Affiliate of Vitruvian Health

“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: 30553 Based on review of facility policy, review of on-call general surgery schedules, medical record review, review of transfer center audio communication, and interviews, the facility failed to provide an appropriate medical screening examination and provide an appropriate transfer for 1 patient (#5) who presented with abdominal pain of 22 Emergency Department (ED) records reviewed. The findings include: Patient #5 was admitted to Facility A’s ED on 10/14/2024 at 8:46 PM with complaints of abdominal pain. The patient had previous abdominal surgeries. Diagnostic testing showed a Bowel Obstruction, a Fecal Impaction, and Sepsis. The facility had on-call general surgery capacity and capabilities. The patient developed hypotension (low blood pressure) requiring the use of vasopressors (medications to treat low blood pressure), intravenous fluids, oxygen, and antibiotics. Facility B was called and accepted Patient #5 for transfer without consulting Facility A’s on-call general surgeon for intervention and/or stabilization. On arrival at Facility B, the patient required intubation, the insertion of a central venous and arterial line, and intravenous fluid resuscitation. The patient was taken emergently to surgery for a bowel resection where she deteriorated. The surgery was completed and she was admitted to the surgical intensive care unit with plans to return to the operating room once the patient stabilized. The patient suffered a cardiac arrest and expired on 10/15/2024. Cross Refer to A-2407 and A-2409.”

“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: 30553 Based on review of facility policy, review of facility on-call schedules, medical record review, review of transfer audio communication, and interviews, the facility failed to provide stabilizing treatment for one (1) patient (#5) who presented with abdominal pain of 22 Emergency Department (ED) records reviewed. The findings include: Review of facility policy, “Emergency Medical Treatment Active Labor Act,” revised 2/5/2021, showed “...medical screening examination is the process required to reach, with reasonable clinical confidence, the point at which it can be determined whether or not an emergency medical condition exists...is a ongoing process, and the medical records must reflect continued monitoring based on the patient’s needs and must continue until the patients is either stabilized, admitted to inpatient care, or appropriately transferred...stabilized means, with respect to an emergency medical condition, that no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer or the individual from a facility...this includes coverage available through the hospital’s on-call physician roster. The hospital is responsible for treating the individual within the capabilities of the hospital as a whole...” Review of the facility’s On-Call Provider Schedules for 10/14/2024 and 10/15/2024 showed the facility had a general surgery on-call provider. The surgeon was not called or consulted in relation to Patient #5. Medical record review of an ED Nursing Triage Record for Patient #5, dated 10/14/2024 at 8:46 PM, showed the patient presented by Emergency Medical Services (EMS) with a distended abdomen and diarrhea for 4 weeks. Medical record review of an ED Provider Note, dated 10/14/2024 at 8:48 PM, showed the patient had an onset of abdominal pain which started 3 hours prior to arrival. Her physical examination showed an distended abdomen with marked tenderness. Medical record review of the diagnostic testing dated 10/14/2024, showed the following: 9:16 PM - Complete Blood Count (CBC) with an elevated white blood count of 15.2 (normal 5-10) and elevated Neutrophils 13.2 9:16 PM - Comprehensive Metabolic Panel (CMP): BUN 24 (normal 6-24), Creatinine 1.37 (normal 0.7-1.3) 9:16 PM - Lipase 84 (normal 13-78) 9:16 PM - Elevated Lactic Acid 5.7 (normal 0.5-2.2). 11:08 PM - Computed Tomography (CT) scan of the abdomen and pelvis: severe distention of the colon with stool and air, fecal impaction, possible colonic ileus (lack of movement in the intestines) versus metabolic pseudoobstruction considered. There was no colitis (inflammation of the colon) or diverticulitis (infection in the colon). Possible stricture or mass at the gastroesophageal junction of the esophagus, and no pneumoperitoneum (air in peritoneum). Medical record review of the Medication Administration Record, dated 10/14/2024, showed the following medications were administered: Dilaudid (pain medication) 1 mg IV at 9:18 PM Zofran 4 mg IV at 10:10 PM Zosyn (antibiotic) 3.375 grams IV at 10:53 PM Normal Saline IV fluids started at 10:54 PM; total of 2449 milliliters. Norepinephrine (vasopressor) drip at 0.5 micro kilograms per kilogram (mcg.kg/min) started at 11:27 PM 10/15/2024 Fleets enema at 12:06 AM Norepinephrine drip decreased to 0.3 micro mcg/kg/min at 1:29 AM. Medical record review of an ED Provider Note, dated 10/15/2024 at 1:21 AM, showed “...attempted removal of fecal impaction. I removed a very large amount of soft stool and patient passed a minimal amount of gas. She has a rectal mass or hemorrhoids which bleed mildly at the time of the procedure...” Her diagnoses included Abdominal Pain, Large Bowel Obstruction, and Sepsis. The patient was accepted at [Facility B]...” Medical record review of an EMTALA transfer form, dated 10/15/2024 at 1:22 AM, showed Patient #5 was transferred to Facility B and was transported by EMS on 10/15/2024. Medical record review of an admission History and Physical from Facility B, dated 10/15/2024 at 3:01 AM, showed the patient presented from an outside facility with abdominal pain. The patient’s family reported increased abdominal pain for the past few days with no bowel movements for 10 days. The labs showed severe distention of the colon with stool and air, a fecal impaction, and possible stricture or mass in the gastroesophageal junction. On arrival at Facility B’s Surgical Intensive Care Unit the patient was “...grossly hypotensive requiring multiple pressors and required intubation and a central line and arterial line placement. The patient had a Lactate of 10 and a leukocytosis of greater than 25. Patient was already starting to develop acute kidney injury with a creatinine of 1.6 and she had a PH that was below 7...plan is to take the patient emergently to the operating room and continue sepsis resuscitation...” Medical record review of an Operative Report, dated 10/15/2024 at 6:57 AM, showed Subtotal Abdominal Colectomy (bowel resection), Enterorrhaphy (stitching of the intestine), Extensive Lysis of adhesions, and application of temporary abdominal closure with negative pressure dressing was performed. The patient was “...unstable at the time of the conclusion of the case and was taken to the ICU for ongoing resuscitation...” Medical record review of a Discharge Summary, dated 10/15/2024 at 12:29 PM, showed Patient #5 had multi-system failure related to bowel ischemia/perforation and expired. She had been taken to surgery and then transferred to the SICU. She suffered a cardiac arrest where resuscitation was unsuccessful. She expired on 10/15/2024. Review of an audio recording from the transfer center at Facility B showed the transfer center was contacted on 10/15/2024 by ED Provider #1 from Facility A. ED provider #1 stated the patient was a long-term surgery patient from Erlanger Medical Center which needed transfer. Her diagnoses included Ischemic Bowel and Sepsis. The patient would require ICU admission and probable emergent surgical intervention. The patient presented with abdominal pain and distention. The patient stated she had not had a bowel movement for several weeks. The patient’s labs were “...crappy...WBC was 15 thousand, Lactic Acid 5.7...ischemic bowel possibly necrotic bowel and septic...” Her blood pressure had dropped where she was started on a Levophed drip and her blood pressure had stabilized. The physician stated “...I would not be surprised if the patient did not survive...there is nothing we do for her here...” The patient was hypothermic (low temperature) and “circling the drain.” During an interview on 12/11/2024 at 9:50 AM, the Risk Manager stated the patient presented with abdominal pain with distention. Her CT showed a bowel obstruction and an elevated Lactic Acid. The ED provider felt the patient needed surgical intervention and called Facility B. The ED provider did not call the on-call surgeon for the patient. The patient developed hypotension, she was started on Levophed and transferred to Facility B. On 10/18/2024, Facility B called about questions related to patient’s transfer. On arrival at Facility B the patient had decompensated. There was discussion related to whether the facility had an on-call surgeon who could have evaluated and treated the patient. The on-call surgeon was not called or consulted for the patient. The ED Medical Director spoke with ED Provider #1 who confirmed he had not called the on-call surgeon for evaluation and arranged the transfer to Facility B. During a telephone interview on 12/11/2024 at 1:00 PM, ED Provider #1 stated the patient arrived by EMS with abdominal pain and distention. Diagnostic testing was completed where the CT scan showed a bowel obstruction and a fecal impaction. Her laboratory diagnostic testing showed an elevated Lactic Acid and White Blood Count. The patient developed hypotension and a Levophed drip was started. She was given IV antibiotics and IV fluids. He called Facility B to initiate a transfer related to possible surgical intervention. Facility B accepted the patient for transfer. ED Provider #1 stated the facility did have on-call surgery capabilities and confirmed he had not consulted with the on-call surgeon prior to transfer. During a telephone interview on 12/11/2024 at 1:15 PM, the ED Medical Director stated the patient had a bowel obstruction and deterioated while in the ED. He confirmed the facility did have on-call surgery capabilities and the on-call provider should be consulted for potential surgical cases. During a telephone interview on 12/11/2024 at 4:30 PM, Facility B’s Risk Manager stated there were concerns related to the patient was transferred with an unstable condition and in need of surgical intervention. Facility A had confirmed on-call general surgery was not consulted and did not evaluate the patient. The delay could have contributed the increased risk of mortality for the patient. Patient #5 was unstable on arrival Facility B’s Intensive Care Unit (ICU), she required intubation, the insertion of central and arterial lines, and aggressive fluid resuscitation. The patient was taken for emergent surgery where she remained critical. The surgery was completed and she was taken back to SICU. The patient suffered a cardiac arrest and expired on 10/15/2024. Cross Refer to 2409.”

