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Based on interview and record review, the facility failed to protect and promote each patients' rights when:

1. The Center for Behavioral Health unit (CBH,a secured 20-bed unit that provides intensive psychiatric treatment for patients suffering from acute psychiatric disorders and secondary substance abuse disorders) did not have adequate staff to provide continuous line of sight (LOS, a level of observation that requires a designated staff member to perform constant and continuous visual observation of a patient to prevent patients from harming themselves or others) observation for two of 17 CBH patients (Patient 2 and Patient 3) on legal holds (the involuntary detainment of an adult who is experiencing a mental health crisis and at risk for harming themselves or others). As a result, one nursing assistant (NA, an unlicensed staff member that provides basic nursing care and assists in maintaining a safe environment) was assigned to perform continuous LOS observations on Patient 2 and Patient 3, who were admitted into two separate rooms, and not simultaneously visible to the NA. This failure resulted in Patient 2, a high-suicide risk patient, being discovered unresponsive, with bluish-colored skin, and a pulse oximetry cord (SPO2 cord, a cable that connects to an oxygen measuring device) wrapped several times around her neck. Subsequently, a code blue was activated, the ligature cord was removed, and Patient 2 regained consciousness.

An Immediate Jeopardy under A-0144 was issued on 12/01/23. The hospital submitted a plan to remove the immediacy on 12/01/23 and the Immediate Jeopardy was removed during onsite verification on 12/04/23. (Refer to A 144, Finding 1)

2. The CBH unit was not staffed with an adequate number of NAs or mental health technicians (MHTs, an unlicensed staff member that assists licensed nurses with behavioral interventions and maintaining a safe environment) to designate a staff member to conduct 15-minute patient safety rounds (a minimum level of observation required on every CBH patient to monitor patient safety. Each patient's location, activity, and behaviors are observed and documented in 15 intervals. Safety rounds take the entire 15 minutes, before they are repeated for the next interval). As a result, a CBH clinical supervisor (CBHCS, a registered nurse who supervises the operations and nursing services of the CBH unit), a CBH registered nurse (RN)s, or a CBH licensed vocational nurse (LVN) was assigned to provide complete direct-care nursing services to six CBH patients while also being assigned to perform the unit's 15-minute patient safety rounds, to all CBH patients, during the 10/01/23 day shift, 10/08/23 day shift, 10/12/23 night shift, 10/15/23 day shift, 10/18/23 day shift, 11/01/23 night shift, 11/11/23 night shift, 11/15/23 night shift, and 11/26/23 night shift. This failure potentially placed all CBH patients at risk for poor nursing care, compromised safety, and an unsafe environment. (Refer to A 144, Finding 2)

3. The CBH unit did not implement the facility's Staffing Plan Policy, and utilize the facility's Patient Classification System Matrix, to identify patient acuity levels and determine patient needs, which included: Patient hours in physical restraints, line of sight or 1:1 observation level, suicide risk, seclusion placement, oxygen tubing ligature risk, intravenous line (IV, a tube placed through the skin into a vein to deliver fluids or medication) placement/ ligature risk, fall risk or other higher acuity needs. As a result, the CBH unit was unable to determine appropriate staffing levels of licensed and unlicensed staff needed to meet the patients' needs, and maintain a safe environment, from 10/01/23 - 11/30/23. This failure potentially placed all CBH patients at risk for poor nursing care, compromised safety, and an unsafe environment. (Refer to A 144, Finding 3)

4. The facility's staff failed to ensure that the use of restraints for Patient 1 was in accordance with a physician (MD), or other licensed independent practitioner (LIP), order. This failure resulted in Patient 1 being placed in bilateral soft wrist restraints without an MD/LIP order. (Refer to A-0168)

5. Based on interview and record review, the facility failed to provide continuous monitoring of a patient in restraints when staff did not perform 15 minute Behavioral Health Restraint Assessments (BHRA, assessments conducted every 15 minutes that assesses a patient's vital signs, hygiene and elimination needs, nutrition and hydration needs, and physical and psychosocial needs) when Patient 1 was placed in bilateral soft-wrist restraints. This failure resulted in Patient 1 remaining in restraints without his safety needs, physical needs, or psychosocial needs being frequently assessed and reevaluated. As a result, Patient 1 remained in restraints for 6 hours and 37 minutes without his vitals signs being measured, without being offered a lunch time meal tray, and without being reevaluated to determine if Patient 1 met criteria to discontinue restraint use. (Refer to A 0175)

The cumulative effect of these systemic problems caused actual harm to one patient in the CBH and had the potential to compromise the safety and quality of care for all patients in the CBH and ED.

Based on observation, interview, and record review the facility failed to provide a safe environment, reduce ligature risk (an item that can be used for the purpose of hanging or strangulation), and protect patients admitted to the Center for Behavioral Health unit (CBH, a secured 20-bed unit that provides intensive psychiatric treatment for patients suffering from acute psychiatric disorders and secondary substance abuse disorders) from self-harm or harming others when:

1. The CBH unit did not have adequate staff to provide continuous line of sight (LOS, a level of observation that requires a designated staff member to perform constant and continuous visual observation of a patient to prevent patients from harming themselves or others) observation for two of 18 patients (Patient 2 and Patient 3) on legal holds (the involuntary detainment of an adult who is experiencing a mental health crisis and at risk for harming themselves or others). As a result, one nursing assistant (NA, an unlicensed staff member that provides basic nursing care and assists in maintaining a safe environment) was assigned to perform continuous LOS observations on Patient 2 and Patient 3, who were admitted into two separate rooms, and not simultaneously visible to the NA. This failure resulted in Patient 2, a high-suicide risk patient, being discovered unresponsive, with bluish-colored skin, and a pulse oximetry cord (SPO2 cord, a cable that connects to an oxygen measuring device) wrapped several times around her neck. Subsequently, a code blue was activated, the ligature cord was removed, and Patient 2 regained consciousness.

2. The CBH unit was not staffed with an adequate number of NAs or mental health technicians (MHTs, an unlicensed staff member that assists licensed nurses with behavioral interventions and maintaining a safe environment) to designate a staff member to conduct 15-minute patient safety rounds (a minimum level of observation required on every CBH patient to monitor patient safety. Each patient's location, activity, and behaviors are observed and documented in 15 intervals. Safety rounds take the entire 15 minutes, before they are repeated for the next interval). As a result, a CBH clinical supervisor (CBHCS, a registered nurse who supervises the operations and nursing services of the CBH unit), a CBH registered nurse (RN)s, or a CBH licensed vocational nurse (LVN) was assigned to provide complete direct-care nursing services to six CBH patients while also being assigned to perform the unit's 15-minute patient safety rounds, to all CBH patients, during the 10/01/23 day shift, 10/08/23 day shift, 10/12/23 night shift, 10/15/23 day shift, 10/18/23 day shift, 11/01/23 night shift, 11/11/23 night shift, 11/15/23 night shift, and 11/26/23 night shift. This failure potentially placed all CBH patients at risk for poor nursing care, compromised safety, and an unsafe environment.

3. The CBH unit did not implement the facility's Staffing Plan Policy, and utilize the facility's Patient Classification System Matrix, to identify patient acuity levels and determine patient needs, which included: Patient hours in physical restraints, line of sight or 1:1 observation level, suicide risk, seclusion placement, oxygen tubing ligature risk, intravenous line (IV, a tube placed through the skin into a vein to deliver fluids or medication) placement/ ligature risk, fall risk or other higher acuity needs. As a result, the CBH unit was unable to determine appropriate staffing levels of licensed and unlicensed staff needed to meet the patients' needs, and maintain a safe environment, from 10/01/23 - 11/30/23. This failure potentially placed all CBH patients at risk for poor nursing care, compromised safety, and an unsafe environment.

Findings

1. A review of the facility's policy titled, "Suicide Risk Assessment", dated 11/2019, indicated that the facility was committed to identifying the patient at risk for suicide and providing a safe environment. The policy further indicated patients who screened positive for suicide risk were
further assessed to determine the degree of risk. Once risk was determined, the patient was placed on the corresponding level of observation. Patients at risk for suicide would maintain determined levels of observation and interventions until discontinued by the licensed independent mental health practitioner. An order by the licensed independent mental health practitioner was required to remove suicide levels of observation and interventions.

A review of the facility's policy titled, "Levels of Observation - Behavioral Health Program", dated 6/2023, indicated that the policy's purpose was to provide protection to patients and ensure that staff monitoring of patients was instituted to prevent patients from harming themselves or others. The policy further indicated there were three levels of staff monitoring. At a minimum, all CBH patients were to be monitored every 15 minutes and their location, activity, and behaviors were to be recorded at 15-minute intervals. The second level of
observation, or LOS, required that a designated staff member always have the patient within visual view due to increased precautions for danger to self. When a patient on LOS observation showers, change clothes, or toilets, staff would remain outside, with the door slightly open, and visually check the patient every 30 seconds. The constant LOS observation was an alternative if the third level of observation, 1:1 constant observation (a designated staff member has constant visualization of a patient and is within arm's length of the patient), would further agitate a patient. Any discontinuation of observation, or lessening of the level of observation, must be discontinued by a medical doctor (MD) order.

A review of medical records indicated that Patient 2 was a 70-year-old female who arrived at the facility's emergency department by ambulance, on 9/26/23, due to an intentional overdose (when a person deliberately takes drugs to harm themselves). Patient 2 was subsequently admitted to the facility's intensive care unit and placed on mechanical ventilation (a machine that helps deliver oxygen into and out of the lungs) for acute on chronic respiratory failure (a sudden worsening of an ongoing lung condition). On 9/27/23, Patient 2 was extubated (breathing tube removed), transferred to the facility's medical unit, and medically cleared to receive minimal medical services and intense psychiatric care on the facility's CBH unit. Records indicated Patient 2 had been feeling suicidal and was severely depressed because her
son, who was living with her, had been missing for more than two weeks. Patients 2's diagnosis included severe depression, schizoaffective disorder, suicidal ideation, and chronic obstructive pulmonary disease.

A review of Patient 2's Columbia Suicide Risk Assessment, dated 9/26/23, at 1:00 pm, indicated that Patient 2 was at moderate risk, due to suicidal ideation without a plan, and required 15-minute safety rounds and LOS observation.

A review of the facility's hospitalist (MD 2) order, dated 9/27/23, indicated that Patient 2 was receiving daily respiratory therapy treatment, oxygen via nasal cannula to maintain oxygen saturations over 90% (a measurement of blood oxygen that is normally 97 -100 %), and oral prednisone (a steroid medication) to assist with respiratory distress.

