SSM Health Depaul Hospital St Louis

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 41865 Based on interview, record review, policy review and video review, the hospital failed to provide care in a safe setting when they failed to follow their internal policy for patients requesting to leave Against Medical Advice (AMA), when one patient (#7) was allowed to sign out AMA without physician notification, crawled out into highway traffic and died. (A-0144) This failed practice resulted in a systemic failure and noncompliance with 42 CFR 482.13 Condition of Participation (CoP): Patient’s Rights.”

“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: 41865 Based on interview, record review, policy review and video review, the hospital failed to provide care in a safe setting when they failed to follow their internal policy for patients requesting to leave Against Medical Advice (AMA), when one patient (#7) was allowed to sign out AMA without physician notification, crawled out into highway traffic and died. Findings Include: Review of Patient #7’s medical record showed: - She was a 62-year-old female admitted on 07/12/25 for altered mental status (AMS, mental functioning ranging from slight confusion to coma). - At the time of her admission she was alert and oriented (A&O) to only her person and the time. She could not recall what led up to her hospitalization. - She was determined to be an elopement risk and was placed with a one-to-one (1:1, continuous visual contact with close physical proximity) sitter. - On 07/12/25, a Neurology (a branch of medicine concerned with the study and treatment of disorders of the nervous system) Consult Note showed the patient’s electroencephalography (EEG, a recording of brain activity, often used to evaluate presence of seizure activity), Magnetic Resonance Imaging (MRI, test that uses a magnetic field and radio waves to create images of the organs and tissues within the body) and computed tomography (CT, a combination of x-rays [test that creates pictures of the structures inside the body-particularly bones] and a computer to produce detailed images of blood vessels, bones, organs and tissues in the body) testing, resulted in no acute findings. The neurologist documented it was possible this was the patient’s baseline cognitive level, and that the patient’s confusion was “likely due to multiple medical/metabolic derangements and medication effects.” - On 07/13/25, a Psychiatry (branch of medicine concerned with the study of mental health disorders) Consult showed that she scored an eight out of 30 on the Saint Louis University Mental Status (SLUMS, an assessment tool for mild cognitive impairment and dementia. Score of 27-30 is normal, 21-26 suggests mild neurocognitive disorder, and 20 or below indicates dementia) assessment tool. The primary concern was neurocognitive, and she did not meet criteria for inpatient psychiatric care. She did not have capacity for medical decision making. The psychiatrist documented that the “patient would benefit from appointing a surrogate medical decision maker, a medical durable power of attorney for health care (DPOA, a legal document that lets a person name someone else to make decisions about their health care in case they were not able to make those decisions themselves)” as the patient was refusing medications to help with agitation and AMS. - On 07/13/25 at 5:25 PM, a Nursing Progress Note showed the patient’s 1:1 sitter reported that the patient was pacing, looking for her keys and getting ready to leave. The nurse documented, “the patient is A&O to name and time and is unable to safely leave and make decisions for herself.” Shortly after 6:00 PM the patient left her room and attempted to elope. The sitter walked along with her so she would remain safe and attempted to re-direct her, which did not work and made the patient more upset. The patient insisted she needed to pick up her grandkids. The patient spoke with her daughter on the phone and when her daughter said she wasn’t coming, the patient stated she would take the bus instead. Security was notified, and after redirection and medication the patient was calmer. - On 07/14/25, a Physician Progress note showed the patient still had some confusion, but was medically stable, and needed long-term facility placement. - On 07/14/25, a Neurology Progress note showed the patient’s AMS was likely “toxic metabolic encephalopathy (a disease in which the functioning of the brain is affected by an illness or organs that are not working as well as they should, such as with a viral infection or toxins in the blood) secondary to a urinary tract infection (UTI, an infection in any part of the urinary system, the kidneys, ureters, bladder and urethra) which had resolved.” - On 07/14/25, a Social Services Consult Note showed the patient needed nursing home placement. The Social Worker (SW) sent out seven referrals for placement. - On 07/15/25 at 11:22 AM, a Social Service Resource Note showed the SW spoke with the patient’s daughter who expressed that the family was unsure if they would like to proceed with nursing home placement or if they wanted the patient return home. “SW made her aware the patient is stable for discharge, and requested she have further discussion with family today, and have a final answer regarding possible home discharge.” - On 07/15/25 at 3:13 PM, a Care Coordination Progress Note showed the patient’s son stated that the family was wanting to take the patient home, and they were working on arrangements. Her expected discharge date was 07/16/25. - On 07/15/25 at 7:35 PM, a Nursing Progress Note showed the “patient comes down to desk, followed by sitter and states she is leaving AMA. Patient is A&O times four, able to state name, birthdate, location, situation and time. Papers signed by patient, and she ambulated out of the hospital.” - On 07/15/25 at 7:37 PM, an internal electronic health record (EHR) chat conversation showed Staff N, Charge Nurse, sent the night shift Hospitalist (physician whose primary professional focus is the general medical care of hospitalized patients) a message that stated that the patient “signed AMA papers, was assessed and she is A&O x four. Aware of situation, time and location. Insisted on leaving. FYI.” The hospitalist responded, “ok.” - On 07/16/25, 10:19 AM, a Discharge Summary documented by the patient’s primary physician showed, “patient was allowed to leave AMA by charge nurse despite sitter being at patient’s bedside and the fact that patient is not able to make her own decisions, per psych. I was not notified either.” Review of the hospital’s policy titled, “Patient Leaving Against Medical Advice, Leaving Before Being Evaluated or Discharged, Patient Elopement and Abduction,” dated 10/03/23, showed: - Patients identified as an elopement risk would not be permitted to leave the unit without a staff member. - If a patient expressed a desire to leave, the nurse was to contact the provider caring for the patient immediately and encourage the patient to stay until they speak to, or were evaluated by, the provider. - The provider, or staff, should attempt to inform the patient of the risks associated with refusing examination or treatment or leaving the healthcare facility AMA. - Patients had the right to leave the healthcare facility at their discretion unless the patient had a cognitive impairment that resulted in the patient’s inability to care for their basic physical needs. Review of the hospital’s policy titled, “Continuous Observation for Patient Safety: Use of Patient Safety Assistant or Tele Sitter,” dated 04/10/25, showed: - The primary staff nurse was expected to provide a report to the Patient Safety Assistants (PSA). - The PSA was expected to verbally redirect patients, as warranted, and utilize appropriate redirection/de-escalation techniques, relevant to the patient specific situations. They would receive a hand-off from the off-going PSA at the start of a shift, and from the nurse/charge nurse every shift. They would notify the bedside team of any abnormal findings, observations and/or safety concerns. - The nurse would assess for the following risk factors for discontinuation; patient was able/willing to follow safety instructions, patient no longer had a medical or behavioral need for continuous observation and patient was no longer a wandering or elopement risk. During an interview on 07/23/25, at 11:20 AM, Staff J, Registered Nurse (RN) Case Manager, stated that she spoke with the patient’s daughter, whom the patient lived with, as well as the patient’s son, to determine what the patient’s baseline cognition was. They reported that she had been confused for more than a year but at the time of admission her confusion was worse than it had ever been. On 07/14/25, after speaking with the daughter during the initial assessment, she agreed to nursing home placement, but later during an interdisciplinary team meeting, she learned that the son wanted to take the patient home. During that meeting, they also heard from the psychiatrist, who felt the patient