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

A-0395 RN SUPERVISION OF NURSING CARE A registered nurse must supervise and evaluate the nursing care for each patient. Based on observations, interviews and document review, the facility failed to ensure the registered nurse (RN) implemented and evaluated fall prevention measures and interventions for patients with increased susceptibility to falls. Specifically, nursing staff failed to evaluate the efficacy of fall prevention devices to ensure the volume of the alarm was audible and the fall prevention device functioned appropriately for four of four patients assessed as a high fall risk. (Patient #2, #6, #7, #8)

Based on observations, interviews and document review, the facility failed to ensure the registered nurse (RN) implemented and evaluated fall prevention measures and interventions for patients with increased susceptibility to falls. Specifically, nursing staff failed to evaluate the efficacy of fall prevention devices to ensure the volume of the alarm was audible and the fall prevention device functioned appropriately for four of four patients assessed as a high fall risk. (Patient #2, #6, #7, #8)

Findings include:

Facility policies:

The Fall Prevention Program policy dated 9/22/20 read, a fall assessment will be performed for all patients. A fall was defined as an abrupt, unintended descent to the floor or other surface such as a counter, another person or an object. The RN will perform a Fall Risk Assessment for every patient as part of the patient safety, risk, and regulatory assessment. The assessment will be documented in the Electronic Health Record (EHR). The RN will perform subsequent Fall Risk Assessments when receiving a patient transfer to the unit, after a change in patient condition, following a patient fall at the facility and during every nursing shift.

Patients susceptible to falls exhibit some but not all of the following fall risk indicators: confusion, dizziness, lethargy, inability to follow directions and/or instructions, muscle weakness, unsteady gait, urine and stool incontinence, prolonged bed rest, a history of falls (within the last three months), hypotension (low blood pressure), outward impulsive behaviors and routine usage of walkers, canes and or crutches. Patients displaying fall risk indicators are determined to be at an increased risk for falls and considered high fall risk patients.

High fall risk patients are to have fall risk interventions implemented to reduce their risk for a fall. Fall risk interventions include: bed and or chair exit alarms (bed/chair exit alarms), tethering of medical devices and clinical equipment such as intravenous (IV) medication tubing and poles, oxygen tubing and drainage tubing. Routine use of fall prevention devices such as gait belts and staff assistance with patient ambulation and re-positioning. Application of yellow non-slip footwear, a yellow hospital gown, a yellow fall risk armband in addition to appropriate fall risk signage or yellow hall light allowed for visual indication of high fall risk susceptibility. White board updates related to the patient's assistive devices and level of assistance (LOA) are displayed on the white board within the patient room. Placement of the patient's call-light and personal items within the reach of the patient, removal of clutter from the patient's room, positioning of the patient bed in a low and locked position and placement of two to three side rails. Safety rounding/observation, utilization of a virtual or private sitter for the patient. Fall risk and prevention education for the patient and family members in addition to fall risk and prevention hand off communication between nursing staff.

The following universal fall precautions are to be implemented for all patients: Frequent patient rounding, clutter free patient rooms, non-yellow non-skid footwear and or non-skid socks, increased lighting, locked and secured wheels on patient wheelchairs, beds and commodes, placement of the patient bed in the lowest position, patient education and continued re-education related to call light use and placement of the patient's personal items, cell phone/telephone, remote control and call light within close reach of the patient.

The Alarm System Efficacy for Patient Care policy dated 6/14/20 read, patient care units were defined as areas in which medical equipment was used to diagnose, treat and monitor patients and their care. An alarm was defined as an audible or visual alert emitted from medical equipment to notify clinical staff of an urgent patient need or concern. A patient care device was defined as medical equipment used to treat, monitor or diagnose patients.

Patient care devices must be tested and verified as operational and capable of alerting staff of urgent patient needs. Nursing staff will evaluate and assess patient care devices to ensure the efficacy and functionality of the patient care device. Nursing staff will ensure patient care device alarms work properly and emit audible and or visual notification alerts. Audible alerts must be sufficiently heard over competing ambient noise within the patient care unit.

The Serious Safety Event policy dated 5/2019, defined a patient safety event as any patient event, incident, or condition which resulted or could potentially result in patient harm. A patient safety event included but was not limited to the following: An ineffective or defective patient care system, policy or process. Breakdown, failure or human error associated with patient care systems and processes. Additionally, patient safety events encompass adverse events, no-harm events, close calls, and hazardous conditions.

Instructions For Use (IFUs):

The Stryker Secure II Med-Surg Bed Model 3002 IFU read, all functions and features of the bed should be tested to ensure the bed works properly. The bed's exit system alerts staff when a patient was about to exit the bed and was not intended to replace patient monitoring.

