**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review and staff, Medical Director #1, Cardiologist, LifeVest Resident Representative and LifeVest Technician interviews, the facility failed to consult with Medical Director #1 when Resident #119's LifeVest (an external defibrillator designed to detect certain life-threatening rapid heart rhythms and, if needed, automatically deliver a treatment shock to restore normal heart rhythm) delivered treatment shocks to her multiple times in the early morning hours on [DATE]. The LifeVest Resident Representative contacted Resident #119's Cardiologist on [DATE] about Resident #119's severe episodes of ventricular tachycardia, a life-threatening rapid heart rate. The Cardiologist called the facility and requested to talk to the Medical Director. The Cardiologist recommended that the resident be sent to the hospital for evaluation. The emergency department at hospital #1 determined Resident #119 had significant fluid overload with severe congestive heart failure and she was transferred to another hospital for further evaluation and monitoring. The discharge summary from hospital #2 dated [DATE] indicated that Resident #119 was admitted to the critical care unit on [DATE] and was deceased on [DATE]. Discharge diagnoses included acute heart failure, cardiogenic shock, cardiac arrhythmia, acute hypoxic respiratory failure, acute kidney failure, and sustained ventricular tachycardia. The certificate of death dated [DATE] at 10:41 AM indicated the immediate cause of death was acute hypoxic respiratory failure and acute on chronic congestive heart failure with the approximate interval of onset to death for the immediate causes was 2 weeks. Other significant condition contributing to death was cardiogenic shock. This deficient practice occurred for 1 of 1 resident reviewed for notification of change (Resident #119).Immediate jeopardy began on [DATE] when Resident #119 received multiple treatment shocks from the external defibrillator device and the facility failed to consult the physician immediately. Immediate Jeopardy was removed on [DATE] when the facility implemented an acceptable plan of Immediate Jeopardy removal. The facility will remain out of compliance at a scope and severity of D (no actual harm with potential for more than minimal harm that is immediate jeopardy) to ensure education is completed and monitoring systems are in place and are effective. Findings included:Review of the manufacturer's information and the instructional videos for the LifeVest external defibrillator revealed that the device is prescribed for residents at risk for sudden cardiac death, a condition that occurs without warning with no signs that something is about to happen due to an electrical malfunction of the heart causing a dangerously fast heartbeat with no signs or symptoms. The LifeVest uses electrodes to continuously monitor the heart's electrical activity and detect dangerous heart rhythms, such as ventricular tachycardia and ventricular fibrillation. The device is designed to deliver an electrical shock to the heart when an abnormal rhythm is detected to restore a normal heart rhythm. The manufacturer's instructions indicated that if a treatment shock is delivered, the physician is to be called immediately, and an announcement is made by the device with this instruction. If the vest discharges, it means either the person has an unstable arrythmia (heartbeat) requiring immediate physician attention, or the device is malfunctioning. Both require medical evaluation as soon as possible.An interview with the LifeVest Technician on [DATE] at 5:00 PM revealed that the device does not provide continuous real time monitoring by a medical professional. The LifeVest Technician stated that the device was set with parameters and if the heart rate was above the set parameter, the device alarmed. The information from the device went into a server which could be reviewed by the physician. The technician stated that if a shock was delivered, it was recorded on the downloaded information. The technician stated that the information from the device was downloaded into the system every 24 hours, however there were sometimes issues with connectivity. The technician indicated that the blue gel was released prior to a shock being delivered. A button can be pressed to delay the shock from being delivered. 5 shocks are administered, then if more shocks are indicated they will be delivered based on the heart rhythm. The technician stated that if an abnormal heart rhythm was detected, the device emitted a siren alarm which was loud and identifiable. If the device administered a shock, the blue gel was released onto the skin. The technician stated that if the device continuously sounded, the physician and the device manufacturer should have been notified right away to check the equipment. A technician is available 24 hours per day 7 days per week to walk through issues with the device and if the technician is unable to resolve the issue via phone, a technician will come out within 24 hours to fix it or replace the device. Resident #119 was admitted on [DATE] with diagnosis which included ischemic cardiomyopathy (a condition that occurs when the heart muscle is damaged by lack of blood supply making it difficult for the heart to pump) requiring a LifeVest external defibrillator device, hypertensive heart disease, atrial fibrillation, coronary artery disease, chronic kidney disease with heart failure, acute on chronic systolic heart failure, and diabetes. Review of Resident #119's electronic record revealed a physician order dated [DATE] which indicated LifeVest was to be worn at all times every shift. Resident #119 was discharged from the nursing home to the hospital on [DATE] with a diagnosis of gastrointestinal hemorrhage and was readmitted on [DATE].A physician order revealed an order dated [DATE] indicated the LifeVest was to be worn at all times every shift. The order did not contain directives for when to notify the provider.An interview conducted with Nurse Aide (NA) #2 on [DATE] at 10:06 AM revealed