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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 §482.13 Patient Rights was out of compliance.

A-0154 (e) USE OF RESTRAINT OR SECLUSION Patient Rights, Restraint or Seclusion. All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion 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. Based on observations, interviews, and document review, the facility failed to ensure patients were free from physical confinement or restraint except when there was a risk of serious injury and harm or deemed otherwise medically necessary. This failure had the potential to affect all patients at the facility.

Based on observations, interviews, and document review, the facility failed to ensure patients were free from physical confinement or restraint except when there was a risk of serious injury and harm or deemed otherwise medically necessary. This failure had the potential to affect all patients at the facility.

Findings include:

Facility policies:

The Elopement Precautions and Response to Missing Person policy defined "at risk" as a patient who is susceptible to mistreatment, self-neglect, or exploitation because of their inability to perform or obtain services necessary for his or her health, safety, or welfare or lacks sufficient understanding or capacity to make or communicate responsible decisions concerning his or her person or affairs. Elopement is defined as a patient leaving unexpectedly or without warning, and without informing a healthcare professional caring for the patient. The patient may communicate intent to leave but not receive information on the consequences of leaving before departure. The policy defined patients at risk for elopement/escape as patients who were angry about admission, repeated verbal threats or made actual attempts to leave, patients who displayed confused or disoriented behavior (e.g., patients who wander), and patients were posed an imminent danger to themselves or others (e.g., suicidal or homicidal). The policy further read, that staff were to follow the following precautions and responses to reduce the risk [of patient elopement]: providers or nurses were to identify patients who were at risk for elopement/escape and place the patient on elopement precautions. Elopement precautions may include the implementation of video monitoring/patient safety attendant. The use of safety gowns and door signs for visual cues. Remove the patient's shoes and personal clothing from the room and provide the patient with slip-resistant socks and a safety gown. Staff were to reassess the patient during each shift to assess the need for continued elopement precautions and document in the safety section of the head-to-toe flowsheet of the electronic medical record (EMR) the assessment and the rationale for continued elopement precautions.

The Patient Restraints and Seclusion policy read, for a patient to be secluded, the patient must be alone in a room or area from which they are not allowed to leave and no one else is allowed to enter. Seclusion is not a standard treatment for the patient's underlying medical or psychiatric condition. A restraint order from a responsible caregiver (provider) is required for the application of restraints or seclusion.

The Continuous Video/Audio Monitoring (CVAM) of Patients policy read, the purpose of the policy was to provide guidelines for continuous video/audio monitoring (CVAM) of patients on inpatient units who are deemed at risk for injury or harm. The policy defined CVAM as the observation of patients 24/7 through the use of continuous live video and audio connection. The CVAM system is used in patient rooms to allow remote observers to monitor, identify potential safety issues, alert staff, and intervene quickly. CVAM is a nursing intervention and is ordered and discontinued by nursing staff based on their assessment of a patient's need for monitoring and their suitability. Physicians and Advanced Practice Practitioners (APPs) may, however, order this intervention. CVAM use is included within the general consent for treatment document.

The following types of patients meet inclusion criteria for the use of CVAM: Patients who have impaired judgment, sensory, memory, or concentration issues, and/or diminished awareness of safety constraints due to their medical condition, mental status, or inadequate decision-making capacity. Patients who are deemed a wandering or elopement risk and who can be redirected. In order to be eligible for CVAM, a patient in this condition must be able to be redirected. The nurse will notify the patient and family that CVAM usage will be implemented to promote patient safety. The nurse will document patient/family education regarding CVAM in the patient care record/education plan, initiation, use, and discontinuation in the patient's EMR.

Manufacturer instructions for use (IFU):

The AliMed IQ Duo Plus Alarm IFU read, the dual-functioning IQ Duo Plus Alarm operates as a pull-tab alarm (a fall prevention alarm that audibly alerts caregivers when a patient attempts to rise out of their chair or bed). The IQ Duo Plus Alarm is an integral part of any Fall Management program. Read the instruction sheet before using the IQ Duo Plus Alarm. Failure to do so may result in injury or death to a person in your care.

1. The facility failed to ensure patients at risk for elopement were free from physical confinement in their rooms. Specifically, pull-tab fall alarms were placed on the doors of patients determined to be an elopement risk in order to physically confine the patients within their rooms.

