Medical Center of Mckinney

“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: 45847 . Based on observation, record review, and interview, Facility A failed to comply with 42 CFR §489.24, Special responsibilities of Medicare hospitals in emergency cases. . Based on record review, interview, and policy review, the hospital, Facility B, failed to provide an appropriate Medical Screening Examination (MSE) for 1 of 20 patients whose medical records were reviewed (Patient #1). Patient #1, a 66-year-old female, arrived at the Emergency Department (ED) on 2/28/2025 at 8:11 PM as a transfer from Facility A, the sending hospital, where she was diagnosed with multiple emergency medical conditions (EMC)s including severe sepsis, cholecystitis, elevated troponin and acute kidney injury. The facility failed to perform an electrocardiogram (EKG) within its capabilities, despite clinical findings of an elevated troponin, B-type natriuretic peptide (BNP) and potassium, that required further cardiac evaluation. Patient #1 required a second transfer from Facility B to Facility C on 03/01/2025 at 12:38 AM. Patient #1 died upon arrival to Facility C before any necessary treatment could be provided. . Based on record review, interview, and policy review, the hospital, Facility B, failed to provide stabilizing treatments for 1 of 20 patients whose medical records were reviewed (Patient #1). The hospital, Facility B, transferred Patient #1 with unstable EMCs to Facility C, a third receiving hospital. Patient #1, a 66-year-old female who arrived at the hospital Emergency Department (ED) on 02/28/2025 at 8:11 PM as a transfer from Facility A, the sending hospital, with multiple EMCs including acute kidney injury with hyperkalemia. Patient #1 did not receive appropriate stabilizing treatment for hyperkalemia within the hospital’s capabilities. . Cross Reference: Tag A-2406 - 42 CFR §489.24 (a) (c) Appropriate Screening Examination. Tag A-2407 - §489.24(d)(1)(i) - Stabilize the medical condition .”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 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: 45847 . Based on record review, interview, and policy review, the hospital, Facility B, failed to provide an appropriate Medical Screening Examination (MSE) for 1 of 20 patients whose medical records were reviewed (Patient #1). Patient #1, a 66-year-old female, arrived at the Emergency Department (ED) on 2/28/2025 at 8:11 PM as a transfer from Facility A, the sending hospital, where she was diagnosed with multiple emergency medical conditions (EMC)s including severe sepsis, cholecystitis, elevated troponin and acute kidney injury. The facility failed to perform an electrocardiogram (EKG) within its capabilities, despite clinical findings of an elevated troponin, B-type natriuretic peptide (BNP) and potassium, that required further cardiac evaluation. Patient #1 required a second transfer from Facility B to Facility C on 03/01/2025 at 12:38 AM. Patient #1 died upon arrival to Facility C before any necessary treatment could be provided. . Findings included: Medical Record Review at Facility A, the sending hospital: Patient #1, a 66-year-old female, arrived at the hospital’s Emergency Department (ED) by private vehicle on 02/28/2025 at 11:26 AM with chief complaints of shortness of breath and suspected (by her husband) dehydration. . The Impression and Plan by the ED physician, Staff #7, included diagnoses of EMCs as follows: 1. AKI (acute kidney injury) 2. Cholecystitis (gallbladder inflammation) 3. Elevated troponin (heart muscle damage) 4. Severe sepsis (an infection that has progressed to cause acute organ dysfunction) . Review of Systems (ROS) included constitutional symptoms of weakness and fatigue and respiratory symptoms of shortness of breath and cough. . Abnormal chemistry results related to Patient #1’s EMCs resulted at 12:04 PM were as follows: 1. Potassium level -- 5.6 mmol/L -- Normal range is between 3.4 mmol/L and 4.5 mmol/L. 2. Lactic Acid Level -- 7.61 mmol/L -- Normal range is between 0.50 mmol/L and 2.20 mmol/L. 3. Troponin TNIH -- 763.73 ng/L -- Normal range is between 0.00 ng/L and 34.11 ng/L. 4. BNP (B-type natriuretic peptide) -- 714 pg/mL - Normal is less than 100 pg/mL. . Patient #1 was transferred to Facility B via EMS for evaluation and treatment of her diagnosed emergency medical conditions identified at Facility A. . Medical Record Review at Facility B: On 02/28/2025 an “EMS or Call-in Pre-Approval” was documented as occurring at 6:33 PM. and “EMS or Call-in Check-in (arrival time)” at 8:11 PM for Patient #1. . Abnormal Chemistry at 9:22 PM: Potassium 5.9 mmol/L Normal 3.5-5.3 mmol/L. Troponin 235 ng/L Normal <53 ng/L . Facility A obtained an elevated troponin level, BNP, elevated potassium level, and an electrocardiogram (EKG) on 02/28/2025 at 11:48 AM prior to transferring Patient #1 to Facility B. The EKG had T-wave changes, not elevation, and was not reviewed or interpreted at Facility A. Facility B failed to review the EKG from the medical records received from Facility A or obtain a follow up EKG on Patient #1 to rule out NSTEMI in the setting of an elevated troponin. . Abnormal Hematology at 9:22 PM: WBC (white blood cells) 21.2 K/mm3 Normal 4.8-10.8 K/mm3 . Patient #1 departed (Facility B) at 12:38 AM and was transported