Erie County Medical Center

“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: 48608 Based on policy review, medical record review, document review, and interview, in 1 of 13 medical records reviewed, it was determined facility nursing staff failed to administer the correct dose of medication; perform a “read-back” verification when receiving a verbal order from a physician; did not document who gave the verbal order; and the physician did not sign the written, verbal order (Patient #1). Reference: 482.23 (c)(1), (c)(1)(i) & (c)(2): The administration of drugs. 482.23 (c)(3)(i): Verbal orders for drugs.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 48608 Based on policy review, medical record review, document review, and interview, in 1 of 13 medical records reviewed, it was determined the physician failed to document the history and physical update assessment prior to a planned procedure, including review of medication allergies (Patient #1). Reference: 482.51(b)(1)(ii): Updated examination.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 48608 Based on policy review, medical record review, document review, and interview, in 1 of 13 medical records reviewed, nursing staff failed to administer the correct dose of medication (Patient #1). Findings include: Review of the “Medication Administration and Documentation” policy reviewed on March 2024 revealed when orders are received from the physician/provider, the registered nurse (RN) will review the orders for appropriateness and accuracy. An order for a medication to be administered in the Ambulatory Care Center will be placed in the medical record by the physician/provider. The nurse reviews the order for appropriateness and accuracy. The nurse obtains the medication from the medication room in the Ambulatory Care Center or Pharmacy. The nurse prepares the medication in the medication prep area. Medications are administered and documented only by the nurse who prepares the medication and are taken directly to the patient for immediate administration. The nurse will use a two patient identifier and confirm allergies prior to the medication administration. Review of the medical record for Patient #1 revealed on 04/17/24, Staff (D), Registered Nurse, documented a verbal order on a physician’s order form for three grams of Ancef (an antibiotic used to treat bacterial infections/pre-procedures and is part of the Cephalosporin line of medications) IV (intravenous- in vein), that was given at 11:12 AM. However, at 11:06 AM, the medication administration record indicated Staff (D) administered two grams of Cefazolin (Ancef) to Patient #1. Review of the pharmacy report for the automated medication delivery system (AMD) revealed on 04/17/24 at 11:06 AM two grams of Ancef was pulled from the AMD by Staff (D), Registered Nurse, under Patient #1’s name/profile. Interview on 05/20/25 at 03:35 PM with Staff (U), Pharmacist and Staff (V), Pharmacist, verified the automated medication delivery system report from the automated medication dispensing (AMD) unit in interventional radiology that indicated on 04/17/24, two grams of Ancef was pulled by Staff (D), Registered Nurse, on override status, unverified by pharmacy, and administered to Patient #1. Interview on 05/21/25 at 10:50 AM with Staff (B) and Staff (A), Hospital Administration, verified the incorrect dose was administered to Patient #1.”

“VERBAL ORDERS FOR DRUGS CFR(s): 482.23(c)(3)(i) If verbal orders are used, they are to be used infrequently. This Standard is not met as evidenced by: 48608 Based on policy review, medical record review, and interview, in 1 of 13 medical records reviewed, nursing staff failed to perform a read-back verification when receiving a verbal order from a physician, did not document who gave the verbal order, and the physician did not sign the written, verbal order. Findings include: Review of the “Order Management” policy, revised March 2024, revealed all orders for treatment shall be entered by a physician or provider with current privileges except in emergency situations that may require a verbal order or telephone order to begin treatment immediately. To promote safety, a prescriber is required to enter all orders electronically or write all orders prior to execution. Verbal and telephone orders must be entered into the electronic medical record (EMR) and document the order as read back to the authorizing provider. During downtime, the orders are written on the “Physician Order Form,” and read back to the physician/provider. The practitioner documenting the verbal or telephone order must document their name and title as well as the name of the physician/provider giving the order. Review of the medical record for Patient #1 revealed on 04/17/24 at 11:12 AM, Staff (D) Registered Nurse, documented a verbal order on the physician order sheet for three grams of Ancef (an antibiotic used to treat bacterial infections/pre-procedures and is part of the Cephalosporin line of medications) IV (intravenous- in vein) that was given 11:12 AM. There is no read-back verification between the registered nurse and the physician, and there is no indication what provider gave the order. The section for the physician to confirm the verbal order is blank. Interview on 05/21/25 at 10:05 AM with Staff (T), Physician, revealed they gave Staff (D), Registered Nurse, a verbal order to administer three grams of Ancef to Patient #1. Interview on 05/21/25 at 10:50 AM with Staff (A), and Staff (B), Hospital Administration, verified that the verbal order written was not appropriately written or signed off by Staff (E), Physician.”