An interdisciplinary treatment plan, dated 10/02/23, indicated that Patient 2 was a danger to self, expressed suicidal ideation, and required line of sight observation due to ligature risk from the oxygen tubing and SPO2 cord.

A review of RN 6's nurse's notes dated, 10/10/23, at 12:11 am, indicated that Patient 2 reported she had suicidal ideation, without a plan, and that she was hearing voices telling her to kill herself for being a "bad mom."

A review of RN 7's nurse's notes dated, 10/10/23, at 7:30 am, indicated that at the start of day shift, at approximately 6:30 am, Patient 2 was found unresponsive, with the SPO2 cord wrapped around her neck. Patient 2's "LOS for night shift was reportedly checking on another patient at the time. Patient 2 was slightly blue, and a code blue was called. SPO2 cord was unwrapped and pt's oxygen was increased to 10 liters/ nasal cannula." Patient 2's oxygen saturations increased to 97%, heart rate was 85 beats per minute (bpm), blood pressure was 162/86, and respiratory rate (RR, breaths per minute) was 18. "After approximately 10 minutes Patient 2 began responding to staff."

A review of RN 8's Code Blue nurse's notes, dated 10/10/23, at 7:15 am, indicated that RN 8 responded to an overhead code blue call for the CBH unit. "On arrival Patient 2 had a good carotid pulse ... was breathing spontaneously, had HR at 84 bpm, and O2 sats were in the mid-90s on 2/L of oxygen via nasal cannula." Records indicated the CBH staff were at the patient's bedside and stated Patient 2 had the SPO2 cord wrapped around her neck. Patient 2 was blue in the face when the CBH staff intervened, and removed the SPO 2 cord, prior to the code team's arrival. RN 8 notified Patient 2's psychiatrist, MD 3, of the strangulation attempt. MD 3 ordered a computed tomography scan (CT, an imaging test that detects injury) of Patient 2's head and neck.

A review of MD 3's progress notes, dated 10/10/23, at 1:28 pm, indicated that, "apparently this patient was watched by partial line of sight, line of sight was also for patient in the next room, the patient was found by the nurse's aide from the morning shift ... and discovered to have a pulse oximeter wrapped around her neck twice ... CODE BLUE was called ... CT of her head and neck was ordered which was reported to be within normal limits ...." When Patient 2 returned from the CT, she was alert, had a normal neurological exam, and was able to walk with assistance. MD 3 consulted with MD 2 and ordered arterial blood gases (ABG, a lab test that measures oxygen and carbon dioxide levels in the blood), electrocardiography (EKG, a recording of the hearts activity), a complete metabolic panel (CMP, a lab test that shows how well the kidney and liver are working), and troponins (TROP, a lab test that measures the troponin protein that is released in the blood during a heart attack).

A review of the facility document titled, "Behavioral Health Staffing Sheet", dated 10/09/23, indicated that the unit had one CBHCS, two RNs, two LVNs, one NA, and one MHT scheduled to work the 10/09/23, night shift, and provide care to 18 CBH patients. One RN was floated (removed from their home unit to work in an area that is short-staffed) off of the CBH unit to work in the Emergency Department. CBHCS was assigned to manage the unit and supervise two LVNs. One RN was working a double shift (24 hours) and was assigned to provide care to five CBH patients. Two LVNs were assigned to six CBH patients each. One NA was assigned to provide continuous LOS to Patient 2 (Room 326) and Patient 3 (Room 325). One MHT was assigned to perform the unit's 15-minute patient safety rounds.

During a concurrent observation and interview in the CBH unit, on 12/04/23, at 6:42 am, RN 4 reported she had been a relief Clinical Supervisor on the CBH unit for five years and verified she worked as relief clinical supervisor, on 10/09/23 night shift, when Patient 2 attempted to strangulate herself. RN 4 stated the event occurred at approximately 6:30 am, or at change of shift, while RN 4 was giving report in the unit's secured conference room, so she was not present when Patient 2 was discovered with a SPO2 cord around her neck. RN 4 stated at the start of the 10/09/23, night shift, the CBH unit did not have enough NAs or MHTs scheduled to conduct safety rounds and LOS observations. RN 4 requested more NAs, but the facility was unable to provide the CBH unit with more staff. This resulted in NA 2 performing LOS on two patients at the same time. RN 4 stated the staff shortage created a situation where Patient 2 and Patient 3 did not receive constant LOS supervision, because, "one person cannot have eyes on two patients at all times, especially if the patients are in separate rooms." RN 4 reported that LOS observation was initiated by an MD order and was intended for one staff member to always have continuous eyes on one patient. LOS was not intended to be a partial line of sight, which was what occurred when NA 2 was assigned LOS to more than one patient. RN 4 stated Patient 2's strangulation attempt could have been prevented if the unit had enough staff to correctly implement the MD's LOS order.

During a concurrent interview and record review in the CBH unit, on 12/04/23, at 6:06 am, MHT verified he worked the 10/09/23 night shift, and was present on 10/10/23, at 6:30 am, when Patient 2 attempted to strangle herself. MHT stated that Patient 2 had been on LOS observation since being admitted to the unit because Patient 2 was suicidal and had medical tubing and cords that were a potential ligature risk. MHT reported that during the 10/09/23, night shift, the CBH unit was short-staffed and only had two staff members scheduled to perform 15-minute patient safety rounds and LOS observations. Since the CBH unit had two LOS patients (Patient 2 and Patient 3) MHT was assigned to perform safety rounds and NA 2 was assigned to provide LOS observation on both Patient 2 and Patient 3, at the same time. MHT stated that Patient 2 and Patient 3 were admitted to separate, private rooms, with exit doorways located right next to each other. NA 2 sat outside the doorways and attempted to continuously observe Patient 2 and Patient 3 as best as he could throughout the night shift. MHT stated that assigning NA 2 to perform LOS observation on both Patient 2 and Patient 3 was "extremely unsafe" because it was impossible for NA 2 to have both patients in his field of vision at the same time.

During an interview in the facility's conference room, on 12/11/23, at 6:09 pm, NA 2 reported he had worked as an NA at the facility's CBH unit for approximately 6 years. NA 2 verified he worked on 10/09/23, night shift, and was assigned to provide LOS observation to Patient 2 and Patient 3. NA 2 stated that RN 4 requested more aide support for the night shift, but it was not provided, so the CBH staff had to do "the best they could with what they had." NA 2 reported that both Patient 2 and Patient 3 were very high-risk patients and at risk for harming themselves or others. Since Patient 2 and Patient 3 were in separate, private rooms, located right next to each other, he (NA 2) opted to sit in the hallway, near their open doorways, to perform LOS observation. NA 2 stated it was not an "ideal situation" because he was unable to have a constant view of both patients. At approximately 6:20 am, near the change of shift, Patient 3 had increased agitation and was pacing in her room and yelling threats. NA 2 turned his chair toward Patient 3's room, with his back toward Patient 2's door, so he could prop his foot against Patient 3's door to ensure she did not exit her room. NA 2 reported during this time, day shift staff members had entered Patient 2's room and yelled for staff to initiate a Code Blue (an emergency code indicating a patient is in need of resuscitation due to respiratory or cardiac arrest). NA 2 stated he did not leave his post to assist the day shift staff with Patient 2's Code Blue because Patient 3 was very triggered by the commotion and becoming a risk to harm herself or others.

During a concurrent observation and interview in the CBH unit, on 12/04/23, at 8:03 am, NA 1 reported she worked the 10/10/23, day shift, and was the staff member that discovered Patient 2 with the cord wrapped around her neck. NA 1 reported she had a habit of saying good morning to the CBH patients prior to getting her day-shift assignment. When NA 1 approached Patient 2's room, she noticed that NA 2 was sitting in a chair outside of Patient 2 and Patient 3's room, providing partial LOS to both patients. NA 2 had his back to Patient 2's door with his foot propped up on Patient 3's door to secure it from being fully opened. NA 1 reported when she entered Patient 2's room, the room was very dark, and Patient 2 had the bed sheet placed above her chin. When NA 1 approached Patient 2's vital sign machine, that was connected to the SPO2 cord, NA 1 noticed the machine was completely "flatlined", and not detecting Patient 2's heart rate or oxygen levels. NA 1 began speaking to Patient 2 while she attempted to trouble shoot the machine. When Patient 2 did not respond NA 1 pulled down Patient 2's sheet and discovered that Patient 2's SPO2 cord was wrapped two times around Patient 2's neck and cinched tightly across her throat. LVN 3 entered Patient 2's room, turned on the light, and immediately assisted NA 1. Patient 2 was unresponsive, blue in the face, and had her hands clenched on the end of the cord. LVN 3 administered a sternal rub and yelled out for a staff member to call a Code Blue and bring the code cart, while NA 1 attempted to remove the cord from Patient 2's neck. NA 1 stated that because the SPO2 cord was wrapped so tightly around Patient 2's neck, LVN 3 had to break the cord from the vital signs machine to untangle and release the cord. NA 1 reported that the Code Blue team arrived while the CBH nurses were transferring Patient 2 to a CPR board and detected Patient 2's pulse and respirations. CPR was not initiated and Patient 2 slowly regained consciousness and stabilized. NA 1 stated that Patient 2 was very disoriented, and did not know her name, date, or her location, hours after the suicide attempt.

During an interview in the facility conference room, on 12/05/23, at 3:35 pm, LVN 3 verified she worked in the CBH unit, on 10/10/23, day shift, and assisted NA 1 when she discovered Patient 2 unresponsive with an SPO2 cord wrapped around her neck. LVN 3 stated when she entered the unit on 10/10/23 to receive report and begin her day shift, she noticed that NA 2 was seated in the hallway, in front of Patient 2 and Patient 3's doors, attempting to perform LOS on both patients. LVN 3 stated that NA 2 could not visualize Patient 2 because he was positioned with his back to Patient 2's door. LVN 3 entered Patient 2's room because she heard a lot of commotion and observed NA 1 troubleshooting Patient 2's vital sign machine. When LVN 3 turned on Patient 2's light, she observed Patient 2 with her SPO2 cord wrapped several times around her neck. Patient 2's was unresponsive, with peri-oral cyanosis (when the mouth and lips turn blue due to a lack of oxygen in the blood), and her hands were clenched tightly around the cord. LVN 3 administered a sternal rub (a firm rub on the chest to test for a patient's consiouness), and yelled for staff to call a Code Blue and retrieve the code cart. LVN 3 stated that the cord was wrapped so tightly around Patient 2's neck that she had to climb on top of Patient 2 to lift her head and neck and attempt to unwrap the cord. LVN 3 released the cord from Patient 2's neck by breaking the SPO2 cord from the vital signs machine. LVN 3 stated the Code Blue team arrived quickly and assumed care of Patient 2. Since the Code Blue team detected that Patient 2 had a pulse stable blood pressure, they did not initiate CPR.

