Kaleida Health

“MEDICAL STAFF BYLAWS CFR(s): 482.22(c) The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must: This Standard is not met as evidenced by: 48506 Based on policy review, medical record review, and interview, in six of six medical records reviewed, the hospital failed to enforce their medical bylaws and ensure ordered psychiatric consultations were completed within 24 hours (Patient #1, Patient #8, Patient #9, Patient #10, Patient #11, and Patient #12). Findings include: Review of the document “Rules and Regulations of the Medical and Dental Staff of Kaleida Health,” dated May 2025, indicated a consultation is required if a significant question exists as to the diagnosis or the best or most appropriate procedure or therapy to utilize. The consultant shall document and sign a report of findings, opinions and recommendations. The consultant’s report shall be completed and placed in the patient’s medical record within 24 hours of the request for such consultation. Review of the medical record for Patient #1 revealed on 05/14/26, they presented to the hospital for lethargy (sluggish or drowsy) and were admitted. On 05/25/26 at 11:08 AM, an inpatient consultation for psychiatry was ordered for Patient #1 to be seen on 05/26/26 for behavioral reasons. However, a psychiatric consult was not performed until 06/01/26 by Staff (HH), Psychiatrist. Review of the medical record for Patient #8 revealed on 05/22/26, they presented to the hospital with medication non-compliance, encephalopathy (altered mental status), and were admitted. On 06/04/26 at 02:34 PM and on 06/06/26 at 07:14 AM, an inpatient consultation for psychiatry was ordered for mood disorder (condition affecting your mental state), paranoia (extreme feeling of someone trying to harm you), and a history of bipolar (mental health disorder causing extreme shifts in mood). On 06/12/26 at 10:28 AM, an inpatient consultation for psychiatry was ordered to address capacity to make medical and living decisions, as Patient #8 was hallucinating, had paranoia and confusion. From 06/04/26 to 07/23/26 (date of onsite survey, Patient #8 remained hospitalized), there was no evidence that a psychiatry consultation was completed. Review of the medical record for Patient #9 revealed on 04/06/26, they presented to the hospital with altered mental status and were admitted. On 06/16/26 at 03:45 PM an inpatient consult for psychiatry was ordered to determine capacity. However, a psychiatric consult was not performed until 06/18/26 at 10:50 PM by Staff (HH), Psychiatrist. Review of the medical record for Patient #10 revealed on 01/11/26, they presented to the hospital after a recent discharge from the hospital and a fall. On 01/30/26 at 04:01 PM, a psychiatry consultation was ordered for severe depression and anxiety. From 01/30/26 to 02/04/26 there was no evidence that a psychiatry consultation was completed. On 02/12/26 at 03:30 PM, a psychiatry consultation was ordered for depression, poor motivation, and a long hospital stay. From 02/12/26 to 02/16/26, there was no evidence that a psychiatry consultation was completed. On 07/02/26 at 03:00 PM, an inpatient consultation to psychiatry was ordered. From 07/02/26 to 07/23/26 (date of onsite survey, Patient #8 remained hospitalized), there was no evidence that a psychiatry consultation was completed. Review of the medical record for Patient #11 revealed on 07/09/26, they presented to the hospital for altered mental status and were admitted. On 07/10/25 at 02:51 PM, a psychiatry consultation was ordered for capacity. However, a psychiatric consult was not performed until 07/14/26 at 09:31 PM by Staff (HH), Psychiatrist. Review of the medical record for Patient #12 revealed on 07/18/26, they presented to the hospital for generalized weakness and admitted. On 07/20/26 at 01:39 PM, a psychiatry consultation was ordered to determine capacity for an underlying psychiatric history. From 07/20/26 to 07/23/26, (date of onsite survey, Patient #12 remained hospitalized), there was no evidence that a psychiatry consultation was completed. Interview on 07/23/26 at 02:10 PM with Staff (B), Director of Regulatory Affairs, revealed Staff (HH), Psychiatrist, is the contracted psychology provider for the hospital. There have been times when there are issues with real time documentation of psychiatric consults. Sometimes it will take 48-72 hours for documentation to be completed. Interview on 07/23/26 at 02:28 PM with Staff (B), Director of Regulatory Affairs, revealed Staff (HH), Psychiatrist, did not have any disciplines in their credentialing file related to timeliness of consults or subsequent provider charting on them. Interview on 07/23/26 at 03:30 PM with Staff (HH), Psychiatrist, revealed they usually see patients within 24 hours. Staff (HH) stated they do not have weekend coverage, they are the only person providing psychiatric consultations for the hospital and cannot see every patient within the Monday through Friday timeframe they work. Any consultation that would come in on a Friday, Saturday, or Sunday, would be seen the following week. Staff (HH) does not provide coverage for psychiatric service when they are unavailable. Staff (HH) stated that they are required to follow the Medical Bylaws Rules and Regulations set forth by the hospital.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 32261 Based on document review, medical record review, and interview, the hospital failed to operate under bylaws approved by the governing body which is responsible for the quality of medical care provide to patients in the hospital. Specifically, the hospital failed to enforce Medical/Dental Staff Bylaw’s. Staff (D), Surgeon, and Staff (CC), Physician, refused to be interviewed by New York State (NYS) Department of Health (DOH) survey staff during a Federal Allegation complaint survey investigation. Reference: 482.22 (c): Tag #0353- Medical Staff Bylaws”

“MEDICAL STAFF BYLAWS CFR(s): 482.22(c) The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must: This Standard is not met as evidenced by: 32261 Based on document review, medical record review, and interview, the hospital failed to enforce Medical/Dental Staff Bylaws. Specifically, Staff (D), Surgeon, and Staff (CC), Physician, refused to be interviewed by New York State (NYS) Department of Health (DOH) survey staff during a Federal Allegation complaint survey investigation. Findings Include: Review of the document “Bylaws of Medical and Dental Staff of Kaleida Health,” dated 05/20/20, revealed every member of the staff shall abide by: the Bylaws, Rules and Regulations, and Policies, as well as State and Federal laws and regulations; act in a lawful, ethical and professional manner, including adherence to the ethical standards and principles set forth in the codes of ethics and principles adopted by his or her profession or specialty and to state and federal laws and regulations; and appear at any special meeting called by the Staff President or his designees or as otherwise provided by bylaws. Review of the outpatient medical record for Patient #1, dated 11/24/25, and the outpatient medical record, dated 12/08/25, and the inpatient medical record, from 12/08/25 to 12/25/25, revealed Staff (D), Surgeon, participated in Patient #1’s care. (Staff CC, Physician, conducted the mortality review). Interview on 02/11/26 at 09:30 AM with Staff (EE), Director of Regulatory Affairs, revealed that both Staff (D), Surgeon, and Staff (CC), Physician, declined to be interviewed by the NYS DOH. Both providers were reminded that declining the interview, they are in violation of the facility’s medical staff bylaws.”

