documented, “Pt. [sic] brought by [County EMS] for intercept w/ Air EMS to direct flight to KC [Kansas City] d/t MVC [motor vehicle collision] head on collision. pt. [sic] decompensated while in EMS truck, reported PEA [pulseless electrical activity] w/ EMS and Flight staff performing compressions. pt. [sic] brought to ED for stabilization for transfer. pt. [sic] intubated prior to arrival to EMS, pt. [sic] on spine board, c-collar, deformed LLE [left lower extremity] w [with]/ open fractures, open fractures to RLE [right lower extremity]. Rt. [right] humerus [upper arm bone] IO [intraosseous - directly into the bone] placed pta [prior to arrival]. 1 unit blood given prior to arrival, IO epinephrine x 2 given PTA. PEA on monitor upon arrival to ED Trauma 2. Code Blue in progress (27 minutes after arrival to facility via EMS). During an interview on 03/28/24 at 8:00 AM Staff A, MD stated that, one of the helicopter crew came into the ED and asked if the hospital would get them two units of O negative blood, I told them not without the patient being in the ED and having a medical record number. At that time, “I got up and walked out into the ambulance bay where EMS and Helicopter crews were performing CPR [cardiopulmonary resuscitation] at that time I took over.” During an interview on 03/28/24 at 12:47 PM, Staff K, EMT Flight Crew, stated that EMS reported the hospital will not let them in the facility, “when I arrived the patient was in the back of the ambulance in the ambulance bay, I was told that they initially wouldn’t even open the ambulance bay door. Our crew got in the truck and the patient needed more interventions we needed more blood I talked to Staff A, he said I cannot give you blood without an order; I said well then, I need to bring the patient inside, I walked off and said “see you in a minute” it wasn’t long and Staff A came out to the ambulance bay. “ Review of a document titled, “ACRH Incident Reports” dated 11/01/23 to 03/27/24 showed, “Several Emergency Medical Service providers throughout the region have expressed concern regarding a potential Emergency Medical Treatment and Active Labor Act violation at Allen County Regional Hospital. It was reported that both ground and air ambulance personnel responded to ACRH to transfer a critical trauma patient. It was reported the original plan was for the Ground Ambulance to rendezvous with the Air Ambulance at ACRH. Upon clinical deterioration of the patient, to the point they were hemodynamically unstable, Ambulance personnel attempted to present to ACRH ED with no avail for a period.” Patient 1 transferred to Hospital 2 on 03/21/24 at 4:50 PM by helicopter. Patient 1 was admitted to Hospital 2 on 03/21/24 at 5:45 PM with a diagnosis of motor vehicle accident and trauma red. Patient 2 expired on 03/22/24 at 3:53 AM.”

“PATIENT CARE POLICIES CFR(s): (1) The CAH’s health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law. This Standard is not met as evidenced by: 47233 Based on record review, policy review, document review and interview the Critical Access Hospital (CAH) failed to ensure the emergency department (ED) completed electrocardiogram (EKG) per CAH policy for 6 of 8 patients reviewed (Patient 2, 3, 12, 15, 16, and 19) who presented with chest pain or shortness of breath. The CAH’s failure to obtain an EKG in a timely manner has the potential to place patients at risk for unidentified medical needs and deterioration of their condition. Findings Include: Review of a CAH policy titled, “Management of Acute Coronary Syndromes (ACS), PC-081” Revised 09/05/23 showed, “To provide an outline for the stratification of patients that present with chest discomfort and the recommendations for treatment by the American College of Cardiology (ACC) and the American Heart Association (AHA). Hospital personnel will obtain an ECG within 5 minutes of arrival with a chief complaint of chest discomfort or symptoms indicative of cardiac ischemia. (Reference 12-Lead Electrocardiogram (ECG) in Lippincott) Physician will interpret the ECG within 10 minutes of arrival with chief complaint of chest discomfort...” Patient 2 Review of Patient 2’s medical record showed Patient 2 presented to the Emergency Department (ED) on 03/21/24 at 2:19 PM with a chief complaint of chest pain, back pain and nausea and discharged home on 03/21/24 at 7:31 PM after Medical Screening Exam (MSE) ruled out Emergency Medical Condition (EMC). The medical record showed an Electrocardiography (EKG) (an electrical recording of the hearts activity) was interpreted on 03/21/24 at 3:33 PM, 14 minutes after arrival, and not within 10 minutes as required by policy. Patient 3 Review of Patient 3’s medical record showed Patient 3 presented to the ED on 12/15/23 at 6:56 PM with a chief complaint of sharp localized left side chest pain and discharged home on 12/15/23 at 9:01 PM after MSE ruled out EMC. The medical record showed an Electrocardiography (EKG) (an electrical recording of the hearts activity) was interpreted on 12/15/23 at 9:01 PM, 29 minutes after arrival, and not within 10 minutes as required by policy. Patient 12 Review of Patient 12’s medical record showed Patient 12 presented to the ED on 12/11/23 at 1:08 PM with a chief complaint of shortness of breath and discharged home on 12/11/23 at 4:00 PM after MSE ruled out EMC. The medical record showed an EKG was interpreted on 12/11/23 at 1:19 PM, 12 minutes after arrival, and not within 10 minutes as required by policy. Patient 15 Review of Patient 15’s medical record showed Patient 15 presented to the ED on 01/07/24 at 11:36 PM with a chief complaint of shortness of breath and Patient 15 was transferred to a higher level of care on 01/08/24 at 6:05 AM after MSE ruled out EMC and patient stabilized within hospital capabilities. The medical record showed an EKG was interpreted on 01/07/24 at 11:30 PM, 14 minutes after arrival, and not within 10 minutes as required by policy. Patient 16 Review of Patient 16’s medical record showed Patient 16 presented to the ED on 02/13/24 at 6:24 PM with a chief complaint of shortness of breath and discharged home on 02/13/24 at 9:43 PM after MSE ruled out EMC. The medical record showed an EKG was interpreted on 02/13/24 at 6:43 PM, 19 minutes after arrival, and not within 10 minutes as required by policy. Patient 19 Review of Patient 19’s medical record showed Patient 19 presented to the ED on 03/21/24 at 5:40 PM with a chief complaint of chest pain and discharged home on 03/21/24 at 8:08 PM after MSE ruled out EMC. The medical record showed an EKG was interpreted on 03/21/24 at 5:57 PM, 17 minutes after arrival, and not within 10 minutes as required by policy. During an interview on 03/27/24 at 8:53 AM with Staff H, RN stated, “ ...ECG times are a work in progress and unsure how often they meet door to ECG times, but hospital would like to meet 5 minute time frame ...” During an interview on 03/28/24 at 8:00 AM with Staff A, MD stated that, the problem with delayed EKG’s is Respiratory Therapy (RT) is called to ED to do EKG and we are waiting on the RT to come perform the EKG. During an interview on 03/28/24 at 8:38 AM with Staff B, RN stated that, we have standing orders to call RT to do an EKG but we are all capable of obtaining EKG. During an interview on 03/28/24 at 9:30 AM with Staff I, RT stated that, if a patient comes in with chest pain the staff call us to do the EKG if we are not available, they can do their own.”