“UPDATED EXAM CFR(s): Prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies: (ii) An updated examination of the patient, including any changes in the patient’s condition, must be completed and documented within 24 hours after admission or registration when the medical history and physical examination are completed within 30 days before admission or registration and except as provided under paragraph (b)(1)(iii) of this section. This Standard is not met as evidenced by: 48608 Based on policy review, medical record review, document review, and interview, in 1 of 13 medical records reviewed, the physician failed to document the history and physical update assessment prior to a planned procedure, including review of medication allergies (Patient #1). Findings include: Review of the “Medical/Dental Staff Rules and Regulations,” dated January 2023, indicated every patient shall have a complete history, and physical (H&P) examination performed by a qualified practitioner within 30 days before or within 24 hours after admission/registration, but prior to a surgery or procedure requiring anesthesia services. An updated examination of the patient is to be performed including any changes in the patient’s condition, when the H&P was completed within 30 days before admission/registration. If the H&P reflects the patient’s condition at admission, the H&P can be utilized and an update or note which confirms that the patient has been examined, and the information is current and accurate is made in the chart within 24 hours by the attending staff member. Review of the “Interdisciplinary Assessment, Reassessment, and Plan of Care Patient,” policy, dated January 2024, indicated for a patient admission, prior to surgery or a procedure requiring anesthesia, a history and physical examination shall be completed by the appropriate credentialed practitioner within 30 days or with 24 hours after admission. An admission assessment will be completed in the surgical services department prior to the patient procedure. Data collection may begin at the pre-op visit but must be reviewed and confirmed on the day of the surgery. Before the surgery, the patients H&P is completed, reviewed, updated, and recorded in the medical record. Review of the pre-operative medical clearance assessment, dated 04/04/24, for Patient #1 performed by their primary care physician’s office revealed Patient #1 presented for a surgical clearance. Allergies to Cephalexin, Meloxicam, and Sulfa (all antibiotics) were noted. Patient #1 had no history of reaction to anesthesia but fights going to sleep. The assessment is stamped on the bottom with a “History and Physical (H&P) Update Re-exam,” that indicates a “H&P must be performed on admission or within 30-days before visit. If greater than 30 days, a new H&P must be completed. Patient seen and examined today; H&P reviewed. Any significant changes in condition in the Progress Notes.” The section for the “date, time, and signature,” are blank. On 04/15/24 at 08:31 AM, a copy of this pre-operative medical clearance assessment was faxed to the hospital’s pain management clinic and was present within the medical record on 04/17/24 for the outpatient procedure. Review of the medical record for Patient #1 revealed on 04/17/24 at 09:30 AM Patient #1 had a planned elective outpatient procedure for a Basal Vertebral Nerve Ablation (burning of a lumbar spinal nerve to disable communication of pain to the brain) of the L5-S1 (lumbar vertebrae #5 to sacral vertebrae #1). Review of the outpatient procedure documentation “ECMC Cardiovascular IR Suite- Entire Case Report,” dated 04/17/24, revealed the following “Chronological Log,” related to Patient #1: -Patient #1 had an allergy to Sulfa. -At 09:43 AM, Patient #1 was admitted to the holding area, has no reactions to contrast, and is currently not on blood thinners. -At 09:44 AM, consent was signed. -At 11:12 AM, 3.0 grams of Ancef (antibiotic) were given preoperatively by Staff (D), Registered Nurse in the left forearm IV. (The medication was ordered by Staff (T), Physician, per verbal order). -At 11:15, Patient #1 arrived in the procedure room. -At 11:22 AM, the physician arrived and a “time out,” was conducted with all staff and Patient #1. At 11:23 AM, sedation was started and ended at 12:30 PM. At 12:35 PM, the case ended. -At 12:39 PM, a code was called. Patient #1 was transferred to the MICU. Interview on 05/21/25 at 10:05 AM with Staff (T), Physician, revealed they took care of Patient #1 every three months for the previous four or five years and the only listed allergy in their office medical chart was Sulfa (antibiotic medication). Allergies are assessed at every medical office visit, as well as preoperatively in the procedural area. Staff (T) recalled that Patient #1 stated they were allergic to Sulfa medications during the preoperative assessment. Staff (T) confirmed they performed the preoperative assessment, but it was not documented.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 49420 Based on policy review, video review, medical record review, document review, and interview, in 1 of 20 medical records reviewed, it was determined the hospital failed to keep Patient #2 free from abuse. Findings include: Review of the policy “Triage of Psychiatric Patients from the Emergency Department to the CPEP/Comprehensive Psychiatric Emergency Program,” last reviewed 05/2022, revealed patients will be medically evaluated in the medical emergency department. After the medical evaluation and treatment, the medical emergency department will determine the proper disposition of the patient. The medical emergency department triage nurse will contact the charge nurse in the CPEP for report. The patient will be accompanied to the CPEP by either emergency department staff or the CPEP staff. Crisis services, law enforcement, and ambulance personnel may also accompany the patient as needed. Review of the policy “2023 Code of Conduct,” revealed inappropriate conduct may include sub-quality care, patient abuse, harassment, fraud and abuse and other illegal activities problems and issues, especially those that have compliance implications. All patients have the right to be free from restraints and seclusion of any kind that is not medically necessary or is used as a means of coercion, discipline, convenience, or retaliation by staff. Ensure that patients shall be free from abuse or neglect. All employees have a duty to report any instances or suspected instances of such behavior. Review the policy “Use of Force,” last reviewed 02/2024, revealed hospital public safety officers use only the force necessary to effectively bring an incident under control while