that she was assigned to Resident #119 on [DATE] from 11:00 PM to 7:00 AM. NA #2 stated that Resident #119 had a device that she thought was to kick start the heart. NA #2 stated that she recalled on the night of [DATE] Resident #119's LifeVest device from 11:00 PM to 7:00 AM was going off all night. NA #2 could not recall if the device was beeping or if it was another sound. NA #2 stated that she let Nurse #1 know that the device was sounding and she did not know what the nurse did about it or if the nurse went in to assess the resident. Attempts were made to interview Nurse #1 were unsuccessful with text messages sent on [DATE] at 2:16 PM and [DATE] at 12:31 PM with no return call received. Nurse #1 was an agency nurse that worked as needed at the facility and was assigned to Resident #119 on [DATE] from 7:00 PM to 7:00 PM. Nurse #1 no longer worked at the facility. A health status note dated [DATE] at 8:32 PM written by Nurse #5 revealed that the off going nurse from the 7:00 PM to 7:00 AM shift (Nurse #1) reported that Resident #119's LifeVest was shocking Resident #119 all through the night. The note indicated that Nurse #1 stated that she changed the battery for the LifeVest, and Resident #119 was fine. The note indicated that Nurse #5 immediately went to check Resident #119 and observed the resident was lying in bed with brown dried emesis on her gown and around her mouth. The note did not indicate that the physician was notified and there were no vital signs recorded. The note stated that Nurse #5 observed that the pads of the electrodes for the LifeVest had leaked gel onto Resident #119's skin and her upper body was covered in gel. Resident #119 was cleaned, and the electrode pads were replaced. LifeVest was placed back on the resident. Resident #119 was alert and responsive but grunting. Nurse #5 notified Support Nurse #1 of the situation. Resident #119 vomited again and did not eat during the shift. The oncoming nurse (Nurse #7) was informed of concerns with the LifeVest and that Resident #119 had vomited. An interview was conducted with Nurse #5 on [DATE] at 1:15 PM. Nurse #5 was assigned to Resident #119 frequently and was assigned to her on [DATE] from 7:00 AM to 7:00 PM. Nurse #5 indicated that Resident #119 had a LifeVest cardiac defibrillator device. Nurse #5 stated that on the morning of [DATE], she received in report from the off going night shift nurse (Nurse #1) that Resident #119's LifeVest device was shocking the resident all night and that the device was sounding all night. Nurse #5 stated she asked the off going nurse (Nurse #1) if she had notified the provider or assessed Resident #119 and was told no, she had not. Nurse #5 stated that Nurse #1 did not indicate why she had not notified the provider or assessed the resident when the shocks occurred. Nurse #5 stated she immediately went to the room and observed Resident #119 was soaked with the blue conducting gel on her chest and upper body from the LifeVest device. Nurse #5 stated she and the Nurse Aide cleaned the resident, obtained vital signs and reapplied the electrodes and the LifeVest device. Nurse #5 indicated she informed Support Nurse #1 what was reported to her regarding Resident #119's condition and being shocked by the LifeVest. A follow up interview with Nurse #5 on [DATE] at 2:30 PM revealed that she did not notify the physician on [DATE] that Resident #119 was shocked by the LifeVest during the night shift. Nurse #5 stated that she thought Support Nurse #1 was going to notify the provider, and that she did not follow up to ensure that the physician was notified. Voice mail messages and text messages were sent to Nurse #7 on [DATE] at 11:25 AM, [DATE] at 12:24 PM, and [DATE] at 12:35 PM. Nurse #7 was assigned to Resident #119 on [DATE] from 7:00 PM to 7:00 AM. Nurse #7 was an agency nurse that was no longer employed at the facility. An interview with Support Nurse #1 on [DATE] at 12:05 PM revealed she recalled that Resident #119 had a LifeVest device. Support Nurse #1 stated that if the blue gel was released, a shock was administered. Support Nurse#1 stated that on the morning of [DATE], Resident #119 had blue gel on her chest which indicated that she received a shock. Support Nurse #1 stated the provider should have been notified that the LifeVest was sounding and a shock was administered. Support Nurse #1 stated the resident should have been assessed including vital signs and the provider should have been notified immediately when the shock occurred or as soon as possible after it was discovered that it occurred. Support Nurse #1 stated she did not notify a provider on [DATE] that Resident #119 received a shock from the LifeVest during the early morning hours and explained that she thought Nurse #5 would have done this. Support Nurse #1 stated she should have followed up with Nurse #5 to be sure that she had notified the provider of the shock from the LifeVest. Support Nurse #1 stated she was responsible for managing the residents on 3 halls, so she thought that the floor nurses were responsible for notifying the provider of changes in condition. An interview conducted with Nurse #8 on [DATE] at 11:41 AM indicated that she was assigned to Resident #119 on [DATE] from 7:00 AM to 7:00 PM and was assigned to the resident frequently. Nurse #8 stated that she did not recall any significant changes in Resident #119's condition on [DATE] from 7:00 AM to 7:00 PM. Nurse #8 stated that she did not think that Resident #119 being slow to respond to verbal stimuli, not eating and not showing interest could have been symptoms of a change in condition that required notifying the provider. An interview with the LifeVest Resident Representative on [DATE] at 4:30 PM revealed she had access to her patients' device information and shared alerts and other information with the doctors and cardiologists. She indicated that she called Resident #119's Cardiologist on [DATE] and informed him that the resident had a run of ventricular tachycardia (v tach), a dangerous rapid heart rhythm. The Representative stated that if a resident had a run of