During a concurrent interview and record review in the facility's conference room, on 12/11/23, at 1:50 pm, MD 3 stated he had been the Medical Director of the CBH unit since it opened in 2015. MD 3 reported he initiated a full LOS observation order on Patient 2 because Patient 2 was severely depressed, expressed suicidal ideation, and had medical equipment that was a ligature risk. MD 3 stated that the facility's policies, and his expectations, were that LOS observation required the attention of one single staff member on one single patient. MD 3 reported that the CBH unit observation levels were intentionally simple, and black and white, so there was no confusion with safe staffing expectations. MD 3 stated that the facility had on-going issues with insufficient staffing in the CBH unit, which led to Patient 2's partial LOS, and compromised patient safety.

2. A review of the facility's policy titled, "Safety Patient Rounds", dated 6/2023, indicated that the policy's purpose was to provide a minimum level of observation to continually monitor and supervise patient safety. The policy further indicated that the clinical supervisor would assign a staff member at the beginning of each shift to be responsible for conducting continual patient rounds. Patient rounds were to be completed every 15 minutes, on every patient, and documented on the Special Precautions/Observation Record in the patient's medical record.

A review of the facility's policy titled, "Levels of Observation - Behavioral Health Program", dated 6/2023, indicated that the policy's purpose was to provide protection to patients and ensure that staff monitoring of patients was instituted to prevent patients from harming themselves or others. The policy further indicated there were three levels of staff monitoring. At a minimum, all CBH patients were to be monitored every 15 minutes and their location, activity, and behaviors were to be recorded at 15-minute intervals.

During a concurrent record review and interview in the facility's conference room, on 12/05/23, at 4:10pm, CBHCS stated patient safety rounds were critical in keeping CBH patients safe. The staff member conducting the rounds observed for escalating behaviors, potential triggers that may lead to harm, scanned the patients' environment to identify potential safety risks, and engaged with patients to promote socialization. CBHCS verified that the CBH unit did not have sufficient staff scheduled to designate one staff member the responsibility of conducting 15-minute patient safety rounds on the following dates: 10/01/23 day shift, 10/08/23 day shift, 10/12/23 night shift, 10/15/23 day shift, and 10/18/23 day shift. CBHCS reported since the CBH unit was not provided with enough staff during these shifts, either the CBH LVNs, RNs, or CBHCS were assigned to perform 15-minute patient safety rounds on every patient in the unit while also being responsible for providing direct nursing care to six CBH patients. CBHCS reported it was impossible to perform both roles at the same time. When this occurred, safety round checks were frequently not conducted in 15-minute intervals, and the Special Precautions/Observation Record was not documented in real time, because the workload was unsustainable.

During a concurrent interview and record review in the facility's conference room, on 12/11/23, at 1:30 pm, RN 5 verified that the CBH unit did not have sufficient staff scheduled to designate one staff member the sole responsibility of conducting 15-minute patient safety rounds on the following dates: 11/01/23 night shift, 11/09/23 night shift, 11/11 night shift, 11/15/23 night shift, and 11/26/23 night shift. CBHCS reported since the CBH unit was not provided with enough staff during these shifts, either the CBH LVNs, RNs, or CBHCS were assigned to perform 15-minute patient safety rounds on every patient in the unit while also being responsible for providing direct nursing care to six CBH patients. RN 5 stated performing both assignments was very difficult and usually resulted in either nursing tasks or safety rounds not being completed timely.

During an interview in the CBH unit, on 12/04/23, at 6:42 am, RN 4 stated 15-minute patient safety rounds must be performed by one designated staff member, who was not assigned to any other tasks, in order to conduct the rounds correctly. The staff member assigned to safety rounds must locate the patient, make eye contact with the patient, observe the patient's current behaviors, and assess for any potential triggers. If a patient was sleeping, the staff member must get eyes on the patient's face and observe that the patient's chest was rising and falling to ensure the patient was breathing. RN stated that patient safety rounds take the entire 15 minutes to perform because the unit census (the number of patients admitted to a unit daily) was frequently 15-18 patients and CBH patients can be very active since they have the freedom to move around the unit. When one 15-minute patient safety round was completed, the next interval begins. RN 4 stated that the CBH unit frequently did not have enough NAs or MHTs scheduled to conduct safety rounds. When this occurred, a LVN, RN, or CBHCS would have to split time between their nursing care duties while attempting to conduct safety rounds on every patient in the CBH unit. RN 4 stated these assignments were unrealistic, and unsafe, because the licensed nurses had to rush through rounds in order to prevent a delay in their nursing care.

During a concurrent interview and record review in the facility's conference room, on 12/11/23, at 1:50 pm, MD 3 reported he had been the Medical Director of the CBH unit since it opened in 2015. MD 3 stated it was his expectation, and standard of practice, that the 15-minute patient safety rounds should be assigned to one staff member whose only job was to conduct patient safety rounds. MD 3 stated the CBH unit was rarely under census, and if the 15-minute safety rounds were done correctly, they would take the entire 15 minutes to complete before the process must be repeated. MD 3 stated it was unrealistic, and unsafe, to assign patient safety rounds to a LVN, RN, or CBHCS because it would completely take the licensed nurse away from the nursing services they should be delivering, or result in the 15-minute patient safety rounds not being completed properly. MD 3 reported that the unit's Level of Observation Policy was intentionally clear to to mean that one staff member should be assigned to each level of observation (15-minute safety rounds, LOS, and 1:1 close contact), with no other responsibilities, to maintain a safe environment.

During a concurrent interview and record review, on 12/13/23, at 3:45 pm, the Chief Nursing Officer (CNO), who was also acting as interim CBH Director (ICBHD), stated that the CBH unit had three levels of observation that included 15-minute patient safety rounds, LOS, and 1:1 "arms length" observation. CNO/ICBHD stated that his expectation was for one staff member to be assigned to each observation level, without any other patient assignments. If that was not possible, and absent no other resources, the 15-minute patient safety rounds would fall to the CBHCS. If the CBHCS could not perform the task, the staffing issue should be escalated to the nursing supervisor (a nurse responsible for overseeing staffing levels in a facility) or current unit director.

3. A review of the facility's policy titled, "Staffing Plan- Center for Behavioral Health", dated 5/2023, indicated, "A patient classification system shall be used on a day-to-day and shift-by-shift basis to determine the number of staff required to meet the needs of patients."

A review of the facility's document titled, "Patient Classification Totals & Variance Reporting", dated 5/2023, indicated that CBH patients were classified as Level I - Level V based on acuity needs that included: physical restraint hours, 1:1 or LOS observations, suicide risk, seclusion or isolation, oxygen use, IV placement, fall risk, and other.

A review of the facility's document titled, "Behavioral Health Acuity" (BHA), dated 10/01/23 through 11/30/23, indicated that only patients with LOS or 1:1 close contact observation were being measured to determine daily staffing needs.

During a concurrent interview and record review in the facility's conference room, on 12/05/23, at 4:10 pm, CBHCS 1 stated she had been employed as a CBHCS for five years. CBHCS reported she had never seen the facility's "Patient Classification Totals & Variance Reporting" document and had not been instructed to utilize the matrix to determine appropriate staffing levels. CBHCS reported that the current Behavioral Health Acuity Form was created by the former CBH Director (FCBHD) and primarily used to determine how many patients require LOS or 1:1/Close Contact observation. The Behavioral Health Acuity form did not provide measures on CBH patient needs related to elopement risk, suicide risk, oxygen use, fall risk, or physical restraint hours. CBHCS stated measuring patient acuity levels would be very helpful because it would result in CBH staffing levels being based on clinical decisions and not on the number of staff available.

During a concurrent interview and record review in the Nursing Supervisor's (NS) office, on 12/05/23, at 5:40 pm, NS stated that the CBH clinical supervisors sent her a Behavioral Health Acuity report daily to help her determine the unit's staffing levels, and decide if additional staff were required to meet the CBH patient needs. NS reported that the Behavioral Health Acuity report mainly identified the number of CBH patients on LOS or close contact observation. The report did not address other patient complexities that may require more licensed and unlicensed staffing to ensure patient safety. NS stated there was no process to "loop her in" on any other CBH patient needs to ensure she allocated enough staff to CBH.

During a concurrent interview and record review, on 12/13/23, at 3:45 pm, CNO/ICBHD was asked to review the CBH Staffing Plan policy and Patient Classification & Variance Reporting document and compare it to the Behavioral Health Acuity Form that the facilty was
currently utilizing. CNO/ICBHD stated that the current Behavioral Health Acuity form being implemented was not the correct form required by the CBH Staffing Plan Policy, and did not provide measures that indicated the intensity of care needed for each CBH patient to ensure
safety.

Based on interview and record review, the facility staff failed to ensure that the use of restraints for Patient 1 was in accordance with a physician (MD), or other licensed independent practitioner (LIP), order. This failure resulted in Patient 1 being placed in bilateral soft-wrist restraints without an MD/LIP order.

Findings:

The facility's policy titled, "Restraints: Violent Behavior or Seclusion," dated 6/2023, was reviewed and indicated: "1. The policy and procedure is in effect for all departments and services in the acute care facility...3. Restraint may only be used when less restrictive interventions have been determined to be ineffective...15. If a Licensed Independent Provider (LIP, physicians, physician assistants, or advanced practiced registered nurses) are not able to issue an order, a Registered Nurse (RN) may initiate the use of restraints based on an appropriate assessment of the patient 15.1 If the initiation of the restraints is by the RN, the attending physician must be consulted as soon as possible and within one hour .... 16. Restraint is discontinued by a competent RN or LIP at the earliest possible time, regardless of the length of time identified in order." The policy further indicated that, "all restraints are time limited as follows ... 4 hours for adults (18 years of age or older...."

A review of Patient 1's medical records indicated that Patient 1 was a 79-year-old male transported to the facility's ED on 10/23/23, at 6:04 pm. Patient 1 was discovered at his home with hyperglycemia (high blood glucose), agitation, covered in urine and feces, and gravely disabled. Patient 1's wife was unable to care for him due to his progression of moderate dementia with agitation, uncontrolled insulin dependent diabetes, and an increase in frequency of falls. Patient 1 was identified as being gravely disabled, not being able to meet his basic needs, and awaiting disposition to a memory care facility. Patient 1 remained on a prolonged patient hold in the facility's Emergency Department, while receiving medical care and blood glucose management, and awaiting placement in a long-term living facility.