protecting the lives of the officer and others. The use of force must be objectively reasonable based upon the totality of the circumstances. The officer must only use that force they reasonably believe to be necessary to effectively bring an incident under control or take a person into custody. The use of weapons by hospita1public safety officers as a means of subduing a patient to place that individual in restraint or seclusion is not authorized. Hospital public safety officers shall utilize the following tools: officer presence; verbal commands; control tactics (places hands on the suspect and advises him/her that they are in violation of hospital policy and/or New York State laws and subject to possible arrest); manual compliance (employ pressure point control or mechanical compliance including wrist locks, arm bar or other ‘come along’ techniques). Prohibited uses of force shall not be used for the following reasons: against persons who are handcuffed or restrained unless it is used to prevent injury, escape, or otherwise overcome active or passive resistance posed by the subject. Review on 10/28/24 of the medical record for Patient #2 revealed on 09/11/24 at 09:25 PM revealed Patient #2 was taken into police custody due to making multiple threats to kill their mother, burn the house down, and kill themselves. At 09:31 PM, Patient #2 arrived at the emergency department for a mental health evaluation with police in handcuffs and wearing a spit hood. At 09:46 PM, Patient #2 was triaged, refusing to answer questions. At 09:46 PM, a medical screening examination was documented indicating Patient #2 was agitated on exam requiring four-point restraints and a spit hood. Patient #2 was medically stable for transfer to the CPEP. At 09:48 PM, Patient #2 was transferred to the CPEP and arrived at 09:56 PM. Review on 10/29/24 of the surveillance video “ED-Back of Trauma Toward Ambulant ENT,” revealed video footage, dated 09/11/24, of the emergency department near the trauma room located on the ground floor revealed the following: -At 00:02, Patient #2 was sitting in a chair with a spit hood on and in handcuffs. There were multiple police officers and hospital public safety officers standing around Patient #2. Patient #2 attempted to kick Staff (M), Hospital Public Safety Officer. -At 00:04, Staff (M), Hospital Public Safety Officer placed their right knee on top of Patient #2’s legs. -At 00:20, Patient #2 was attempting to kick Staff (M), Hospital Public Safety Officer who placed their right knee and left hand on top of Patient #2’s legs. -At 00:22, Staff (M), Hospital Public Safety Officer, released their right knee and left hand from Patient #2’s legs. -At 01:02, Patient #2 was sitting still in the chair. Staff (M), Hospital Public Safety Officer, pushed Patient #2’s head into the wall with both hands. Review on 10/29/24 of the surveillance video “ED-Triage Ambulance Area,” revealed an “overhead” view of video footage, dated 09/11/24, of the emergency department triage ambulance area located on the ground floor revealed the following: -At 00:03, Staff (M), Hospital Public Safety Officer pushed Patient #2 ’ s head into the wall with both hands forcefully. -At 00:06, Patient #2 attempted to kick Staff (M), Hospital Public Safety Officer who placed their right knee on top of Patient #2’s legs and their right hand on Patient #2’s shoulder. -At 00:24, Staff (M), Hospital Public Safety Officer released their right knee and right hand off Patient #2’s body. -At 00:58, Patient #2 removed the spit hood and kicked it away. -At 01:00, a police officer picked up the spit hood. -At 01:06, Staff (M), Hospital Public Safety Officer pushed Patient #2’s head forcefully back into the wall. The police officer reapplied the spit hood. -At 01:25, Staff (T), Registered Nurse was standing in front of Patient #2 and began talking to them. A police officer had their right hand on the back of Patient #2’s neck, holding it. Review on 10/29/24 of the surveillance video “ED-Triage E-F EMS Overflow,” revealed video footage, dated 09/11/24, of the emergency department triage/emergency medical staff overflow area located on the ground floor revealed the following: -At 02:01, Patient #2 was visualized “flying” backwards into a chair in exam room E. An unidentified hospital public safety officer is seen on top of Patient #2. -From 02:03 to 02:10, an unidentified hospital public safety officer and Staff (M), Hospital Public Safety Officer were on top of Patient #2 while Patient #2 was thrashing in exam room E. -At 02:32, Staff (M), Hospital Public Safety Officer was still on top of Patient #2 in the chair in exam room E. -At 03:33, Staff (M), Hospital Public Safety Officer, two unidentified hospital public safety officers, and Staff (NN), Registered Nurse attempted to place Patient #2 on the gurney. -At 03:35, Staff (M), Hospital Public Safety Officer, two unidentified hospital public safety officers, one police officer, and Staff (NN), Registered Nurse continued to try to secure Patient #2 on the gurney. Patient #2 was thrashing and sitting up. -At 03:36, Staff (M), Hospital Public Safety Officer, pushed Patient #2’s upper body and head down onto the stretcher with force and then held the left shoulder down with their left hand. Two police officers and two unidentified hospital public safety officers were holding down Patient #2’s limbs (to apply restraints). -At 03:39, Staff (M), Hospital Public Safety Officer was holding Patient #2’s head down into the gurney with both hands. Staff (M), Hospital Public Safety Officer had their right hand on Patient #2’s head and their left hand on top of Patient #2’s right hand. -At 03:45, Staff (RR), Patient Care Technician and Staff (LL), Patient Care Technician attempted to place both ankle restraints on Patient #2 while they were on the gurney. Staff (M), Hospital Public Safety Officer was holding Patient #2’s head down into the gurney with both hands. -At 04:20, Staff (OO), Physician Assistant, was at the side of the gurney. Staff (M), Hospital Public Safety Officer was holding Patient #2’s head down into the gurney with both hands. -At 04:39, Staff (M), Hospital Public Safety Officer, released Patient #2’s head. -At 08:48, Staff (M), Hospital Public Safety Officer handed the handcuffs to a police officer. -At 10:34, all the four-point restraints were successfully applied. All staff, policy, and hospital public safety officers removed their hands from Patient #2. Patient #2 sat up and started thrashing around on the gurney. -At 11:17, Staff (LL), Patient Care Technician, pushed the gurney into exam room E. Patient #2 continued to thrash around. Multiple community police officers and