Burgess Health Center

“CLINICAL RECORDS CFR(s): §485.638 Condition of Participation: Clinical Records This Condition is not met as evidenced by: 50212 Based on medical record review, policy review, observations, and staff interviews, the Critical Access Hospital’s (CAH’s) administrative staff failed to ensure attending physicians produced and maintained appropriate clinical records for all patients as follows per hospital policy and Medical Staff Bylaws: 1. Attending physicians failed to maintain complete and accurate clinical records per hospital policy and Bylaws, including documentation of pertinent past medical history and medical screening examinations. (see C-1104); 2. Hospital staff failed to produce evidence of properly executed informed consents per hospital policy, including documentation of the time of patient consent and name/signature of the person who explained the procedure(s) to the respective patient or guardian. (see C-1110); and 3. Hospital staff failed to implement appropriate protective measures to maintain the confidentiality of clinical records, including preventing access to clinical records by unauthorized individuals. (see C-1120). The cumulative effect of these systemic failures and deficient practices resulted in an inability of the CAH’s administrative staff to ensure the quality, reliability, and confidentiality of services provided to patients met acceptable standards of practice, resulting in an increased risk of adverse health and privacy outcomes for patients.”

“RECORDS SYSTEM CFR(s): The records are legible, complete, accurately documented, readily accessible, and systematically organized. This Standard is not met as evidenced by: 50212 Based on medical record review, policy review, and staff interviews, the CAH’s administrative staff failed to ensure all attending physicians produced complete and accurate clinical documentation per hospital policy and Medical Staff Bylaws for 4 of 21 patients sampled (Patients #3, #12 #14 and #29). Failure to produce and maintain a complete and accurate set of clinical records could result in missed diagnoses of emergency medical conditions (EMCs) and reduced quality of care, each of which increase patients’ risk of suffering adverse outcomes, which could include a deterioration in health, disability, or death. A complete set of clinical records comprises all orders, test results, evaluations, treatments, interventions, care provided, and the patient’s response to treatments, interventions, and care. Findings include: 1. Review of the CAH’s 2/28/22 Medical Staff Bylaws revealed the following: “Article VI: Medical Staff Membership . . . Responsibilities of Membership . . .Timely complete and sign medical records for all Hospital patients to whom the member provides care in accordance with all Hospital and Medical Staff policies.” 2. Further review of the CAH’s 2/28/22 Medical Staff Bylaws revealed the following: “Article XIII: Committees of the Medical Staff . . . Other Committee Functions . . . The Executive Committee shall be responsible for carrying out, on a regular basis and according to established schedules, Medical Staff functions relating to medical records . . . In the event that any of the functions enumerated below are delegated to subcommittees, the President of the Medical Staff shall appoint a chair of such subcommittee from among the members of the Medical Staff. The specific functions to be carried out include, in addition to other functions designated from time to time, the following: a. Medical Records. Examine medical records and be responsible for their maintenance with the required standards. Currently maintained records will be reviewed to assure that they properly describe the condition and progress of the patient, therapy provided and outcomes, and that they meet the criteria of medical comprehension of the case in the event of transfer of physician responsibility for patient care.” 3. Further review of the CAH’s 2/9/22 Medical Staff Rules and Regulations revealed the following: “...Medical Records...Attending Physician Duties...The attending physician (and when applicable, other attending practitioners) shall be held responsible for the preparation of a complete medical record for each patient. This record shall include . . . complaint, personal history . . . history of present illness, physical examination . . . provisional diagnosis on admission . . . progress notes, final diagnosis, condition on discharge . . .” 4. Review of the CAH’s 2/9/22 Medical Staff Rules and Regulations revealed the following: “... Progress Notes. Pertinent progress notes shall be completed at the time of observation, sufficient to permit continuity of care. Wherever possible, the patient’s clinical problems shall be identified in the progress notes and correlated with specific orders as well as the results of tests and treatment.” 5. Further review of the CAH’s 2/9/22 Medical Staff Rules & Regulations revealed the following: “An appropriate medical record shall be kept for every person presented for treatment in the emergency room. Such record should include identification of person; information concerning time and means of arrival; pertinent details of injury or illness for which treatment sought including history and physical, emergency care provided prior to arrival, and vital signs; description of examination, treatment, and advice rendered, including diagnostic and therapeutic orders and clinical observations; whether a physician was called and, if so, matters communicated to and from the physician; reports of treatment, test and results; diagnosis; and conclusion of treatment. Should the person leave the hospital, the record should also include a description of the person’s condition at that time, the person’s reason for leaving, destination, instructions given to patient and/or family, and whether the departure was against the advice of clinical staff.” 6. Review of the policy “Access and Maintenance of the Electronic Health Record” revealed the following: “(the hospital) will create a complete electronic health record (EHR) for each patient.” 7. Review of the policy “Clinical Pertinence Review” revealed the following: “The medical record contains . . . the record and findings of the patient’s assessment; a statement of the conclusions or impressions drawn from the medical history and physical examination; the diagnosis or diagnostic impression . . . The history and physical includes chief complaints, details of present illness, relevant past/social/family history, body system inventory, physical exam, conclusions/impressions, (and) plan of treatment . . . Assessments for Emergency Room patients shall include final disposition, patient’s condition and instructions for follow up care.” 8. Review of the policy “Emergency Medical Treatment and Active Labor Act (EMTALA) “revealed that appropriate documentation of an MSE should include the following: “ongoing vital signs including temperature, pulse, respiration, and blood pressure; pain scale and supporting details; documentation of allergies and/or medical conditions; description of injury or illness; and diagnostic testing (laboratory and radiology). Additionally, appropriate ED record documentation should include the following: “history, physical exam; assessment of whether the individual had an emergency medical condition; actions taken to determine condition and interventions provided; results of any diagnostic testing and narrative describing QMP or Physician findings, conclusions and plan of care; discharge/transfer vitals . . . “ 9. Review of Patient #3’s medical record revealed: a. The face sheet, dated 2/9/24, for Patient #3’s medical record identified Staff F ED Physician as the attending physician of the patient. b. Documentation in the medical record revealed Staff B ED RN documented Patient #3 presented to the ED on 2/9/24 at 3:45 AM with complaints of intermittent back pain at approximately 28-weeks of pregnancy. Further review of the documentation revealed Staff B informed Staff F ED Physician of the patient’s symptoms, and Staff F determined the reported symptoms indicated possible contractions. Staff F ED Physician instructed Staff B to recommend Patient #3 contact their Obstetric (OB) provider via phone and travel to their OB provider in another town approximately 38 miles away. c. The medical record did not contain evidence Staff F ED Physician (Attending Physician) signed the medical record, completed a progress note, documented their findings related to an MSE, or documented any treatment orders-including orders for discharge. 10. During an interview on 3/4/24 at 1:00 PM, Staff F ED Physician confirmed their presence in the ED upon Patient #3’s arrival and confirmed that they did not document their findings related to the patient’s presenting complaints or symptoms, did not provide any orders for testing or treatment, including orders for discharge, and did not document their medical decision-making in the patient’s medical record. 11. Review of Patient #12’s medical record revealed: a. The face sheet, dated 8/31/23, for Patient #12’s medical record identified Staff DD ED Provider/Physician Assistant as the attending physician of the patient. b. Documentation in the medical record revealed Staff C ED Critical Care Paramedic (CCP) documented Patient #12 presented to the ED on 8/31/23 at 3:47 PM with complaints of vaginal bleeding of unknown etiology and a PMH significant for recent pregnancy and preexisting kidney stone, status post placement and removal of a nephrostomy tube and subsequent placement of a ureteral stent. Further review of the documentation revealed Staff C informed Staff DD ED Provider/Physician Assistant of the patient’s symptoms, and Staff DD determined the patient did not have an EMC. c. The medical record did not contain evidence Staff DD ED Provider/Physician Assistant (Attending Physician) signed the medical record, completed a progress note, provided support for a diagnosis, documented their findings related to an MSE, or documented any treatment orders including orders for discharge. 12. Review of Patient #14’s medical record revealed: a. The face sheet, dated 8/26/23, for Patient #14’s medical record identified Staff D ED Physician as the attending physician of the patient. b. Documentation in the medical record revealed Staff J ED CCP documented Patient #14 presented to the ED on 8/26/23 at 11:12 PM with complaints of nausea and cramping at 4-6 weeks of pregnancy with a PMH significant for 3 previous miscarriages. Staff J ED CCP alerted Staff D ED Physician of the patient’s vital signs and signs and symptoms associated with the patient’s chief complaint. Per the documentation, the patient requested fetal monitoring services, to which Staff D ED Physician informed the patient the CAH lacked such capabilities. Further review of the documentation revealed Staff D ED Physician determined the patient did not have an EMC. c. The medical record did not contain evidence Staff D ED Physician (Attending Physician) signed the medical record, completed a progress note, provided support for a diagnosis, documented their findings related to an MSE, or documented any treatment orders-including orders for discharge. Additionally, Staff D ED Physician failed to accurately document the patient’s final disposition as having left against medical advice (AMA). 13. During an interview on 5/14/24 at 4:15 PM, Staff D ED Physician (Attending Physician) confirmed their presence in the ED upon Patient #14’s arrival and confirmed that they did not document their findings related to the patient’s presenting complaints or symptoms, did not provide any orders for testing or treatment-including orders for discharge, and did not document their medical decision-making in the patient’s medical record. 14. Review of Patient #29’s medical record revealed: a. The face sheet, dated 12/7/23, for Patient #29’s medical record identified Staff D ED Physician as the attending physician of the patient. b. Documentation in the medical record revealed Staff BB ED RN documented Patient #29 (3-year-old child) presented to the ED on 12/7/23 at 9:05 PM with symptoms characterized as a coughing fit, excessive crying, and a period of unresponsiveness. Further review of the documentation revealed Staff BB ED RN informed Staff D ED Physician of the patient’s symptoms. Staff D ED Physician determined the patient did not have an EMC and recommended the patient follow-up with their Primary Care Provider (PCP). c. The medical record did not contain evidence that Staff D ED Physician (Attending Physician) signed the medical record, completed a progress note, provided support for a diagnosis, documented their findings related to an MSE, or documented any treatment orders-including orders for discharge. 15. During an interview, on 3/5/24 at 10:30 AM, Staff N Director of Emergency & Inpatient Services reported that the minimum expectations for documentation on ED patients include vital signs, chief complaint, signs and symptoms, consultation between the CCP or RN and provider, medical recommendations(s) of the provider, and final disposition. Staff N acknowledged that the CAH’s attending providers failed to meet these expectations for all patients who presented to the ED for medical care. 16. During an interview, on 5/22/24 at 7:00 AM, Staff O ED Medical Director confirmed their presence on and oversight of the Executive Committee responsible for ensuring attending physicians met their obligations to ensure every patient (including ED patients) have a complete medical record that meets the required standards set forth by the Board of Directors, applicable standards of practice, and state and federal regulations. Staff O acknowledged prevalent and ongoing difficulties related to attending providers failing to maintain complete and accurate clinical records for all patients, for which the CAH has implemented disciplinary measures as part of previous corrective actions to attenuate the occurrence of incomplete clinical documentation, including the imposition of monetary fines. The cumulative effect of these deficient practices resulted in a systematic failure to maintain complete and accurate clinical records, which in turn poses a potential risk of a serious adverse outcome for patients whom the CAH’s administrative staff failed to ensure attending providers appropriately documented pertinent findings related to the respective patients’ PMH and/or MSE. Proper documentation of patients’ PMH and MSE informs the continuing treatment and care of patients; therefore, the absence of proper documentation poses a potential risk of administering contraindicated (inappropriate or ill-advised) medications or procedures, which could result in serious adverse outcomes up to and including death.”

