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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QAPI was out of compliance.

A-0286 Standard: Program Scope. 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. The hospital must measure, analyze, and track ...adverse patient events ... Program Activities .....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. 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: ...That clear expectations for safety are established. Based on interviews and document review, the facility failed to analyze adverse patient safety events and implement preventive action in order to prevent reoccurrence, in four of seven patient safety events reviewed.

Based on interviews and document review, the facility failed to analyze adverse patient safety events and implement preventive action in order to prevent reoccurrence, in four of seven patient safety events reviewed.

Findings include:

Facility policies:

The Performance Excellence Plan for 2020 read, priorities for data collection include data on critical events or outcomes and potentially high risk or problem prone processes. Data is used to evaluate the effectiveness of improving processes or outcomes of care, improving patient safety, and reducing the risk of sentinel events. Data on critical processes and outcomes are collected and analyzed on a regular basis and action is taken as necessary with oversight by the Performance Excellence Committee. Each department and service line in the hospital is expected to participate in the hospital's performance excellence effort. This includes identification, assessment and improvement of critical processes and outcomes. This data should be used to identify improvement opportunities and demonstrate expected improvements are achieved. Actions are undertaken when planned improvements are not achieved or sustained.

Risk and safety events are reported via an electronic reporting system. Each event is reviewed by the Risk Management Department and follow-up conducted as indicated.

The Safety Event Identification, Analysis and Reporting policy read, the purpose is to outline the process for identifying, reporting and analyzing actual and near miss safety events. Reporting safety events is critically important to attaining a high reliability organization. An action plan to prevent recurrence is a document which lists measurable action item steps that must be taken in order to prevent a safety event, and should include both process and measurable outcomes. Action items are monitored at regular intervals to determine effectiveness or identify need to review actions.

The online safety event reporting system is used for reporting, identifying, tracking, trending and analyzing safety events. A patient safety event is an event not consistent with routine patient care, accepted performance standards, or facility procedures which either did or could result in injury or loss to a patient. Associates will report potential safety events via the online event reporting system.

Department Leader is to conduct initial review and investigation of patient safety events and complete follow-up. The risk manager is to conduct the initial review and investigation of the patient safety event and assign follow-up to others. The Department Leader is to read, understand, investigate and document follow-up. Every reasonable effort should be made to complete the above steps within three business days of the patient safety event.

The Fall Prevention and Post Fall Management policy read, Assessment, intervention, documentation and evaluation promote proactive healthcare practices for patient care planning to minimize the risk for falls. All inpatients will be assessed for fall risk utilizing the Morse Fall Risk assessment tool. For all high fall risk patients, implement the following measures. High Fall Risk Interventions include but are not limited to: Appropriate alarm. A High Risk Fall patient is identified if their Morse score is equal to or greater than 50.

1. The facility failed to analyze patient safety events according to facility policy to evaluate processes, identify improvement opportunities and implement preventive action to prevent reoccurrence.

a. Review of two patient safety events categorized as falls revealed both falls involved patients who were on specialty beds. In both events, the bed exit alarms on the specialty beds were not correctly activated and the patients were found on the floor. Document and record review further revealed a third patient safety event occurred, in which a patient on a bariatric bed was found on the floor unresponsive and it was discovered the bed alarm was not correctly activated (Cross Reference 0395).

i. On 9/28/2, a patient safety event was reported on the surgical unit which nurse found the patient out of bed. The patient was naked on their knees and had their arms on the bed. A staff assist was called and the patient was assisted back into bed. The patient was on a specialty bed and the bed was not plugged in correctly. The report further read the patient was identified as a fall risk: the most recent Morse score for the patient was 95. According to the Fall Prevention policy, a score of 95, classified the patient as high risk for falls and warranted fall precautions to include appropriate alarms.

The Registered Nurse (RN) Shift Supervisor for the surgical unit (Supervisor) #11 entered a follow-up summary which read, the patient was a high fall risk but the alarm was not on when the patient was in bed. The documentation read, the specialty beds were not compatible with the hospital alarm system, and the bed alarms had to be manually turned on. The patient's primary nurse reported the bed alarm was not manually turned on. Supervisor #11 documented education was provided to the nursing staff about fall alarms, and staff were educated to place a different bed alarm device on specialty beds.

ii. On 12/13/21, a second patient safety event was reported on the surgical unit. The report read, staff heard a patient's pulse oximeter alarm and when staff checked on the patient the patient, he was lying on the floor on their side. The patient had gotten out of their specialty bed unattended, and the bed did not alarm. The report further read, the alarm on the specialty bed was activated but was not correctly activated to communicate with the hospital alarm system. The report read the patient was a fall risk and their last Morse score was 85. According to the fall prevention policy, a score of 85 was a high fall risk and warranted the use of fall precautions which included appropriate alarms.

Supervisor #11 entered a follow-up summary which read, the patient fell from a bariatric bed which was not compatible with the hospital alarm system. The documentation further read the unit had seen an increase in falls from bariatric beds. Supervisor #11 documented education was provided to staff and due to continued issues with the bariatric beds staff were told to place a different bed alarm device on every bariatric bed.

iii. The facility provided additional documentation related to the investigation and follow-up actions conducted in response to the two events which involved patients on specialty beds. The documentation included educational materials about fall prevention, which included an educational packet developed in July 2020 before either event occurred. In two emails sent on 2/17/21, Supervisor #11 wrote this education was reviewed as part of the follow-up for both events, and was an ongoing fall prevention education for staff on the surgical unit. The educational materials did not specifically address the use of fall alarms on specialty or bariatric beds.

iv. The additional documentation provided did not include investigation of the noted issues with bariatric and specialty beds and their incompatibility with the hospital alarm system, which was identified as a contributing factor to both patient safety events. In addition, the education which was provided to staff did not include education about the use of bed exit alarms on bariatric and specialty beds and was not implemented specifically in response to the patient safety events, but was already an ongoing educational initiative on the unit.