hospital public safety officers including Staff (M), Hospital Public Safety Officer entered exam room E. Review on 10/29/24 of the surveillance video “ED-Toward Employee Entrance,” revealed video footage dated 09/11/24 of the emergency department employee entrance revealed the following: -At 11:37, Patient #2 was seen on a gurney thrashing around with four-point restraints applied and spit hood over their head. -At 11:41, Patient #2 was thrashing around on the gurney. Staff (O), Hospital Public Safety Officer pushed Patient #2’s head into the gurney with both hands. At 11:46 Staff (O), Hospital Public Safety Officer was holding Patient #2 ’ s head down into the stretcher with their left hand at Patient #2 ’ s jaw line. There were four other unidentified hospital public safety officers around the gurney. Staff (LL), Patient Care Technician and an unidentified hospital public safety officer were looking at Patient #2’s left arm restraint. -At 11:50, Staff (LL), Patient Care Technician and an unidentified hospital public safety officer were still looking at Patient #2’s left arm restraint. Patient #2 lifted their arm up off the gurney. At this time there were also three community police officers visualized. Staff (LL) was attempting to readjust Patient #2 ’ s left arm restraint until 13:14 and the entire time Staff (O), Hospital Public Safety Officer was holding Patient #2 ’ s head down on the gurney with their left hand at Patient #2’s left jaw line. -At 13:17, Staff (LL), Patient Care Technician began pushing the gurney that Patient #2 was laying on. Staff (O), Hospital Public Safety Officer continued to hold Patient #2 ’ s head down onto the gurney with their left hand at Patient #2’s jaw line. -At 13:21, Patient #2 and the gurney they were on were out of the video. Review on 10/29/24 of the surveillance video “ED-OR Patient Transport Elevator,” revealed video footage dated 09/11/24 of the emergency department elevators located on the ground floor revealed the following: -At 11:49, Patient #2 was calm in four-point restraints, with a spit hood applied, waiting for the elevator. An unidentified hospital public safety officer and Staff (LL), Patient Care Technician were looking at the restraint on Patient #2’s left arm. -At 13:25, Staff (O), Hospital Public Safety Officer was holding the left side of Patient #2’s head at the jaw area into the gurney. Staff (LL), Patient Care Technician, four police officers and five hospital public safety officers were standing around Patient #2 on the gurney. Patient #2 was calm at this time and the spit hood was on. -At 13:28, Staff (LL), Patient Care Technician pushed Patient #2 into the elevator on the gurney. Staff (O), Hospital Public Safety Officer was still holding Patient #2’s head at the jawline. Patient #2 was calm and still had the spit hood on. Two other hospital public safety officers entered the elevator. Review on 10/29/24 of the surveillance video “ED-FL1 Patient Elevators, “ revealed video footage dated 09/11/24 of the emergency department patient elevators located on the ground revealed the following: -At 13:48, Staff (LL), Patient Care Technician, Staff (O), Hospital Public Safety Officer, and two unidentified hospital public safety officers start to exit the elevator. Staff (LL), Patient Care Technician pulled the gurney with Patient #2, out of the elevator. -At 13:50, Patient #2 was on the gurney in four-point restraints with a spit hood on, completely out of the elevator. Staff (O), Hospital Public Safety Officer was holding the left side of Patient #2 ’ s head at the jawline. Patient #2 was calm and still had the spit hood on. -At 13:52 Staff (O), Hospital Public Safety Officer released Patient #2’s head and placed their left hand on Patient #2 ’ s left shoulder. Patient #2 sat straight up in the gurney in four-point restraints. -At 13:55, Staff (O), Hospital Public Safety Officer took both of their hands and “slammed” the left side of Patient #2 ’ s head into the gurney. -At 13:57, Staff (O), Hospital Public Safety Officer released their right hand from Patient #2 ’ s head and held the left side of their head at the jawline. -At 14:02, Patient #2 and all staff were no longer seen. Review on 10/28/24 of the “Department Incident Report,” dated 10/07/24, revealed Staff (MM) was reviewing video footage from an unrelated incident and witnessed Staff (M), Hospital Police Safety Officer slam Patient #2 against the wall in emergency medical services triage area in the medical emergency department. Staff (MM) reported this event to Staff (N), Director of Safety and Security. Staff (M), Hospital Police Safety Officer was with Patient #2 who was brought in by police to the emergency department triage area. Staff (M), Hospital Police Safety Officer slammed Patient #2 up against the wall and aggressively pushed Patient #2’s head onto the bed using both hands to hold Patient #2 ’ s head down with an excessive use of force. Staff (O), Hospital Police Safety Officer slammed Patient #2 down during transport to the CPEP and pushed Patient #2’s head down into the bed with both hands while Patient #2 was in four-point restraints. The hospital policies and processes for these events were the use of force policy and the hospital ’ s code of conduct. Facts supporting the allegations were video review and witness statements that indicated Staff (M) and Staff (O), both Hospital Police Safety Officers, exercised excessive use of force identified as patient abuse. The recommended action was termination. Interview on 10/28/24 at 11:30 AM, Staff (K), Assistant Vice President Behavioral Health, revealed they reviewed the video surveillance regarding Patient #2. Staff (K) discussed the video findings with Staff (N), Director of Safety and Security. It was determined that an unnecessary use of force was used on Patient #2 by Staff (M) and Staff (O), Hospital Public Safety Officers. Interview on 10/29/24 at 11:15 AM, Staff (KK), Patient Care Technician, revealed they were sitting as a 1:1 monitor of another patient when two police officers brought Patient #2 into the emergency department. Patient #2 was verbally aggressive and agitated. Hospital public safety officers were aggressive with Patient #2 by holding all four limbs and holding down Patient #2’s head into the gurney with a spit hood in place. Staff (KK) stated there was no reason for Patient #2 to have their head held down if all four limbs were restrained.