v tach greater than 1 minute, a shock was delivered. The device can deliver up to 5 shocks. The Representative stated that the data recorded from Resident #119's LifeVest on [DATE] just after midnight indicated that v tach was detected. The representative stated that there were multiple episodes of v tach on the night of [DATE] and when she received that information, she reached out to the Cardiologist. An interview with the Cardiologist on [DATE] at 3:36 PM revealed that the LifeVest device is designed to detect dangerous arrhythmia including ventricular tachycardia and ventricular fibrillation and deliver an electrical shock to restore the heart to a normal rhythm. The Cardiologist stated that the physician should be notified when the device delivered a shock and if unable to contact the physician, the resident should immediately be sent to the hospital for evaluation. The Cardiologist stated that he received a call on [DATE] from the LifeVest Resident Representative who stated that Resident #119 was shocked by the device during the early morning hours on [DATE] when the abnormal heart rhythm ventricular tachycardia, a dangerous rapid heart rate, was detected. The Cardiologist stated he immediately called the facility on [DATE] and recommended that Resident #119 be sent to the hospital for evaluation. A health status note dated [DATE] at 5:00 PM written by Support Nurse #1 indicated that the facility received a call from the Cardiologist who stated that a remotely acquired EKG (electrocardiogram) strip received from the LifeVest manufacturing company showed severe episode of ventricular tachycardia (a dangerous rapid heart rhythm). The Cardiologist spoke with Medical Director #1. Upon the Cardiologist's recommendation due to the resident not being stable, Medical Director #1 gave an order to send Resident #119 to the emergency department for further evaluation. Emergency Medical Services was contacted, and Resident #119 was transported to the hospital. Support Nurse #1 was interviewed on [DATE] at 12:05 PM. Support Nurse #1 stated the Cardiologist called the facility on [DATE] and was adamant that he spoke with Medical Director #1 regarding Resident #119. Support Nurse #1 stated she immediately went and informed Medical Director #1, who was in the building at the time, that the Cardiologist was on the phone and requested to speak with him. After speaking with the Cardiologist, Medical Director #1 gave the order to send Resident #119 to the hospital due to a dangerous heart arrhythmia. An interview with Medical Director #1 on [DATE] at 3:52 PM revealed that he had just started in the position at the facility in early February 2025 when the incident with Resident #119 occurred. Medical Director #1 stated he was not notified that Resident #119's LifeVest had alarmed or shocked her due to arrhythmia on [DATE]. Medical Director #1 stated when the LifeVest alarm sounded due to an arrhythmia, the resident should have been sent to the emergency room, and the provider should have been notified. Medical Director #1 stated that when the device shocked Resident #119, the nurse should have immediately assessed the resident, sent her to the hospital for evaluation and notified the provider. When the LifeVest discharges an electrical shock to the resident, it means the person had an unstable arrythmia requiring immediate physician attention, or the device malfunctioned and administered a shock when it was not required. Both require evaluation. Review of an Emergency Department (ED) report for hospital #1 dated [DATE] indicated that Resident #119 presented to the hospital with a LifeVest device on. Resident #119 presented after the LifeVest detected a cardiac arrhythmia and the cardiologist requested evaluation at the nearest emergency room. Resident #119 was somnolent, difficult to understand with closed eyes and was unresponsive on presentation to the ED. Resident #119 was noted to have 4+ pitting edema (a type of swelling where when pressure is applied on the area a temporary indentation or pit remains for a short time after the pressure is released) from toes to abdomen. The impression indicated that Resident #119 was evaluated due to a cardiac arrhythmia and was significantly fluid overloaded with severe congestive heart failure. Resident #119 was transferred to hospital #2 for further evaluation and monitoring. Review of the discharge summary for hospital #2 dated [DATE] indicated that Resident #119 was admitted to the critical care unit on [DATE] and was deceased on [DATE]. Resident #119's discharge diagnoses included acute heart failure, cardiogenic shock, cardiac arrhythmia, acute hypoxic respiratory failure, acute kidney failure, and sustained ventricular tachycardia. Review of Resident #119's certificate of death dated [DATE] at 10:41 AM indicated the immediate cause of death was acute hypoxic respiratory failure and acute on chronic congestive heart failure with the approximate interval of onset to death for the immediate causes was 2 weeks. Other significant condition contributing to death was cardiogenic shock, a life-threatening condition in which the heart suddenly can't pump enough blood characterized by sudden, rapid heartbeat (tachycardia). An interview was conducted on [DATE] at 2:20 PM with the Director of Nursing (DON) and the Clinical Services Director. The DON and Clinical Services Director stated that they expected that if something occurred such as the LifeVest delivered a shock, the provider would be notified immediately for further instructions. The DON and Clinical Services Director stated the physician should have been notified immediately when the LifeVest alarmed. The DON was unable to state why the physician was not notified other than that the nurse that worked on the night of [DATE] was an agency nurse who no longer worked at the facility. The DON stated that she expected that the nurses recognized and reported changes in condition to the medical provider. The Administrator was notified of immediate jeopardy on [DATE] at 12:10 PM.The facility provided the following credible allegation of