Furthermore, Supervisor #11 noted in her follow-up documentation for both events, staff were instructed to use a different bed alarm device on specialty and bariatric beds. However, there was no evidence this preventive action was reviewed to determine whether it was successful to prevent future falls. When a second event occurred on 12/13/20 the same preventive action was educated to staff without evidence it had been demonstrated effective after the first event on 9/28/20.

v. A third patient safety event occurred on 1/28/21. Review of the patient safety event report and the patient's medical record revealed the patient (Patient #2) was a high fall risk and required a bariatric bed. The patient was found unresponsive on the floor next to his bed and subsequently died.

A patient safety event report was entered on 1/29/21. The report read, at 7:50 p.m. on 1/28/21, the CNA entered Patient #2's room and found the patient lying on the floor next to the bed, between the bed and window. The patient was unresponsive, not breathing and did not have a palpable pulse.

Review of Patient #2's medical record revealed he required a specialty bariatric bed. The medical record also revealed Patient #2 was a high fall risk. On 1/28/21 at 9:00 a.m., a RN student documented Patient #2 was on a specialty bed with four side rails up for safety. The RN student further documented, the patient was on fall precautions, his gait and ability to transfer were weak, and he forgot his limitations. The RN student documented Patient #2's Morse Fall Risk score was 60, which according to facility policy indicated the patient was a high fall risk and required fall risk interventions.

The RN student completed an additional assessment at 11:00 a.m. The assessment read, fall interventions in place based on the patient's individual needs which included activation of bed alarm, and supervised ambulation.

b. The facility provided additional documentation related to the investigation conducted after the event when Patient #2 was found unresponsive on the floor. According to the documentation provided, the facility determined the bed alarm on Patient #2's bariatric bed was not correctly activated to the hospital alarm system and this was a contributing factor to the event. This had previously been identified as a contributing factor to the two similar events which occurred on 9/28/20 and 12/13/20. However, there was no evidence the preventive actions implemented in response to the first two events were monitored to ensure they were effective to prevent future falls, and a third event subsequently occurred.

c. Interviews with leadership responsible to investigate patient safety events revealed department leaders were expected to review safety events, implement preventive actions, and document their efforts to prevent future events. Interviews further revealed incomplete investigation and follow-up for the two patient safety events involving specialty beds potentially contributed to the third event when Patient #2 was found unresponsive on the floor.

i. On 2/18/21 at 9:00 a.m., the Patient Safety Program Manager (Manager) #12 was interviewed. Manager #12 stated she reviewed patient safety events reported through the online reporting system and she ensured the investigation and follow-up actions for the event were assigned to department leaders. Manager #12 stated department leaders were expected to review the event, document their findings and any preventive actions implemented within one week of the event. She stated she then reviewed the findings and closed the event within 30 days. She stated she did not close an event until she observed an effort toward improvement or prevention.

Manager #12 stated when a department leader reviewed an event, the leader was expected to verify the details of the event, the processes involved in the event, any harm which occurred, and how the leader planned to prevent future similar events. Manager #12 stated preventive actions were important to reduce the risk of harm to patients.

Manager #12 reviewed the patient safety event which occurred on 9/28/20. She stated the department leader who reviewed the event, Supervisor #11, determined the alarms on the specialty beds did not have the capability to connect to the hospital alarm system. She stated Supervisor #11 therefore instructed her staff to use a different bed alarm device instead. However, Manager #12 stated she did not know if this plan was monitored to ensure it was adhered to or effective to prevent future falls.

Manager #12 stated after the second event on 12/13/20 the department leader on the surgical unit was responsible to investigate the issues identified with bed alarms on specialty beds and to provide education to staff. Manager #12 stated when she reached out to the department leader on 1/22/21, an investigation had not yet been completed and preventive actions had not been implemented or monitored to prevent similar events. Manager #12 stated she took over the responsibility to investigate the issues identified with alarms on specialty beds because the manager needed help and had not been able to completely investigate the issue.

This was in contrast to Manager #12's statement in which department leaders were expected to investigate and document their findings within one week of the event, and Manager #12 was expected to review and close the event within 30 days after the event occurred.

Manager #12 stated when the events of 9/28/20 and 12/13/20 were investigated, the investigation was limited to the surgical unit where the events occurred. However, she stated because there were other units in the facility which used specialty beds, the discussion and review of the issues identified with alarms on specialty beds should have extended to other units in order to increase patient safety.

ii. On 2/17/21 at 1:00 p.m., the Director of Risk (Director) #6 and Director of Quality (Director) #7 were interviewed. Director #6 reviewed the events which occurred on 9/28/20 and 12/13/20. She stated Supervisor #11 assisted the nurse manager for the surgical unit to investigate and implement action in response to patient safety events on the unit. Director #6 stated Supervisor #11 investigated both events, and her determination at the time was the specialty beds were not compatible with the hospital alarm system. She stated Supervisor #11 therefore educated her staff to use a different bed alarm device for specialty beds.

Director #6 confirmed the education which Supervisor #11 provided to staff as part of her follow-up to the events on 9/28/20 and 12/13/20 was part of an ongoing educational initiative about fall prevention which had already been implemented prior to the events. She stated she was not aware of any other action which occurred immediately after the two events to investigate the issues identified with bed alarms on specialty and bariatric beds. However, Director #6 stated since the third event which involved a bariatric bed on 1/28/21, leadership discovered the specialty beds were compatible with the hospital alarm system.

iii. A second interview with Director #6 and Director #7 was conducted on 2/17/21 at 5:00 p.m. Director #6 stated safety events were reviewed to monitor for apparent trends. She stated department leaders and her department were responsible to act on any trends identified through patient safety events. She stated if trends were identified with specific processes, it was important to implement actions or changes to the process and then determine whether those changes were effective to improve the process. She stated this was part of the facility's work to improve responses to patient safety events.