The display panel located on the footboard of the bed will indicate when the bed exit alarm was on or off. The bed exit on indicator will light up when the bed exit function has been activated on the bed

1. The facility failed to ensure nursing staff implemented patient care devices (bed/chair exit alarms) used to monitor high risk fall patients were functional and audibly and or visually alerted staff of an immediate patient concern.

A. Document review revealed nursing staff failed to evaluate and verify bed/chair alarms were operational and alerted nursing staff of urgent patient needs.

a. According to the Alarm System Efficacy for Patient Care policy, patient care devices used to treat, monitor or diagnose patients were to be evaluated for efficacy by nursing staff. Patient care device alarms must be assessed, tested and verified as operational. Nursing staff would ensure the patient care device alarms emit audible and or visual notification alerts which could be heard over competing ambient noise on the patient care unit and patient care device alarms must sufficiently alert nursing staff of an immediate patient concern.

b. Patient #2 was admitted on 6/1/21 at 1:27 a.m. She was diagnosed with dyspnea/hypoxemia (shortness of breath), dizziness, altered mental status and a history of recent falls.

i. On 6/1/21 at 4:48 a.m., a fall risk assessment was performed for Patient #2. The fall risk assessment revealed Patient #2 was assessed to be a high fall risk. A bed exit alarm (a patient care device used to monitor when a patient attempted to exit the bed) was indicated as the fall intervention to be placed for the patient.

At 8:00 a.m., a subsequent fall risk assessment was performed by the RN for Patient #2. The patient was re-assessed as a high fall risk with the following fall interventions: bed/chair exit alarm and supervised/assisted ambulation (supervision/assistance to walk and get in and out of bed) by nursing staff.

ii. Patient #2's medical record revealed on 6/1/21, a procedure order was entered by her physician for post-fall assessments to be performed.

Post fall documentation revealed on 6/1/21 at 9:40 a.m., Patient #2 experienced a patient safety event in her room. Patient #2 had been found lying on the floor in her room by the RN.

According to the Serious Safety Event policy, an adverse event was considered a patient safety event and defined a patient safety event as an event, incident, or condition which resulted or could result in patient harm.

iii. On 6/1/21 at 5:30 p.m., a Clinical Note written by the orthopedic physician caring for Patient #2 revealed Patient #2 suffered epistaxis (a nosebleed), periorbital ecchymosis (bruising around the eyes as a result of a traumatic injury to the head and or face) and a fractured left hip (a break in the upper bone of the leg) as a result of the fall in her room.

iv. The adverse event report revealed follow up fall documentation for Patient #2. The adverse event report read, the RN for the patient stated Patient #2's bed exit alarm had been activated at the time the patient fell, but appeared to be defective.

Prior to the adverse event which occurred on 6/1/21, there was no evidence the RN had evaluated the efficacy of Patient #2's bed exit alarm to ensure the patient care device was functional and effectively monitored the patient.

According to facility policy, the RN for the patient should have verified the efficacy of the bed alarm and ensured an audible and or visual notification would be emitted to alert nursing staff when the patient attempted to exit the bed.

c. The medical records for Patient #6 and #7 were reviewed.

i. Patient #6's medical record revealed the patient experienced an adverse event on 4/17/21 at 9:45 p.m.

On 4/18/21 at 12:55 a.m., a Clinical Note entered by the patient's physician stated Patient #6 experienced an unwitnessed fall in her room and a computed tomography (CT) of the head (a noninvasive diagnostic imaging procedure performed to see the inside of the head) was performed and showed Patient #6 had a contusion (bleeding and tissue damage underneath the skin) on the left front side of her head.

At 7:06 a.m., a Hospitalist Progress Note stated Patient #6 experienced an unwitnessed fall during the night and the patient exhibited increased confusion and required increased administration of supplemental oxygen.

ii. Patient #7 exhibited the following fall risk indicators: generalized weakness, unsteady or impaired gait and usage of a walker.

The fall risk assessment performed for Patient #7 revealed the patients was susceptible to falls and was assessed to be a high fall risk.

iii. Fall risk interventions implemented for both patients were bed exit alarms and supervised/assisted ambulation.

There was no evidence in either medical record the RN for the patient evaluated the bed exit alarms to ensure the alarm alerted nursing staff of bed exit attempts.

According to facility policy, the RN for Patient #6 and #7 should have ensured the bed exit alarm functioned, was activated and would emit an audio and or visual alert if the patient tried to exit the bed .