“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: 30553 Based review of facility policy, review of on-call schedules, medical record review, review of transfer center audio communication, and interviews, the facility inappropriately transferred Patient #5, one of 22 sampled patients, to Facility B when the hospital had the capability and capacity to provide treatment for the identified emergency medical condition. The findings include: Review of facility policy, “Emergency Medical Treatment Active Labor Act,” revised 2/5/2021, showed “...capability...the level of care that the personnel of the hospital can provide within the training and scope of their professional licenses. This includes coverage available through the hospital’s on-call physician roster. The hospital is responsible for treating the individual within the capabilities if the hospital as a whole...Appropriate transfer...the transferring hospital provides medical treatment within its capacity that minimizes the risks of individual’s health...if a patient is determined to have an Emergency Medical Condition (EMC) and ...the treating physician determines that the hospital has exhausted all capabilities to stabilize the patient’s EMC, and that the benefits of an appropriate transfer outweigh the risks of transfer, the hospital shall take reasonable steps to initiate an appropriate transfer...” Review of the facility’s On-Call Provider Schedules for 10/14/2024 and 10/15/2024, showed the facility had a general surgery on-call provider. The surgeon was not called or consulted in relation to Patient #5. Medical record review of an ED Nursing Triage Record dated 10/14/2024 at 8:46 PM, showed Patient #5 presented by Emergency Medical Services (EMS) with a distended abdomen and diarrhea for 4 weeks. Medical record review of an ED Provider Note dated 10/14/2024 at 8:46 PM, showed Patient #5 had an onset of abdominal pain, which started 3 hours prior to arrival. Her physical examination showed a distended abdomen with marked tenderness. Medical record review of an ED Provider Note dated 10/15/2024 at 1:21 AM, showed “...attempted removal of fecal impaction. I removed a very large amount of soft stool and patient passed a minimal amount of gas. She has a rectal mass or hemorrhoids which bleed mildly at the time of the procedure...” Her diagnoses included Abdominal Pain, Large Bowel Obstruction, and Sepsis. The patient was accepted at [Facility B]...” Medical record review of an EMTALA transfer form, dated 10/15/2024 at 1:22 AM, showed Patient #5 was transferred to Facility B and was transported by EMS on 10/15/2024. Medical record review of an admission History and Physical from Facility B, dated 10/15/2024 at 3:01 AM, showed the patient presented from an outside facility with abdominal pain. The patient’s family reported increased abdominal pain for the past few days with no bowel movements for 10 days. The labs showed severe distention of the colon with stool and air, a fecal impaction, and possible stricture or mass in the gastroesophageal junction. On arrival at Facility B’s Surgical Intensive Care Unit the patient was “...grossly hypotensive requiring multiple pressors and required intubation and a central line and arterial line placement. The patient had a Lactate of 10 and a leukocytosis of greater than 25. Patient was already starting to develop acute kidney injury with a creatinine of 1.6 and she had a PH that was below 7...plan is to take the patient emergently to the operating room and continue sepsis resuscitation...” Medical record review of an Operative Report, dated 10/15/2024 at 6:57 AM, showed Subtotal Abdominal Colectomy (bowel resection), Enterorrhaphy (stitching of the intestine), Extensive Lysis of adhesions, and application of temporary abdominal closure with negative pressure dressing was performed. The patient was “...unstable at the time of the conclusion of the case and was taken to the ICU for ongoing resuscitation...” Medical record review of a Discharge Summary, dated 10/15/2024 at 12:29 PM, showed the patient had multi-system failure related to bowel ischemia/perforation and expired. She was taken to surgery and then transferred to the SICU. She suffered a cardiac arrest where resuscitation was unsuccessful. She expired on 10/15/2024. Review of an audio recording from the transfer center at Facility B showed the transfer center was contacted on 10/15/2024 by ED Provider #1 from Facility A. Her diagnoses included Ischemic Bowel and Sepsis. The patient would require ICU admission and probable emergent surgical intervention. The patient presented with abdominal pain and distention. The patient stated she had not had a bowel movement for several weeks. The patient’s labs were “...crappy...WBC was 15 thousand, Lactic Acid 5.7...ischemic bowel possibly necrotic bowel and septic...” Her blood pressure had dropped where she was started on a Levophed drip and her blood pressure had stabilized. The physician stated “...I would not be surprised if the patient did not survive...there is nothing we do for her here...” The patient was hypothermic (low temperature) and “circling the drain.” During an interview on 12/11/2024 at 9:50 AM, the Risk Manager stated the patient presented with abdominal pain with distention. Her CT showed a bowel obstruction and an elevated Lactic Acid. The ED provider felt the patient needed surgical intervention and called Facility B. The patient developed hypotension, she was started on Levophed and transferred to Facility B. On 10/18/2024 Facility B called about questions related to Patient #5’s transfer. On arrival at Facility B, the patient had decompensated. There was discussion related to whether Facility A had an on-call surgeon who could have evaluated and treated the patient. The on-call surgeon was not called or consulted for the patient. The ED Medical Director spoke with ED Provider #1 who confirmed he had not called the on-call surgeon for evaluation and arranged the transfer to Facility B. During a telephone interview on 12/11/2024 at 11:20 AM, RN #2 stated the patient presented with abdominal pain and distention. The patient developed hypotension and an elevated heart rate. The patient was started on Levophed drip related to her blood pressure. The patient was transferred to Facility B. During a telephone interview on 12/11/2024 at 1:00 PM, ED Provider#1 stated the patient arrived by EMS with abdominal pain and distention. Diagnostic testing was completed and the CT scan showed a bowel obstruction and a fecal impaction. Her laboratory diagnostic testing showed an elevated Lactic Acid and White Blood Count. The patient developed hypotension where a Levophed drip was started. She was given IV antibiotics and IV fluids. He called Facility B to initiate a transfer related to possible surgical intervention. Facility B accepted the patient for transfer. ED Provider #1 stated the facility did have on-call surgery capabilities and confirmed he had not consulted with the on-call surgeon prior to transfer. During a telephone interview on 12/11/2024 at 1:15 PM, the ED Medical Director stated the patient had a bowel obstruction and deterioated while in the ED. He confirmed the facility did have on-call surgery capabilities and the on-call provider should be consulted for potential surgical cases. During a telephone interview on 12/11/2024 at 4:30 PM, Facility B’s Risk Manager stated there were concerns related to Patient #5’s transfer with an unstable condition and in needed surgical intervention. Facility A had confirmed he on-call general surgeon was not consulted and did not evaluate the patient. The delay could have contributed the increased risk of mortality for the patient. The patient was unstable on arrival Facility B’s Intensive Care Unit (ICU), she required intubation, the insertion of central and arterial lines, and aggressive fluid resuscitation. The patient was taken for emergent surgery where she remained critical. The surgery was completed and she was taken back to SICU. The patient suffered a cardiac arrest and expired on 10/15/2024. Cross Refer to 2407.”

