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Based on policy review, medical record review, document review, and interview, in one of one medical records reviewed, it was determined that nursing staff failed to implement the provider's order for a sitter at the bedside (in-person, constant observation), instead implemented virtual safety monitoring (remote patient monitoring via camera) (Patient #1).

Cross Reference:
482.13(c)(2): The patient has the right to receive care in a safe setting.

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.

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.

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.