“PATIENT VISITATION RIGHTS CFR(s): 482.13(h)(1), (h)(2) [A hospital must have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation.] A hospital must meet the following requirements: (1) Inform each patient (or support person, where appropriate) of his or her visitation rights, including any clinical restriction or limitation on such rights, when he or she is informed of his or her other rights under this section. (2) Inform each patient (or support person, where appropriate) of the right, subject to his or her consent, to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time. This Standard is not met as evidenced by: 42611 Based on policy review, medical record review, document review, and interview, in one of 14 medical records reviewed, visitation restrictions were never lifted when Patient #1 was admitted to the intensive care unit on a ventilator and/or prior to Patient #1’s death. The healthcare proxies (HCP) and family were only able to spend a limited amount of time with Patient #1 prior to their death. Findings include: Review of the policy “Notification of Patient Rights,” dated 02/07/20, includes a patient has the right to authorize those family members and other adults who will be given priority to visit consistently with your abilities to receive visitors. Review of the booklet “Your Rights as a Hospital Patient in New York State (NYS),” dated August 2022, indicated NYS has a law that allows the patient to appoint someone they trust as their “health care agent,” to decide about treatment if the patient loses the ability to decide for themselves. Review of the policy “Patient Visitation,” last revised 11/08/23, included each patient has the right to determine, who may and may not visit. The facility will not restrict, limit or deny visitation privileges based on race, color, religion, sex, ethnic origin, sexual orientation, gender identity and expression, marital status, disability, socioeconomic status or physical appearance. The facility has the authority to restrict any visitor that is disruptive; however, this should occur in conjunction with the nurse manager or designee and security. When a visitor is restricted, the nurse manager or designee must enter the restriction into the secured facility intranet computer application “Kaleida Scope.” Review of the policy “Advance Directives- Health Care Proxy, Living Will, MOLST (Medical Ordes for Life-Sustaining Treatment),” dated 07/14/25, indicated an advance directive means a type of written or oral instruction relating to the provision of health care when an adult becomes incapacitated, including but not limited to a health care proxy, a living will, and a consent to the issuance of an order not to resuscitate (DNR- Do Not Resuscitate order). A Health Care Proxy (HCP) is a form of advanced directive which delegates the authority to another adult to make health care decisions on behalf of the patient when that patient becomes incapacitated (unable to make their own decisions). The HCP agent shall receive medical information to make informed decisions regarding the patient’s health care. Review of the hospital medical record for Patient #1 revealed the following: - On 08/10/25, Patient #1 was admitted for sepsis (life threating infection throughout the body). On 08/14/25 the document “Health Care Proxy (HCP),” indicated Patient #1 provided verbal consent for Patient #1’s sibling and parent as the HCPs. -On 09/19/25 at 10:50 PM, Staff (DD), Nurse Practitioner, documented Patient #1 was vaping in the room. The nurses had security come up to remove the vape. Patient #1 reported their parent took it home stating they only used it once. Staff (DD) told Patient #1 they cannot vape while they are in the hospital. -On 09/21/25 at 10:16 AM, Staff (BBB), Physician, documented Patient #1’s parent was visiting. Patient #1 threatened self-harm after an altercation with staff to take away a vape pen. Patient #1 threatened to self-harm to nursing staff and the overnight provider after being uncooperative during a blood transfusion. Restrict visitation for now due to it is unknown how Patient #1 is getting vape pens. Continue 1:1 monitoring and a psychiatry consult for a lethality assessment. -On 09/22/25 at 10:30 AM, Staff (EE), Nurse Practitioner, documented to restrict visitation for now, due to unknown how Patient #1 is getting vape pens. Psychiatry was consulted and felt Patient #1 was a low lethality risk. Will discontinue 1:1 monitoring. -On 09/28/25 at 08:01 AM, Staff (SS), Nurse Practitioner, documented they had a discussion with the nurse who indicated a breast milk baggie and black residue was found in the bathroom sink. Patient #1 also had a lighter in bed. Patient #1 reported a “friend” came and needed the baggie for breast milk. Patient #1 was verbally aggressive on exams. -From 09/28/25 01:21 PM to 10/15/26 (end of order), Staff (SS), Nurse Practitioner documented a communication order for no visitors. -On 09/29/25 at 10:54 AM, Staff (SS), Nurse Practitioner, documented Patient #1 wanted to go outside and have a cigarette. Patient #1 became agitated and stated they want to leave AMA (against medical advice) to have a cigarette outside and then come back through the ED (emergency department). At 03:56 PM, Patient #1 returned. Admit Patient #1 to medicine with no visitors. -On 10/09/25 at 11:33 PM, Staff (I), Nurse Practitioner, documented Patient #1 has a history of polysubstance use. There was concern this hospitalization for an illicit substance brought in by a visitor. Patient #1 was given a dose of Narcan (medication used to reverse opioid overdose) with improvement in mentation. Patient #1 denied having any visitors today or taking illicit substances. Patient was transferred to telemetry and again noted to be very somnolent and difficult to arouse. Patient #1 was given a repeat dose of Narcan with improvement in mentation. Security was notified and made note Patient #1 is to have no visitors. -On 10/10/25 at 12:54 AM Staff (QQQ), Registered Nurse, documented Patient #1 was short of breath, abdominal breathing, had bilateral crackles in chest, was diaphoretic (sweating heavily), and was pale. Oxygen saturation was at 76% on 2 Liters (L) of oxygen via nasal cannula. Oxygen was increased oxygen to 4 L nasal cannula. Patient #1 was slow to arouse, and a “Rapid Response” was called at approximately 11:30 PM. Narcan was administered due to lethargy. At approximately 12:35 AM, Patient #1 was transferred to the Intensive Care Unit (ICU). Patient #1’s condition continued to deteriorate. -On 10/11/25 at 10:36 AM Staff (G), Nurse Practitioner, documented Patient #1’s parent and sibling were updated. The sibling was present at Patient #1’s bedside. -On 10/11/25 at 10:49 AM Staff (G), Nurse Practitioner, documented Patient #1’s parent and Patient #1’s sibling was notified of the cardiac arrest. -On 10/11/25 at 10:55 AM Staff (G), Nurse Practitioner, documented Patient #1’s parent was updated as well as Patient #1’s sibling who is present at Patient #1’s bedside. -On 10/11/25 at 12:12 PM Staff (G), Nurse Practitioner, documented Patient #1’s sibling who is the HCP, Patient #1’s parent, and another sibling and other family members were at Patient #1’s bedside. -On 10/11/25 at 01:02 PM, Staff (WW), Registered Nurse, documented Patient #1 was pronounced deceased by Staff (G), Nurse Practitioner. Notification was given to attending physician, consulting physician, a family member, and Patient #1’s parent. Review of the letter “Final Response,” dated 11/24/25, included a final response from the hospital to the complainant regarding a complaint that was submitted. The hospital acknowledged and apologized for the restrictions on visitation that were placed and not removed when Patient #1 went to the ICU; and the lack of communication in providing regular updates to family, as communication to family is vital to ensure patient safety and satisfaction. Interview on 01/21/26 at 11:40 AM with Staff (W), Registered Nurse, revealed that visitors are allowed in the ICU and if the patient is very ill, they will be allowed to stay beyond the visiting hours. If a patient is coding, they will let the family observe what is happening and then the provider will update the family with what is happening. Interview on 01/21/26 at 02:45 PM and on 01/21/26 at 02:44 PM with Staff (L), Security Manager, revealed on 10/10/26 and 10/11/26 there were visitor restrictions for Patient #1, but Staff (L) were unsure of the details. Interview on 01/22/26 at 09:30 AM with Staff (I), Nurse Practitioner, indicated vaguely remembering on 09/29/25 putting in a note from concern from the nursing staff on visitor restrictions due to suspected substance abuse. This never got communicated to the front desk or security. Interview on 01/22/26 at 12:00 PM with Staff (B), Director of Nursing Services, verified the evidence.”

“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: 52113 Based on policy review, medical record review, and interview, the hospital failed to ensure an incident event report was completed when a cardiac heart monitor fell on Patient #1’s foot causing swelling and pain. Findings include: Review of the policy “Corporate Event Reporting,” dated 01/22/25, revealed when an event occurs that resulted or could have resulted in an unintended adverse development in a patient’s condition, whether an inpatient or outpatient, the web-based event reporting system (STARS) must be accessed and a report entered. If a medical device caused or contributed to this, staff are to complete a “STARS” report. Review of the medical record for Patient #1 revealed on 06/23/25 at 04:05 PM, Patient #1 presented to the hospital. On 06/23/25 at 04:35 PM, Staff (Q), Physician, ordered constant cardiac monitoring by telemetry (continuous tracking of heartbeat using electrodes and monitor). At 10:59 PM, the registered nurse notified Staff (L), Physician Assistant that a heart monitor dropped on Patient #1’s foot a few days prior. The left foot assessment by Staff (L) noted increased left foot swelling, redness, and pain with palpation. An x-ray was ordered. Interview on 08/14/25 at 03:30 PM with Staff (C), Hospital Administrator, revealed no incident event report was completed for Patient #1.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 48506 Based on policy review, medical record review, and interview, in one of two records reviewed, the peripherally inserted central catheter (PICC) dressing was not changed every seven days (Patient #1). Findings include: Review of the policy “IV Care and Maintenance-Adult,” last revised 12/02/22, revealed a PICC line dressing change is needed every seven days and as needed. The hospital PICC team will assess the PICC site and provide dressing care maintenance. Review on 12/13/24 of the medical record for Patient #1, dated 02/29/24 to 04/04/24, revealed on 03/04/24 at 05:00 PM, a PICC was placed by interventional radiology. On 03/14/24 at 02:15 PM, Staff (JJJ), Registered Nurse changed the PICC dressing for Patient #1 (on the tenth day). On 03/22/24 at 02:23 PM, Staff (KKK), Registered Nurse, changed the PICC dressing for Patient #1 (on the eighth day). On 03/30/24 at 05:30 PM, Staff (LLL), Registered Nurse changed the PICC dressing for Patient #1 (on the eighth day). Interview on 12/18/24 at 11:04 AM with Staff (SS), Quality Management Project Coordinator verified the PICC line dressing changes for Patient #1 were not performed every seven days per policy on 03/14/24, 03/22/24, and 03/30/24.”

“PRE-ANESTHESIA EVALUATION CFR(s): 482.52(b)(1) [The policies must ensure that the following are provided for each patient:] A pre-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, performed within 48 hours prior to surgery or a procedure requiring anesthesia services. This Standard is not met as evidenced by: 48506 Based on policy review, medical record review, and interview, in one out of six records reviewed, a pre-anesthesia evaluation was not completed prior to surgery (Patient #2). Findings include: Review of the policy “Sedation for Operative and Invasive Procedures, Diagnostic Testing and Therapeutic Procedures,” last revised 07/01/21, revealed monitoring and documentation for minimal, moderate, and deep sedation/anesthesia includes a provider pre-sedation evaluation. The provider pre-sedation evaluation will include a history and physical, a focused physical examination, vital signs, identification of a Mallampati scale (visual evaluation of the throat to predict how difficult it might be to insert a breathing tube. Scoring is one to four with a higher score indicating a potentially more difficult intubation process), and an identification of an American Society of Anesthesiologists (ASA-used to estimate a patient anesthesia risk. One is a health patient, six is a deceased person. A four is a patient with severe systemic disease that is a constant threat to life) status. Review on 12/11/24 of the medical record for Patient #2, dated 11/26/24, revealed at 09:00 AM, Patient #2 presented to the hospital for an elective laparoscopic (minimally invasive surgical procedure using a camera) insertion of a ventricular peritoneal shunt (a medical device that drains excess cerebrospinal fluid from the brain into the abdomen). At 11:10 AM, the anesthesia record revealed, Patient #2 was intubated without difficulty. At 12:45 PM, the anesthesia record revealed Patient #2 was extubated and breathing on their own. At 01:10 PM, the anesthesia record revealed Patient #2 was transferred to the post anesthesia care unit on a face mask providing oxygen. At 01:52 PM, the anesthesia note by Staff (W), Physician documented a post-anesthesia assessment that Patient #2 was at their mental baseline, needed no respiratory or cardiac support, denied pain and nausea, and had a normal hydration status. At 02:45 PM, Patient #2 was discharged to home. (There was no evidence found that a pre-sedation anesthesia evaluation was completed) Interview on 12/11/24 at 06:07 PM with Staff (N), Quality Project Manager, verified a pre-sedation anesthesia evaluation was not documented in Patient #2’s medical record. Interview on 12/12/24 at 09:32 AM with Staff (B), Chief Quality and Patient Safety Officer, verified the pre-sedation anesthesia evaluation could not be located.”