“RECORDS SYSTEM CFR(s): For each patient receiving health care services, the CAH maintains a record that includes, as applicable-- (i) Identification and social data, evidence of properly executed informed consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient; This Standard is not met as evidenced by: 50212 Based on medical record review, policy review, and staff interview, the CAH’s administrative staff failed to ensure attending providers maintained clinical records that include evidence of a properly executed informed consent form (ICF) for 14 of 20 sampled patients (#12, #14, #21, #23, #25, #26, #28, #29, #30, #31, #32, #33, #34 and #35) who presented to the ED for emergency medical services. Failure to document each necessary component of an ICF could prevent verification that CAH staff properly obtained informed consent prior to initiating patient treatment. Findings include: 1. Review of the policy “General Consents” revealed “A patient’s medical record must contain evidence of the patient’s or his/her legal representative’s general consent for treatment during each inpatient or outpatient encounter.” The policy did not stipulate the following requisite components of a properly executed informed consent: time of patient consent, name of procedure(s), name of practitioner(s) performing the procedure(s), statement that the patient or guardian received an explanation of the procedure, signature of professional person witnessing the consent, and name/signature of person who explained the procedure to the patient or guardian. 2. Review of the CAH’s 2/28/22 Medical Staff Bylaws revealed the following: “Article VI: Medical Staff Membership . . . Responsibilities of Membership . . .Timely complete and sign medical records for all Hospital patients to whom the member provides care in accordance with all Hospital and Medical Staff policies. “ 3. Further review of the CAH’s 2/28/22 Medical Staff Bylaws revealed the following: “Article XIII: Committees of the Medical Staff . . . Other Committee Functions . . . The Executive Committee shall be responsible for carrying out, on a regular basis and according to established schedules, Medical Staff functions relating to medical records . . . In the event that any of the functions enumerated below are delegated to subcommittees, the President of the Medical Staff shall appoint a chair of such subcommittee from among the members of the Medical Staff. The specific functions to be carried out include, in addition to other functions designated from time to time, the following: a. Medical Records. Examine medical records and be responsible for their maintenance with the required standards. Currently maintained records will be reviewed to assure that they properly describe the condition and progress of the patient, therapy provided and outcomes, and that they meet the criteria of medical comprehension of the case in the event of transfer of physician responsibility for patient care. “ 4. Further review of the CAH’s 2/9/22 Medical Staff Rules and Regulations revealed the following: “...Medical Records...Attending Physician Duties...The attending physician (and when applicable, other attending practitioners) shall be held responsible for the preparation of a complete medical record for each patient. This record shall include . . . complaint, personal history . . . history of present illness, physical examination . . . provisional diagnosis on admission . . . progress notes, final diagnosis, condition on discharge . . .” 5. During an interview on 5/20/24 at 1:19 PM, Staff M (Director of Compliance & Quality) reported that the CAH’s staff did not document the time of patient consent when using a paper Consent for Treatment form in lieu of the electronic equivalent. 6. Review of 20 patient medical records revealed the following: a. Review of the medical record for Patient #12 revealed: 1) The face sheet, dated 8/31/23, for Patient #12’s medical record identified Staff DD ED Provider/Physician Assistant (PA) as the attending physician of the patient. 2) On 8/31/23, the CAH’s administrative staff failed to ensure Staff DD ED Provider/PA (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. b. Review of the medical record for Patient #14 revealed: 1) The face sheet, dated 8/26/23, for Patient #14’s medical record identified Staff D ED Physician as the attending physician of the patient. 2) On 8/26/23, the CAH’s administrative staff failed to ensure Staff D ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. c. Review of the medical record for Patient #21 revealed: 1) The face sheet, dated 5/14/24, for Patient #21’s medical record identified Staff EE ARNP as the attending physician of the patient. 2) On 5/14/24, the CAH’s administrative staff failed to ensure Staff EE ARNP (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. d. Review of the medical record for Patient #23 revealed: 1) The face sheet, dated 5/13/24, for Patient #23’s medical record identified Staff DD ED Provider/PA as the attending physician of the patient. 2) On 5/13/24, the CAH’s administrative staff failed to ensure Staff DD ED Provider/PA (Attending Physician Assistant) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. e. Review of the medical record for Patient #25 revealed: 1) The face sheet, dated 5/12/24, for Patient #25’s medical record identified Staff FF ED Physician as the attending physician of the patient. 2) On 5/12/24, the CAH’s administrative staff failed to ensure Staff FF ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. f. Review of the medical record for Patient #26 revealed: 1) The face sheet, dated 5/13/24, for Patient #26’s medical record identified Staff FF ED Physician as the attending physician of the patient. 2) On 5/13/24, the CAH’s administrative staff failed to ensure Staff FF (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. g. Review of the medical record for Patient #28 revealed: 1) The face sheet, dated 12/4/23, for Patient #28’s medical record identified Staff GG ED Physician as the attending physician of the patient. 2) On 12/4/23, the CAH’s administrative staff failed to ensure Staff GG ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. h. Review of the medical record for Patient #29 revealed: 1) The face sheet, dated 12/7/23, for Patient #29’s medical record identified Staff D ED Physician as the attending physician of the patient. 2) On 12/7/23, the CAH’s administrative staff failed to ensure Staff D ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. i. Review of the medical record for Patient #30 revealed: 1) The face sheet, dated 12/23/23, for Patient #30’s medical record identified Staff O ED Physician as the attending physician of the patient. 2) On 12/23/23, the CAH’s administrative staff failed to ensure Staff O ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. j. Review of the medical record for Patient #31 revealed: 1) The face sheet, dated 1/15/24, for Patient #31’s medical record identified Staff DD ED Provider/PA as the attending physician of the patient. 2) On 1/15/24, the CAH’s administrative staff failed to ensure Staff DD ED Provider/PA (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. k. Review of the medical record for Patient #32 revealed: 1) The face sheet, dated 2/22/24, for Patient #32’s medical record identified Staff E ED Physician as the attending physician of the patient. 2) On 2/22/24, the CAH’s administrative staff failed to ensure Staff E ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. l. Review of the medical record for Patient #33 revealed: 1) The face sheet, dated 3/29/24, for Patient #33’s medical record identified Staff O ED Physician as the attending physician of the patient. 2) On 3/29/24, the CAH’s administrative staff failed to ensure Staff O ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. m. Review of the medical record for Patient #34 revealed: 1) The face sheet, dated 4/12/24, for Patient #34’s medical record identified Staff GG ED Physician as the attending physician of the patient. 2) On 4/12/24, the CAH’s administrative staff failed to ensure Staff GG ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian. n. Review of the medical record for Patient #35 revealed: 1) The face sheet, dated 4/25/24, for Patient #35’s medical record identified Staff DD ED Provider/PA as the attending physician of the patient. 2) On 4/25/24, the CAH’s administrative staff failed to ensure Staff DD ED Provider/PA (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.”

“PROTECTION OF RECORD INFORMATION CFR(s): The CAH maintains the confidentially of record information and provides safeguards against loss, destruction, or unauthorized use. This Standard is not met as evidenced by: 50212 Based on policy review, observation, and staff interviews, the CAH’s administrative staff failed to provide adequate safeguards to maintain the confidentiality of clinical records. Failure to implement appropriate protective measures to prevent unauthorized access to clinical records could result in unauthorized use of protected health information (PHI) and the erosion of patient confidence in confidentiality. Findings include: 1. Review of the policy “Secure Filing of Medical Records” revealed: a. “Medical records housed within the hospital shall be kept in secure areas at all times. Medical records shall not be left unattended in areas accessible to unauthorized individuals.” b. “File rooms located in Burgess Health Center remains [sic] locked at all times and accessed only by the Health Information Management Department staff or nursing supervisors for patient care.” 2. On 5/15/24 at 11:30 AM, a tour of an on-site record storage facility revealed the presence of a substantial quantity of insufficiently secured patient medical records and personnel files stacked in cardboard boxes absent any mechanism to prevent individuals with access to the facility from inappropriately accessing the clinical records. 3. On 5/15/24 at 11:45 AM, an interview with Staff AA (Maintenance Mechanic) revealed a number of maintenance personnel possess keys to either of two locked entrances of the storage facility, which housed a variety of other items in which said personnel may routinely enter the facility to obtain, as well as a remote control to enable entry through a third overhead door. The cumulative effect of these deficient practices resulted in a substantial quantity of clinical records remaining accessible to unauthorized individuals with no reason to retain access to said records.”