would benefit from having a DPOA. She did not speak to the patient’s family again but, “that was to be discussed with the patient’s daughter or son on the 15th, however, no one was able to reach them.” During an interview on 07/23/25, at 10:50 AM, Staff I, Master of Social Work (MSW), stated that on 07/15/25, she spoke with the patient’s daughter, who stated the family was still unsure about taking the patient home, or proceeding with nursing home placement. Staff I explained that the patient was medically stable, and that the family needed to decide about discharge. She had called the patient’s son “a couple of times, with no answer, and no option to leave a voicemail.” During a telephone interview on 07/23/25 at 10:10 AM, Staff H, Clinical Partner (CP), stated that he was Patient #7’s sitter during day shift on 07/15/25. He had been assigned to her previously and was familiar with her. He stated that the first day he was her sitter, on 07/12/25, she was confused, would repeatedly ask the same questions and was always saying she needed to get home to her grandchildren. During the day on 07/15/25, the patient’s cousin came to visit and brought the patient flowers. She was slightly confused, and slept on and off, but became more confused as the afternoon when on. In the early afternoon hours, she put on her shoes, then looked in her purse and pulled out a spoon. She attempted to leave the room and said that she needed to get to the kitchen to clean the dishes. He was able to redirect her. He stated he reported that incident to the day shift nurse. At the end of his shift Staff F, Patient Care Technician (PCT), was taking his place. During report he told her that the patient was pleasant but was possibly becoming more confused and explained “the spoon incident” to her. During a telephone interview on 07/23/25, at 9:45 AM, Staff F, PCT, stated that she was Patient #7’s sitter during evening shift on 07/15/25. It was the first time she had been the sitter for this patient. She received report from Staff H, CP, and was told the patient had a sitter for safety. Staff H did not elaborate any further. When she walked into Patient #7’s room she was packing her bags. The patient stated, “she had to get home because she had a granddaughter with a disability.” She had on a blue paper scrub shirt, with a cardigan sweater over top, and pants on. The patient left her room and walked to the nurse’s station. At the nurse’s station she told Staff N, Charge RN, that the patient was wanting to leave. Staff N grabbed an AMA form and “told me she had the patient. She said she would call and let me know where I was floating to next.” During the hospital’s telephone interview on 07/17/25, at 11:22 AM, Staff N, Charge RN, stated that at 7:30 PM the sitter was behind the patient, who expressed intent to leave AMA. She assessed the patient’s orientation, and her responses were appropriate. The patient claimed a car was waiting for her. She proceeded with the AMA as she felt she was unable to stop the patient. No bus pass was provided to the patient, as the unit did not stock them. The patient was given, and signed, the AMA form after reading it. She contacted the hospitalist, via secure chat, after the patient left and received an “ok” response. She attempted to contact both the patient’s son and daughter but there was no answer. She informed the House Supervisor of the patient’s discharge. She did not review the note from 07/13/25 indicating the patient’s incompetence. She was unaware of any notes that the patient was incompetent. She stated there was no mention of that during the handoff report she received from the off-going shift nurse. She reported having difficulty reviewing charts, due to her workload, and typically didn’t have time to access patient charts until midnight. Review of the hospital’s video footage, dated 07/15/25, showed: - At 7:30:50 PM, Patient #7 walked toward and entered the sixth-floor elevator. She proceeded to the main lobby and exited out the main lobby entrance at 7:32:41 PM. - From 7:32:46 PM through 7:37:02 PM, she walked toward the main road, onto the sidewalk and proceeded past parking lots four and five. - At 7:38:00 PM, she walked back across the main road, into parking lot six, and continued through parking lot six, toward parking lot seven. - From 7:41:01 PM through 7:41:45 PM, she was speaking to someone in their car, in parking lot seven. She then proceeded north toward parking lot eight. (Staff M, Regulatory Specialist, stated the hospital conducted an interview with the person in the car, who was a hospital employee, and Patient #7 had asked them how to get to the bus stop). - From 7:41:46 PM through 7:46:23 PM, she continued to walk north on the sidewalk along the main road, past parking lots eight, nine and 10. - At 7:48:12 PM, she exited the sidewalk, walked through a non-hospital parking lot, and onto a sidewalk heading north, until she was out of camera view at 7:52:06 PM.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 51292 Based on observation, interview, record review and policy review, the hospital failed to: - Ensure one Behavioral Health Unit (BHU) patient room was free from contraband (items that are illegal, forbidden, or that can be used to harm self or others); (A-0144) - Ensure soap and excess paper towels were removed from three of four BHU dayrooms; (A-0144) - Ensure a plastic trash bag was removed from a game available for patient use on the BHU; (A-0144) - Ensure two of three seclusion (the involuntary confinement of a patient alone in a room or area from which the patient was physically prevented from leaving) rooms in the BHU area had psychiatric safe screws; (A-0144) - Ensure sharps were not available for patient or visitor access; (A-0144) and - Ensure restraints (any manual method, physical or mechanical device that limits the ability of free movement of arms, legs, body, or head) were ordered by a licensed practitioner (LP) responsible for the care of one current patient (#36) and one discharged patient (#54) of four restrained patient records reviewed. (A-0168) The severity and cumulative effect of these practices had the potential to place all patients at risk for their health and safety, also known as an Immediate Jeopardy (IJ). As of 02/26/25, the hospital provided immediate action plans sufficient to remove the IJ when the hospital implemented corrective actions that included removing all excess paper towels from patient rooms and dayrooms. This failed practice resulted in a systemic failure and noncompliance with 42 CFR 482.13 Condition of Participation (CoP): Patient’s Rights. Please refer to A-0144 and A-0168.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 39840 Based on observation, interview, record review and policy review, the hospital failed to ensure: - Nutritional supplements were not expired; (A-0749) - Expired food was not available for patient use; (A-0749) - Food was dated in patient nutrition rooms and in the kitchen; (A-0749) - Food was covered in the kitchen freezer; (A-0749) - Open beverages were not present in restricted areas; (A-0749) - Staff beverage containers were spillproof; (A-0749) - Earrings were contained in head covering in the Operating Room (OR); (A-0749) - Clean all surfaces in the patient rooms during terminal cleaning; (A-0750) - Clean all surfaces of the back area of the kitchen including the kitchen floors and ceilings; (A-0750) - Clean the stove top and inside a food warmer; (A-0750) - Clean the grill hood; (A-0750) - Clean the stand-up mixer; (A-0750) - Clean the cook prep table; (A-0750) - Store the mixer blade in a clean area of the kitchen; (A-0750) - Maintain the floor integrity in the kitchen; (A-0750) - Empty the accumulated trash located in trash cans in kitchen; (A-0750) - Remove personal items from the food prep service area in the kitchen; (A-0750) - Clean all surfaces of the crash carts (mobile cart which contains emergency medical supplies and medication) on five units; (A-0750) - Clean the microwave, refrigerators and coffee machines in the patient nutrition rooms; (A-0750) - Clean the freezers in the Operating Room (OR) storage room; (A-0750) - Clean the storage bins in the Obstetrics (OB, the branch of medical science concerned with childbirth and caring for and treating women in or in connection with childbirth) medication room; (A-0750) - Clean point of care testing equipment between patients; (A-0750) - Ensure multiple surfaces throughout the OR were in good repair and easy to clean; (A-0750) and - Ensure Sterile Processing Department (SPD, area designated to clean, prepare, sterilize [process that eliminates viruses and bacteria], store and track reusable medical and surgical instruments or equipment) was free of dust accumulation. (A-0750) The severity and cumulative effects of these systemic practices resulted in the hospital’s non-compliance with 42 CFR 482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs and resulted in the hospital’s failure to ensure quality health care and safety. The hospital census was 307.”