“INTRAOPERATIVE ANESTHESIA RECORD CFR(s): 482.52(b)(2) [The policies must ensure that the following are provided for each patient:] An intraoperative anesthesia record. This Standard is not met as evidenced by: 48506 Based on policy review, medical record review, and interview, in two out of six records, a complete intraoperative anesthesia record was not documented (Patients #1 and #2). Findings include: Review of the “Rules and Regulations of the Medical and Dental Staff,” dated 02/11/19, revealed the medical record will thoroughly document all operative, other procedures, and the use of anesthesia. Operative reports shall be dictated or written immediately after surgery. Documentation of the attending staff member’s supervision of the patient care provided by residents must include as a minimum: the teaching physician was present at the time the service was furnished; the presence of the teaching physician during procedures is documented by the physician or resident in the procedure record or an addendum to the procedure record; and in evaluation and management procedures, the teaching physician must personally document his or her participation in the service in the medical record. Review on 12/13/24 of the medical record for Patient #1, dated 02/29/24 to 04/04/24, revealed on 02/29/24 at 04:50 PM, the anesthesia record documented Staff (NN), Resident Physician performed an endotracheal intubation on Patient #1 using a glide scope with Staff (U), Anesthesiologist in attendance. Patient #1 had a limited oral opening, but there was good visualization with glide scope. Patient #1’s arytenoids (cartilage found in the larynx, which are essential to the production of vocal sound) were fully visible. With the use of the “Dr. Teddy Rutkowski” method with endotracheal tube over fiberoptic, there was some railroading (studding over each cartilage) at the arytenoids, but the tube passed easily through the vocal cords. Interview on 12/18/24 at 01:00 PM with Staff (U), Anesthesiologist revealed the “Dr. Teddy Rutkowski” method describes a glide scope with fiber optic (video laryngoscope that provides clear view of the vocal cords and laryngeal inlet to help with difficult airway management). The record documented Staff (U) was in the room with Staff (NN), Resident Physician, the entire time. This procedure requires two hands with the glide scope and two hands for the fiber optic device, so Staff (U) and Staff (NN), Resident Physician, intubated Patient #1 together. Staff (U) could not recall what device Staff (U) was holding. Staff (NN) was a senior resident and was not a novice with intubation. The documentation system was flawed. Interview on 12/18/24 at 03:17 PM with Staff (S), Attending Physician/Kaleida Health System Chief Quality Officer, and Staff (M), Medical Director of Anesthesiology, revealed they reviewed the anesthesia note for Patient #1 on 02/29/24 at 07:16 PM that indicated the ETT size 7.0 tube was secured at 20 centimeters and performed by Staff (NN), Resident Physician with Staff (U) Anesthesiologist in attendance. There is the ability to free text a note. Staff (S) and Staff (M) indicated that the “Dr Teddy Rutkowski” method requires two people to perform the procedure: one to hold the glide scope and another to hold the fiber optic device. From the documentation review, it was unclear on who performed what part of the procedure. Interview on 12/18/24 at 04:09 PM with Staff (NN), Resident Physician revealed they were there for the intubation of Patient #1 with the glide scope, using the “Dr. Teddy Rutkowski” method. This process requires two people to perform, one using the glide scope and the other using the fiberoptic device. Staff (NN) believed they held the glide scope and Staff (U), Anesthesiologist used the fiberoptic device. During the procedure for Patient #1, Staff (NN) and Staff (U), Anesthesiologist, took turns doing the documentation. The “performed by” and “in attendance” sections must be picked from a drop-down box and cannot be free text. Staff (NN) stated that based on the documentation for Patient #1, “you can’t tell who performed the intubation.” There is no policy for intraoperative anesthesia record documentation. Review on 12/11/24 of the medical record for Patient #2, dated 11/26/24, revealed at 11:10 AM, the anesthesia record documented Patient #2 was intubated. At 12:45 PM, the anesthesia record documented Patient #2 was extubated and breathing on their own. (There was no documentation of which provider intubated or extubated Patient #2). Interview on 12/11/24 at 06:07 PM with Staff (N), Quality Project Manager, verified these findings.”

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 48608 Based on policy review, medical record review, and interview, in one of ten medical records reviewed, it was determined the facility failed to complete the process for obtaining advance directives and medical orders for life sustaining treatment, which resulted in Patient #1 being intubated against their expressed wishes. Findings include: Review of the policy “Medical Orders for Life Sustaining Treatment including do not resuscitate (DNR)” dated on 10/26/20 revealed a physician will place an order for do not resuscitate (refrain from cardiopulmonary resuscitation), do not intubate (do not insert breathing tube), and/or other life sustaining treatment. Do not intubate orders are patient specific. Orders go into effect once they are signed. The medical orders for life sustaining treatment order (MOLST) form must be filled out completely and signed by the patient or delegated individual, the physician, nurse practitioner, or physician Assistant and at least one witness. Staff are then notified of the do not resuscitate/life sustaining treatment order. Review of the medical record for Patient #1 revealed on 09/23/24 at 04:50 PM, a medical order for life sustaining treatments (MOLST- selected treatment options permitted by the patient, family, or proxy) form was completed and signed by Patient #1 and Staff (W), Physician. The document indicated cardiopulmonary resuscitation would be performed if the heart stops beating, with a trial of non-invasive ventilation only (external supply of oxygen for breathing support). If the trial ventilation failed, do not intubate (insert tube into throat to provide breathing support by a machine). The form lacked the signature of at least one witness. On 09/25/24 at 05:11 AM, Patient #1 was found on the floor in the restroom bleeding from the rectum and vomiting blood. Patient #1 was intubated and transferred to the surgical intensive care unit. Interview on 11/19/24 at 11:55 AM with Staff (K), Registered Nurse, revealed on 09/25/24 at 05:00 AM, a rapid response (overhead nursing emergency page requesting additional help for a declining patient) was called after Patient #1 fell. Patient #1 was unstable and confused. The MOLST form in the medical record was incomplete, there were no witness signatures. Patient #1 was moved by staff from the floor to the bed and intubated (breathing tube inserted into mouth and throat to support breathing) them due to deteriorating breathing. Nurses are responsible for ensuring advance directive forms are completed and in the medical record when applicable.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 48506 Based on policy review, document review, medical record review, and interview, nursing staff must adhere to policies and procedures of the hospital and nursing administration must provide adequate supervision and evaluation of nursing personnel. 1.Nursing staff did not obtain an order for the insertion of a urinary foley catheter (tube that goes in the bladder to drain urine) for two of four medical records reviewed (Patients #22 and #23). 2.The hospital does not have a facility protocol for the irrigation of a urinary (Foley) catheter. Findings #1: Review on 09/06/24 of the policy “Prevention of Catheter-Associated Urinary Tract Infections - Adult/ Pediatric,” last revised 01/31/22 revealed “urinary (foley) catheters (a tube used to drain urine from the bladder) should be inserted when necessary and left in place only for as long as needed. A provider’s order and document reason for use should be documented in the medical record.” Review on 09/06/24 of the medical record for Patient #22 dated 09/02/24 at 03:00 PM revealed Patient #22 arrived at the emergency department via ambulance with a possible drug overdose and was admitted to the intensive care unit. At 03:00 PM, Staff (BB) Registered Nurse, documented a urinary (foley) catheter was inserted. There was no evidence of a physician order for the insertion of the urinary (foley) catheter in the medical record. Review on 09/06/24 of the medical record for Patient #23 dated 09/04/24 at 07:45 PM revealed Patient #23 arrived at the emergency department via ambulance with bloody vomit and alcohol abuse disorder and was admitted to the intensive care unit. On 09/05/24 at 04:00 AM Staff (GG), Registered Nurse, documented a urinary (foley) catheter was inserted to monitor urinary output. There was no evidence of a physician order for the insertion of the urinary (foley) catheter in the medical record. Interview on 09/06/24 at 12:00 PM with Staff (A), Chief Quality Officer, and on 09/06/24 at 02:00 PM with Staff (F), Director of Critical Care, verified Patient #22 and Patient #23 did not have a physician order for the insertion of a urinary foley catheter. Findings #2: Review on 09/06/24 of facility documents revealed no evidence of a policy, guidance document, and/or staff education for the irrigation (flushing) of a urinary foley catheter. Review on 09/06/24 of the “Registered Professional Nurse Essential Competency Assessment Tool,” last revised 11/2019, did not include a competency (ability to perform) for the irrigation (flushing) of a urinary foley catheter. Interview on 09/05/24 at 02:45 PM with Staff (P), Registered Nurse, revealed if a patient’s urinary foley catheter needed to be manually irrigated, they would obtain a sterile irrigation kit and follow the providers order regarding what solution and how much of the solution was to be used. After the irrigation was completed, all supplies would be discarded. New supplies would be used if manual irrigation of the urinary foley catheter was required again. Interview on 09/05/24 at 03:20 PM with Staff (Q), Registered Nurse, revealed they use sterile fluid each time the irrigation of a urinary foley catheter is completed. The syringe is reused, placed in the original package, and stored in the patient’s room on the corner wall shelving. The syringe is replaced every 24 hours by the night shift registered nurse. Interview on 09/06/24 at 10:10 AM with Staff (S), Registered Nurse, revealed they would perform manual urinary foley catheter irrigation with an order from a provider. Staff (S) would open the supplies at the bedside. The syringe is reused and discarded after each shift. Staff (S) stated the policy for manual irrigation was available, however they were unable to locate the policy on the hospital intranet. Interview on 09/06/24 at 11:45 AM with Staff (F), Director of Critical Care, revealed the registered nurse initial/annual competency assessment tool does not include irrigation (flushing) of a urinary foley catheter. Interview on 09/06/24 at 02:00 PM with Staff (A), Chief Quality Officer, revealed there was no policy found for manual/hand irrigation of a urinary foley catheter.”