A review of licensed vocational nurse (LVN)1's nursing notes, dated 11/06/23, at 9:08 am, indicated LVN 1 applied soft wrist restraints on Patient 1 via an Emergency Department Clinical Supervisor's (EDCS) verbal order, because Patient 1 had been, "getting out of bed for the past two hours", was unsteady on his feet, and was becoming increasingly agitated.

A review of LVN 1's nursing notes, dated 11/06/23, indicated that LVN 1 continued to keep Patient 1 in two-point soft restraints while he slept from 12:54 pm to 3:55 pm. LVN 1 removed Patient 1's restraints at 3:55 pm, for 6 hours and 47 minutes after LVN 1 placed Patient 1 in restraints.

During a concurrent record review and interview, conducted in the Director of Performance Improvement's Office (DPI), on 12/07/23, at 11:59 am, DPI stated, on 11/06/23, at 9:08 am, LVN 1 placed Patient 1 in bilateral soft-wrist restraints for a total of 6 hours and 47 minutes without an MD or LIP order. DPI stated that Patient 1 did not have an MD/ LIP order to initiate restraint use, or a second order for continued restraint use once Patient 1 remained in restraints beyond four hours.

During a concurrent interview and record review, conducted in the facility's conference room, on 12/12/23, at 2:14 pm, LVN 1 stated she requested that the EDCS provide a verbal order to apply restraints on Patient 1 because Patient 1 was getting increasingly agitated, not following commands, and was at risk for falling due to being unsteady on his feet. LVN 1 reported that she did not request for the EDCS to perform a face- to-face restraint assessment on Patient 1, or seek an MD/LIP order for restraint initiation and continued restraint use, because she was unaware that an MD/LIP order was required.

During a concurrent interview and record review, conducted in the DPI's office, on 12/13/23, at 10:10 am, the Emergency Department Director (EDD) reported that ED RNs can initiate restraint use, but they are required to get a MD/LIP order within 1 hour of the restraints being applied. EDD stated that LVN 1 kept Patient 1 in restraints, from 9:08 am to 3:55 pm, without obtaining an RN assessment or MD/LIP order. EDD stated that records indicated Patient 1 was asleep and cooperative while being restrained, which may have indicated that Patient 1 did not meet criteria for continued restraint use. EDD acknowledged that if LVN 1 notified an MD/LIP that Patient 1 was sleeping after bilateral soft-wrist restraints were applied, the MD/LIP may have denied restraint use and advised LVN 1 of less restrictive interventions.

During a concurrent interview and record review, conducted in the DPI's office, on 12/13/23, at 3:45 pm, the Chief Nursing Officer (CNO) stated that the facility's restraint process was primarily intended to protect the patient. If a RN was unable to engage a provider for an order, the policy allowed an RN to emergently restrain a patient after performing a face-to-face patient evaluation. CNO stated if a RN initiated restraint use on a patient, an MD/LIP must be notified, and provide a written or verbal restraint order within one hour. CNO reported that if restraint use was on-going there were criteria for continuing orders, continuing use, and discontinuing restraints. CNO verified that medical records indicated Patient 1 did not receive a RN face-to- face restraint assessment and did not have an MD/LIP order that approved restraint initiation or continued restraint use.

Based on interview and record review, the facility failed to provide continuous monitoring of a patient in restraints when staff did not perform 15 minute Behavioral Health Restraint Assessments (BHRA, assessments conducted every 15 minutes that assesses a patient's vital signs, hygiene and elimination needs, nutrition and hydration needs, and physical and psychosocial needs) on one of four patients (Patient 1). As a result, Patient 1 remained in bilateral soft-wrist restraints for 6 hours and 47 minutes, without vitals sign monitoring, blood glucose monitoring, food, hydration, or behavior reevaluation to determine if Patient 1 met criteria for continued restraint use. This failure resulted in Patient 1 being restrained without safety needs, physical health needs, or psychosocial needs being met.

Findings:

The facility's policy titled, "Restraints: Violent Behavior or Seclusion", dated 6/2023, was reviewed and indicated: "1. The policy and procedure is in effect for all departments and services in the acute care facility...3. Restraint may only be used when less restrictive interventions have been determined to be ineffective..." The policy further indicated that "A staff member who is trained and competent must assess the patient Every 15 Minutes: 1. Behavior, 2. Signs of injury associated with application of restraint or seclusion. 3. Physical and psychological comfort. 4. Circulation. " Every two hours a staff member must assess the patients "5. Skin care and range of motion in the extremities. 6. Nutrient and hydration. 7. Hygiene and elimination. 8. Vital Signs...Document on available flow sheets..."

A review of Patient 1's medical records indicated that Patient 1 was a 79-year-old male transported to the facility's ED on 10/23/23, at 6:04 pm. Patient 1 was discovered at his home with hyperglycemia (high blood glucose), agitation, covered in urine and feces, and gravely disabled. Patient 1's wife was unable to care for him due to his progression of moderate dementia with agitation, uncontrolled insulin dependent diabetes, and an increase in frequency of falls. Patient 1 was identified as being gravely disabled, not being able to meet his basic needs, and awaiting disposition to a memory care facility. Patient 1 remained on a prolonged patient hold in the facility's Emergency Department Overflow (EDOF, a 7-bed, contained section of the Emergency Department (ED) for patients on legal mental health holds or patients requiring psychiatric stabilization), while receiving medical care and blood glucose management, and awaiting placement in a long-term living facility.

A review of licensed vocational nurse (LVN)1's nursing notes, dated 11/06/23, at 9:08 am, indicated LVN 1 applied soft wrist restraints on Patient 1 via an Emergency Department Clinical Supervisor's (EDCS) verbal order, because Patient 1 had been, "getting out of bed for the past two hours," was unsteady on his feet, and was becoming increasingly agitated.

A review of LVN 1's nursing notes, dated 11/06/23, indicated that LVN 1 continued to keep Patient 1 in two-point (refers to two upper extremities) soft wrist restraints while he slept from 12:54 pm to 3:55 pm. LVN 1 removed Patient 1's restraints at 3:55 pm, for 6 hours and 47 minutes after LVN 1 placed Patient 1 in restraints.

During a concurrent interview and record review, conducted in the Director of Performance Improvement's (DPI) office, on 12/07/23, at 11:59 am, DPI stated, on 11/06/23, at 11:33 am, LVN 1 administered one BHRA assessment to Patient 1 while Patient 1 was placed in bilateral soft-wrist restraints. DPI stated that since Patient 1 remained in restraints from 9:09 am - 3:55pm, or approximately seven hours, LVN 1 should have administered at least 25 BHRA assessments to ensure Patient 1's needs were being met while restrained, assess Patients 1's safety while restrained, and evaluate if continued restraint was appropriate. DPI reported that it is the facility's policy, and standard of practice, for LVNs and RNs to evaluate restrained patients every 15 minutes. The evaluation assesses for changes in patient behavior to consider discontinuing restraint use, assesses for signs of injury or decreased circulation related to restraint use, and provides the patient with psychological support. DPI reported that LVNs and RNs are also required to assess restrained patients every two hours for skin breakdown related to restraint use, offer food and hydration, offer bathroom or elimination access, and monitor vital signs. All restraint assessments are required to be documented on the facility's BHRA flowsheet.

During a concurrent interview and record review, conducted in the facility conference room, on 12/12/23, at 2:14 pm, LVN 1 stated, on 11/06/23, she did not perform the required BHRAs while Patient 1 was restrained, from 9:08 am to 3:55 pm, because LVN 1 was the only nurse working in the contained EDOF unit, and was assigned a full patient load, without RN supervision or support. LVN 1 reported her workload was not manageable and that she had to prioritize her nursing services. LVN 1 stated she decided to not prioritize Patient 1's BHRAs, and skip monitoring his vitals, blood glucose, restraint placement, or circulation, because she did not want to risk triggering Patient 1's behaviors and cause him more agitation. LVN 1 reported once Patient 1 fell asleep in restraints, she did not wake him to perform the 15 minute BHRAs, or remove the restraints, because he was "sleeping peacefully." LVN 1 acknowledged that "sleeping peacefully" was a behavior that did not meet criteria for restraint use. LVN 1 stated she continually observed Patient 1's respirations from afar, and ensured his chest was rising and falling, while he slept in restraints. LVN 1 reported, at 3:55 pm, she woke Patient 1 from sleep, removed his restraints, checked Patient 1's blood glucose, and offered food and drink because Patient 1 had not eaten since 9:08 am, when the restraints were placed.

During a concurrent interview and record review, conducted in the DPI's office, on 12/13/23, at 10:10 am, EDD stated, on 11/06/23, LVN 1 performed one BHRA while Patient 1 was restrained from 9:08 am to 3:55 pm. EDD reported that her expectations, and the facility's policy, required LVNs and RNs to perform BHRAs every 15 minutes. EDD stated these assessments are required to ensure patient safety, to meet the patients' physical health needs, and ensure restraint use is still warranted. EDD reported that Patient 1's clinical records indicated Patient 1 was asleep and cooperative while being restrained, which did not meet criteria for continued restraint use. EDD stated that assigning LVN 1 to EDOF on 11/06/23, without an RN assigned to the EDOF unit to provide supervision and assistance, was an unsafe staffing assignment that compromised Patient 1's health and safety.

During a concurrent interview and record review, conducted in the DPI's office, on 12/13/23, at 3:45 pm, the Chief Nursing Officer (CNO) stated that the facility's restraint process was primarily intended to protect the patient. CNO reported that if restraint use was on-going, there were frequent assesments required to ensure patient safety, meet patient needs, and continue restraint use. CNO acknowledged that LVN 1's lack of restraint assessments placed Patient 1 at risk for potential harm and unnecessary retraint use.

Based on interview and record review;

1. The facility failed to have an adequate number of registered nurses (RN) in the Emergency Department (ED) to provide immediate supervision of patient care provided to patients by licensed vocational nurses (LVNs) and prevent the medication administration error to one of one patients, by a LVN assigned to the patient's care. (Refer to Finding A 392)

2. The facility's registered nurses (RN) failed to perform initial and on-going patient assessments for 27 of 27 of patients assigned to licensed vocational nursing staff on the Center for Behavioral Health Unit (CBH, a secured 20-bed unit that provides intensive psychiatric treatment for patients suffering from acute psychiatric disorders and secondary substance abuse disorders). (Refer to Finding A 395)

An Immediate Jeopardy under A-0392 was issued on 12/07/23. The hospital submitted a plan to remove the immediacy on 12/14/23 and the Immediate Jeopardy was removed during onsite verification on 12/15/23.