Director #6 stated the facility had identified an issue regarding the use of bed alarms on specialty and bariatric beds. Director #6 stated when the first event on 9/28/20 occurred, Supervisor #11 believed the specialty beds were not compatible with the hospital alarm system. She stated Supervisor #11 then used current or previous education to respond to the event, and implemented an action to place a different bed alarm device on the bariatric beds to prevent future falls. Director #6 stated she did not know if this process had been monitored to determine whether it was effective to prevent falls.

Director #6 stated when a second similar event occurred in a relatively short period of time, the department leader should have determined the action plan from the first event was not effective to prevent the problem. Director #6 stated when the first action plan was shown to be ineffective a new action should have occurred. She stated this should have included auditing the use of the different bed alarm device on specialty beds or further investigation to determine whether the hospital alarm system could be used for specialty beds. She stated when the second event occurred the department leader could also have escalated the problem to other departments or leadership to identify different approaches to prevent recurrence of similar falls.

Director #6 stated it was her responsibility to assure follow-up to patient safety events was effective, and she stated this was important to impact patient safety.

d. Further review of patient safety events revealed two additional events in which the investigation or follow-up action was not completed according to facility policy in order to prevent reoccurrence.

i. On 1/10/2, a patient safety event report was entered for the surgical unit. The report read, a staff member entered a patient's room and found the patient with their nasal cannula (a tube used to deliver supplemental oxygen via a patient's nose) and supplemental oxygen off. The patient's oxygen saturations were 74%.The patient was placed on 3 liters per minute (LPM) of oxygen to bring the patient's oxygen saturations above 90%.

The follow-up summary entered by the department leader responsible to investigate the event read, the follow-up action was to educate and remind staff to trace lines and ensure patients' oxygen was turned on.

The facility provided additional documentation for the safety event which read, the department leader sent the information to the floor nurse for follow-up and reiterated the need to trace patient lines. There was no evidence this education to the nursing staff occurred, and there was no further documentation of analysis or preventive action conducted in response to this event.

ii. On 1/20/21, a patient safety event report was entered for the medical unit. The event report read, a patient was intermittently agitated and impulsive throughout the night. At 6:00 a.m., the patient's bed alarm sounded and the nurse responded, but did not arrive in time to prevent a fall. The patient had their blanket wrapped around their legs and when they stepped out of the blanket the patient fell and hit their head against the bathroom door.

The follow-up summary entered by the department leader responsible to investigate the event read, the patient was known to be impulsive and the fall occurred after staff attempted to manage the patient for seven days with the use of alarms and high risk fall precautions. The department leader documented the patient would have benefited from a sitter or lap belt to increase patient safety and minimize caregiver fatigue. However, the department leader identified staff were reluctant to implement these strategies because sitters were costly and could impact patient discharge planning. The department leader recommended team education and messaging was required to help prioritize patient safety in complex situations.

The facility provided additional documentation for the safety event which included minutes from two hospital safety huddles conducted on 1/20/21 and 2/1/21. According to the facility's notes related to the event, the hospital safety huddles were widely shared throughout the organization with hospital associates and the huddle key takeaways reflected the safety event which occurred on 1/20/21.

The safety huddle minutes for 1/20/21 read, due to an increase in patient falls, staff were to collaborate to identify risks and prevention opportunities and were to review post fall assessments and documentation expectations. The huddle minutes for 2/1/21 read, the fall which occurred on 1/20/21 was reviewed and the lesson learned was to recognize increased risk for falls with medications, and implement alarming lap bands for impulsive patients.

The facility was unable to provide evidence staff who were responsible for direct patient care were made aware of the recommendations discussed in the safety huddles, and there was no evidence the recommendation to use lap bands for impulsive patients was implemented or monitored to ensure effectiveness.

iii. On 2/18/21 at 9:00 a.m., Manager #12 was interviewed. Manager #12 stated when a fall occurred, department leaders were expected to analyze what caused the fall and implement an improvement plan. She stated these actions were department-driven to involve staff in the department where the fall occurred.

Manager #12 reviewed the event which occurred on 1/20/21 when a patient who was impulsive fell. She stated the medical unit where the event occurred did not frequently care for impulsive or disoriented patients. She stated the department leader for the medical unit planned to collaborate with the neuro unit to identify best practices to care for impulsive patients and implement those practices on the medical unit. She stated she did not know whether this collaboration had occurred or whether the preventive action was implemented and successful.

The facility was unable to provide evidence the medical unit and neuro unit collaborated to identify and implement practices to prevent future falls. The hospital safety huddle minutes from 1/20/21 and 2/1/21, which the facility provided as evidence of the investigation and follow-up to the event, did not specify actions taken on the medical unit to prevent recurrence of similar events. This was in contrast to Manager #12's statement an improvement plan to respond to a fall needed to be department-specific.

Manager #12 reviewed the event which occurred on 1/10/21 when a patient was found without oxygen. She stated there was a process error in the investigation of this event and the necessary documentation did not occur. She stated the department leader who reviewed a safety event was expected to identify contributing factors and any specific individuals involved in the event who did not follow processes as expected. She stated she did not know if the department leader responsible to investigate the 1/10/21 event identified the individual who failed to connect the patient's oxygen or the contributing factors which led to the event. Manager #12 stated although the safety event was closed in the online reporting system on 2/9/21, she did not know the status of the department leader's review and investigation of the event.

The documentation the facility provided for the 1/10/21 event read, the department leader sent the information to the nurse on the unit where the event occurred (the surgical unit) for follow-up and reiterated the need to trace patient lines.

The facility was unable to provide evidence this education to the nursing staff occurred, and there was no further documentation of analysis or preventive action conducted in response to the event.