“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: 49420 Based on policy review, medical record review, document review, and interview, in three of three medical records reviewed, it was determined clinical staff did not ensure all patients receive care in a safe setting. Nursing staff failed to implement provider orders for a bedside (in-person, constant observation) sitter (Patient #1, #17, and #21). Nursing implemented a virtual (remote) patient safety monitoring observer despite Patient #1’s clinical presentation. Patient # 1 experienced an aspiration event and could not be resuscitated. The facility’s failure to implement a provider’s order for a bedside sitter by using virtual safety monitoring placed patients at risk for serious harm, injury or death. Findings include: Review of the policy “The Role and Responsibility of the Sitter Assignment - Acute Care Sites”, last revised 10/27/22, indicated a “sitter” assignment is to “provide the safe management of patients who are at risk for suicidal or homicidal ideation, and/or acute behavioral outbursts that may cause harm to themselves or others. A bedside attendant or companion is a caregiver who provides combative, confused, distressed, or patient at risk of falling, supervision with companionship and care. A bedside attendant or companion for non-suicidal/homicidal patients in need of a sitter requires a provider order.” Review of the policy “Virtual Patient Safety Observation”, last revised 01/22/24, indicated that “All 1:1 sitter requests made by the Provider order must be clarified if the registered nurse believes the patient is suitable for Virtual Patient Safety Monitoring. The Provider and registered nurse should document the conversation in a clinical note. The nursing supervisor must approve the sitter (bedside) and virtual patient safety monitoring (remote) requests and confirm the availability of equipment and the remote observer. Review on 04/23/24 of the medical record and virtual (remote) patient safety observer documentation (not part of the medical record) for Patient #1 revealed: -On 02/23/24 at 12:43 AM, Staff (KK), Physician ordered that the feeding tube was ok to use based on imaging results that the tube was in the stomach. At 06:31 AM, Staff (N), Physician Assistant, ordered a bedside (in-person, constant observation) sitter due to behavior and did not add a comment indicating that a virtual sitter could be used. -From 02/23/24 at 07:00 AM through 02/26/24 at 01:00 PM, a virtual patient safety monitor observer was implemented by nursing staff instead of a bedside (in-person, constant observation). Initial setup of the monitor indicated that Patient #1 was confused, non-redirectable, and at risk for falls and pulling out their feeding tube. (No order and/or documentation was found to indicate the use of a virtual (remote) patient safety observer was approved by the physician for Patient #1). -From 02/23/24 to 02/26/24, nursing staff documented that Patient #1 had an altered mental status, forgetful of limitations, and was dependent for all care. Staff assigned as the virtual safety monitor observer documented that intermittently, Patient #1 was anxious, restless, sliding down in the bed, and attempting to get out of bed. -On 02/26/24 at 01:51 AM, the virtual safety patient monitoring observer documented that Patient #1 was anxious in bed, moving around a lot. The virtual (remote) patient safety monitor attempted to redirect Patient #1 and staff came into the room to assist. At 07:51 AM, the virtual patient safety monitor sounded the alarm. At 09:47 AM, Patient #1 was restless. At 09:55 AM, Patient #1 was attempting to get out of bed. The virtual (remote) patient safety monitor attempted to redirect Patient #1 without success and sounded the alarm. Staff immediately came to the room to assist Patient #1. At 10:00 AM, 10:31 AM, 11:11 AM, and 12:04 PM, Patient #1 was awake and restless. At 12:27 PM, a provider checked on Patient #1. At 12:57 PM, the virtual patient safety monitor activated the alarm. At 01:00 PM, Patient #1’s virtual safety patient monitor was discontinued. -On 02/26/24 at 08:00 AM, Staff (O), Registered Nurse documented Patient #1 was alert, awake and confused, would forget limitations, and was dependent for all care including incontinence care. The head of the bed was elevated due to the continuous feeds (to prevent aspiration). At 11:40 AM, Staff (O), Registered Nurse documented that Patient #1’s feeding tube was assessed, had continuous feeds infusing, with no complications. At 12:59 PM, code blue (medical emergency that requires resusictation) was called. At 01:21 PM the resuscitation event ended, and Patient #1 was pronounced deceased by Staff (CC), Physician. At 01:41 PM, Staff (CC), Physician documented Patient #1 expired at 01:21 PM from an aspiration event followed by cardiac arrest. At 02:58 PM, Staff (O), Registered Nurse documented that the virtual (remote) patient safety monitor alarm went off. Patient #1 was found with stomach contents coming out of their mouth, was unresponsive, was not breathing, and was pulseless so cardiopulmonary resuscitation was started and a code blue was called. Patient #1 was pronounced deceased at 01:21 PM. At 07:44 PM, Staff (LL), Hematologist documented (addendum) Patient #1 was examine earlier in the day, was awake but not alert, and was encephalopathic (disorder that affects the brain and causes altered mental status). Patient #1 was not following commands and continued to move a lot in the bed. Interview on 04/23/24 at 03:05 PM, Staff (O), Registered Nurse, revealed that a virtual patient safety monitoring was used on Patient #1 due to being a fall risk. Staff (O) was unaware that the sitter order was for bedside (in-person, constant) sitter. The virtual patient safety monitor was observing the patient up until the cardiac arrest. Patient #1 was on continuous tube feeds (feeding tube into the stomach) and kept slipping down in the bed. Patient #1 required to be boosted up in the bed every ten minutes. While Staff (O) was in another patient’s room, the virtual patient safety monitoring alarm sounded meaning there was an immediate concern with Patient #1. Staff (P), Registered Nurse, found Patient #1 had slid down in the bed, had gastric contents coming out of their mouth, was pulseless, and was not breathing. A code was called, and Staff (P), Registered Nurse started cardiopulmonary resuscitation with chest compressions. Staff (O) stated that they were in the room just ten minutes prior to the event and had to boost Patient #1 up in bed at that time. Patient #1’s mental status was alert, only spoke one-word answers with painful stimulation, and was not redirectable. Patient #1 was very restless and would have been better with an in-person bedside sitter. Interview on 04/23/24 at 03:20 PM, Staff (P), Registered Nurse, stated that Patient #1 was restless and moving in the bed a lot. During the 02/26/24 shift, the bed alarm and virtual patient safety monitoring alarm went off about three times due to Patient #1 constantly sliding down in the bed. Staff (P) heard Patient #1’s virtual patient safety monitoring alarm go off at about 12:45 PM. When Staff (P) entered the room, Patient #1 was in cardiac arrest with stomach contents on them. If a patient is not appropriate for the virtual patient safety monitoring, an in-person sitter can be requested. Staff (P) felt that Patient #1 should have had an in-patient sitter instead of the virtual patient safety monitoring. Staff (P) was unaware that Patient #1 had an order for bedside (in-person, constant) observation and assumed the order was for the virtual patient safety monitoring since Patient #1 was on the virtual patient safety monitor at the beginning of the shift. Review on 04/24/24 of the medical record and virtual (remote) patient safety observer documentation (not part of the medical record) for Patient #17, dated 02/08/24 at 10:57 AM, Patient #17 was admitted to the hospital with a history of significant cognitive deficit (impaired thinking skills). On 02/24/24 at 09:45 AM, Staff (MM), Nurse Practitioner ordered a bedside (in-person, constant observation) sitter due to behavior and did not add a comment indicating that a virtual sitter could be used. On 02/25/24 at 08:06 AM, Staff (MM), Nurse Practitioner documented a bedside sitter was ordered due to Patient #17 having increased agitation, delirium, and being combative. From 02/26/24 at 01:13 AM through 02/26/24 at 03:21 PM, a virtual patient safety monitor observer was implemented by nursing staff instead of a bedside (in-person, constant observation) due to behavior. (No order and/or documentation was found to indicate the use of a virtual patient safety observer was approved by the physician for Patient #17). Virtual (remote) safety monitor observers documented that intermittently, Patient #17 was restless, getting close to the edge of the bed, and removing their gown and medical equipment. On 02/26/24 at 03:47 PM, Staff (MM), Nurse Practitioner, discontinued the order for a bedside sitter. Review on 04/24/24 of the medical record and virtual (remote) patient safety observer documentation (not part of the medical record) for Patient #21 dated 04/16/24 at 7:52 PM Patient #21 was admitted to inpatient status for seizures. On 04/17/24 at 03:38 AM, Patient #21 experienced three seizures. At 04:03 AM, Staff (NN), Nurse Practitioner ordered bedside (constant observation) sitter. (No order and/or documentation was found to indicate the use of a virtual patient safety observer was approved by the physician for Patient #21). At 07:00 AM, 09:00 AM, 11:00 AM and 01:17 PM nursing staff documented that “visual sitter” was in place. At 01:47 PM the virtual (remote) patient safety observer documented that the monitor was disconnected as Patient #21 was discharged. Interview on 04/23/24 at 09:50 AM and 11:10 AM with Staff (B), Chief Nursing Officer revealed a physician’s order would be required for the remote virtual patient safety monitoring program to be utilized. A discussion would be held and documented in the medical record between the provider and the nurse to determine which modality of sitter (bedside or remote) would be appropriate. Interview on 04/23/24 at 10:45 AM, Staff (G), Registered Nurse, revealed that virtual patient safety monitoring needs a provider order. The provider must enter a comment into the order that states virtual patient safety monitoring. The virtual patient safety monitoring can be utilized for appropriate patients in place of an in-person sitter when the provider and the nurse agree that this is safe for the patient. Staff (G) stated that the appropriate patients for the virtual patient safety monitoring would be redirectable, fall risk, abscond risk, and/or pulling at lines or tubes. Interview on 04/23/24 at 11:15 AM, with Staff (K), Registered Nurse, revealed that virtual (remote) patient safety monitoring was used on the unit for patients that are redirectable, pulling at lines/tubes, attempting to get out of bed, and at risk for falls. If virtual patient safety monitoring is utilized, the provider would be contacted and an order would be placed. Interview on 04/24/24 at 08:55 AM, Staff (N), Physician Assistant, when an order is placed for constant observation, a staff member will sit with the patient for safety. To determine if a virtual patient safety observer monitoring is appropriate, Staff (N) would assess the patient and a conversation would occur between the provider and the nurse. They would review the reasons why or why not the virtual patient safety monitoring is appropriate. If virtual patient safety monitoring is appropriate, the sitter order will need to be modified. “Tele sitter “will be entered in the comments section or special instructions section of the order. If the patient was not redirectable, virtual patient safety monitoring would not be used. Interview on 04/24/24 at 09:35 AM, Staff (J), Director of Nursing, revealed at a minimum, a patient on virtual patient safety monitoring would need to be alert to self, and redirectable. If not, then the patient would need a sitter at the beside (in-person). Nursing responsibilities for a patient on virtual patient safety monitoring would include an order placed for a bedside sitter and a conversation would take place between the nurse and the provider to discuss if the patient was appropriate for the virtual patient safety monitoring. The conversation between the nurse and the provider would be documented in the electronic medical record.