“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: 47335 Based on document review, observation, and staff and patient interviews, the Critical Access Hospital (CAH) failed to ensure the Emergency Department (ED) staff followed hospital policy which resulted in 1 of 20 sampled patients (patient #3) not being registered in the ED log or appropriately transferred, 5 of 20 emergency patients reviewed (patients #3, #5, #8, #12, and #14) not receiving an appropriate medical screening exam (MSE) and/or stabilizing treatment after presenting to the ED requesting medical care. Failure to maintain a complete log may result in the hospital’s inability to track the care provided to each individual who comes to the ED and may also create an expectation among hospital staff that some individuals who come to the ED may not need to be provided an appropriate MSE. Failure to provide an appropriate MSE and/or stabilizing treatment or an appropriate transfer places patients at immediate risk for deterioration of their health and wellbeing as a result of unidentified and/or untreated emergency medical conditions and creates a reasonable expectation that an adverse outcome resulting in serious injury, harm, impairment, or death will occur. Findings include: 1. Review of the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations revealed in part, Section “4 Medical Records A. Attending Physician Duties. The attending physician (and when applicable, other attending practitioners) shall be held responsible for the preparation of a complete medical record for each patient. This record shall include ... physical examination, practitioner order ...” Section “10. Emergency Care, B. Medical Screenings of Patient Seeking Emergency Care. All patients seeking emergency medical care at a dedicated emergency department will have a medical screening exam by a qualified medical personnel. The list of qualified medical personnel will be maintained by the organization.” The Medical Staff Rules and Regulations did not designate staff qualified to perform medical screening examinations on individuals who come to the emergency department (ED) requesting medical care. 2. Review of the policy number 14606336 “Emergency Medical Treatment and Labor Act (EMTALA),” Last Revised 06/2004, revealed in part: “ ...All individuals seeking emergency care from this facility will be screened to determine if they have an emergency medical condition, using any resources routinely available to the ED, including ancillary services ...Individuals with emergency medical conditions must be stabilized ... A central log will be maintained noting each individual who presents him/herself to the ED and the disposition of each case ...Neither the initial medical screening nor any needed stabilizing treatment may be delayed by inquiries about payment, insurance status ...Emergency medical condition in a pregnant woman in labor exists ... A woman experiencing contractions is in true labor unless a physician certifies that after a reasonable time of observation, the woman is in false labor. A registered nurse qualified in obstetrics may score the patient according to procedure ... Neither advanced registered nurse practitioners (ARNPs) nor physician assistants (PAs) can certify false labor ...” Section “VII. MEDICAL SCREENING EXAMINATION, D. Personnel requirements for medical screening: 1. Registered nurse and/or paramedic in consultation with physician, 2. Physician’s Assistant (PA), 3. Nurse Practitioner (ARNP), 4. Physician, 5. Physician, Nurse Practitioner, or Physician’s Assistant along with ancillary services. 6. In some cases the registered nurse and/or paramedic, PA, or ARNP may deem it necessary to consult with the on-call physician after assessing the patient to determine if an emergency condition exists. When the physician makes treatment or transfer decisions by telephone, the physician remains liable for such decisions ... H. Documentation on the Emergency Room Record: 1. History, physical exam 2. Assessment of whether the individual had an emergency medical condition. 3. Actions taken to determine condition and interventions provided. 4. Results of any diagnostic testing and narrative describing QMP or physician findings, conclusions and plan of care. 5. Discharge/transfer vitals. 6. Entries should be timed and signed with identified initials or actual signatures indicating level of licensure.” Section “VIII. DEFINITION OF EMERGENCY MEDICAL CONDITION: C. Psychiatric emergency medical conditions exists when an individual presents an immediate threat to him/herself or others, for example, if the individual has attempted suicide or is violent. Other psychiatric disturbances covered under this regulation include ... a dissociative state, and inability to comprehend danger or to care for one’s self ...psychiatric patients who have an emergency condition would also have to be stabilized using the appropriate therapeutic measures, i.e., medication, seclusion, or restraint under medical supervision, so that the immediate threat to the individual’s health or to the safety of others would be removed, even if the underlying psychiatric problem were not addressed ...” “ ...Symptoms of substance abuse - these patients are viewed as medically unstable under the law and have been given some special considerations under the law. Because symptoms of substance abuse can mask other medical conditions, physicians and hospital staff need to provide an intense screening exam and provide documentation in the medical records of the caregiver’s thought processes that led them to deem the patient stable/unstable ... If the patient leaves, a Leaving Against Medical Advice (AMA) form should be filled out and signed by the patient, if the staff member documents sufficient observation to support a conclusion that the patient understands the implications of the risks and benefits. If the patient refuses to sign, documentation of the attempt made by hospital personnel to secure such signature should be documented on the form ...” Section “X. STABILIZATION OF EMERGENCY MEDICAL CONDITIONS A. General Definition - an individual who presents themselves to the Emergency Department is assessed as having an emergency medical condition must be provided with treatment as may be required to stabilize the individual’s condition within the staffing capabilities and facilities available at the hospital or, if the medical benefits of transfer outweigh the risks, take actions to assure the appropriateness of the transfer. To stabilize is defined to mean that no material deterioration of the condition is likely within reasonable medical probability to result from or occur during a transfer.” Section “XI. APPROPRIATE TRANSFER OF AN INDIVIDUAL TO ANOTHER MEDICAL FACILITY C. Conditions to be Met Prior to Transfer 1. This facility must provide the medical treatment within its capacity which minimizes the risks to the individual’s health and, or a woman in labor, to the unborn child. 2. The receiving facility has available space and qualified personnel for the treatment of the individual. 3. The receiving facility has agreed to accept the transfer and to provide appropriate medical treatment. Documentation of the receiving physician should also be made.” 3. Review of the policy number 14728070 “Mental Health Evaluation in Emergency Department,” Last Reviewed 12/1/22, revealed in part: Section “V. Guidelines, A. Triage and Medical Screening Exam, 4. The physician will perform and document ongoing assessments of the patient regarding interventions and orders with any change in patient status. 5. Nursing will reassess the patient every 15-30 minutes based on the patient’s condition. Frequency of checks will occur consistent with the level of risk. ... C. Implementing Behavioral Management Precautions-If patient displays any high-risk behaviors, then: If the patient’s behavior warrants it, the patient may be placed on behavioral management precautions (encompassing suicide precautions), which may necessitate restraints (chemical or physical), a sitter, and/or seclusion ... Chemical restraints that may be used, but not limited to are: Haldol, Zyprexa, Valium and Ativan [brand names of common psychiatric medications]. ... E. Determining the Plan of Care in the Emergency Department, 3. If no outside placement is immediately available for the patient, the patient will be admitted to the Med/Surg unit with all necessary behavior management precautions that were implemented in ED. F. Care of Pediatric Patients with High-Risk Behavior ... 4. Risk Assessments will be performed hourly using age-appropriate language during questioning of the pediatric patient.” 4. Review of the policy number 14720649 “Obstetrical Triage and Assessment,” Last Revised 1/22, revealed in part: Section “V. Procedure, 2.a. If an individual is prior to 20 weeks pregnant, they will be evaluated by the provider, with consultation of appropriate local PCP and/or OB/GYN if necessary.” The policy continued at 2.b. “If an individual is greater than 20 weeks pregnant and complains of obstetrical complaints or has an obstetrical emergency, evaluation will be done by the ED provider along with a consult with an OB/GYN specialist for a determination regarding the treatment plan and/or transfer” ... At B. 2. The policy revealed in part, “The assessment according to the patient’s gestational age and chief complaint documented in the medical record may include, but not limited to the following: Evaluation of fetal heart tones by Doppler equipment. Regularity and duration of uterine contractions. Fetal position and station. Cervical dilation. Status of the membranes. Vital signs (VS) of the pregnant individual. Consultation with an OB/GYN ...” 5. Review of patient #3’s medical record revealed: a. On 2/9/24 at 3:45 AM, patient #3, a 28-week pregnant patient, presented to the ED for symptoms consistent with contractions and preterm labor. The medical record face sheet (includes patient demographic information) identified Physician F as the Attending Physician. Staff B, registered nurse (RN) documented in the medical record “Upon arrival, patient is leaning over, moaning, taking deep breaths and holding her back.” ...” RN asks patient how many minutes pass in between each episode of pain. She states she is unsure, but she thinks around 4-5 minutes. She says this is her first pregnancy ... She states her OB doctor is in Sioux City, RN informs patients that we do not have OB or external fetal monitoring. RN speaks to ED provider, Dr. [physician F] about patient’s situation. Dr. [physician F] states, if patient is comfortable with it, she feels it is in the patient’s and baby’s best interest for the patient to call her OB and drive to Sioux City as her symptoms are consistent with contractions.” The CAH failed to complete any assessment, obtain vital signs, complete an appropriate MSE, provide patient #3 with stabilizing treatment or arrange an appropriate transfer after presenting with symptoms of preterm labor (labor that occurred after 20 weeks of gestation and prior to 37 weeks). ED staff failed to have patient #3 evaluated by a physician or QMP, consult with an OB/GYN, or follow hospital policy number 14720649 “Obstetrical Triage and Assessment” for an evaluation which may include, but not limited to “evaluation of fetal heart tones by Doppler equipment, regularity and duration of uterine contractions, fetal position and station, cervical dilation, status of the membranes, vital signs of the pregnant individual, and consultation with an OB/GYN” to confirm whether patient # 3 was in labor and treatment or transfer plans. (Cross refer C2406, C2407 and C2409.) b. During an interview on 3/4/24 at 1:00 PM, Physician F recalled patient #3 came into the ED, and Staff B, ED RN, reported a 28-week pregnant patient presented with episodes of back pain. Physician F recalled asking Staff B if patient #3 contacted their OB provider. Physician F recalled coming out of the call room, and Staff B reported they told patient #3 to contact their OB provider to see what they recommended. Physician F denied ever talking to patient #3 while they were at the ED. Physician F said they felt patient #3 was “non-emergent.” Physician F said they felt the most expedient thing for patient #3 would be for them to consult their OB provider, because the CAH didn’t have the ability to monitor for contractions. Physician F acknowledged patient #3 didn’t receive an appropriate MSE after presenting to the ED and requesting medical care. Physician F’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. c. During an interview on 2/21/24 at 1:00 PM, Physician E reported anytime a woman comes to the ED with abdominal pain, and is known to be pregnant, it warrants medical attention and “should be seen by a provider, and not a RN or paramedic.” When asked about the assessment to determine a patient is in labor, Physician E said she would “check maternal vital signs, check fetal heart tones, assess the cervix, check for ruptured membranes, check the abdomen for contractions, I can palpate the contractions, and figure out how far along the patient is by measuring from the pubic bone to the top of the uterine fundus. 