“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: 30553 Based on review of facility policy, medical record review and interviews, the facility failed to ensure an accurate and complete medical screening examination (MSE) for 1 patient (#1) who presented to the Emergency Department (ED) for lightheadedness and fatigue of 22 records reviewed. The findings include: Patient #1 presented to the ED on 6/14/2024 by Emergency Medical Services (EMS) with lightheadedness and fatigue. The patient reported her family checked her blood pressure and it was low. The patient had previous history of Atrial fibrillation. EMS started an intravenous line and gave the patient a fluid bolus. The patient was triaged and evaluated by the ED Provider where diagnostic laboratory and radiology testing was completed. Diagnostic testing did not show findings suggestive of Sepsis, however, a urinalysis was ordered and was not completed prior to the patient being discharged. Later on 6/14/2024, the patient presented to Facility B with worsening symptoms. The patient had an elevated White Blood Count, elevated Lactic Acid, and her urine showed findings suggestive of a Urinary Tract Infection. She was started on intravenous antibiotics and given IV fluids with improvement. The patient was admitted with the diagnosis of Sepsis. On 6/15/2024 the preliminary results for the blood cultures, completed at Facility A, showed gram negative rods and E.coli. The patient remained at Facility B until 6/17/2024 when she was discharged home on oral antibiotics. Refer to A-2406”

“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: 30553 Based on review of facility policy, review of an Emergency Medical Services (EMS) run report, medical record review and interviews, the facility failed to ensure an accurate and ongoing medical screening examination (MSE) for 1 patient (#1) who presented to the Emergency Department (ED) with lightheadedness, fatigue, low grade fever and failed to complete diagnostic testing ordered by the physician of 22 records reviewed. The findings include: Review of the facility policy, “Emergency Medical Treatment and Active Labor Act (EMTALA)” last revised on 2/5/2021, showed “...a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in: placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy; Serious impairment to bodily functions; or Serious dysfunction of any bodily organ or part... Medical Screening Examination (MSE) is the process required to reach, with reasonable clinical confidence, the point at which it can be determined whether or not an emergency medical condition exists, or a woman is in labor. Such screening must be performed by qualified medical personnel...and within the hospital’s capacity and capability. The MSE is an ongoing process, and the medical records must reflect continued monitoring based on the patient’s needs and must continue until the patient is either stabilized, admitted to inpatient care, or appropriately transferred...” Review of an EMS run report dated 6/14/2024, showed EMS was requested related to Patient #1 being lightheaded while at home with nausea. The patient had complaints of feeling lightheaded and a “funny feeling” with nausea and muscle cramps. She had a previous history of Atrial fibrillation. Her vital signs were as follows: blood pressure 108/68, pulse 82, respirations 18, pulse oximeter 98%, and temperature 98.5®F (degrees Fahrenheit). During transport, an intravenous (IV) line was started, the patient was given 1000 milliliters of Normal Saline, 4 milligrams (mg) of Zofran (medication used for nausea) and started on oxygen at 2 liters/min via nasal cannula. The patient was transported to Facility A’s ED. Medical record review of an ED Nursing Triage record, dated 6/14/2024 at 1:45 PM, showed the patient presented via EMS with complaints of lightheaded and dizziness which started the same day. EMS had established an IV and given IV fluids. The patient’s vital signs were as follows: blood pressure 97/70 with a mean arterial pressure of 79, pulse 100, respirations 18, pulse oximetry 96% on room air, and temperature 99®F. The patient was triaged with an Emergency Severity Index (ESI) score of a 2, indicating urgent needs. Medical record review of an ED Physician record, dated 6/14/2024 at 2:05 PM, showed Patient #1 presented with generalized fatigue, lightheadedness and nausea intermittently over the past week and “while eating a sandwich” got nauseous and thought the nausea caused the lightheadedness which lasted 5-10 minutes and resolved on its own. She denied chest pain, shortness of breath, cough, congestion, runny nose, headaches, change in vision, focal neuro deficits, abdominal pain, vomiting, or urinary or bowel complaints. The patient had previous history of Atrial fibrillation. A urinalysis (UA) was ordered but was not completed for the patient prior to discharge. Medical record review of an ED Physician’s Discharge note, dated 6/14/2024 at 5:05 PM, showed the patient’s diagnoses included nausea and fatigue. The patient was instructed to follow-up with her Primary Care Physician in 1-2 days or return to the ED sooner if symptoms persist, worsen or concerns. No prescriptions were given to the patient and no antibiotics were provided. Medical record review of a Discharge Disposition Summary, dated 6/14/2024 at 6:41 PM, showed the patient was discharged. Medical record review of a Microbiology report from Facility A, dated 6/15/2024 at 7:35 AM, showed the patient’s blood culture showed Gram Negative Rods. The results were called to the ED Provider. On 6/17/2024 at 7:58 AM, the blood culture showed growth of Escherichia Coli. Medical record review of an ED Physician’s note, dated 6/15/2024 at 10:00 AM, showed “...called and spoke to patient. She is currently at [name of Facility B] ED being evaluated. She will communicate with them that she had two positive blood cultures here...” Medical record review of an ED Physician’s Note, dated 6/20/2024 at 3:19 PM, showed “...blood culture results reviewed and positive for E.coli. Upon chart review from ED visit on 6/14/2024, she did not receive any antibiotics and no urinalysis was performed. I spoke with patient on the phone number listed on her facesheet and she reports that she was seen at [Facility B’s] ED 2 times since her visit here at [Facility A] and has been treated with Amoxicillin and Cefdinir [antibiotics] and feels better...” Medical record review of an ED Nursing Triage Record from Facility B, dated 6/14/2024 at 10:54 PM, showed the patient presented to the ED with complaints of hypotension. The patient had been discharged from Facility A’s ED the same day. The patient presented lethargic, she had right lower extremity edema, and generalized weakness. Her vital signs were as follows: Blood pressure 109/56, Pulse 100, Respirations 17, and Temperature 101®F. Medical record review of an ED Physician’s Record from Facility B, dated 6/14/2024 at 11:02 PM, showed the patient presented with general weakness and light headedness. She had gone to Facility A’s ED where she was given IV fluids and blood work was obtained. She was discharged home. Later she continued to not feel well and had a low blood pressure in the 80’s. Medical record review of a Urinalysis report from Facility B, dated 6/15/2024, showed the urine showed trace amounts of ketones, small amount of leukocytes, small amount of blood, 8 UR WBC’s (normal 0-2), 5 UR RBC’s (normal 0-2), and mucus strands. A reflex culture was not completed. Medical record review of a Hospitalist Progress Note, dated 6/16/2024, showed the patient’s diagnoses included Sepsis, possible Urinary Tract Infection (UTI), Bacteremia (bacteria in the urine) with elevated WBC (22 on admission now 6.9), fever, elevated Lactic Acid, and low blood pressure...The patient was on Zosyn and had received Vancomycin and “...suspect this is UTI source, could be GI tract source without clear symptoms and bland UA here...” The patient reported urinary frequency and having to get up at night to urinate which had recently occurred just prior to admission. Medical record review of a Discharge Summary, dated 6/17/2024 at 11:40 AM, showed the patient’s primary discharge diagnosis was E.coli and Sepsis likely due to UTI. The patient was placed on an oral 3rd generation cephalosporin (antibiotic) for 7 days. The patient confirmed urinary frequency. She was discharged home in stable condition. During a telephone interview on 6/24/2024 at 3:50 PM, with the complainant stated the patient passed out at home and it was thought to be related to a low blood pressure. EMS transported the patient to Facility A for evaluation and the patient was unable to walk. The patient had a fever of 101®F and had previous history of Atrial fibrillation. The facility ‘ran some test’ including blood work, chest x-ray, and an EKG and within 3 hours she was sent home. Upon discharge at Facility A the family took her to Facility B the same day, where her blood pressure was better and she got IV fluids. Within 1-2 hours the patient met the sepsis criteria, she was given IV antibiotics, and she was admitted to Facility B with Sepsis. He stated Facility A called