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Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.13, PATIENT RIGHTS, was out of compliance.

A-0144 The patient has the right to receive care in a safe setting. Based on observations, interviews and document review, the facility failed to ensure at-risk patients were supervised according to facility policies and physician orders, in two of two facility incidents were reviewed involving patients with an "At Risk Patient" order (Patient #2 and Patient #6). Furthermore, the facility failed to ensure staff understood the requirements of the At-Risk Patient policy and had the necessary knowledge to consistently implement safety interventions for at-risk patients.

Based on observations, interviews and document review, the facility failed to ensure at-risk patients were supervised according to facility policies and physician orders, in two of two facility incidents reviewed involving patients with an "At Risk Patient" order (Patient #2 and Patient #6). Furthermore, the facility failed to ensure staff understood the requirements of the At-Risk Patient policy and had the necessary knowledge to consistently implement safety interventions for at-risk patients.

Findings include:

Facility policies:

The At-Risk Patients and Behavioral Health Precautions policy read, The "At-Risk" patient is identified as any patient who meets one of the following criteria: A physician determines that the patient has a physical or mental condition that acutely increases his/her risk of harm to self or others; and is assessed as being a risk for elopement, placing him or her at serious or life-threatening medical risk; and lacks decisional capacity and does not understand the health risks involved with a decision to leave against medical advice. The patient's treating provider will conduct initial and ongoing assessments to determine if a patient continues to meet "At-Risk" criteria and to assess for the level of monitoring the patient will require.

When a patient is found to meet At-Risk criteria, the following Behavioral Health Precautions will be put into place to maintain safety. The staff who are monitoring the patient's condition and behavior will document using the "At-Risk Monitoring Checklist." At-Risk patients will be monitored at a ratio appropriate to their condition. At a minimum, At-Risk patients will be placed in a ligature resistant room and/or the patient will be provided continuous or 1:1 monitoring. At-Risk patients will not be left unattended, nor allowed to walk around the nursing unit unsupervised. They will not be allowed to leave the unit for any reason. Continuous observation is conducted in person or via video monitoring.

The Remote Virtual (Camera) Sitter and Bedside 1:1 Sitter policy read, Patients will be assessed for appropriateness by the primary RN. Inclusion criteria (for virtual sitter): Delirium/ Restlessness; Confusion; Elopement Risk; History of falls or identified to be at an acute risk for falls based on institutional fall risk indicator.

Reference:

A document provided by facility staff on the 10th Floor Orthopedic/ Neuro unit, entitled "If We Get a Patient with an At-Risk Order" read, Patient will likely have a 1:1 sitter, if not, will have an Avasure sitter. Ensure patient monitoring checklist is filled out every 15 minutes.

1. The facility failed to ensure an at-risk patient (Patient #2) was monitored according to facility policies and physician orders. Staff did not implement a 1:1 bedside or remote virtual sitter for safety and the patient was left unattended on the nursing unit. Patient #2 subsequently eloped from the facility.

a. Review of a facility incident report (report) from 6/1/20 revealed Patient #2 was sitting at the end of the unit hallway. The RN who was in charge of monitoring Patient #2 was called to provide care to another patient. The RN on return to the hallway where the patient was left unmonitored, found the patient gone.

b. Patient #2's medical record was reviewed. On 6/1/20 at 7:09 p.m., Physician #4 entered a discharge summary. The discharge summary revealed Patient #2 was admitted for a seizure after being diagnosed with a brain tumor. The discharge summary read, the patient was recommended rehab, was not stable for discharge; he eloped.

A Brief Operative Note, entered by the neurosurgeon on 5/28/20 at 2:33 p.m. revealed Patient #2 had been diagnosed with a right temporal brain tumor and had a craniotomy (an operation in which a bone flap is removed from the skull to access the brain) and resection (the process of cutting out tissue or part of an organ) performed.

i. The medical record revealed while Patient #2 was in the ICU (intensive care unit) following his surgery he experienced significant post-operative agitation, confusion, and impulsivity. The patient required non-behavioral restraints for safety from 4:04 p.m. on 5/28/20 until 9:31 a.m. on 5/31/20. Nursing documentation revealed the patient also required a 1:1 bedside sitter and 24-hour continuous supervision from 5/27/20 until 5/30/20.

On 5/31/20 at 4:00 p.m. Patient #2 was transferred from the ICU to the tenth floor Orthopedic/ Neuro unit. There was no documentation in the medical record a 1:1 bedside sitter or a remote virtual sitter were in place following the patient's transfer to the 10th Floor.

ii. The medical record revealed on 6/1/20, the day Patient #2 eloped from the facility, multiple staff documented the patient exhibited confusion, impulsivity, and deficits in cognitive and physical functioning requiring supervision for safety.

Examples included:

A nursing fall assessment entered at 8:24 a.m. read, the patient exhibited confusion, disorientation, or impulsivity. The patient also had lower extremity weakness. The patient's fall risk score was 12, making him a high fall risk.

A nursing note entered at 9:34 a.m. read, the patient's wife reported the patient had hallucinations the two previous days.

At 12:22 p.m., a physical therapist documented the patient continued to require supervision for safety. The discharge recommendation was home with 24/7 supervision. The patient required tactile cues for balance and safety, demonstrated impaired balance and judgement along with decreased mobility, cognition and safety awareness.

At 12:34 p.m., an occupational therapist documented the patient demonstrated deficits in cognition and safety awareness. The recommendation for discharge was rehab or home with 24/7 assistance. During treatment the patient was emotionally labile, confused, jumped around on the timeline of events, and confused staff with each other. The patient's daughter was present and attempted to redirect the patient regarding why it was unsafe to go home, but this upset the patient.

At 2:15 p.m., a "Ticket to Ride" (a note which accompanied the patient during transport) was completed for Patient #2's transport to an MRI (magnetic resonance imaging, a scan which revealed detailed images of the organs and body), The Ticket to Ride identified Patient #2 as a high fall risk.

A care management discharge planning note entered at 4:56 p.m. read, Patient #2 had poor safety awareness and was impulsive.