20 weeks would be 20 cm, 30 weeks would be 30 cm if you have an average size kid.” Physician E said “we don’t have continuous electronic fetal heart monitoring here. We do have a doppler, but we cannot do continuous fetal heart monitoring in the ED, or tocometry” (a pressure-sensitive contraction transducer used to record the frequency and duration of uterine contractions). d. During an interview on 3/6/24 at 3:48 PM, patient #3 recalled going to the ED on 2/9/24 for medical care. Patient #3 reported having extreme pain in the upper back and upper right abdominal area, and crying in pain. Patient #3 reported ED staff told them it sounded like “back labor, and recommended patient #3 go to their OB”. Patient #3 recalled being told the CAH “didn’t have the ability for ultrasound, and they didn’t want patient #3 to pay for an ED visit at the CAH.” Patient #3 reported they left the ED and drove 45 minutes (40 miles) to another town. Patient #3 denied being offered an MSE or treatment. Patient #3 reported they felt like “once ED staff heard they were pregnant, they said they could not help” patient #3. e. Review of a second medical record revealed patient # 3 presented to Hospital B on 2/9/24 at 4:41 AM complaining of sharp, stabbing pain to the middle of the back that began the night before. Patient # 3 was examined by obstetrical physician T who determined the patient was not in labor. f. During an interview on 3/7/24 at 3:00 PM Hospital B’s advanced registered nurse practitioner (ARNP) U recalled Patient #3 came to Hospital B with complaints of right upper abdominal pain, was cleared by obstetrics first and then came to the ED where the patient was further examined, and an ultrasound confirmed she had gallstones. g. The ED central log, dated 2/9/24, lacked documentation of patient #3’s name and reason for coming to the ED. (Cross refer C2405.) 6. Review of patient #14’s medical record revealed: a. Patient # 14 presented to the ED on Saturday 8/26/23 at 11:12 PM. The medical record face sheet identified Physician D as the Attending Physician. Staff J, critical care paramedic (CCP) documented in a late entry note (8/27/23 at 3:55 AM) that the patient stated “she is concerned she is having a miscarriage”, that she was told yesterday by a physician in [name of town] that she was 4-6 weeks pregnant, that she has had “cramping for the last two days as well as nausea” and that she believed she was having a miscarriage “as she has had 3 in the past.” Staff J, CCP documented that patient # 14 was discharged on 8/26/23 at 11:12 PM and in a “Miscellaneous Nursing Note” documented the patient and mother of boyfriend are not content after Dr. [physician D] “informs then that we do not have ultrasound this evening. They ask to leave so they are allowed to leave non-emergent and state they will be going to Sioux City.” (Cross refer C206 and C2407). b. Patient # 14’s medical record lacked of evidence of an appropriate medical screening examination, or any type of diagnostic testing or evaluation within the CAH’s capability, such as consideration by a physician or QMP of the possibility of ectopic pregnancy (a fetus implanted and growing outside the uterus) and history, examination, monitoring, and available laboratory test to evaluate other potential emergency medical conditions, such as, but not limited to, miscarriage with severe hemorrhage, infection, hemodynamic compromise (such as low blood pressure due to bleeding), hemorrhagic shock, coagulopathy, and trauma, which could have resulted in placing the health of patient # 14 in serious jeopardy, serious impairment to bodily functions, and/or serious dysfunction of any bodily organ or part. ED staff failed to conduct the evaluation required by hospital policy, including consultation with an OB/GYN on patient # 14’s condition as specified by hospital policy number 14720649 “Obstetrical Triage and Assessment.” c. During an interview on 3/12/24 at 9:33 AM, patient #14 reported being pregnant, and going to the ED for concerns of a miscarriage, because of bleeding. Patient #14 asked for an ultrasound, but Physician D said they didn’t have ultrasound available at that time and could not do it. Patient #14 reported they left the ED, and drove 45 minutes to another hospital, and recalled being given Morphine (pain medication) for their cramps. Patient # 14 reported she could not remember the name of the hospital and confirmed that she miscarried the pregnancy. d. During an interview on 3/4/24 at 3:15 PM, Physician D indicated their policy for a patient presenting to the ED for a possible miscarriage would be to “examine the patient and do a pregnancy test to check for pregnancy, we would do labs on the patient, we would check her pregnancy levels.” Physician D indicated they would typically obtain an ultrasound and if an ultrasound was not available, they would contact the patient’s OB provider, or transfer the patient to another facility if needed.” “If they are ‘stable’, we can discharge them and scheduled them to come back in the morning for the ultrasound. Sometimes we have kept them in the ED and watched them until morning when we can get an ultrasound.” Physician D added “We may give them fluids if needed. It depends on how ‘stable’ the patient is. We would check their blood pressure to see what that is doing. Most of the time the patient is ‘stable’ and we can go from there.” When asked why patient # 14 was not seen by a provider, Physician D said “I did see this patient for like 30 minutes. I examined her and when they found out we did not have ultrasound available at that time the mother-in-law got upset and they wanted to leave.” Physician D said, “we were told when we started the ‘non-emergent process’ we still had to go in and see the patient but with ‘non-emergent patients’ we will let the nurse know the patient is ‘non-emergent’ and the nurse documents the patient was seen by the provider and they were stable. We do not do a full ED provider note on the patient.” Physician D’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. e. On 5/8/24 PM during a follow up interview Physician D clarified he examined patient # 14’s abdomen, lungs, heart and oral cavity but did not document his examination. 7. Review of patient #8’s medical record revealed: a. On 8/23/23 at 10:39 AM, patient #8, who had a history of opioid use disorder (OUD), presented to the ED for a complaint of opioid withdrawal. Documentation in the medical record showed patient #8 reported stomach cramps, nausea, vomiting, diarrhea, general aches, and back pain of 8 out of 10 (0 being no pain, and 10 being the worst possible pain), and chills. CCP C documented “Patient and family with him are looking for resources and are happy to take him somewhere else for treatment today. They noted they didn’t know where to start.” CCP C documented contact with a recovery center and noted “they do have a walk in assessment clinic but they cannot do inpatient ‘detox.’” “[Advanced Registered Nurse Practitioner (ARNP) P] and I discuss this with the patient and the patient gets up and notes that he would like to go to Sioux City instead.” ARNP P documented “Patient was brought back from Des Moines reports withdrawing from heroin and fentanyl. Patient has started withdrawal symptoms of fatigue and jitteriness. Family reports they know he does not need to be here they just not sure where to go. Educated family that we do not have specialized care for that ‘detox’ here [name of hospital] in Sioux City would have those facilities. [Name of facility] in Sioux City will work with him after ‘detox’ has been done. At this time patient got up and left prior to filling out discharge paperwork to get specialist care.” ED staff documented patient #8 got up and left the ED on 8/23/23 at 11:23 AM with a disposition of “AMA (against medical advice).” (Cross refer C2406 and C2407.) b. The medical record lacked evidence the CAH provided patient #8, within its capabilities, an appropriate MSE for his presenting signs and symptoms and stabilizing treatment for acute opioid withdrawal, of which it documented actual knowledge. ED staff did not provide or offer within its capabilities, lab testing (by way of example, creatine kinase (CK) for rhabdomyolysis, a serious medical condition that can be fatal or result in permanent disability, when damaged muscle tissue releases its proteins and electrolytes into the blood, or for electrolyte disturbances or dehydration to determine the need for IV fluids), or to assess for any psychiatric disturbances associated with drug withdrawal such as suicidal or homicidal thoughts, or determine if the patient was withdrawing from alcohol or other drugs (such as benzodiazepines) which can be life-threatening, or determine if the patient required medication to control the patient’s pain and vomiting. ED staff failed to explain the medical risks of leaving and failed to try and get the patient to stay for further examination and treatment. ED staff failed to follow hospital policy number 14606336 “Emergency Medical Treatment and Labor Act (EMTALA)” and to explain the medical risks of leaving prior to receiving an MSE and failed to document the discussion in patient #8’s medical record prior to his AMA departure. c. During an interview on 3/5/24 at 9:00 AM, ARNP P reported if a patient with active withdrawal symptoms presented to the ED, and verbalized they “wanted to detox,” she would make sure the patient was “stable” first. ARNP P reported she would “obtain labs and contact the on-call provider to see if the patient could be admitted to inpatient.” ARNP P reported the CAH didn’t have specialized treatment for things such as fentanyl withdrawal. ARNP P reported they would “assist with finding placement at an inpatient or outpatient setting, but patient #8 got up while she was talking to them and left”. ARNP P reported she didn’t have an opportunity to offer other services to patient #8. d. During an interview on 2/22/24 at 10:00 AM, Staff C, Critical Care Paramedic (CCP) reported “if a patient wanted to leave AMA, they would find out why the patient wanted to leave and explain why they should stay.” “They would inform the ED provider the patient wanted to leave, and the ED provider would talk with the patient.” Staff C reported if the patient refused to sign the AMA form, they would “document what happened, and that the patient refused to sign the AMA form.” 8. Review of patient #12’s medical record revealed: a. On 8/31/23 at 3:47 PM, patient #12 presented to the ED for a complaint of “known kidney stones since December of 2022.” The medical record face sheet identified Physician Assistant, Certified (PA-C) V as the “Attending Physician.” Patient #12 reported they previously had a nephrostomy tube (to allow urine to drain from the kidney through an opening in the skin on the back), which was removed on 8/7/23. Notes referred to patient #12 having recently had a baby 8/25/23 in another state and had a ureteral stent (small tube placed inside the ureter to help urine pass from a kidney into the bladder) placed on 8/25/23 as well as bleeding when she wiped ... “unsure if it is from her urine or from her period.” ED staff CCP C documented that patient #12 had an elevated heart rate (tachycardia) and reviewed the patient’s “vital signs and the signs and symptoms associated with [patient #12’s] chief complaint” with an unnamed ED “provider” and that the “ER Provider has deemed that this patient is ‘non-emergent’ according to the medical screening exam.” (Cross refer C2406 and C2407.) b. The medical record did not contain evidence of medical decision making by the Attending Physician or that patient #12 received an appropriate MSE or stabilizing treatment for an emergency medical condition (bleeding of unknown origin and an elevated heart rate) known to the CAH. The CAH provided disparate cae and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and its Amended February 9, 2022 Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. c. During an interview on 2/22/24 at 11:45 AM, ARNP G did not recall Patient #12, but reported that a patient with similar symptoms and medical history would be a patient they would work-up in the ED to rule out an emergency medical condition (EMC). ARNP G’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. d. Review of the August 2023 ED on-call schedule revealed