Strong Memorial Hospital

“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: 49420 Based on policy review, observation, medical record review, document review, and interview, in one of five medical record reviewed, clinical staff did not notify Patient #2’s spouse (power of attorney) and/or the family about Patient #2’s health status, specifically, changes in their condition. Findings include: Review of the document “Patients’ Bill of Rights in a Hospital,” dated September 2019, revealed that as a patient they would receive complete information about the diagnosis, treatment, and prognosis. Receive all the information needed to give informed consent for a procedure or treatment. Participate in all decisions about treatment. Review of the policy “Disclosure of Unanticipated or Negative Outcomes Policy,” dated 04/10/23, revealed that the hospital encourages open and ongoing communication with the patient and/or family about all aspects of their health care, and the results of such care. Patients and/or their family have the right to be provided with sufficient information about their health care to enable them to make meaningful health care decisions. If there is an unanticipated outcome the patient and/or their family should be notified. Review of the policy “Restraints for Non-Violent, Non-Self-Destructive Behaviors Policy,” dated 03/10/25, revealed that restraints are to be used only after less restrictive alternatives have failed. (The policy does not require caregiver/healthcare proxy/guardian/family notification for the use of restraints.) Review of the policy “Inpatient Fall and Injury Prevention Policy,” dated 04/10/25, revealed that admitted patients are assessed for fall risk and care is established based on specific risk factors by the registered nurse within 24 hours of admission, daily, after a patient fall, and significant changes in patient status. For patients that sustain a fall the provider is notified, and the patient’s plan of care is reviewed and updated as appropriate. The pediatric patient’s caregiver will be notified. (The policy failed to address the need to notify the family for an adult patient that falls.) Review of the policy “Medical Record Content and Documentation Policy,” dated 09/10/25, revealed that progress notes should document the course of treatment, response to treatment, and changes in patient condition. Review of the acute rehabilitation unit medical record for Patient #2 revealed no evidence the spouse and/or family were notified after a change in condition on the following days: -On 10/09/25, Patient #2 was admitted to the acute rehabilitation unit after sustaining a traumatic brain injury and orientation to self only (not aware of place, time, or their situation). A “Patient Care Agreement,” designated Patient #2’s spouse as the caregiver and their contact information was provided. -01/14/26, mitts (soft padded glove used to prevent self-harm or interference with medical treatment) and a left soft wrist restraint were implemented due to agitation and Patient #2 not being safe (continually removing nose packing). -On 01/24/26, a posey bed (enclosed with a tent-like bed for patients are risk for falls) was implemented due to agitation and the inability to redirect Patient #2 after they sustained a fall. -On 02/07/26 and on 03/10/26, Patient #2 fell out of their bed. Interview on 06/11/26 at 02:30 PM with Staff (A), Director of Quality, revealed at the time Patient #2 was in the hospital, there was not a policy about the provider calling family with a change of status or a fall. Interview on 06/11/26 at 09:05 AM with Staff (BB), Physician, revealed the resident communicates to the family if there is an injury from a fall or imaging needs to be completed. If there is no injury the family will be updated at the next family meeting. Interview on 06/12/26 at 09:35 AM with Staff (AA), Resident, revealed they were assigned to Patient #2 when they fell on 01/24/26. Staff (AA) would have documented a note in the medical record if they called the family about the fall. If a patient falls and has an injury or needs imaging the family will be called right away. Staff (AA) did not remember calling the family about Patient #2’s fall. Interview on 06/12/26 at 09:45 AM with Staff (GG), Resident, revealed that if a patient had a fall and there was no injury, the family would get notified the next day. If there was an injury or imaging performed, the family would be called right away. Interview on 06/12/26 at 10:30 AM with Staff (A), Director of Quality, verified these findings.”

“DISPOSAL OF TRASH CFR(s): 482.41(b)(6) (4) The hospital must have procedures for the proper routine storage and prompt disposal of trash. This Standard is not met as evidenced by: 49205 Based on observation and interview, the facility failed to ensure biohazardous waste, specifically sharps containers (puncture resistance container designed to dispose of medical instruments that can cut or puncture skin), are properly stored and/or secured in the Verticare area. Findings include: Observation on 07/29/25 at 10:00 AM and on 07/30/25 at 09:30 AM in the Verticare area revealed 28 out of 28 patient treatment rooms had a sharps container located on the floor and open, not secured to prevent tipping, spillage, and theft. Interview on 07/30/25 at 09:30 AM, Staff (E), Hospital Administration, revealed sharps containers are not required to be secured to the floor in the Verticare area. The sharps containers that are on the floor do not having openings that an adult would be able to fit a hand into. Typically, children are not roomed in the Verticare area, but if they were to be it would be the responsibility of the adult supervising the child to ensure that they do not get into the sharp’s container. Interview on 07/30/25 at 10:00 AM, Staff (C), Hospital Administration, revealed the hospital does not have a policy related to securing sharps containers.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 49205 Based on policy review, medical record review, and interview, in 1 of 20 medical records reviewed, it was determined the emergency department (ED)/comprehensive psychiatric emergency progam (CPEP) staff failed to ensure Patient #1 had access to appropriate resources for a safe discharge after three presentations on 05/01/25. After the 3rd discharge from Hospital #1, Department of Public Safety (DPS- security and peace officers) Officers brought Patient #1 to another hospital (Hospital #2) for psychiatric evaluation/treatment due to continued behaviors and inability to care for self. Findings include: Review of the policy “Patient Discharge Guidelines,” effective 10/24/23, revealed it is the facility’s policy to review each patient being discharged from the ED to determine the patient’s capacity to return safely to their place of residence. The facility will provide appropriate collateral referrals (i.e. home health care), resources (i.e. clothing, shelter), and transportation in support of safe patient discharge. The procedure includes the patient is dressed in weather appropriate clothing, the patient’s access to their residence has been confirmed, and appropriate transportation has been confirmed or arranged, with social work assisting as needed. If the nurse identifies a barrier to safe discharge the primary nurse should consult with the social work to complete a safe and adequate discharge for the patient. The social worker and/or primary nurse arranges required services for the patient, dependent upon the patient’s risk profile. When resources for safe patient discharge cannot be secured at the time of patient ’ s medical readiness for discharge, the patient will remain in the ED until they can safely be discharged. Documentation of efforts (along with barriers) to discharge will be in the patient’s medical record. For challenging discharges, contact social work as early as possible. Social work will attempt to arrange lodging in an area shelter. Review of the policy “Discharge of Patients from CPEP” effective 03/24/25, revealed patients discharged from the CPEP are evaluated to determine the patient’s capacity to return safely to their place of residence. CPEP will provide appropriate referrals, resources, and transportation and support of safe patient discharge. CPEP provider makes the decision to discharge the patient after the initial face to face assessment or the full evaluation. Discharge planning includes completing a safety plan and include a copy with the after-visit summary. Appropriate referrals will be completed to address the needs related to mental health, substance use, and other social determinants of health. Collateral information will be updated, the patient will be told of the updates and follow up plan. Upon discharge, ensure the patient is appropriately dressed for the weather and document accordingly. Ensure the patient can access their residence, they have proper transportation upon discharge, and there are specific transportation requirements for patients identified as vulnerable persons. Review of the medical record at Hospital #1 for Patient #1, dated 05/01/25 (1st presentation), revealed: - At 12:51 PM, Patient #1 arrived at the emergency department. A note by Staff (AA), CPEP Nurse Practitioner, revealed Patient #1 was dropped off at the hospital after they were released from jail. Patient #1 was there voluntarily and not on Mental Hygiene Trasnsport (MHT) status. Patient #1 denied having any suicidal or homicidal thoughts and had no desire to harm themselves. Patient #1 stated they were hurt by their significant other, and had various bruising on their arms from their significant other, but declined medical treatment. Patient #1 stated that they were at the hospital to obtain medication for their significant other. Patient #1 repeatedly asked for their mother, which Staff (AA) reminded Patient #1 they could contact their mother on their own. Patient #1 stated they were sad because their brother had died, which is something that happened many years ago and is known as a reason for their emotional distress. Patient #1 denied having any other psychiatric needs. Patient #1 is well known to community CPEP/ED services, presenting often for various psychiatric and medical complaints in the context of poor coping, and seeking shelter or food. Patient #1 is known to behaviorally dysregulate (difficulties in controlling or regulating behaviors) inside and outside of the hospital setting. Patient #1 was connected with Strong Ties ACT (Assertive Community Treatment- community care management program which is the highest level of care prior to requiring inpatient services), who report that they believe that Patient #1’s presentations are behavioral in nature. Patient #1 was to be discharged with passes for public transportation and was provided information for two homeless shelters. - At 01:25 PM, a clinical evaluator note by Staff (BB), Registered Nurse, revealed a secure chat conversation was held with the Strong Ties ACT Nurse Practitioner, who reported Patient #1 could be discharged to a homeless shelter if they are not banned from there. Patient #1 had an appointment with Strong Ties ACT team scheduled for 05/06/25. Staff (BB) attempted to contact the homeless shelter but was unable to reach staff there. - At 01:33 PM, the CPEP disposition note by Staff (BB), Registered Nurse, revealed Patient #1 was being discharged to the community. Patient #1 was homeless and there was no family notification of discharge. Patient #1 had their own bus pass. Belongings and valuable were given to Patient #1. - At 02:01 PM, a CPEP triage note by Staff (CC), Registered Nurse, revealed Patient #1 began making nonsensical statements and attempted to relieve themselves of the floor three times. Patient #1 was positive for confusion and decreased concentration. Patient #1 denied suicidal ideations and was noncompliant with the rest of the triage process. - At 02:05 PM, a CPEP note by Staff (BB), Registered Nurse, revealed staff had difficulty redirecting Patient #1’s behaviors despite positive re-enforcement. Staff (BB) and two other CPEP registered nurses escorted Patient #1 off the unit and Patient #1 attempted to pull their pants down in the elevator. Staff (BB) and staff escorted Patient #1 to the front ED entrance. Patient #1 again started to pull their pants down while raising their shirt. Staff (BB) informed Patient #1 that willingly exposing their genitals to others, including children present, would result in felony charges related to indecent exposure to minor children as well as public indecency. Patient #1 immediately pulled their pants back up, covering themselves with their shirt and hospital