the patient on 6/15/2024 and told her the blood cultures were positive, the patient had Sepsis, and they wanted her to return to the ED. The patient had already been admitted to Facility B where she remained for 4 days and was discharged. During an interview on 6/25/2024 at 3:15 PM, ED Physician #1 stated he evaluated the patient on 6/14/2024 and stated the patient presented to the ED with complaints of lightheadedness and fatigue for the past week. The patient did not complain of chest pain, shortness of breath, or urinary symptoms. The patient’s vital signs were stable. He stated, related to sepsis, the patient did not meet sepsis criteria but on admission her heart rate was 100. He stated “...she did not trigger the sepsis protocol based on her presentation, but I ordered many of the labs for sepsis. Her WBC and Lactic Acid were normal. IV fluids were started by EMS and she was given a liter bolus of Normal Saline. We drew 2 blood cultures but did not have those results prior to discharge. The urine was ordered but not collected prior to discharge. Based on the labs, chest x-ray, and clinical presentation, I did not feel the patient needed antibiotics and she had a primary care provider. She was not hypotensive. The blood culture results came back positive for Gram Negative Rods and E.coli. The Physician’s Assistant called the patient and was told the patient was at [Facility B] being treated. It looks like she got treated with Amoxicillin and Cefdinir. Based on the lab findings and the patient’s clinical presentation, antibiotics were not indicated at that time. There was no primary source of infection...” During an interview on 6/26/2024 at 11:35 AM, ED Nurse Manager #1 stated the sepsis protocol would be triggered related to the patients’ vital signs. The sepsis protocol would be initiated if 2 or more of the criteria triggered for a patient. The only trigger for the patient was a heart rate greater than 90 but the patient’s EKG showed the heart rate was trending downward. The Nurse Manager confirmed the urinalysis was ordered, but was not completed prior to discharge. During a telephone interview on 6/26/2024 at 2:00 PM, ED Physician #2 stated the standard of care was not to give antibiotics without an identifiable source. The patient did not meet sepsis criteria related to her vital signs and no urinary complaints. Diagnostic testing was completed to include a chest x-ray, CBC, CMP, and Lactic Acid which showed no acute findings. A urinalysis was ordered but was not completed prior to the patient’s discharge.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 36003 Based on review of facility policy, review of Quality Assessment and Performance Improvement (QAPI) Plan, medical record review, review of video surveillance footage, review of facility documentation, observation, and interviews the facility’s Governing Body failed to provide oversight to ensure the Behavioral Health (BH) courtyard fence was maintained to prevent elopement (ran away), failed to ensure investigation of a patient elopement, and failed to ensure implementation of processes to prevent recurrence of elopement for 1 patient (Patient #9) who eloped of 2 behavioral health patients reviewed of 12 patients reviewed, which had the potential to affect all BH patients. The findings include: Review of the facility’s policy titled, “Event Reporting Policy,” last reviewed 1/5/2023 showed “...The purpose of this policy is to provide guidance for communicating, reporting, investigating and acting upon a patient safety event including near miss, precursor and serious safety events, sentinel events, serious reportable/never event and hospital acquired conditions...Required Action Steps (Supervisor/Department Manager)...Supervisor on duty to notify the Department Manager and/or Administrator On-Call (AOC) of an event that is potentially serious, sentinel, serious reportable/never event or hospital acquired condition...Review events reported and if the event appears to have resulted in moderate to severe harm or death, immediately notify next level leader, Risk and/or Quality...Conduct brief/limited investigation (apparent cause analysis) on events which are precursor [events where a deviation from generally accepted performance standards reaches the patient and results in minimal harm or no detectable harm] or near miss [close call] harm events...This information is critical for patient safety efforts and to prevent recurrence...Required Action Steps (Risk and/or Quality...Review Supervisor/Department Manager investigation and determine if additional investigation is needed...Apply the Safety Event Classification [an outcome based classification system involving 3 steps: determining if there were deviations from generally accepted performance standards (GAPS), establish if there is a direct cause-and-effect relationship between deviations and the outcome and classify the level of patient harm resulting from the event]...Serious Safety Events, Sentinel Events, Serious Reportable/Never Events and Hospital Acquired Conditions require a more thorough and credible Root Cause Analysis [RCA-a process to find out what happened, why it happened, and determine what changes need to be made] and will be facilitated by trained Risk and Quality professionals...Required Action Steps (Executive Team-CEO [Chief Executive Officer], CNO [Chief Nursing Officer], CQO [Chief Quality Officer])...If it is determined the event meets or potentially meets (pending investigation) the definition of a Serious Safety Event, Sentinel Event, Serious Reportable/Never Event, and/or Hospital Acquired Condition notify Market CEO/CMO [Chief Medical Officer] /CQO and Regional President...Patient safety event types in ERS [event reporting system] include Preventable Events, Sentinel Events, Never Events, Serious, and Near Misses and Hospital Acquired Conditions and are generally categorized as follows...Behavioral - Patient Protection Events, Elopement...” Review of the facility’s policy titled, “Quality Assessment and Performance Improvement Plan,” dated 3/2/2023 showed “...The Board of Trustees (BOT), Medical Staff, and Administration have the overall responsibility and accountability for the quality of care and services provided...The Board of Trustees has ultimate authority and responsibility for the effective implementation of the Quality Assessment and Performance Improvement Plan and Program (QAPI), and authorized the Medical Staff and Administration to enact this plan...Administration has responsibility for the provision of patient care and services provided by the hospital...” Medical record review showed Patient #9 was admitted to the facility’s Behavioral Health Unit (West Campus) on 6/16/2023 with diagnoses of Psychosis. Other diagnoses included Behavioral Disturbance, Schizoaffective Disorder, Drug Induced Psychosis, Depression, Amphetamine and THC (marijuana) Abuse, and Hepatitis C. During a psychiatric evaluation on 6/17/2023, Patient #9 became belligerent and aggressive, yelling and demanding to leave at once. On 6/19/2023, Patient #9 asked when she would be able to leave the facility. On 6/20/2023, the patient requested to leave against medical advice (AMA). She began screaming that she would be “...leaving today...” when she was told a physician would have to evaluate her before she could leave AMA. The patient continued to make threatening comments and gestures toward staff on through 6/23/2023. Medical record review of a Behavioral Health Nursing note dated 6/24/2023 showed “...At approximately 1400 [2:00 PM], pt [Patient #9] pushed her way through small opening in fenced area outside as the patient’s were taken outside for nursing group therapy...Work order placed to fence repair...” Review of video surveillance footage of the Behavioral Health Unit courtyard for 6/24/2023 from 1:30 PM-2:20 PM showed a group of patients and 2 staff members identified as Registered Nurses (RNs) entered the courtyard at 1:31 PM. The RNs sat down in the picnic area and did not have all patients in their line of sight. Patient #9 (identified by facility staff) entered the courtyard at 1:38 PM and 52 seconds and began walking around the picnic area. At 1:40 PM, Patient #9 walked toward the back of the courtyard, toward the fence, and out of camera view. The RNs remained in the picnic table area. The patients and 2 RNs returned to the building at 2:12 PM. Patient #9 was not seen on video surveillance footage after 1:40 PM. The patients route of elopement could not be visualized. Review of an event report showed an elopement from the Behavioral Health Unit occurred on 6/24/2023 at 2:00 PM. “...RN x2 assisted pt’s outside for group therapy. As RN #1 was escorting another patient back inside to use the bathroom, the patient [Patient #9] (who eloped) pushed her way through an opening in the fenced area outside and eloped from facility...A work order has been placed to have the fence repaired...” Review of a purchase order dated 8/8/2023 (45 days after elopement) showed pricing for renovations of the Behavioral Health Unit (West Campus), including replacement of the courtyard fence. The delivery date listed on the