the on-call provider included PA-C V and Physician W were available to the ED to provide a medical screening examination and necessary stabilizing treatment at the time patient #12 came to the ED. 9. Review of patient #5’s medical record revealed: a. On 1/3/24 at 2:05 PM, patient #5, a teenager, presented to the ED for a behavioral health (BH) court committal with a judicially-identified risk to themselves or others and documentation on court paperwork available to the hospital and provided as part of the medical record that he “wants to put a bullet in his head.” At 2:25 PM, Staff A, CCP documented the guardian “believes that he is a flight risk. I notified that if he does run, we will call law enforcement as he is a danger to himself and others and is on court hold.” Documentation showed laboratory testing completed on patient #5 at 4:01 PM showed an elevated white blood cell count of 18.4 (hospital reference range 4.8 to 10.8) and a positive drug screen for benzodiazepines and cannabinoids (marijuana). The medical record did not include evidence that staff obtained the patient’s vital signs including respiratory rate, heart rate, blood pressure or temperature. At 7:38 PM (5 1/2 hours after arriving at the ED), Staff A documented patient #5 “pushed his Grandmother [sic] to the side and ran out the back door” prior to being provided an appropriate medical screening examination and stabilizing treatment. The disposition was listed as “AMA.” (Cross refer C2406 and C2407.) b. The medical record lacked evidence that ED staff provided the patient with an appropriate medical screening examination including ongoing assessments of the patient regarding interventions and orders with any change in patient status. The patient did not receive stabilizing treatment for his known mental health emergency including hourly risk assessments for a patient demonstrating high-risk behaviors as required by hospital policy number 14728070 “Mental Health Evaluation in the ED.” ED staff also failed to monitor patient #5 or have them evaluated by a physician for appropriate use of physical or chemical restraints to decrease their risk of elopement. c. During an interview on 3/4/24 at 3:15 PM, Physician D recalled patient #5 eloped from the ED shortly after their shift started. Physician D reported hospital staff contacted law enforcement. Physician D reported they didn’t see patient #5 and couldn’t speak to whether they attempted medication with patient #5 prior to their elopement. Physician D’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 47335 Based on document review and staff interviews, the Critical Access Hospital (CAH) failed to maintain a complete ED log for at least one individual who came to the ED (patient #3) seeking medical care. Failure to maintain a complete log may result in the hospital’s inability to track the care provided to each individual who comes to the ED seeking care for a potential emergency medical condition (EMC). Findings include: 1. Review of patient #3’s medical record revealed: a. On 2/9/24 at 3:45 AM, patient #3, a 28-week pregnant patient, presented to the ED for symptoms consistent with contractions and preterm labor. The medical record face sheet (includes patient demographic information) identified Physician F as the Attending Physician. Staff B, registered nurse (RN) documented in the medical record “Upon arrival, patient is leaning over, moaning, taking deep breaths and holding her back.” ...” RN asks patient how many minutes pass in between each episode of pain. She states she is unsure, but she thinks around 4-5 minutes. She says this is her first pregnancy ... She states her OB doctor is in Sioux City, RN informs patients that we do not have OB or external fetal monitoring. RN speaks to ED provider, Dr. [physician F] about patient’s situation. Dr. [physician F] states, if patient is comfortable with it, she feels it is in the patient’s and baby’s best interest for the patient to call her OB and drive to Sioux City as her symptoms are consistent with contractions.” The CAH failed to complete any assessment, obtain vital signs, complete an appropriate MSE, provide patient #3 with stabilizing treatment or arrange an appropriate transfer after presenting with symptoms of preterm labor (labor that occurred after 20 weeks of gestation and prior to 37 weeks). ED staff failed to have patient #3 evaluated by a physician or QMP, consult with an OB/GYN, or follow hospital policy number 14720649 “Obstetrical Triage and Assessment” for an evaluation which may include, but not limited to “evaluation of fetal heart tones by Doppler equipment, regularity and duration of uterine contractions, fetal position and station, cervical dilation, status of the membranes, vital signs of the pregnant individual, and consultation with an OB/GYN” to confirm whether patient # 3 was in labor and treatment or transfer plans. (Cross refer C2406, C2407 and C2409.) 2. Review of the 2/9/24 ED log between 12:00 AM to 6:30 AM revealed staff did not enter patient # 3 in the ED log. 3. During an interview on 2/21/24 at 4:00 PM Staff B ED registered nurse (RN) confirmed patient # 3 presented to the ED on 2/9/24. “I was working that night. She came in through the front doors of the ER. She was holding her back and said this was her first pregnancy. I asked how far along she was, and she said she was 28 weeks pregnant.” “I went back into the ED, talked with the provider, and decided that it was possible back contractions. She was never brought back into the ED. The provider recommended that she call her OB and go to Sioux City.” Staff B confirmed ED physician F was in the ED but did not see or speak to patient # 3 when she presented seeking medical care. Staff B said that patient # 3 “never got checked into the ED.” 4. During an interview on 3/5/24 at 10:30 AM, the Director of Emergency and Inpatient Services confirmed Patient #3 presented to the ED on 2/9/24, and didn’t get admitted to the ED or recorded on the ED log,”

“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: 47335 Based on document review, and staff and patient interviews, the Critical Access Hospital (CAH) failed to provide 5 of 20 emergency patients reviewed (patients #3, #5, #8, #12, and #14) with an appropriate medical screening examination (MSE) when they presented to the hospital’s dedicated ED requesting examination or treatment for a medical condition. Failure to provide an appropriate MSE places current and future patients at immediate risk for deterioration of their health and wellbeing as a result of unidentified and/or untreated emergency medical conditions and creates a reasonable expectation that an adverse outcome resulting in serious injury, harm, impairment, or death will occur. The cumulative effect of these deficient practices resulted in the hospital’s inability to ensure the safe and effective delivery of care to all patients and places current and future patients at immediate risk for deterioration of their health and wellbeing as a result of unidentified and/or untreated emergency medical conditions and creates a reasonable expectation that an adverse outcome resulting in serious injury, harm, impairment, or death will occur. Findings include: 1. Review of patient #3’s medical record revealed: a. On 2/9/24 at 3:45 AM, patient #3, a 28-week pregnant patient, presented to the ED for symptoms consistent with contractions and preterm labor. The medical record face sheet (includes patient demographic information) identified Physician F as the Attending Physician. Staff B, registered nurse (RN) documented in the medical record “Upon arrival, patient is leaning over, moaning, taking deep breaths and holding her back.” ...” RN asks patient how many minutes pass in between each episode of pain. She states she is unsure, but she thinks around 4-5 minutes. She says this is her first pregnancy ... She states her OB doctor is in Sioux City, RN informs patients that we do not have OB or external fetal monitoring. RN speaks to ED provider, Dr. [physician F] about patient’s situation. Dr. [physician F] states, if patient is comfortable with it, she feels it is in the patient’s and baby’s best interest for the patient to call her OB and drive to Sioux City as her symptoms are consistent with contractions.” The CAH failed to complete any assessment, obtain vital signs, complete an appropriate MSE, provide patient #3 with stabilizing treatment or arrange an appropriate transfer after presenting with symptoms of preterm labor (labor that occurred after 20 weeks of gestation and prior to 37 weeks). ED staff failed to have patient #3 evaluated by a physician or QMP, consult with an OB/GYN, or follow hospital policy number 14720649 “Obstetrical Triage and Assessment” for an evaluation which may include, but not limited to “evaluation of fetal heart tones by Doppler equipment, regularity and duration of uterine contractions, fetal position and station, cervical dilation, status of the membranes, vital signs of the pregnant individual, and consultation with an OB/GYN” to confirm whether patient # 3 was in labor and treatment or transfer plans. (Cross refer C2407 and C2409.) b. During an interview on 3/4/24 at 1:00 PM, Physician F recalled patient #3 came into the ED, and Staff B, ED RN, reported a 28-week pregnant patient presented with episodes of back pain. Physician F recalled asking Staff B if patient #3 contacted their OB provider. Physician F recalled coming out of the call room, and Staff B reported they told patient #3 to contact their OB provider to see what they recommended. Physician F denied ever talking to patient #3 while they were at the ED. Physician F said they felt patient #3 was “non-emergent.” Physician F said they felt the most expedient thing for patient #3 would be for them to consult their OB provider, because the CAH didn’t have the ability to monitor for contractions. Physician F acknowledged patient #3 didn’t receive an appropriate MSE after presenting to the ED and requesting medical care. Physician F’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. c. During an interview on 2/21/24 at 1:00 PM, Physician E reported anytime a woman comes to the ED with abdominal pain, and is known to be pregnant, it warrants medical attention and “should be seen by a provider, and not a RN or paramedic.” When asked about the assessment to determine a patient is in labor, Physician E said she would “check maternal vital signs, check fetal heart tones, assess the cervix, check for ruptured membranes, check the abdomen for contractions, I can palpate the contractions, and figure out how far along the patient is by measuring from the pubic bone to the top of the uterine fundus. 20 weeks would be 20 cm, 30 weeks would be 30 cm if you have an average size kid.” Physician E said “we don’t have continuous electronic fetal heart monitoring here. We do have a doppler, but we cannot do continuous fetal heart monitoring in the ED, or tocometry” (a pressure-sensitive contraction transducer used to record the frequency and duration of uterine contractions). d. During an interview on 3/6/24 at 3:48 PM, patient #3 recalled going to the ED on 2/9/24 for medical care. Patient #3 reported having extreme pain in the upper back and upper right abdominal area, and crying in pain. Patient #3 reported ED staff told them it sounded like “back labor, and recommended patient #3 go to their OB”. Patient #3 recalled being told the CAH “didn’t have the ability for ultrasound, and they didn’t want patient #3 to pay for an ED visit at the CAH.” Patient #3 reported they left the ED and drove 45 minutes (40 miles) to another town. Patient #3 denied being offered an MSE or treatment. Patient #3 reported they felt like “once ED staff heard they were pregnant, they said they could not help” patient #3. e. Review of a second medical record revealed patient # 3 presented to Hospital B on 2/9/24 at 4:41 AM complaining of sharp, stabbing pain to the middle of the back that began the night before. Patient # 3 was examined by obstetrical physician T who determined the patient was not in labor. f. During an interview on 3/7/24 at 3:00 PM Hospital B’s advanced registered nurse practitioner (ARNP) U recalled Patient #3 came to Hospital B with complaints of right upper abdominal pain, was cleared by obstetrics first and then came to the ED where the patient was further examined, and an ultrasound confirmed she had gallstones. g. The ED central log, dated 2/9/24, lacked documentation of patient #3’s name and reason for coming to the ED. (Cross refer C2405.) 