Manager #12 stated if investigation and follow-up was not completed in response to patient safety events, there was the risk for missed opportunities to identify processes which did not work and to prevent future harm to patients.

iv. On 2/17/21 at 1:00 p.m., Director #6 and Director #7 were interviewed. Director #6 reviewed the patient safety event which occurred on 1/10/21, when a patient was found without oxygen and their oxygen saturation was 74%. Director #6 stated she could not provide any meaningful follow-up which occurred in response to the patient safety event. She stated Supervisor #11 was responsible to investigate this event but did not document follow-up or preventive actions taken in response to the event.

This was in contrast to the Safety Event Identification, Analysis and Reporting policy, which read the department leader was to conduct initial investigation of patient safety events and complete follow-up, and every reasonable effort was to be made to complete these steps within three business days of the patient safety event.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 NURSING SERVICES was out of compliance.

A-0395 A registered nurse must supervise and evaluate the nursing care for each patient. Based on interviews and document review, the facility failed to ensure nursing staff monitored patients according to facility policy and physician orders. Specifically, nursing staff failed to implement a bed alarm for a patient identified as a fall risk. In addition, nursing staff failed to adhere to physician orders for a patient who needed a safety sitter, and did not consult the physician prior to discontinuing the sitter. Finally, nursing staff failed to monitor a patient with a new tracheostomy who was on heated high flow oxygen on continuous pulse oximetry. The failure was identified in one of three patient medical records reviewed (Patient #2).

Based on interviews and document review, the facility failed to ensure nursing staff monitored patients according to facility policy and physician orders. Specifically, nursing staff failed to implement a bed alarm for a patient identified as a fall risk. In addition, nursing staff failed to adhere to physician orders for a patient who needed a safety sitter, and did not consult the physician prior to discontinuing the sitter. Finally, nursing staff failed to monitor a patient with a new tracheostomy who was on heated high flow oxygen on continuous pulse oximetry. The failure was identified in one of three patient medical records reviewed (Patient #2).

Findings include:

I. Facility policies and references:

A. Policies

1. The Fall Prevention and Post Fall Management policy read, Assessment, intervention,
documentation and evaluation promote proactive healthcare practices for patient care planning to minimize the risk for falls. Falls assessment will occur upon admission and with each shift assessment and when a patient is transferred from one unit to another and as indicated throughout the patient admission. All inpatients will be assessed for fall risk utilizing the Morse Fall Risk assessment tool. Factors to consider on assessment may include: mental status, gait, transferring and ambulatory aids.

For all high falls risk patients, implement the following measures. High Fall Risk Interventions include but are not limited to: appropriate alarms. A High Risk Fall patient is identified if their Morse score is equal to or greater than 50.

2. The Pulse Oximetry policy read, the purpose was to establish a consistent procedure for respiratory therapists and nurses to accurately and non-invasively measure and document arterial oxygen saturation (SpO2). Physician order was required. Physician/respiratory therapist to place order. Respiratory therapists and nurses may monitor oximetry. Patients with continuous oximetry orders will have oximeters with enabled audible alarms set. Appropriate alarms are to be active with appropriate ranges which include but are not limited to HR and SPO2.

3. The Oxygen Therapy policy read, the purpose was to provide a multidisciplinary approach to the administration of oxygen with the intent of treating or preventing the symptoms and manifestation of hypoxia. High Flow Systems deliver a prescribed gas mixture at flow rates that exceed the patient demand. High-flow nasal cannula (HFNC) is a non-invasive respiratory support modality which provides conditioned (heated and fully humidified) gas mixtures to patients via a nasal cannula interface.

High flow is considered flow >15 LPM. Acute neuro patients (closed head injury, stroke, etc...) will be placed on O2 to keep SpO2 > 90%. It is vital to rapidly identify and treat all causes of hypoxia in the acute stroke patient, as a failure to do so will lead to poorer clinical outcomes.
Continuous oximetry will be considered on patients if there is a condition where desaturation is likely.

B. References

1. The Decision Tree for Sitter Use read, clinical indicators for sitters include the patient is impulsive, pulling at lines, drains, tubings or dressing without ability to be redirected, fall risk combined with any of the above risk factors, physician assessment and documented rationale. Alternatives prior to sitter include patient alarms (bed or chair sensors). If the patient meets one or more of the clinical indicators for a sitter, and restraints cannot be used to maintain patient safety without causing further agitation to the patient, staff are to assess if the patient escalates behavior when alone in the room. If yes, use a safety sitter. If not, use the least restrictive interventions possible to maintain patient safety.

2. The Patient Sitter Responsibilities and Agreement read, the facility's priority is to provide safe and compassionate care for all of our patients. In some instances, this may include the implementation of a 1:1 sitter in order to ensure the patient remains safe during the course of their stay. The sitter is to assume responsibility for all daily cares of the patient including to ensure all appropriate fall interventions are in place, keep the patient safe to prevent falls and removal of lines or tracheostomies (a tube which is surgically inserted into the neck in order to open a direct airway into the trachea).

I. Failure to implement a bed exit alarm for a patient at high risk for falls

1. The nursing staff failed to implement a bed exit alarm for a patient who was identified as a high fall risk and required a specialty bariatric bed.

A. Document Review

1. According to the Fall Prevention policy, if a patient was identified as a high fall risk with a Morse score greater than or equal to 50, nursing staff were to implement fall risk interventions such as alarms. Nursing staff were to include factors in a patient's fall risk assessment such as the patient's mental status and gait or mobility limitations.