B. Observations, record review and patient interviews revealed nursing staff failed to implement safety interventions for Patient #8.

a. According to the Fall Prevention Program policy, fall risk interventions were implemented for patients identified as high fall risks. Fall risk interventions include: The activation of bed/chair exit alarms, the application of a yellow hospital gown and socks in addition to a yellow fall risk armband categorized the patient as a high fall risk and required the patient to have supervised assistance when ambulating and re-positioning. In-room white board documentation of patient assistive devices and the level of assistance (LOA) needs of the patient. Positioning of the patient's bed in the lowest, locked position with two to three side rails in an upright and locked position.

Patients were identified as high fall risk patients and deemed to have an increased risk for falls when the following signs and symptoms were present: altered mental status, dizziness, lethargy, inability to follow directions and/or instructions, generalized and localized muscle weakness, unsteady gait, mobility and or balance issues, use of assistive ambulation devices, experience incontinence (urine and or stool), experienced a recent fall or falls (within the last three months), are hypotensive (low blood pressure) or have impulsive behavior(s).

b. On 9/1/21 from 8:13 a.m. to 9:39 a.m., observations occurred on the Progressive Care Unit (PCU) and Medical Telemetry (Tele) unit.

i. Observations of Patient #8 and the patient's room revealed Patient #8 was assessed to be a high fall risk patient. Patient #8 had on a yellow hospital gown, yellow non-skid socks and a yellow fall risk armband. The white board in Patient #8's room had stand by assist (SBA) written out on the board and an additional written notation which stated Patient #8 was not to use the walker in her room without assistance from the nursing staff.

According to facility policy, high fall risk patients wore yellow hospital gowns, yellow non-skid socks and a yellow fall risk armband to indicate the patient was a high fall risk. Additionally, patients who experience generalized weakness, unsteady gait and routinely used assistive ambulation devices were considered a high fall risk .

According to the Alarm System Efficacy for Patient Care policy, patient care device alarms must be tested and verified as operational, specifically the alarms must be evaluated and emit an audible and or visual notification to alert nursing staff of an immediate patient concern.

ii. At 8:44 a.m., observations revealed the bed exit alarm function for Patient #8's bed was not activated when RN #1 entered the patient's room. The bed exit on indicator light located on the footboard of Patient #8's bed was not illuminated.

According to the Stryker Secure II Med-Surg Bed Model 3002 IFU, the bed exit system alerted staff when a patient attempted to exit the bed. The bed exit on indicator light was illuminated when the bed exit function was activated. The bed exit function must be activated for the bed exit system to alert staff. The bed exit feature does not replace physical patient monitors. Additionally, functions and features need to be routinely tested and evaluated to ensure the bed functioned properly.

iii. At 8:58 a.m., RN #1 exited Patient #8's room to retrieve pain medication for the patient. RN #1 did not ensure the bed exit alarm function had been activated prior to exiting Patient #8's room.

At 9:03 a.m., RN #1 returned to Patient #8's room and administered the requested pain medication to the patient. The bed exit alarm function had been deactivated while RN #1 retrieved pain medication for the Patient #8.

iv. At 9:07 a.m., RN #1 was observed activating the bed exit alarm on Patient #8's before she exited the patient room.

c. On 9/1/21 at 9:08 a.m., an interview was conducted with Patient #8. Patient #8 stated she was admitted to the facility on 8/30/21. She stated she had right shoulder surgery and experienced a fall shortly after the surgery. The patient stated she hit her head when she fell. Patient #8 stated the fall occurred because she tried to use her walker without assistance and fell when she tried to stand up. She stated she hit her head on a nearby table when she fell. She stated shortly after the fall, she began having tremors, slurred speech and seizures.

Patient #8 stated the personal walker she used had four wheels and was easier to maneuver. She found it difficult to use the two-wheeled walker the facility placed in her room because she felt unsteady on her feet when she attempted to be mobile.

C. Interviews with staff revealed nursing staff had not evaluated bed/chair exit alarms to ensure the patient care device functioned properly and alerted nursing audibly and or visually of an immediate patient concern.

i. On 8/30/21 at 12:00 p.m., an interview was conducted with RN #2. RN #2 stated she recalled Patient #2 and the safety event which occurred. She stated Patient #2 had been confused and the patient had tried to stand up and fell. RN #2 stated Patient #2 had been assessed to be a high fall risk and should have had a bed/chair exit alarm activated to monitor the patient. She stated Patient #2 was found after she fell in her room lying on the floor. She further stated Patient #2 had blood present on her face and in her mouth after the fall. RN #2 stated Patient #2 had been injured due to the fall, she stated Patient #2 sustained a fractured hip when she fell.