2. Review of patient #14’s medical record revealed: a. Patient # 14 presented to the ED on Saturday 8/26/23 at 11:12 PM. The medical record face sheet identified Physician D as the Attending Physician. Staff J, critical care paramedic (CCP) documented in a late entry note (8/27/23 at 3:55 AM) that the patient stated “she is concerned she is having a miscarriage”, that she was told yesterday by a physician in [name of town] that she was 4-6 weeks pregnant, that she has had “cramping for the last two days as well as nausea” and that she believed she was having a miscarriage “as she has had 3 in the past.” Staff J, CCP documented that patient # 14 was discharged on 8/26/23 at 11:12 PM and in a “Miscellaneous Nursing Note” documented the patient and mother of boyfriend are not content after Dr. [physician D] “informs then that we do not have ultrasound this evening. They ask to leave so they are allowed to leave non-emergent and state they will be going to Sioux City.” (Cross refer C2407). b. Patient # 14’s medical record lacked of evidence of an appropriate medical screening examination, or any type of diagnostic testing or evaluation within the CAH’s capability, such as consideration by a physician or QMP of the possibility of ectopic pregnancy (a fetus implanted and growing outside the uterus) and history, examination, monitoring, and available laboratory test to evaluate other potential emergency medical conditions, such as, but not limited to, miscarriage with severe hemorrhage, infection, hemodynamic compromise (such as low blood pressure due to bleeding), hemorrhagic shock, coagulopathy, and trauma, which could have resulted in placing the health of patient # 14 in serious jeopardy, serious impairment to bodily functions, and/or serious dysfunction of any bodily organ or part. ED staff failed to conduct the evaluation required by hospital policy, including consultation with an OB/GYN on patient # 14’s condition as specified by hospital policy number 14720649 “Obstetrical Triage and Assessment.” c. During an interview on 3/12/24 at 9:33 AM, patient #14 reported being pregnant, and going to the ED for concerns of a miscarriage, because of bleeding. Patient #14 asked for an ultrasound, but Physician D said they didn’t have ultrasound available at that time and could not do it. Patient #14 reported they left the ED, and drove 45 minutes to another hospital, and recalled being given Morphine (pain medication) for their cramps. Patient # 14 reported she could not remember the name of the hospital and confirmed that she miscarried the pregnancy. d. During an interview on 3/4/24 at 3:15 PM, Physician D indicated their policy for a patient presenting to the ED for a possible miscarriage would be to “examine the patient and do a pregnancy test to check for pregnancy, we would do labs on the patient, we would check her pregnancy levels.” Physician D indicated they would typically obtain an ultrasound and if an ultrasound was not available, they would contact the patient’s OB provider, or transfer the patient to another facility if needed.” “If they are ‘stable’, we can discharge them and scheduled them to come back in the morning for the ultrasound. Sometimes we have kept them in the ED and watched them until morning when we can get an ultrasound.” Physician D added “We may give them fluids if needed. It depends on how ‘stable’ the patient is. We would check their blood pressure to see what that is doing. Most of the time the patient is ‘stable’ and we can go from there.” When asked why patient # 14 was not seen by a provider, Physician D said “I did see this patient for like 30 minutes. I examined her and when they found out we did not have ultrasound available at that time the mother-in-law got upset and they wanted to leave.” Physician D said, “we were told when we started the ‘non-emergent process’ we still had to go in and see the patient but with ‘non-emergent patients’ we will let the nurse know the patient is ‘non-emergent’ and the nurse documents the patient was seen by the provider and they were stable. We do not do a full ED provider note on the patient.” Physician D’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. e. On 5/8/24 PM during a follow up interview Physician D clarified he examined patient # 14’s abdomen, lungs, heart and oral cavity but did not document his examination. 3. Review of patient #8’s medical record revealed: a. On 8/23/23 at 10:39 AM, patient #8, who had a history of opioid use disorder (OUD), presented to the ED for a complaint of opioid withdrawal. Documentation in the medical record showed patient #8 reported stomach cramps, nausea, vomiting, diarrhea, general aches, and back pain of 8 out of 10 (0 being no pain, and 10 being the worst possible pain), and chills. CCP C documented “Patient and family with him are looking for resources and are happy to take him somewhere else for treatment today. They noted they didn’t know where to start.” CCP C documented contact with a recovery center and noted “they do have a walk in assessment clinic but they cannot do inpatient ‘detox.’” “[Advanced Registered Nurse Practitioner (ARNP) P] and I discuss this with the patient and the patient gets up and notes that he would like to go to Sioux City instead.” ARNP P documented “Patient was brought back from Des Moines reports withdrawing from heroin and fentanyl. Patient has started withdrawal symptoms of fatigue and jitteriness. Family reports they know he does not need to be here they just not sure where to go. Educated family that we do not have specialized care for that ‘detox’ here [name of hospital] in Sioux City would have those facilities. [Name of facility] in Sioux City will work with him after ‘detox’ has been done. At this time patient got up and left prior to filling out discharge paperwork to get specialist care.” ED staff documented patient #8 got up and left the ED on 8/23/23 at 11:23 AM with a disposition of “AMA (against medical advice).” (Cross refer C2407.) b. The medical record lacked evidence the CAH provided patient #8, within its capabilities, an appropriate MSE for his presenting signs and symptoms and stabilizing treatment for acute opioid withdrawal, of which it documented actual knowledge. ED staff did not provide or offer within its capabilities, lab testing (by way of example, creatine kinase (CK) for rhabdomyolysis, a serious medical condition that can be fatal or result in permanent disability, when damaged muscle tissue releases its proteins and electrolytes into the blood, or for electrolyte disturbances or dehydration to determine the need for IV fluids), or to assess for any psychiatric disturbances associated with drug withdrawal such as suicidal or homicidal thoughts, or determine if the patient was withdrawing from alcohol or other drugs (such as benzodiazepines) which can be life-threatening, or determine if the patient required medication to control the patient’s pain and vomiting. ED staff failed to explain the medical risks of leaving and failed to try and get the patient to stay for further examination and treatment. ED staff failed to follow hospital policy number 14606336 “Emergency Medical Treatment and Labor Act (EMTALA)” and to explain the medical risks of leaving prior to receiving an MSE and failed to document the discussion in patient #8’s medical record prior to his AMA departure. c. During an interview on 3/5/24 at 9:00 AM, ARNP P reported if a patient with active withdrawal symptoms presented to the ED, and verbalized they “wanted to detox,” she would make sure the patient was “stable” first. ARNP P reported she would “obtain labs and contact the on-call provider to see if the patient could be admitted to inpatient.” ARNP P reported the CAH didn’t have specialized treatment for things such as fentanyl withdrawal. ARNP P reported they would “assist with finding placement at an inpatient or outpatient setting, but patient #8 got up while she was talking to them and left”. ARNP P reported she didn’t have an opportunity to offer other services to patient #8. d. During an interview on 2/22/24 at 10:00 AM, Staff C, Critical Care Paramedic (CCP) reported “if a patient wanted to leave AMA, they would find out why the patient wanted to leave and explain why they should stay.” “They would inform the ED provider the patient wanted to leave, and the ED provider would talk with the patient.” Staff C reported if the patient refused to sign the AMA form, they would “document what happened, and that the patient refused to sign the AMA form.” 4. Review of patient #12’s medical record revealed: a. On 8/31/23 at 3:47 PM, patient #12 presented to the ED for a complaint of “known kidney stones since December of 2022.” The medical record face sheet identified Physician Assistant, Certified (PA-C) V as the “Attending Physician.” Patient #12 reported they previously had a nephrostomy tube (to allow urine to drain from the kidney through an opening in the skin on the back), which was removed on 8/7/23. Notes referred to patient #12 having recently had a baby 8/25/23 in another state and had a ureteral stent (small tube placed inside the ureter to help urine pass from a kidney into the bladder) placed on 8/25/23 as well as bleeding when she wiped ... “unsure if it is from her urine or from her period.” ED staff CCP C documented that patient #12 had an elevated heart rate (tachycardia) and reviewed the patient’s “vital signs and the signs and symptoms associated with [patient #12’s] chief complaint” with an unnamed ED “provider” and that the “ER Provider has deemed that this patient is ‘non-emergent’ according to the medical screening exam.” (Cross refer C2407.) b. The medical record did not contain evidence of medical decision making by the Attending Physician or that patient #12 received an appropriate MSE or stabilizing treatment for an emergency medical condition (bleeding of unknown origin and an elevated heart rate) known to the CAH. The CAH provided disparate cae and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and its Amended February 9, 2022 Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. c. During an interview on 2/22/24 at 11:45 AM, ARNP G did not recall Patient #12, but reported that a patient with similar symptoms and medical history would be a patient they would work-up in the ED to rule out an emergency medical condition (EMC). ARNP G’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. d. Review of the August 2023 ED on-call schedule revealed the on-call provider included PA-C V and Physician W were available to the ED to provide a medical screening examination and necessary stabilizing treatment at the time patient #12 came to the ED. 5. Review of patient #5’s medical record revealed: a. On 1/3/24 at 2:05 PM, patient #5, a teenager, presented to the ED for a behavioral health (BH) court committal with a judicially-identified risk to themselves or others and documentation on court paperwork available to the hospital and provided as part of the medical record that he “wants to put a bullet in his head.” At 2:25 PM, Staff A, CCP documented the guardian “believes that he is a flight risk. I notified that if he does run, we will call law enforcement as he is a danger to himself and others and is on court hold.” Documentation showed laboratory testing completed on patient #5 at 4:01 PM showed an elevated white blood cell count of 18.4 (hospital reference range 4.8 to 10.8) and a positive drug screen for benzodiazepines and cannabinoids (marijuana). The medical record did not include evidence that staff obtained the patient’s vital signs including respiratory rate, heart rate, blood pressure or temperature. At 7:38 PM (5 1/2 hours after arriving at the ED), Staff A documented patient #5 “pushed his Grandmother [sic] to the side and ran out the back door” prior to being provided an appropriate medical screening examination and stabilizing treatment. The disposition was listed as “AMA.” (Cross refer C2407.) b. The medical record lacked evidence that ED staff provided the patient with an appropriate medical screening examination including ongoing assessments of the patient regarding interventions and orders with any change in patient status. The patient did not receive stabilizing treatment for his known mental health emergency including hourly risk assessments for a patient demonstrating high-risk behaviors as required by hospital policy number 14728070 “Mental Health Evaluation in the ED.” ED staff also failed to monitor patient #5 or have them evaluated by a physician for appropriate use of physical or chemical restraints to decrease their risk of elopement. c. During an interview on 3/4/24 at 3:15 PM, Physician D recalled patient #5 eloped from the ED shortly after their shift started. Physician D reported hospital staff contacted law enforcement. Physician D reported they didn’t see patient #5 and couldn’t speak to whether they attempted medication with patient #5 prior to their elopement. Physician D’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties.”