A. Observations conducted on 10/24/23 between 1:00 p.m. and 3:00 p.m. revealed pull-tab alarms were present and readily accessible for use on inpatient unit 3 West.

i. Inpatient room 351 was observed at 1:44 p.m. Observations revealed the room was equipped with a bed alarm system, a pressure pad chair alarm system, and an AliMed IQ Duo Plus (pull-tab) Alarm device.

ii. At 1:52 p.m., observations revealed three additional AliMed IQ Duo Plus (pull-tab) Alarm devices stored in a drawer at the nurses' station.

iii. During the observation, clinical nurse manager (CNM) #5 stated pull-tab alarms were no longer used as chair alarms. CNM #5 stated pull-tab alarms had been replaced by a pressure sensitive pad placed under the patient. CNM #5 stated pull-tab alarms should not have been present in patient rooms or on the inpatient units as the facility no longer used the device as part of the fall prevention program.

B. Interviews conducted with staff on 10/24/23, 10/25/23, and 10/26/23 revealed a practice of pull-tab alarms being used as door alarms to physically confine patients within their rooms.

i. Staff member (SM) #3 stated nursing staff routinely used pull-tab alarms on the doors of patients who were at risk for elopement. SM #3 stated s/he was instructed to not remove pull-tab alarms from patient doors. SM #3 stated staff placed pull-tab alarms on the doors of elopement risk patients to ensure patients did not exit their rooms. SM #3 stated pull-tab alarms were a form of restraint when used as a door alarm.

ii. SM #6 stated nursing staff placed pull-tab alarms on the doors of patients who were at risk for elopement to ensure the patients did not leave their rooms. SM #6 further stated pull-tab alarms were used to physically confine confused and disoriented patients to their rooms. SM #6 stated the use of pull-tab alarms as a door alarm increased patient confusion and frustration. SM #6 stated patients who were confused, disoriented, or identified as at risk for elopement needed continuous monitoring to ensure their safety. SM #6 stated patients with pull-tab alarms on the door were not continuously monitored by staff. SM #6 also stated a pull-tab alarm used to hinder patients from moving freely or physically confine patients was considered a restraint.

Both SM #3 and SM #6 stated they had not been provided training or education on how pull-tab alarms should have been implemented and used to prevent patients from eloping.

iii. SM #4 stated pull-tab alarms were placed on the doors of elopement risk patients. SM #4 stated pull-tab alarms were routinely used for inpatients on the internal medicine (IM) unit and on the 3 West medical surgical inpatient unit (3 West). SM #4 stated use of pull-tab alarms on patient doors was a nurse driven practice and pull-tab alarms were placed on the patient doors to ensure elopement risk patients remained in their rooms. SM #4 stated patients were not allowed to leave their rooms and were directed to remain in their rooms when pull-tab alarms alerted staff the patient was attempting to leave.

iv. SM #2 stated pull-tab alarms were initially used throughout the facility as chair alarms to prevent patients from falling. SM #2 stated staff stopped using the pull-tab alarm as a fall prevention device when the facility transitioned to a pressure-sensitive chair pad to detect when patients attempted to stand. SM #2 stated after pressure-sensitive chair pads were implemented, staff used the pull-tab alarms as door alarms for elopement risk patients. SM #2 further stated the use of pull-tab alarms as door alarms was routinely implemented on all inpatient units.

SM #2 stated pull-tab alarms were placed on doors to purposely block patients from leaving their rooms. SM #2 stated pull-tab alarms audibly alerted staff the patient was attempting to exit their room. S/he further stated when a pull-tab alarm was heard staff rushed to the patient's room and directed the patient to remain in their room. SM #2 stated pull-tab alarms prevented patients from wandering around the unit.

SM #2 stated s/he did not consider pull-tab alarms used as door alarms a form of restraint, however, SM #2 stated pull-tab alarms placed on patient doors physically confined the patient in their room. SM #2 further stated patients were not informed an alarm would be placed on their door to alert staff when they attempted to leave their room.