immediate jeopardy removal: Identify those recipients who have suffered, or are likely to suffer, a serious adverse outcome as a result of the noncompliance.The facility failed to ensure the physician was notified of a significant change for Resident #119.Resident #119's LifeVest shocked her multiple times in the early morning hours (beginning shortly after midnight) of [DATE]. Nurse #1 observed the device deliver shocks to the resident and did not notify the physician. The physician was not notified until [DATE] when Resident #119's Cardiologist contacted the facility and recommended the resident be sent to the hospital for evaluation after being notified by the LifeVest's manufacturer that the resident had a severe episode of ventricular tachycardia.Resident #119 did not return to the facility after discharge on [DATE]. Facility has not been able to contact Nurse #1, and she is no longer working in the facility. The Administrator and Director of Nursing attempted to contact Nurse #1 on [DATE], but the number was not operational.On [DATE], the facility initiated a comprehensive response to address the identified noncompliance related to failure to notify provider of an acute change in Resident # 119's condition. The Direct care nurses conducted an immediate assessment of 100% of current residents to identify any acute changes in condition that had not been communicated to the appropriate medical provider. This included symptoms or signs that were:- Acute or sudden in onset - Markedly more severe than usual - Unrelieved by previously prescribed measures - Indicative of respiratory distress (e.g., difficulty breathing, low oxygen saturation, new onset cough or congestion, decreased appetite)During the above audit, it is noted that no residents were found to be using wearable cardiac devices.The audit was completed on [DATE]. There were 5 residents identified with acute changes in condition. For each of these residents, the provider was notified, and appropriate medical orders were implemented by the direct care staff on [DATE].Additionally, on [DATE], the Director of Nursing (DON) reviewed the progress notes to include the E -interact transfer and change in condition assessments for all resident transfers to an acute care hospital within the past 30 days to ensure provider notification had occurred for any acute change in condition. The audit confirmed that provider notification was completed timely for 14 out of 14 residents.Specify the actions the entity will take to alter the process or system failure to prevent a serious adverse outcome from occurring or reoccurring and when the action will be completed. To prevent recurrence, the DON began in-servicing all licensed nurses (Registered Nurses and Licensed Practical Nurses) and certified Nurse Aides (CNAs), including full-time, part-time, PRN (as needed), and agency staff, on [DATE]. The training emphasized the importance of timely provider notification for any acute change in condition. This included symptoms or signs that were:- Acute or sudden in onset - Markedly more severe than usual - Unrelieved by previously prescribed measures - Indicative of respiratory distress (e.g., difficulty breathing, low oxygen saturation, new onset cough or congestion, decreased appetite) Specific training for a resident with a LifeVest was if a person's LifeVest discharges, it means the person may have an unstable arrythmia or that the device is malfunctioning or both, and both of these would require immediate physician notification. Training for licensed nursing staff began on [DATE] and includes viewing the 26-minute LifeVest instructional video designed for both patients and caregivers. Following the video, the Director of Staff Education utilized a competency checklist to validate staff understanding. This competency checklist includes verbalization of understanding of the knowledge of the LifeVest purpose and function, application and maintenance, emergency response, communication and education as well as the location and contents of the quick reference guide for LifeVest. This training initiative was coordinated by the Director of Nursing. All current staff must complete this training by [DATE] to care for residents with wearable cardiac devices. Staff who do not complete the training by [DATE] will not be permitted to work until the training is completed.The Director of Nursing and the Director of Staff Development will do a daily reconciliation of the schedule to ensure all licensed staff and CNAs have completed the training as indicated above.This in-service training has been incorporated into the orientation program for all new facility and agency staff.No staff shall work without this training after [DATE]. Alleged date of Immediate Jeopardy removal: [DATE]The immediate jeopardy removal plan was validated on [DATE]. A sample of staff including the Administrator, Director of Nursing, Staff Development Director, nurses, nurse aides and medication aides were interviewed regarding in-services they received related to the deficient practice. All staff interviewed stated they had received in-service training regarding the LifeVest purpose and function, application and maintenance and emergency response. Validation indicated that licensed nurses had completed a competency checklist regarding the LifeVest device and the indications for when to notify the physician. The nurses that were interviewed indicated that they had received training regarding timely provider notification of acute changes in condition. The immediate jeopardy was removed on [DATE].