At 5:50 p.m., RN #2 documented she contacted Physician #4 to notify the physician Patient #2 had pulled out his IVs (intravenous catheters).

iii. The medical record revealed on the day Patient #2 eloped from the facility, there was an active "At Risk Patient" order in place. The order was signed by Physician #4 on 6/1/20 at 8:34 a.m. and read, Patient #2's reason for at risk designation was he had conditions which increased his harm risk to self/others, was an elopement risk, and lacked capacity to understand risks of leaving AMA.

c. Interviews revealed Patient #2 exhibited increased restlessness and agitation on the day he eloped from the facility. Nursing staff did not implement a 1:1 sitter or remote virtual sitter to supervise the patient, and allowed Patient #2 to sit unattended at the end of the hallway. This was in contrast to the policy which read, at a minimum, At-Risk patients would be placed in a ligature resistant room and/or the patient would be provided continuous or 1:1 monitoring and would not be left unattended or allowed to walk around the nursing unit unsupervised.

i. On 7/8/20 at 10:19 a.m. RN #2 was interviewed. RN #2 confirmed she was the primary nurse for Patient #2 on 6/1/20, the day he eloped from the facility. She stated every time Patient #2 would get up, the bed alarm would go off and the patient would get angry and yell at her. She stated Patient #2 was forgetful, confused and impulsive and wanted to get out of his room all the time.

RN #2 stated Patient #2 pulled his IVs out because he said he did not need them. She stated his mental status contributed to this, and stated an oriented person would not likely remove an IV but a confused patient might.

RN #2 stated Patient #2 did not have a sitter on the day she took care of him. She stated she felt he would have benefited from a sitter, but she did not ask for one because there was no staff available to sit with the patient.

RN #2 stated she brought Patient #2 into the hallway because he was agitated, basically pushing her out of the doorway in order to get out of the room, and she was unable to keep him in his room. She stated she allowed him to sit at the end of the unit hallway so he could look out the windows, and she watched him from the nurse's station. She stated she was called into a different patient's room in order to saline lock the patient. She stated when she returned, Patient #2 was gone.

RN #2 could not remember if there was an "At Risk Patient" order in place for Patient #2.

ii. On 7/8/2020 at 8:34 a.m. the charge nurse for the tenth floor (Charge RN #1) was interviewed. Charge RN #1 stated fall assessments were completed for all patients, and the fall assessment would generate a score to indicate whether a patient was low or high risk for falls. She stated a score of 12 would indicate a patient was at high risk for falls. RN #1 stated if she was caring for a patient who was a high fall risk or was impulsive, she would stay close to the patient.

Charge RN #1 confirmed she was charge nurse on the day Patient #2 eloped from the facility. She stated Patient #2 had an "At Risk Patient" order in place. She stated by the end of the day the patient was starting to get restless, pulled out his IVs and told RN #2 he was going home. Charge RN #1 stated RN #2 brought Patient #2 to sit near the elevators to calm him down, and when RN #2 received a call about another patient she told Patient #2 she would be right back. When RN #2 returned, the patient was gone.

Charge RN #1 stated patients with head injuries or neurological conditions tended to be impulsive. She stated allowing an impulsive patient to be in the hallway alone was not safe because the patient could walk down the stairs or could fall. Charge RN #1 confirmed Patient #2 did not have a sitter on the day he eloped.

iii. On 7/9/2020 at 1:54 p.m., the Manager of Clinical Nursing for the tenth floor (Manager #6) was interviewed. Manager #6 stated on the day Patient #2 eloped from the facility, the patient's primary nurse noticed he was getting more agitated. Manager #6 saw Patient #2 in his room and stated he was restless, standing up, and trying to put his jacket on over his gown.

Manager #6 stated RN #2 brought Patient #2 to the end of the hall to offer the patient a change of pace. He stated in hindsight it was not acceptable for the nurse to leave Patient #2 alone, and in general it was not acceptable to leave a patient alone if there were safety concerns regarding the patient.

Manager #6 stated Patient #2 had an "At Risk Patient" order because he did not have the cognitive ability to make his own decisions. On review of Patient #2's medical record, Manager #6 observed RN #2 acknowledged the order on the day she took care of Patient #2. He stated when patients had an "At Risk Patient" order they typically had a 1:1 sitter or remote virtual sitter per facility policy. Manager #6 stated Patient #2 did not have a 1:1 sitter or a remote virtual sitter when he was on the 10th Floor.

2. The facility failed to ensure an at-risk patient (Patient #6) was monitored according to facility policies and physician orders. Patient #6 had an "At Risk Patient" order in place and exhibited disorientation, impulsivity, and inability to follow directions. However, staff did not implement a 1:1 bedside or remote virtual sitter for safety, and the patient subsequently fell in her room and was injured.

a. Review of a second report from 5/12/20 revealed, Patient #6 was confused with AMS (altered mental status) and also had an at risk order in place. Patient #6 was on the waitlist for Avasys (remote virtual sitter). Staff found the patient at her door after a sustained fall.

b. Patient #6's medical record was reviewed. On 5/11/20 at 5:48 p.m., a history and physical (H&P) was completed which read, the patient was admitted with altered mental status, a urinary tract infection, and acute congestive heart failure. Patient #6 was very agitated and impulsive on exam. The patient was placed on at-risk status.

The medical record revealed the physician placed an "At Risk Patient" order at 5:48 p.m. on 5/11/20. The order read, "Reason for At Risk Designation: Has condition increasing harm risk to self/others AND is elopement risk AND lacks capacity to understand risks of leaving against medical advice (AMA)."

A nursing note entered on 5/12/20 at 7:58 a.m. read, the patient was alert and oriented only to herself, and was confused, impulsive, unable to follow directions and exhibited poor safety awareness. Fall precautions were in place. The patient had a fall around 2:05 a.m. and had an abrasion to her nose and forehead from the fall.

c. On 7/13/2020 at 11:54 a.m., Patient Safety Managers (Manager #7 and Manager #8) were interviewed. Manager #7 confirmed he reviewed the incident involving Patient #6. He stated Patient #6 was a high fall risk and was impulsive. He stated staff had fall precautions in place for the patient but did not have the Avasys in place because there was a waitlist for the remote sitter at the time.