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 48506 Based on interview, policy review, document review, and medical record review, in eight of eight medical records reviewed, it was determined nursing staff failed to supervise and evaluate the nursing care as evidenced by: 1.The registered nurse failed to evaluate patient care on an ongoing basis. Specifically, there were no nursing notes in the medical record indicating that virtual (remote) patient safety monitoring was in place; no conversations/reports between the nursing staff and virtual (remote) patient safety monitor observer, no documentation of hourly observations by the virtual (remote) patient safety monitoring observer; and no nursing assessment of the ongoing need for the use of a virtual patient safety observer each shift were found in the medical record (Patient #1, #2, #8, #9, #15, #18, #20, and #21). 2.Nursing staff failed to notify and/or provide education to the patient and/or their representative regarding the use of a virtual patient safety monitoring observer (Patient #1, #2, #8, #9, #15, #18, #20, and #21). Findings #1: Review on 04/23/24 of the policy “Virtual Patient Safety Observation,” last revised 01/22/24, indicated the virtual patient safety monitoring observer will document observations in the electronic medical record hourly and as needed. The registered nurse will assess patient safety and the ongoing need for virtual patient safety monitoring every shift/as needed and will document it. (Observation, medical record review, and interview indicated that the virtual patient safety monitor observer does not have the ability to document their observations and/or conversations with onsite clinical staff, in the electronic medical record). Review on 04/24/24 of the policy “Documentation of Patient Care-Adult/Pediatric,” revised 02/21/22, indicated that patient documentation in the electronic medical record is continuous from admission through discharge from the hospital. The registered nurse collaborates with the medical team for all components of the nursing process and for its implementation and documentation. Clinical notes are written by the registered nurse for changes in patient condition not noted elsewhere, for an invasive procedure, inability to carry out a provider order if the patient refuses, and the patient’s response to interventions such as: improvement, no change, deterioration, compliance or noncompliance to the plan or care. Clinical notes should be written to describe observations and interventions that are not charted elsewhere. These include actions and interventions not specifically outlined in the standard care plan or protocols, immediate actions taken to manage a critical event, inability to carry our specific planned interventions from the standard of care, significant communication with the provider, and patient/caregiver education. Review on 04/24/24 of the medical records and virtual (remote) patient safety monitor observation documentation revealed the following: -From 02/23/24 to 02/26/24, a virtual patient safety monitor observer was implemented by nursing staff due to Patient #1 being confused, non-redirectable, and at risk for falls and pulling out their feeding tube. On 02/26/24 at 01:21 PM, Patient #1 was pronounced deceased, and virtual patient safety monitoring observation was discontinued. -From 02/17/24 to 02/24/24, a virtual (remote) patient safety monitor observer was implemented for Patient #2 due to a fall risk. On 02/24/24 at 10:58 PM, the virtual patient safety monitoring observation was discontinued, and Patient #2 was put on a 1:1 in-person sitter. -From 03/06/24 to 03/21/24, a virtual patient safety monitor observer was implemented by nursing staff for Patient #8 due to a fall risk. On 03/21/24 at 03:04 PM, virtual patient safety monitoring observation was discontinued. -From 04/12/24 to 04/15/24, a virtual patient safety monitor observer was implemented by nursing staff for Patient #9 due to seizures. On 4/15/24 at 10:26 AM, virtual patient safety monitoring observation was discontinued. -From 02/24/24 to 02/28/24, a virtual patient safety monitor observer was implemented by nursing staff for Patient #15 due to being anxious and trying to get out of bed. On 4/15/24 at 10:26 AM, patient safety observation monitor was discontinued. On 02/28/24 at 12:25 PM virtual patient safety monitoring observation was discontinued. -From 04/21/24 to 04/23/24, a virtual patient safety monitor observer was implemented by nursing staff for Patient #18 due to confusion. On 4/23/24 at 10:26 AM, virtual patient safety monitoring observation was discontinued when Patient #18 was transferred to another facility. -From 04/23/24 to 04/24/24, a virtual patient safety monitor observer was implemented by nursing staff for Patient #20 due to agitation and attempting to get out of bed. On 4/24/24 at 03:07 PM, virtual patient safety monitoring observation was discontinued when Patient #20 was transferred to a higher level of care. -On 04/17/24, a virtual patient safety monitor observer was implemented by nursing staff for Patient #21 due to seizures. On 4/17/24 at 01:47 PM, virtual patient safety monitoring observation was discontinued when Patient #21 was discharged. (Nursing staff do not have access to the virtual (remote) patient safety monitor observer documentation. No documentation was found in the medical records to indicate virtual (remote) patient safety monitoring was in place, there were no conversations/reports between the nursing staff and virtual (remote) patient safety monitor observer, no documentation of hourly observations by the virtual (remote) patient safety monitoring observer, and no nursing assessment of the ongoing need for the use of a virtual patient safety observer each shift). Interview on 04/23/24 at 03:05 PM, Staff (O), Registered Nurse, revealed they are unable to see any documentation from the virtual patient safety observer in the electronic medical record. Interview on 04/24/24 at 09:35 AM, Staff (J), Director of Nursing, revealed once the patient is on virtual patient safety monitoring, the nurse would communicate to the assigned patient safety monitoring observer each shift for parameters (of care). The nurse is responsible for writing a clinical note every shift regarding virtual patient safety monitoring is in place and any events that occurred. Staff (J) did not review Patient #1’s chart but thought the virtual patient safety monitor alarmed to alert staff of Patient #1 vomiting. Interview on 04/24/24 at 01:00 PM with Staff (E), Director of Regulatory Affairs revealed virtual (remote) patient safety monitoring observer documentation is not entered into the electronic medical record. The [contracted virtual patient monitoring company] and Buffalo General Medical Center have a shared drive that can be viewed by hospital administration. The shared drive does not link into the electronic medical record. Nursing staff on the floor do not have access this this information. Findings #2: Review of the policy “Virtual Patient Safety Observation,” last revised 01/22/24, indicated that virtual (remote) patient safety monitoring does not require signed patient consent. Before monitoring is initiated, the patient and family should receive verbal education about virtual patient safety monitoring. Documentation of successful education should be documented in the patient’s medical record. Review of the document “Patient’s Bill of Rights in a Hospital,” dated 02/2019, revealed as a patient in a hospital in New York State, “you have the right to receive complete information about your diagnosis, treatment, and prognosis; to receive all the information you need to give informed consent for any proposed procedure or treatment; and to participate in all decisions about your treatment.” Medical record review on 04/24/24 revealed a virtual (remote) patient safety monitoring observer was implemented, however, there is no evidence that the patient and/or their representative were informed and/or educated on the use of the virtual observation for eight of eight patients: Patient #1 from 02/23/24 to 02/26/24, Patient #2 from 02/17/24 to 02/24/24, Patient #8 from 03/06/24 to 03/21/24, Patient #9 from 04/12/24 to 04/15/24, Patient #15 from 02/24/24 to 02/28/24, Patient #18 from 04/21/24 to 04/23/24, Patient #20 from 04/23/24 to 04/24/24, and Patient #21 on 04/17/24. Interview on 04/24/24 at 09:35 AM, Staff (J), Director of Medical Surgical Nursing, revealed that there is no consent needed from a patient and/or their family. The patient and/or their family should be educated regarding the use of the virtual safety patient monitoring. Interview on 04/23/24 at 10:45 AM, Staff (G), Registered Nurse, revealed that before initiating the virtual safety patient monitoring, the patient and the family are notified. The patient and/or the family would be educated on the need for virtual safety patient monitoring. If they refuse the monitoring, an in-patient sitter will be utilized.