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review and staff, LifeVest Technician, LifeVest Resident Representative, Medical Director #1 and Cardiologist interviews, the facility failed to protect Resident #119's right to be free from neglect. Resident #119 was admitted on [DATE] with a LifeVest (a wearable device designed to detect life-threatening rapid heart rhythm and, if needed, automatically deliver a treatment shock to restore normal heart rhythm). The nurses and nurse aides had no training on how to care for and manage a resident who required a LifeVest and staff neglected to provide necessary care and services after the LifeVest delivered several treatment shocks. Nurse #1 observed the device deliver treatment shocks to the resident in the early morning hours of [DATE] and took no action with the exception of notifying the oncoming first shift nurse that the Life Vest was shocking the resident all through the night. The Physician was not contacted to evaluate Resident #119 after the treatment shocks were delivered as specified in the manufacturer's instructions. Due to ineffective staff communication and lack of comprehensive assessments Resident #119's significant change from her baseline was not recognized or acknowledged by the staff. On [DATE], Resident #119's Cardiologist contacted the facility and recommended the resident be sent to the hospital for evaluation after being notified by the LifeVest's manufacturer that the resident had a severe episode of ventricular tachycardia (a life-threatening rapid heart rate) on [DATE]. The emergency department (ED) at hospital #1 determined Resident #119 had significant fluid overload with severe congestive heart failure and noted Resident #119 was somnolent, difficult to understand with closed eyes and was unresponsive on presentation to the ED. Resident #119 was transferred to another hospital for further evaluation and monitoring. These failures had a high likelihood of resulting in serious harm or death for Resident #119. Immediate jeopardy began on [DATE] when Resident #119 received multiple treatment shocks from the LifeVest and the facility neglected to provide the necessary care and services and consult with the physician about an evaluation for a potential arrhythmia. Immediate jeopardy was removed on [DATE] when the facility implemented an acceptable plan of immediate jeopardy removal. The facility will remain out of compliance at a scope and severity of D (no actual harm with potential for more than minimal harm that is immediate jeopardy) to ensure education is completed and monitoring systems are in place and are effective. The findings included:This is cross-referred to:F580: Based on record review and staff, Medical Director #1, Cardiologist, LifeVest Resident Representative and LifeVest Technician interviews, the facility failed to consult with Medical Director #1 when Resident #119's LifeVest (an external defibrillator designed to detect certain life-threatening rapid heart rhythms and, if needed, automatically deliver a treatment shock to restore normal heart rhythm) delivered treatment shocks to her multiple times in the early morning hours on [DATE]. The LifeVest Resident Representative contacted Resident #119's Cardiologist on [DATE] about Resident #119's severe episodes of ventricular tachycardia, a life-threatening rapid heart rate. The Cardiologist called the facility and requested to talk to the Medical Director. The Cardiologist recommended that the resident be sent to the hospital for evaluation. The emergency department at hospital #1 determined Resident #119 had significant fluid overload with severe congestive heart failure and she was transferred to another hospital for further evaluation and monitoring. The discharge summary from hospital #2 dated [DATE] indicated that Resident #119 was admitted to the critical care unit on [DATE] and was deceased on [DATE]. Discharge diagnoses included acute heart failure, cardiogenic shock, cardiac arrhythmia, acute hypoxic respiratory failure, acute kidney failure, and sustained ventricular tachycardia. The certificate of death dated [DATE] at 10:41 AM indicated the immediate cause of death was acute hypoxic respiratory failure and acute on chronic congestive heart failure with the approximate interval of onset to death for the immediate causes was 2 weeks. Other significant condition contributing to death was cardiogenic shock. This deficient practice occurred for 1 of 1 resident reviewed for notification of change (Resident #119). F684: Based on record review and staff, Medical Director #1, Cardiologist, LifeVest technician and LifeVest patient representative interviews, the facility failed to obtain physician directives for staff about what to do when the LifeVest delivered a shock, identify the seriousness of Resident #119's cardiac status and the need for a comprehensive medical evaluation when a LifeVest (an external defibrillator device designed to detect certain life-threatening rapid heart rhythms and, if needed, automatically deliver a treatment shock to restore normal heart rhythm) shocked the resident multiple times in the early morning hours (beginning shortly after midnight) of [DATE]. Nurse #1 observed the device deliver shocks to the resident and took no action with the exception of notifying the oncoming first shift nurse that the LifeVest was shocking the resident all through the night. From [DATE] through [DATE] the facility failed to consult with the physician regarding the LifeVest having delivered treatment shocks to the resident and provide ongoing nursing assessment. According to the manufacturer's instructions, a resident with a LifeVest is to be evaluated by a physician for potential arrhythmia once the vest delivers a treatment shock. On [DATE], Resident #119's Cardiologist contacted the facility and recommended the resident be sent to the hospital for evaluation after being notified by the LifeVest's manufacturer that the resident had a severe episode of ventricular tachycardia (a life-threatening rapid heart rate). The emergency department at hospital #1 determined Resident #119 had significant fluid overload with severe congestive heart failure and she was transferred to another hospital for further evaluation and monitoring. The discharge summary from hospital #2 dated [DATE] indicated that Resident #119 was admitted to the critical care unit on [DATE] and was deceased on [DATE]. Discharge diagnoses included acute heart failure, cardiogenic shock, cardiac arrhythmia, acute hypoxic respiratory failure, acute kidney failure, and sustained ventricular tachycardia. The