On review of the medical record, Manager #8 observed there was an "At Risk Patient" order in place for Patient #6. She stated the At-Risk Patient policy required one-to-one monitoring for at-risk patients, and stated Avasys would be an option. However, Manager #7 stated if a patient was considered low risk, the patient would not require continuous observation. This was in contrast to the policy which read, at a minimum, At-Risk patients would be placed in a ligature resistant room and/or the patient would be provided continuous or 1:1 monitoring and would not be left unattended or allowed to walk around the nursing unit unsupervised.

On review of Patient #6's medical record there was no documentation regarding whether she was considered a low or high risk patient, and the "At Risk Patient" order placed by the physician did not specify her level of risk.

d. Interviews revealed facility staff lacked understanding of the at-risk designation and the level of supervision required for at-risk patients.

i. On 7/8/20 at 10:19 a.m. Registered Nurse (RN #2) was interviewed. RN #2 stated an at-risk patient was a higher risk to leave AMA, or a patient who was not of sound mind or could harm themselves. She was uncertain whether an at-risk patient would get a specific physician order. RN #2 stated she had not received education regarding at-risk patients.

ii. On 7/8/20 at 3:15 p.m. RN #18 was interviewed. RN #18 stated the "At Risk Patient" order was for patients who were more likely to flee the hospital, but was also for patients who were confused or trying to get out of bed. She stated at-risk patients usually had an Avasys (remote virtual sitter), and stated all at-risk patients either had a remote virtual sitter or a 1:1 sitter to monitor the patient. She stated at-risk patients were not allowed to ever be alone.

iii. On 7/8/20 at 3:40 p.m. RN #19 was interviewed. RN #19 stated the "At Risk Patient" order was placed to prevent patients from leaving the hospital for 72 hours. He stated at-risk patients might include patients who were confused or might cause harm to self or others. He stated at-risk patients required continuous observation, unless the patient was in some form of restraints.

iv. On 7/9/20 at 9:43 a.m. RN #20 was interviewed. RN #20 stated the at-risk designation was very broad, and would include patients who were at risk for falls or had a brain injury. She stated monitoring for an at-risk patient could include keeping the door half open to monitor, keeping the patient close to nurse's station, and possibly getting a sitter.

v. In an interview conducted on 7/8/20 at 8:34 a.m., the charge nurse for the tenth floor (Charge RN #1) stated the "At Risk Patient" order was similar to a mental health hold (M1). She stated it was for patients who were not safe to make their own decisions and were not allowed to leave the hospital against medical advice. She said patients with neurological deficits or patients who tried to harm themselves were assessed differently than at-risk patients.

vi. On 7/9/20 at 8:32 a.m. the weekend charge nurse for the tenth floor (Charge RN #3) was interviewed. Charge RN #3 stated the At-Risk Patient policy pertained to any patient who was confused, who could easily escape or fall, or who was at risk for self-harm.

Charge RN #3 stated if a patient was considered a flight risk the patient would need a sitter or remote virtual sitter. However, she stated if an at-risk patient was considered low risk, or was able to follow instructions, then the patient could be monitored according to nursing unit norms without a 1:1 or remote virtual sitter. She stated it was a gray area whether the at-risk order placed by the physician needed to be followed, and would depend on the situation and whether the patient was determined to be following commands appropriately.

vii. In an interview conducted on 7/9/20 at 1:56 p.m., the Manager of Clinical Nursing for the tenth floor (Manager #6) stated typically patients with an at-risk order would have a 1:1 sitter or Avasys camera (remote virtual sitter). He stated this requirement could be customized or forgiven based on a physician's orders.

viii. In an interview conducted on 7/13/20 at 11:54 a.m. with the Patient Safety Managers (Manager #7 and Manager #8), Manager #8 stated the At-Risk Patient policy required one-to-one monitoring for at-risk patients. However, Manager #7 stated if a patient was considered low risk, the patient did not require continuous observation.

ix. On 7/9/20 at 1:01 p.m. Physician #4 and Physician #5 were interviewed. Physician #4 stated the "At Risk Patient" order was placed for patients who were at risk for leaving the hospital, were at risk of harm to self or others, or were intoxicated. She stated the provider was ultimately responsible for assessing whether a patient was considered at-risk. She stated normally the patient would be under supervision, and sometimes would need a sitter or a form of restraints. Physician #4 was not certain whether at-risk patients always required continuous observation.

Physician #5 stated the "At Risk Patient" order could also be placed for patients who lacked capacity to make decisions. He stated some at-risk patients required a 1:1 sitter and others did not, and stated the At-Risk Patient policy dictated whether a patient was considered low, intermediate, or high risk.

These interviews were in contrast to the At Risk Patient policy which read at a minimum, At-Risk patients would be placed in a ligature resistant room and/or the patient would be provided continuous or 1:1 monitoring and would not be left unattended or allowed to walk around the nursing unit unsupervised.

x. On 7/13/20 at 2:35 p.m. Chief Nursing Officer (CNO #16) was interviewed. CNO #16 stated 1:1 monitoring was required for the at-risk patient.

Based on the manner and degree of standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PROGRAM was out of compliance.

A-0286 -(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. Based on interviews and document review, the facility failed to ensure staff investigated adverse patient safety events in order to identify contributing factors and prevent reoccurrence of incidents in nine facility incidents reviewed.

Based on interviews and document review, the facility failed to ensure staff investigated adverse patient safety events in order to identify contributing factors and prevent reoccurrence of incidents in nine facility incidents reviewed.

Findings include:

Facility Policies:

The Quality, Patient Safety, and Performance Improvement Plan read, the purpose of the plan is to provide a framework for continual improvement in the delivery of safe care. The Quality Director and Patient Safety Office has oversight over collection and analysis of data as well as ongoing evaluation of service delivery and care. Goals of the Quality Plan include: to ensure the highest quality of care for all patients; proactively reduce or eliminate the risk of harm to patients; identify and analyze high-risk or problem prone processes for improvement opportunities; and maintain compliance with standards and requirements established by regulatory agencies.