to Facility C via ambulance service. . The patient had several emergency medical conditions diagnosis at Facility B which included: 1) Severe sepsis with end organ damage and lactic acidosis 2) Cholecystitis with acute transaminitis and suspected common bile duct stone 3) Acute renal failure with hyperkalemia . Medical Record Review at Facility C, the final receiving hospital: On 03/01/2025 Staff #28, the ED Triage RN, documented at 1:20 AM assigned a Priority level 1 (Resuscitation - immediate, life-saving intervention is required). Vital signs documented: Oxygen delivery: resuscitation bag/mask, temperature 97.5 degrees Fahrenheit, and pulse 0. . Staff #28’s notes included: Patient #1 was brought in as a transfer. Upon the arrival of Patient #1, staff were called to the ambulance bay to find Patient #1 unresponsive and pulseless. CPR was started immediately, and Patient #1 was rolled into room 7. Staff #28 noted that Patient #1 was blue, pulseless, made no respiratory effort, had no neurological responses to person, place, time, or situation, and had a Glasgow coma scale (GCS) score of 3. . Death Certificate Review: Immediate Cause of Death: “Sepsis” Underlying Causes: “choledocholithiasis, cholangitis, bile acid disorder, family history of same”. . Policy Review: Facility B’s policy titled, “EMTALA - Texas EMTALA Medical Screening Examination and Stabilization Model Policy”, last reviewed and implemented on 09/2024, stated on page 1 of 20: “ ...Policy: An EMTALA obligation is triggered when an individual comes to a dedicated emergency department (“DED”) and: 1. the individual or a representative acting on the individual’s behalf requests an examination or treatment for a medical condition; ... ...The MSE must be completed by an individual (i) qualified to perform such an examination to determine whether an EMC exists, or (ii) with respect to a pregnant woman having contractions, whether the woman is in labor and whether the treatment requested is explicitly for an EMC. If an EMC is determined to exist, the individual will be provided necessary stabilizing treatment, within the capacity and capability of the facility, or an appropriate transfer as defined by and required by EMTALA ...” . And on page 2 of 20: “ ...ii. The individual arrives as a transfer from another hospital or health care facility. Upon arrival of a transfer, a physician or qualified medical person (“QMP”) must perform an appropriate MSE. The physician or QMP shall provide any additional screening and treatment required to stabilize the EMC. The MSE of the individual must be documented. This type of screening cannot be performed by the triage nurse ...” . And on page 16 of 20: “ ...Once the hospital has provided an appropriate MSE and stabilizing treatment within its capability, an appropriate transfer may be effected by following the appropriate transfer provisions ...” . Facility B’s policy titled, “EMTALA - Texas Transfer Model Policy”, last reviewed and implemented on 09/2024, stated on page 7-8 of 16: 1. Transfers of Individuals Who Are Not Medically Stable Requirements Prior to Transfer. After the hospital has provided medical treatment within its capability to minimize the risks to the health of an individual with an EMC who is not medically stable, the hospital may arrange an appropriate transfer for the individual to another more appropriate or specialized facility. Evaluation and treatment shall be performed and transfer shall be carried out as quickly as possible for an individual with an EMC which has not been stabilized or when stabilization of the individual’s vital signs is not possible because the hospital does not have the appropriate equipment or personnel to correct the underlying process. The following requirements must be met for any transfer of an individual with an EMC that has not been stabilized: a. Minimize the Risk. Before any transfer may occur, the transferring hospital must first provide, within its capacity and capability, medical treatment to minimize the risks to the health of the individual or unborn child. b. Individual’s Request or Physician’s Order. Any transfer to another medical facility of an individual with an EMC must be initiated either by a written request for transfer from the individual or the legally responsible person acting on the individual’s behalf or by a physician order with the appropriate physician or QMP and Physician certification as required under EMTALA. Any written request for a transfer to another medical facility from an individual with an EMC or the legally responsible person acting on the individual’s behalf shall indicate the reasons for the request and that he or she is aware of the risks and benefits of the transfer ...” . Interviews: Staff #15, the Vice President of Quality, was interviewed via email on 08/20/2025 at 4:35 PM. Staff #15 indicated that the transfer and screening processes were followed correctly by Facility B staff and stated, “The medical record shows that the ED provider performed a new MSE and work-up and consulted GI and surgery after seeing the LFT’s were almost double what they had been told on the request for transfer. The discussion with our providers was that the stone(s) needed to be removed to treat the patient.” There was no mention of the elevated troponin or an EKG. . Staff #18, the ED Medical Director/accepting physician at Facility B, a 20-year contracted employee at Facility B, was interviewed via email on 08/25/2025 at 4:35 PM. Staff #18 indicated that Facility B did not get an accurate picture of Patient #1’s condition prior to accepting her as a transfer. Staff #18 indicated that Patient #1 was clinically “sicker” than the labs and information shared by Facility A had indicated. Staff #18 further indicated he had concerns about the changes in the LFT’s upon arrival but did not mention the lack of follow-up on Patient #1’s elevated troponin or the lack of obtaining an EKG during the MSE by Staff #17. .”