gown. Once to the front of the hospital, Staff (BB) gave Patient #1 their discharge paperwork, bus passes, and a copy of the “Interim Ban from University of Rochester Properties,” that DPS issued to Patient #1. Staff (BB) explained the criteria and nature of the ban. Patient #1 proceeded to look directly at Staff (BB), then threw all the paperwork and bus passes about the ground. DPS quickly presented, re-iterated the ban information while instructing Patient #1 to leave the premises. Patient #1 took a few steps, started to disrobe then touch themselves inappropriately. At that time, Staff (BB) and CPEP staff left the situation to return to their unit. Review of the medical record at Hospital #1 for Patient #1, dated 05/01/25 (2nd presentation), revealed the following: - At 03:20 PM, the 9.41 Mental Health Transport (MHT- Section 9.41 of the mental health law authorizes police or peace officers to remove an individual who appears to be mentally ill and is conducting themselves in a manner likely to result in serious harm to self or others, from the community to a hospital for a psychiatric evaluation) document by a local law enforcement officer, indicated at approximately 02:45 PM, the police officer observed Patient #1 sitting in the back of a public bus naked. Patient #1 then began screaming, hitting themselves and biting their arms. Patient #1 could not communicate with responders on scene, refused any help, and would not get off the bus. Patient #1 was eventually escorted from the bus, placed under 9.41 status and transported to Hospital #1. The order indicated Patient #1 was a danger to self/others were, they were unable to care for self and they attempted to hurt/kill self/others. - At 03:46 PM, a triage note by Staff (EEE), ED Registered Nurse, indicated Patient #1 was brought in on an MHT for a psychiatric evaluation. Patient #1 was on the bus naked, attempting to hit other people on the bus. Patient #1 denied suicidal/homicidal ideation. - At 04:02 PM, a CPEP provider triage and referral note by Staff (K), CPEP Nurse Practitioner, revealed Patient #1 arrived at CPEP with police on a 9.41 MHT status for a psychiatric evaluation. Patient #1 was well known to CPEP as they were a high utilizer of ED/CPEP services. Patient #1 was last seen in CPEP earlier in the day and was discharged to a homeless shelter. Patient #1 presented after being observed unclothed, screaming, and hitting their self. Patient #1 has presented to the ED or CPEP 25 times in the past 30 days and was last admitted to inpatient psychiatric unit from 01/30/25-02/14/25 with an altered mental status (noticeable change in a person’s level of awareness, cognition, or consciousness compared to their normal baseline) and medication nonadherence (failure to take medications as prescribed by their healthcare provider). Patient #1 was currently connected with Strong Ties ACT for outpatient mental health care. Staff (K) observed Patient #1 sitting in a chair exhibiting behavioral control but refusing to answer why they were back in the hospital. Staff (K) re-enforced that Patient #1 should not disrobe in the public setting and informed Patient #1 that they would again be discharged to go to the homeless shelter. Patient stated “no, no, no” and then covered their head with a blanket. Patient #1 presented with no evidence of mania, psychosis, intoxication or withdrawal symptoms. Staff (K) indicated Patient #1’s presentation was most consistent with ineffective individual coping in the context of poor distress tolerance, housing insecurity, limited coping skills and is not consistent with the signs, symptoms, or timeline of a major mood or thought disorder that would benefit from or require an inpatient admission. Patient #1 would benefit from a less restrictive setting. Staff (K) had a secure chat conversation with Strong Ties ACT Nurse Practitioner, who had no new information and advised that Patient #1 return to the homeless shelter. Patient #1 had an appointment with Strong Ties on 05/06/25 (five days later). No additional mental health services are required because Patient #1 is enrolled in appropriate treatment. Plan for Patient #1 was to refrain from taking clothes off in public settings and return to shelter via bus pass. - At 04:24 PM, a discharge note by Staff (BB), Registered Nurse, revealed Staff (BB) and Staff (K), CPEP Nurse Practitioner, observed Patient #1 who was sitting calmly in a reclining chair, appropriately covered with shirt and paper scrub bottoms. As Staff (BB) and Staff (K) approached, Patient #1 immediately started pulling up their shirt, rambled incoherently, rubbing their eyeball with their bare fingers and then put their fingers in their mouth. Staff (K) completed their evaluation and informed Patient #1 that they would again be discharged. Patient #1 then stated “no, no, no”, then sat back in the chair and crossed their arms. DPS officers assisted with placing Patient #1 in a wheelchair and moving them to the front of the hospital. Patient #1 continued to attempt to touch themselves inappropriately in the presence of DPS officers. Patient #1 was provided bus passes and after visit summary. Review of the medical record at Hospital #1 for Patient #1, dated 05/01/25 (3rd presentation), revealed the following: - At 05:35 PM, the 9.41 Mental Health Transport (MHT) document by Staff (DD), DPS Officer, revealed Staff (DD) arrived to find Patient #1 naked on the street yelling at cars. Patient #1 was on the sidewalk naked, crying., could not answer any questions, and refused all directions. Staff (DD) and other DPS officers attempted to assist Patient #1 with getting their clothes on, but Patient #1 refused. Eventually Patient #1 was wrapped in a blanket. Patient #1 stated that they wanted to die and was not making sense. Patient #1 stated that they needed to go find their sibling, pointing and walking towards a nearby cemetery. Patient #1 was at a high traffic intersection at a very busy time of day. Based on Patient #1’s behavior, inability to follow instructions or answer questions, and putting themselves in a dangerous situation, Patient #1 was placed under a 9.41 MHT status and taken back to Hospital #1’s ED via wheelchair. - At 05:51 PM, the ED triage note by Staff (EE), Registered Nurse indicated Patient #1 was brought in by DPS on a MHT after being found naked at the bus stop. Patient #1 was seen wandering around, speaking incoherently. Patient #1 was discharged less than an hour ago. Patient #1 was seen by ED physician in triage. Unable to obtain vital signs. - At 05:46 PM, a note by Staff (J), ED Attending Physician, revealed Patient #1 presented in the company of DPS officers after being found naked at the bus stop. Patient #1 continued to speak incoherently and talk over Staff (J). Patient #1 was not cooperative and would not follow commands. There was no evidence of trauma and Patient #1 appeared at their well-known baseline. The physical exam revealed Patient #1 appeared non-toxic (suggests the individual appears generally healthy and stable), was alert, speaking incoherently, and unable to assess for orientation. Patient #1 remained uncooperative, continued to attempt to reach down their pants and expose themselves. Patient #1 is homeless and has frequent ED presentations after stripping naked outside of the hospital. Staff (J) had seen Patient #1 within the past couple of hours when discharged from CPEP. The CPEP team felt that Patient #1 was malingering (the intentional fabrication or exaggeration of physical or psychological symptoms for an external gain) and displaying personality disorder not indicative of acute psychiatric decompensation and not likely benefit from further hospitalization. Patient #1 otherwise appeared at their baseline and would be discharged back to the community. - At 06:16 PM, Patient #1 was dismissed from the ED. There was no departure condition, after-visit summary, collateral contact, or social work involvement documented in this medical record for this presentation. Review of the “Mental Health Transport 9.41” document, dated 05/01/25 at 07:45 PM, by Staff (V), DPS Officer, revealed Patient #1 was recently taken to Hospital #1 on a 9.41 MHT status, but was immediately discharged and was not evaluated. Patient #1 is well known to CPEP and per staff, at their baseline and was not having a psychiatric problem, but more of a behavioral problem. Patient #1 had been discharged without proper clothing, still wrapped in the blanket that DPS provided on the previous 9.41 MHT. Due to Patient #1 still being naked, rambling unintelligibly, and refusing to give officers and information, the PIC team (Person in Crisis- a unit that responds to individuals experiencing mental health crises or other social and community emergencies) was called. Patient #1 was evaluated by a PIC team member who reported Patient #1 needed a higher level of care then PIC could provide and that Hospital #1’s CPEP was refusing to provide care. The PIC team recommended Patient #1 be placed on a 9.41 MHT status and transported to a different hospital (Hospital #2). At 06:51 PM Staff (V) placed Patient #1 under 9.41 MHT status and Patient #1 was transported to Hospital #2. The care and custody of Patient #1 was turned over to the medical staff at Hospital #2. The order indicated Patient #1 was a danger to self/others were, they were unable to care for self, and they placed self in dangerous situation. Review of the medical record at Hospital #2 for Patient #1, from 05/01/25 to 05/02/25, revealed the following: - On 5/01/25 at 08:15 PM, a note by Staff (AAA), ED Attending Physician, revealed Patient #1 presented to the ED after being placed under a 9.41 MHT status three times that day (at Hospital #1). Patient #1 was walking naked, taken to Hospital #1 and were discharged by their CPEP. Hospital #1 DPS officers contacted the PIC team after Patient #1 had been discharged the final time by Hospital #1’s CPEP over the phone. Patient #1 was placed under a 9.41 MHT status and brought to this ED. Patient #1 was seen by psychiatry and case was discussed with Staff (BBB), Psychiatrist who recommended discharge of Patient #1 in the morning to Strong Ties ACT team or emergency housing. Likely these visits were related to Patient #1’s ongoing issues of developmental delay and personality disorder. Staff (BBB) stated there was no need for an acute psychiatric admission. There was no emergency housing available that night, so Patient #1 was moved to the crisis intervention unit (CIU). Upon arrival in the CIU, Patient #1 started wandering around spitting at security staff and exposing themselves. Patient #1 was placed in physical restraints and medicated for agitation. Unfortunately, Patient #1 continued to yell, wander, exposing themselves and spitting on security staff when they were released from physical restraints. Patient #1 was placed back in restraints and care was transferred to the oncoming ED provider. - On 05/02/25 at 07:29 AM, a note by Staff (CCC), ED Attending Physician, revealed they had a detailed discussion with Patient #1 about there being no clinical indication for further emergent intervention or inpatient treatment. Verbal and written discharge instructions were provided. Patient #1 was encouraged to return for any worsening symptoms, persisting symptoms, or any other concerns. Patient #1 was provided the opportunity to ask question and was then discharged directly to the Strong Ties ACT center team. Interview on 06/05/25 at 02:45 PM with Staff (V), DPS Peace Officer, revealed they were made aware Patient #1 initially presented to the ED on 05/01/25 (1st presentation) by local law enforcement after being released from jail. Patient #1 was discharged from Hospital #1’s ED with a bus pass and went to a bus shelter. Patient #1 was brought to Hospital #1 again after disrobing and yelling at traffic (3rd presentation). Staff (V) was instrumental in finding clothing for Patient #1 obtaining pants, shirt, and shoes, and assisting with dressing. Patient #1 arrived at 05:47 PM (3rd presentation), was evaluated by the ED provider and the registered nurse. The ED provider told Staff (V) Patient #1’s behavior was at baseline (normal). The ED RN called the CPEP, and was told CPEP would not accept Patient #1. Social work was contacted but had further options, and Patient #1 was discharged. Staff (V) spoke with their DPS Sergeant, who confirmed Patient #1 was banned from multiple shelters and had no other resources available. At 06:02 PM, Staff (V) assisted Patient #1 into their police vehicle outside the hospital entrance and called the PIC team for guidance. The PIC team informed Staff (V) that Patient #1 was banned from all shelters