purchase order was 10/20/2023. Review of a letter from the general contractor to the Facilities Director showed “...Fencing for the behavioral health unit has been ordered (10/25/2023) [4 months after elopement] and we intend to install as soon as material arrives. Materials is scheduled to be delivered the 2nd week of November and we will begin asap [as soon as possible]...” During an interview on 11/1/2023 at 9:17 AM, in the conference room, the Risk Manager confirmed she was not involved in a Root Cause Analysis with Behavioral Health management or staff regarding Patient #9’s elopement. Observation of the Behavioral Health Unit (West Campus) on 11/1/2023 at 10:15 AM showed the facility had 2 courtyards. Each courtyard had a 6-foot wooden fence around the perimeter of the courtyard. The fence in the courtyard where Patient #9 eloped had 2 new boards (not worn/weathered). There was what appeared to be a new corner board in the corner where it was thought Patient #9 eloped. New screws (not rusted) were observed in the boards on each side of the corner. During an interview on 11/1/2023 at 10:40 AM, in the BH conference room, the BH Nurse Manager confirmed an RCA had not been conducted and new processes had not been implemented following Patient #9’s elopement from the courtyard. In a second interview on 11/2/2023 at 11:03 AM, the BH Nurse Manager confirmed the patients present in the courtyard when Patient #9 eloped were not interviewed to determine if anyone witnessed the patient’s elopement. The BH Nurse Manager confirmed the courtyard had video surveillance cameras, confirmed the video surveillance footage for 6/24/2023 had not been reviewed, and confirmed the BH facility did not have a specific process to monitor patients during outdoor activities. During an interview on 11/1/2023 at 1:20 PM, in the conference room, the Facilities Director stated a broken section of the courtyard fence was repaired, a broken corner piece was replaced, and the area where it was thought the patient eloped through was secured with metal straps on 6/25/2023. In a second interview on 11/2/2023 at 10:49 AM, the Facilities Director stated the facility received an estimate for planned renovations of the Behavioral Health Unit, including supplies and labor for a new courtyard fence on 8/8/2023. The Facilities Director stated the fencing for the courtyard was not ordered until 10/25/2023 (4 months after the elopement). When asked why ordering was delayed, the Facilities Director stated instead of having 2 separate capital equipment requests for the fence and renovations, the facility wanted to do 1 capital equipment request to include the fence replacement and other renovations at the facility.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 36003 Based on facility policy review, medical record review, review of video surveillance footage, review of facility documentation, observation, and interviews the facility failed to protect patient rights to receive care in a safe environment for 1 Behavioral Health (BH) patient (Patient #9) of 2 BH patients reviewed of 12 patients reviewed, which had potential to affect all BH patients. The findings include: Patient #9 was admitted to the Behavioral Health Unit (West Campus) on 6/16/2023 with diagnoses of Psychosis. Other diagnoses included Behavioral Disturbance, Schizoaffective Disorder, Drug Induced Psychosis, Depression, Amphetamine and THC (marijuana) Abuse, and Hepatitis C. Patient #9 asked when she would be able to leave the facility on 6/19/2023. She requested to leave against medical advice (AMA) on 6/20/2023 and began screaming that she would be “...leaving today...” when she was told a physician would have to evaluate her before she could leave AMA. On 6/24/2023 at approximately 2:00 PM, Patient #9 eloped, undetected, from the courtyard through an opening in the fence during outdoor activities. Review of video surveillance footage showed the 2 RNs supervising the patients did not have all patients in their line of sight. Patient #9 left view of the camera at 1:40 PM and did not return into view. Surveillance video footage showed the patients and 2 RNs returned to the building at 2:12 PM (32 minutes after Patient #9 left view of the camera). Interviews with the 2 RNs present in the courtyard revealed the group of patients were taken inside when they realized Patient #9 was missing. Patient #9 returned to the facility on 6/24/2023 at 7:02 PM. The elopement event was entered in the event reporting system on 6/24/2023 and had been reviewed by the Risk Manager and the Interim Behavioral Health Director. A Root Cause Analysis (RCA-a process to find out what happened, why it happened, and determine what changes need to be made) had not been conducted by the facility. The facility’s failure to conduct a thorough investigation, failure to implement processes to prevent further patient elopements, and failure to ensure patient rights to receive care in a safe setting placed all BH patients at risk. Refer to A-0144.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 36003 Based on review of facility policy, review of Quality Assessment and Performance Improvement Plan (QAPI), medical record review, review of video surveillance footage, review of facility documentation, observation, and interviews the facility’s QAPI failed to ensure an ongoing, quality assessment and performance improvement program related to the Behavioral Health (BH) facility and monitoring of BH patients for 1 BH patient of 2 BH patients reviewed of 12 patients reviewed which had potential to place all BH patients at risk. The findings include: Patient #9 was admitted to the Behavioral Health Unit (West Campus) on 6/16/2023 with diagnoses of Psychosis. Other diagnoses included Behavioral Disturbance, Schizoaffective Disorder, Drug Induced Psychosis, Depression, Amphetamine and THC (marijuana) Abuse, and Hepatitis C. Patient #9 asked when she would be able to leave the facility on 6/19/2023. She requested to leave against medical advice (AMA) on 6/20/2023 and began screaming that she would be “...leaving today...” when she was told a physician would have to evaluate her before she could leave AMA. On 6/24/2023 at approximately 2:00 PM, Patient #9 eloped, undetected, from the courtyard through an opening in the fence during outdoor activities. Review of video surveillance footage showed the 2 RNs supervising the patients did not have all patients in their line of sight. Patient #9 left view of the camera at 1:40 PM and did not return into view. Surveillance video footage showed the patients and 2 RNs returned to the building at 2:12 PM (32 minutes after Patient #9 left view of the camera). Interviews with the 2 RNs present in the courtyard revealed the group of patients were taken inside when they realized Patient #9 was missing. Patient #9 returned to the facility on 6/24/2023 at 7:02 PM. The elopement event was entered in the event reporting system on 6/24/2023 and had been reviewed by the Risk Manager and the Interim Behavioral Health Director. A Root Cause Analysis had not been conducted by the facility. The Chief Quality Officer was not aware of the elopement until 10/30/2023. The facility’s failure to conduct a thorough investigation and failure to implement processes to prevent further patient elopements placed all behavioral patients at risk. Refer to A-0286.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 36003 Based on medical record review, review of video surveillance footage, review of facility documentation, and interview the facility failed to ensure a Registered Nurse (RN) supervised Behavioral Health patients during outdoor activities for 1 BH patient (Patient #9) of 2 BH patients reviewed of 12 patients reviewed which had potential to affect all BH patients. The findings include: Patient #9 was admitted to the Behavioral Health Unit (West Campus) on 6/16/2023 with diagnoses of Psychosis. Other diagnoses included Behavioral Disturbance, Schizoaffective Disorder, Drug Induced Psychosis, Depression, Amphetamine and THC (marijuana) Abuse, and Hepatitis C. Patient #9 asked when she would be able to leave the facility on 6/19/2023. She requested to leave against medical advice (AMA) on 6/20/2023 and began screaming that she would be “...leaving today...” when she was told a physician would have to evaluate her before she could leave AMA. On 6/24/2023 at approximately 2:00 PM, Patient #9 eloped, undetected, from the courtyard through an opening in the fence during outdoor activities. Review of video surveillance footage showed the 2 RNs supervising the patients did not have all patients in their line of sight. Patient #9 left view of the camera at 1:40 PM and did not return into view. Surveillance video footage showed the patients and 2 RNs returned to the building at 2:12 PM (32 minutes after Patient #9 left view of the camera). Interviews with the 2 RNs present in the courtyard revealed the group of patients were taken inside when they realized Patient #9 was missing. The RN’s failure to continually monitor Behavioral Health patients during outdoor activities placed all Behavioral Health patients at risk. Refer to A-0395.”