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 42611 This CONDITION is not met as evidenced by: Based on medical record review, document review, video review, and interview, it was determined that the facility failed to protect and promote the rights of all patients as evidence by: While in the psychiatric emergency department, Patient #1 swallowed two plastic spoons that required surgical intervention (A-0144). A hospital public safety assistant punched Patient #3 in the face/head multiple times while they were being manually restrained by four hospital public safety assistants and/or staff members (A-0145). This event resulted in an Immediate Jeopardy, posing a serious risk of harm to patients. On 11/02/23 at 02:50 PM, an Immediate Jeopardy situation was identified for the CoP of Patient Rights. The facility provided immediate corrective actions that included in-person re-education to all staff and providers working in the psychiatry areas of the hospital on the following policies: “Prevention of Abuse,” “Restraint and Seclusion,” and “Occurrence Reporting, and Employee Patient Relationships.” All incidents of alleged abuse will be acted upon immediately to include administrative leave for the accused staff member, a full investigation, and corrective disciplinary actions if warranted. Auditing on staff education and for all restraints & seclusion events will be conducted to ensure staff compliance with policies and to identify any incidents of abuse so that appropriate actions, reporting, and corrective follow up can be conducted. On 11/03/2023 at 10:25 AM, the Immediate Jeopardy was removed based on onsite surveyor’s observations, document review, and staff interviews which verified that the corrective action plan was fully implemented. Cross Reference: 482.13(c)(2) Patient Rights: Care in Safe Setting. 482.13 (c)(3) Patient Rights: Free from Abuse/harassment. 482.13 (c)(3) Patient Rights: Free from Abuse/harassment.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 42611 Based on policy review, medical record review, document review, and interview, staff did not allow the patient or their representative the right to make informed decisions regarding care provided to all patients. 1. Staff did not notify the patient and/or the patient representative/guardian/healthcare proxy about a change in condition for one of nineteen patients (Patient #1). Patient #1 swallowed two plastic spoons in the comprehensive psychiatric emergency program/department and required surgical intervention to remove the spoons. 2. Staff did not provide discharge instructions to the patient, the group home staff, or the patient representative/guardian/healthcare proxy for one of nineteen patients (Patient #1). Findings #1: Review of the policy “Informed Consent” last revised June 2022 indicated that consent must be obtained for endoscopies below the level of larynx (organ in the top of the neck involved in breathing and producing sounds) and above the anal canal. A patient with the mental capacity to understand the risks, benefits and alternatives of treatment may consent to treatment. A health care proxy/agent may consent for a patient who does not have the mental capacity to understand the risks, benefits, and alternatives to treatment. Review of the medical record for Patient #1 revealed on 05/27/23 at 10:10 PM, Patient #1 arrived in the emergency department with a history of PICA (condition where a person compulsively swallows non-food items) and suicidal ideation with a plan. Patient #1 has an intellectual disability and resides in a group home. Patient #1’s mother is the appointed healthcare proxy/guardian. On 05/28/23 at 12:44 AM, Patient #1 was sent to the psychiatric emergency department on suicide observation. On 05/28/23 at 06:40AM, Patient #1 swallowed two plastic spoons. At 10:29 AM, Patient #1 was sent to the emergency department for evaluation. An x-ray confirmed Patient #1 swallowed the spoons. On 05/28/23 at 01:49 PM, consent for general anesthesia and an esophagogastroduodenoscopy (a flexible tube to examine esophagus, stomach, and small intestine) procedure was obtained from Patient #1. (No evidence was found in the medical record to indicate the mother/healthcare proxy/guardian were notified that Patient #1 swallowed two spoons and required surgical intervention for their removal). Interview on 10/25/23 at 10:57 AM with Staff (B), Emergency Department Manager, verified these findings. Findings #2: Review the policy “Emergency Department Discharge Planning,” last revised May 2022 indicated that staff members issuing instructions must determine that the patient or significant other understands the instructions and can verbalize the understanding. When prepared discharge instructions are used, the patient and/or significant other is asked to sign noting receipt and understanding of the instructions. When discharging a patient to a facility, a copy of the emergency department visit and paperwork will be sent with the patient, including discharge instructions which includes prescriptions, medications, discharge instructions with follow-up, referrals, the provider report, the supervisory notes, consults, and the history & physical. The registered nurse or provider will contact the facility to notify them that the patient has been discharged, and is on their way back, indicating the mode of transportation. This will be documented in the nursing care record. Documentation must be made by the nursing staff related to any instructions rendered and copies that are sent in the electronic medical record nursing care record. Every attempt will be made to involve family and/or the significant other in all aspects of emergency department patient care. Review on 10/25/23 of the medical record for Patient #1 revealed on 05/27/23 at 10:10 PM, Patient #1 was brought to the emergency department by ambulance. Patient #1 had a history of PICA (the eating or craving of things that are not food) and suicidal ideation with a plan. Patient #1 has an intellectual disability and resides in a group home. Patient #’s mother is the appointed healthcare proxy/guardian. On 05/28/23 at 06:40 AM Patient #1 swallowed two plastic spoons and required an esophagogastroduodenoscopy to remove the objects. On 05/29/23 at 12:07 AM, the patient signature page to document receipt of the discharge instructions was signed by the registered nurse and an unknown individual, not by Patient #1, the group home staff, and/or the healthcare proxy/guardian. On 05/29/23 at 12:09 AM, Patient #1 was discharged back to the group home. Interview on 10/26/23 at 11:15 AM with Staff (L), Vice President of Transplant & Renal Services (covering for the vacationing Vice President of Nursing) stated that after discussion with the information technology staff, they were unable to determine if Patient #1, the group home staff, and/or the healthcare proxy/guardian received discharge instructions.”