“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: 40189 Based on observation, interview, record review and policy review, the hospital failed to ensure the safety of all patients when they failed to: - Ensure one Behavioral Health Unit (BHU) patient room was free from contraband (items that are illegal, forbidden, or that can be used to harm self or others); - Ensure soap and excess paper towels were removed from three of four BHU day rooms; - Ensure a plastic trash bag was removed from games available for patient use on the BHU; - Ensure two of three seclusion (the involuntary confinement of a patient alone in a room or area from which the patient was physically prevented from leaving) rooms on the BHU had psychiatric safe screws; and - Ensure sharps were not available for patient or visitor access. Findings included: Review of the hospital’s policy titled, “Behavioral Health Precautions and Monitoring,” dated 12/25/24, showed staff will conduct a search of patient belongings and environment, removing all potential self-harming objects. The most common form of self-harm is using a sharp object to cut one’s skin. Other forms include, but are not limited to, behavior such as burning, scratching, swallowing foreign objects or hitting or banging body parts. Observation on 02/24/25 at 1:45PM, in the dayroom on the Acute Care BHU, showed large stacks of paper towels and open soap bottles at the sink, accessible to patients. Observation on 02/24/25 at 1:50 PM, in room 1010 on the Acute Care BHU, showed an unattended and unopened bottle of shampoo lying on a patient bed. Observation on 02/24/25 at 1:50 PM, in the BHU’s seclusion room between the Pediatric/Adolescent Unit and the Adult South Unit, showed four non-psychiatric safe screws in the restraint bedroom’s door. When the door was closed, the screws faced the interior of the seclusion room and were accessible to patients. Observation on 02/24/25 at 2:00 PM, showed an unused large trash bag lying on a shelf in an unlocked cupboard of the Intermediate BHU group therapy room. Observation on 02/24/25 at 2:10 PM, in the Pediatric/Adolescent BHU seclusion room, showed two non-psychiatric safe screws that attached the face plate of the dead bolt lock to the door. Observation on 02/25/25 at 1:50 PM, in the dayroom of the Pediatric/Adolescent BHU, showed large stacks of paper towels and open soap bottles, accessible to patients. Observation on 02/25/25 at 1:55 PM, in the dayroom on the Intermediate Care BHU, showed large stacks of paper towels and open soap bottles at the sink, accessible to patients. During an interview on 02/24/25 at 1:50 PM, Staff M, BHU Charge Registered Nurse (RN), stated that the seclusion room between the Pediatric/Adolescent Unit and Adult South Unit was used for pediatric, adolescent and adult patients. During an interview on 02/24/25 at 1:50 PM, Staff A, RN Manager, stated that all patient rooms on the Acute BHU were left unlocked for patient access. During an interview on 02/25/25 at 1:45 PM, Staff A, RN, stated that staff keep a “working knowledge” of what personal care items were in possession of the patients. Review of the hospital’s policy titled, “Needle and Sharps Safety,” dated 04/23/24, showed sharps must not be left unattended or unsecured in patient care areas. After use all needles/sharps (including disposable needles, finger stick lancets, protected intravenous [IV, in the vein] catheter stylets, etc.) must immediately (or as soon as feasible) be disposed of in puncture resistant, leak-roof sharps containers located in each patient room and within patient-care departments. Observation on 02/24/25 at 2:43 PM, on Five South, showed a large bin full of blood sugar lancets on the nurses’ station counter unattended. Observation on 02/25/25 at 12:10 PM, on Six North, showed three unused butterfly needles left in Patient #40’s windowsill from a prior nurse attempt to draw blood cultures. Observation on 02/25/25 at 11:50 AM, on Six North, showed Staff FFF, IV Therapy RN, left the used IV catheter stylet in the Patient #40’s bed following insertion of an IV catheter. During an interview on 02/24/25 at 2:43 PM, Staff X, Critical Care Director, stated that needles were not to have been left unattended at the nurses’ station and could have been a safety risk to patients and visitors. During interviews on 02/25/25 at 12:00 PM and 12:15 PM, Staff FFF, IV Therapy RN, stated that the catheter stylet should have been removed immediately after use and the butterfly needles should not have been left in the patient’s windowsill. 46856 51292”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 46856 Based on interview, record review and policy review, the hospital failed to ensure restraints (any manual method, physical or mechanical device that limits the ability of free movement of arms, legs, body, or head) were ordered by a licensed practitioner (LP) responsible for the care of one current patient (#36 ) and one discharged patient (#54) of four restrained patient records reviewed. This failure created an unsafe environment and had the potential to place all patients admitted to the hospital at risk for their safety. Findings included: Review of the hospital’s policy titled, “Violent Restraint Utilization (for the Management of Violent or Self-Destructive Behaviors),” dated 08/15/24, showed that written orders for seclusion (the involuntary confinement of a patient alone in a room or area from which the patient was physically prevented from leaving) or restraints for violent or self-destructive behaviors are limited to four hours for adults 18 years or older. If the order is about to expire and the Registered Nurse’s (RN) assessment indicates that the patient requires continued restraint, the RN will contact the physician (or other LP if permitted by state law) and request that the original order be renewed for another period of time. Once a restraint is discontinued, reapplication constitutes a new episode and the procedure must start at the beginning, including a new order. Review of Patient #36’s medical record showed the following: - On 02/23/25 at 2:13 PM, he was placed in a therapeutic hold (treatment technique in which a violent patient is physically contained by people). - At 2:14 PM, he was placed in a restraint chair. - At 2:23 PM, an order was obtained for the therapeutic hold and restraint chair. - At 3:35 PM, he was released from the restraint chair and placed in seclusion. - At 7:26 PM, a seclusion order was placed, three hours and 51 minutes after Patient #36 was placed in seclusion. - At 10:14 PM, a seclusion order was placed. - On 02/24/25 at 1:56 AM, a seclusion order was placed. - At 6:06 AM, a seclusion order was placed. - At 9:15 AM, a seclusion order was placed. - At 1:15 PM, a seclusion order was placed. - At 1:45 PM, he was released from seclusion. - Patient #36 was in seclusion without an order for three hours and 51 minutes. Review of Patient #54’s medical record showed the following: - On 10/01/24 at 2:05 PM, she was placed in four-point violent restraints (medical cuffs applied to both arms and both legs to prevent someone form causing harm to themselves or others). - At 2:23 PM, a physician order was placed for four-point violent restraints. - At 7:05 PM, she was placed in seclusion. - There was no documentation that she was released from four-point violent restraints, nor was there an order for seclusion. - At 11:00 PM, seclusion was discontinued. Patient #54 was in seclusion for a total of three hours and 55 minutes without an order. - At 11:15 PM, she was placed in four-point violent restraints. - There was no order for restraints. - On 10/02/24 at 8:17 AM, a physician order was placed for four-point violent restraints. Patient #54 was in four-point restraints for nine hours and two minutes, without an order. - At 9:30 AM, she was released from the restraints. During an interview on 02/26/25 at 1:50 PM, Staff X, Nursing Manager, stated that if a patient remained in violent restraints, she expected nursing to follow hospital policy and have the order renewed every four hours. There were no restraint orders for Patient #54 on 10/01/24 at 2:23 PM through 10/02/24 at 8:17 AM. During an interview on 02/27/25 at 1:12 PM, Staff RRRR, CNO, stated that all restraint and seclusion should have an order.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 39840 Based on observation, interview and policy review, the hospital failed to ensure: - Nutritional supplements were not expired; - Expired food was not available for patient use; - Food was dated in patient nutrition rooms and in the kitchen; - Food was covered in the kitchen freezer; - Open beverages were not present in restricted areas; - Staff beverage containers were spillproof; and - Earrings were contained in head covering in the Operating Room (OR). Findings included: Although requested, the hospital failed to provide a policy that addressed expiration dates for nutritional supplements. Observation on 02/24/25 at 2:35 PM, on unit two south, showed six bottles of nutritional supplements with expiration dates of 11/01/24 for three, 12/01/24 for one, 08/01/24 for one, and 06/01/24 for one. During an interview on 02/24/25 at 2:35 PM, Staff S, Manager, stated that expired nutritional supplements should not be available for patient use. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that food and nutritional items should be not expired. Review of the hospital’s policy titled, “Food Safety Policies and Standards,” revised 10/01/24, showed refrigerated, ready-to-eat, food prepared and held in a food establishment must be clearly marked with a use-by/discard date. The use-by/discard date cannot exceed seven days as required in the FDA Retail Food Code with the day of preparation counted as day one. Observation on 02/24/25 at 2:10 PM, on unit five south, in the nutrition room refrigerator, showed a wrapped sandwich with an expiration date that could not be read. During an interview on 02/24/25 at 2:12 PM, Staff X, Critical Care Director, stated that the sandwich expiration date could not be read and should have been discarded. Observation on 02/25/25 at 10:00 AM, on unit six north, in the nutrition room refrigerator, showed a wrapped sandwich with an expiration date 02/23/25. Observation on 02/25/25 at 2:30 PM, in the kitchen, showed a dry flour bin with an expiration date of 02/04/25. During an interview on 02/25/25 at 2:30 PM, Staff TT, Executive Chef, stated that the flour was expired and should be discarded. Review of the hospital’s policy titled, “Food Safety Policies and Standards,” revised 10/01/24, showed food packaged by a food processing plant shall be clearly marked at the time the original container is opened. The date marked may not exceed the manufacturer’s use-by date. Food that is required to be date marked must be discarded if it is in a container or package that does not bear a date or day or is inappropriately marked with a date or day that exceeds seven days. The manufacturer’s expiration dates must be adhered to. Observation on 02/25/25 at 2:30 PM, in the kitchen walk in freezer, showed one open bag of frozen vegetables, seven prepared frozen kosher meals, one open large bag of frozen raw ground beef patties and one open box of frozen country fried steak without open dates. Observation on 02/25/25 at 2:45 PM, in the kitchen walk-in dairy refrigerator, showed one unopened bag of baby carrots without a manufacturer’s use-by date and one open gallon jar of mayonnaise without an opened or best use-by date. During an interview on 02/25/25 at 2:45 PM, Staff TT, Executive Chef, stated that the opened food packages or containers should have had a label with the date the product was opened and the best use-by date. Without the dates, they should be discarded. Review of the hospital’s policy titled, “Food Safety Policies and Standards,” revised 10/01/24, showed foods frozen in the freezer unit must be properly covered and labeled with the date frozen and a use-by date. Food must be covered/protected from environmental contamination during storage. Observation on 02/25/25 at 2:30 PM, in the kitchen freezer, showed one opened bag of frozen vegetables, seven prepared frozen kosher meals, one opened large bag of frozen raw ground beef patties and one opened bag of frozen country fried steak uncovered and unsealed. During an interview on 02/25/25 at 2:30 PM, Staff TT, Executive Chef, stated that he agreed the opened and uncovered frozen food items should have been resealed in the plastic bags. Review of the hospital’s policy titled, “Food Safety Policies and Standards,” revised 10/01/24, showed lockers or other suitable facilities must be provided for the storage of employee’s possessions. Personal items may not be stored in a way that could contaminate exposed food or clean equipment. Observation on 02/25/25 at 2:30 PM, in the kitchen, on the shelves under the prep table, showed staff members’ personal drink containers and a step stool where food serving supplies were stored. During an interview on 02/25/25 at 2:30 PM, Staff TT, Executive Chef, stated that he expected staff beverage containers to be stored in the designated area away from where food was prepared. Observation on 02/25/25 at 2:48 PM, in the dish room, showed three personal drinks on the clean dishes shelf. During an interview on 02/25/25 at 2:50 PM, Staff SS, General Manager, stated that personal drinks were not to be in the dish room. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that personal drinks should be stored in the designated areas. Observation on 02/24/25 at 2:49 PM, on unit three south, in the designated staff refreshment area located above the patient nourishment area, showed three open and uncovered staff drink containers. The patient nourishment area included the patient nourishment refrigerator, dried packaged patient food items and patient condiments in bins. During an interview on 02/24/25 at 2:49 PM, Staff W, Registered Nurse (RN) Manager, stated that the staff drinks were “okay as long as they were located on the counter” in the designated staff nutrition area. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that she expected employee drink containers to be covered and spill proof. Review of the hospital’s policy titled, “Surgical Attire,” dated 07/08/24, showed all jewelry must be contained or confined within scrub attire. Observation on 02/26/25 at 9:25 AM, showed Staff YYY, Circulating Nurse (role performed by a registered nurse who ensures the patient’s safety during all phases of a surgical procedure); Staff ZZZ, Vendor; Staff AAAA, RN First Assistant (RNFA, nurse with specialized training to assist a physician); Staff BBBB, Surgeon; and Staff CCC, Scrub Nurse (nurse that assists the surgical team and passes instruments to the surgeon during surgery), wearing earrings not contained in their head covering while working in the OR. Observation on 02/26/25 at 9:50 AM, showed Staff DDDD, Certified Registered Nurse Anesthetists (CRNA, registered nurses who have obtained graduate-level education and board certification in anesthesia); Staff EEEE, Scrub Nurse and Staff FFFF, Circulating Nurse, wearing earrings not contained in their head covering while working in the OR. During an interview on 02/26/25 at 9:30 AM, Staff T, Surgical Services Director, stated that earrings were to be contained in the head covering. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that earrings should be contained in the head covering while in the OR. 40189 50496”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 39840 Based on observation, interview, record review and policy review, the hospital failed to: - Clean all surfaces in the patient rooms during terminal cleaning; - Clean all surfaces of the back area of the kitchen including the kitchen floors and ceilings; - Clean the stove top and inside a food warmer; - Clean the grill hood; - Clean the stand-up mixer; - Clean the cook prep table; - Store the mixer blade in a clean area of the kitchen; - Maintain the floor integrity in the kitchen; - Empty the accumulated trash located in trash cans in kitchen; - Remove personal items from the food prep service area in the kitchen; - Clean all surfaces of the crash carts (mobile cart which contains emergency medical supplies and medication) on five units; - Clean the microwave, refrigerators and coffee machines in the patient nutrition rooms; - Clean the freezers in the Operating Room (OR) storage room; - Clean the storage bins in the Obstetrics (OB, the branch of medical science concerned with childbirth and caring for and treating women in or in connection with childbirth) medication room; - Clean point of care testing equipment between patients; - Ensure multiple surfaces throughout the OR were in good repair and easy to clean; - Ensure Sterile Processing Department (SPD, area designated to clean, prepare, sterilize [process that eliminates viruses and bacteria], store and track reusable medical and surgical instruments or equipment) was free of dust accumulation. Findings included: Review of the hospital’s policy titled, “NAM-SOFT-CLEA_HLC_033_S_Operating Room _Surgical Invasive Areas and Delivery Rooms Terminal Cleaning at the End of Each Day,” revised 03/2019, showed unused rooms should be cleaned once during each 24-hour period during the regularly scheduled work week. All surfaces were to be damp dusted. Staff were to spot wash walls and wall vents with the disinfectant solution. Observation on 02/24/25 at 1:45 PM, rooms 334 and 335, in the Intensive Care Unit (ICU, a unit where critically ill patients are cared for), showed black marker writing, fingerprints and a sticky adhesive type of substance on the glass wall windows of the patient rooms. During an interview on 02/24/25 at 1:45 PM, Staff U, Charge Registered Nurse (RN), stated that both rooms had been terminally cleaned and were ready to accept a patient. He expected the glass wall/windows of the patient rooms that are used to write down communication about the patient to be free of sticky residue and to be cleaned after a patient was moved from the room. Review of the hospital’s policy titled, “Food Safety Policies and Standards,” revised 10/01/24, showed the materials for indoor floors, walls and ceiling surfaces must be smooth, durable and easily cleanable. Review of the hospital’s untitled and undated document, showed staff were to sweep and mop the floors daily. Although requested, a completed kitchen cleaning log for the floors was not provided. Observation on 02/25/25 at 2:20 PM, in the kitchen, showed the floors had debris and a buildup of a light and dark brown substances on the floor. During an interview on 02/25/25 at 2:20 PM, Staff TT, Executive Chef, stated that the floors did not appear clean. They were to be cleaned daily in the evening. Observation on 02/25/25 at 2:28 PM, in the kitchen, showed copious amounts of dust accumulation on all ceiling vents. Observation on 02/25/25 at 2:32 PM, in the pot and pan room of the kitchen, showed copious amounts of dust accumulation on three ceiling vents. Observation on 02/25/25 at 2:45 PM, in the dish room, showed copious amounts of dust accumulation on the ceiling vents. During an interview on 02/25/25 at 3:05 PM, Staff TT, Executive Chef, stated that environmental services staff was responsible to clean the vents after hours on a monthly basis. Review of the hospital’s undated documented titled, “Food Safety Policies and Standards,” revised 10/01/24, showed non-food contact surfaces must be cleaned at a frequency necessary to preclude the accumulation of soil residues. Cooking, baking equipment and the interior of microwave ovens must be cleaned and sanitized every 24 hours Observation on 02/25/25 at 2:20 PM, showed the kitchen stove top surface was unclean and had a buildup of black charred debris. During an interview on 02/25/25 at 2:20 PM, Staff TT, Executive Chef, stated that stove top was unclean and was to be cleaned daily. Observation on 02/25/25 at 2:15 PM, in the kitchen, showed a food warmer with debris and dried liquid from a spill. During an interview on 02/25/25 at 3:00 PM, Staff TT, Executive Chef, stated that the food warmer was cleaned weekly or as needed. Review of the hospital’s undated documented titled, “Table 11.4 Schedule of Inspection for Grease Buildup,” showed systems serving high-volume cooking operations, such as 24-hour cooking, charbroiling or wok cooking were to be inspected quarterly. Review of the hospital’s undated document titled, “St. Louis Cleaning and Restoration,” showed the kitchen hoods were cleaned on 05/30/24. The kitchen hoods were not cleaned and inspected quarterly per hospital policy and were six months overdue. The hoods were due to be cleaned and inspected by 08/30/24 and 11/30/24. During an interview on 02/25/25 at 2:20 PM, Staff TT, Executive Chef, stated that the hood appeared unclean and was last cleaned and inspected on 06/06/24. The next service would have been due in three months. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that she expected the kitchen grill hoods to be cleaned on a regular basis and as needed. She expected them to be free of dust and grease drips. Review of the hospital’s untitled and undated document, showed staff were to clean, sanitize & wipe down the mixer after each use. Although requested, a completed kitchen cleaning log for the mixer was not provided. Observation on 02/25/25 at 2:30 PM, showed the large stand-up kitchen mixer had dust, dried debris and a powdery substance on the housing. During an interview on 02/25/25 at 2:30 PM, Staff TT, Executive Chef, stated that the stand-up mixer appeared to be unclean. It was to be cleaned nightly. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that she expected the stand-up mixer to be cleaned after each time a product was prepared. Review of the hospital’s undated documented titled, “Food Safety Policies and Standards,” revised 10/01/24, showed non-food contact surfaces must be cleaned at a frequency necessary to preclude the accumulation of soil residues. The contact surface of the food preparation table is cleaned and sanitized at a frequency determined by regulatory code. Observation on 02/25/25 at 2:30 PM, showed the cook prep table surface to be unclean with dust and debris. The shelves under the prep table had a step stool where food serving supplies were stored. Several metal brackets attached to the wall, hanging three feet over of the food prep table with dust and collections of a light brown liquid substance dripping onto the surface of the prep table. During an interview on 02/25/25 at 2:30 PM, Staff TT, Executive Chef, stated that he was responsible for the cleaning schedule and if staff did not complete the items on the list, he counseled them. He would have expected the prep table surface to be cleaned after use, free of debris and personal items. The dirty wire racks should also be cleaned daily or removed from the wall as they were not being used. Review of the hospital’s policy titled, “Food Safety Policies and Standards,” revised 10/01/24, showed clean equipment and utensils must be stored in a clean location, where they are not exposed to dust or other contamination. Observation on 02/25/25 at 2:30 PM, in the kitchen prep area, showed the large wire stand up blender mixing paddle, stored on top of the warming oven, covered with dust particles. During an interview on 02/25/25 at 2:30 PM, Staff TT, Executive Chef, stated that he was unsure why the wire mixing blade was stored on top of the warming oven. It should not have been stored there. It should have been stored on the rack in the clean equipment room, after it was cleansed and ready for use. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that she would not expect the mixer blade to be stored on top of a dusty surface. IT should be stored in a clean area. Review of the hospital’s policy titled, “Food Safety Policies and Standards,” revised 10/01/24, showed materials for indoor floors must be smooth, durable and easily cleanable. Observation on 02/25/25 at 2:20 PM, showed the kitchen floor integrity was impaired. There were over 100 pea sized to three inch in diameter round holes in the epoxy flooring. Observation on 02/25/25 at 2:35 PM, in several high traffic areas in the kitchen, showed large areas of the floor missing, making cleaning difficult. During an interview on 02/25/25 at 2:20 PM, Staff VV, Client Executive District Manager, stated that a capital request had been placed for the floor replacement with heat rated epoxy to occur sometime before March. Review of the hospital’s policy titled, “Food Safety Policies and Standards,” revised 10/01/24, showed the refuse and recyclable containers must be thoroughly cleaned at a frequency necessary to prevent them from build-up of soil or becoming attractant to pests, in a way that does not contaminate food, equipment, or utensils. Refuse and recyclables must be removed from the premises at a frequency that will minimize the development of objectionable odors and other conditions that could harbor pests. Review of the hospital’s untitled and undated document, showed the staff in the patient cook area of the kitchen were to empty the trash cans as needed. Although requested, a completed kitchen cleaning log documenting trash removal was not provided. Observation on 02/25/25 at 2:20 PM, showed the kitchen trash cans stored in between two heated ovens were full of plastic and paper trash. During an interview on 02/25/25 at 2:20 PM, Staff TT, Executive Chef, stated that the trash cans are “emptied constantly” and “are not normally full of trash.” During an interview on 02/25/25 at 2:20 PM, Staff ZZ, Dietary Operations Manager, stated that the trash bins are “usually emptied every 20 minutes.” Review of the hospital’s policy titled, “Food Safety Policies and Standards,” revised 10/01/24, showed the lockers or other suitable facilities must be provided for the orderly storage of employee’s possessions. Personal items may not be stored in a way that could contaminate exposed food or clean equipment. Observation on 02/25/25 at 2:30 PM, in the kitchen, showed the prep table surface to be unclean with a wrist splint, paper and a clip board. The shelves under the prep table had a step stool where food serving supplies were stored. During an interview on 02/25/25 at 2:30 PM, Staff TT, Executive Chef, stated that he would have expected the prep table surface to be clean. Paper items “ideally should not be” on the food prep table surface. Review of the hospital’s document titled, “Infection Prevention and Control for Safe Healthcare Delivery,” dated 04/2024, showed to break the chain where germs live, staff will minimize or eliminate possible exposures by cleaning, disinfecting and sterilizing equipment. Observation on 02/24/25 at 2:49 PM, on the ICU South unit, showed one crash cart with dust accumulation on the top. Observation on 02/24/25 at 2:05 PM, on the OB unit, showed a crash cart with dust accumulation on the top. During an interview on 02/24/25 at 2:05 PM, Staff Q, Family Birthplace Manager, stated that patient care staff cleaned the crash cart. Observation on 02/24/25 at 2:40 PM, on two South unit, showed a crash cart with dust accumulation on the top. During an interview on 02/24/25 at 2:40 PM, Staff S, Manager, stated that patient care staff cleaned the crash cart. Observation on 02/26/25 at 9:50 AM, in the OR area, showed a crash cart with dust accumulation on the top. During an interview on 02/26/25 at 9:50 AM, Staff T, Surgical Services Director, stated that OR staff cleaned the crash cart. Observation on 02/26/25 at 10:18 AM, in the Endoscopy area, showed a crash cart with dust accumulation on the top. During an interview on 02/26/25 at 10:18 AM, Staff XXX, Endoscopy Manager, stated that Endoscopy staff cleaned the crash cart. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that she expected the crash carts to be free of dust. Although requested, the hospital failed to provide a policy that addressed nutrition room equipment cleaning to include microwaves, refrigerators and coffee machines. Observation on 02/24/25 at 1:50 PM, in the OB patient nutrition room, showed a dirty microwave that was for patient use only. During an interview on 02/24/25 at 1:50 PM, Staff Q, Family Birthplace Manager, stated that staff were responsible to clean the microwave, and they tried to monitor it. Observation on 02/24/25 at 1:50 PM, in the OB patient nutrition room, showed a refrigerator with debris on the inside and dried liquid from a spill. During an interview on 02/24/25 at 1:55 PM, Staff Q, Family Birthplace Manager, stated that staff were to clean the refrigerator. Observation on 02/24/25 at 2:23 PM, on unit two south, showed a refrigerator with debris on the inside and dried liquid from a spill. During an interview on 02/24/25 at 2:32 PM, Staff S, Manager, stated that staff were to clean the refrigerator. Observation on 02/24/25 at 1:55 PM, in the OB patient nutrition room, showed a coffee machine that had coffee grounds and dried liquid on and around the machine. During an interview on 02/24/25 at 1:55 PM, Staff Q, Family Birthplace Manager, stated that she was not sure who cleaned the coffee machine. Observation on 02/25/25 at 10:00 AM, on unit six north, showed a microwave with food splatters on floor and walls, coffee pots with brown stains and fingerprints, drawers with dirt and debris, and cabinet handles with dirt and debris. During an interview on 02/25/25 at 10:00 AM, Staff P, Nurse Manager, stated that nursing was responsible for maintaining the nutrition area and it did not meet her expectations. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that the equipment, including the microwave, refrigerator and coffee machine in the patient nutrition rooms should be clean. Although requested, the hospital failed to provide a policy that addressed cleaning of the freezers in the OR. Observation on 02/26/25 at 9:37 AM, in the OR storage room, showed two freezers with debris in the bottom. During an interview on 02/26/25 at 9:37 AM, Staff T, Surgical Services Director, stated that there should be no debris in the bottom of the freezer and OR staff were responsible to clean the freezers. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that the refrigerators and freezers should be clean. Review of the hospital’s document titled, “Infection Prevention and Control for Safe Healthcare Delivery,” dated 04/2024, showed to break the chain where germs live, staff will minimize or eliminate possible exposures by cleaning and disinfecting equipment. Observation on 02/24/25 at 2:00 PM, in the OB medication room, showed dust accumulation in the storage bins where supplies were kept. During an interview on 02/24/25 at 2:00 PM, Staff Q, Family Birthplace Manager, stated that environmental services staff were responsible for cleaning the medication room. Review of the hospital’s policy titled, “Medication Administration,” dated 02/16/24, directed staff to clean any equipment between patients. Observation on 02/25/25 at 11:30 AM, showed Staff CCC, Care Partner, performed a point of care test on Patient #16 and then performed a point of care test on Patient #39. She failed to clean the machine between patient use. During an interview on 02/25/25 at 11:40 AM, Staff CCC, Care Partner, stated that she cleaned the machine when she finished testing her assigned patients. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that equipment should be cleaned between patient use. Review of the hospital’s policy titled, “NAM-SOFT-CLEA_HLC_033_S_Operating Room _Surgical Invasive Areas and Delivery Rooms Terminal Cleaning at the End of Each Day,” revised 03/2019, showed furniture and cabinets are to be clean and free of dust. Observation on 02/26/25 at 9:40 AM, in the storage room with sterile supplies, showed a large wooden cabinet with 40 small drawers. The drawers were chipped in areas and the back of the cabinet showed splintering wood pieces. During an interview on 02/26/25 at 9:40 AM, Staff T, Surgical Services Director, stated that a wooden cabinet did not belong in a storage room with sterile supplies. Observation on 02/26/25 at 9:38 AM, in the storage room with sterile supplies, showed peeling masking tape on the wire carts. During an interview on 02/26/25 at 9:38 AM, Staff WWW, Infection Preventionist, stated that she was aware of the peeling tape and confirmed that cleaning the tape would be impossible. Observation on 02/26/25 at 9:45 AM, in OR 6, showed a metal cabinet with a loose rubber seal inside the door and rust at the bottom of the cabinet. During an interview on 02/26/28 at 9:45 AM, Staff T, Surgical Services Director, stated that the rubber seal should be intact and the rust should not be present. Observation on 02/26/25 at 9:48 AM, in OR 7, showed adhesive residue on the outside of the door. During an interview on 02/26/25 at 9:48 AM, Staff T, Surgical Services Director, stated that there should be no adhesive on the OR door. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that OR should be free of dust debris and items should be with a smooth surface for cleaning. Observation on 02/26/25 at 10:21 AM, in SPD, showed dust accumulation on the workstation where instruments were processed, on top of the file cabinets, at the pack and prep cabinets, on the copier and printer, and on the computer desk. During an interview on 02/26/25 at 10:21 AM, Staff T, Surgical Services Director, stated that those areas should not be dusty. SPD staff were responsible to clean those areas. Observation on 02/26/25 at 10:30 AM, in the pass-through window in SPD, showed shedding particle board around the base of the window. During an interview on 02/26/25 at 10:30 M, Staff T, Surgical Services Director, stated that there should be no shedding around the window area. During an interview on 02/27/25 at 12:30 PM, Staff WWW, Infection Preventionist, stated that SPD should be free of dust debris. 50496 51292”

“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: 41474 Based on interview, record review, digital video recording review and policy review, the hospital failed to maintain an accurate central log for patients presenting to the Emergency Department (ED) for care when they failed to enter one patient (#23) on the ED log, and provide within its capability and capacity stabilization for one patient (#3) of 23 ED records reviewed from 02/15/24 through 07/15/24. These failed practices had the potential to cause harm to all patients who presented to the ED seeking care for an emergency medical condition (EMC). Findings included: Review of the hospital’s policy titled, “Emergency Medical Treatment and Labor Act (EMTALA, an act/law that obligates the hospital to provide medical screening, treatment and transfers of individuals with an emergency medical condition),” revised 12/13/23, showed the following: - Any individual presenting to an SSM Hospital or dedicated ED requesting emergency care receives a medical screening examination (MSE) conducted by Qualified Medical Personnel to determine the presence of an EMC. - In the event an individual presents with an EMC, ED staff will provide stabilizing treatment to the extent of the hospital’s capability and capacity and, if indicated, provide an appropriate transfer to another hospital. - An EMC is defined as a medical condition manifesting itself by acute symptoms of sufficient severity including psychiatric (relating to mental illness) disturbances and substance abuse such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual in serious jeopardy. - A MSE is an examination which is sufficiently detailed to reveal whether the patient suffers from an EMC, which includes an individual under the influence of drugs or alcohol, or an individual expressing suicidal (to cause one’s own death) or homicidal thoughts (HI, thoughts or attempts to cause another’s death) or gestures, and must include medically indicated screens, tests, mental status evaluations, history and physical examination, etc. - Stabilized means 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. - The MSE must be provided within the capability of the hospital’s ED, including ancillary services routinely available to the ED, to determine whether or not an EMC exists. - If an EMC is determined to exist, all ministries shall provide any necessary stabilizing treatment or provide an appropriate transfer. - Psychiatric patients are considered stable when they are protected and prevented from injuring or harming him/herself or others. - A central log would be maintained containing information on each individual who came on the hospital campus requesting assistance. This documentation would occur whether the patient left before an MSE could be performed or if they refused treatment.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 49489 Based on interviews, record review, digital video recording review and policy review, the hospital failed to maintain an accurate central log for patients who presented to the Emergency Department (ED) for care. The hospital failed to enter one patient (#23) on the log of 23 records reviewed from 02/15/24 through 07/15/24. This failure had the potential to affect all patients that presented to the ED. The hospital’s average monthly census was 3,235. Findings included: Review of the hospital’s policy titled, “Emergency Medical Treatment and Labor Act (EMTALA, an act/law that obligates the hospital to provide medical screening, treatment and transfers of individuals with an emergency medical condition)” dated 12/13/23, showed any individual who presented to the ED would receive a medical screening exam (MSE) to determine the presence of an emergency medical condition (EMC). The medical personnel would provide stabilizing treatment to the extent of their capability. Individuals had the right to refuse a MSE if they chose to leave before evaluation and treatment. The medical record would contain a description of the exam and treatment that was refused by the individual. Psychiatric patients were considered stable when they were protected and prevented from injuring or harming themselves or others. A central log would be maintained containing information on each individual who came on the hospital campus requesting assistance. This documentation would occur whether the patient left before an MSE could be performed or if they refused treatment. Review of Patient #23’s medical record showed he was a 64-year-old man brought to the ED by Emergency Medical Services (EMS, emergency response personnel, such as paramedics, first responders, etc.) on 06/13/24 at 7:10 PM, for possible heat exposure. He had a normal physical assessment, normal mood and behavior, and denied suicidal ideation (SI, thoughts of causing one’s own death). An electrocardiogram (EKG, test that records the electrical signal from the heart to check for different heart conditions) and chest X-ray (test that creates pictures of the structures inside the body-particularly bones) were unremarkable. He was given IV (in the vein) fluids and was able to eat and drink in the ED. Repeat blood work showed improvement after the IV fluids. He was diagnosed with non-traumatic rhabdomyolosis (serious syndrome due to muscle injury where the muscles bread down), weakness, and heat exhaustion and discharged on 06/14/24 at 1:45 AM. Review of the EMS D record titled, “Prehospital Care Report,” dated 06/14/24, showed at 3:20 AM Patient #23 wanted to go to the hospital. He became aggressive and combative with EMS and then the ED staff. The ED staff told the patient to leave, and security escorted the patient off the hospital’s property. Review of the video footage from the DePaul Hospital ED on 06/14/24 showed: - At 3:38 AM EMS entered the ED with Patient #23 on a stretcher. - At 3:39 AM two ED staff members approached the patient and EMS crew and appeared to interact calmly. A security guard stood nearby watching the patient. - At 3:40 AM the patient stood up off the stretcher and started walking followed by the security guard. EMS staff stayed in the ED and conferred with the ED staff. - At 3:41 AM Patient #23 walked out of the ED into the ambulance bay. Two security officers walked several paces behind him. The patient raised two middle fingers as he walked away. The officers followed him at a distance. - At 3:42 AM the EMS crew left the hospital in the ambulance. Review of the hospital’s undated spreadsheet titled, “EMTALA ED and OB,” showed a central log of ED and OB patients who presented for care. Patient #23 was found on the log for his visit on 06/13/24. His encounter when he presented with EMS on 06/14/24 was not logged in this spreadsheet. During an interview on 07/16/24 at 2:54 PM, Staff T, ED Charge Nurse, stated that she received the EMS report about patient #23. She could not register the patient because he was uncooperative and didn’t want to give his information. When asked about EMS having the patient’s information, she stated that in hindsight they could have made a chart. During an interview on 07/17/24 at 9:00 AM, Staff AA, ED Medical Director, stated that all patients who presented to the ED should be logged, even if they declined care.”