“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: 47335 Based on document review and staff and patient interviews, the Critical Access Hospital (CAH) failed to provide 5 of 20 emergency patients reviewed (patients #3, #5, #8, #12, and #14) with the appropriate stabilizing treatment when they presented to the hospital’s dedicated ED seeking emergency medical care. Failure to provide appropriate stabilizing treatment places current and future patients at immediate risk for deterioration of their health and wellbeing as a result of unidentified and/or untreated emergency medical conditions and creates a reasonable expectation that an adverse outcome resulting in serious injury, harm, impairment, or death will occur. The cumulative effect of these deficient practices resulted in the hospital’s inability to ensure the safe and effective delivery of care to all patients and places current and future patients at immediate risk for deterioration of their health and wellbeing as a result of unidentified and/or untreated emergency medical conditions and creates a reasonable expectation that an adverse outcome resulting in serious injury, harm, impairment, or death will occur. Findings include: 1. Review of patient #3’s medical record revealed: a. On 2/9/24 at 3:45 AM, patient #3, a 28-week pregnant patient, presented to the ED for symptoms consistent with contractions and preterm labor. The medical record face sheet (includes patient demographic information) identified Physician F as the Attending Physician. Staff B, registered nurse (RN) documented in the medical record “Upon arrival, patient is leaning over, moaning, taking deep breaths and holding her back.” ...” RN asks patient how many minutes pass in between each episode of pain. She states she is unsure, but she thinks around 4-5 minutes. She says this is her first pregnancy ... She states her OB doctor is in Sioux City, RN informs patients that we do not have OB or external fetal monitoring. RN speaks to ED provider, Dr. [physician F] about patient’s situation. Dr. [physician F] states, if patient is comfortable with it, she feels it is in the patient’s and baby’s best interest for the patient to call her OB and drive to Sioux City as her symptoms are consistent with contractions.” The CAH failed to complete any assessment, obtain vital signs, complete an appropriate MSE, provide patient #3 with stabilizing treatment or arrange an appropriate transfer after presenting with symptoms of preterm labor (labor that occurred after 20 weeks of gestation and prior to 37 weeks). ED staff failed to have patient #3 evaluated by a physician or QMP, consult with an OB/GYN, or follow hospital policy number 14720649 “Obstetrical Triage and Assessment” for an evaluation which may include, but not limited to “evaluation of fetal heart tones by Doppler equipment, regularity and duration of uterine contractions, fetal position and station, cervical dilation, status of the membranes, vital signs of the pregnant individual, and consultation with an OB/GYN” to confirm whether patient # 3 was in labor and treatment or transfer plans. (Cross refer C2409.) b. During an interview on 3/4/24 at 1:00 PM, Physician F recalled patient #3 came into the ED, and Staff B, ED RN, reported a 28-week pregnant patient presented with episodes of back pain. Physician F recalled asking Staff B if patient #3 contacted their OB provider. Physician F recalled coming out of the call room, and Staff B reported they told patient #3 to contact their OB provider to see what they recommended. Physician F denied ever talking to patient #3 while they were at the ED. Physician F said they felt patient #3 was “non-emergent.” Physician F said they felt the most expedient thing for patient #3 would be for them to consult their OB provider, because the CAH didn’t have the ability to monitor for contractions. Physician F acknowledged patient #3 didn’t receive an appropriate MSE after presenting to the ED and requesting medical care. Physician F’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. c. During an interview on 2/21/24 at 1:00 PM, Physician E reported anytime a woman comes to the ED with abdominal pain, and is known to be pregnant, it warrants medical attention and “should be seen by a provider, and not a RN or paramedic.” When asked about the assessment to determine a patient is in labor, Physician E said she would “check maternal vital signs, check fetal heart tones, assess the cervix, check for ruptured membranes, check the abdomen for contractions, I can palpate the contractions, and figure out how far along the patient is by measuring from the pubic bone to the top of the uterine fundus. 20 weeks would be 20 cm, 30 weeks would be 30 cm if you have an average size kid.” Physician E said “we don’t have continuous electronic fetal heart monitoring here. We do have a doppler, but we cannot do continuous fetal heart monitoring in the ED, or tocometry” (a pressure-sensitive contraction transducer used to record the frequency and duration of uterine contractions). d. During an interview on 3/6/24 at 3:48 PM, patient #3 recalled going to the ED on 2/9/24 for medical care. Patient #3 reported having extreme pain in the upper back and upper right abdominal area and crying in pain. Patient #3 reported ED staff told them it sounded like “back labor, and recommended patient #3 go to their OB”. Patient #3 recalled being told the CAH “didn’t have the ability for ultrasound, and they didn’t want patient #3 to pay for an ED visit at the CAH.” Patient #3 reported they left the ED and drove 45 minutes (40 miles) to another town. Patient #3 denied being offered an MSE or treatment. Patient #3 reported they felt like “once ED staff heard they were pregnant, they said they could not help” patient #3. e. Review of a second medical record revealed patient # 3 presented to Hospital B on 2/9/24 at 4:41 AM complaining of sharp, stabbing pain to the middle of the back that began the night before. Patient # 3 was examined by obstetrical physician T who determined the patient was not in labor. f. During an interview on 3/7/24 at 3:00 PM Hospital B’s advanced registered nurse practitioner (ARNP) U recalled Patient #3 came to Hospital B with complaints of right upper abdominal pain, was cleared by obstetrics first and then came to the ED where the patient was further examined, and an ultrasound confirmed she had gallstones. g. The ED central log, dated 2/9/24, lacked documentation of patient #3’s name and reason for coming to the ED. 2. Review of patient #14’s medical record revealed: a. Patient # 14 presented to the ED on Saturday 8/26/23 at 11:12 PM. The medical record face sheet identified Physician D as the Attending Physician. Staff J, critical care paramedic (CCP) documented in a late entry note (8/27/23 at 3:55 AM) that the patient stated “she is concerned she is having a miscarriage”, that she was told yesterday by a physician in [name of town] that she was 4-6 weeks pregnant, that she has had “cramping for the last two days as well as nausea” and that she believed she was having a miscarriage “as she has had 3 in the past.” Staff J, CCP documented that patient # 14 was discharged on 8/26/23 at 11:12 PM and in a “Miscellaneous Nursing Note” documented the patient and mother of boyfriend are not content after Dr. [physician D] “informs then that we do not have ultrasound this evening. They ask to leave so they are allowed to leave non-emergent and state they will be going to Sioux City.” b. Patient # 14’s medical record lacked of evidence of an appropriate medical screening examination, or any type of diagnostic testing or evaluation within the CAH’s capability, such as consideration by a physician or QMP of the possibility of ectopic pregnancy (a fetus implanted and growing outside the uterus) and history, examination, monitoring, and available laboratory test to evaluate other potential emergency medical conditions, such as, but not limited to, miscarriage with severe hemorrhage, infection, hemodynamic compromise (such as low blood pressure due to bleeding), hemorrhagic shock, coagulopathy, and trauma, which could have resulted in placing the health of patient # 14 in serious jeopardy, serious impairment to bodily functions, and/or serious dysfunction of any bodily organ or part. ED staff failed to conduct the evaluation required by hospital policy, including consultation with an OB/GYN on patient # 14’s condition as specified by hospital policy number 14720649 “Obstetrical Triage and Assessment.” c. During an interview on 3/12/24 at 9:33 AM, patient #14 reported being pregnant, and going to the ED for concerns of a miscarriage, because of bleeding. Patient #14 asked for an ultrasound, but Physician D said they didn’t have ultrasound available at that time and could not do it. Patient #14 reported they left the ED, and drove 45 minutes to another hospital, and recalled being given Morphine (pain medication) for their cramps. Patient # 14 reported she could not remember the name of the hospital and confirmed that she miscarried the pregnancy. d. During an interview on 3/4/24 at 3:15 PM, Physician D indicated their policy for a patient presenting to the ED for a possible miscarriage would be to “examine the patient and do a pregnancy test to check for pregnancy, we would do labs on the patient, we would check her pregnancy levels.” Physician D indicated they would typically obtain an ultrasound and if an ultrasound was not available, they would contact the patient’s OB provider, or transfer the patient to another facility if needed.” “If they are ‘stable’, we can discharge them and scheduled them to come back in the morning for the ultrasound. Sometimes we have kept them in the ED and watched them until morning when we can get an ultrasound.” Physician D added “We may give them fluids if needed. It depends on how ‘stable’ the patient is. We would check their blood pressure to see what that is doing. Most of the time the patient is ‘stable’ and we can go from there.” When asked why patient # 14 was not seen by a provider, Physician D said “I did see this patient for like 30 minutes. I examined her and when they found out we did not have ultrasound available at that time the mother-in-law got upset and they wanted to leave.” Physician D said, “we were told when we started the ‘non-emergent process’ we still had to go in and see the patient but with ‘non-emergent patients’ we will let the nurse know the patient is ‘non-emergent’ and the nurse documents the patient was seen by the provider and they were stable. We do not do a full ED provider note on the patient.” Physician D’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. e. On 5/8/24 PM during a follow up interview Physician D clarified he examined patient # 14’s abdomen, lungs, heart and oral cavity but did not document his examination. 3. Review of patient #8’s medical record revealed: a. On 8/23/23 at 10:39 AM, patient #8, who had a history of opioid use disorder (OUD), presented to the ED for a complaint of opioid withdrawal. Documentation in the medical record showed patient #8 reported stomach cramps, nausea, vomiting, diarrhea, general aches, and back pain of 8 out of 10 (0 being no pain, and 10 being the worst possible pain), and chills. CCP C documented “Patient and family with him are looking for resources and are happy to take him somewhere else for treatment today. They noted they didn’t know where to start.” CCP C documented contact with a recovery center and noted “they do have a walk in assessment clinic but they cannot do inpatient ‘detox.’” “[Advanced Registered Nurse Practitioner (ARNP) P] and I discuss this with the patient and the patient gets up and notes that he would like to go to Sioux City instead.” ARNP P documented “Patient was brought back from Des Moines reports withdrawing from heroin and fentanyl. Patient has started withdrawal symptoms of fatigue and jitteriness. Family reports they know he does not need to be here they just not sure where to go. Educated family that we do not have specialized care for that ‘detox’ here [name of hospital] in Sioux City would have those facilities. [Name of facility] in Sioux City will work with him after ‘detox’ has been done. At this time patient got up and left prior to filling out discharge paperwork to get specialist care.” ED staff documented patient #8 got up and left the ED on 8/23/23 at 11:23 AM with a disposition of “AMA (against medical advice).” b. The medical record lacked evidence the CAH provided patient #8, within its capabilities, an appropriate MSE for his presenting signs and symptoms and stabilizing treatment for acute opioid withdrawal, of which it documented actual knowledge. ED staff did not provide or offer within its capabilities, lab testing (by way of example, creatine kinase (CK) for rhabdomyolysis, a serious medical condition that can be fatal or result in permanent disability, when damaged muscle tissue releases its proteins and electrolytes into the blood, or for electrolyte disturbances or dehydration to determine the need for IV