As evidenced by:

1a. A RN was not immediately available to supervise LVN staff assigned in Emergency Department Overflow (EDOF, a 7-bed, contained section of the Emergency Department (ED) for patients on legal mental health holds or patients requiring psychiatric stabilization) and provide assistance with patient care and medication administration verification of insulin (a medication used to regulate the amount of sugar in the blood) administration. As a result, Patient 1 was administered an incorrect dose of 70 units of Humalog insulin (a short-acting insulin that last 2-4 hours), as opposed to the correct medical doctor (MD) ordered dose of 7 units. (Refer to A 392, Finding 1a)

1b. A RN was not immediately available to supervise the patient care and medication administration by LVN staff in EDOF and ensure the facility's Blood Glucose (BG - blood sugar) Management and Hypoglycemia (low blood glucose) Protocol was implemented for Patient 1 in EDOF, who sustained a blood glucose of 50 milligrams (mg) per deciliter (dL) (normal range is 70 -100 mg/dL), following an insulin administration error. As a result, Patient 1 did not receive appropriate nursing services or care while he experienced lethargy, somnolence (excessive sleepiness and drowsiness), and a deterioration of neurological status (a decrease in brain function). (Refer to A 392, Finding 1b)

1c. A RN was not immediately available in EDOF to perform a registered nurse face-to-face evaluation or assessment that is required by facility Policy and Procedure to initiate a behavioral restraint order. As a result, LVN 1 placed Patient 1 in restraints, without RN evaluation or assessment, for approximately six hours. (Refer to A 392, Finding 1c)

1d. An RN was not immediately available in EDOF to provide RN patient care services, perform a physical health assessment, and change of condition assessment on Patient 1 in EDOF. As a result, Patient 1 did not receive a start of shift baseline physical health assessment or change of condition assessments when Patient 1 presented lethargic, somnolent, and was noted to have severe confusion and neurological deterioration following an incorrect insulin administration error. (Refer to A 392, Finding 1d)

1e. The EDOF unit did not utilize a patient classification system to determine that appropriate staffing levels, and staff classifications (RN, LVN), were followed to meet the patients' needs. As a result, an LVN was assigned to nursing care for Patient 1 who was triaged (the sorting of patients according to the urgency of their need for care) as a Level II acuity (a method used to categorize ED patient needs. A Level II patient is considered unstable due serious acute injury and will become Level I without immediate attention) in the facility's EDOF unit.
These failures resulted in actual harm to Patient 1 due to a preventable medication error and could further result in potential medication errors, treatment errors, nursing care errors, patient injury, harm, impairment, and death. (Refer to A 392, Findings 1 a -e)

2. Registered nurses (RN) failed to perform initial and on-going patient assessments of 27 of 27 patients (Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, patient 25, Patient 26, Patient 27, and Patient 28) assigned to licensed vocational nursing (LVN) staff on the Center for Behavioral Health Unit (CBH, a secured 20-bed unit that provides intensive psychiatric treatment for patients suffering from acute psychiatric disorders and secondary substance abuse disorders). (Refer to Finding A 395)

The cumulative effect of these systemic problems had the potential to compromise the safety and quality of care for patients in the CBH and ED, and caused actual harm to one patient in the CBH.

Based on observation, interview, and record review, the facility failed to have an adequate number of registered nurses (RN) to provide immediate supervision of patient care provided by Licensed Vocational Nurses (LVNs) and be immediately available to provide patient assessments, evaluations of patient care, safe and effective care as needed by patients, and implement its staffing polices in the Emergency Department when:

1a. A RN was not immediately available to supervise LVN staff assigned in Emergency Department Overflow (EDOF, a 7-bed, contained section of the Emergency Department (ED) for patients on legal mental health holds or patients requiring psychiatric stabilization) and provide assistance with patient care and medication administration verification of insulin (a medication used to regulate the amount of sugar in the blood) administration. As a result, Patient 1 was administered an incorrect dose of 70 units of Humalog insulin (a short-acting insulin that last 2-4 hours), as opposed to the correct medical doctor (MD) ordered dose of 7 units.

1b. A RN was not immediately available to supervise the patient care and medication administration by LVN staff in EDOF and ensure the facility's Blood Glucose (BG - blood sugar) Management and Hypoglycemia (low blood glucose) Protocol was implemented for Patient 1 in EDOF, who sustained a blood glucose of 50 milligrams (mg) per deciliter (dL) (normal range is 70 -100 mg/dL), following an insulin administration error. As a result, Patient 1 did not receive appropriate nursing services or care while he experienced lethargy, somnolence (excessive sleepiness and drowsiness), and a deterioration of neurological status (a decrease in brain function).

1c. A RN was not immediately available in EDOF to perform a registered nurse face-to-face evaluation or assessment that is required by facility Policy and Procedure to initiate a behavioral restraint order. As a result, LVN 1 placed Patient 1 in restraints, without RN evaluation or assessment, for approximately six hours.

1d. An RN was not immediately available in EDOF to provide RN patient care services, perform a physical health assessment, and change of condition assessment on Patient 1 in EDOF. As a result, Patient 1 did not receive a start of shift baseline physical health assessment or change of condition assessments when Patient 1 presented lethargic, somnolent, and was noted to have severe confusion and neurological deterioration following an incorrect insulin administration error.

1e. The EDOF unit did not utilize a patient classification system to determine that appropriate staffing levels, and staff classifications (RN, LVN), were followed to meet the patients' needs. As a result, an LVN was assigned to nursing care for Patient 1who was triaged (the sorting of patients according to the urgency of their need for care) as a Level II acuity (a method used to categorize ED patient needs. A Level II patient is considered unstable due serious acute injury and will become Level I without immediate attention) in the facility's EDOF unit.

These failures resulted in actual harm to Patient 1 due to a preventable medication error and could further result in potential medication errors, treatment errors, nursing care errors, patient injury, harm, impairment, and death.

Findings:

The facility's manual titled, "Plan for Provision of Patient Care", dated 10/2023, was reviewed and indicated: "The Emergency Department's scope is to provide emergency care 24 hours a day, seven (78) days a week. The ED consists of 16 critical care beds, 10 Fast Track Beds, 3 RAP (Rapid Assessment Process) beds, 7 overflow beds (EDOF), for a total of 36 beds .... The ED's progressive path of reporting is as follows: Patient Care Techs (PCT)/ Unit Secretary (US/ EMT/ Advanced ED Tech, Licensed Vocational Nurse (LVN), Registered Nurse (RN), Clinical Supervisor (CS), Director of Emergency Services (EDD), and Chief Nursing Officer (CNO) .... Licensed Vocational Nurses are utilized in the low acuity area as well as the arrival and lobby area to assist with monitoring of waiting patients and patient care tasks. They are also utilized to assist with patient holds and discharge as needed and any other task that is within their scope of practice. They are supervised by other RNs in the Emergency Department."

The facility's policy titled, "Patient Classification Emergency Department", dated 6/2023, was reviewed and indicated: "A Patient Classification System shall be used to determine the acuity of patients being cared for in the ED and the staffing level needs to meet the patients' needs .... Patient acuity will be assigned during triage... Level I (Emergent) Immediate danger of loss of life, limb, or vision ... Level II (Unstable): Serious acute injury, will become level I without attention ... Level III (Potentially Unstable): Acute illness or injury, stable at his time, has the potential to become unstable ... Level IV (Stable) Patient is not in danger of losing life of limb, but has pain or discomfort ... Level V(Routine): Patient came in the ED for a routine visit, i.e. med refill, suture removal, etc., ...."

The facility's policy titled, "Scope of Vocational Nursing Practice/RN Supervision", dated 10/2023, was reviewed and indicated: "The LVN is authorized to perform services which require the technical and manual skills acquired in an accredited vocational nursing school, and which are practiced under the direction of a licensed physician or Reregistered Nurse (RN). The responsible RN must delegate tasks within the LVN scope of practice and must oversee the performance to ensure high quality of care." The policy further indicated the Nursing Process/Documentation procedures included,
"5.6 Ongoing communication between the RN and LVN is required to ensure patient care needs are met.
5.7 Each patient must be evaluated on an individual basis for appropriate delegation of responsibilities. This evaluation must be based on patient condition/needs and LVN experience and competency ....
5.11 RN intervenes as necessary if tasks are being performed improperly.
Supervision of the LVN: Provide direction and clear expectations of how a task is performed. Monitors performance to assure compliance with established practice, standards, policies, and procedures."

A review of Patient 1's medical records indicated that Patient 1 was a 79-year-old male transported to the facility's ED on 10/23/23, at 6:04 pm. Patient 1 was discovered at his home with hyperglycemia (high blood glucose), agitation, covered in urine and feces, and gravely disabled. Patient 1's wife was unable to care for him due to his progression of moderate dementia with agitation, uncontrolled insulin dependent diabetes, and an increase in frequency of falls. Patient 1 was subsequently placed on a 5150 hold (involuntarily detaining an adult who is experiencing a mental health crisis). He was triaged by the facility's ED, at 6:33 pm, as an acuity Level II. Patient 1's vital signs at triage were: heart rate (HR) 81 beats per minute (bpm), respiratory rate 14, blood pressure (BP) 167/79, pulse oximetry (measurement of oxygen circulating in the blood) 98%, and a laboratory result showing that his blood glucose level of greater than 600 mg/dL. Laboratory results on 10/23/23, at 6:46 pm, indicated Patient 1's BG level was 914 mg/dL, and was treated with subcutaneous Humalog, Novolog (a short-acting insulin that lasts 2-4 hours), and Lantus (a long acting insulin that gives a steady level of insulin over 24 hours) per the facility's blood glucose management protocol. On 10/28/23, at 11:56 pm, Patient 1 was medically cleared for a mental health evaluation and treatment and placed in an EDOF bed pending a Psychotherapy Crisis Evaluation (PCE, an assessment to determine a patients mental health status). On 10/24/23, at 2:57 pm, MD 1 performed a PCE and determined Patient 1 did not meet the criteria for a 5150 hold. Patient 1's 5150 was rescinded based on signs and symptoms that exhibited dementia (a decline in mental ability severe enough to interfere with daily life) and not a mental health disorder. Patient 1 was identified as being gravely disabled, not being able to meet his basic needs, and awaiting disposition to a memory care facility. Patient 1 remained in the facility's EDOF on a prolonged patient hold, while receiving medical care and BG management, and awaiting placement in a long-term living facility.

1a. The facility's policy titled, "High Alert Medications", dated 10/2023, was reviewed and indicated: "High-Alert medications bear a heightened risk for causing significant patient harm when they are used in error ... Identified high alert medications used ... include Insulin .... Insulin is to be independently double-checked by a second nurse when a dose is prepared for administration ...."