certificate of death dated [DATE] at 10:41 AM indicated the immediate cause of death was acute hypoxic respiratory failure and acute on chronic congestive heart failure with the approximate interval of onset to death for the immediate causes was 2 weeks. Another significant condition contributing to death was cardiogenic shock. This deficient practice occurred for 1 of 1 resident reviewed for professional standards (#119). F726: Based on record review and staff, Medical Director #1, Cardiologist, Resident Representative, LifeVest technician, and LifeVest patient representative interviews the facility failed to ensure staff were trained and competent to care for a resident who wore a LifeVest (a device designed to detect certain life-threatening rapid heart rhythms and, if needed, automatically deliver a treatment shock to restore normal heart rhythm). Resident #119 received a treatment shock multiple times by the LifeVest she was wearing in the early morning hours (beginning shortly after midnight) on [DATE]. Nurse #1, an agency nurse assigned to Resident #119, observed the device deliver the treatment shocks to Resident #119 and took no action with the exception of notifying the oncoming first shift nurse (Nurse #5) that the LifeVest was shocking the resident all through the night. The 7 of 7 staff members that cared for Resident #119 from [DATE] through [DATE] that included Nurse #1, Nurse #5, Nurse #6, Nurse #8, Nurse Aide (NA) #2, NA #6, and NA #7 had not been trained on how to respond if the LifeVest alarmed or sounded or how to respond if the LifeVest delivered a treatment shock. Per the manufacture instructions, if a treatment shock was delivered, the physician was to be called immediately, and an announcement was made by the device with this instruction. Resident #119's Cardiologist contacted the facility on [DATE] and recommended the resident be sent to the hospital for evaluation after being notified by the LifeVest's manufacturer that the resident had a severe episode of ventricular tachycardia (a life-threatening rapid heart rate). The emergency department at hospital #1 determined Resident #119 had significant fluid overload with severe congestive heart failure and she was transferred to another hospital for further evaluation and monitoring. The discharge summary from hospital #2 dated [DATE] indicated that Resident #119 was admitted to the critical care unit on [DATE] and was deceased on [DATE]. Discharge diagnoses included acute heart failure, cardiogenic shock, cardiac arrhythmia, acute hypoxic respiratory failure, acute kidney failure, and sustained ventricular tachycardia. The certificate of death dated [DATE] at 10:41 AM indicated the immediate cause of death was acute hypoxic respiratory failure and acute on chronic congestive heart failure with the approximate interval of onset to death for the immediate causes was 2 weeks. Another significant condition contributing to death was cardiogenic shock (medical emergency resulting from inadequate blood flow to the body's organ due to dysfunction of the heart). The Administrator was notified of immediate jeopardy on [DATE] at 12:10 PM.The facility provided the following credible allegation of Immediate Jeopardy removal: Identify those recipients who have suffered, or are likely to suffer, a serious adverse outcome as a result of the noncompliance. Failure to protect Resident #119 from neglect, with cross-references to F580, F684, and F726. On [DATE] the facility failed to adhere to its abuse/neglect policy and failed to protect Resident #119 from neglect by not recognizing and responding to a resident's change in condition. Specifically, staff did not notify the Medical Director; did not identify the seriousness of resident's condition and need for a comprehensive medical evaluation; and did not ensure staff were trained and competent to care for a resident who wore a Life Vest, resulting in a failure to provide timely medical intervention.Upon learning of the allegation of neglect on [DATE], the Administrator submitted an initial report to the Department of Health and Human Services and report to Adult Protective Services. Resident #119 discharged from the facility on [DATE]. Nurse #1 no longer works for the facility. The Administrator and the Director of Nursing attempted to contact Nurse #1 on [DATE], but the number was not operational.As of [DATE], a review conducted by the Director of Nursing confirmed that there have been no residents with a Life Vest residing in the facility since [DATE]. On [DATE] all current residents were assessed for changes in condition to ensure appropriate care and services were provided. The nurse management team consisting of the Director of Staff Education, Minimum Data Set Nurse Coordinator, and 3 Licensed Practical Nurse Support Staff conducted comprehensive head-to-toe assessments of all residents with a Brief Interview for Mental Status (BIMS) score of 12 or less to identify any signs of distress or neglect. No concerns were identified. On [DATE], residents with a BIMS score of 13 or higher were interviewed by the nurse management team regarding any concerns related to abuse, neglect, or care. All residents denied any such concerns.Additionally, on [DATE], the nurse management team completed immediate assessments of 100% of current residents to identify any unreported acute changes in condition. This included symptoms that were:- Acute or sudden in onset- Markedly more severe than usual- Unrelieved by previously prescribed measures- Indicative of respiratory distress (e.g., difficulty breathing, low oxygen saturation, new onset cough or congestion, decreased appetite)On [DATE], corrective actions were completed for 5 out of 116 residents who were identified as having a change in condition. Providers were notified, and orders were carried out by direct care staff.On [DATE], the Director of Nursing audited all hospital transfers from the past 30 days to ensure provider notification occurred for any acute changes in condition. The audit confirmed that provider notification was completed for all 14 residents