“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: 42611 Based on policy review, medical record review, and interview, the facility failed to provide care in a safe setting as evidenced by: 1. Patient #1 had a history of PICA (the eating or craving of things that are not food) and swallowed two plastic spoons while on level one observation in the comprehensive psychiatric emergency program/department, that required surgical intervention for removal. 2. Nursing staff failed to provide ongoing assessment and monitoring of vital signs for four of sixteen patients (Patient #2, #3, #21, and #31) in the emergency department. Findings #1: Review of the policy “Levels of Patient Observation in Psychiatry” last revised November 2022 indicated that each patient will be observed according to the level of observation ordered by the physician, and the observation will be documented in the patient’s medical record. Rounding intervals as per provider order for Level 1 are observations every 15 minutes. Review on 10/25/23 of the medical record for Patient #1 revealed on 05/27/23 at 10:10 PM, Patient #1 arrived at the emergency department with a history of PICA (condition where a person compulsively swallows non-food items) and suicidal ideation with a plan. Patient #1 has an intellectual disability and resides in a group home. Patient #1 has a history of swallowing items, such as coins and screws, and has had multiple procedures in the past to remove them. On 05/28/23 at 12:44 AM, Patient #1 was admitted to the comprehensive psychiatric emergency program/department on Level 1 observations (every 15 minutes) ordered by the physician. On 05/28/23 at 06:40AM, Patient #1 swallowed two spoons which were visualized on an abdominal x-ray. On 05/28/23 at 02:27 PM, the spoons were surgically removed under general anesthesia. Interview on 10/26/23 at 10:20 AM with Staff (T), Vice President of Behavioral Health stated that there is no formal process or protocol for the collection of meal trays and silverware. Interview on 10/26/23 at 10:54 AM with Staff (OO), Clinical Manager of Behavioral Health stated through investigation it was found that Patient #1 took spoons off the tray, went into the bathroom, and swallowed two spoons and a Band-Aid. There is no process to account for silverware. Interview on 10/26/23 at 11:08 AM with Staff (S), Comprehensive Psychiatric Emergency Program Behavioral Health Manager verified the findings and stated that snack carts contain juice, crackers, cereal, and yogurt. The cart is brought out into the milieu once a shift. Silverware is not typically stored on the cart. However, a spoon is needed to eat cereal and yogurt. Staff do not check to ensure patients the return utensils. There is no formal education provided to the staff regarding utensil collection. Findings #2: Review of the policy “Nursing Assessment/Reassessment and Emergency Department Documentation” last reviewed March 2023 indicated that assessments may be ongoing per acuity and patient condition. Acuity is determined by the emergency severity index rating system. Patients with an emergency severity index score (a scale of 1-5 with a score of 1 being the most serious) between one and three will have a registered nurse initial assessment and vital signs assessed at triage or upon entry to the treatment area. Re-assessments and vital signs will be repeated at least every two hours, with any change in condition, and within 30 minutes of discharge. A complete set of vital signs is considered: blood pressure, heart rate, respiratory rate, blood-oxygen saturation, and temperature assessments. Assessments and re-assessments must be documented in the electronic medical record or the emergency department nursing care record. Review of the policy “Emergency Department Nursing Protocols” last reviewed December 2021 indicated that patients who arrive to the emergency department with a condition of an overdose, are to be placed on a cardiac monitor, monitor the EKG rhythm strip every two hours, and as needed, obtain a full set of vital signs, and administer oxygen to maintain a blood oxygen saturation of greater than or equal to 95%. Review of the medical record for Patient #2 revealed on 08/01/23 at 06:58 PM, Patient #2 presented to the emergency department with a complaint of head pain following a motor vehicle accident. At 07:01 PM, Patient #2 was assessed, and vital signs were obtained. At 07:04 PM, an emergency severity index score of three was assigned by the triage nurse. (No vital signs were documented during the time frame from 08/01/23 at 07:04 PM to 08/02/23 at 12:10 AM). On +08/02/23 at 12:10 AM, the provider departure note indicated that Patient #2 left without being seen). Review on 12/25/23 of the medical record for Patient #3 revealed on 08/01/23 at 06:56 PM, Patient #3 presented to the emergency department with a complaint of status post motor vehicle accident with neck pain. At 06:58 PM, Patient #3 was assessed, and vital signs were obtained. At 07:02 PM, an emergency severity index score of three was assigned by the triage nurse. (No vital signs were documented during the time frame from 08/01/23 at 06:58 PM to 08/02/23 at 12:10 AM. On 08/02/23 at 12:10 AM the registered nurse departure note indicated that Patient #3 eloped at 12:10 AM. Review on 10/25/23 of the medical record for Patient #21 revealed on 07/25/23 at 01:10 PM Patient #21 presented to the emergency department with a complaint of coughing up blood and had blood clots in the foley catheter. Patient #21 was immediately placed on a cardiac monitor, vital signs were obtained, and an emergency severity index score of two was assigned by the triage nurse. (No vital signs or cardiac rhythm assessments were documented during the time frame from 07/25/23 at 01:10 PM to 07:15 PM when vital signs were obtained). Review on 10/26/23 of the medical record for Patient #31 revealed on 08/01/23 at 06:56 PM, Patient #3 presented to the emergency department with a complaint of status post motor vehicle accident with neck pain. At 07:02 PM, Patient #31 was assessed, vital signs were obtained, and an emergency severity index score of three was assigned by the triage nurse. (No vital signs were documented during the time frame from 08/01/23 at 07:02 PM to 08/02/23 at 12:10 AM). On 08/02/23 at 12:11 AM, the registered nurse departure note indicated Patient #31 left the emergency department, the disposition was documented as elopement. Interview on 10/25//23 at 10:57 AM with Staff (C), Assistant Vice President of Emergency Department and Critical Care, verified these findings.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 42611 Based on policy review, video review, medical record review, document review, policy review, and interview, the facility failed to ensure that all patients are free from all forms of abuse, neglect, and harassment for one of three patients (Patient #32). 1. Patient #32 was punched in the face/head three times by a hospital patient safety assistant while being manually restrained. 2. Staff did not report the alleged abuse that occurred on 07/22/23 related to Patient #32. 