The Occurrence Reporting Policy read, the purpose is to define what types of events are reported, timeframes and processes for reporting occurrences. An occurrence is defined as an event which could have resulted or did result in unnecessary harm to a patient. The person involved or who discovers the event should enter the occurrence into the facility's system. Managers will review the event and add any additional investigative findings and document findings in the report. The patient safety managers are responsible for analyzing occurrence data and sharing data with appropriate groups throughout the organization.

The Safety Classification Levels of Harm read, the first category is serious safety events (SSE) which are rated on a scale from one to five. One is when a deviation in gaps have occurred leading to the death of a patient. Five is classified as moderate temporary harm which is when a deviation occurs resulting in significant harm lasting for a limited time. The second category is titled precursor safety event (PSE). This category is rated on a scale from one to four. One is minimal permanent harm that requires little or no intervention for the patient. Four is no harm occurred and there is sufficient information to determine that no harm has occurred to the patient. The last category is a near miss event (NME). This is rated on a scale from one to three. The near miss events are when there is an early barrier catch and the error does not reach the patient.

The At-Risk Patients and Behavioral Health Precautions policy read, the "At-Risk" patient is identified as any patient who meets one of the following criteria: A physician determines that the patient has a physical or mental condition that acutely increases his/her risk of harm to self or others; and is assessed as being a risk for elopement, placing him or her at serious or life-threatening medical risk; and lacks decisional capacity and does not understand the health risks involved with a decision to leave against medical advice. The patient's treating provider will conduct initial and ongoing assessments to determine if a patient continues to meet "At-Risk" criteria and to assess for the level of monitoring the patient will require.

When a patient is found to meet At-Risk criteria, the following Behavioral Health Precautions will be put into place to maintain safety. The staff who are monitoring the patient's condition and behavior will document using the "At-Risk Monitoring Checklist." At-Risk patients will be monitored at a ratio appropriate to their condition. At a minimum, At-Risk patients will be placed in a ligature resistant room and/or the patient will be provided continuous or 1:1 monitoring. At-Risk patients will not be left unattended, nor allowed to walk around the nursing unit unsupervised. They will not be allowed to leave the unit for any reason. Continuous observation is conducted in person or via video monitoring

Reference:

The Nurse Manager Job description read, the managers are responsible for the management of clinical nursing practices and patient care delivery on their units. The roles of the manager include: coaches and mentors staff to achieve quality patient care; implements and monitors effective performance improvement programs; and ensures results of quality improvement activities are integrated into nursing practice.

1. The facility failed to ensure staff who were responsible for reviewing, investigating and analyzing facility incidents did so, in order to prevent reoccurrence (Cross-reference 0144).

A. Interviews with staff revealed a lack of facility oversight, staff training, analysis of incidents and implementation of necessary interventions to prevent reoccurrence.

1. On 7/9/20 at 1:54 p.m., an interview was conducted with the Nurse Manager (Manager #6) for the Neuro/Ortho unit who stated he was responsible for completing investigations of incidents which occurred on the unit. Manager #6 stated he had not received any training from the facility on how to investigate facility incidents. He further stated he had no resources which guided him during the investigation and there was no deadline to complete the investigations.

A similar interview was conducted on 7/13/2020 at 1:30 p.m., with the Intensive Care Unit (ICU) Nurse Manager (Manager #17) who stated she also was responsible for investigating incidents which occurred in the ICU, yet had not been provided any training related to facility incident reports.

2. On 7/13/20 at 12:30 p.m., an interview was conducted with Patient Safety Manager (Manager #9). Manager #9 stated nurse managers were supposed to interview staff regarding an incident. Manager #9 stated she did not close an incident until the manager entered the results of their investigation. Manager #9 stated if a manager entered the investigation as complete, then it was determined to be completed. Manager #9 stated she did not have oversight or the ability to question the managers to ensure appropriate interventions or actions were taken to prevent reoccurrence.

3. On 7/13/20 at 12:33 p.m., Patient Safety Manager (Manager #7) and Patient Safety Manager (Manager #8) were interviewed. Both safety managers confirmed no training had been provided to unit managers on how to investigate facility incidents. Both then confirmed the untrained managers were responsible for conducting the investigations for their respective units.

According to the Quality, Patient Safety, and Performance Improvement Plan, the Quality Director and Patient Safety Office has oversight over collection and analysis of data as well as ongoing evaluation of service delivery and care. The goals were to ensure the highest quality of care for all patients; proactively reduce or eliminate the risk of harm to patients; identify and analyze high-risk or problem prone processes for improvement opportunities; and maintain compliance with standards and requirements established by regulatory agencies.

4. On 7/13/20 at 2:37 p.m., an interview was conducted with the Director of Quality (Director #10). Director #10 stated nurse managers were expected to assist the patient safety managers to investigate incidents and document with details the interventions performed after an incident. She stated the patient safety managers were to make sure the investigation was completed before the incident was closed.

Director #10 stated she recognized patient safety managers had not facilitated investigations of incidents and determine whether investigations by the unit manager were sufficient or not prior to the survey. She stated the concern was an area of opportunity for the facility and stated there were further opportunities regarding staff documentation in the internal reporting system.

Director #10 stated if a patient safety event was not investigated, the opportunity for process improvement to close the gap was lost.

B. Review of multiple incidents revealed the facility failed to investigate adverse patient incidents in order to identify causes and contributing factors and therefore did not implement preventive measures in order to reduce the risk of future patient harm.

According to the Occurrence Policy, managers will review the event and add any additional investigative findings and document findings in the report. The patient safety managers are responsible for analyzing occurrences.

1. At Risk Patients

a. Review of a facility incident revealed an at risk patient (Patient #2) who was not monitored according to facility policies and physician orders subsequently eloped from the facility. Preventive measures were not implemented in order to prevent other at-risk patients from eloping.

Review of the facility incident report (report) revealed, on 6/1/20 at 6:33 p.m. Patient #2 was sitting at the end of the unit hallway. The RN who was in charge of monitoring Patient #2 was called to provide care to another patient. The RN on return to the hallway where the patient was left unmonitored, found the patient gone.