2. Patient #2's medical record was reviewed. The History and Physical (H&P) written on 1/13/21 at 1:18 p.m. read, Patient #2 was admitted for altered mental status, headache and unsteady gait. Patient #2 was found to have an intracranial hemorrhage (acute bleeding in the skull or brain).

a. Review of the medical record revealed Patient #2 required a specialty bariatric bed. The medical record also revealed Patient #2 was a high fall risk patient. Nursing staff and other hospital staff documented Patient #2 was a fall risk due to limitations in his mobility, impulsivity, and impairment due to the stroke. Examples included:

i. On 1/13/21 at 11:47 a.m., a physician's assistant (PA) placed an order which designated the patient as a Fall Risk.

ii. On 1/28/21 at 9:00 a.m., a registered nurse (RN) student documented Patient #2 was on a specialty bed with four side rails up for safety. The RN student further documented, the patient was on fall precautions, his gait and ability to transfer were weak, and he forgot his limitations. The RN student documented Patient #2's Morse Fall Risk score was 60, which according to facility policy indicated the patient was a high fall risk and required fall risk interventions.

The RN student completed an additional assessment at 11:00 a.m. The assessment read, fall interventions in place based on the patient's individual needs included activation of bed alarm, and supervised ambulation.

iii. On 1/28/21 at 2:38 p.m., a nurse practitioner (NP) documented Patient #2 had a sitter at his bedside because he was impulsive. The NP's note was attested by the critical care physician (MD) #2.

b. Review of the medical record revealed on 1/28/21, Patient #2 was found unresponsive on the floor and subsequently died.

i. On 1/28/21 at 9:14 p.m., RN #3 entered a nursing note which read, Patient #2 arrested. RN #3 documented when he rounded on the patient at 7:00 p.m. the patient's bed side rails were up and the call light was in reach of the patient. When a Certified Nursing Assistant (CNA) rounded on the patient at 7:50 p.m. she found the patient face down next to the bed unresponsive. A Code Blue was called and cardio-pulmonary resuscitation (CPR) was initiated, however Patient #2 did not recover and was pronounced dead at 8:08 p.m.

3. A patient safety event was entered on 1/29/21. The safety event was identified as a fall event. The event read, at 7:50 p.m. the CNA entered Patient #2's room and found the patient lying on the floor next to the bed, between the bed and window. The patient was unresponsive, not breathing and did not have a palpable pulse.

B. Staff Interviews

1. Interviews with nursing staff revealed Patient #2 required a bed exit alarm due to his high risk for falls. However, the bed alarm on Patient #2's specialty bariatric bed was not correctly activated to alarm outside of his room, and therefore did not alert nursing staff when he exited the bed on 1/28/21. Interviews with nursing staff further revealed lack of knowledge regarding how to activate bed exit alarms for bariatric and specialty beds.

a. On 2/11/21 at 3:47 p.m., RN #4 was interviewed. RN #4 stated nurses implemented fall risk precautions including bed and chair alarms for high fall risk patients. RN #4 stated it was important to ensure the bed alarm was activated so the alarm was audible in the hallway as well as in the patient's room. RN #4 stated patients were put on bed alarms to ensure the patient did not get up without assistance.

RN #4 stated she had not participated in any recent training regarding the use of specialty and bariatric beds.

b. On 2/17/21 at 10:29 a.m., the Charge Nurse for the surgical unit (Charge RN) #5 was interviewed. Charge RN #5 stated the surgical unit often had patients who underwent bariatric surgeries. She stated the charge nurse was responsible to ensure bariatric surgery patients had fall alarms correctly activated. She stated patients might need a specialty bariatric bed due to their weight. Charge RN #5 stated there were also other types of specialty beds which may be used for patients on the surgical unit.

Charge RN #5 stated it was important for nurses to be educated to the specialty beds because the controls on the bed were different, and the nurse had to ensure the alarm was on and properly connected to the hospital alarm system. Charge RN #5 stated the bariatric beds were higher above the ground, and so a fall from the bariatric bed was potentially more dangerous.

Charge RN #5 stated nurses were responsible to implement alarms for patients who were high fall risk to ensure the patients' safety. She stated this included patients who had a Morse score of 45 or greater, who exhibited weakness or changes in their neurological status, or if they had other risk factors for falls.

c. On 2/11/21 at 7:15 a.m., RN #3 was interviewed. RN #3 stated nurses evaluated a patient's behavior and condition to assess a patient's fall risk. RN #3 stated he assessed if the patient was impulsive, able to use a call light, or confused. He stated if a patient was impulsive, they may try to get up on their own.

RN #3 stated when he assumed care of Patient #2 on 1/28/21 at 7:00 p.m., he left Patient #2 in bed with all four of the bed side rails up. He stated nurses raised the bed side rails if they had concern the patient was at risk for falls. RN #3 confirmed the information he documented in his nursing progress note, which read at 7:50 p.m. the unit CNA found Patient #2 unresponsive on the floor next to his bed.

RN #3 stated after Patient #2 died, a process gap was identified with the use of bariatric beds. RN #3 stated the bed exit alarm on Patient #2's bariatric bed had been set but was not activated to alarm overhead on the unit or to the nursing staff's mobile phones. He stated the bed alarm was not correctly activated because the bariatric beds were not compatible to interact with the hospital alarm system.

RN #3 stated he discussed the event involving Patient #2 with his nursing leadership. He stated leadership had identified the need for hospital-wide process changes in order to ensure bed alarms on bariatric beds were activated correctly. RN #3 stated this included the need to re-educate nursing staff about how to correctly activate the bed exit alarms for bariatric beds. RN #3 stated as of the date of the interview, leadership was still developing this education and the education had not yet been implemented.

d. On 2/11/21 at 10:27 a.m., RN #1 was interviewed. RN #1 stated nurses were responsible to implement interventions for high fall risk patients, which could include alarms, sitters or restraints if needed. She stated patients with brain injuries were often impulsive, and could be cooperative at one time but an hour later become impulsive. RN #1 stated on the neuro-trauma unit (where Patient #2 was located) the protocol was for nurses to implement a bed alarm for every patient on the unit.