“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: 45847 . Based on record review, interview, and policy review, the hospital, Facility B, failed to provide stabilizing treatments for 1 of 20 patients whose medical records were reviewed (Patient #1). The hospital, Facility B, transferred Patient #1 with unstable EMCs to Facility C, a third receiving hospital. Patient #1, a 66-year-old female who arrived at the hospital Emergency Department (ED) on 02/28/2025 at 8:11 PM as a transfer from Facility A, the sending hospital, with multiple EMCs including acute kidney injury with hyperkalemia. Patient #1 did not receive appropriate stabilizing treatment for hyperkalemia within the hospital’s capabilities. . Findings included: Medical Record Review at Facility A, the sending hospital: Patient #1, a 66-year-old female, arrived at the hospital’s Emergency Department (ED) by private vehicle on 02/28/2025 at 11:26 AM with chief complaints of shortness of breath and suspected (by her husband) dehydration. . The Impression and Plan by the ED physician, Staff #7, included diagnoses of EMCs as follows: 1. Acute Kidney Injury (AKI) 2. Cholecystitis (gallbladder inflammation) 3. Elevated troponin (indicator of heart muscle damage) 4. Severe sepsis . Review of Systems (ROS) included constitutional symptoms of weakness and fatigue and respiratory symptoms of shortness of breath and cough. . Abnormal chemistry results related to Patient #1’s EMCs resulted at 12:04 PM were as follows: 1. Potassium level -- 5.6 mmol/L -- Normal range is between 3.4 mmol/L and 4.5 mmol/L. 2. Lactic Acid Level -- 7.61 mmol/L -- Normal range is between 0.50 mmol/L and 2.20 mmol/L. 3. Troponin TNIH -- 763.73 ng/L -- Normal range is between 0.00 ng/L and 34.11 ng/L. 4. BNP (B-type natriuretic peptide) -- 714 pg/mL - Normal is less than 100 pg/mL. . Patient #1 was transferred to Facility B via EMS for evaluation and treatment of her diagnosed emergency medical conditions identified at Facility A. . Medical Record Review at Facility B: On 02/28/2025 an “EMS or Call-in Pre-Approval” was documented as occurring at 6:33 PM. and “EMS or Call-in Check-in (arrival time)” at 8:11 PM for Patient #1. . The key abnormal chemistry results at 9:22 PM included: 1. Potassium -- 5.9 mmol/L -- this is up from 5.6 mmol/L at Facility A at 9 hours and 16 minutes later. 2. Troponin -- 235 ng/L -- this is up from 763.73 ng/L at Facility A at 9 hours and 16 minutes later. . Abnormal Hematology at 9:22 PM: WBC (white blood cells) 21.2 K/mm3 Normal 4.8-10.8 K/mm3 . Staff #17 consulted with Staff #21, the on-call Gastroenterologist, at 9:46 PM. Staff #17 documented that Staff #21 stated that he spoke to the transfer center about Patient #1 and he had refused the transfer due to the inability to properly care for her. Facility B currently did not have the equipment required to obtain an ERCP. Staff #17 documented that Staff #21 wanted Patient #1 to be transferred to a facility that could obtain an ERCP. . Staff #17 documented the following: “Clinical Impression Primary Impression: Cholecystitis Secondary Impressions: AKI (acute kidney injury), Elevated LFTs, Severe sepsis” . The decision to transfer was documented by Staff #17 at 9:58 PM with the accepting hospital being to (Facility C - MCP), acceptance by Staff #25 (the accepting physician on the departing MOT). The transfer reason was “Higher level of care”. . Sodium chloride 1-liter IV bolus (for dehydration/kidney support) was given to Patient #1 at 11:27 PM. . Calcium Gluconate 1 gram in 100 mL of sodium chloride (for elevated potassium level) was given via IV to Patient #1 at 11:29 PM. . A re-evaluation & MDM (medical decision making) note was entered by Staff #17 as follows: “ ...Labs today show leukocytosis of 21, lactate of 5.8. (patient) received ceftriaxone and fluids prior to transfer here but will add Zosyn. Right upper quadrant ultrasound obtained here shows concern for cholecystitis as well as stone present. Given the significantly elevated LFTs concern for possible choledocholithiasis as well or possible hepatitis. Added on a hepatitis panel. Working on transfer to facility with ERCP capability labs also show AKI with creatinine of 2.77. Potassium is elevated at 5.8. . Staff #17 documented the following: “Critical Care ... The high probability of sudden, clinically significant deterioration in the patient’s condition required the highest level of my preparedness to intervene urgently ... treat and/or prevent clinically significant deterioration that could result in severe disability or death ...” . Staff #20 (ED RN for Patient #1) documented a “Reason for transfer: Services not offered; specialist