Patient #2's medical record was reviewed. The medical record revealed on 6/1/20, the day Patient #2 eloped from the facility, multiple staff documented the patient exhibited confusion, impulsivity, and deficits in cognitive and physical functioning requiring supervision for safety. (Cross Reference A-0144).

The medical record further revealed on the day Patient #2 eloped from the facility, there was an active "At Risk Patient" order in place. The order was signed by Physician #4 on 6/1/20 at 8:34 a.m. and read the reason for at risk designation was, Patient #2 had conditions which increased his harm risk to self/others, was an elopement risk, and lacked capacity to understand risks of leaving against medical advice (AMA).

i. Review of the report and investigation revealed the unit manager did not identify the patient required 1:1 continuous monitoring due to being an "At risk Patient", therefore no preventative actions were implemented to prevent reoccurrence.

On 6/2/20 Manager #6 documented his investigation as; the patient was found by his wife after a three and a half hour search; the patient was fine and there was no harm done to the patient. The report further read the patient was not an elopement risk and did not display any concerning signs he would elope.

The follow up read, Manager #6 would have RN #2 amend her note to display the patient had eloped and not left AMA.

In summary, review of the report revealed no evidence the quality program reviewed the incident for causes or contributing factors and there was no evidence a change in processes was considered in order to prevent reoccurrence of the incident. Furthermore, there was no indication the quality program identified the patient as "at risk," investigated if other "at risk" patients could elope using the same unsecured elevator, or reviewed if education was needed by staff to understand which patients were "at risk" and how to monitor them.

ii. Interviews with staff confirmed the lack of investigation, process review and corrective actions following Patient #2's elopement.

On 7/9/20 at 1:54 p.m., the incident involving Patient #2 was reviewed with Manager #6. Manager #6 stated he and other staff members who investigated the incident were not aware at the time of the investigation the patient had an "At Risk Patient" order and was an elopement risk. Manager #6 did not provide education to staff members or take action to ensure the "At-risk" policy was being followed.

On 7/8/20 at 10:19 a.m., an interview was conducted with Registered Nurse (RN #2). RN #2 stated no education was provided to her related to the incident and she had never received education regarding patients with the "At Risk Patient" order.

On 7/13/20 at 12:33 p.m., Manager #8 was interviewed regarding the incident which involved Patient #2. Manager #8 stated she reviewed the nursing documentation and the neurosurgeon's documentation. Manager #8 stated Manager #6's investigation read the patient was not an elopement risk, therefore she did verify the information Manager #6 documented.

Manager #8 stated if she had known the "At Risk Patient" order was in place at the time Patient #2 eloped from the facility, the investigation, follow-up and staff education would have been different.

b. A second report was reviewed for Patient #6 who was not monitored according to facility policies and physician orders and subsequently had an unwitnessed fall.

i. Review of the report revealed, on 5/12/20 at 4:23 a.m., Patient #6 was confused with AMS (altered mental status) and also had an at risk order in place. Patient #6 was on the waitlist for Avasys (remote virtual sitter). Staff found the patient at her door after a sustained fall.

Patient #6's medical record was reviewed. The medical record revealed the physician placed an "At Risk Patient" order at 5:48 p.m. on 5/11/20. The order read the reason for the at risk designation was she had conditions which increased her harm risk to self/others, was and elopement risk, and lacked capacity to understand risks of leaving AMA.

ii. Review of the follow up from the report revealed a lack of investigation into the causes for the fall involving Patient #6 as well as identification of appropriate corrective actions.

On 5/13/20 the nursing unit manager for the fourth floor documented in the report acknowledgement of the Avasys (remote virtual sitter) was unavailable and the patient bed alarm was audible in the room but not heard outside of the room (i.e. at Nurse's Station).

The nursing unit manager documented he would discuss with staff members involved for learning opportunities to include at risk order and options for staff if the Avasys not available.

On review of the incident, there was no evidence the incident was investigated per policy and the discussion with staff had occurred to prevent future patient harm.

iii. Interviews with staff confirmed the lack of investigation, process review and corrective actions following Patient #6's fall.

The incident involving Patient #6 was discussed with Manager #7, who was the patient safety manager who completed the report for Patient #6. Manager #7 stated the patient was on the waitlist for a remote virtual sitter and the proper fall interventions were in place. Manager #7 further stated there was often a waitlist for the remote virtual sitter, however the waitlist was not looked at as a contributing factor for Patient #6's fall. Manager #7 stated there was no requirement for certain patients to have a virtual sitter. Manager #7 was unable to recall if the patient had an "At-risk" order in place when she fell.

This was in contrast to the policy which read, at a minimum, at-Risk patients would be placed in a ligature resistant room and/or the patient would be provided continuous or 1:1 monitoring and would not be left unattended or allowed to walk around the nursing unit unsupervised.

Manager #7 further was unable to provide any evidence the fourth floor unit manager did any follow up for Patient #6 to include; discussed with staff members involved for learning opportunities to include at risk order: if Avasys was not available, could staff have pulled the aide as a sitter or asked MD for mesh bed; was at risk policy followed.

This was in contrast to the QAPI plan.

2. Posey Bed

a. The facility failed to investigate an incident involving a patient who was able to unzip his Posey bed (an enclosed bed used to prevent a patient from falling or rolling out of bed) and attempted to climb out. The nursing manager did not identify factors which contributed to the event and therefore measures were not implemented to prevent reoccurrence.

i. A report dated 5/19/20 at 10:14 a.m., read staff were alerted after a loud crash was heard that a patient was able to remove half of his body from a Posey bed. The patient had knocked over his tray table and was using it to pull himself out. Staff assisted the patient back into the Posey bed and noted the Posey bed was not fully zipped on one side, allowing the patient to get a finger into the opening and unzip the bed enough to crawl out.

The facility investigation into the incident revealed, the incident was documented as closed, resolved with increased vigilance.

ii. In an interview conducted on 7/13/20 at 1:30 p.m. with Manager #17 who was the manager of the unit in which the Posey bed incident occurred. On review, Manager #17 stated she had not completed the incident report and was unable to determine from the report investigation if the Posey bed was faulty or if there was human error involved. Manager #17 was unable to identify actions taken in order to prevent the event from occurring again.