and there were no other options available. The PIC team recommended Patient #1 be placed under MHT status and taken to another facility (Hospital #2) as it appeared Patient #1 required a higher level of care that Hospital #1’s CPEP is refusing to provide. Staff (V) drove approximately one block away to be off Hospital #1’s property and placed Patient #1 under a 9.41 MHT status to transport them to Hospital #2. Telephone interview on 06/10/25 02:45 PM with Staff (DD), DPS Officer, revealed on 05/01/25. Staff (DD) received a call around 05:30 PM to respond to a person unclothed, walking, screaming, and crying on the sidewalk not far from Hospital #1. Staff (DD) received assistance from Staff (V), DPS Officer, who spoke Spanish. DPS Officers attempted to de-escalate Patient #1 and calm them down. Patient #1 was not directable and was speaking words that did not make sense in both languages. Patient #1 was put unclothed in the back of the car as the intersection was exceptionally busy at the time. Staff (DD) called the hospital to bring blankets to cover Patient #1 who had exited the back of the car. Patient #1 would not get back in the car and was unable to respond to questions. Patient #1 was placed under a 9.41 MHT status. Patient #1 was covered with a blanket and escorted back to the hospital in a wheelchair. Staff (DD) drove near the facility so they could type up the 9.41 MHT documentation and print it. Before the paperwork was printed, Staff (DD) observed Patient #1 outside, already discharged. Patient #1 was outside the ED entrance of Hospital #1 with additional DPS Officers. One of the additional DPS officers went back to the ED to speak with the social worker. DPS Officers on site were advised that Patient #1 had exhausted community resources, and no housing options were available. The PIC team was contacted by a DPS Officer and promptly arrived. PIC team members spent approximately 30 minutes trying to communicate with Patient #1 with little success. The PIC team advised the DPS Officers that Patient #1 had exhausted community housing resources and was banned from all shelters or emergency housing. The PIC team recommended Patient #1 be placed under a 9.41 MHT status and transported to another hospital (Hospital #2) for treatment. Staff (DD) was aware Patient #1 was already seen earlier in the day for the same reasons, was medically cleared, and discharged (at Hospital #1). Staff (DD) was concerned for Patient #1 ’ s safety, as traffic was very busy in the area, and concerned that Patient #1 would wander into traffic. Also, because Patient #1 was only wrapped in a blanket. Staff (DD) was familiar with Patient #1 but in the past, but Patient #1 had been re-directable. On this day they were not directable and appeared to not be at their baseline behavior. If Patient #1 had a place to go after discharge they would have driven them there to ensure safety. Staff (DD) stated Patient #1 has a community care plan that began after this day, and they have not seen Patient #1 since then. Interview on 06/11/25 at 02:45 PM with Staff (ZZ), DPS Sergeant, revealed the initial call came in to assist Patient #1 who was standing in a busy traffic area bordering Hospital #1’s property, at little after 05:00 PM. Patient #1 was not wearing clothing and had no property or paperwork. Staff (ZZ) was familiar Patient #1. Patient #1 was directed to put their clothing on. Patient #1 replied in a combination of English and Spanish language that sounded like “gibberish.” Patient #1 was in a busy intersection area, was disrupting traffic with their behavior, wearing no clothing. DPS covered Patient #1 with blankets. DPS officers attempted to direct Patient #1 out of the immediate area of traffic. Staff (ZZ) was aware of a previous 9.41 MHT transportation that day initiated by the local law enforcement, when Patient #1 was physically removed without clothing from a public bus (2nd presentation). Patient #1 was brought back to the hospital by the other DPS officers. When Staff (ZZ) arrived back to Hospital #1, Patient #1 was immediately discharged again. A different DPS officer went into Hospital #1 asking for clothing and the PIC team was called for assistance. Three PIC team members showed up to help and stated there were no community resources available for housing. The PIC team explained the Patient #1 was still in need of assistance, so the PIC team supervisor was called. The PIC team and DPS officers agreed to send Patient #1 to a different hospital (Hospital #2).. Staff (ZZ) did not think it was safe for Patient #1 to be discharged to the community as they were not directable, they continued to disrobe, continued to yell at cars driving by, it was raining, and traffic near the bus stop was extremely busy at this time of day. An ambulance was called for transportation. After waiting approximately 30 minutes Staff (ZZ) made the decision to allow a DPS officer to transport Patient #1 to Hospital #2 in their patrol car. Interview on 06/05/25 at 03:00 PM with Staff (J), ED Attending Physician, revealed Patient #1 arrived at the ED multiple times on 05/01/25. Patient #1 went to CPEP once, and the second time the psychiatric provider came to the ED to evaluate Patient #1 prior to discharge. When Patient #1 arrived at the ED a third time for public exposure, they presented in a similar manner. Staff (J) evaluated Patient #1 and found no acute changes or further emergent complaints from previous discharge. Patient #1 was discharged without a call to CPEP and has the discretion to use their clinical judgement to determine if CPEP needs to be consulted. Interview on 06/05/25 at 04:00 PM with Staff (K), Nurse Practitioner, revealed they recall seeing Patient #1 in the medical ED during the 2nd presentation on 05/01/25. Patient #1 speaks Spanish and can speak English, but it can be unclear jumping from thought to thought and sounding like gibberish. Staff (K) has not seen Patient #1 disrobe or become violent although this is noted in the medical record as common behaviors. Staff (K) stated with multiple admissions on the same day, and Patient #1 already seen in the CPEP, it would be typical for Patient #1 to be seen in the medical ED instead of bringing them to CPEP. Patient assessments include determining safety, to clear them for discharge, to assist with collateral knowledge, to provide bus passes, and to see if further admission to the CPEP is required. Patient #1 was at their baseline behavior when seen on 05/01/25 during the 2nd presentation to the facility and did not meet admission criteria. Patient #1 was directable. Staff (K) does not think Patient #1 disrobing in public is a danger to herself or others. Patient #1 was given the proper resources and instructions to follow up with Strong Ties assertive community treatment service (ACTS) team (on 05/06/25) which was appropriate. Interview on 06/06/25 at 12:35 PM, with Staff (Z), Senior Clinical Evaluator, revealed Patient #1 was well known. Staff (Z) did not think the discharge of a naked patient obstructing traffic was necessarily safe, but the behavior did not warrant a psychiatric admission. Telephone/video interview on 06/06/25 at 09:00 AM with Staff (W), Primary Therapist, revealed they work as part of Strong Ties Assertive Community Treatment (ACT) Team, which is a county wide program that is the highest level of outpatient care an individual can receive prior to being admitted for inpatient care. The ACTS team will assist by bringing patients to appointments, scheduling appointments, providing injections, delivering oral medications, and helping to arrange shelter. ACT is a transitional service for clients with or without housing and who frequent emergency room for basic physical or mental health needs. When services are required, CPEP is required to contact the team. The ACT team has on-call availability 24 hours a day, seven days per week. Patient #1 has been a member of their team for several years. Staff (W) was initially contacted around 10:00 PM on 05/01/25 by the facility Patient #1 had presented multiple times. After the 3rd presentation to Hospital #1, Patient #1 was brought to another hospital (Hospital #2). Hospital #2 notified Staff (W) that Patient #1 had presented under 9.41 MHT status. Hospital #2 was concerned as to why Patient #1 was brought to their hospital versus being brought back to Hospital #1, who has a higher-level care and more appropriate psychiatric program. Staff (W) informed Hospital #2 staff that Patient #1 has housing insecurity, and it was common for them to have dysregulated behavior when the discharge planning process is initiated. In addition, Patient #1 was banned from all local shelters except one on 05/01/25 and is now banned from all local shelters. Patient #1 can be selectively opportunistic to have their needs met, including premeditated violent attacks, therefore, Patient #1 is a risk to harm others or themselves. Patient #1 could also have negative behavior if they are admitted for secondary gain, to get their needs met. This reinforces the negative behavior that worked in their favor, and they will continue to express similar negative behaviors for secondary gain. Patient #1 does not fit the lower level of psychiatric care offered at Hospital #2. Interview on 06/10/25 at 07:00 AM with Staff (CC), CPEP Registered Nurse, revealed they triaged Patient #1 in the CPEP on 05/01/25 (1st presentation to the hospital) who was requesting medication for their spouse and was upset when the CPEP would not provide it. Patient #1 proceeded to lower their pants and use the restroom on the floor. Patient #1 was instructed to pull up their pants, however they continued to repeat the same behavior. Patient #1 is known to be violent and instigate fights with other patients when agitated, resulting in restraints to be used. Patient #1 is known to disrobe as part of trying to get what they want. Staff (CC) stated they are unsure if the Strong Ties ACT team was contacted. Staff (CC) stated they were unaware of Patient #1 disrobing in public. When Patient #1 was discharged, Staff (CC) walked them down to the exit with DPS. Patient #1 was wearing paper scrubs upon discharge. Staff (CC) stated public indecency and disrobing is not appropriate, but they do not think it is unsafe. Patient #1 was aware to keep their clothing on in public. It is common for certain patients to arrive to the ED and CPEP multiple times per day. When a patient arrives under 9.41 MHT status, they must be evaluated by the CPEP. Interview on 06/11/25 at 09:30 AM with Staff (AA), CPEP Nurse Practitioner, revealed Patient #1 was known to the service and Patient #1 arrived to the CPEP on 05/01/25 at their baseline behavior and dysregulated. Psychiatric technicians assisted Patient #1 to dress however, they do not recall seeing Patient #1 disrobe in CPEP and had not previously seen Patient #1 exhibiting these behaviors. A patient who receives Strong Ties ACT team will always have personal and professional collateral (obtaining additional information regarding an individual from outside sources- friends, relatives, outpatient case manages or providers) called upon presentation to CPEP. Staff (AA) did not remember speaking with a member of the Strong Ties ACT team during this admission and were unsure what their treatment plan recommendation was. Patient #1 appeared at their baseline behavior and did not meet admission criteria. Telephone interview on 06/11/25 at 10:00 AM with Staff (EE), ED Registered Nurse, revealed Patient #1 is very well known to the service and arrived at the ED (3rd presentation) on 05/01/25 approximately 10 minutes after the previous discharge, covered in blankets provided by DPS after being found disrobed at the bus stop not far from the property. Staff (EE) stated they thought they called CPEP who advised them Patient #1 was seen within the last hour and could be discharged. The ED provider assessed Patient #1 and advised them they would be discharged as they were seen within the last hour. Interview on 06/11/25 at 12:50 PM with Staff (BB), CPEP Registered Nurse, revealed Patient #1 is known to the service and on 05/01/25, Patient #1 presented to the ED. Patient #1 was deemed to have behavioral concerns and was inappropriate for psychiatric admission, therefore was discharged to the community clothed in paper scrubs with a plan to go to the single homeless shelter. Patient #1 presented with typical baseline behavior, although Staff (BB) had never seen them disrobe before. Staff (BB) assisted with discharging Patient #1. When Staff (BB) observed Patient #1 start to disrobe, they instructed Patient #1 to put their clothes back on, as there are minors in the community.”