“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: 36003 Based on facility policy review, review of Quality Assessment and Performance Improvement Plan (QAPI)medical record review, review of video surveillance footage, review of facility documentation, observation, and interviews the facility failed to provide care in a safe setting during outdoor activities resulting in elopement (ran away) for 1 Behavioral Health (BH) patient (Patient #9) of 2 BH patients reviewed of 12 patients reviewed which had potential to affect all BH patients. The findings include: Review of the facility’s policy titled, “Elopement Prevention/Response Plan,” last reviewed 4/12/2023 showed once an elopement occurs “...Available staff will immediately search for patient on unit and any suspected location of exit...The Security Staff and Administrative House Supervisor will monitor the video footage for location of patient...Following an actual event, appropriate investigation will be conducted to assess for additional actions that may lead to improvements in patient safety related to elopement...” Review of the facility’s policy titled, “Event Reporting Policy,” last reviewed 1/5/2023 showed “...The purpose of this policy is to provide guidance for communicating, reporting, investigating and acting upon a patient safety event including near miss, precursor and serious safety events, sentinel events, serious reportable/never event and hospital acquired conditions...Required Action Steps (Supervisor/Department Manager)...Supervisor on duty to notify the Department Manager and/or Administrator On-Call (AOC) of an event that is potentially serious, sentinel, serious reportable/never event or hospital acquired condition...Review events reported and if the event appears to have resulted in moderate to severe harm or death, immediately notify next level leader, Risk and/or Quality...Conduct brief/limited investigation (apparent cause analysis) on events which are precursor [events where a deviation from generally accepted performance standards reaches the patient and results in minimal harm or no detectable harm] or near miss [close call] harm events...This information is critical for patient safety efforts and to prevent recurrence...Required Action Steps (Risk and/or Quality...Review Supervisor/Department Manager investigation and determine if additional investigation is needed...Apply the Safety Event Classification [an outcome based classification system involving 3 steps: determining if there were deviations from generally accepted performance standards (GAPS), establish if there is a direct cause-and-effect relationship between deviations and the outcome and classify the level of patient harm resulting from the event]...Serious Safety Events, Sentinel Events, Serious Reportable/Never Events and Hospital Acquired Conditions require a more thorough and credible Root Cause Analysis [RCA-a process to find out what happened, why it happened, and determine what changes need to be made] and will be facilitated by trained Risk and Quality professionals...Required Action Steps (Executive Team-CEO [Chief Executive Officer], CNO [Chief Nursing Officer], CQO [Chief Quality Officer])...If it is determined the event meets or potentially meets (pending investigation) the definition of a Serious Safety Event, Sentinel Event, Serious Reportable/Never Event, and/or Hospital Acquired Condition notify Market CEO/CMO [Chief Medical Officer] /CQO and Regional President...Patient safety event types in ERS [event reporting system] include Preventable Events, Sentinel Events, Never Events, Serious, and Near Misses and Hospital Acquired Conditions and are generally categorized as follows...Behavioral - Patient Protection Events, Elopement...” Review of the facility’s policy titled, “Quality Assessment and Performance Improvement Plan,” dated 3/2/2023 showed “...The committees, departments and improvement teams are responsible for the delivery and evaluation of care and service they provide on an on-going basis...Priorities for safety and quality improvement are identified based upon improvement opportunities identified from...analysis of safety events, and root cause analysis investigations. The QIC [Quality Improvement Committee], MEC [Medical Executive Committee], BOT [Board of Trustees] and Hospital Executive Leadership will collaborate to establish hospital-level quality and patient safety strategic imperatives. Prioritization is performed annually, when improvement opportunities arise, or when changes occur in the internal or external environment...” Medical record review showed Patient #9 was admitted to the facility’s Behavioral Health Unit (West Campus) on 6/16/2023 with diagnoses of Psychosis. Other diagnoses included Behavioral Disturbance, Schizoaffective Disorder, Drug Induced Psychosis, Depression, Amphetamine and THC (marijuana) Abuse, and Hepatitis C. During a psychiatric evaluation on 6/17/2023, Patient #9 became belligerent and aggressive, yelling and demanding to leave at once. On 6/19/2023, Patient #9 asked when she would be able to leave the facility. On 6/20/2023, the patient requested to leave against medical advice (AMA). She began screaming that she would be “...leaving today...” when she was told a physician would have to evaluate her before she could leave AMA. The patient continued to make threatening comments and gestures toward staff on through 6/23/2023. Medical record review of a Psychiatry Progress note dated 6/24/2023 at 4:30 PM showed “...Pt eloped from the unit prior to seeing the pt...’ Medical record review of a Behavioral Health Nursing note dated 6/24/2023 showed “...At approximately 1400 [2:00 PM], pt [Patient #9] pushed her way through small opening in fenced area outside as the patient’s were taken outside for nursing group therapy...At approximately 1600 [4:00 PM], the patient’s mother notified this facility...that pt had arrived at her house [approximately 13 miles from the facility]...Work order placed to fence repair...” Review of video surveillance footage of the Behavioral Health Unit courtyard for 6/24/2023 from 1:30 PM-2:20 PM showed a group of patients and 2 staff members identified as Registered Nurses (RNs) entered the courtyard at 1:31 PM. The RNs sat down in the picnic area and did not have all patients in their line of sight. Patient #9 (identified by facility staff) entered the courtyard at 1:38 PM and 52 seconds and began walking around the picnic area. At 1:40 PM, Patient #9 walked toward the back of the courtyard, toward the fence, and out of camera view. The RNs remained in the picnic table area. The patients and 2 RNs returned to the building at 2:12 PM. Patient #9 was not seen on video surveillance footage after 1:40 PM. The patients route of elopement could not be visualized. Review of an event report showed an elopement from the Behavioral Health Unit occurred on 6/24/2023 at 2:00 PM. “...RN x2 assisted pt’s outside for group therapy. As RN #1 was escorting another patient back inside to use the bathroom, the patient [Patient #9] (who eloped) pushed her way through an opening in the fenced area outside and eloped from facility...A work order has been placed to have the fence repaired...” Review of a purchase order dated 8/8/2023 showed pricing for renovations of the Behavioral Health Unit (West Campus), including replacement of the courtyard fence. The anticipated delivery date listed on the purchase order was 10/20/2023. Review of a letter from the general contractor to the Facilities Director showed “...Fencing for the behavioral health unit has been ordered (10/25/2023) and we intend to install as soon as material arrives. Materials is scheduled to be delivered the 2nd week of November and we will begin asap [as soon as possible]...” Observation of the Behavioral Health Unit (West Campus) on 11/1/2023 at 10:15 AM showed the facility had 2 courtyards. Each courtyard had a 6-foot wooden fence around the perimeter of the courtyard. The fence in the courtyard where Patient #9 eloped had 2 new boards (not worn/weathered). There was what appeared to be a new corner board in the corner where it was thought Patient #9 eloped. New screws (not rusted) were observed in the boards on each side of the corner. During an interview on 11/1/2023 at 10:40 AM, in the BH conference room, the BH Nurse Manager confirmed an RCA had not been conducted and new processes had not been implemented following Patient #9’s elopement from the