There was no evidence an investigation occurred which addressed the patient's ability to get out of the Posey Bed and no causative factors determined. Furthermore, there was no documentation in the report which indicated education was provided to staff to prevent reoccurrence of the patient safety incident.

3. Similar incidents

A review of six other facility incidents dated from 1/1/20 to 7/6/20 were reviewed. The review of the incidents revealed a similar lack of investigation and follow-up to prevent reoccurrence.

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

A-0392 The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for bedside care of any patient.

Based on interviews and document review, the facility failed to ensure adequate availability of nursing staff to meet the unit acuity and safely monitor the needs of high risk patients who required one-to-one (1:1) monitoring. Additionally, the facility failed to ensure the nursing staffing matrix was adhered to when making unit staffing assignments. The failure was identified in two of eight inpatient nursing units surveyed.

Based on interviews and document review, the facility failed to ensure adequate availability of nursing staff to meet the unit acuity and safely monitor the needs of high risk patients who required one-to-one (1:1) monitoring. Additionally, the facility failed to ensure the nursing staffing matrix was adhered to when making unit staffing assignments. The failure was identified in two of eight inpatient nursing units surveyed.

Findings include:

Facility Policies:

The Staffing Guideline Policy read, staffing in hospitals is complex and closely associated with patient safety and outcomes. The clinical manager will adhere to these guidelines, staff to the Average Daily Census (ADC) core staffing. The staffing coordinator will adhere to these guidelines; work collaboratively with the clinical manager to ensure units are staffed adequately. Department leadership must plan adequate coverage for individual unit staffing 24 hours a day, seven days a week.

The At-Risk Patients and Behavioral Precautions policy read, when a patient is found to meet At-Risk criteria, the following Behavioral Health Precautions will be put into place to maintain safety. At a minimum, At-Risk patients will be placed in a ligature resistant room and/or the patient will be provided continuous or 1:1 monitoring. At-Risk patients will not be left unattended. Continuous observation is conducted in person or via video monitoring.

The Remote Virtual (Camera) Sitter and Bedside 1:1 Sitter policy read, a bedside 1:1 sitter keeps patients safe when the virtual sitter has failed or when increased bedside observation is required.
References:

The RN (Registered Nurse) Charge Job Description read, job summary: Provides shift leadership and support to the nursing and support staff. Delegates to non-RN personnel in accordance with State Board of Nursing and hospital policy. Manages resources and patient flow through matching nursing competencies with individualized patients and unit needs. Effectively uses time, personnel, equipment and supplies to provide high quality, cost effective patient care.

The Staffing Matrices for the fourth and tenth floor read, a requirement for one Charge Nurse to work on each day and night shift. This requirement was distinct from the required number of floor nurses, and did not change based on the patient census. The Staffing Matrices included the allowable patient to nurse ratios; however, the matrices read RN ratios DO NOT include charge RNs. The Staffing Matrix for the tenth floor required two CNAs when there were 15 or more patients on the unit during the day, and 17 or more patients on the unit during the night. The maximum allowable patient to CNA ratio on the tenth floor was 16 patients to one CNA.

The Staffing Matrix for the fourth floor read, two Certified Nursing Assistants (CNAs) were required when there were 14 or more patients on the unit during the day, and 16 or more patients on the unit during the night. The Staffing Matrix included the allowable patient to CNA ratios, and the maximum allowable patient to CNA ratio on the fourth floor was 15 patients to one CNA.

1. The facility failed to follow their own staffing matrix and ensure an adequate number of staff were available to perform patient care needs.

A. Document Review

Document review revealed two incidents in which patients (Patient #2 and Patient #6) who had an active "At Risk Patient" order did not have a 1:1 sitter or remote virtual sitter (video monitoring) in place.

According to the At-Risk Patients and Behavioral Precautions policy, at a minimum, At-Risk patients would be placed in a ligature resistant room and/or the patient would be provided continuous or 1:1 monitoring. At-Risk patients would not be left unattended. Continuous observation was required to be conducted in person or via video monitoring.

1. Patient #2's medical record was reviewed. The medical record revealed on the day Patient #2 eloped from the facility, there was an active "At Risk Patient" order in place. The order was signed by Physician #4 on 6/1/20 at 8:34 a.m. and read, Patient #2's reason for at risk designation was he had conditions which increased his risk of harm to self/others, was an elopement risk, and lacked capacity to understand risks of leaving AMA.

There was no evidence a 1:1 bedside sitter or a remote virtual sitter were provided to Patient #2 who had an active "At Risk Patient" order the day he eloped from the facility.

2. Patient #6's medical record was reviewed. The medical record revealed the physician placed an "At Risk Patient" order at 5:48 p.m. on 5/11/20. The order read the reason for the at risk designation was she had conditions which increased her risk of harm to self/others, was and elopement risk, and lacked capacity to understand risks of leaving AMA.

There was no evidence a 1:1 bedside sitter was provided to Patient #6 who had an active "At Risk Patient" order, while waiting for a remote virtual sitter prior to Patient #6's fall.

3. The facility provided Nursing Assignment Sheets for the fourth and tenth floors from 5/22/20 to 7/12/20, and an additional assignment sheet for 5/12/20 for the tenth floor.