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 49420 Based on policy review, medical record review, and interview, in one of one medical records reviewed, it was determined that staff failed to file an incident/adverse event report (“STARS”) and investigate the unexpected death per hospital policy (Patient #1). Finding include: Review on 04/25/24 of the policy “Serious Events”, last revised 09/01/21, revealed it is policy to ensure a prompt, thorough and credible investigation, including action when a serious event occurs to facilitate quality care and treatment for patients. A serious event is defined as an event that has resulted in an unanticipated death or major permanent loss of function, not related to the natural course of the patient’s illness or underlying condition and/or the event is listed on the New York State Department of Health-New York Patient Occurrence and Tracking System reportable code list. Immediately upon discovering the occurrence of an unexpected adverse event, the staff member is to notify their supervisor. The supervisor is to notify the site president and the risk management department of the occurrence. If a medical device may have caused or contributed to this, complete a “STARS,” adverse event report. The supervisor is to complete the internal event report. The manager of the department will interview patients and/or families who are willing and able to gather evidence regarding the event. The manager for regulatory affairs will initiate with the site president, the site chief medical officer, the site chief nursing officer, and the site chief quality and safety officer an initial assessment to determine if the event meets the definition and criteria to be considered a serious event. If it is determined that the event meets criteria for a New York Patient Occurrence Report Tracking System, the manager for regulatory affairs, the site chief quality and safety officer, chief medical officer, and the chief nursing officer will conduct a full root cause analysis by convening a site investigatory team composed of the various disciplines applicable to the event. Review of the policy “The Role and Responsibility of the Sitter Assignment - Acute Care Sites” last revised 10/27/22 indicated a bedside attendant or companion is a caregiver who provides combative, confused, distressed, or patient at risk of falling, supervision with companionship and care. A bedside attendant or companion for non-suicidal/homicidal patients in need of a sitter requires a provider order. Review on 04/23/24 of the medical record and virtual patient safety observer documentation (not part of the medical record) for Patient #1 dated 01/27/24 to 02/26/24 revealed: -On 02/23/24 at 06:31 AM, Staff (N), Physician Assistant ordered bedside (in-person, constant observation) sitter due to behavior and did not add a comment indicating that a virtual sitter could be used. -From 02/23/24 at 07:00 AM through 02/26/24 at 01:00 PM, a virtual patient safety monitor observer was implemented by nursing staff instead of a bedside (in-person, constant observation). Patient #1 was confused, non-redirectable, and at risk for falls and pulling out their feeding tube. (No order and/or documentation was found to indicate the use of a virtual patient safety observer was approved by the physician for Patient #1). -From 02/23/24 to 02/26/24, nursing staff documented that Patient #1 had an alerted mental status, forgetful of limitations, and was dependent for all care. Staff assigned as the virtual safety monitor observer documented that intermittently, Patient #1 was anxious, restless, sliding down in the bed, and attempting to get out of bed. -On 02/26/24 at 01:51 AM, the virtual safety patient monitoring observer documented that Patient #1 was anxious in bed, moving around a lot. They attempted to redirect Patient #1 and staff came into the room to assist. At 07:51 AM, virtual patient safety monitor sounded the alarm. At 09:47 AM, Patient #1 was restless. At 09:55 AM, Patient #1 was attempting to get out of bed. They attempted to redirect Patient #1 without success and sounded the alarm. Staff immediately came to the room to assist Patient #1. At 10:00 AM, 10:31 AM, 11:11 AM, and 12:04 PM, Patient #1 was awake and restless. At 11:43 AM, staff took off Patient #1’s mitts and did not put back on. At 12:27 PM, a provider checked on Patient #1At 12:58 PM, the alarm was activated. -On 02/26/24 at 08:00 AM, Staff (O), Registered Nurse documented Patient #1 was alert, awake and confused, would forget limitations, and was depended for all care including incontinence care. The head of the bed was elevated due to the continuous feeds (to prevent aspiration). At 11:40 AM, Staff (O), Registered Nurse documented that Patient #1’s feeding tube was assessed, had continuous feeds infusing, with no complications. At 12:59 PM, code blue was called. At 01:21 PM, Patient #1 was pronounced deceased by the physician. At 01:41 PM, Staff (CC), Physician documented Patient #1 expired at 01:21 PM from an aspiration event followed by cardiac arrest. At 02:58 PM, Staff (O), Registered Nurse documented that the visual patient safety monitor alarm went off notifying staff that something was wrong with Patient #1. Patient #1 was found with stomach contents coming out of their mouth, was unresponsive, was not breathing, and was pulseless. Cardiopulmonary resuscitation was started, and a code blue (medical emergency requiring resuscitation)was called. Patient #1 was pronounced deceased at 01:21 PM. At 07:44 PM, Staff (LL), Hematologist documented (addendum) Patient #1 was examine earlier in the day, was awake but not alert, and was encephalopathic (disorder that affects the brain and causes altered mental status). Patient #1 was not following commands and continued to move a lot in the bed. Interview on 04/23/24 at 03:05 PM, Staff (O), Registered Nurse, revealed that a virtual patient safety monitoring was used on Patient #1 due to being a fall risk. Staff (O) was unaware that the sitter order was for bedside (in-person, constant) sitter. Patient #1 was on continuous tube feeds (feeding tube into the stomach) and kept slipping down in the bed. Patient #1 required to be boosted up in the bed every ten minutes. While Staff (O) was in another patient’s room, the virtual patient safety monitoring alarm sounded meaning there was an immediate concern with Patient #1. Staff (P), Registered Nurse, found that Patient #1 had slid down in the bed, had gastric contents coming out of their mouth, was pulseless, and was not breathing. A code was called, and Staff (P), Registered Nurse started cardiopulmonary resuscitation with chest compressions. Staff (O) stated that they were in the room just ten minutes prior to the event and had to boost Patient #1 up in bed at that time. Patient #1’s mental status was alert, only spoke one-word answers with painful stimulation, and was not redirectable. Patient #1 had fall precautions in place that included the bed placed in the lowest position, wearing yellow socks/wristband, and a bed alarm was on. Staff (O) stated that Patient #1 was very restless and would have been better with an in-person bedside sitter. Staff (O) was unable to see any documentation from the virtual patient safety observer in the electronic medical record. Interview on 04/23/24 at 03:20 PM, Staff (P), Registered Nurse, stated that Patient #1 was restless and moving in the bed a lot. During the 02/26/24 shift, the bed alarm and virtual patient safety monitoring alarm went off about three times due to Patient #1 constantly sliding down in the bed. Staff (P) heard Patient #1 ’ s virtual patient safety monitoring alarm go off at about 12:45 PM. When Staff (P) entered the room, Patient #1 was in cardiac arrest with stomach contents on them. Staff (P) felt that Patient #1 should have had an in-patient sitter instead of the virtual patient safety monitoring. Interview on 04/24/24 at 08:55 AM, Staff (N), Physician Assistant, revealed if a patient was not redirectable, virtual patient safety monitoring observation would not be used. Interview on 04/24/24 at 09:35 AM, Staff (J), Director of Nursing, revealed there was no event report done because the virtual patient safety observer’s response was appropriate; they sounded the alarm to alert the nursing staff of a problem. Patient #1event did not meet reporting criteria. Staff (J) would initiate an incident report or the New York Patient Occurrence Reporting and Tracking System report for any event that meets the reportable criteria. Staff were upset that Patient #1 coded while being monitored by a virtual sitter and if Patient #1 had an in-person sitter, maybe the event would not have happened. Interview on 04/24/24 at 10:42 PM with Staff (E), Director of Regulatory Affairs revealed there was no event report completed for Patient #1 because aspiration was the assumption of cause of death and would not be something that would be reported. Interview on 04/25/24 at 11:47 AM with Staff (C), Chief Quality & Patient Safety Officer revealed the only review completed for the 02/26/24 event was a mortality review. If a cause for concern was identified, the quality team would have been notified for a full review. Based on what was written in the mortality review, (no documentation of Patient #1 ’ s aspiration) there was no cause for concern. If there was a cause for concern, an immediate conversation would have been conducted between Staff (C) and Staff (JJ), Kaleida Health Chief Quality Officer. Patients aspirate in many different settings and at different times of their hospitalization. The aspiration event of Patient #1 was not a concern that would have a further quality review. Staff (C) stated that if an event occurred while a patient is on the virtual monitor, an incident report would be completed by the staff and the manager would review. Staff (C) was unaware that the providers progress note indicated aspiration as the cause of Patient #1’s death. The mortality report for Patient #1 indicated that no further review was necessary. Interview on 04/25/24 at 01:50 PM with Staff (B), Chief Nursing Officer, revealed that they were unaware that Patient #1 expired due to aspiration. Staff (B) stated that aspiration was not noted on the mortality report, so they did not investigate it. Patient #1’s death was reviewed by quality but there were no significant findings. Many patients aspirate and aspiration could be expected for any patient depending on the diagnosis and treatment.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 49420 Based on policy review, medical record review and interview, nursing staff did not monitor and/or implement measures to prevent patient skin breakdown and did not notify the provider of worsening skin integrity for three of three patients (Patient # 1, #14, and #16). Failure to monitor skin integrity has the potential for an adverse patient event. Findings include: Review on 02/21/24 of policy “Pressure Injury Prevention and Management” last revised 03/20/23 revealed an evaluation of skin integrity, from head to toe, anterior and posterior surfaces, skin temperature, edema, change in tissue consistency in relation to surrounding tissue and the presence of pressure injuries would be completed and documented on upon admission and discharge, once every shift and with any significant change in patient condition. Without any prevention an at-risk patient can develop skin breakdown within one to two hours. Prevention methods include support surface that meets the patient’s needs, elevation of heels completely off surfaces, turning and reposition at least every two hours in bed, use the 30 degree tilted side-lying position (alternating from right side to back to left side) or the prone position, reposition every hour when a patient is in a chair, reposition tubes throughout the shift, manage friction, shear, and excessive moisture, provide nutritional support, and apply prophylactic dressings to bony prominences. Continue to turn and reposition the individual regardless of the support surface in use. Assess a pressure injury when changing the dressing for wound bed type, amount and consistency of exudate, odor, tunneling/undermining, surrounding skin and pain. Measure length, width, depth, tunnels (passageways formed underneath the surface of the skin) or undermining (erosion occurring underneath the visible wound resulting in more extensive damage beneath the skin surface) weekly and document in the medical record. Send a wound enterostomal therapy nurse referral if