not available Services required for transfer, Gastroenterology” at 12:37 AM. . Patient #1 departed (Facility B) at 12:38 AM. . Diagnoses for this ED Visit included: Primary Diagnosis: Calculus of gallbladder with acute cholecystitis without obstruction. Other Diagnoses: Sepsis, unspecified organism; severe sepsis without septic shock; personal history of other venous thrombosis and embolism; and long term (current) use of Aspirin; and other specified abnormal findings of blood chemistry. . Patient #1 did not receive appropriate treatment for her hyperkalemia, such as a sufficient dose of calcium gluconate, insulin/glucose, albuterol, or a potassium lowering agent. . Medical Record Review at Facility C, the final receiving hospital: On 03/01/2025 Staff #28, the ED Triage RN, documented at 1:20 AM assigned a Priority level 1 (Resuscitation - immediate, life-saving intervention is required). Vital signs documented: Oxygen delivery: resuscitation bag/mask, temperature 97.5 degrees Fahrenheit, and pulse 0. . Staff #28’s notes included: Patient #1 was brought in as a transfer. Upon the arrival of Patient #1, staff were called to the ambulance bay to find Patient #1 unresponsive and pulseless. CPR was started immediately, and Patient #1 was rolled into room 7. Staff #28 noted that Patient #1 was blue, pulseless, made no respiratory effort, had no neurological responses to person, place, time, or situation, and had a Glasgow coma scale (GCS) score of 3. . Death Certificate Review: Immediate Cause of Death: “Sepsis” Underlying Causes: “choledocholithiasis, cholangitis, bile acid disorder, family history of same”. . Policy Review: Facility B’s policy titled, “EMTALA - Texas EMTALA Medical Screening Examination and Stabilization Model Policy”, last reviewed and implemented on 09/2024, stated on page 1 of 20: “ ...Policy: An EMTALA obligation is triggered when an individual comes to a dedicated emergency department (“DED”) and: 2. the individual or a representative acting on the individual’s behalf requests an examination or treatment for a medical condition; ... ...The MSE must be completed by an individual (i) qualified to perform such an examination to determine whether an EMC exists, or (ii) with respect to a pregnant woman having contractions, whether the woman is in labor and whether the treatment requested is explicitly for an EMC. If an EMC is determined to exist, the individual will be provided necessary stabilizing treatment, within the capacity and capability of the facility, or an appropriate transfer as defined by and required by EMTALA ...” . And on page 2 of 20: “ ...ii. The individual arrives as a transfer from another hospital or health care facility. Upon arrival of a transfer, a physician or qualified medical person (“QMP”) must perform an appropriate MSE. The physician or QMP shall provide any additional screening and treatment required to stabilize the EMC. The MSE of the individual must be documented. This type of screening cannot be performed by the triage nurse ...” . And on page 15 of 20: “ ...The determination of whether an individual is stable is not based on the clinical outcome of the individual’s medical condition. An individual has been provided sufficient stabilizing treatment when the physician treating the individual in the DED has determined, within reasonable clinical confidence, that no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer of the individual from a facility, ...” . And on page 16 of 20: “ ...Once the hospital has provided an appropriate MSE and stabilizing treatment within its capability, an appropriate transfer may be effected by following the appropriate transfer provisions ...” . Facility B’s policy titled, “EMTALA - Texas Transfer Model Policy”, last reviewed and implemented on 09/2024, stated on page 7-8 of 16: 1. Transfers of Individuals Who Are Not Medically Stable Requirements Prior to Transfer. After the hospital has provided medical treatment within its capability to minimize the risks to the health of an individual with an EMC who is not medically stable, the hospital may arrange an appropriate transfer for the individual to another more appropriate or specialized facility. Evaluation and treatment shall be performed and transfer shall be carried out as quickly as possible for an individual with an EMC which has not been stabilized or when stabilization of the individual’s vital signs is not possible because the hospital does not have the appropriate equipment or personnel to correct the underlying process. The following requirements must be met for any transfer of an individual with an EMC that has not been stabilized: a. Minimize the Risk. Before any transfer may occur, the transferring hospital must first provide, within its capacity and capability, medical treatment to minimize the risks to the health of the individual or unborn child. b. Individual’s Request or Physician’s Order. Any transfer to another medical facility of an individual with an EMC must be initiated either by a written request for transfer from the individual or the legally responsible person acting on the individual’s behalf or by a physician order with the appropriate physician or QMP and Physician certification as required under EMTALA. Any written request for a transfer to another medical facility from an individual with an EMC or the legally responsible person acting on the individual’s behalf shall indicate the reasons for the request and that he or she is aware of the risks and benefits of the transfer ...” . Interviews: Staff #18, the ED Medical Director/accepting physician at Facility B, was interviewed via email on 08/25/2025 at 4:35 PM. Staff #18 indicated that he felt that they (Facility B) did not get an accurate picture of the patient’s (Patient #1’s) condition. Patient #1 was clinically “sicker” than the labs and information shared by (Facility A). .”