The Nursing Assignment Sheets revealed multiple instances in which Certified Nursing Assistants (CNAs) were assigned to act as a 1:1 sitter, or in which the unit was short one CNA, resulting in patient to staff ratios which exceeded the ratios allowed by the facility staffing matrices.

a. A CNA was reassigned from the 10th floor to act as a sitter on the night shift of 5/12/20 when the unit census was 18 patients and on the night shift of 6/27/20 when the unit census was 17 patients. On the shifts when a CNA was pulled to act as a sitter or when the unit was short a CNA, the entire nursing unit was left with one CNA to care for all patients. This was in contrast to the ratios allowed by the Staffing Matrix used on the tenth floor which allowed a maximum patient to CNA ratio of 16 patients to one CNA.

b. A CNA was reassigned from the fourth floor to act as a sitter on the night shift of 5/20/20 when the unit census was 16 patients, and on the day shift of 6/10/20 when the unit census was 16 patients and the night shift of 6/18/20 when the unit census was 18 patients. On the shifts when a CNA was pulled to act as a sitter or when the unit was short a CNA, the entire nursing unit was left with one CNA to care for all patients. This was in contrast to the ratio allowed by the Staffing Matrix used on the fourth floor which allowed a maximum patient to CNA ratio of 15 patients to one CNA.

c. The fourth floor was short one CNA on the day shift of 5/21/20 when the unit census was 17 patients, and on both day and night shift of 7/6/20 when the unit census was 19 patients. This was also in contrast to the Staffing Matrix used on the fourth floor which allowed a maximum of 15 patients to one CNA.

4. The Nursing Assignment Sheets provided by the facility revealed multiple instances in which the charge nurse had patients assigned to them. This was in contrast to the Staffing Matrices used by the fourth and tenth floors to determine staffing assignments, which read RN ratios do not include charge RNs.

a. The Staffing Assignment Sheets for the tenth floor revealed the night shift charge nurses had at least three patients assigned to them on every shift from 5/22/20 to 7/12/20. On nine shifts during this time period the night shift charge nurse was assigned five patients, which according to the staffing matrix was considered a full patient load. The day shift charge nurse was assigned patients on twelve shifts during this time period. On two shifts the day shift charge nurse was assigned four patients, which was considered a full patient load for the day shift.

b. The fourth floor Staffing Assignment Sheets revealed the night shift charge nurse had at least three patients assigned to them on every shift from 5/22/20 to 7/12/20. On 6/29/20 the night shift charge nurse had a full patient assignment of five patients. In addition, the day shift charge nurse was assigned patients on 18 shifts during the previously stated time period.

B. Interviews

Interviews with facility staff revealed Patient #2 and Patient #6 did not have 1:1 sitters according to the At-Risk Patients and Behavioral Precautions policy. Additionally, interviews revealed overall staffing levels were not adequate to meet the need for 1:1 monitoring of high risk patients, unit acuity, or the facility staffing matrices.

a. On 7/8/20 at 10:19 a.m., Registered Nurse (RN #2) was interviewed. RN #2 was the primary nurse for Patient #2 on the day he eloped from the facility. She stated she felt a sitter was needed for Patient #2, but there was no staff available that day to sit with the patient. She stated if Patient #2 had a sitter, he would not have been able to elope from the unit.

b. On 7/8/20 at 8:34 a.m., the charge nurse for the tenth floor (Charge RN #1) was interviewed. Charge RN #1 stated Patient #2 had an "At Risk Patient" order in place the day he eloped from the facility. She stated she recalled the unit was short a CNA and it was a "terribly" busy day. She stated she felt staffing contributed to the occurrence because there were not as many people available to watch the patient, and staff were busy attending to call lights and the needs of other patients.

c. On 7/9/20 at 1:54 p.m., the Manager of Clinical Nursing for the tenth floor (Manager #6) was interviewed. Manager #6 stated Patient #2 had an "At Risk Patient" order because he did not have the cognitive ability to make his own decisions. He stated when patients had an "At Risk Patient" order they typically had a 1:1 sitter or remote virtual sitter per the facility policy. Manager #6 stated Patient #2 did not have a 1:1 sitter or a remote virtual sitter when he was on the tenth floor.

d. On 7/13/20 at 11:54 a.m., Patient Safety Managers (Manager #7) was interviewed. Manager #7 stated staff did not have the remote virtual sitter in place for Patient #6 because there was a waitlist for the remote sitter at the time.

2. Interviews with facility staff revealed adequate staff, specifically CNAs, were not available to ensure 1:1 monitoring for at-risk patients and other patients who required supervision for safety.

a. In an interview conducted on 7/8/20 at 10:19 a.m., RN #2 stated if the unit did not have staff available, then a patient might not get a 1:1 sitter.

b. On 7/9/20 at 8:32 a.m., the weekend charge nurse for the tenth floor (Charge RN #3) was interviewed. Charge RN #3 stated staffing could be a determining factor in whether a patient would get a 1:1 sitter. Charge RN #3 stated there were times when patients needed a sitter for safety, but the unit could not get a sitter due to lack of available staff.

c. On 7/13/20 at 12:34 p.m., Manager #6 was interviewed. Manager #6 stated when an at-risk patient required a 1:1 sitter, he would speak with the facility staffing office to determine if a CNA was available to be a sitter. He stated if there were two CNAs on the unit one would be reassigned from the floor to sit 1:1 with the patient.

d. On 7/13/20 at 2:35 p.m., Chief Nursing Officer (CNO #16) was interviewed. CNO #16 confirmed if a patient needed 1:1 staff supervision, the unit would reassign a CNA or other staff to act as a sitter. CNO #16 confirmed 1:1 monitoring was required for at-risk patients, and she stated the facility had recently seen an increase in patients who were at-risk or had behavioral concerns.

3. Interviews revealed when a CNA was reassigned from the unit staffing to act as a 1:1 sitter, the unit would be left short-staffed according to the staffing matrix. When the unit was short a CNA, adequate staff were not available to respond to patient needs and complete patient care tasks.

a. On 7/13/20 at 10:50 a.m., CNA #22 was interviewed. CNA #22 stated the responsibilities of the CNA included getting vital signs, checking blood sugars, providing CHG (Chlorhexidine Gluconate, a cleaning product which killed germs) baths for patients with central lines (a central venous catheter, a type of intravenous line), assisting patients with ADLs (activities of daily living, which include walking, feeding, toileting and bathing), and turning patients every two hours in order to prevent skin breakdown.

CNA #22 stated the number of CNAs working each shift had decreased since the staffing grid was changed. She stated it was more difficult to complete expected tasks with less staff. CNA #22 stated she had observed longer delays in patient call lights being answered since staffing changes were implemented.

b. On 7/8/20 at 6:15 a.m., CNA #20 was interviewed. She stated the previous week there were two days the unit was understaffed and had only one CNA. CNA #20 stated there was a patient who needed a 1:1 sitter for the previous month, so a CNA was consistently reassigned from the unit to sit with the patient which left the floor short a CNA.