The facility's protocol titled, "In-Patient Hyperglycemia Management", dated 5/10/23, was reviewed and indicated that patients' pre-prandial (before meals) blood sugar goal is 80-140 mg/dL. The corrective insulin to be used after meals was Humalog insulin and the dosage should be calculated by using the insulin adjustment tool.

The facility's document titled, "ER Daily Staffing", dated 11/06/2023, was reviewed and indicated that LVN 1 and patient care technician (PCT)1 were assigned to provide patient care in the facility's secured EDOF area. The EDOF area did not have an ED registered nurse or resource nurse staffed. The daily staffing sheet did not indicate the number of patients receiving care in the EDOF or identify what patients were assigned to LVN 1.

A review of the Medication Administration Record (MAR), dated 11/06/23, at 9:27 am, was reviewed and indicated that Patient 1's BG before breakfast was 287 mg/dL. The MAR indicated LVN 1 administered 7 units of Humalog insulin, per facility's insulin adjustment tool, to correct the 287 BG. Patient 1 did not require insulin for carbohydrate correction because he only had 2 grams of carbohydrate intake during breakfast.

A review of the MAR dated 11/06/23, at 6:19 pm, indicated that Patient 1's BG before dinner was 194 mg/dl. Records indicated that LVN 1 administered 2 units of Humalog insulin, per facility's insulin adjustment tool, to correct the 194 mg/dL BG. Patient 1 did not require insulin for carbohydrate correction for his dinner intake.

During an interview conducted in the facility ED, on 12/05/23, at 6:03 pm, LVN 1 stated she had worked at the facility's ED for approximately three months. LVN 1 reported she was employed as an LVN in a community medical clinic prior to being hired by the facility and had no previous hospital experience. LVN 1 verified she was the only licensed nurse assigned to the EDOF unit, on 11/06/23 day shift, and that she provided nursing care to four patients who were receiving medical and mental health services. LVN 1 stated that she was nervous about this assignment because she had never worked in the separated and contained EDOF unit, and she did not have a RN in the EDOF unit to provide supervision or assistance with patient care. LVN 1 stated during the 11/06/23, end of shift report with the EDOF night shift RN 1, RN 1 identified a Humalog insulin near miss (a medication error that is intercepted before the medication is administered) and an actual medication error that occurred when LVN 1 administered Humalog insulin to Patient 1 at 9:27 am. The medication errors were identified when LVN 1 requested RN 1 to provide a second verification of Patient 1's dinner time, 2 unit Humalog insulin dose. LVN 1 stated RN 1 was "alarmed" and did not approve the nighttime insulin dose because LVN 1 incorrectly drew up 10 times the amount of insulin in a 1 cc (cubic centimeter a measurement of volume used for the dosing of medications.) tuberculin syringe (TB syringe, a 1 cc syringe that has graduated marks numbered 1-10. Each mark accounts for 0.1 cc of volume) instead of using a 50 unit insulin syringe (a 0.5 cc syringe that is marked with 50 marks for each unit of insulin. Each mark accounts for 0.01 cc of volume). LVN 1 stated since she had no experience with drawing up insulin in a syringe, she confused the TB syringe with an insulin syringe because the two syringes looked similar and were stored in the supply room next to each other. LVN 1 stated since the TB syringe had marks numbered from 1-10, she incorrectly assumed that the number two on the TB syringe was the equivalent of 2 units of insulin. Instead, the number two on the TB syringe was actually ten times the amount, or 20 insulin units. RN 1 prompted LVN 1 to waste the incorrect 20 unit insulin dose and RN 1 demonstrated the process for preparing an insulin dose using a correct insulin syringe. LVN 1 stated she immediately notified RN 1 that she used the same TB syringe, and same method, for Patient 1's morning insulin dose of 7 units. LVN 1 demonstrated to RN 1 that she filled the TB syringe with insulin up to the number 7, or .7 cc, which was the equivalent of 70 units, and administered the 70 unit insulin dose to Patient 1 following his breakfast. LVN stated since there was not a RN available to verify the morning dose of insulin, she interrupted the ED Director (EDD) in her office and requested that she provide second verification of the "supposive" 7 unit insulin dose. LVN 1 stated the EDD looked up briefly, verified that the TB syringe plunger was pulled back to the number seven, and stated "yes that's seven." Since LVN 1 had no experience with administering insulin from a syringe and had never drawn up insulin into an insulin syringe, she depended on the EDD to identify her mistake through the second verification process. LVN 1 immediately notified the EDD of the morning insulin error at the change of shift.

During a concurrent observation and interview conducted in the EDOF supply room with LVN 1 and ED Clinical Supervisor (EDCS) 1, on 12/05/23, at 6:33 pm, LVN 1 was asked to identify the syringe she used to draw up Patient 1's Humalog insulin and demonstrate how much insulin she backfilled into the syringe. LVN 1 pulled a TB syringe from a storage bin that was located directly next to an insulin syringe storage bin. Both bins were correctly marked with clear labels that read 'insulin' and 'TB'. LVN 1 stated the two syringes had similar colored caps and were located right next to each other, making it easy for her to confuse the syringes. LVN 1 and EDCS verified that the TB syringe was a 1 cc syringe with different markings than the 0.5 cc insulin syringe. LVN 1 identified that she used a TB syringe and pulled back the plunger to the "7" mark that indicated 0.7 cc of volume. EDCS was asked to take an insulin syringe and pull back the plunger to the mark that indicated a 7 unit insulin dose. EDCS reported that a 7 unit dose was equal to .07 cc on the insulin syringe. LVN 1 and EDCS 1 stated that 0.7 cc in the TB syringe equaled ten times the amount of insulin in the insulin syringe, or 70 units.

During an interview on 12/04/23, at 7:11 am, RN 1 verified she was assigned to work at the facility's EDOF unit during the 11/06/23 night shift. RN 1 stated when she arrived to work for her night shift, she noticed that LVN 1 was working in the EDOF unit alone, without any RN supervision or support. RN 1 stated during change of shift report LVN 1 requested that she verify a 2 unit Humalog insulin dose for Patient 1. RN 1 reported that LVN 1 accidentally drew up ten times the insulin amount, or 20 units of Humalog insulin, because she used a TB syringe and was measuring the volume incorrectly. RN 1 immediately corrected the near miss and provided LVN 1 with education and demonstration of correctly preparing an insulin dose. RN 1 stated that LVN 1 began crying and reported that she used the same TB syringe for Patient 1's 7 unit morning dose. LVN 1 demonstrated to RN 1 that she back filled the TB syringe with insulin up to the 0.7 cc mark, or 70 units, and administered the 70 units to Patient 1 for his morning dose. RN 1 prompted LVN 1 to immediately report the insulin medication error to the EDD.

During a concurrent interview and record review conducted in the EDD's office, on 12/06/23, at 3:00 pm, EDD stated she was familiar with Patient 1's insulin administration error that occurred on 11/06/23. EDD stated that RN 1 identified LVN 1's morning insulin error retrospectively while she was performing a second verification with LVN 1 for Patient 1's evening dose. EDD reported that LVN 1 requested for RN 1 to perform a second verification on an incorrect insulin dose that was draw up in a TB syringe. RN 1 identified the error, disposed of LVN 1's incorrect dose, and provided LVN 1 with education on correctly drawing up insulin. EDD stated that LVN 1 immediately presented to her office and reported Patient 1's morning insulin error. EDD reported that on 11/06/23 the EDOF unit was staffed unsafely, and that LVN 1 should have never been left alone to work in the EDOF unit without RN oversight and assistance. Since LVN 1 was alone in the EDOF, she approached the EDD in her office an asked for a second verification on Patient 1's morning insulin dose. EDD was in the middle of processing administrative reports and hurriedly looked up at the syringe, verified that the plunger was pulled back to the number "7", and replied "yes that is seven". EDD stated if she had slowed down, and looked closely at the syringe, she would have recognized that LVN 1 was using a larger TB syringe and miscalculating the insulin dose.

During a concurrent interview and record review conducted at the facility's pharmacy, on 12/06/23, at 3:30 pm, the Director of Pharmacy (DOP), stated Patient 1 should have received 7 units on 11/06/23, at 9:27 am, for his 287 BG. DOP stated that a 1 cc TB syringe loaded with 0.7 cc Humalog insulin was the equivalent of 70 units of insulin, or ten times the amount of Patient 1's indicated 7 unit dose. DOP stated that administering an insulin dose that is ten times the indicated amount could result in hypoglycemia, patient disorientation, unresponsiveness, somnolence (drowsiness, strong desire to fall asleep), lethargy (a decrease in consciousness), irritability, fast HR, diaphoresis (sweating), diabetic coma, and potential death.

During an interview conducted in the EDOF, on 12/06/23, at 4:15 pm, Physician's Assistant (PA) 1 reported he had worked at the facility's ED as a Licensed Independent Provider (LIP, physicians, physician assistants, or advanced practiced registered nurses) for four years. PA 1 stated that LVNs were frequently assigned to higher acuity level patients (Level II and Level III) in the ED and EDOF unit without RN supervision or oversight. PA 1 stated that if a patient was administered an incorrect dose of insulin that exceeded the indicated amount the patient may become unarousable, experience lethargy, fatigue, disorientation, confusion, irritability, and ultimately death.

During a concurrent interview and record review conducted in the Director of Performance Improvement's (DPI) office, on 12/13/23, at 3:45 pm, the CNO verified that neither LVN 1 or EDD notified Patient 1's provider that a medication error occurred. CNO stated it was the responsibility of all licensed nurses to notify providers of medication errors so that the MD can assess and treat the patient for harm related to the medication error and order any necessary diagnostics.

1b. The facility's policy titled, "Blood Glucose Monitoring and Management", dated 3/2023, was reviewed and indicated: "Nursing Alert! Only the RN may calculate the number of carbohydrates that the patient has eaten. This is because the RN will use the number of the carbohydrates eaten to determine the correct insulin coverage. The RN will follow the hospital's glucose management policy and procedure."

A review of the facility's document titled, "In-Patient Hyperglycemia Management", dated 5/10/23, indicated that BG checks must be administered four times daily, and are to be scheduled before meals and before sleep.

A review of the facility's document titled, "Hypoglycemia-Adult", date 5/10/23, indicated symptoms of low BG may include: "confusion, slurred speech, abnormal behavior, numbness, fatigue/sleepiness, convulsions/seizures, loss of consciousness". The document further indicated that BG monitoring for hypoglycemia must occur "every 15 minutes treatment for hypoglycemia until the patient is stabilized and glucose value is above 70 mg/dl." For mild to moderate hypoglycemia (BG value of 50-70 with alert patient) give one 60 ml bottle of Dex-4 solution (a sugar liquid used to treat very low blood glucose) every 15 minutes or four Dex 4 tablets (a sugar tablet used to treat very low blood glucose). If patient is unable to swallow administer Dextrose 50% (intravenous sugar solution used to treat very low blood glucose), 25 cc, IV solution every 15 minutes until BG is above 70 mg/dl. For sever hypoglycemia (glucose below 50 gm/dl, patient is conscious/alert, but may be disoriented) give 2 bottles of Dex 4 Solution every 15 minutes. or 8 Dex 4 tablets. If patient is unable to swallow administer Dextrose 50% 25 cc, IV every 15 minutes until BG is above 70 mg/dl.