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 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: 45521 2406 Based on a review of facility policy, patient records, and interviews, the facility failed to perform and document an appropriate medical screening examination (MSE), to include a complete psychiatric evaluation by qualified medical personnel for patients experiencing a psychiatric emergency, to determine if the patient was stable or had an emergency medical condition in 2 of 20 (Patients #1 and 14). Patient # 1 had an order for a psychological assessment but left against medical advice. Patient # 14 arrived with suicidal ideation without a plan. Patient # 14 was discharged home with the behavioral team, patient, and parent agreeing to outpatient services. Medical Record Patient # 1 A review of the document titled “Patient Medical Chart” for Patient 1, revealed the patient arrived at the facility on 10/23/24 at 2:58 pm in police custody for psychiatric assessment. Patient #1 was triaged at 3:20 AM. The MSE was started at 3:06 AM. However, there is no evidence Patient #1 received a psychiatric evaluation for their psychiatric medical emergency condition. The patient record indicates the patient left against medical advice (AMA). A review of the document titled, “Apprehension by Police Officer Without Warrant (APOWW)”, revealed the under section 1 “I have a reason to believe and do believe that the above named person evidences a substantial risk of serious harm to himself/herself, or others based upon the following : (handwritten) Patient was involved in a disturbance with his family. We arrived to screaming in the house, Patient #1 had a blank stare, with huge pupils, (illegible) about bed and not responding to the officers. He was clearly in a mental health crisis. We went to APOWW him and he resisted officers. Under section 4. My beliefs are based upon the following recent behavior, overt acts, attempts, statements, or threats observed by me or reliably reported to me : Parents advised has diagnosis bipolar and schizo affective disorder and is off his meds, screaming, and mentally (illegible) body in crisis.” The APOWW is signed by a peace officer and indicates Patient #1 was restrained and transported to Facility A on 10/23/2024 at 02:46 AM. A review of the document titled Emergency Provider Report” by Staff # 1, DO Emergency Medicine, revealed the following: “History of Present Illness The patient is a 26-year-old male with a past medical history of schizoaffective disorder who presents to the emergency department via police with an EDO[Emergency Detention Order] for psychiatric assessment. Patient was reportedly causing a public disturbance which is why the police were called, they reported that the patient was making hyperreligious statements and at 1 point the police had to take him to the ground and put him in cuffs but no other details were provided. No report of the patient making any statements about harming himself or others, and no reported SI or HI. On arrival to the emergency department the patient is now refusing to answer any questions. It was reported however the patient has been off of his medication though I do not know how long he has been off of his medications.” A review of the document titled “Rapid Initial Assessment” by Staff # 3, RN on 10/23/2024 at 3:10 AM revealed the following: Per mom and dad, Patient #1 has been off his medication for a couple of weeks and was becoming aggressive towards them. A review of the document titled “Emergency Notes” by Staff # 2, RN on 10/23/2024: 4:32 AM: “Requested security to escort Pt out.” 04:33 AM: “Pt left @ this time with MPD[McKinney Police Department] & Security. Given drivers license.” Patient # 14 A review of the document titled “Emergency Provider Report” by Staff # 6, on 10/23/2025 at 11:17 AM revealed the following: History of Present Illness “This is a patient with no significant past medical history no allergies no surgeries on no medications. Patient suffered physical abuse as a child from her father. She saw a psychiatrist afterwards and there was concern for possible bipolar disorder then. She is presenting for acute suicidal ideation without a plan. Patient has been having increased amounts of arguments with her mother and states that she is unable to control her anger and emotions. Has a history of self-harm but no loss of arms. Denies any HI. Denies any AVH. Does consume marijuana occasionally.” ... Vital signs on 10/23/25 at 11:18 AM: Temperature-36.5C, Pulse-85, Respirations-18, Blood Pressure-114/70, SPO2-100% on room air. ... “Lab Statement: Laboratory studies reviewed and considered in the medical decision-making” Clinical Impression was noted as a mood disorder. Patient # 14 was discharged home on 10/23/2024 at 1:10 PM. Discharge Instructions include referrals to a Behavioral Health Intensive outpatient program and to a Behavioral Health Partial Hospital Program. A review of the document titled “Detailed Assessment” by Staff # 7, RN on 10/23/2024 revealed the following: 11:18 AM: Anxiety, Depression, and Post-traumatic stress disorder was noted. 