“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: 41474 Based on interview, record review, and policy review, the hospital failed to ensure that emergency medical conditions (EMC) were stabilized for one patient (#3) of 23 Emergency Department (ED) sample cases reviewed from 02/15/24 through 07/15/24, when they were discharged with an unstable medical condition. Findings included: Review of the hospital’s policy titled, “Emergency Treatment and Labor Act (EMTALA, an act/law that obligates the hospital to provide medical screening, treatment and transfers of individuals with an emergency medical condition),” revised 12/13/23, showed the following: - The hospital is committed to compliance with the requirements of EMTALA and will ensure any individual presenting to a dedicated ED requesting emergency care receives a medical screening examination (MSE) conducted by Qualified Medical Personnel to determine the presence of an EMC. - In the event an individual presents with an EMC dedicated ED staff will provide stabilizing treatment to the extent of the hospital’s/dedicated ED capability and capacity and, if indicated, provide an appropriate transfer to another hospital with the capability and capacity to treat the individual. - An EMC is defined as a medical condition manifesting itself by acute symptoms of sufficient severity including psychiatric (relating to mental illness) disturbances and substance abuse such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual in serious jeopardy. - A MSE is an examination which is sufficiently detailed to reveal whether the patient suffers from an EMC, which includes an individual under the influence of drugs or alcohol, or an individual expressing suicidal (to cause one’s own death) or homicidal (HI, thoughts or attempts to cause another’s death) thoughts or gestures, and must include medically indicated screens, tests, mental status evaluations, history and physical examination, etc. - Stabilized means 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. - If an EMC is determined to exist, all ministries shall provide any necessary stabilizing treatment or provide an appropriate transfer. - Psychiatric patients are considered stable when they are protected and prevented from injuring or harming him/herself or others. Review of the Emergency Medical Service (EMS, emergency response personnel, such as paramedics, first responders, etc.) document titled, “EMS Incident 011467,” dated 03/09/24, from EMS G, showed that Patient #3’s chief complaint was paranoia and he had been off his medications. He had a medical history of anxiety (a feeling of fear or worry experienced intermittently), bipolar disorder (a mental disorder that causes unusual shifts in mood by alternating periods of emotional highs and lows) and schizophrenia (serious mental disorder that affects a person’s ability to think, feel and behave clearly) and his mental status was documented as anxious, paranoid (excessive suspiciousness without adequate cause) and manic (elevated or excited mood or behavior). Upon arrival to the scene the patient was awake and alert, standing in the driveway with police. Patient #3 reported to EMS that he wanted to go to a mental health facility because he did not feel safe and he thought there were a lot of people coming after him and his family. He had not slept in two days and had been off his medications for at least six months. A verbal report was given to staff at SSM DePaul ED. Review of Patient #3’s medical record dated 03/09/24, from Hospital A, showed the following: - He arrived at the hospital via EMS at 3:50 PM, for paranoid behavior and not making sense. - Vital signs (VS, measurements of the body’s most basic functions) were within normal limits and a physical examination showed he was awake, alert and paranoid. - A behavioral health assessment showed Patient #3 reported a mental health history but was unable to state his diagnosis. The patient reported a history of suicidal ideation (SI, thoughts of causing one’s own death), paranoia and auditory hallucinations (AH, hearing things that are not heard by others, imaginary) but denied suicidal behavior, HI, suicidal actions and visual hallucinations (VH, seeing things that are not seen by others, imaginary). He reported a history of using ecstasy but had not used it in about three years. He drank alcohol once per week and had his last drink a few days prior. The patient was able to contract for safety outside of the hospital but was not able to show forward thinking. Aggressive behaviors included getting into a fight earlier in the day at a fast food restaurant. - A calculated Columbia Suicide Severity Rating Scale (C-SSRS, scale to evaluate a person’s risk to self-inflicted harm and desire to end one’s life) showed there was no risk indicated. - Mental status symptoms included paranoid delusions (false ideas about what is taking place or who one is) and AH with increased severity and frequency. A mental status examination showed he had poor insight, with a calm, flat, distracted and suspicious mood/affect (the expression of emotion or feelings displayed to others). His behavior was cooperative with good eye contact, but he was distracted. - A Patient Health Questionnaire 2 (PHQ-2, a brief screening tool for major depression [a long period of feeling worried or empty with a loss of interest in activities once enjoyed], a score of three or greater indicated major depressive disorder is likely) showed a score of three. The patient reported feeling down, depressed or hopeless nearly every day. The score prompted a Patient Health Questionnaire 9 (PHQ-9, a brief screening tool that can assist clinicians with diagnosing depression and monitoring treatment response, a score of 20-27 indicated severe depression, and treatment should include antidepressants with or without psychotherapy) to be completed and the patient scored a 21. - Nursing documentation showed that Patient #3’s family called and expressed many concerns for Patient #3, but the family was unable to get to the hospital to complete an affidavit (a written statement confirmed by oath, for use as evidence in court). - No ancillary testing was completed, and no medications were administered during the ED visit. Central intake determined that Patient #3 did not meet inpatient criteria and the patient would follow up with out-patient resources that were provided to him. He was discharged to his home at 10:02 PM, with a diagnosis of unspecified psychosis (a serious mental illness characterized by defective or lost contact with reality). Review of Patient #3’s medical record dated 03/10/24, from Hospital A, showed the following: - Patient #3 presented to the ED by private vehicle at 3:18 PM, with a chief complaint of behavioral health concerns. Patient #3’s mother reported he was very paranoid and aggressive and she was worried about him. She felt he was a danger to himself and others and he had not slept in three days. - Physician documentation showed Patient #3 had paranoid behavior, was aggressive, actively hallucinating, lunging at shadows, speaking nonsensically and not able to be easily redirected. A psychiatric assessment showed he was paranoid, labile (abnormal variability in mood with repeated, rapid and abrupt shifts in emotional expression) and tangential (a type of thought disorder in which each of a series of thoughts seems less closely related to the original thought than the one before it). A behavioral health evaluation was ordered. - Patient #3’s mother and Staff Z, Registered Nurse (RN), completed affidavits related to Patient #3’s behavior. Staff Z wrote in her affidavit that Patient #3 arrived at the ED agitated, highly delusional, paranoid and not directable as he was responding to what appeared to be AH and VH. He attempted to elope (when a patient makes in intentional, unauthorized departure from a medical facility), lunged aggressively at two other patients on the unit and was not able to contract for safety. Patient #3’s mother wrote in her affidavit that he had been moving non-stop, working, hanging out, not sleeping, stressing about work, felt threatened, was paranoid and depressed. He used illegal drugs to self-medicate. He did not make sense when he was talking, and he could not be trusted. He had been very unpredictable and aggressive towards others. She woke up the morning of 03/10/24 and Patient #3 had let strangers in while they were asleep. He attacked someone on 03/09/24. - An electrocardiogram (ECG, test that records the electrical signal from the heart to check for different heart conditions) was performed and was negative. - At 3:38 PM, Zyprexa (medication used to treat mental disorders) and Ativan (a medication used to treat anxiety or sleep difficulty) were administered as an injection intramuscularly (IM, within the muscle). - At 5:02 PM, his blood pressure (BP, normal adult blood pressure is between 90/60 and 120/80) was elevated at 140/98. His VS were not rechecked during the ED visit. - At 5:47 PM, Physician documentation showed Patient #3 had a history of schizophrenia, medication non-compliance, was combative upon his arrival, actively hallucinating, speaking to people who were not there, attacking shadows and also other patients. He was unable to be de-escalated or re-oriented. He had been sedated with IM medication and was medically cleared for psychiatric evaluation and inpatient admission. The clinical impression was schizophrenia, agitation requiring sedation, bizarre and aggressive behavior. The diagnosis and treatment were significantly limited due to alcohol and substance use. His final disposition was pending the central intake evaluation. - At 8:20 PM, central intake reviewed the patient’s chart and discussed the case with Staff R, Behavioral Health Nurse Practitioner (NP). Based on the information discussed it was determined that the patient did meet criteria for an inpatient behavioral health admission for psychosis. - At 8:30 PM, documentation showed attempts were made to complete a behavioral health assessment, but Patient #3 was too sedated to participate. - At 9:06 PM, a licensed clinical social worker (LCSW), attempted to perform a behavioral health intake evaluation but each section showed “patient was just awake prior to the evaluation, then refused to wake for the evaluation.” - At 9:21 PM, Physician documentation showed he spoke with central intake and the plan was made for an involuntary admission (a legal process through which a person is hospitalized and treated for mental health disorders without their consent). - Included within the medical record