a pressure injury is present for staging and recommendations. The provider must prescribe all wound care for stage three and stage four pressure injuries, unstageable and suspected deep tissue injuries or wounds that require packing. Report the following situations to the provider: the presence of any and/or additional pressure injury incidence, any injury that has deteriorated in appearance, stage, or presence of necrotic (dead) tissue, signs, and symptoms of a wound or systemic infection, or poor response to the current treatment following two weeks of consistent therapy. Review of Patient #1 medical record from 08/25/23 thru 10/04/23 revealed the following: -On 08/25/23 at 05:35 PM, the nurse’s initial admission skin assessment stated that Patient #1 did not have any pressure ulcers on admission. At 05:37 PM, the physician’s history and physical stated that Patient #1’s skin had an occipital chronic non-healing wound and an open left frontal cranial wound. -From 08/26/23 through 08/27/23, daily (every 12 hours) nursing documentation revealed no indication that Patient #1 had pressure ulcers. -On 08/28/23 at 02:08 PM, the registered nurse requested a wound and skin referral for a sacral pressure ulcer (a shield-shaped bony structure that is located at the base of the lumbar vertebrae and that is connected to the pelvis) however, there is no evidence that the nurse communicated to the provider regarding the sacral pressure ulcer or for treatment orders. -From 08/29/23 to 09/01/23, daily (every 12 hours) nursing documentation noted the sacral wound was present. There is no evidence that the nurse communicated to the provider regarding the pressure ulcer. The daily provider notes lacked documentation of a sacral pressure ulcer. -On 09/02/23 at 05:47 PM, a wound care consult was conducted. Patient #1 had a right lower buttock deep tissue injury that was not present on admission. Venelex ointment (an ointment that is used on the skin to cover wounds) was recommended three times a day for skin protection and to leave the wound open to air. The provider was notified, and the care recommendations were approved. The consult was completed. The wound was to be managed by the primary team on an ongoing basis. -From 09/03/23 to 09/12/23, the nursing shift documentation noted the sacral ulcer as a deep tissue injury. There was no documented evidence that the ulcer had evolved to an unstageable ulcer. -On 09/12/23 at 05:01 PM, a wound care consult was conducted. A sacral ulcer was not present on admission had evolved to an unstageable ulcer. The primary team was notified, and the wound was to be managed by the primary team on an ongoing basis. -From 08/25/23 to 10/03/23 the nurse’s documentation every shift (every 12 hours) included skin assessments. Patient #1 sacrum was intact until 08/28/23. Patient #1 was repositioned every two hours and was on an alternating air mattress with pillows to assist with body position. Review of Patient #14 medical record from 01/13/24 thru 02/02/24 revealed the following: -On 1/13/24 at 10:46 AM, the nurse’s initial admission skin assessment stated that Patient #14’s skin was pink, warm, and dry, and intact. At 12:11 PM, the physician’s history and physical stated that Patient #14’s skin was intact, warm, and dry, and no rashes. -From 01/13/24-01/24/24, the nursing shift documentation noted Patient #14’s skin was pink, warm, dry, and intact. -On 01/25/24 at 09:51 AM, the registered nurse requested a wound and skin referral for a sacral pressure ulcer (a shield-shaped bony structure that is located at the base of the lumbar vertebrae and that is connected to the pelvis). The nurse documentation noted the pressure ulcer however, there is no evidence that the nurse communicated to the provider regarding the sacral pressure ulcer or for treatment orders. -From 01/25/24 to 01/26/25 the nursing documentation noted that the sacral wound was present. There was no evidence that the nurse notified the provider of the pressure ulcer. The daily provider notes lacked documentation of a sacral pressure ulcer. -On 01/27/24 at 11:42 AM, a wound care consult was conducted. Patient #14 had one sacral unstageable pressure ulcer and a stage one sacral pressure ulcer that were not present on admission. Recommendations for treatment included to cleanse the sacrum with Vashe (wound cleanser), apply Calmoseptine lotion (protects and heals skin irritation) twice a day as needed, and place an abdominal pad (thick gauze pad used to treat large wounds or wounds with drainage) for added comfort and protection without tape. Recommendations to nursing were to turn and position Patient #14 every two hours and as needed, and to offload pressure to sacrum with wedges and pillows. The wound care consult was completed. The wounds were to be managed by the primary team on an ongoing basis. Reconsult the wound team as needed. The primary team and nurse were notified of the recommendations. The wound recommendation orders were co-signed by the provider. -From 01/25/24 to 02/02/24, the daily provider notes state skin is intact. There was no evidence that the provider was aware of the sacral pressure injury. -From 01/13/24 to 02/02/24 the nurse’s documentation every shift (every 12 hours) included skin assessments. Patient #14’s skin was intact until 01/25/24. After this the nurses documented treatments completed to the ulcers in their shift assessments. Patient #14 was repositioned every two hours and was on an alternating air mattress. Review of Patient #16 medical record from 12/18/23 thru 02/21/24 revealed the following: -On 12/18/23 at 07:37 PM, the provider’s history and physical stated that Patient #16’s skin was not intact. Patient #16 had wounds on both hands and multiple healing ulcers on both lower extremities. -On 12/18/23 at 09:56 PM, the provider ordered a wound and skin referral due to wounds on both hands. -On 12/19/24 at 12:00 PM, the nurse’s initial admission skin assessment stated that Patient #16’s had wounds on both hands. -On 12/20/23 at 04:18 PM, the nurse requested a wound and skin referral due to wounds on both hands. -From 12/20/23-01/01/24, the nursing shift documentation noted non-pressure abscesses (swollen area within the body tissue containing an accumulation of pus) and all other skin was intact. -On 12/23/23 at 09:52 AM, wound care consult was conducted. Recommendations were provided for treatment of hand wounds. Patient #16 was noted to have intact skin on heels and sacrum and no redness. -On 01/02/23 the nurse documented the redness to the sacrum and a foam protective dressing was applied. There was no evidence that the nurse notified the provider of the pressure ulcer. The provider notes lacked documentation of a sacral pressure ulcer. -On 01/03/23 the nurse documented a deep tissue injury on the sacrum and foam protective dressing intact that the sacral wound was present. There was no evidence that the nurse notified the provider of the pressure ulcer. The provider notes lacked documentation of a sacral pressure ulcer. -From 01/04/23 to 01/10/23 the nursing shift documentation noted a deep tissue injury on the sacrum with a foam protective dressing intact. There was no evidence that the nurse notified the provider of the pressure ulcer. The provider notes lacked documentation of a sacral pressure ulcer. -On 01/06/24 at 11:30 PM, the registered nurse requested a wound and skin referral due to a deep tissue injury on the sacrum. -On 01/10/24 at 06:51 PM, wound care consult conducted. There was an unstageable pressure ulcer on the sacrum that was not present on admission. Recommendations for treatment were to clean with Vashe (cleansing solution) and apply a nickel thick layer of Santyl (ointment that removes dead tissue from wounds) to scattered tan slough (dead tissue). The ulcer was to be covered with Vashe (cleansing solution) moistened gauze and covered with an abdominal pad twice a day and as needed for drainage. Bilateral heels were intact with boggy (abnormal texture of tissue) blanchable pink. While in bed heel protection boots were to be applied. The wound care consult was completed. The wound was to be managed by the primary team on an ongoing basis. Reconsult the wound team as needed. The recommendations were communicated to the nurse and the primary team. The wound recommendation orders were co-signed by the provider. -From 01/10/24 to 01/19/24 the nursing shift documentation noted the sacral ulcer. The documentation lacked evidence of the pressure injury to Patient #16’s heels. -On 01/17/23 at 06:00 PM, the provider requested a wound and skin referral due to pressure ulcers. -On 01/19/24 at 03:29 PM, the wound care consult was conducted. Two heel pressure ulcers were noted that were not present on admission. The left heel had a stage two (a shallow open ulcer with a red or pink wound bed) pressure ulcer, and the right heel had a stage one (pressure-related alteration of skin with non-blanchable redness over a bony area) pressure ulcer. No treatment plan or interventions were documented. No documentation related to the sacral pressure ulcers was noted. The wound care consult was complete. The wound was to be managed by the primary team. -From 01/19/24 at 08:00 PM, the nursing shift documentation noted the bilateral heel ulcers for the first time. -From 01/06/23 to 01/20/24, the daily provider notes did not document the sacral pressure injury or heel pressure injuries. - From 12/19/23 to 02/21/24 the nurse’s documentation every shift (every 12 hours) included skin assessments. Nurses documented treatments completed to the wounds and ulcers in their shift assessments. Patient #16 was repositioned every two hours and was on an alternating air mattress. Pillows and foam wedges were used to keep Patient #16 in desired body position. Patient #16’s heels were floated off the bed. Interview on 02/21/24 at 04:35 PM with Staff (W), Wound Registered Nurse, revealed the wound care team follow the care of patients that have a wound vacuum in place. The wound care team would not follow the care of a patient that had an unstageable wound. During a consult, the wound care team would recommend treatments for the care of the wound to the provider. The wound care team would then sign off and have the primary team follow the care of the wound. A 0.7 cm by 1 cm by 0 cm wound may be able to heal within a month of time. When providing a wound consult, if a nutrition consult was not ordered Staff (W) would request the consult. Interview on 02/22/24 at 11:56 AM with Staff (A), Chief Nursing Officer and Staff (PP), Director of Regulatory Affairs, confirmed these findings and revealed there is no formal policy for a wound nurse consult. The expectation is that the wound nurse would complete the wound consult within 24 hours. Interview on 02/22/24 at 12:00 PM with Staff (B), Chief Quality and Patient Safety, confirmed these findings and revealed the wound nurse consult is to provide recommendations to the primary provider. The wound nurse would then turn care of the patient over to the primary provider to follow through on the care. The wound nurse is not expected to follow up with care on a wound. When another wound consult is ordered, the wound nurse would provide another consult. The wound nurse follows the care of patients that have wound vacs in place. There is not a policy for a wound nurse consult.”