3. The facility failed to thoroughly investigate and identify allegations of abuse reported by Patient #32, that occurred on 07/22/23, in a timely manner. Findings #1: Review of the policy “Restraint and Seclusion -Psychiatry” last reviewed February 2023 indicated the purpose of the policy is to guide staff in the steps necessary to support patient and staff safety and how to respond if imminent dangerousness persists and is risking the safety of patient and staff. Hospital Patient Safety Assistants will be required to attend annual in-service to include early identification of risk situations, alternative interventions and de-escalation strategies, safe physical interventions, and holding the patient while the nursing staff apply restraints. Review on 11/01/23 of the video with Staff (L), Vice President of Transplant and Renal Services (covering for the vacationing Vice President of Nursing) revealed on 07/22/23 at approximately 04:44 AM, Patient #32 was noted to be standing near the locked exit door of the comprehensive psychiatric emergency program. Staff (XX), Community Mental Health Technician was sitting in a chair (in front of the nursing station) to the left of Patient #32, writing on a clip board. Staff (XX) stood up and motioned with his right hand at the exit door window as if gesturing someone to come to them. Security staff enter the unit through the door and Staff (XX) pointed to Patient #32. Staff (CCC), Hospital Public Safety Assistant placed their left open palm on Patient #32’s chest and motioned Patient #32 away from the door. Staff (WW), Hospital Public Safety Assistant entered through the exit door. Staff (CCC), Hospital Public Safety Assistant placed two open palms on Patient #32’s chest and bent down to retrieve an item off the floor. Staff (XX), Hospital Public Safety Assistant Correct placed their hands on Patient #32, who grabbed and lifted Staff (WW), off the ground and dropped Staff (WW), onto a row of blue plastic chairs. Staff (CCC) took a hold of Patient #32’s hooded sweatshirt with his right hand and pulled the sweatshirt over Patient #32’s head. a third Hospital Public Safety Assistant enters through the exit door and places hands on Patient #32’s upper arms from behind. Staff (CCC), Hospital Public Safety Assistant; Staff (WW), Hospital Public Safety Assistant and a third Hospital Public Safety Assistant struggle with Patient #32 to the floor. The struggle between staff and Patient #32 continues the floor while additional Comprehensive Psychiatric Emergency Program staff respond and move chairs out of the way. Staff (WW) can be seen using a closed fist to punch Patient #32 in the face/head three times, while Patient #32 was being manually held down by four hospital patient safety assistants and clinical staff. Review of the medical record for Patient #32 revealed that on 07/22/23 at 09:27 AM, the registered nurse documented that Patient #32 stated they were hurt during an altercation with staff and requested a medical evaluation. At 12:13 PM, Patient #32 complained of a pain level of seven (zero for no pain, ten for the most severe pain) in the back of the head and lower back, Patient #32 indicated it resulted from being punched and restrained. No visible signs of injury was found on exam. Patient #32 denied any other symptoms. Patient #32 denied imaging or pain medication stating, “I would rather go to my primary care provider to be checked out, I just want to go home.” There is no documentation of the event in the medical record. Findings #2: Review of the policy “Code of Conduct” last reviewed 01/10/23, indicated that all employees, management, volunteers, and others, virtually everyone staff encounters have an affirmative duty to bring forward any compliance related concerns. Inappropriate conduct includes any activity designed to eliminate by encouraging system-wide integrity, including sub-quality care, patient abuse, harassment, fraud and abuse and other illegal activities, especially those that have compliance issues. We shall ensure that all patients are free from abuse or neglect. All employees have a duty to report any instances or suspected instances of such behavior. Review of the policy “Professionalism Policy” last reviewed April 2021 indicated that all employees conduct themselves in a professional and cooperative manner within the hospital facilities. Staff will take prompt and appropriate action to address reports of unprofessional behavior by any member of staff. Reports may be made online using the electronic occurrence reporting system and utilizing the chain of command. Patients and visitors are referred to the Patient experience team. Examples of unprofessional conduct includes unprofessional physical contact with another individual or other aggressive behavior that is threatening or intimidating. Review of the policy “Occurrence Reporting” last reviewed June 2020 indicates that any staff member may identify an occurrence anonymously into the electronic reporting system. The staff member should notify the supervisor. A physician will examine the patient and the supervisor will notify hospital administration. A mandated reporter’s failure to report of suspected reportable incident is a serious matter with consequences to an individual and to program’s operating certificate including discipline, termination, loss of credential or certification caused by failure to report. The purpose of reporting and subsequent investigation is to ensure that persons receiving services who are compromised physically, mentally, and emotionally are protected from avoidable actions or inactions of staff who are entrusted with their care who would have opportunities to cause them harm (physical or mental). Incidents are reportable (abuse or neglect) to the Vulnerable Persons Central Register (VPCR). Abuse and Neglect reporting must be initiated made by a mandated reporter to the VPCR immediately after a reportable incident is discovered. Review on 11/01/23 of the video with Staff (L), Vice President of Transplant and Renal Services (covering for the vacationing Vice President of Nursing) revealed on 07/22/23 at approximately 04:44 AM, Staff (WW), Hospital Patient Safety Assistant can be seen using a closed fist and punching Patient #32 in the face/head three times, while Patient #32 was being manually held down by four hospital patient safety assistants and clinical staff. Multiple other staff members and hospital patient safety assistants can be seen standing in the vicinity and observing the manual hold placed on Patient #32. Review of the Vulnerable Persons Central Register incident report for abuse and neglect was filed on the incident date of 07/22/23 at 09:15 AM by the victim (Patient #32). Patient #32 reported being slammed to the floor and punched in the head/face. An unknown staff member tried to smother Patient #32 with their shirt. An unknown staff member administered a medication injection in the right shoulder of Patient #32. (There is no evidence that any staff member filed an occurrence report, adverse event report, security report, or an incident report related to the alleged abuse that occurred during the restraint event on 07/22/23 at 04:44 AM). Interview on 11/02/23 at 2:00 PM with Staff (L) Vise President of Transplant & Renal Services (covering for the vacationing Vice President of Nursing) verified the findings. Findings #3: Review of the policy “Occurrence Reporting” last reviewed June 2020 indicated that examples of reportable events include disruptive actions, concerns that warrant investigation, and events that may result in harm to an individual. The patient safety department will review occurrences via the electronic reporting system with the Chief Safety Officer to determine if any regulatory agency must be notified. Summary reports are provided to executive leadership for action plan implementation and sustainment. Reporting certain events (abuse) to the New York Justice Center is required by law. The purpose of reporting and subsequent investigation is to ensure that persons receiving services who are compromised physically, mentally, and emotionally and are protected from avoidable actions or inactions of staff who are entrusted with their care who have opportunities to cause them harm (physical or mental). Abuse and Neglect reporting must be made by a mandated reporter to the Vulnerable Persons Central Register (New