“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: 42611 Based on policy review, document review, medical record review, and interview, the facility failed to comply with the Emergency Medical Treatment and Active Labor Act (EMTALA). This failure potentially placed all patients at increased risk for adverse outcomes. Findings #1 include: Document review from 12/12/23 to 12/14/23 at Strong Memorial Hospital West Brockport revealed no evidence of a policy that encompasses all the Emergency Medical Treatment and Active Labor Act (EMTALA) requirements and regulations. Specifically, there is no policy related to the following EMTALA requirements: -The transfer utilizes qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. -If a physician is not physically present in the emergency department at the time of a patient transfer, the physician assistant can sign the transfer certification after consultation with a physician who agrees with the certification and subsequently co-signs the certification. -The patient or patient representative requests (consent to) the transfer, after being informed of the hospital’s obligations and of the risk of transfer. The request must be in writing. Interview on 12/14/23 at 02:21 PM with Staff (B), Assistant Director of Nursing, Quality and Patient Safety Outcomes at Strong Memorial Hospital West Brockport emergency department confirmed the facility does not have an Emergency Medical Treatment and Active Labor Act (EMTALA) policy. Additional Findings Include: The hospital failed to ensure that all requirements of an appropriate transfer to another medical facility were met. Specially, Strong Memorial Hospital West Brockport emergency department staff failed document that patients were stable to transfer by personal vehicle for two of four patients (Patient #1 and #10); no evidence was found to indicate the attending physician was consulted and agreed with the physician assistant for the transfer for three of seven patients (Patient #1, #10, and #19). The attending physician also did not co-sign the Acute Patient Transfer Certification; staff did not obtain consent from the patient/patient representative for the transfer to another hospital for 2 of 18 patients (Patients #7, and #8); and staff failed to provide specific risks of transfer based on the medical condition of five of five patients (Patient #1, #7, #8, #10 and #19) (A2409). Cross Reference: 489.24 (e) (1)-(2) Appropriate Transfer”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 42611 Based on policy review, medical record review, document review, and interview, the facility failed to ensure that all requirements of an appropriate transfer to another medical facility were met. Specifically, Strong Memorial Hospital West Brockport - Emergency department staff failed to document that patients were stable to transfer by personal vehicle for two of four patients (Patient #1 and #10) to a higher level of care at another hospital. Instead, personal vehicles were used for the transfers. - There was no evidence to indicate that the attending physician was consulted and agreed with and co-signed the “Acute Patient Transfer Certification” of the Strong Memorial Hospital West Brockport physician assistant for the transfer of three of seven patients (Patient # 1, #10, and #19). -Emergency department staff did not obtain patient/patient representative consent to transfer to another hospital for 2 of 18 patients (Patients #7, and #8). -Emergency department staff failed to provide specific risks of transfer based on the patient’s medical condition for five of five patients. (Patient #1, #7, #8, #10, and # 19). This is evidenced by: Review of the Strong Memorial Hospital West Brockport policy “Patient Transfer Process,” last revised 12/14/21, and “Transfer to Higher Level of Care for Strong West and Urgent Care” last revised 11/13/23, indicated a patient may drive themselves or be driven via private vehicle according to provider discretion. The patient must be accepted by a receiving provider and the same transfer process should be followed. If the provider feels the patient is not stable enough to transfer via private vehicle or if the patient refuses transfer to a higher level of care, the provider may have the patient sign out against medical advice. The facility does not have an Emergency Medical Treatment and Active Labor Act (EMTALA) policy. Review of the “Bylaws of the Medical Staff Strong Memorial Hospital of the University of Rochester,” last revised 04/06/22, indicated that “dependent allied health professional staff (physician assistants) are not members of the medical staff and may only practice under the supervision of an attending medical staff member per law/regulation or by hospital/department policy in which the supervising physician is credentialed.” Review of the “Acute Patient Transfer” form revealed that staff are to complete all sections of the form. The “Transfer Arrangements” section lists the receiving hospital and name of accepting physician and check off boxes to indicate the receiving hospital has available space, qualified staff, and has agreed to accept the patient. The section has a check off box to indicate the patient has been assessed and will be transferred by qualified personnel and transportation equipment including the use of necessary and medically appropriate life support measure to manage expected risks until the patient is received by the accepting facility. (The form does not document the required mode of transportation (personal car, ambulance) and/or an appropriate level of personnel and equipment (BLS/basic life support, ACLS/advanced cardiac life support) needed to accompany the patient during transfer). The “Transferring Provider’s Certification” section has a line for the provider who executed the transfer to sign and date certifying the information listed on the form. (The form does not require co-signature by the attending physician when a physician assistant facilitated the transfer). The “Consent to Transfer” section has check off boxes to indicate if the patient and/or the legally responsible person on behalf of the patient requests, consents to, or refuses transfer, and has been informed of the benefits and risks involved in transfer. There is a line for the patient and a line for the legally responsible person to sign. “The Benefits and Risks of Transfer (Complete A & B)” section lists “expected benefits of transfer include and risks of transfer include: (check one) no significant risk, or worsening of existing condition, please detail. 1. Review of the Strong Memorial Hospital West Brockport emergency department medical record for Patient #1, dated 11/25/23, revealed at 09:46 AM, Patient #1 arrived at the emergency department via car with the complaint of a cough, shortness of breath, chest tightness, and mild dizziness/lightheadedness. At 10:20 AM, Patient #1’s blood pressure was 198/88 (normal blood pressure is less than 120/80). At 10:20 AM Staff (U), Physician Assistant assessment indicated “will obtain labs as well as imaging, including ultrasound of the right lower extremity, chest x-ray, and reassess.” The chest x-ray results indicated mild pulmonary edema (fluid buildup in the lungs), an ultrasound indicated there was a blood clot in the right leg and the electrocardiogram indicated left atrial enlargement (one chamber of the heart gets bigger than normal), an incomplete left bundle branch block (a partial block of the electrical impulses of the heart), left ventricular hypertrophy with secondary repolarization abnormality (condition where the hearts main pumping chamber thickens and can cause abnormalities on an electrocardiogram), and an anterior ST elevation (an elevation can be caused by a blockage in one of the hearts main blood vessels.) Lab results indicated the following: -red blood cell count of 3.6 million per microliter (measures the number of red blood cells in your body, normal is 4.35 to 5.65 million per microliter of blood for men) -hemoglobin of 10.3 grams per deciliter (a protein inside red blood cells that carry oxygen; normal is 13.5 - 17.5 grams per deciliter for men) -hematocrit of 32% (the amount of whole blood that is made up of red blood cells; normal is 40-50% for men) -glucose of 137 (sugar in your blood; a normal non-fasting glucose is under 125) -sodium of 147 (a type of electrolyte/mineral in blood; normal is 135 - 145) -potassium of 3.2 (a mineral in your blood that helps with heart function; normal is 3.7 - 5.2 milliequivalents per liter) -chloride of 109 (an electrolyte that reflects your bodies fluid balance; normal is 96 - 106 milliequivalents per liter) -blood urea nitrogen of 37 (BUN, measures the amount of urea nitrogen - a waste product removed by the kidneys; normal is 6 - 24 milligrams per deciliter) -creatinine of 2.72 (measurement of how well your kidneys are filtering waste; normal is 0.7 - 1.3 milligrams per deciliter for men) -B-type natriuretic peptide (BNP) of 5,845 (measurement of a protein made when your heart has to work harder to pump; higher levels of b-type natriuretic peptide can be a sign of heart failure; normal is less than 100 picograms per milliliter) -initial high sensitive troponin was 85 (the first of a series of blood draws that detect a protein in the blood released when the heart muscle has been damaged; normal is below 14 nanograms per liter) -one-hour high sensitivity troponin was 84 (a blood test drawn one hour after the first blood draw that detects a protein in the blood released when the heart muscle has been damaged; normal is belove 14 nanograms per liter) -three-hour high sensitivity troponin was 80 (a blood test drawn three hours after the first blood draw that detects a protein in the blood released when the heart muscle has been damaged; normal is belove 14 nanograms per liter). At 03:05 PM, Staff (U) placed an order for Lasix (diuretic) 40 milligrams to be administered. At 03:07 PM, Staff (O), Registered Nurse documented Patient #1 will transfer to a receiving hospital via private car with their spouse. At 03:12 PM, Patient #1’s blood pressure was 192/87. At 03:16 PM, Staff (U), Physician Assistant ordered the saline trap can remain in place during transfer. At 03:19 PM, Lasix 40 mg was administered per Staff (U) Physician Assistant order. At 03:39 PM, Patient #1 was discharged via personal car to another hospital. At 04:50 PM, Staff (U) Physician Assistant documented they called the transfer center, Patient #1 will go to another hospital (higher level of care) for cardiac consult, echocardiogram, and admission, “Patient #1 is amenable to this and was transferred.” Review of the “Acute Patient Transfer” form for Patient #1, dated 11/25/23, was incomplete and did not address Patient #1’s medical condition, transfer arrangements, or risks of transfer specific to Patient #1’s medical condition. The section for Consent to Transfer was not signed by Patient #1 or Patient #1’s representative. The document was signed by Staff (U), Physician Assistant, however, there was no documentation found which indicated that Staff (U) consulted with the physician or that the physician agreed with the transfer. Interview