courtyard. In a second interview on 11/2/2023 at 11:03 AM, the BH Nurse Manager confirmed the patients present in the courtyard when Patient #9 eloped were not interviewed to determine if anyone witnessed the patient’s elopement. The BH Nurse Manager confirmed the courtyard had video surveillance cameras, confirmed the video surveillance footage for 6/24/2023 had not been reviewed, and confirmed the BH facility did not have a specific process to monitor patients during outdoor activities. During an interview on 11/1/2023 at 1:20 PM, in the conference room, the Facilities Director stated a broken section of the courtyard fence was repaired, a broken corner piece was replaced, and the area where it was thought the patient eloped through was secured with metal straps on 6/25/2023. In a second interview on 11/2/2023 at 10:49 AM, the Facilities Director stated the facility received an estimate for planned renovations of the Behavioral Health Unit, including supplies and labor for a new courtyard fence on 8/8/2023. The Facilities Director stated the fencing for the courtyard was not ordered until 10/25/2023 (4 months after the elopement). When asked why ordering was delayed, the Facilities Director stated instead of having 2 separate capital equipment requests for the fence and renovations, the facility wanted to do 1 capital equipment request to include the fence replacement and other renovations at the facility.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 36003 Based on review of facility policy, review of Quality Assessment and Performance Improvement Plan (QAPI), medical record review, review of video surveillance footage, review of facility documentation, observation, and interviews the facility failed to identify an adverse event (event in which care resulted in an undesirable clinical outcome) as a serious safety event, failed to conduct a root cause analysis (RCA-a process to find out what happened, why it happened, and determine what changes need to be made), failed to implement preventative actions and mechanisms and systematically monitor processes to ensure no future patient events occurred after 1 BH patient (Patient #9) eloped during outdoor activities of 2 BH patients reviewed of 12 patients reviewed. The facility’s failure had potential to affect all BH patients. The findings include: Review of the facility’s policy titled, “Elopement Prevention/Response Plan,” last reviewed 4/12/2023 showed once a patient’s unauthorized absence was discovered “...Available staff will immediately search for patient on unit and any suspected location of exit...The Security Staff and Administrative House Supervisor will monitor the video footage for location of patient...Following an actual event, appropriate investigation will be conducted to assess for additional actions that may lead to improvements in patient safety related to elopement...” Review of the facility’s policy titled, “Event Reporting Policy,” last reviewed 1/5/2023 showed “...The purpose of this policy is to provide guidance for communicating, reporting, investigating and acting upon a patient safety event including near miss, precursor and serious safety events, sentinel events, serious reportable/never event and hospital acquired conditions...Required Action Steps (Supervisor/Department Manager)...Supervisor on duty to notify the Department Manager and/or Administrator On-Call (AOC) of an event that is potentially serious, sentinel, serious reportable/never event or hospital acquired condition...Review events reported and if the event appears to have resulted in moderate to severe harm or death, immediately notify next level leader, Risk and/or Quality...Conduct brief/limited investigation (apparent cause analysis) on events which are precursor [events where a deviation from generally accepted performance standards reaches the patient and results in minimal harm or no detectable harm] or near miss [close call] harm events...This information is critical for patient safety efforts and to prevent recurrence...Required Action Steps (Risk and/or Quality...Review Supervisor/Department Manager investigation and determine if additional investigation is needed...Apply the Safety Event Classification [an outcome based classification system involving 3 steps: determining if there were deviations from generally accepted performance standards (GAPS), establish if there is a direct cause-and-effect relationship between deviations and the outcome and classify the level of patient harm resulting from the event]...Serious Safety Events, Sentinel Events, Serious Reportable/Never Events and Hospital Acquired Conditions require a more thorough and credible Root Cause Analysis and will be facilitated by trained Risk and Quality professionals...Required Action Steps (Executive Team-CEO [Chief Executive Officer], CNO [Chief Nursing Officer], CQO [Chief Quality Officer])...If it is determined the event meets or potentially meets (pending investigation) the definition of a Serious Safety Event, Sentinel Event, Serious Reportable/Never Event, and/or Hospital Acquired Condition notify Market CEO/CMO [Chief Medical Officer] /CQO and Regional President...Patient safety event types in ERS [event reporting system] include Preventable Events, Sentinel Events, Never Events, Serious, and Near Misses and Hospital Acquired Conditions and are generally categorized as follows...Behavioral - Patient Protection Events, Elopement...” Review of the facility’s policy titled, “Quality Assessment and Performance Improvement Plan,” dated 3/2/2023 showed “...Administration has responsibility for the provision of patient care and services provided by the hospital. The committees, departments and improvement teams are responsible for the delivery and evaluation of care and service they provide on an on-going basis. Administration will provide the resources and education to empower the culture of continuous performance improvement...Priorities for safety and quality improvement are identified based upon improvement opportunities identified from Clinical Scorecard analysis, comparisons to external benchmarks, strategic objectives, analysis of safety events, and root cause analysis investigations. The QIC [Quality Improvement Committee], MEC [Medical Executive Committee], BOT [Board of Trustees] and Hospital Executive Leadership will collaborate to establish hospital-level quality and patient safety strategic imperatives. Prioritization is performed annually, when improvement opportunities arise, or when changes occur in the internal or external environment...” Medical record review showed Patient #9 was admitted to the facility’s Behavioral Health Unit (West Campus) on 6/16/2023 with diagnoses of Psychosis. Other diagnoses included Behavioral Disturbance, Schizoaffective Disorder, Drug Induced Psychosis, Depression, Amphetamine and THC (marijuana) Abuse, and Hepatitis C. During a psychiatric evaluation on 6/17/2023, Patient #9 became belligerent and aggressive, yelling and demanding to leave at once. On 6/19/2023, Patient #9 asked when she would be able to leave the facility. On 6/20/2023, the patient requested to leave against medical advice (AMA). She began screaming that she would be “...leaving today...” when she was told a physician would have to evaluate her before she could leave AMA. The patient continued to make threatening comments and gestures toward staff on through 6/23/2023. The patient eloped from the facility prior to being seen by the physician on 6/24/2023. Medical record review of a Behavioral Health Nursing note dated 6/24/2023 showed “...At approximately 1400 [2:00 PM], pt [Patient #9] pushed her way through small opening in fenced area outside as the patient’s were taken outside for nursing group therapy. At approximately 1600 [4:00 PM], the patient’s mother notified this facility that pt had arrived at her house [approximately 13 miles from the facility]...Work order placed to fence repair...” Review of video surveillance footage of the Behavioral Health Unit courtyard for 6/24/2023 from 1:30 PM-2:20 PM showed a group of patients and 2 staff members identified as Registered Nurses (RNs) entered the courtyard at 1:31 PM. The RNs sat down in the picnic area and did not have all patients in their line of sight. Patient #9 (identified by facility staff) entered the courtyard at 1:38 PM and 52 seconds and began walking around the picnic area. At 1:40 PM, Patient #9 walked toward the back of the courtyard, toward