A review of MD 2's notes dated, 10/28/23, at 11:10 pm, indicated that Patient 1 "exhibited altered mental status with a random glucose in the 60s" that improved with the administration of intravenous dextrose.

A review of the Medication Administration Record dated 11/06/23, at 9:27 am, indicated that Patient 1's BG before breakfast was 287 mg/dL. Records indicated LVN 1 administered 7 units of Humalog insulin, per the facility's insulin adjustment tool, to correct the 287 BG. Patient 1's 7 unit Humalog dose was later identified as a medication error that had an actual dosage of 70 units Humalog.

A review of LVN 1's nursing notes, dated 11/06/23, at 10:10 am, approximately 43 minutes after the insulin medication administration error, indicated that LVN 1 placed Patient 1 in soft wrist restraints because Patient 1 was becoming frustrated and restless.

A review of LVN 1's nursing notes, dated 11/06/23, at 12:54 pm, approximately 3 hours 27 minutes after the insulin medication administration error, indicated that Patient 1 was currently sleeping with no signs of distress.

A review of LVN 1's nursing notes, dated 11/06/23, at 1:45 pm, approximately 4 hours 17 minutes after the insulin medication administration error, indicated that LVN 1 did not want to wake the patient for vitals because he was resting peacefully after having a difficult time with remaining calm.

A review of LVN 1's nursing notes, dated 11/06/23, at 2:37 pm, approximately 5 hours 10 minutes after the insulin medication administration error, indicated that Patient 1 was continuing to rest peacefully.

A review of LVN 1's nursing notes, dated 11/06/23, at 2:44 pm, approximately 5 hours 17 minutes after the insulin medication administration error, indicated that LVN 1 did not perform a BG check on Patient 1 because he was finally resting peacefully and had not eaten anything since breakfast.

A review of LVN 1's nursing notes, dated 11/06/23, at 3:55 pm, approximately 6 hours 28 minutes after the insulin medication administration error, indicated that Patient 1's BG was 50 gm/dL at 3:55 pm. LVN 1 offered Patient 1 a yogurt to increase BG levels.

A review of LVN 1's nursing notes, dated 11/06/23, at 4:05 pm, approximately 6 hours 38 minutes after the insulin medication administration error, indicated that LVN 1 woke Patent 1 to perform a BG check and offer yogurt for a BG of 50 gm/dL. Patient 1 fell while attempting to transfer to a chair to eat the yogurt. LVN 1 indicated Patient 1 went back to bed and was sleeping again.

A review of LVN 1's nursing notes titled, "Neuro Assessment Flow Sheet", dated 11/0623, at 4:11 pm, indicated that Patient 1 had deteriorating Neuro changes. Patient 1 "did not seem to be getting better mentally and seemed to be extremely confused and unoriented ...."

During a concurrent record review and interview, on 12/07/23, at 11:59 am, DPI stated that Patient 1's clinical record indicated, on 11/06/23, that LVN 1 performed BG checks at 9:07 am, 3:55 pm, and 6:19 pm. DPI stated that LVN 1 did not check Patient 1's BG for the required before-lunch-check, which followed LVN 1's insulin medication administration error or wake Patient 1 for his lunchtime tray. DPI stated, when Patent 1's BG measured 50 gm/dl, at 3:55 pm, LVN 1 did not administer Patient 1 Dex-4 oral solution, Dex-4 tablets, Dex 5% IV fluids, or recheck Patient 1's BGs every 15 minutes, as required per protocol, to ensure Patient 1's BG levels were increasing.

During a concurrent interview and record review, on 12/12/23, at 2:14 pm, LVN 1 reported she had no experience with independently providing nursing services to an insulin dependent diabetic patient and had never implemented the facility's In-Patient Hyperglycemia Management or Hypoglycemia protocols before. LVN 1 stated that Patient 1 had confusion, disorientation, and extreme sleepiness after she administered the incorrect insulin dose. Since LVN 1 had never worked in the EDOF unit, and was unfamiliar with Patient 1's baseline, she thought these symptoms were behaviors related to Patient 1's dementia. LVN stated that Patient 1 was extremely agitated and restless during the 11/05/23 night shift, so she opted to not wake Patient 1, on 11/06/23, for his lunchtime BG check or lunch tray so he could, "catch up on his sleep." LVN 1 was asked if she was familiar with the nursing processes to treat a blood glucose of 50 gm/dl. LVN 1 stated that she was not familiar with the specific steps of the Hypoglycemia Protocol, and there was not a RN available to help LVN 1 detect Patient 1's low BG symptoms or treat Patient 1's low BG levels. LVN 1 confirmed she did not perform repeat BG level checks on Patient 1 following his 50 gm/dl BG. LVN stated that, "in general" she knew to offer Patient 1 food to increase his BG level. Patient 1 ate "some yogurt" so she thought he was "out of the woods." Once RN 1 arrived at the EDOF unit for the 11/06/23 night shift, RN 1 notified LVN 1 that she did not treat Patient 1's 50 gm/dL BG correctly or follow the facility's Hypoglycemia protocol. LVN 1 stated it would have been nice have an RN present during day shift to "coach LVN 1 on BG management." LVN 1 reported both her and RN 1 were relieved that Patient 1's next BG check, at 6:19 pm, had increased to 194 gm/dL.

During a concurrent interview and record review conducted in the EDOF unit, on 12/06/23, ED RN 2 reported that the facility's In-Patient Hyperglycemia Management protocol required licensed nurses to check patients' BG levels at a minimum of four times daily. These checks were always performed before meals and before bedtime. RN 2 stated there were no acceptable reasons for a licensed nurse to waive these routine checks. It was more common for ED and EDOF patients to require BG checks more than four times daily because these patients were typically unstable or their mental health behaviors may also mimic symptoms of low or high blood glucose levels. If patients were sleeping, licensed nurses should always wake their patient to perform the required BG checks and offer a meal tray. RN 2 reported that most experienced licensed ED nurses will frequently add an additional BG check after insulin administration to make sure their patient's blood glucose levels were responding appropriately to the insulin as an "extra safety net."

During a concurrent interview and record review conducted at the facility's pharmacy, on 12/06/23, at 3:30 pm, DOP stated the facility's BG Management Policy and Hyperglycemia Protocol required licensed nurses to check patients' BG levels at a minimum of four times daily. DOP reported that licensed nurses were always expected to wake up sleeping patients to check BG levels, especially if a patient was exhibiting unusual sleepiness, fatigue, or a sudden change in neurological status after a Humalog dose. Licensed nurses should be particularly aware of patients with mental health overlay, because the only absolute way of knowing if symptoms were related to blood glucose or dementia was by checking blood glucose levels. DOP stated that LVN 1 should have immediately notified an RN to implement the Hypoglycemia protocol and administer Dex 4 solution or tablets, or intravenous dextrose to quickly raise Patient 1's blood glucose levels. DOP stated even though all licensed nurses attended the blood glucose management training at the facility's skills fair, managing a patient with uncontrolled insulin dependent diabetes and dementia may require continual nursing assessments to ensure BG levels stay within safe parameters.

During a concurrent interview and record review conducted in the DPI's office, on 12/13/23, at 10:10 am, EDD stated that the facility's Blood Glucose Management Protocol required licensed nurses to check patient's BG four times daily, which included before meals and before sleep. EDD reported Patient 1's clinical records indicated LVN 1 did not check Patient 1's BG level before lunch because she did not want to wake Patient 1 from sleep. EDD stated this was an unacceptable reason to waive Patient 1's BG check and that patients should always be aroused for BG monitoring and to be offered food. EDD stated that LVN 1 did not follow the facility's Hypoglycemia Protocol when she opted to treat Patient 1's 50 gm/dL BG with a yogurt. LVN 1 should have initiated the mild to moderate Hypoglycemia Protocol and consult with an ED RN to see if Patient 1 required an intravenous dextrose infusion. LVN 1 did not perform BG rechecks every 15 minutes on Patient 1 to ensure he received appropriate interventions until his BG increased to 70 mg/dL. EDD repeated that assigning LVN 1 to EDOF on 11/06/23, without an RN assigned to the EDOF unit for oversight and supervision was an unsafe staffing assignment.

During a concurrent interview and record review conducted in the DPI's office, on 12/13/23, at 3:45 pm, CNO reported that assigning an LVN to EDOF without the presence of an RN was an unsafe staffing plan. CNO stated that LVN 1 did not implement the BG Management Policy that required continuous BG monitoring or the Hypoglycemia protocol to rapidly treat Patient 1's low BG. CNO stated he expected staff to speak up if they could not implement nursing services with the resources they have so, management could provide more support. CNO agreed that once RN 1 presented to the EDOF for the 11/06/23 night shift, Patient 1 received appropriate BG management nursing care.

1c. The facility's policy titled, "When to Use Seclusion or Restraint", dated 6/2023, was reviewed and indicated: "Restraint or seclusion is only used to protect a patient or others from harm when alternative methods (less restrictive) are determined to be ineffective."

The facility's policy titled, "Restraints: Violent Behavior or Seclusion", dated 6/2023, was reviewed and indicated: "1. This policy and procedure is in effect for all departments and services in the acute care facility .... 3. Restraint may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. ... 15. If a Licensed Independent Provider (LIP, physicians, physician assistants, or advanced practiced registered nurses) are not able to issue an order, a Registered Nurse (RN) may initiate the use of restraints based on an appropriate assessment of the patient .... 16. Restraint is discontinued by a competent RN or LIP at the earliest possible time, regardless of the length of time identified in order. 17. When restraint intervention is discontinued based on an assessment of a patient's condition, a new order is required to reinstate the intervention." The policy further indicated that, "all restraints are time limited as follow ... 4 hours for adults (18 years of age or older...."

A review of MD orders dated 11/06/23, 5:30 am, indicated Patient 1's night shift RN, RN 3, initiated a two-point (both upper extremities) soft restraint order on Patient 1 because Patient 1 assaulted RN 3 and was at risk for self-harm or harming others. Patient 1's restraint order was co-signed by an MD at 6:30 am and, per policy, expired at 10:30 am. RN 3 removed Patient 1's restraints at 6:35 am because, Patient 1 remained calm and cooperative.