SM #2 then stated the use of pull-tab alarms as door alarms was discussed with nursing leadership daily. SM #2 further stated during the hand-off report nurses informed the charge nurse and clinical nurse manager of the patients who had a pull-tab alarm placed on the door.

v. During an interview with SM #1, s/he stated pull-tab alarms were implemented at the discretion of the nurse. SM #1 stated s/he had previously tried to remove a pull-tab alarm from a patient's door and was instructed to leave the pull-tab alarm on the door. SM #1 further stated s/he had attempted to remove the door alarm from the patient's door since door alarms were a type of restraint. SM #1 stated while attempting to remove the pull-tab alarm s/he was instructed that the alarm needed to remain in place to prevent the patient from eloping. S/he further stated s/he was told the door alarm had been placed on the patient's door as a patient sitter was not available to monitor the patient.

SM #1 stated s/he was concerned about patient safety whenever a pull-tab alarm was placed on a patient door. SM #1 stated pull-tab alarms were usually placed on the doors of patients who experienced altered mental awareness and/or increased confusion and when the patients were physically confined to their rooms, their confusion and disorientation could worsen. Furthermore, SM #1 stated when patients were confined to their rooms, they were at an increased risk of experiencing an unwitnessed fall.

C. Interviews with inpatient clinical managers and facility leadership revealed clinical managers were aware nurses placed pull-tab alarms on patient doors to physically restrict the patients to their rooms.

i. On 10/25/23 at 2:56 p.m., interviews were conducted with clinical nurse manager (CNM) #7 and CNM #8.

CNM #7 stated nurses communicated which patients were elopement risks with nursing leadership during daily huddles on the unit. CNM #7 stated as the clinical manager she was informed of which elopement precautions and interventions were implemented for elopement risk patients.

CNM #7 stated she was aware nurses used pull-tab alarms as door alarms. CNM #7 stated she encouraged nurses to use continuous video/audio monitoring (CVAM) instead of pull-tab alarms on patient doors. CNM #7 stated confused and/or disoriented patients were at risk of eloping and required increased safety measures and the use of pull-tab alarms on the doors was an intervention implemented to increase patient safety. CNM #7 stated she did not consider the use of door alarms to be a restraint or a means of physically restricting the patient to their room. CNM #7 was unable to define what a restraint was and declined to respond.

CNM #8 stated he was also aware nurses used pull-tab alarms as door alarms. CNM #8 stated pull-tab alarms were used as door alarms to identify the patient had not eloped and was not attempting to elope. CNM #8 stated nurses informed clinical managers of the patients they determined to need a door alarm in daily huddles.

Both CNM #7 and CNM #8 explained that they discussed the use of pull-tab alarms as door alarms to prevent patient elopement with facility leadership on a daily basis during the daily safety huddles and bed meetings.

ii. On 10/25/23 at 4:46 p.m., quality director (Director) #9 was interviewed. Director #9 stated he had not been aware that pull-tab alarms were used as door alarms until the morning of 10/25/23. Director #9 stated he was informed staff used the pull-tab alarm in an unapproved manner during the daily safety huddle meeting on 10/25/23. Director #9 stated staff were not directed to use pull-tab alarms as door alarms for elopement risk patients and facility leadership had not been aware they were used this way until surveyors identified concerns.

iii. On 10/25/23 at 5:15 p.m., an interview with chief nursing officer (CNO) #10 was conducted. CNO #10 stated she had not observed pull-tab alarms being used as door alarms on the inpatient units and did not believe nursing staff used pull-tab alarms as door alarms. CNO #10 stated she did not think there were risks involved in using pull-tab alarms as door alarms.

D. Interviews with staff were in contrast to the Elopement Precautions and Response to Missing Person policy, the CVAM of Patients policy, the Patient Restraints and Seclusion policy, and the AliMed IQ Duo Plus Alarm IFU.

According to the Elopement Precautions and Response to Missing Person policy and the CVAM of Patients policy, elopement precautions included the implementation of video monitoring and/or direct patient monitoring by a patient safety attendant. There was no evidence in the policies advising fall prevention devices and pull-tab alarms were permitted to be used as door alarms to confine elopement risk patients to their rooms. Furthermore, the Patient Restraints and Seclusion policy read, patients were considered restrained and/or secluded when confined alone in a room or area and not allowed to leave.

Lastly, according to the AliMed IQ Duo Plus Alarm IFU, the pull-tab alarm was to be used as part of fall prevention programs, and failure to use the pull-tab alarm as intended during patient care could result in injury and/or death. There was no evidence in the IFU that pull-tab alarms could or should have been used as door alarms.