the fence, and out of camera view. The RNs remained in the picnic table area. The patients and 2 RNs returned to the building at 2:12 PM. Patient #9 was not seen on video surveillance footage after 1:40 PM. The patients route of elopement could not be visualized. Review of an event report showed an elopement from the Behavioral Health Unit occurred on 6/24/2023 at 2:00 PM. “...RN x2 assisted pt’s outside for group therapy. As RN #1 was escorting another patient back inside to use the bathroom, the patient [Patient #9] (who eloped) pushed her way through an opening in the fenced area outside and eloped from facility...A work order has been placed to have the fence repaired...” During the entrance conference on 10/30/2023 at 12:30 PM, in the conference room, the Chief Quality Officer (CQO) was asked if any elopements from the Behavioral Health Unit had occurred since 1/2023. The CQO stated she was not aware of any elopements from the Behavioral Health Unit. During an interview on 11/1/2023 at 9:17 AM, in the conference room, the Risk Manager confirmed she was not involved in a RCA with Behavioral Health management or staff related to Patient #9’s elopement. During an interview on 11/1/2023 at 10:40 AM, in the BH conference room, the BH Nurse Manager confirmed an RCA had not been conducted and new processes had not been implemented following Patient #9’s elopement from the courtyard. In a second interview on 11/2/2023 at 11:03 AM, the BH Nurse Manager confirmed the patients present in the courtyard when Patient #9 eloped were not interviewed to determine if anyone witnessed the patient’s elopement. The BH Nurse Manager confirmed the courtyard had video surveillance cameras, confirmed the video surveillance footage for 6/24/2023 had not been reviewed, and confirmed the BH facility did not have a specific process to monitor patients during outdoor activities.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 36003 Based on medical record review, review of video surveillance footage, review of facility documentation, and interview the nursing staff failed to ensure all patients were monitored and accounted for during outdoor activities for 1 Behavioral Health (BH) patient (Patient #9) of 2 (BH) patients reviewed of 12 patients reviewed which had potential to affect all BH patients. The findings include: Medical record review of a Psychiatric Evaluation Report dated 6/17/2023 at 11:04 AM showed Patient #9 was admitted to the Behavioral Health Unit on 6/16/2023 at 4:08 PM. Patient #9’s past medical history and active problems included Anxiety, Chronic Bipolar Disease, Drug use affecting pregnancy, Hepatitis C, and Pregnancy. The patient reported she was there “...because Jesus put her here. She denies AVH [audiovisual hallucinations], but did admit that she ‘hears spirits’...” Patient denied suicidal and homicidal thoughts. She reported methamphetamine and marijuana use. “...Pt [patient] initially refused to come speak with Dr. [doctor]. Pt then came in and immediately became belligerent and aggressive, yelling and demanding to leave at once...” Medical and Mental health conditions were documented as Schizophrenia and Meth Use Disorder. The psychiatric evaluation recommended admission to inpatient psychiatric unit. Medical record review of a Psychiatric history and physical dated 6/17/2023 at 1:37 PM showed Patient #9’s diagnoses included Behavioral Disturbance, Schizoaffective Disorder, Drug Induced Psychosis, Depression, Amphetamine and THC abuse, and Hepatitis C. The treatment plan included continued rehabilitation and counseling. Medical record review of Psychiatry Progress Notes showed Patient #9 was calm but was asking when she would be allowed to leave on 6/19/2023. On 6/20/2023, the patient was initially calm and asking to leave against medical advice (AMA). “...Discussed with patient that she will be evaluated by the MD [medical doctor] to determine if she is safe to be discharged AMA. Patient immediately became agitated and following provider down the hallway. Patient making threatening statements and gestures towards staff stating that she will be leaving today. Began yelling and cussing at staff...” On 6/21/2023, the patient continued to be intermittently irritable. “...Making threatening and aggressive comments and gestures towards certain staff members. Unable to properly evaluate patient on a daily basis secondary to patient becoming irritated and aggressive...” She was compliant with medications. There were no changes in Patient #9’s behavior on 6/22/0223. Patient #9 threw a cup of water on the physician on 6/23/2023. Medical record review of a Psychiatry Progress note dated 6/24/2023 at 4:30 PM showed “...Pt eloped from the unit prior to seeing the pt. Informed that the pt went to her mother’s home and that she is now in route back to the hospital...” Medical record review of a Behavioral Health Nursing note dated 6/24/2023 showed “...At approximately 1400 [2:00 PM], pt [Patient #9] pushed her way through small opening in fenced area outside as the patient’s were taken outside for nursing group therapy...At approximately 1600 [4:00 PM], the patient’s mother notified this facility...pt had arrived at her house [approximately 13 miles from the facility]...” Review of video surveillance footage of the Behavioral Health Unit courtyard for 6/24/2023 from 1:30 PM-2:20 PM showed: 1:31 PM and16 seconds: Patients enter courtyard (9 patients) 1:31 PM and 51 seconds: Female Registered Nurse (RN) entered courtyard and sat down with her back facing the back of the courtyard. 1:33 PM and 53 seconds: Male RN entered the courtyard. 1:34 PM and 42 seconds: Male RN sat down at the picnic table. 1:38 PM and 52 seconds: Patient #9 entered courtyard and walked to picnic table area. 1:40 PM and 38 seconds: Patient #9 talked to another patient behind the picnic tables (side toward back of courtyard). 1:40 PM and 51 seconds: Patient #9 walked toward back of courtyard toward fence and out of camera view. 1:41 PM and 25 seconds: Both RNs remain in picnic table area. 1:57 PM and 44 seconds: Female RN and female patient walked toward building. 1:58 PM and 10 seconds: Female RN Reentered courtyard and sat on left side of the picnic table. 2:00 PM and 01 second: Female patient returned to the courtyard. 2:11 PM and 46 seconds: Patients and RNs stood up. Patients start gathering activity items and start walking toward building. 2:12 PM and 32 seconds: Patients and RNs out of view. 2:13 PM and 35 seconds: Male RN in view; briefly looks around and goes back toward building. 2:15 PM and 33 seconds: Female staff member in view; briefly looks around and goes back toward building. Patient #9 was not seen on video surveillance footage after 1:40 PM. The patients route of elopement could not be visualized. Review of an event report showed an elopement from the Behavioral Health Unit occurred on 6/24/2023 at 2:00 PM. “...RN x2 assisted pt’s outside for group therapy. As RN #1 was escorting another patient back inside to use the bathroom, the patient [Patient #9] (who eloped) pushed her way through an opening in the fenced area outside and eloped from facility...” During a telephone interview on 11/1/2023 at 8:45 AM, RN #1 stated sometime midday, he and another nurse took some patients outside for some fresh air. He stated they went back inside, did a head count, and discovered “...we had a patient missing...” When asked if Patient #9 eloped through the fence RN #1 replied “...I think we made the general assumption that was how she left...” RN #1 stated he did not see the patient go through the fence. RN #1 could not recall how many patients were in the courtyard when Patient #9 eloped. During a telephone interview on 11/1/2023 at 9:03 AM, RN #2 stated “...We had gone outside for a group. I looked up and noticed I didn’t see her [Patient #9]. We had been out there [courtyard] about 10 minutes. RN #2 stated she and the other RN took everyone back in and did a head count. RN #2 stated she immediately knew which patient was missing. “...She was very, very thin...I believe she got out through a loose board or opening. It’s not a tall fence either...” When asked how many patients were in the courtyard, RN #2 stated “...I don’t know...it was probably...maybe a dozen...” During an interview on 11/2/2023 at 11:03 AM, in the BH conference room, the BH Nurse Manager confirmed the BH facility did not have a specific process to monitor patients during outdoor activities.”