RN #1 stated she was assigned to Patient #2 during the day shift of 1/28/21, which was the shift prior to the shift in which the fall occurred. She stated Patient #2 was in a bariatric bed due to his size. She stated she did not know the difference between the bariatric beds but she knew there was more than one kind of bariatric bed available for use at the facility. She stated some of the bariatric beds were compatible with the hospital alarm system, and these alarmed overhead when activated. She stated others were not compatible with the hospital alarm system.

RN #1 stated she activated the bed alarm for Patient #2's bariatric bed. She stated she did not know if the bed alarm for Patient #2's bed was connected to the hospital alarm system, since he did not at any point set off the bed alarm.

RN #1 stated there was a need for process changes for the use of bed alarms on bariatric beds. She stated the bed alarms on all beds should connect to the hospital alarm system in order to ensure there were no gaps in care when patients needed bed alarms for safety.

C. Leadership Interviews

1. Interviews with facility leadership revealed nursing staff had not been educated to the use of bed exit alarms on bariatric and specialty beds, and therefore a consistent process to implement bed alarms on bariatric beds was not in place.

a. On 2/16/21 at 12:59 p.m., the Nurse Manager for the neuro-trauma unit (Manager) #5 was interviewed. Manager #5 stated many patients on the neuro-trauma unit were cognitively impaired and required monitoring to remain safe. She stated interventions for patients who had cognitive impairment included bed alarms and chair alarms to ensure if a patient attempted to get up by themselves the staff were alerted.

Manager #5 stated she did not believe the bed alarm on Patient #2's bariatric bed was correctly activated on 1/28/21 when he was found unresponsive on the floor next to his bed. She stated RN #1 told her the alarm was activated on the bed, however when Manager #5 spoke with the evening nursing staff they reported the bed alarm feature was not working correctly and did not alert staff when Patient #2 left the bed. Manager #5 stated Patient #2 was a high risk patient.

Manager #5 stated since the event on 1/28/21, she was informed there was a required step in the hospital alarm system to activate the bed alarm on a bariatric bed, and she stated she needed to re-educate her staff to this process.

Manager #5 stated every patient bed should have the capability for a bed exit alarm to be implemented regardless of the type of bed. She stated nursing staff, including charge nurses and herself, were responsible to ensure all necessary safety interventions were in place for patients and to ensure bed alarms were activated correctly.

Manager #5 stated she was frustrated because nursing staff throughout the facility were not educated about the use of alarms on bariatric beds. She stated since the event on 1/28/21 she recognized the need for education to ensure nursing staff understood how to use the bariatric beds and she was in the process to develop this education.

On the date Manager #5 was interviewed, it had been 20 days since the event occurred when Patient #2 was found unresponsive on the floor and died. As of the date of the interview, facility leadership had not yet developed or implemented facility-wide education about the use of bed alarms on bariatric beds.

b. On 2/17/21 at 7:31 a.m., the Director of Risk (Director) #6 and the Director of Quality (Director) #7 were interviewed. Director #6 stated she led the investigation of the event which occurred on 1/28/21 when Patient #2 was found unresponsive next to his bed and subsequently died.

Director #6 stated one of the findings of the investigation was staff did not understand how to activate bed alarms on bariatric beds. She stated nursing staff had developed inconsistent processes to implement alarms for patients on bariatric beds because nurses did not know the beds were capable to connect with the hospital alarm system. Director #6 stated nurses were trained to use bariatric and specialty beds, however she stated it was clear the training had not adequately educated nurses to use the bariatric beds.

Director #6 stated since the event on 1/28/21 facility leadership recognized the need to develop a consistent process for staff to use bariatric beds and to ensure staff were knowledgeable to use the bed alarm safety features on bariatric beds.

c. On 2/17/21 at 11:33 a.m., the Director of Process Improvement (Director) #8 was interviewed. Director #8 stated since the event involving Patient #2, he assisted to determine how the bariatric and specialty beds interfaced with the hospital alarm system. He stated nursing staff were previously unaware the bariatric beds had the capability to connect to the hospital alarm system, however he stated leadership was working to correct this misunderstanding. Director #8 stated the use of bed alarms on bariatric and specialty beds was discussed during hospital-wide safety huddles, which were attended by nursing leadership, however leadership was still in the process to develop and provide specific education for nursing staff.

Director #8 stated it was important to ensure nurses were knowledgeable about the function of the bariatric beds because the nurse needed to ensure the bed alarm was correctly activated and connected to the hospital alarm system. Director #8 stated charge nurses, shift supervisors and nursing managers also needed to be re-educated to the use of bariatric bed alarms because nurse leaders needed to inform their staff and enforce the correct use of bed alarms for patients.

Director #8 stated when a safety risk was identified or an event occurred, it was important for staff to receive accurate information and education because clinical staff needed to ensure all safety precautions were in place for their patients.

II. Failure to maintain a safety sitter according to physician orders

1. The nursing staff failed to ensure a one-to-one safety sitter was maintained according to physician orders and facility protocols for a patient who required a sitter due to impulsivity. The nurse did not consult the attending physician before she discontinued the safety sitter and the patient subsequently was found unresponsive on the floor and died.

A. Document Review

1. The Decision Tree for Sitter Use read, if a patient was impulsive, pulling at lines drains or tubes, or was a fall risk combined with any other risk factor, the patient met criteria for a one-to-one safety sitter. In addition, a patient met criteria for a sitter if the physician's assessment and documented rationale warranted a safety sitter.