on 12/14/23 at 01:30 PM with Staff (U), Physician Assistant revealed a patient leaving by car would get instruction on where to go. Sometimes the physician assistant will sign the transfer form without the physician co-signature. Staff (U) will document if the patient is stable to transfer by car. The patient must consent to driving themselves by car for transfer. Staff (U) would not exclude a patient from being transferred by car that had high blood pressure, a deep vein thrombosis (blood clot), and was given Lasix within 30 minutes of discharge. It depends on the total condition of the patient. Staff (U) revealed they consult with the attending physician on a case-by-case basis. If the physician is consulted, the physician will cosign the physician assistant note. Sometimes the physician assistant will sign the transfer form without the physician co-signature. Staff (U) would document if they spoke to the physician about a transfer, and if the physician saw the patient. If the attending physician did not see the patient, Staff (U) would not document it. 2. Review of the Strong Memorial Hospital West Brockport emergency department medical record for Patient #7 revealed on 11/19/23 at 04:07 PM, Patient #7 presented to the emergency department for severe abdominal pain with nausea. A workup including bloodwork and a CT scan were ordered and obtained. At 04:07 PM, the resident indicated Patient #7’s presentation is concerning for hepatitis with continued unrelieved pain. At 10:48 PM, nursing documented that Patient #7 departed via private car to another medical facility. Review of the “Acute Patient Transfer” form, dated 11/19/23, did not address risks of transfer specific to Patient #7’s medical condition and was “checked off” to indicate Patient #7 consented to the transfer, however, the patient/responsible person signature sections were blank. (No evidence was found in the medical record to indicate Patient #7/patient representative consented to transfer to another medical facility and/or to be transferred via personal car.) 3. Review of the Strong Memorial Hospital West Brockport emergency department medical record for Patient # 8 revealed on 09/28/23 at 07:39 PM, Patient #8 presented to the emergency department for ear pain with drainage. Physician orders were placed for a CT scan to evaluate for signs of mastoiditis (a bacterial infection and inflammation of the mastoid bone, located behind the ear), antibiotics, and pain medication. On 09/29/23 at 08:20 AM, nursing documented that Patient #8 was transferred to another medical facility via ambulance. Review of the “Acute Patient Transfer” form, dated 09/28/23, did not provide detailed explanation of the risks of transfer specific to Patient #8’s medical condition and the section indicating Patient #8 consents to or refuses transfer was not checked off and the patient/patient representative signature sections were blank. (No evidence was found in the medical record to indicate Patient #8/patient representative was informed of the risks of transfer based on medical condition and consented to transfer to another medical facility via ambulance.) 4. Review of the Strong Memorial Hospital West Brockport emergency department medical record for Patient #10, dated 09/08/23, revealed at 10:10AM, Patient #10 arrived ambulatory at the emergency department and was seen by Staff (LLL), Physician Assistant for the complaint of right-side neck pain and worsening bilateral extremity (hands/arm or feet/legs) numbness/tingling for three weeks with the right leg was “giving out.” The CT scan (scan that uses x-ray and computer processing to create cross sectional images) showed severe degenerative (medical condition that causes a part of the body to become weaker or have less function) changes with canal stenosis (narrowing of the spine). The case was discussed with another hospital’s transfer center, neurosurgery staff, and the emergency department team who accepted Patient #10 for transfer for a spine consult and possible MRI (use magnetic fields and radio waves to generate images) imaging. Patient #10 will transfer by personal vehicle. The spouse was aware to drive Patient #10 directly to the other hospital emergency department without stopping. At 02:20 PM, Patient #10 was discharged via personal car to another hospital. Review of the “Acute Patient Transfer” form for Patient #10, dated 09/08/23, did not address Patient #10’s medical condition, transfer arrangements, or risks of transfer specific to Patient #10’s medical condition. The document was signed by Staff (LLL), Physician Assistant, however, there was no documentation found which indicated that Staff (LLL) consulted with the physician or that the physician agreed with the transfer. 5. Review of the Strong Memorial Hospital West Brockport emergency department medical record for Patient #19, dated 10/01/23 revealed at 12:57 PM, Patient #19 arrived with their spouse and daughter and was seen by Staff (MMM), Physician Assistant for concerns for safety at home due to a progressive cognitive decline with a concern for dementia. A plan was made by Staff (MMM), to facilitate transfer to another hospital for physical and occupational therapies and evaluation for a higher level of care due to a decline at home. Review of the “Acute Patient Transfer” form for Patient #19, dated 10/01/23, revealed the section for risks of transfer were filled out as “no significant risk” and was not specific to Patient #10’s medical condition. The document was signed by Staff (MMM), Physician Assistant, however, there was no documentation found which indicated that Staff (MMM) consulted with the physician or that the physician agreed with the transfer. Interview on 12/15/23 at 09:25AM and 02:30 PM with Staff (M), Assistant Quality Officer verified emergency department staff failed to document that Patients #1 and Patient #10 were stable to transfer by personal vehicle to a higher level of care at another hospital. Instead, personal vehicles were used for the transfers. Staff (M) also verified emergency department staff did not obtain Patients #7 and #8 consent to transfer to another hospital. Interview on 12/15/23 at 08:30 PM with Staff (L), Associate Quality Officer, verified that the physician assistant did not consult with the physician prior to a patient transfer, and the physician did not countersign the “Acute Patient Transfer” form to indicate agreement with the transfer order for Patients #1, #10, and #19. Staff (L) verified that Strong Memorial Hospital West Brockport does not have a policy that requires the Physician Assistant to consult with a physician prior to a patient transfer, and/or requires a physician to countersign the “Acute Patient Transfer” form to indicate agreement with the physician assistant transfer order.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 48506 Based on policy review, medical record review, document review, and interview, the hospital failed to ensure the Quality Assurance and Performance Improvement Program involved all departments/services and focused on indicators to improve health outcomes and prevent/reduce medical errors as evidenced by: the Quality Assurance and Performance Improvement Program does not monitor the effectiveness, safety, and quality of care related to the virtual (remote) patient safety monitoring observation program (A0273). The Quality Assurance and Performance Improvement Program failed to identify, analyze, and track adverse events for Patient #2 related to the dislodgement of the gastric feeding tube three out of four times and tracheostomy three out of three times (A0286). Cross Reference: 482.21(a), (b)(1), (b)(2)(i), (b)(3)- Data Collection & Analysis 482.21(a), (c)(2), (e)(3)- Patient Safety”

“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: 48506 Based on policy review, medical record review, document review, and interview, in one of one medical record reviewed, it was determined that the facility failed to ensure that all patients receive care in a safe setting for one patient (Patient #2), as evident by: 1. Nursing staff failed to implement a physician order for a bedside sitter (in-person, constant observation) for Patient #2, but instead implemented a virtual (remote) patient safety monitoring observation sitter. Patient #2 was able to dislodge their tracheostomy tube (breathing tube in neck) three times in four months (11/23/23, 12/17/23, and 01/02/24) and their gastric feeding tube (used for nutrition) four times in two months (11/08/23, 11/15/23, 12/11/23, and 12/31/23). Failure to implement physician orders and appropriate safety interventions resulted in additional surgical procedures to replace the tracheostomy and gastric tube. 2. Nursing staff were unable to review documentation of hourly observations by the virtual (remote) patient safety monitoring observation sitter in the medical record for Patient #2. Failure to have access to all patient information prohibits a full assessment of a patient’s condition/needs by the nursing staff and has the potential for an adverse patient event. 3.On 12/17/23, the virtual (remote) patient safety monitoring observation sitter failed to notify in-person nursing staff of Patient #2 dislodging their tracheostomy. This failure of notification has the potential for a delay in care and/or a patient adverse event. Findings #1: Review of the policy “Virtual Patient Safety Observation Procedure”, last revised 07/20/22, revealed all 1:1 (in-person, constant observation) sitter requests (physician orders) made by a provider must be clarified with the provider if the registered nurse believes the patient is suitable for virtual (remote) patient safety monitoring observer monitoring. The registered nurse should document the conversation with the provider in the medical record and request that the provider order be discontinued. Review of the medical record from 10/08/23 to 01/09/24 revealed nursing staff failed to execute physician order for a bedside (in-person) sitter and failed to implement additional and/or changes to safety interventions after the multiple dislodgments of the tracheostomy tube (breathing tube) and gastric tube (feeding tube), to prevent further adverse events as evidenced by the following: -On 10/08/23 at 02:23 PM, Patient #2 was admitted to the medical intensive care unit for accidental drug overdose, respiratory failure, electrolyte abnormalities, underlying infection, and aspiration. -From 10/08/23 to 01/09/24, nursing staff assessed Patient #2 for safe environment and implemented fall precautions. -From 10/08/23 to 01/09/24, nursing staff documented that Patient #2 was impulsive, had poor judgement, had poor safety awareness, and had poor attention/concentration with intermittent agitation including trying to get out of bed and pulling at lines. -On 10/20/23 at 11:33 AM, a tracheostomy tube (tube placed in small opening in neck to assist breathing) was inserted. On 11/07/23, a gastric feeding tube (tube inserted in the stomach for nutrition) was placed. -From to 11/07/23 to 11/08/23 and 11/10/23 to 01/09/24, an abdominal binder was applied to prevent gastric tube dislodgement. -On 11/08/23 at 08:12 AM, Staff (UUU), Critical Care Physician, documented that Patient #2 pulled out their gastric feeding tube the previous night due to agitation. A foley catheter was placed in the gastric tube tract to keep the tract from closing. At 10:51 AM, the gastric tube was replaced by interventional radiology (procedure using x-ray guidance). -On 11/15/23 at 09:57 PM, Staff (SSS), Licensed Practical Nurse, documented that Patient #2 pulled out their gastric feeding tube. The provider was notified. -On 11/16/23 at 02:00 PM, interventional radiology (procedure using x-ray guidance) procedure to replace the gastric tube was attempted and not successful. At 08:58 PM, the gastric tube was replaced in the operating room via a laparoscopic gastrostomy tube (a surgeon makes two small incisions in the abdomen, one for the gastric tube and one for a camera, allowing the surgeon to see the stomach and other organs) placement. -From 11/16/23 to 11/18/23, and 11/20/23 to 12/11/23, the physician ordered bilateral soft wrist restraints due to Patient #2’s inability to fully comply with directions and for pulling at lines. -On 11/22/23 at 10:06 AM, Staff (HHH) Physician, ordered a bedside in-person, constant observation sitter. -From 11/22/23 to 01/09/24, nursing staff documented that a virtual (remote) patient safety monitoring observer was in place for continuous monitoring of Patient #2 (no evidence was found to indicate the use of virtual (remote) patient safety monitoring was discussed/approved by the physician and/or that a bedside, in-person sitter was utilized during the entire hospitalization). -On 11/23/23 at 01:36 PM, Staff (UU), Registered Nurse, documented Patient #2 received 50 milligrams of Benadryl (sedating medication to decrease agitation) at 10:00 AM with no effect. At 11:30 AM, while in the medical rehabilitation gym, Patient #2 pulled out their tracheostomy tube. -On 11/23/23 at 05:21 PM, the tracheostomy tube was initially replaced by the respiratory therapist but was not replaced into the proper position. Staff (VVV) Ear/Nose/Throat Physician placed a new tracheostomy tube via a flexible scope with a camera to verify placement. -On 12/11/23 at 07:57 PM, Staff (TTT) Registered Nurse, documented Patient #2’s gastric feeding tube was found to be dislodged from their abdomen. Patient #2 had both mitts and bilateral soft wrist restraints on. The trauma surgery provider attempted to replace the gastric feeding tube three times without success. A foley catheter was inserted by the provider into gastric tube tract and was secured with tape and an abdominal binder. -On 12/11/23 at 09:21 PM, Staff (VV) Physician replaced the gastric tube at the bedside. -From 12/12/23 to 12/17/23, the physician ordered bilateral soft wrist and soft ankle restraints due to Patient #2’s inability to fully comply with directions to maintain personal safety. -On 12/17/23 at 03:36 PM, Staff (W), Registered Nurse, documented Patient #2 pulled out the tracheostomy tube at 10:45 AM while in the medical rehabilitation unit. Patient #2 had on bilateral soft wrist and ankle restraints and was on the virtual (remote) patient safety monitoring. The respiratory therapist inserted a new tracheostomy tube without difficulty and the provider assessed Patient #2. -From 12/18/23 to 12/19/23, bilateral soft wrist and a left ankle restraints were ordered daily for Patient #2’s confusion/disorientation, inability to fully comply with directions, and for pulling at lines. -From 12/21/23 to 01/09/24, bilateral soft wrist restraints were ordered due to Patient #2’s inability to fully comply with directions and for pulling at lines. -On 12/31/23 at 07:05 PM, Staff (PPP) Registered Nurse, documented Patient #2 was found in bed with their legs hanging over the side rail. The gastric feeding tube was lying next to them with the balloon still inflated and extension tubing still connected. -On 12/31/23 at 06:03 PM, Staff (VV) Physician replated the gastric tube at the bedside. -On 01/02/24 at 02:38 PM, Staff (RRR) Registered Nurse documented Patient #2’s tracheostomy was dislodged while in the gym with physical therapy. At 03:58 PM, the tracheostomy tube was replaced by Staff (SS) Respiratory Therapist, at the bedside. -On 01/09/24, the provider discontinued the bedside in-person, constant observation sitter. Review of the staff assignment sheets dated 11/08/23, 11/23/23, 12/11/23, 12/17/23, 12/31/23, and 01/02/24 (dates Patient #2 pulled out their tracheostomy or gastric tube) revealed no evidence that Patient #2 had a bedside (in-person, constant observation) sitter assigned to their care. Interview on 05/21/24 at 01:52 PM with Staff (UU), Registered Nurse revealed Patient #2 had their feeding tube and tracheostomy tube dislodged multiple times. Patient #2 always had an abdominal binder on to help keep the feeding tube in place. Additional interventions implemented to prevent tube dislodgment were a virtual (remote) patient safety monitoring observer, mitts, restraints, and being placed close to the nurse’s station for faster interventions. Patient #2 had music therapy and other recreational therapies to help keep them calm. Staff (UU) felt Patient #2 warranted a bedside (in-person, constant observation) sitter, however a sitter is generally not available. Interview on 05/22/24 at 09:00 AM with Staff (VV), General Surgeon revealed they were called three times for dislodgement of Patient #2’s feeding tube. The third time, Staff (VV) inserted a red rubber catheter to keep the tract open until another feeding tube could be placed (replaced on 12/31/23). Staff (VV) does not recall if any adjunctive therapy was in place such as an abdominal binder. Any patient that has a feeding tube is at risk of dislodgment. Interview on 05/22/24 at 12:00 PM with Staff (W), Registered Nurse, revealed Patient #2 had a virtual (remote) patient safety monitoring observer the whole admission and did not recall ever seeing an in-person, constant sitter at the bedside. Patient #2 would have benefited from a bedside (in-person, constant observation) sitter, not just having someone watching (remotely) Patient #2 remove their tubes. Interview on 05/23/24 at 09:00 AM with Staff (BBB), Physician and Staff (DDD), Resident Physician revealed on 11/15/23 Staff (DDD) was notified of the dislodgement of Patient #2’s gastric tube. A foley catheter was inserted through the abdominal stoma to prevent the hole from closing until the gastric tube could be replaced (replaced on 12/31/23). Medications were changed. A bedside (in-person, constant observation) sitter would have been a reasonable request for Patient #2. Staffing is very challenging. Physicians must think about using restraints for patients due to bedside (in-person, constant observation) sitters not being available. On 12/31/23, Patient #2 removed their feeding tube. General surgery was notified, and the feeding tube was reinserted at the bedside. On 12/31/23, Patient #2 was in bilateral wrist restraints and an abdominal binder on prior to dislodging the gastric tube. Interview on 05/23/24 at 12:27 PM with Staff (HHH), Physician revealed on 12/11/23, Patient #2 pulled out their gastric feeding tube. A foley catheter was inserted into the stoma to keep it open. On 11/22/23, a bedside (in-person, constant observation) sitter was ordered to keep the Patient #2 safe and help to prevent additional tube dislodgements. Patient #2 was difficult to redirect and unable to follow commands due to decreased cognitive function. It was not possible to have a meaningful dialogue with Patient #2. The virtual (remote) patient safety monitoring observer was not ideal but was the best option available at the time. Interventions that were used to prevent tube dislodgements were an abdominal binder, redirection, insertion of a low-profile gastric tube, medications (for anxiety), restraints, and bolus (one time) feedings instead of continuous. Interview on 05/29/24 at 11:57 AM with Staff (B), Assistant Director of Nursing Quality Officer confirmed Patient #2 had a virtual (remote) patient safety monitoring observer, not a bedside (in-person) sitter, and that there is no documentation in the medical record of a conversation between the provider and nurse for the use of a virtual (remote) sitter instead of a bedside (in-person, constant observation) sitter. Interview on 05/29/24 at 06:30 PM with Staff (A) Associate Quality Officer, Staff (B) Assistant Director of Nursing, Staff (F) Assistant Quality Officer, verified these findings. Findings #2: Review of the policy “Virtual Patient Safety Observation Procedure”, last revised 07/20/22, revealed the registered nurse would assess patient safety and ongoing need for a virtual (remote) patient safety monitoring observation sitter and document every shift. (The virtual patient safety monitoring observation sitter documentation was not a part of the electronic medical record). Review of the medical record for Patient #2 from 11/22/23 to 01/09/24 revealed no evidence of virtual (remote) patient safety monitoring observation documentation or registered nurse shift assessments related to patient safety/ongoing need for the virtual (remote) patient safety monitoring observation sitter, in the medical record. Interview on 05/29/24 at 11:52 with Staff (V), Geriatric Psychiatric Specialist Manager, revealed the virtual (remote) patient safety monitoring observation sitter documents their observations on paper forms remotely, but the information is not included in the patient’s electronic medical record. Bedside caregivers and nursing staff cannot visualize any virtual (remote) patient safety monitoring observation sitter documentation. Findings #3: Review of the policy “Virtual Patient Safety Observation Procedure”, last revised 07/20/22, revealed the virtual (remote) patient safety observer will verbally interact with the patient to divert from potentially unsafe behaviors and/or activities using various diversional tactics, including the possible activation of an alarm at the bedside to inform all available staff to respond when a patient is thought to be in imminent danger. When necessary, the virtual (remote) patient safety observer will communicate observations and patient needs to the appropriate bedside care provider assigned to the patient. Review of the virtual (remote) patient safety monitoring observation form (not part of the medical record) for Patient #2, dated 12/17/23, revealed at 11:00 AM, Patient #2 was awake, in bed, and had visitors. The virtual (remote) patient safety monitoring observer documented that Patient #2 pulled their tracheostomy out and no other action was needed. (No evidence was found to indicate that the virtual (remote) patient safety monitoring observer contacted the hospital caregiver/nursing staff.) Interview on 05/29/24 at 11:37 AM with Staff (III), Virtual (remote) Patient Safety Monitoring Observation Sitter revealed on 12/17/23, Patient #2’s virtual sitter camera was in privacy mode when they heard Patient #2’s father calling for help. Staff (III) did not see Patient #2 dislodge their tracheostomy and could not recall notifying the hospital bedside caregiver/nursing staff that Patient #2 removed their tracheostomy.”