CNA #20 stated the unit was more chaotic when there was only one CNA available to care for patients. She stated when there was less staff available on the floor, it was harder to attend to patients who may be confused or attempted to get out of bed.

c. In an interview conducted on 7/8/20 at 10:19 a.m., RN #2 stated the tenth floor recently had an at-risk patient who needed a 1:1 sitter during his entire hospitalization, which resulted in the unit often being short of a CNA. RN #2 stated when a CNA was reassigned to sit with a patient, there was sometimes only one CNA on the unit to care for 24 patients. This was in contrast to the ratios allowed by the Staffing Matrix used on the tenth floor which allowed a maximum patient to CNA ratio of 16 patients to one CNA.

RN #2 stated the CNA was responsible for getting vital signs, and stated nurses were not always able to help with this task. She further stated the CNA needed to care for patients who could not roll or turn by themselves and patients with fractures who required the assistance of two or three staff members.

d. On 7/8/20 at 8:34 a.m. Charge RN #1 was interviewed. Charge RN #1 stated when the unit was short a CNA other staff needed to take on other tasks in addition to their own workload. Charge RN #1 stated there were not as many people available to respond if a high-risk patient attempted to get out of bed, which could lead to a fall. She stated she had observed more "near-falls" since the new staffing grid went into effect.

4. Interviews with facility staff revealed staffing levels outlined by the current staffing matrices did not adequately meet the needs of high acuity patients and the overall acuity of the units.

a. On 7/8/20 at 10:19 a.m., RN #2 was interviewed. RN #2 stated the tenth floor had high acuity patients such as patients with hip fractures and patients with brain bleeds. She stated patients with fractures often required two to three staff members to lift them, and patients with brain bleeds were often confused. RN #2 stated since the new staffing grid went into effect, she felt the floor was always short-staffed even when staffing levels were accurate according to the grid.

b. On 7/9/20 at 9:08 a.m., RN #13 was interviewed. RN #13 stated she felt all her patients were high acuity the past week. RN #13 stated she was warned one of her patients would be "a handful," while she was also assigned a patient on two IV (intravenous) antibiotics, a patient who reported high levels of pain after a surgery which required multiple medication administration and assessment of pain, and a new admission. RN #13 stated she felt she neglected certain patients at times in order to care for others.

RN #13 stated a manageable assignment depended on the acuity of the patients. She stated when there was higher acuity patients on the unit, she felt nurses should take fewer patients to provide adequate care. RN #13 stated in the unit and charge nurses seemed overwhelmed in the past week, even when there was adequate staff according to the staffing grid.

c. On 7/9/20 at 11:06 a.m., RN #15 was interviewed. RN #15 stated the acuity on the tenth floor was higher on the weekends due to trauma patient admissions. She stated caring for trauma patients required a great deal of time. She stated weekends were more chaotic because nurses had the maximum number of patients allowed by the staffing ratios, and there were never enough CNAs available.

d. On 7/8/20 at 8:34 a.m., Charge RN #1 was interviewed. Charge RN #1 stated greater than half of the patients on the tenth floor were high-acuity patients who required a lot of the staff's time. She stated patients who were admitted with falls, head injuries, and broken hips could turn into total care patients, who required hourly turns and the assistance of multiple staff to get out of bed.

Charge RN #1 stated since the new staffing grid was implemented there were less staff on the floor and the change had impacted staff's ability to perform their jobs and respond to patient needs.

e. In an interview conducted on 7/13/20 at 12:34 p.m., Manager #6 stated the acuity tool in EPIC (the electronic health record system) was incorporated into the assignment of patients to nurses in order to split patients up based on acuity. Manager #6 stated the staffing matrix changed in April which increased the number of patients RNs could be assigned. Manager #6 did not provide evidence as to whether acuity was used to determine the number of staff needed for each shift.

5. Interviews and document review revealed nurses were not staffed in adequate numbers to ensure the charge nurses were able to fulfill their expected job duties.

The RN Charge Job Description required the charge nurse to provide shift leadership and support to nursing staff, and effectively use time and personnel to provide high quality patient care.

a. On 7/13/20 at 2:35 p.m., CNO #16 was interviewed. CNO #16 stated the facility attempted to staff charge nurses without patients unless necessary on a case by case basis. She stated it was not the normal expectation on any shift for charge nurses to take a full load of patients, because charge nurses should be available for charge nurse duties.

b. On 7/8/20 at 3:43 p.m., RN #12 was interviewed. RN #12 stated since the change to staffing levels were implemented, there were less RNs and CNAs on the unit. She stated when the unit was short-staffed, the charge RN needed to become an extra "set of hands" to assist other staff.

c. In an interview conducted on 7/9/20 at 8:32 a.m., Charge Nurse #3 stated she was guaranteed to have one to two patients, and sometimes a full load of patients on her shifts. Charge Nurse #3 stated the charge nurses being assigned patients had become the unit normal for weekends because the unit was almost always short a CNA and sometimes a nurse. This was in contrast to CNO #16's interview which stated it was not the normal expectation on any shift for charge nurses to take a full load of patients.

d. On 7/13/20 at 12:34 p.m., Manager #6 stated charge nurse responsibilities included creating the nurse assignments for the shift, incorporating the acuity tool in EPIC to determine nurse assignments, using the staffing matrix to determine staffing needs, and training new charge nurses. He stated the goal for day shift was to keep the charge nurse without patients, however depending on the census sometimes the charge nurse would have to take one to three patients. He stated on night shifts the charge nurse typically would have a full assignment of patients, which was up to five patients.

Manager #6 stated for as long as he could remember, it was an unwritten rule for the night charge nurse to take patients. This was in contrast to CNO #16's interview which stated it was not the normal expectation on any shift for charge nurses to take a full load of patients, because charge nurses should be available for charge nurse duties. Manager #6 stated the charge nurse's ability to complete their duties depended on how busy the unit was.