reviewed. No corrective action was required.Specify the actions the entity will take to alter the process or system failure to prevent a serious adverse outcome from occurring or reoccurring and when the action will be completed.On [DATE], the Administrator and Director of Nursing conducted in-service training for all staff (full-time, part-time, as needed, and agency) on the abuse/neglect policy, including procedures for identifying, reporting, and preventing abuse and neglect. This training was delivered in person and by phone. Staff who did not complete the training by [DATE] were restricted from working until completion.On [DATE], the Director of Nursing began targeted education for all licensed nurses (Registered Nurses, Licensed Practical Nurses), and certified nursing assistants on the importance of notifying providers of any acute change in condition. Training included emphasis on timely care and services, and the definition of neglect as failure to act during a medical emergency. The training also included:- Recognizing types of changes in condition- Appropriate response protocols- Notification procedures- When to initiate Emergency Medical ServicesAdditionally, beginning [DATE], all Registered Nurses (RNs) and Licensed Practical Nurses (LPNs) are required to complete education and competency validation prior to providing care to any resident with a wearable cardiac device. This will be completed by the Director of Nursing, Minimum Data Set Nurse and Director of Staff Education. Specific training for a resident with a Life Vest was if a person's Life Vest discharges, it means the person may have an unstable arrythmia or that the device is malfunctioning or both, and both of these would require immediate physician notification. Nurses received training to complete a comprehensive assessment and notify the medical provider of findings and concerns. On [DATE] Nurses were trained on the emergency response to include areas of: if the Life Vest delivers a shock, when to notify the physician and document the event and understanding of when to remove the Life Vest. On [DATE] the Administrative nursing team to include the Director of Nursing, the Director of Staff Education, the 3 licensed practical nurse support nurses and the Minimum Data Set nurses were educated by the Regional Nurse Consultant to ensure that orders directing care for residents with Life Vests are obtained from the physician and entered into the medical record to include: maintenance and emergency response. On [DATE] the Minimum Data Set Nurse was educated by Regional Nurse Consultant to ensure that all residents with a Life Vest have a care plan moving forward that will include directives of what to do in the event the vest delivers a shock. On [DATE], the Director of Admissions was instructed by the Administrator that any prospective resident with a wearable cardiac device must undergo a clinical review to ensure staff competency before acceptance. On [DATE], a Life Vest manufacturer representative came to the facility to complete a hands-on review of the care and function of the Life Vest, utilizing a demo vest, with the Director of Nursing and the Director of Staff Education. Instruction manual with several resource documents were provided. On [DATE], the Director of Nursing created a life-vest quick reference guide for each nursing station. Contents of the manual included a patient checklist, a quick reference guide for trouble shooting, an educational overview for patients and families on use of the Life Vest, and the manufacturers manual for the Life Vest. The 24- hour help line number is also located on the outside and inside of the manual. Training for licensed nursing staff began on [DATE] and includes viewing the 26-minute Life Vest instructional video designed for both patients and caregivers. Following the video, the Director of Staff Education utilized a competency checklist to validate staff understanding. This competency checklist includes verbalization of understanding of the knowledge of the Life Vest purpose and function, application and maintenance, emergency response, communication and education as well as the location and contents of the quick reference guide for Life Vest. On [DATE], all Certified Nursing Assistants received education from the Director of Nurses, Director of Staff Education, and the Minimum Data Set Nurse Coordinator on the need to immediately report to the staff nurse when a resident utilizing a Life Vest receives a shock treatment or expresses any other concerns.The Interdisciplinary Team-including the Administrator, Director of Nursing, Nurse Managers, Minimum Data Set Coordinators, Unit Manager, Support Nurse, Therapy, Health Information Management, Dietary Manager, Medical Director, and Pharmacist-was informed of the neglect allegation on [DATE] and actively participated in the removal plan. The Director of Nursing and the Director of Staff Education along with the individual department managers will do a daily reconciliation of the schedule to ensure all staff have completed the training and education as indicated above. This training has been incorporated into the orientation process for all new employees and agency staff. All licensed nurse new hires, including agency staff, must complete mandatory training and competency checks before being assigned to residents using these devices. The Administrator and Director of Nursing will ensure that any staff member who did not complete the required training by [DATE] will not be able to work until training is completed.The Administrator is responsible for ensuring full implementation of the removal plan. Alleged date of Immediate Jeopardy removal: [DATE] The removal plan of the Immediate Jeopardy was validated on [DATE]. A sample of staff including the Administrator, Director of Nursing, Support Nurse #1, nurses, nurse aides and medication aides were interviewed regarding in-service training received related to the deficient practice. All staff interviewed stated they had been in serviced regarding the importance of staff understanding that all residents have a right to be free of neglect and they indicated that they understood that failing to provide the necessary care and services to residents constituted neglect. The staff interviewed indicated that the in-service training they received stated that failure to notify the physician of significant changes including receiving shocks from a wearable defibrillator device constituted neglect. The removal date of [DATE] was validated.