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 48506 Based on medical record review, policy review, interviews, and document review, the Quality Assurance and Performance Improvement Program did not monitor the effectiveness, safety of services, and quality of care provided by the virtual (remote) patient safety monitoring observation program. Findings include: Review of the policy “Quality Assessment and Performance Improvement Plan”, last revised on 03/29/23, revealed quality and safety in the organization is monitored by review of data for identified performance measures. Performance measures are chosen based on management plan goals; quality councils and quality improvement coordinating groups performance improvement plans and initiatives; requirements/recommendations; quality assessment and performance improvement plan; evidence-based practice and system level performance indicators, and the ability to track results against benchmarks. Each departmental quality program is responsible for providing the resources and oversight for quality assurance and performance improvement activities within their department, with oversight by the hospital quality program. Each department head is responsible for quality monitoring, evaluation, and improvement of all aspects of care and services delivered by the department. Quality of care and services are assessed by regular evaluation of quality and utilization data, case reviews, and systems issues. Quality is improved by regular self-assessment against established quality criteria and compliance with external standards. Departments are responsible for quality across the continuum of care. Review of the “Quality Asurance and Performance Improvement Committee Minutes and Reports,” from 01/2023 to 01/29/24, revealed no evidence that the Quality Assurance and Performance Improvement program is monitoring the virtual (remote) patient safety monitoring observation program to evaluate effectiveness, safety of services, and the quality of care, including the care received by Patient #2. No data and/or indicators were listed in the documentation. Interview on 05/29/24 at 10:47 AM with Staff (A), Associate Quality Officer, Staff (G), Associate Quality Officer and Staff (V), Director of the Virtual (remote) Patient Safety Monitoring program revealed Staff (V) does not participate in quality assurance and performance improvement and no data is collected from the virtual (remote) patient safety monitoring observation sitter or from the department. The program was implemented in April of 2023. Due to lack of staffing and a 60% staffing vacancy rate, the team (Geriatric Specialist Team responsible for assigning a bedside or virtual sitter) has been unable to accommodate requests for a bedside (in-person, constant observation) sitter. The unit the patient is on is then responsible for providing a bedside (in-person, constant observation) sitter. Patient #2 had an order on 11/22/23 for a bedside (in person, constant observation) sitter. The team was unable to provide the bedside sitter, only a virtual (remote) patient safety monitoring observation sitter. Interview on 05/29/24 at 11:30 AM with Staff (A), Associate Quality Officer, verified the findings.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 48506 Based on policy review, medical record review, and interview, the Quality Assurance and Performance Improvement Program failed to ensure an adverse patient event report was submitted for the multiple dislodgments of the gastric feeding tube (11/08/23, 11/15/23, and 12/11/23) and tracheostomy (11/23/23, 12/17/23, and 01/02/24) for Patient #2. Failure to report adverse events prevents the analysis of events to identify potential trends/issues and the implementation of preventative actions to reduce medical errors and adverse patient events. Findings include: Review of the policy “Reporting Adverse Events, Near Miss and Unsafe Conditions - Patients and Visitors Policy,” last revised 07/10/23, revealed an event is an adverse occurrence related to the care and services provided to patients and their visitors. Serious events, including those with an adverse effect on patient outcome, must be reported immediately to area leadership, the office of counsel to the medical center, and/or the quality assurance office. In all cases where an event/adverse outcome, near-miss or close call has occurred, the event must be reported by the end of the shift in which the event occurred, was first discovered, or by the end of the next workday. Staff should report actual or potential patient safety or quality of care events as soon as it can safely be done after the event, via the event reporting system. Review of the medical record for Patient #2 revealed Patient #2 was admitted to the medical intensive care unit for accidental drug overdose, respiratory failure, electrolyte abnormalities, underlying infection, and aspiration. On 10/20/23 at 11:33 AM, a tracheostomy tube was inserted. From 11/22/23 to 01/09/24, a physician order was written for bedside (in-person, constant observation) observation due to agitation and pulling at lines, however, nursing staff instead implemented virtual (remote) patient safety monitoring observation. No documentation was found to indicate the physician agreed with the use of virtual (remote) monitoring. No documentation was found in the medical record of the virtual patient safety monitoring observer observations required to be documented every hour. Patient #2 was able to dislodge their tracheostomy on 11/23/23, 12/17/23, and 01/02/24 and dislodged their gastric tube on 11/08/23, 11/15/23, 12/11/23, and 12/31/23, that required replacement and/or surgical intervention. After each dislodgement event, nursing staff failed to implement interventions to prevent future adverse events. Review of event reporting documentation from 11/08/23 to 01/09/24 revealed the facility provided an adverse event report for the 12/31/23 dislodgement of a gastric tube. No evidence was found of event reports for the gastric tube dislodgements on 11/08/23, 11/15/23, and 12/11/23 and the tracheostomy dislodgements on 11/23/23, 12/17/23, and 01/02/24. Interview on 05/30/24 at 12:30 PM with Staff (A), Associate Quality Officer, revealed that not every tube removal occurrence would need an event report to be submitted. If the removal caused harm, it would be expected that an event report would be submitted. A tracheostomy replacement would not be considered harm, therefore would not need an event report. A simple exchange of a feeding tube would not need an event report. On 11/15/23 when the feeding tube was removed and an abdominal exploratory laparotomy was needed, an event report should have been submitted.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 42611 Based on policy review, document review, medical record review, and interview, the facility failed to ensure the ongoing assessment of patient care provided in the emergency department, as evidenced by: 1. Strong Memorial Hospital West Brockport staff failed to perform belongings/safety checks for four of seven suicidal patients (Patient #11, #26, #27 and #29) and did not implement suicide precautions and 1:1 observation/sitter for five of seven suicidal patients (Patient #11, #25, #26, #27, and #29). 2. Strong Memorial Hospital West Brockport does not have a policy or staff guidance document that addresses the care and observation needs for patients with suicidal ideation being treated in the emergency department. Findings #1: Review of the policy “Care of The Suicidal Patient at Strong West Emergency Department,” last revised on 07/05/22, indicated if a patient screens high risk for suicide based on the Columbus Suicide Severity Rating Scale (suicide risk assessment to determine patient interventions and needs), they will be removed from the waiting room and placed in the appropriate care area. If suicide precautions are ordered, frequent and direct visualization must be provided by the staff as assigned by the charge nurse. A registered nurse is assigned to coordinate the patient’s care and another staff member (licensed practical nurse) may provide 1:1 coverage as available. The charge nurse must be notified for a 1:1 sitter. Review of the medical record “Suicide Observation,” flowsheet section indicated the registered nurse must document the following: if the 1:1 was initiated; if the order was reviewed/obtained for suicide observation; if the 1:1 staff member was in place; and the initial room and patient search. All clothing and belongings are searched by staff and removed from the area. Green socks and a wrist band must be placed on the patient. Staff will modify the patient care area to the safest possible way to prevent self-harm by removing all cords and medical equipment from the room; 1:1 status was explained to patient/family; if there was a suicide attempt within the last year; and if the patient had a suicide plan/ideation (thinking of committing suicide). Each shift (twice daily) nursing documentation on the flowsheet will include the following: a room search to provide a safe environment, patient search with items removed if found, visitation with family/friends, and any verbalization of suicide ideations. Hourly 1:1 documentation of the flowsheet will include: if the 1:1 observation was maintained; what behaviors were observed; was the patient having any unusual thoughts; the use of 1:1 observation interventions (coping skills taught, sleep, encouragement, distraction), and the use of distraction (TV, radio, family visitors, games, activities). Medical record review, dated 09/23/23 at 10:18 AM, revealed Patient #11 presented to the facility for intentional drug overdose and a suicide attempt. The Columbia Suicide Severity Rating Scale indicated Patient #11 was high-risk for suicide. At 11:08 AM, Staff (MMM), Registered Nurse implemented suicide precautions with direct 1:1 observation. (From 11:08 PM to 12:01 PM, there was no documentation that suicide precautions, including room check/modification and belongings check were initiated and/or that 1:1 direct observation was maintained every hour while in the emergency department). Medical record review, dated 10/02/23 at 09:44 PM, revealed Patient #25 presented to the facility for suicidal ideation and cutting the right wrist in an attempted suicide. Patient #25 was assessed using a pediatric suicide screening questions (used for patients ages 8-24) and deemed at “imminent risk” (high risk) of suicide. At 09:48 PM, Staff (I), Registered Nurse implemented suicide precautions with direct 1:1 observation. (From 10/02/23 at 09:48 PM to 10/03/23 at 12:01 AM, there was no documentation that 1:1 direct observation was maintained every hour while in the emergency department). Medical record review, dated 11/01/23 at 11:50 AM, revealed Patient #26 presented to the facility for a suicide attempt. At 12:31 PM, the Columbia Suicide Severity Rating Scale indicated Patient #26 was at high-risk for suicide. (From 12:31 PM to 02:59 PM, there was no documentation that suicide precautions, including a room check/modification and belongings check were initiated and/or that 1:1 direct observation was initiated and maintained every hour while in the emergency department). Medical record review, dated 09/20/23 at 08:49 PM, revealed Patient #27 presented to the facility for suicidal ideation. The Columbia Suicide Severity Rating Scale indicated Patient #27 was high-risk for suicide. At 09:04 PM, Staff (NNN), Registered Nurse implemented suicide precautions with direct 1:1 observation. (From 09/20/23 at 09:04 PM to 09/21/23 at 03:58 AM, there was no documentation that suicide precautions including room check/modification and belongings check were initiated and/or that 1:1 observation was maintained every hour while in the emergency department). Medical record review, dated 10/19/23 at 06:59 PM, revealed Patient #29 presented to the facility for suicidal ideation. At 07:10 PM, Staff (NNN), Registered Nurse implemented suicide precautions with direct 1:1 observation. (From 07:10 PM to 09:52 PM, there was no documentation that suicide precautions, including room check/modification and belongings check were initiated and/or that 1:1 direct observation was maintained every hour while in the emergency department). Interview on 12/15/23 at 02:25 PM with Staff (M), Registered Nurse Assistant Quality Officer verified these findings. Findings #2: Review of facility policies and procedures revealed no evidence of a policy or staff guidance document that describes 1:1 observation and/or the requirements of use in the emergency department. Policies only indicate 1:1 observation can be utilized. Interview on 12/15/23 at 02:25 PM with Staff (L), Assistant Quality Officer, and Staff (M), Registered Nurse/Assistant Quality Officer, verified the findings and stated there is no specific 1:1 observation policy for the Strong Memorial Hospital West Brockport Emergency Department.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 49203 A115 This CONDITION is not met as evidenced by: Based on medical record review, policy review, document review, and interviews, it was determined that the facility failed to protect and promote the rights of all patients as evidenced by the lack of monitoring for Patient #1 by nursing staff, which resulted in an elopement from the facility (A0144). On 11/17/23 at 04:15 PM, an Immediate Jeopardy was identified for the CoP of Patient Rights. The facility implemented immediate interventions that included: education on the definition of wandering, requirements to evaluate patients for the risk of wandering, escape precaution interventions, and the documentation of the escape precautions was provided to all nursing staff. The escape precaution evaluation will be audited weekly for four weeks to ensure that patients identified as risk for wandering are receiving appropriate monitoring. Results will be reviewed by the Nursing Quality Office and presented at the Nursing Practice Quality and Safety Steering Committee. On 11/20/23 at 11:45 AM, the Immediate Jeopardy was removed based on onsite surveyor verification of the immediate actions implemented by the facility through observations, policy review, document review, and interviews. Cross Reference: 482.13(c)(2) Patient Rights: Care in Safe Setting.”