1:22 PM: Patient # 14 was discharged in stable/stabilized condition and was expected to maintain stabilization. Patient # 14 departed with her mother and walked to the car. The facility failed to ensure Patient # 14 received a full medical screening exam that included a psych exam for Patient # 14, who presented to the facility with acute suicidal ideation without a plan. Patient # 14 has past medical diagnoses of: anxiety, depression, and Post Traumatic Stress Disorder. During patient # 14 emergency room visit, no suicidal screening was completed. The facility failed to transfer a patient who had suicidal ideation with a past mental health history. Policy A review of the facility policy titled “PC.PP.112, Texas EMTALA Medical Screening Examination and Stabilization Model Policy”, effective date 12/2000, last revised 09/2024, revealed the facility did not follow its policy: page 10, Section 3e, iii. “Individuals with psychiatric or behavioral symptoms: The medical records should indicate both medical and psychiatric or behavioral components of the MSE. The MSE for psychiatric purposes is to determine if the psychiatric symptoms have a physiologic etiology. The psychiatric MSE includes an assessment of suicidal or homicidal thoughts or gestures that indicates danger to self or others.” Interviews: An interview with Staff # 5, RN, ED Manager, on 01/14/2025 at approximately 11:08 AM revealed that when a patient arrives with the Police, the doctor will speak with the police officer. The nurse will assess for mental health issues, including suicide and homicide ideation. We will have the patient change into blue paper scrubs and grippy socks. We would not restrain the patient if the patient refused care and had no violent/aggressive behaviors. Behavior Health would provide a psychiatric evaluation of the patient next. If the patient were not talking, we would wait for Behavior Health to provide a recommendation. We are working to have Behavioral Health available for psychiatric evaluations 24 hours a day, but at this time, it is hard to cover the 1st and 2nd shifts. An interview with Staff # 1, MD, Emergency Medicine, on 01/14/2025 at approximately 4:43 PM revealed the following: “The Police brought the patient in. I was told he was making religious statements. The patient allowed me to complete a physical examination. He never spoke a word; he only shook his head and made eye contact.” Nursing and I wanted him to stay and have a psychological evaluation, but we needed to complete a blood test first to have him medically cleared, but the patient refused. “He would have benefited from having a Psych Eval, but he didn’t pose a threat to himself or others, and we could not hold him against his will. With the information, I had nothing that rose to that level.” An interview with Staff # 2, RN, ED Charge Nurse, on 01/14/2025 at approximately 4:52 PM revealed the following: “I was notified that the patient was not answering questions for his assessments,” I spoke to Staff # 1, MD Emergency Medicine, and he said we could override the EDO and discharge the patient. It was explained to the patient that he could not get a ride home if he left AMA. I asked the patient to sign the discharge Against Medical Advice (AMA), but he declined and sat on his bed. The patient had to be escorted by Security out of the building; he didn’t want to leave. The Police were also notified that a patient was leaving AMA.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 33326 Based on record reviews, and interviews, the facility failed to protect a patient’s right to care in a safe environment when, (7) seven out of (11) eleven patient’s medical records, chosen, reviewed, and identified by the facility as having been restrained while at the facility, did not have a physician’s order for the use of the restraint and the patient did not receive the one-hour face to face medical provider assessment, as the facility’s policy required. This failure places patients from being inappropriately held against their will and places them at risk for pain, injury, and death. (Patients #3,5,7.8,9, 10, and 11) Findings include: Review of the facility provided policy, Patient’s Rights (Last Revision, 04/24) reflected, “We adopt and affirm as policy the following rights of patient/clients who receive services from our facilities: Considerate and Respectful Care o To receive ethical, high-quality, safe, and professional care without discrimination o To be free from all forms of abuse and harassment ...” Review of the facility provided policy, Security Assistance for Aggressive Behavior (last revised 07/20/22) reflected, “PURPOSE: To provide and maintain a safe environment for patients, visitors, physicians, employees and staff and to assure a timely response to situations involving an actual or potential physical threat. POLICY: A Security Alert will summon additional staff members in an emergency situation in