2. Patient #2's medical record was reviewed. The History and Physical (H&P) written on 1/13/21 at 1:18 p.m. read, Patient #2 was admitted for altered mental status, headache and unsteady gait. Patient #2 was found to have an intracranial hemorrhage (acute bleeding in the skull or brain).

a. Review of Patient #2's medical record revealed Patient #2 exhibited impulsive behavior and confusion on 1/27/21 and 1/28/21. Multiple staff and providers noted Patient #2 was impulsive, forgetful and required a one-to-one sitter for safety. Examples included:

i. On 1/27/21 at 8:04 a.m., the critical care physician (MD) #2 placed a physician order for Patient #2 to transfer from the Intensive Care Unit (ICU) to the neuro-trauma unit. The physician order read, Patient #2 was to transfer to a neuro I bed (intermediate care bed) with a safety sitter.

ii. On 1/27/21 at 7:18 p.m., a nurse entered a shift summary note. The note read, Patient #2 arrived at the neuro-trauma unit at 2:45 p.m. with a sitter at his bedside. The note read, Patient #2 was disoriented to time and needed to use a white board to communicate.

iii. On 1/28/21 at 11:11 a.m., a Registered Nurse (RN) completed a fall risk assessment for Patient #2. The fall risk assessment read, Patient #2 was forgetful of his limitations.

iv. On 1/28/21 at 2:38 p.m., a nurse practitioner (NP) entered a progress note, which was attested to and signed by MD #2. The NP documented Patient #2 pulled out his naso-gastric tube (NG tube, used for delivering tube feeding) on 1/27/21. She documented the NG tube was replaced and a sitter was placed at the bedside for impulsivity.

b. On 1/28/21 at 6:08 p.m., RN #1 entered a nurse shift summary note. RN #1 documented she received orders to discontinue the I Bed status and telemetry monitoring for Patient #2, however there was no evidence in RN #1's documentation she received a physician order to discontinue the safety sitter.

c. On 1/28/21 at 9:14 p.m., RN #3 entered a nursing note. RN #3 documented he was notified in shift change report, the I bed status and safety sitter were discontinued for Patient #2. The note read, at 7:50 p.m. the unit Certified Nursing Assistant (CNA) rounded on Patient #2 and found the patient face down on the floor unresponsive. A Code Blue was called and CPR (cardio-pulmonary resuscitation) was initiated, however Patient #2 did not recover and was pronounced dead at 8:08 p.m.

3. On 1/29/21, a patient safety event was entered. The patient safety event report read, at 7:50 p.m. Patient #2 was found face down on the floor next to his bed. Patient #2 was unresponsive with no respirations or palpable pulse. The patient's tracheostomy (a tube which is surgically inserted into the neck in order to open a direct airway into the trachea) tube was in place but was not connected to oxygen. A Code Blue was called but Patient #2 did not recover.

B. Staff Interviews

1. Interviews with facility nursing staff and providers revealed Patient #2 had a safety sitter due to concerns for impulsivity, in order to prevent the patient from getting up unassisted or pulling at his lines. However, the safety sitter was not maintained according to the physician order, and the nurse did not consult the attending physician before she discontinued the safety sitter for Patient #2.

a. On 2/11/21 at 10:26 a.m., RN #1 was interviewed. RN #1 stated the neuro-trauma unit took patients who experienced brain injuries, strokes, seizures, or drug and alcohol withdrawal. RN #1 stated nurses on the unit could implement a one-to-one safety sitter for patients who were agitated or impulsive, or if the patient was pulling on their lines or tubes.

RN #1 stated nursing staff used the sitter decision tree to determine if a patient needed a one-to-one sitter for safety. She stated it was not necessary for a physician to place an order to initiate or discontinue a safety sitter, and this was left to the discretion of nursing staff.

RN #1 stated Patient #2 had a safety sitter when she assumed care of him on 1/28/21. She stated Patient #2 had pulled on his NG tube in the morning and displaced it. She stated Patient #2 was nonverbal and used his phone to text and communicate his needs to staff. RN #1 stated Patient #2's door had to remain closed because he was on heated high flow oxygen, which was considered an aerosol-generating procedure. She stated due to COVID-19 infection control precautions it was required to keep a patient's door closed during aerosol-generating procedures.

RN #1 stated she communicated with Patient #2's sitter and the charge nurse on the unit because she did not believe Patient #2 needed a safety sitter any longer. She stated they decided to discontinue the sitter, however she did not communicate this information to the patient's attending physician, MD #9. She stated there was no physician order for the sitter and the decision to discontinue the sitter was part of nursing protocol.

This was in contrast to Patient #2's medical record, which revealed on 1/27/21 MD #2 placed a physician order which specified the patient was to have a safety sitter on the neuro trauma unit.

RN #1 stated since the event when Patient #2 was found unresponsive in his room, she would now consult the attending physician before she discontinued a safety sitter.

b. On 2/11/21 at 7:15 a.m., RN #3 was interviewed. RN #3 stated a safety sitter was implemented if the medical team felt it was appropriate. He stated nursing staff could suggest a sitter based on their assessment, however only a physician could order a sitter.

RN #3 stated if a patient was impulsive, the patient might try to get up unassisted or pull on their lines or tubes. RN #3 stated when he assumed care of Patient #2 on 1/28/21, he was informed in shift change report Patient #2 had partially pulled out his NG tube in the morning.

RN #3 stated when he assumed care of Patient #2 on 1/28/21, Patient #2 did not have a safety sitter. He stated the patient had a sitter earlier in the day but it was discontinued. RN #3 stated the nurse documented in the medical record if they discontinued a safety sitter. He stated he always consulted a patient's attending physician before he discontinued a sitter because the care team, including the physician, should agree with this decision.

RN #3's interview conflicted with RN #1's interview, who stated the decision to implement or discontinue a sitter was up to the nurse's discretion and did not require an order or consultation with the attending physician. In addition, Patient #2's medical record did not reveal evidence RN #1 consulted the attending physician before she discontinued the safety sitter, nor did RN #1 document her rationale to discontinue the sitter.

c. On 2/11/21 at 9:56 a.m., MD #2 was interviewed. MD #2 stated if a patient required a safety sitter, this required a physician order. He stated nursing staff could initiate the discussion if they believed a patient needed a sitter, and then the physician placed an order to implement the sitter.