“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: 49203 Based on policy review, medical record review, and interview, the facility failed to provide care in a safe setting for Patient #1. Specifically, the lack of assessment and monitoring by staff resulted in Patient #1 eloping from the facility and being found by the police approximately eight hours later. Additionally, the hospital does not have a policy for wandering precautions. Findings include: Review of the policy “Continuous Observation of Patients for Behavioral Reasons,” last revised 11/10/21, indicated that the need for observation should be assessed by a registered nurse every shift and documented in the medical record. Documentation of the observation for behavioral reasons includes a description of patient behavior, the steps taken to ensure safety, the healthcare providers contacted, the interventions attempted that failed, and any other data to support the measures taken. The frequency is determined according to patient need. If the patient needs to be checked more frequently than once every 4 hours for behavioral reasons, the patient must be observed continuously. Intermittent observation consisting of visual and verbal patient checks (frequency established for each individual patient) are instituted for the patient for behavioral reasons. Documentation is done in the medical record with a registered nurse summarizing the assessment at least every 8 hours/end of shift. Review on 11/17/23 of the medical record for Patient #1 revealed the following: - On 10/23/23, Patient #1 was brought to the emergency department for a mental health evaluation by patient safety officers after being found wandering in one of the research buildings. At 10:03 AM, Staff (MM), Physician documented that Patient # 1 had a history of hypertension, dementia, and presented with concerns for altered mental status. Patient # 1 had other admissions after being found wandering. On 09/29/23, Patient #1 was admitted to another local hospital due to wandering. Patient #1’s wandering and confusion may all be manifestations of dementia. Patient #1 requires 24/7 supervision by their sister, but has been found wandering unattended, suggesting that this is not routinely happening. Patient #1 is pleasantly confused, laughs, answers all questions, and is alert to self only. The plan is that Patient #1 has been admitted to the hospital for further observation and possible placement. - On 10/23/23 at 02:47 PM, Staff (YY), Nurse Practitioner ordered Patient #1 to be admitted for altered mental status, Rhabdomyolysis (condition where skeletal muscle breaks down), and Leukocytosis (condition with elevated white blood cells). “No” is documented in the section indicating Patient #1 required a private room, any type of precautions, and/or psychiatric 1:1 monitoring. - From 10/23/23 to 10/27/24, Patient #1 was seen and examined daily by the attending physician and a resident who document that Patient #1 is confused and does not know where they are/what city they live in currently. The need for 24/7 supervision and a safe discharge due to wandering is documented daily. (No absconding/wandering precautions, supervision orders, or observation/monitoring orders were placed prior to 10/28/23). - On 10/27/23 at 10:42 AM, Staff (WW), Social Worker documented spending 30 minutes with Patient #1. (This is the last documentation of staff observation of Patient #1 on 10/27/23). At 07:42 PM, Staff (H), Registered Nurse documented that at approximately 06:00 PM, Patient #1 had an unwitnessed exit from the unit. The provider, patient safety officers, and police were notified. (No additional documentation by nursing services related to Patient #1 eloping from the facility and/or being returned to the facility is documented). - On 10/28/23 at 05:41 AM, Patient #1’s pain was assessed, and medication was administered. (This is the first nursing documentation after Patient #1 was returned to the hospital). At 06:34 AM and 06:48 AM (documented under the 02:02 AM section), Staff (I), Registered Nurse documented vital signs and a full systems review. Patient #1 was confused but followed commands. Patient #1 has poor safety awareness/judgement. “Yes”, is documented in the section for frequent rounding, the bed alarm, and bedside observation/monitoring. - On 10/28/23 at 07:16 AM, Staff (VV), Physician Resident documented that Patient #1 was examined this morning with the bedside nurse. Patient #1 wandered off the unit at approximately 06:00 PM yesterday, was found, and returned to the unit. (This is the first provider documentation after Patient #1 was returned to the hospital at approximately 02:00 AM). Interview on 11/16/23 at 01:30 PM with Staff (H), Registered Nurse, revealed they worked from 07:00 AM to 07:30 PM the day Patient #1 eloped from the hospital. Staff (H) did not recall a handoff being completed on 10/27/23. Patient #1 was having a good day but was constantly leaving their room coming to the nurse’s station to talk and doing laps around the unit. Frequent rounding means looking in and checking on patients every two hours. Documentation in the medical record every two hours is not required. The flowsheet would be used if a patient was on a 1:1 observation, which Patient #1 was not on. Patient #1 was identified missing at approximately 06:00 PM by the dietitian. Patient #1 was unable to be located. Patient #1 was returned to the hospital wearing her personal clothing. Patient #1 did not need to be on 1:1 observation they did not display exit seeking behaviors. The bed alarm was discontinued because Patient #1 was always up and out of bed causing the alarm to constantly go off. Patient #1 was placed on virtual monitoring after returning to the hospital. Interview on 11/16/23 at 03:30 PM with Staff (I), Registered Nurse, arrived at 07:00 PM to work the evening shift and found out Patient #1 eloped during report. On 10/28/24 at approximately 02:00 AM, the police brought Patient #1 back to the unit. Patient #1 never exhibited any signs of exit seeking. Normally staff round every two hours, but Patient #1 was always in the staff ’ s line of sight. Nursing staff do not document every two-hour monitoring checks. Patient #1 went out the front exit and would not be able to get back in. Interview on 11/17/23 at 02:30 PM with Staff (Y), Attending Medicine Physician, revealed that Patient #1 was found in one of the research buildings. Patient #1 had been admitted for similar wandering episodes in the past. Patient #1 was residing with their sister, although it was suspected this was not actually happening. After a review of Patient # 1’s previous hospitalizations, exit seeking behaviors were not identified as a problem. Staff (Y) stated they would have ordered a higher level of intervention if they felt Patient #1 was a high elopement risk. Interview on 11/17/23 at 01:30 PM with Staff (D) Associate Quality Officer, revealed the hospital does not have a policy for wandering precautions.”

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 49203 Based on policy review, document review, medical record review, and interview the facility did not ensure there was a properly executed informed consent form prior to the surgical procedure in the medical record for three of twenty surgical patients (Patient #15, #16 and #19). Failure to obtain informed consent has the potential for an adverse patient event. Findings Include: Review of policy “Informed Consent Policy,” last revised 05/10/22 indicates that each patient or the patient ’ s authorized representative will be provided with the information they need to enable them to make informed treatment decisions. Informed consent must be documented, in writing, prior to performance of all invasive medical and surgical procedures except in cases of emergency when informed consent cannot be reasonably obtained. The discussion with the patient or the patient’s authorized representative, and their consent to the treatment or procedure, must be documented in the patient’s medical record. All paper documented informed consents will be scanned into and become part of the permanent medical record. Consent documentation must include a signature/date/time by the patient, family, guardian, health care agent and a practitioner/provider or another designated physician member of the surgical/procedural team. Review of policy “Informed Consent Form Guidelines,” (no date) revealed there is one “Consent for Medical or Surgical Procedure” form approved for use at Strong Memorial Hospital practice sites. Review of the “Consent for Medical or Surgical Procedure-SH 419 MR” form, (no date) revealed this informed consent form is to be used by staff that includes risks, benefits, alternatives, surgical procedure being performed, and the provider (s) performing the surgical procedure. The form has a space required for the patient signature, the date and time acknowledging they have been informed of the above (risks, benefits, alternatives, the surgical procedure being performed, and the provider (s) performing the surgical procedure). Additionally, there is a “Care provider ’ s statement “ section requiring provider signature, the date and time acknowledging that the patient has been informed of the risks, benefits, alternatives, and the surgical procedure being performed. Review on 10/18/23 of the medical record for Patient #15 revealed they presented to the facility on 08/15/23 for a robot assisted Sacro colpopexy (surgery to treat pelvic organ prolapse), removal of an IUD (intrauterine device-contraceptive device), supracervical hysterectomy (removal of uterus-female pelvic organ for nourishing developing fetus), and cystoscopy (procedure using a tube to examine the bladder and urethra). The medical record did not include the “Consent for Medical or Surgical Procedure SH 419 MR” form. Review on 10/18/23 of the medical record for Patient #16 revealed they presented to the facility on 08/23/23 for surgical removal of the prostate (small reproductive organ in males) and removal of lymph nodes. The “Consent for Medical or Surgical Procedure SH 419 MR” form lacked the signature of Patient #16. Review on 10/18/23 of the medical record for patient #19 revealed they presented to the facility on 09/21/23 for robot assisted lysis of adhesions (removal of scar tissue) with possible bowel resection (removal of portion of the intestine), and possible temporary ostomy (a portion of the intestine is diverted to an artificial opening in the abdominal wall to allow passage of stool). The “Consent for Medical or Surgical Procedure SH 419 MR” lacked the signature of Patient #19. Interview on 10/18/23 at 10:00 AM with Staff (G), Operating Room Assistant Director of Nursing revealed that informed consent should include both the provider and patient and/or responsible party signature, and the date/time that the informed consent was obtained. Interview on 10/18/23 at 01:28 PM with Staff (CC), Assistant Quality Officer, verified these findings.”