which a patient, visitor or employee becomes unruly and demonstrates the potential to: A. Inflict physical harm on themselves or others. B. Damage the hospital’s property or the property of others. Review of the facility provided policy, “Patient Restraint/Seclusion (Effective 7/1/2023) reflected, “APPENDIX D: DEFINITIONS The definitions of restraint use types are applicable in any setting in the facility and are not driven by diagnosis. A. Physical restraint: Any manual method or physical or mechanical device, material, or equipment attached or adjacent to the patient’s body that he or she cannot easily remove that restricts freedom of movement or normal access to one’s body to include immobilization or reduction of the ability of a patient to move his or her arms, legs, body, or head freely is considered a physical restraint. An object may be a restraint by functional definition, which is when an object restricts the patient’s movement or access to his or her body. Under this definition, many commonly used facility devices and practices could meet this definition of a restraint (e.g., tucking in sheets very tightly, use of side rails to prevent a patient from voluntarily getting out of bed, holding a patient to prevent movement, pinning of mitts on infants, arm restraints and other wrappings that prevent infants, children and/or adults from removing invasive lines or reopening surgical sites, etc.) ... E. Physical Holds: The regulation permits the physical holding of a patient for the purpose of conducting routine physical examinations or tests. However, patients do have the right to refuse treatment. This includes the right to refuse physical examinations or tests. Holding a patient in a manner that restricts the patient’s movement against the patient’s will is considered restraint. This includes holds that some members of the medical community may term “therapeutic holds.” Many deaths have occurred while employing these practices. Physically holding a patient during a forced psychotropic medication procedure is considered a restraint. If the patient is in a physical hold, a second staff person is assigned to observe the patient to ensure safety and the patient’s airway is not compromised. F. Physical Holding for Forced Medications: The application of force to physically hold a patient, in order to administer a medication against the patient’s wishes, is considered restraint. The patient has a right to be free of restraint and also has a right to refuse medications, unless a court has ordered medication treatment. A court order for medication treatment only removes the patient’s right to refuse the medication. Additionally, in accordance with State law, some patients may be medicated against their will in certain emergency circumstances. However, in both of these circumstances, health care staff is expected to use the least restrictive method of administering the medication to avoid or reduce the use of force, when possible. The use of force in order to medicate a patient, as with other restraint, must have a physician’s order prior to the application of the restraint (use of force). If physical holding for forced medication is necessary with a violent patient, the one-hour face-to-face evaluation requirement would also apply. “ During an interview, on afternoon of 05/22/24 in a facility conference room, Staff # Vice President of Quality stated in part, “A restraint is anything that prevents a patient’s movements. All restraints require a physician’s order. The nurse can order the restraint, in an emergency, and then get the order from the physician. There must be at least two staff present, one for the hold and the other to monitor the hold, to ensure the safety of the patient.” Review of the Patient #3’s Behavioral Emergency Response Team (BERT) program performance improvement evaluation form dated, 10/22/23, reflected a physical hold had been checked off as having been performed. A further medical records review reflected, no physician order for the restraint and no one-hour face to face had not been conducted. Review of the Patient #5’s Behavioral Emergency Response Team (BERT) program performance improvement evaluation form dated, 04/23/24, reflected a physical hold had been checked off as having been performed. A further medical records review reflected, no physician order for the restraint and no one-hour face to face had not been conducted. Review of the Patient #7’s Behavioral Emergency Response Team (BERT) program performance improvement evaluation form dated, 04/09/24 at 2:15 pm, reflected a physical hold had been checked off as having been performed. A further medical records review reflected, no physician order for the restraint and no one-hour face to face had not been conducted. Review of the Patient #8’s Behavioral Emergency Response Team (BERT) program performance improvement evaluation form dated, 3/30/24 at 12:00 am, reflected a physical hold had been checked off as having been performed. A further medical records review reflected, no physician order for the restraint and no one-hour face to face had not been conducted. Review of the Patient #9’s Behavioral Emergency Response Team (BERT) program performance improvement evaluation form dated, 03/23/24 at 9:39 am to 10:51 am, reflected a physical hold had been checked