were the affidavits, notice of admission of involuntary patients and application for a 96-hour hold (court-ordered evaluation by behavioral specialists to determine if a person is safe to themselves and others) completed on 03/10/24. - On 03/11/24 at 7:35 AM, Staff R documented Patient #3 was resting in his bed and answered questions appropriately. Patient #3 reported he used ecstasy and at times he would become paranoid when he used it. He denied SI, HI, AH and VH. He denied any compliance with medications or outpatient follow up. His mood continued to be anxious with poor insight, judgement, and decision-making skills. Per Patient #3’s mother the patient had been randomly attacking people in public and had punched someone who had been driving with their window down. He agreed to contract for safety outside of the hospital and was no longer responding to internal stimuli. The plan was made for the patient to discharge to his home and follow up with outpatient behavioral health and a substance abuse program. - Patient safety rounding (15-minute visualization and documentation of the safety of each patient) documentation showed Patient #3 slept from 4:00 PM on 03/10/24 until 7:30 AM on 03/11/24. Documentation on 03/11/24 from 7:45 AM until 8:15 AM, showed he was on a phone call and agitated/upset. - At 8:30 AM, he was agitated/upset and discharged. Review of Patient #3’s medical record dated 03/11/24, at Hospital A, showed: - At 9:58 AM, Patient #3 presented to the ED via private vehicle for behavioral health concerns. - Physician documentations indicated Patient #3 and his aunt presented requesting a psychiatric evaluation. He reported that he was worried about his family. He denied SI and HI, but indicated he was paranoid and had a substance abuse issue. - His VS were obtained; his BP was 133/84. - His physician psychiatric evaluation described his mood, affect and behavior as normal, and his thought content as paranoid. A behavioral health assessment was ordered. - An affidavit completed by Patient #3’s Aunt showed she did not want him to be released from the hospital due to his schizophrenia. She was worried about him harming himself and others. He was paranoid and claimed others knew where he stayed from several years ago and could not sleep because of this. He walked around their home with a knife to protect his family. He invited a stranger up to his mother’s home so he could hurt them. He could not sit still, and from previous experience with him, exhibiting these behaviors, she felt he was not well and could really harm someone if left unsupervised. He threatened slit the throat of a staff member at the hospital. He was paranoid about hospital staff, thinking they were going to do something to him. When she asked who they were, he responded his ex-girlfriend from years ago. - Staff Y, Behavioral Health Tele-Assessor, documented that Patient #3 reported a history of bipolar disorder, SI and hospitalizations. He denied a history of delusions and any type of hallucinations. He reported substance abuse and occasionally drinking alcohol at social events. The patient indicated he did not want to be admitted to inpatient psychiatry, just wanted his medications re-started. He had been off of his psychiatric medications for six months. Patient #3 reported HI toward anyone who touched his family. Two days prior he hit someone in the mouth because they talked about his brother. He denied SI, self-harm or hallucinations. He was not able to contract for safety outside of the hospital and was a danger to others. - His provisional diagnosis was substance induced mood disorder, and Staff Y, Staff R, Behavioral Health NP, and Staff X, Physician, discussed the behavioral health evaluation and CSSR-S moderate risk score. Staff R determined Patient #3 did not meet inpatient criteria for behavioral health services due to him not being a danger to himself or others. - His VS were not rechecked and no ancillary testing was completed. - On 03/11/24 at 11:46 AM, he was discharged to his home. Review of Patient #3’s medical record dated 03/11/24 through 03/13/24, at Hospital F, showed: - At 3:15 PM, Patient #3 presented to the ED via private vehicle for HI. - A behavioral health assessment, urine drug screen and blood work were ordered. - Results indicated an elevated blood alcohol level, high cholesterol and low vitamin D level. - His urine drug screen was positive for marijuana. - Nursing documented Patient #3 denied SI, reported generalized HI, and paranoia. AH were telling him to hurt people. He indicated that he had hurt his brother’s friend earlier in the week. - At 4:26 PM, a behavioral health assessment was completed which determined he would be admitted to inpatient behavioral health. - He was given Zyprexa IM. He remained calm, cooperative and was receptive to the admission. - On 03/13/24, he was transferred to Hospital B for admission to a behavioral health unit. Review of Patient #3’s medical record dated 03/13/24 through 03/15/24, at Hospital B, showed: - He was admitted for a psychiatric evaluation and HI. - The patient was started on cholesterol medication, fluoxetine (an antidepressant drug), Zyprexa and vitamin D. - He was evaluated by a social worker and set up with an outpatient psychiatric provider. - On 03/15/24, he was discharged home with a final diagnosis of schizophrenia and depressive disorder. During an interview on 07/17/24 at 9:00 AM, Staff AA, ED Medical Director, stated that behavioral health tele-assessors evaluated behavioral health patients, but the decision to discharge or admit them fell on the ED Physician. The tele-assessors just collected the information and presented it to the providers. Blood work orders were based on clinical evaluation and physical examination. A positive urine drug screen would not change the decision to admit or discharge a patient. Prescribing medications to behavioral health patients was case specific. ED physicians wouldn’t generally prescribe long term medications. Any medication that required monitoring would be left to the established mental health provider. Affidavits were informative but would not determine a patient’s admission or discharge. During a telephone interview on 07/24/24 at 12:27 PM, Staff HH, ED Service Technician, stated that Patient #3 threatened to slit her throat on 03/10/24. She called security, reported the incident to Staff Z, RN, and the ED Provider. She was surprised that Patient #3 had been discharged on 03/11/24 because of the way he had been acting. During an interview on 07/17/24 at 9:50 AM, Staff R, Behavioral Health NP, stated that he evaluated Patient #3 on 03/10/24 and on 03/11/24 after he woke up. Patient #3 admitted to using ecstasy and had sobered up by the time he saw him. He felt the patient’s psychosis was drug induced. When he evaluated Patient #3, he was alert and safe to go. A 96 hour hold only meant that the patient would be evaluated within 96 hours. He did not know why Staff Y, Behavioral Health Tele-Assessor, would document that the patient was a danger to himself and others. When Staff Y, Staff R and Staff X, ED Physician, spoke about Patient #3 they were all in agreement that his behavior was substance induced and he was safe to go home. If the tele-assessor and ED physician were not in agreement, they would admit the patient. They were usually able to come to a mutual agreement. He did not like to prescribe medications in the ED because there was usually no follow up. If a patient had a reaction to medications he prescribed and there was a bad outcome, he would be responsible. He did not have anything to do with ordering urine drug screens or blood work. It would be nice to know if a patient’s psychosis was drug related or organic, since some patients lied about drug use. During a telephone interview on 07/17/24 at 10:30 AM, Staff Z, RN, stated that Patient #3 acted very bizarre and psychotic. His family was very concerned about his behavior. The patient would give the right answer to questions one minute, then go off on a tangent. He was very disorganized, had flight of ideas and was paranoid. He had attacked people. He lunged at a patient who was sitting on a stretcher in the hallway and ran out of his room and planning to attack another patient he felt had threatened him. He was able to be re-directed and had not threatened her or any other staff member that she knew of. By the time Patient #3 was re-evaluated on his second visit he had sobered up and was no longer exhibiting bizarre behavior. During a telephone interview on 07/17/24 at 11:00 AM, Staff X, ED Physician, stated that he did not remember Patient #3. He would do the medical evaluation for behavioral health patients, then get social work involved. If there were any medical issues he would order laboratory testing, otherwise, nothing would be ordered for behavioral health concerns. Tele-assessors made recommendations to the Behavioral Health NP, who would directly evaluate the patient. If their assessment correlated to the patient, they determined whether to admit or discharge them. Urine drug screens were not very accurate, and he would only order one if he was concerned about a metabolic issue or if the patient’s VS were not stable. He and Staff R decided together whether or not to prescribe medications to behavioral patients. If the patient had a known psychiatric history, then he absolutely would start the patient on psychiatric medications in the ED and have the patient follow up with an outpatient provider to monitor the drug. During a telephone interview on 07/24/24 at 11:45 AM, Staff II, Medical Director of Psychiatry, stated that medications were not always prescribed to behavioral health patients from the ED, it was up to the individual ED Provider. Starting psychiatric medications for patients who had been off of their medications for six months or more, with an unclear diagnosis, could be harmful, especially if they were on illegal substances. He stated that he would prefer a psychiatric patient be stable before prescribing medications. Urine drug screens could be useful and quite beneficial for determining which medications to put a patient on. Those decisions would be up to the ED provider. During a telephone interview on 07/18/24 at 7:30 AM, Staff Y, Behavioral Health Tele-Assessor, stated that she did not remember Patient #3 or his case. She did review the chart and stated that she did not know why Patient #3 was not admitted. She had conversations with ED Providers after she completed behavioral health assessments. She advocated for all her patients, but the ED Provider had the ultimate decision.”