A review of LVN 1's nursing notes, dated 11/06/23, at 9:08 am, indicated LVN 1 reapplied soft wrist restrains on Patient 1 via

Based on interview and record review, the facility's registered nurses (RN) failed to perform initial and on-going patient assessments of patients assigned to licensed vocational nursing (LVN) staff on the Center for Behavioral Health Unit (CBH, a secured 20-bed unit that provides intensive psychiatric treatment for patients suffering from acute psychiatric disorders and secondary substance abuse disorders). This failure caused, or contributed to a RN not supervising, reviewing, or performing independent physical health assessments on 26 of 26 patients (Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, patient 25, Patient 26, Patient 27, and Patient 28) assigned to LVNs.

Findings:

A review of the facility's job description titled, "Job Description- Clinical Supervisor-CBH," revised 2/18, indicated that the CBH Clinical Supervisor (CBHCS) was responsible and accountable for the quality of nursing functions during their shift, which included directing, supervising, and evaluating CBH staff. The CBH CS shall continually assess patient care and direct staff to make immediate changes to a patient's plan of care when needed.

A review of the facility's job description titled, "Job Description - LVN- CBH Department," revised 1/2014, indicated that the CBH LVN provided direct and indirect patient care services, within their scope of practice, and performed under the direction and supervision of a RN.

The facility's policy titled, "Scope of Vocational Nursing Practice/RN Supervision", dated 10/2023, indicated: " ...5.2. The RN must document on each patient at least once per shift ...The assessment must include data which is collected by the LVN, which the RN has reviewed and discussed, with the LVN ...5.8. A registered nurse shall directly provide patient assessments and the findings will be documented in the patient's medical record, for each shift and upon receipt of the patient when he/she is transferred to another patient care areas ..."

A review of patient physical assessments administered to LVN patients on the CBH unit, from 10/01/23 to 12/01/23, indicated that 26 of 26 patients (Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, patient 25, Patient 26, Patient 27, and Patient 28) assigned to LVNs did not include a registered nurse supervising, reviewing, or performing an independent physical health assessment as required by their licensure.

During an interview on 11/28/23, at 10:32 am, LVN 2 stated that CBH RNs do not perform nursing assessments on the patients assigned to her or collaborate with the CBH LVNs throughout a shift. RNs are only involved with an LVN's nursing care if they're asked to administer an intravenous (IV, administering medication through a needle or tube inserted into a vein) medication. LVN 2 stated that RNs do not access her patients and that she provides all nursing care, and performs her own independent physical health assessments, on every patient she's assigned to.

During an interview on 11/28/23, at 10:59 am, RN 3 stated that she had worked in the CBH unit for approximately six years. RN 3 reported that CBH RNs do not perform nursing assessments or provide registered nursing services to patients assigned to LVNs. RN 3 stated she was aware that LVNs had a limited licensure prohibiting them from performing physical health assessments, assessing patient data, or formulating a patient care plan. The facility never had a formal meeting, or method of communication, that outlined procedures for RNs to collaborate with LVNs so that patients received the full scope of nursing services, including registered nursing physical health assessments.

During an interview on 11/28/23, at 11:06 am, CBHCS 1 reported she has worked on the CBH unit for seven years and had been acting as a clinical supervisor for the past five years. CBHCS stated that the CBH RNs are not involved in performing nursing assessments, or providing nursing services to patients assigned to LVNs, because the LVNs work independently on the CBH unit. CBH RNs are only responsible for performing physical health assessments, and change of condition assessments, on their own patients. CBHCS 1 stated that the former CBH Director (FCBHD) informed the unit supervisors to review the LVN's charts at the end of each shift for completeness to ensure that LVNs charted fully and to fulfill the "state requirement for LVN supervision". CBHCS 1 stated the facility never informed the unit supervisors, or CBH RNs, that they were responsible to assess the LVN's patient data or provide registered nursing assessments to the LVN's patients. CBHCS reported if these were the facility's expectations, the CBH unit would have to increase RN staffing to ensure that the CBH RNs had a sufficient amount of time to perform physical health assessments on patients assigned to LVNs.

During a concurrent record review and interview on 12/07/23, at 2:24 pm, the Director of Performance Improvement (DPI) stated that the CBH patients listed above did not receive a RN physical health assessment or registered nursing services during the shifts that Patients 2 - 28 were assigned to LVNs. DPI reported that since an LVN's licensure scope is limiting and prohibits independent patient assessments or the administration of IV medications, RNs are responsible for performinging a minimum of one physical health assessment per shift and administering all IV medications to the LVN's patients. DPI stated that the facility depended on the former CBH unit Director (FCBHD) to communicate these nursing care requirements to the CBH unit nurses. DPI reported that the FCBHD resigned from his position approximately two weeks ago and that the new Chief Nursing Officer (CNO) was acting as the Interim CBH unit Director (ICBHD) while the facility recruited for the position.

During an interview on ,12/13/23, at 3:45 pm, CNO/ICBHD reported he was acting as the ICBHD while the facility recruited for the open position. CNO/ICBHD stated that recently he made it "abundantly clear" to the CBH RNs and CBH clinical supervisors that RNs are responsible for reviewing the LVN's data, completing an independent physical health assessment, and confirming that the patient's plan of care is unchanged. CNO/ICBHD reported that, in most instances, it is expected that a RN "gets eyes on the patient" in order to fulfill this requirement and validate the LVN's findings.

Based on interview and record review, the facility failed to ensure that Patient 1's medical record was accurate and complete, in written or electronic form, when the facility did not have the factual documentation of an insulin administration medication error. This failure resulted in Patient 1's medical record having no documentation that indicated Patient 1 was administered an incorrect dose of 70 units of Humalog insulin (a short-acting insulin that last 2-4 hours).

Findings:

A review of the facility's policy titled, "Medication Safety Opportunities: Reporting," dated 10/23, indicated that the facility encourages reporting of medication safety opportunities (MSOs), formerly known as medication errors, to assess and improve the medication use process and provide a safe environment. The policy's process indicated that..."Staff will document the factual description of the MSO, and document notification of physician and subsequent monitoring in Meditech in the nursing notes for the patient."

A review of medical records indicated that Patient 1 was a 79-year-old male transported to the facility's Emergency Department (ED), from his home, on 10/23/23, at 6:04 pm, for severe agitation, progressive dementia, and hyperglycemia (high blood glucose levels). Patient 1 was triaged by the facility's ED with a blood glucose of 914 milligrams (mg) per deciliter (dL) and treated with subcutaneous Humalog, Novolog (a short-acting insulin that lasts 2-4 hours), and Lantus (a long-acting insulin that gives a steady level of insulin over 24 hours) per the facility's blood glucose management protocol. Patient 1 was subsequently identified as being gravely disabled, not being able to meet his basic needs, and awaiting disposition to a memory care facility. Patient 1 remained in the facility's Emergency Department Overflow (EDOF, a 7-bed, contained section of the Emergency Department (ED) for patients on legal mental health holds or patients requiring psychiatric stabilization) on a prolonged patient hold, while receiving medical care and BG management, and awaiting placement in a long-term living facility.

A review of the Medication Administration Record (MAR), dated 11/06/23, at 9:27 am, and indicated that Patient 1's BG before breakfast was 287 mg/dL. The MAR indicated Licensed Vocational Nurse (LVN) 1 administered 7 units of Humalog insulin, per facility's insulin adjustment tool, to correct the 287 BG. Patient 1 did not require insulin for carbohydrate correction because he only had 2 grams of carbohydrate intake during breakfast.

During a concurrent interview and record review, conducted in the ED Director's (EDD) office, on 12/06/23, at 3 pm, EDD stated on 11/06/23, at 9:27 am, Patient 1 was exposed to an insulin medication administration error that was administered by LVN 1. EDD reported that LVN 1 incorrectly administered 70 units of Humalog insulin to Patient 1, instead of the 7 units that was MD ordered for Patient 1's 287 mg/dL BG. After LVN 1 identified the medication administration error, LVN 1 immediately presented to the EDD's office and reported the event. EDD stated she presumed that LVN 1 had updated Patient 1's medical record to reflect the insulin administration error, and document that 70 units was the actual amount of Humalog insulin administered to Patient 1.

During a concurrent interview and record review, conducted in the Director of Performance Improvement's (DPI) office, on 11/29/23, at 2:15 pm, DPI stated that Patient 1's complete clinical record did not indicate that an overdosed (a dose that is larger than the clinically required dosage) amount of insulin was flagged via the facility's automatic insulin audit. DPI reported that the facility's electronic health records (EHR) had an embedded feature that verified a patient's blood glucose was treated with the correct amount of insulin per the facility's protocol. DPI reported that the only flagged insulin administration events in Patient 1's complete clinical record indicated that Patient 1 was actually underdosed (a dose that is less than the clinically required dosage) and not overdosed. During a follow up interview, conducted in DPI's office, on 12/07/23, at 12:53 pm, with DPI, Chief Executive Officer (CEO), and Chief Nursing Officer (CNO), DPI restated that Patient 1's complete clinical record had no documentation that Patient 1 was incorrectly administered 70 units of Humalog insulin, on 11/06/23, at 9:27 am, or that an insulin medication administration error had occurred. DPI reported she never received an occurrence report, (a confidential facility report that includes data to examine events that may cause patient harm) notifying her and the Director of Pharmacy (DOP), that Patient 1 was administered an incorrect dose of Humalog insulin.

During a concurrent interview and record review, conducted at the facility's pharmacy, on 12/06/23, at 3:30 pm, DOP stated that Patient 1's complete clinical record had no documentation that an incorrect dose of 70 units of Humalog insulin was administered to Patient 1. Instead, Patient 1's MAR, on 11/06/23, at 9:27 am, only had documentation that Patient 1 received 7 units of Humalog insulin, for a 287 mg/dl BG, opposed to the actual 70 units that were administered in error. DOP reported that it was critical for patients' records to have documentation of every medication intervention, including medication administration errors, so that medical providers have a complete picture of a patient's health, and can treat the patient accordingly. DOP stated that without complete and accurate documentation, pharmacy staff are unable to analyze the facility's MSOs and suggest interventions to prevent future patient harm.

During a concurrent interview and record review, conducted in the DPI's office, on 12/13/23, at 3:45 pm, the CNO stated it was his expectation, and the facility's policy, that licensed staff are required to document the following when a medication error is discovered: identify the medication and dosage that was administered in error, describe the chain of events that led up to the medication administration error, and explain what steps were taken to treat the patient following the medication administration error. CNO acknowledged that Patient 1's medical record was not complete nor accurate because it had no documentation of the Humalog insulin administration error.