MD #2 stated he transferred a patient to an I bed with a safety sitter if a patient was impulsive and required one-to-one monitoring. He stated if a patient was impulsive the patient was at risk to fall, which could be catastrophic.

MD #2 stated if nursing staff wanted to discontinue a safety sitter, the nurse consulted the physician. He stated if the physician agreed, they would place a new order to discontinue the sitter.

MD #2 stated Patient #2 exhibited impulsive behavior when he was in the ICU. MD #2 stated a safety sitter was initiated when Patient #2 transferred to the neuro-trauma unit because while Patient #2 was on ICU he frequently pulled on lines and tubes, and if a patient pulled out lines or tubes it could be life-threatening.

d. On 2/11/21 at 1:22 p.m., MD #9 was interviewed. MD #9 stated she assumed care of Patient #2 on 1/28/21, after he transferred to the neuro-trauma unit. She stated when she assumed care for Patient #2 he had a safety sitter in place. She stated she was not aware RN #1 had discontinued the sitter on 1/28/21, until after the event when Patient #2 was found unresponsive on the floor.

MD #9 stated she expected nurses to consult her as the provider before they discontinued a patient's safety sitter. She stated she was not consulted when RN #1 discontinued the safety sitter for Patient #2.

MD #9 stated she felt the safety sitter was necessary to monitor Patient #2. She stated a patient who had a tracheostomy could become impulsive and either move the trach tube or remove it on accident. She stated a safety sitter would be present to stop a patient from pulling out their tracheostomy (airway).

MD #9 stated in the past, nursing staff notified her to implement or discontinue a safety sitter. However, she stated she had not been consulted recently when nursing staff decided to implement or discontinue a safety sitter.

MD #9 stated after the event which involved Patient #2, she spoke with the nurse manager for the neuro-trauma unit (Manager) #5. She stated she asked Manager #5 about why Patient #2's safety sitter was discontinued and who made that decision, however she stated Manager #5 was not able to answer her question. MD #9 stated she was concerned about RN #1's decision to discontinue the sitter on 1/28/21. She stated she believed Patient #2 was a high risk patient who "fell through all the cracks."

C. Leadership Interviews

1. Interviews with facility leadership revealed if a nurse wanted to implement or discontinue a safety sitter for a patient, the nurse was to follow the Decision Tree for Sitter Use. Interviews further revealed, if a physician ordered a safety sitter for a patient, the nurse was to consult with the physician before they discontinued a sitter, however this process was not followed when RN #1 discontinued the sitter for Patient #2 on 1/28/21.

a. On 2/16/21 at 1:00 p.m., Manager #5 was interviewed. Manager #5 stated if nursing staff believed a high risk patient needed one-to-one monitoring, the bedside nurse and charge nurse were responsible to contact the attending physician and obtain an order for a safety sitter. Manager #5 stated the nurse was responsible to use the sitter decision tree every shift or every 12 hours to assess the patient and determine whether the patient met criteria for a safety sitter.

Manager #5 stated there was a nurse-driven protocol regarding implementation and discontinuation of a safety sitter, and part of this protocol was the nurse should communicate with the attending physician if they wanted the safety sitter discontinued. She stated although the nurse did not need a physician order to discontinue a safety sitter, the physician should still be consulted because the physician may have a specific reason to continue the safety sitter.

Manager #5 stated nursing staff did not use the sitter decision tree as often as they were expected to. Manager #5 stated she did not know how nursing staff were educated on the use of the sitter decision tree, and did not remember the last time the decision tree was shared or reviewed with the nurses on the neuro-trauma unit.

Manager #5 stated she did not know if RN #1 used the sitter decision tree to assess Patient #2 and determine whether the patient still met criteria for a safety sitter. She stated RN #1 did not document the use of the sitter decision tree. Manager #5 stated RN #1 did not consult with MD #9 before she discontinued the safety sitter.

Manager #5 stated RN #1 should have had a discussion with MD #9. She stated the physician had ordered a safety sitter for Patient #2 because the physician felt the patient needed a sitter. She stated she wanted nurses to communicate with the physician before the nurse discontinued a safety sitter because the nurse should ensure the physician was in agreement with the plan.

b. On 2/17/21 at 5:00 p.m., the Director of Risk (Director) #6 and the Director of Quality (Director) #7 were interviewed. Director #7 confirmed there was no facility policy which outlined how a safety sitter was ordered or implemented. Director #7 stated nurses were expected to use the sitter decision tree to determine whether a patient met the criteria for a safety sitter.

Director #7 stated the sitter decision tree had been used for many years, but she did not know how nursing staff were educated on the use of the decision tree. Director #7 stated if a patient had a safety sitter, nursing staff were expected to use the sitter decision tree every four to six hours to determine whether the patient still needed a sitter.

This was in conflict to Manager #5's interview, as Manager #5 stated nursing staff were expected to use the sitter decision tree every 12 hours.

Directors #6 and #7 both stated if the physician ordered a safety sitter, the nurse was expected to consult with the physician before the nurse discontinued the safety sitter. Director #7 stated it was possible a nurse might not be aware of all the information a physician knew about a patient. Director #7 stated nursing staff were trained if a physician entered an order for an intervention, there must be a physician order to discontinue the intervention.

This was in conflict to MD #9's interview, as MD #9 stated RN #1 did not notify or consult her before discontinuing the safety sitter for Patient #2. There was no evidence in Patient #2's medical record to indicate RN #1 completed the sitter decision tree or communicated with MD #9 before she discontinued the safety sitter, despite the physician order for a safety sitter on 1/27/21.

III. Failure to monitor a patient via continuous pulse oximetry

1. Nursing staff failed to ensure a patient with a new tracheostomy who was on high flow oxygen was monitored via continuous pulse oximetry (a non-invasive method to measure a person's oxygen saturation) according to physician order and facility protocols. The patient was subsequentl