On 9/2/21 at 10:07 a.m., a second interview was performed with RN #2. RN #2 stated nursing staff were responsible to ensure bed/chair exit alarms were activated for patients assessed to be a high fall risk. She stated the bed had to be connected to the outlet for the bed exit alarm to emit the proper alert when a patient attempted to exit the bed. RN #2 stated if the patient's beds were not plugged in correctly, the bed exit alarm would only be audible in the patient's room and the lights outside the patient's room would not flash to indicate nursing staff there was an immediate patient concern. She stated after the bed was properly plugged in, the bed exit alarm function could be activated on the footboard of the patient bed.

RN #2 stated nursing staff were not required to ensure the bed exit alarm function worked properly. She stated nursing staff checked to see if the bed exit alarm indicator light was on when activating bed exit alarms. RN #2 stated she was not trained on how to ensure bed exit alarms functioned appropriately, she stated she previously observed issues which occurred with bed exit alarms which was how she knew to make sure the bed was properly plugged in before activating the bed exit alarm. RN #2 stated she was not aware of a facility policy to evaluate and check the bed exit alarm and had not performed an evaluation to ensure the bed exit alarm effectively notified nursing staff of an urgent patient concern .

ii. On 9/1/21 at 4:08 p.m., RN #1 stated nursing staff were responsible for ensuring bed/chair exit alarms were properly activated when used for high fall risk patients. She stated patients who were assessed to be a high fall risk required the use of fall risk interventions. RN #1 stated bed/chair exit alarms were activated to help ensure the safety of high fall risk patients.

RN #1 stated the bed exit alarm should have been activated for Patient #8. RN #1 stated she had seen Patient Care Tech (PTC) #3 assist Patient #8 to the restroom earlier that morning. RN #1 stated PTC #3 should have activated the bed exit alarm after she assisted Patient #8. RN #1 stated Patient #8 had been assessed as a high fall risk. RN #1 stated high fall risk patients always had bed exit alarms activated. RN #1 stated she was not aware of how long the bed exit alarm had been deactivated prior to entering Patient #8's room at 8:44 a.m.

RN #1 stated when the bed exit alarm function was activated the bed exit indicator light would light up. She stated the bed exit alarm function was not checked or evaluated except she ensured the bed exit indicator light was on. RN #1 stated she had not been provided training or additional education on how to evaluate a bed exit alarm or how to ensure the bed exit alarm alerted nursing staff.

iii. On 9/1/21 at 1:00 p.m., an interview was conducted with PTC #3. PTC #3 stated bed exit alarms were activated at all times for patients unless specifically instructed by the RN not to activate the exit alarm. She stated bed exit alarms alerted nursing staff when the patient attempted to get out of bed. PTC #3 stated bed exit alarms were loud and the sound would be emitted from the patient's room. She stated, the yellow light outside of the patient's room flashed to alert nursing staff that the patient attempted to exit their bed. Additionally, she stated the unit phones received an mobile alert (secure intra-facility mobile phone communication which alerted staff of an immediate patient concern) bed alarm notification. PTC #3 stated she was not trained how to assess or evaluate if the bed exit alarm functioned. She stated she was not aware the bed exit alarm should be checked.

PTC #3 stated she cared for Patient #8 and had taken her to the restroom before RN #1 went into the patient's room. PTC #3 stated Patient #8 was a high fall risk patient. She stated she knew Patient #8 had a high risk for falls due to the yellow gown, socks and armband the patient had on, additionally, the white board in Patient #8's room stated the patient was a SBA and required assistance when the patient used the walker to ambulate. PTC #3 stated she helped Patient #8 to the restroom and then back into bed. She remembered she activated the bed exit alarm after she handed Patient #8 the call light and moved the bedside table closer to the patient. She further stated she placed the patient's walker out of the way and then exited Patient #8's room. PTC #3 stated she was unsure how the bed exit alarm got deactivated before RN #1 entered the patient's room.

iv. On 9//2 at 9:06 a.m. an interview was conducted with Director (Director) #4. Director #4 stated patients were considered high fall risk if the patient used an assistive walking device. He stated the bed alarm should be activated for all high risk patients. Additionally, bed alarms were to be checked by the Registered Nurse at the start of their shift. Director #4 stated bed alarms were activated when the bed exit button was pressed and the indicator light was illuminated.

Director #4 stated a bed alarm was a patient care device. He stated bed exit alarms monitor patients and when the patient attempted to exit the bed. Director #4 stated he has not checked a bed exit alarm to ensure it functioned properly. He stated he had not been trained or educated to evaluate a bed exit alarm. Furthermore, he stated he was not aware the facility had a policy in place to ensure bed alarms worked.

Director #4 stated a bed exit alarms alerted staff if the patient tried to get out of bed unassisted. He stated it was important for a bed exit alarm to work properly to prevent the patient from an accidental fall.