“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 observations, policy review, medical record review, document review, and interviews, the facility failed to adhere to facility policies. 1. The facility failed to implement policies to ensure expired supplies are not utilized in the ED. 2. The facility failed to make an incident report for the transfer of Patient #2 to the unintended facility. 3. The facility failed to document the appropriate receiving facility on the transfer document. Findings #1: Review of the policy “Non-Conforming Product/ Services Document Procedure,” last revised 08/08/12 indicated that all hospital personnel are responsible for identifying nonconforming services and notifying management of nonconformance. Examples of nonconforming product is out of date shelf-life materials. Observations on 02/21/24 at 10:14 AM in the emergency department supply room revealed four (4) 1000 ml bags of 5% Dextrose and 0.45% Sodium Chloride Injection solution with an expiration date of January 2024. Interview on 02/21/24 at 10:14 AM with Staff (H), Emergency Department Nurse Manager, verified the findings. Findings #2: Review of the policy “Corporate Event Reporting,” last revised 12/22/99 indicated that when an event occurs that did result or could have resulted in an adverse development in a patient’s condition, whether an inpatient or outpatient, the web-based event reporting system (STARS) must be accessed, and a report entered. Review of the Buffalo General Hospital medical record for Patient #2 revealed the following: -On 8/18/23 at 08:12 PM Patient #2 presented to the emergency department for status post left ventricular assistive device (pumps blood from the lower left heart chamber) site with oozing. At 08:16 PM, Patient #2 was triaged. At 09:15 PM a medical screening examination was conducted and concluded that review of Patient’ #2’s cat scan (image of body tissues) chest noting asymmetric enlargement with large acute intramuscular hematoma, Case discussed with left ventricular assistive device (pumps blood from the lower left heart chamber) team and emergency room physician at Rochester General Dr. Higgins excepts transfer of Patient #2. Patient #2will be transferred to Rochester General -On 08/19/23 at 05:39 AM, the acute transfer form indicated Patient #2 was stable and was to be transferred due to an “infection,” and transferred via ambulance for a higher level of care to the left ventricular device (pumps blood from the lower left heart chamber) team treating Patient #2. A physician from Rochester General Hospital was listed as the accepting provider. Report between the sending and receiving registered nurses was documented listing a phone number for the Rochester General Hospital triage registered nurse. Patient #2 consented to the transfer. -On 08/19/23 at 10:38 AM, Staff (DD), Registered Nurse was given report by the night registered nurse that the transfer of Patient #2 to “Rochester Strong” was set up. The paperwork indicated that Patient #2 was going to Strong Memorial Hospital. At 07:50 AM, emergency medical services arrived (at Buffalo General Hospital) to transport Patient #2. Emergency medical services arrived at Strong Memorial Hospital and noted that the transfer was supposed to go to Rochester General Hospital instead. The emergency medical services supervisor came back to the hospital to obtain a new physician certification statement of medical necessity form for the ambulance transportation to Rochester General Hospital. Staff (DD), spoke to “Cindy” at Rochester General Hospital when Patient #2 arrived. The charge nurse was made aware of the situation. (Patient #2 was initially brought to Strong Memorial Hospital instead of Rochester General Hospital as ordered). -On 08/19/23 (no time), the “Physician Certification Statement of Medical Necessity” form for ambulance transportation revealed the transfer destination as “Rochester- Strong” for left ventricular assistive device services not available at the hospital. Patient #2 required cardiac and hemodynamic monitoring during the transport. The form was signed by Staff (GG), Physician. (This form was documented for the initial transfer and indicates “Rochester-Strong” as the transfer destination. The intended destination was Rochester General Hospital. Emergency medical services brought Patient #2 to Strong Memorial Hospital instead of Rochester General Hospital). -On 08/19/23 (no time), the “Physician Certification Statement of Medical Necessity” form for ambulance transportation revealed the transfer destination as Rochester General Hospital for left ventricular assistive device services not available at the facility. Patient #2 required cardiac and hemodynamic monitoring during the transport. The form was signed by Staff (DD), Registered Nurse. (This form was documented to change the destination from Strong Memorial Hospital to the intended Rochester General Hospital after Patient #2 was initially taken to Strong Memorial Hospital) Review of the incident report log from August 2023 to January 2024 revealed no incident reports pertaining to Patient #2. Interview on 02/22/24 at 09:59 AM with Staff (DD), Registered Nurse revealed the paperwork for Patient #2 was filled out and ready. Staff (DD) called Rochester General Hospital to confirm Patient #2 had arrived but was informed that emergency medical services brought Patient #2 to Strong Memorial Hospital instead. Patient #2 refused to get out of the ambulance indicating that they were being treated at Rochester General Hospital for the left ventricular assistive device. Patient #2 was taken to Rochester General Hospital. The emergency medical services supervisor was notified, and a new transfer form was completed by Buffalo General Hospital staff and handed to the supervisor. Staff (DD) indicated that this appeared to be a documentation issue, as all reports were with Rochester General Hospital, where Patient #2 was accepted. Interview on 02/22/24 at 09:29 AM with Staff (B), Chief Quality & Patient Safety Officer verified these findings and revealed that after the discovery of Patient #2 being sent to Strong Memorial Hospital versus the intended facility of Rochester Memorial Hospital, someone should have reviewed it. No investigation or incident report was completed. Findings #3: Review of the policy “Patient Transfer and Medical Screening “last revised 04/07/01 indicated that an appropriate transfer must be carried out in an appropriate manner as follows: the transferring hospital must provide treatment to the individual within its capacity which minimizes the risks to the individual’s health; the transferring hospital should obtain agreement from a receiving facility that it has available space and qualified personnel to treat the individual and that it will accept the transfer and provide appropriate treatment; all medical records related to the emergency condition with which the individual has presented must be sent with the individual if available at the time of transfer. The written document must indicate the individual has been informed of risks and benefits of the transfer and state the reason for the individual’s refusal. Review of the Buffalo General Hospital medical record for Patient #2 revealed the following: -On 08/18/23 at 08:12 PM, Patient #2 presented to the emergency department for status post left ventricular assistive device (pumps blood from the lower left heart chamber) site with oozing. At 08:16 PM, Patient #2 was triaged. At 09:15 PM a medical screening examination was conducted and concluded that review of Patient’ #2’s cat scan (image of body tissues) chest noting asymmetric enlargement with large acute intramuscular hematoma, Case discussed with left ventricular assistive device (pumps blood from the lower left heart chamber) team and emergency room physician at Rochester General Dr. Higgins excepts transfer of Patient #2. Patient #2 will be transferred to Rochester General -On 08/19/23 at 05:39 AM, the acute transfer form indicated Patient #2 was stable and was to be transferred due to an “infection,” via ambulance for a higher level of care to the left ventricular device (pumps blood from the lower left heart chamber) team treating Patient #2. A physician from Rochester General Hospital was listed as the accepting provider. Report between the sending and receiving registered nurses was documented listing a phone number for the Rochester General Hospital triage registered nurse. Patient #2 consented to the transfer. -On 08/19/23 (no time), the “Physician Certification Statement of Medical Necessity” form for ambulance transportation revealed the transfer destination as “Rochester- Strong” for left ventricular assistive device services not available at the hospital. Patient #2 required cardiac and hemodynamic monitoring during the transport. (This form was documented for the initial transfer and indicates “Rochester-Strong” as the transfer destination. The intended destination was Rochester General Hospital. Emergency medical services brought Patient #2 to Strong Memorial Hospital instead of Rochester General Hospital). -On 08/19/23 at 10:38 AM, Staff (DD), Registered Nurse was given report by the night registered nurse that the transfer of Patient #2 to “Rochester Strong” was set up. The paperwork indicated that Patient #2 was going to Strong Memorial Hospital. At 07:50 AM, emergency medical services arrived (at Buffalo General Hospital) to transport Patient #2. Emergency medical services arrived at Strong Memorial Hospital and noted that the transfer was supposed to go to Rochester General Hospital instead. The emergency medical services supervisor came back to the hospital to obtain a new physician certification statement of medical necessity form for the ambulance transportation to Rochester General Hospital. Staff (DD), spoke to “Cindy” at Rochester General Hospital when Patient #2 arrived. The charge nurse was made aware of the situation. (Patient #2 was initially brought to Strong Memorial Hospital instead of Rochester General Hospital as ordered). Interview on 02/22/24 at 09:59 AM with Staff (DD), Registered Nurse revealed the paperwork for Patient #2 was filled out and ready. Staff (DD) called Rochester General Hospital to confirm Patient #2 had arrived but was informed that emergency medical services brought Patient #2 to Strong Memorial Hospital instead. Patient #2 refused to get out of the ambulance at Strong Memorial Hospital indicating that they were being treated at Rochester General Hospital for the left ventricular assistive device. Patient #2 was taken to Rochester General Hospital. Interview on 02/21/24 at 10:14 AM with Staff (H), Emergency Department Nurse Manager, verified the findings.”