fluids), or to assess for any psychiatric disturbances associated with drug withdrawal such as suicidal or homicidal thoughts, or determine if the patient was withdrawing from alcohol or other drugs (such as benzodiazepines) which can be life-threatening, or determine if the patient required medication to control the patient’s pain and vomiting. ED staff failed to explain the medical risks of leaving and failed to try and get the patient to stay for further examination and treatment. ED staff failed to follow hospital policy number 14606336 “Emergency Medical Treatment and Labor Act (EMTALA)” and to explain the medical risks of leaving prior to receiving an MSE and failed to document the discussion in patient #8’s medical record prior to his AMA departure. c. During an interview on 3/5/24 at 9:00 AM, ARNP P reported if a patient with active withdrawal symptoms presented to the ED, and verbalized they “wanted to detox,” she would make sure the patient was “stable” first. ARNP P reported she would “obtain labs and contact the on-call provider to see if the patient could be admitted to inpatient.” ARNP P reported the CAH didn’t have specialized treatment for things such as fentanyl withdrawal. ARNP P reported they would “assist with finding placement at an inpatient or outpatient setting, but patient #8 got up while she was talking to them and left”. ARNP P reported she didn’t have an opportunity to offer other services to patient #8. d. During an interview on 2/22/24 at 10:00 AM, Staff C, Critical Care Paramedic (CCP) reported “if a patient wanted to leave AMA, they would find out why the patient wanted to leave and explain why they should stay.” “They would inform the ED provider the patient wanted to leave, and the ED provider would talk with the patient.” Staff C reported if the patient refused to sign the AMA form, they would “document what happened, and that the patient refused to sign the AMA form.” 4. Review of patient #12’s medical record revealed: a. On 8/31/23 at 3:47 PM, patient #12 presented to the ED for a complaint of “known kidney stones since December of 2022.” The medical record face sheet identified Physician Assistant, Certified (PA-C) V as the “Attending Physician.” Patient #12 reported they previously had a nephrostomy tube (to allow urine to drain from the kidney through an opening in the skin on the back), which was removed on 8/7/23. Notes referred to patient #12 having recently had a baby 8/25/23 in another state and had a ureteral stent (small tube placed inside the ureter to help urine pass from a kidney into the bladder) placed on 8/25/23 as well as bleeding when she wiped ... “unsure if it is from her urine or from her period.” ED staff CCP C documented that patient #12 had an elevated heart rate (tachycardia) and reviewed the patient’s “vital signs and the signs and symptoms associated with [patient #12’s] chief complaint” with an unnamed ED “provider” and that the “ER Provider has deemed that this patient is ‘non-emergent’ according to the medical screening exam.” b. The medical record did not contain evidence of medical decision making by the Attending Physician or that patient #12 received an appropriate MSE or stabilizing treatment for an emergency medical condition (bleeding of unknown origin and an elevated heart rate) known to the CAH. The CAH provided disparate cae and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and its Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. c. During an interview on 2/22/24 at 11:45 AM, ARNP G did not recall Patient #12, but reported that a patient with similar symptoms and medical history would be a patient they would work-up in the ED to rule out an emergency medical condition (EMC). ARNP G’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. d. Review of the August 2023 ED on-call schedule revealed the on-call provider included PA-C V and Physician W were available to the ED to provide a medical screening examination and necessary stabilizing treatment at the time patient #12 came to the ED. 5. Review of patient #5’s medical record revealed: a. On 1/3/24 at 2:05 PM, patient #5, a teenager, presented to the ED for a behavioral health (BH) court committal with a judicially-identified risk to themselves or others and documentation on court paperwork available to the hospital and provided as part of the medical record that he “wants to put a bullet in his head.” At 2:25 PM, Staff A, CCP documented the guardian “believes that he is a flight risk. I notified that if he does run, we will call law enforcement as he is a danger to himself and others and is on court hold.” Documentation showed laboratory testing completed on patient #5 at 4:01 PM showed an elevated white blood cell count of 18.4 (hospital reference range 4.8 to 10.8) and a positive drug screen for benzodiazepines and cannabinoids (marijuana). The medical record did not include evidence that staff obtained the patient’s vital signs including respiratory rate, heart rate, blood pressure or temperature. At 7:38 PM (5 1/2 hours after arriving at the ED), Staff A documented patient #5 “pushed his Grandmother [sic] to the side and ran out the back door” prior to being provided an appropriate medical screening examination and stabilizing treatment. The disposition was listed as “AMA.” b. The medical record lacked evidence that ED staff provided the patient with an appropriate medical screening examination including ongoing assessments of the patient regarding interventions and orders with any change in patient status. The patient did not receive stabilizing treatment for his known mental health emergency including hourly risk assessments for a patient demonstrating high-risk behaviors as required by hospital policy number 14728070 “Mental Health Evaluation in the ED.” ED staff also failed to monitor patient #5 or have them evaluated by a physician for appropriate use of physical or chemical restraints to decrease their risk of elopement. c. During an interview on 3/4/24 at 3:15 PM, Physician D recalled patient #5 eloped from the ED shortly after their shift started. Physician D reported hospital staff contacted law enforcement. Physician D reported they didn’t see patient #5 and couldn’t speak to whether they attempted medication with patient #5 prior to their elopement. Physician D’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties.”

“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: 47335 Based on document review, and staff interview, the Critical Access Hospital (CAH) failed to arrange an appropriate transfer for patient (# 3) of 20 emergency department (ED) records reviewed, when the patient presented to the ED seeking care for symptoms of pre-term labor. Failure to arrange an appropriate transfer placed the patient and future patients at immediate risk for deterioration of their health and wellbeing as a result of delaying transfer to another hospital with the necessary capabilities and capacity for treating their unstabilized emergency medical condition and creates a reasonable expectation that an adverse outcome resulting in serious injury, harm, impairment, or death will occur. Findings include: 1. Review of Patient #3 ’ s medical record revealed: a. On 2/9/24 at 3:45 AM, patient #3, a 28-week pregnant patient, presented to the ED for symptoms consistent with contractions and preterm labor. The medical record face sheet (includes patient demographic information) identified Physician F as the Attending Physician. Staff B, registered nurse (RN) documented in the medical record “Upon arrival, patient is leaning over, moaning, taking deep breaths and holding her back.” ...” RN asks patient how many minutes pass in between each episode of pain. She states she is unsure, but she thinks around 4-5 minutes. She says this is her first pregnancy ... She states her OB doctor is in Sioux City, RN informs patients that we do not have OB or external fetal monitoring. RN speaks to ED provider, Dr. [physician F] about patient’s situation. Dr. [physician F] states, if patient is comfortable with it, she feels it is in the patient’s and baby’s best interest for the patient to call her OB and drive to Sioux City as her symptoms are consistent with contractions.” The CAH failed to complete any assessment, obtain vital signs, complete an appropriate MSE, provide patient #3 with stabilizing treatment or arrange an appropriate transfer after presenting with symptoms of preterm labor (labor that occurred after 20 weeks of gestation and prior to 37 weeks). ED staff failed to have patient #3 evaluated by a physician or QMP, consult with an OB/GYN, or follow hospital policy number 14720649 “Obstetrical Triage and Assessment” for an evaluation which may include, but not limited to “evaluation of fetal heart tones by Doppler equipment, regularity and duration of uterine contractions, fetal position and station, cervical dilation, status of the membranes, vital signs of the pregnant individual, and consultation with an OB/GYN” to confirm whether patient # 3 was in labor and treatment or transfer plans. b. During an interview on 3/4/24 at 1:00 PM, Physician F recalled patient #3 came into the ED, and Staff B, ED RN, reported a 28-week pregnant patient presented with episodes of back pain. Physician F recalled asking Staff B if patient #3 contacted their OB provider. Physician F recalled coming out of the call room, and Staff B reported they told patient #3 to contact their OB provider to see what they recommended. Physician F denied ever talking to patient #3 while they were at the ED. Physician F said they felt patient #3 was “non-emergent.” Physician F said they felt the most expedient thing for patient #3 would be for them to consult their OB provider, because the CAH didn’t have the ability to monitor for contractions. Physician F acknowledged patient #3 didn’t receive an appropriate MSE after presenting to the ED and requesting medical care. Physician F’s interview corroborated disparate care and practices inconsistent with the CAH’s policy number 14606336 “Emergency Medical Treatment and Active Labor Act (EMTALA)” and the CAH’s Amended February 9, 2022, Medical Staff Rules and Regulations pertaining to the Attending Physician’s duties. c. During an interview on 2/21/24 at 1:00 PM, Physician E reported anytime a woman comes to the ED with abdominal pain, and is known to be pregnant, it warrants medical attention and “should be seen by a provider, and not a RN or paramedic.” When asked about the assessment to determine a patient is in labor, Physician E said she would “check maternal vital signs, check fetal heart tones, assess the cervix, check for ruptured membranes, check the abdomen for contractions, I can palpate the contractions, and figure out how far along the patient is by measuring from the pubic bone to the top of the uterine fundus. 20 weeks would be 20 cm, 30 weeks would be 30 cm if you have an average size kid.” Physician E said “we don’t have continuous electronic fetal heart monitoring here. We do have a doppler, but we cannot do continuous fetal heart monitoring in the ED, or tocometry” (a pressure-sensitive contraction transducer used to record the frequency and duration of uterine contractions). d. During an interview on 3/6/24 at 3:48 PM, patient #3 recalled going to the ED on 2/9/24 for medical care. Patient #3 reported having extreme pain in the upper back and upper right abdominal area and crying in pain. Patient #3 reported ED staff told them it sounded like “back labor, and recommended patient #3 go to their OB”. Patient #3 recalled being told the CAH “didn’t have the ability for ultrasound, and they didn’t want patient #3 to pay for an ED visit at the CAH.” Patient #3 reported they left the ED and drove 45 minutes (40 miles) to another town. Patient #3 denied being offered an MSE or treatment. Patient #3 reported they felt like “once ED staff heard they were pregnant, they said they could not help” patient #3. e. Review of a second medical record revealed patient # 3 presented to Hospital B on 2/9/24 at 4:41 AM complaining of sharp, stabbing pain to the middle of the back that began the night before. Patient # 3 was examined by obstetrical physician T who determined the patient was not in labor. f. During an interview on 3/7/24 at 3:00 PM Hospital B’s advanced registered nurse practitioner (ARNP) U recalled Patient #3 came to Hospital B with complaints of right upper abdominal pain, was cleared by obstetrics first and then came to the ED where the patient was further examined, and an ultrasound confirmed she had gallstones. g. During an interview on 3/5/24 at 10:30 AM, the Director of Emergency and Inpatient Services revealed that Patient # 3 “should have been brought into the ED and assessed by a provider to the best of our ability to make sure she was not in labor.” The Director of Emergency and Inpatient Services said that the provider had “the patient’s best interest in mind” and wanted her to go to “another facility where OB was offered” and that “transportation to another hospital by ambulance should have been considered.””