York State Justice Center) immediately after a reportable incident is discovered. The New York State Incident Management and Reporting (Office of Mental Health) reportable incident types include abuse and neglect. Report occurrences to the New York State Justice Center and the New York State Office of Mental Health. The facility is to investigate the occurrence, document the findings, and submit the investigation within 45 days via the web submission of investigation report through the justice center. Review of the policy “New York State Justice Center for the Protection of People with Special Needs Guidance for Staff and Volunteers,” dated August 2018 revealed the Justice Center has authority to investigate all reports of abuse and neglect, can pursue administrative sanctions against staff found responsible for misconduct, and prosecute criminal offenses involving allegations of abuse or neglect. A report must be made within 24 hours of a mandated reporter’s (certain professions such as doctors, nurses are mandated by New York State law to report suspected abuse or neglect) discovery. The incident is classified as reportable or non-reportable and is assigned to the appropriate entity for investigation or review. The Justice Center conducts investigations of abuse and neglect allegations based on severity and makes the final determination on the investigation findings. Review of the report filed by Patient #32 “New York State Justice Center: Vulnerable Persons Central Register Incident Report” for abuse and neglect revealed a complaint was filed on 07/22/23 (incident date) at 09:15 AM by Patient #32. Patient #32 reported they were slammed to the floor and punched in the head/face. An unknown staff member tried to smother Patient #32 with their shirt. An unknown staff member administered a medication injection in the right shoulder of Patient #32. An addendum note to the report dated 07/27/23 at 10:24 AM indicated that Patient #32 had behaviors that warranted restraint, seclusion, and medications. Patient #32 was physically violent and injured staff. Patient #32 alleged staff physically abused them. A medical evaluation did not reveal any injuries. The facility did not provide video footage of the restraint event to the New York State Justice Center for their review. The incident was classified as “non-reportable,” (does not meet the New York State Justice Center criteria for review). Review of the facility complaint Event Log revealed no evidence an incident report was initiated for Patient #32’s complaint of abuse that occurred on 07/22/23. Review of the human resource investigation document “Business Partner Investigation Form” (Human Relations investigation of event on 07/22/23) completed by Staff (III), Employee Relations Partner on 07/22/23 indicated that the New York State Office of Mental Health called requesting the facility to check Patient #32’s location, well-being, and asked whether Patient #32 was seen by a healthcare provider after Patient #32 self-reported a complaint. Patient #32 reported that they were punched in the face and head, stomped, and tramped over by unknown staff members. Patient #32 was in the Comprehensive Psychiatric Emergency Program unit. Patient #32 was assessed by a provider with no injury or bruises noted. The investigation found that video of the event was saved and reviewed by clinical, public safety and human resources. Review of the addendum to the report filed by Patient #32 “New York State Justice Center: Vulnerable Persons Central Register Incident Report” (addendum to the report filed by Patient #32) for abuse and neglect dated 07/27/23 at 10:24 AM indicated that Patient #32 had behaviors that warranted restraint, seclusion, and medications. Patient #32 was physically violent and injured staff. Patient #32 alleged staff physically abused them. A medical evaluation did not reveal any injuries. The facility did not provide video footage of the restraint event to the New York State Justice Center for their review. The incident was classified as “non-reportable,” (does not meet the New York State Justice Center criteria for review). Review of the facility submission of the New York State Justice Center “Vulnerable Persons Central Register Incident Report” (report filed by facility staff after review of the video) for abuse and neglect by Staff (JJJ), Vice President of Behavioral Health dated 08/22/23 at 10:54 AM (31 days later), revealed that on 07/22/23, an unknown staff member punched Patient #32 in the head. While investigating the incident, it was found that there was evidence for the claim of abuse and neglect. The recommendation was to re-categorize the event. Review of video footage on 08/18/23 showed an unknown staff member punch Patient #32 in the head in the Comprehensive Psychiatric Emergency Program unit. Patient #32 was seen by a physician and had no reported injuries. Review of the facility email to the New York State Incident Management and Reporting (Office of Mental Health) dated 08/23/23 at 06:54 AM revealed the facility reported the 07/22/23 incident for abuse and neglect (32 days later). The investigation was delegated to the New York State Justice Center. A return email from the New York Justice Center indicated the case was assigned to investigate the 07/22/23 incident for abuse and neglect. Interview on 10/25/23 at 09:40AM with Staff (R), Assistant Vice President of Behavioral Health, indicated complaints and grievances are input into the Risk Connect System. Each case is reviewed and addressed by the unit manager. Depending on the level of concern of the case, it may go through the Quality Assurance process. If there is harm or safety concerns, then a root cause analysis would be completed. A case where there is harm would be input into the safety module and investigated. Interview on 11/02/23 at 12:20 PM with Staff (DDD), House Council that the incident with Patient #32 on 07/22/23 was discussed at the 09/28/23 Incident Review Committee (confidential Quality Committee). Interview on 11/03/23 at 11:37 AM with Staff (JJJ), Vice President of Behavioral Health stated that “we don’t typically review video unless there is an allegation of abuse.” Patient #32 called the Justice Center. A report was completed and sent to the Justice Center. “We reviewed the video, identified abuse, and submitted an additional report to the Justice Center.” On 08/22/23 the Justice Center determined the case was a significant event and was assigned to the investigation. Once the Justice Center starts an investigation, we must stop our investigation. Interview on 11/03/23 at 1:54 PM with Staff (III), Employee Relations Partner indicated on 09/25/23, they received a call from Staff (DDD), House Council who asked for the discipline, or any documentation related to the 07/22/23 incident with Patient #32. Staff (III) stated that “we did not have any.” The event was closed in Risk Connect (facility incident reporting), although it indicated that the case was assigned to Human Resources. On 09/18/23, a meeting was held, and the video was reviewed. Staff (XX), Community Mental Health Technician waved in the Hospital Patient Safety Assistant and did not utilize de-escalation techniques. The actual take down of Patient #32 and the punching in the head was viewed. Staff (WW), Hospital Patient Safety Assistant was on compensation for suffering a concussion from the incident. Staff (WW), Hospital Patient Safety Assistant filed a police report against Patient #32 for assault. The injuries and police report delayed Human Resources ability to be involved. Interview on 11/03/23 at 02:14 PM with Staff (L), Vice President of Transplant & Renal Services (covering for the vacationing Vice President of Nursing), verified the findings.”