off as having been performed. The staff documented, “Patient was literally a physical hold from the time I arrived on the unit up until the Bert was called off.” Further medical records review reflected, no physician order for the restraint and no one-hour face to face had not been conducted. Review of the Patient #10’s Behavioral Emergency Response Team (BERT) program performance improvement evaluation forms dated 02/14/24, the first Bert was at 8:00 pm, and a second Bert was at 9:03 pm. A physical hold had been checked off as having been performed for both response visits. Further medical records review reflected, no physician order for the restraint and no one-hour face to face had not been conducted. Review of the Patient #11’s Behavioral Emergency Response Team (BERT) program performance improvement evaluation form dated, 10/06/23 at 1:00 pm, reflected a physical hold had been checked off as having been performed. Further medical records review reflected, no physician order for the restraint and no one-hour face to face had not been conducted. During the records review on the afternoon of 5/22/24, Staff #12, Director of Behavioral Health, confirmed the missing physician’s orders and the missing face-to-face assessments and explained the BERT are specially trained staff that will come to emergency behavioral events, they are not there to do a take-down (bringing the patient to the ground). They try to de-escalate the situation and they document the events.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 33589 Based on record review and interview, the facility failed to ensure patient rights for each patient, in that, 2 of 20 behavioral patients (Patient #1 and Patient #15) did not have psychotropic medication consent forms for the administered psychotropic medications. Findings ~ Patient #1 did not have psychotropic medication consent form for the administered psychotropic medications. The patient transferred on 11/09/2022 at 8:35 AM from Parkland after her evaluation in their ER. Orders were received 11/08/2022 for her admit. She was involuntary and Parkland completed the paperwork with the Dallas County Probate Court prior to her arrival. The chief complaint was psychosis with a past medical history: schizoaffective disorder...Severe Bipolar Disorder, recurrent manic episodes, with psychotic behavior. Date Administered Medications 11/10/2022 Haldol/Ativan/Benadryl 11/11/2022 Haldol/Ativan/Benadryl 11/12/2022 Haldol/Ativan/Benadryl 11/14/2022 Haldol/Ativan/Benadryl 11/16/2022 Haldol/Ativan Although the patient allowed the medication at the time, there was no consent form for Haldol, or Ativan. There was no consent form for Benadryl until 11/15/2022. ~ Patient #15 did not have psychotropic medication consent form for the administered psychotropic medication. The patient was admitted with a chief complaint of intentional drug overdose, suicide ideation, and suicide attempt. Extremely aggressive despite medications and a past medical history of depression. Date Administered Medication 4/25/2024 Haldol Although the patient allowed the medication at the time, there was no consent form for Haldol completed. During record review and interview on 5/16/2024 ending at 12:13 PM, Personnel #3 navigated the records and confirmed Patient #1 and #15 received the non-emergent psychotropic medications without a completed consent form. The December 2023 reviewed/revised “Informed Consent for Treatment with Psychoactive Medication” Policy required, “The patient must provide informed consent for all non-emergent psychotropic medicines that have been ordered, prior to the patient receiving the first dose. The February 2017 “Consent to Treatment With Psychoactive Medication Information Sheet for Patients” Handout required, “You have the right to decide whether to take this medication as recommended by your doctor. You can agree to take the medicine, this agreement is called consent...your objection will be recorded...””

“PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION CFR(s): 482.13(a)(2)(iii) At a minimum: In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. This Standard is not met as evidenced by: 33589 Based on record review and interview, the facility failed to ensure patient rights for grievance procedures, in that, Patient #1’s complainant did not receive a written response (resolution of patient complaints concerning the quality of care) back from the facility. Findings Patient #1’s December 2023 grievance was not logged. There were no letters (acknowledgement, extension, and Resolution) for the Patient #1’s December 2023 grievance. During an interview on 4/09/2024 at 3:20 PM, Personnel #1 stated I spoke to the complainant on the phone many times. I pulled the team together and we met with her. The grievance was not logged and the letters were not completed. The facility’s August 2022 Customer Concerns / Complaints /Grievance Policy required both an acknowledgement letter and a Response letter to ensure the compliance of the patient’s right to a timely resolution...The response shall include the name of the hospital, contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process and the date of completion...Log, trend, and analyze data to assist in identifying opportunities to improve care inclusive of timely response.”