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review and staff, Medical Director #1, Cardiologist, LifeVest technician and LifeVest patient representative interviews, the facility failed to obtain physician directives for staff about what to do when the LifeVest delivered a shock, identify the seriousness of Resident #119's cardiac status and the need for a comprehensive medical evaluation when a LifeVest (an external defibrillator device designed to detect certain life-threatening rapid heart rhythms and, if needed, automatically deliver a treatment shock to restore normal heart rhythm) shocked the resident multiple times in the early morning hours (beginning shortly after midnight) of 2/11/25. Nurse #1 observed the device deliver shocks to the resident and took no action with the exception of notifying the oncoming first shift nurse that the LifeVest was shocking the resident all through the night. From 2/11/25 through 2/13/25 the facility failed to consult with the physician regarding the LifeVest having delivered treatment shocks to the resident and provide ongoing nursing assessment. According to the manufacturer's instructions, a resident with a LifeVest is to be evaluated by a physician for potential arrhythmia once the vest delivers a treatment shock. On 2/13/25, Resident #119's Cardiologist contacted the facility and recommended the resident be sent to the hospital for evaluation after being notified by the LifeVest's manufacturer that the resident had a severe episode of ventricular tachycardia (a life-threatening rapid heart rate). The emergency department at hospital #1 determined Resident #119 had significant fluid overload with severe congestive heart failure and she was transferred to another hospital for further evaluation and monitoring. The discharge summary from hospital #2 dated 2/27/25 indicated that Resident #119 was admitted to the critical care unit on 2/13/25 and was deceased on 2/27/25. Discharge diagnoses included acute heart failure, cardiogenic shock, cardiac arrhythmia, acute hypoxic respiratory failure, acute kidney failure, and sustained ventricular tachycardia. The certificate of death dated 2/27/25 at 10:41 AM indicated the immediate cause of death was acute hypoxic respiratory failure and acute on chronic congestive heart failure with the approximate interval of onset to death for the immediate causes was 2 weeks. Another significant condition contributing to death was cardiogenic shock. This deficient practice occurred for 1 of 1 resident reviewed for professional standards (#119).Immediate jeopardy began on 2/11/25 when Resident #119 received multiple treatment shocks from the external defibrillator device which meant the resident possibly had an unstable arrythmia (irregular heart rhythm that means the heart is not effectively pumping enough blood to the body's vital organs increasing the risk of complications like heart failure, stroke, or even sudden cardiac arrest) and staff failed to identify the seriousness of Resident #119's cardiac status which required immediate evaluation by a medical provider. Immediate jeopardy was removed on 8/12/25 when the facility implemented an acceptable plan of immediate jeopardy removal. The facility will remain out of compliance at a scope and severity of D (no actual harm with potential for more than minimal harm that is immediate jeopardy) to ensure education is completed and monitoring systems are in place and are effective. Findings included:Review of the manufacturer's information and the instructional videos for the LifeVest external defibrillator revealed that the device is prescribed for residents at risk for sudden cardiac death, a condition that occurs without warning with no signs that something is about to happen due to an electrical malfunction of the heart causing a dangerously fast heartbeat with no signs or symptoms. The LifeVest uses electrodes to continuously monitor the heart's electrical activity and detect dangerous heart rhythms, such as ventricular tachycardia and ventricular fibrillation. The device is designed to deliver an electrical shock to the heart when an abnormal rhythm is detected to restore a normal heart rhythm. The manufacturer's instructions indicated that if a treatment shock is delivered, the physician is to be called immediately, and an announcement is made by the device with this instruction. If the vest discharges, it means either the person has an unstable arrythmia (heartbeat) requiring immediate physician attention, or the device is malfunctioning. Both must have medical evaluations as soon as possible. The LifeVest device should be removed to bathe, shower or change the garment. The device comes with 2 batteries, and 1 battery is always to be charged while using the other. Changing and charging the batteries was to occur at the same time each day. The monitor, electrode belt or charger is not to be put in water and should not get wet. The data from the device is to be downloaded as directed by the device or at least weekly. If data is not sent in for greater than 7 days, a prompt appears on the monitor which states time to send data.An interview with the LifeVest Manufacturer Technician on 8/6/25 at 5:00 PM revealed that the device does not provide continuous monitoring. The LifeVest Manufacturer Technician stated that the device was set with parameters and if the heart rate was above the set parameter, the device alarms. The information from the device goes into a server which can be reviewed by the physician. The technician stated that if a shock was delivered, it was recorded on the downloaded information. The technician stated that the information from the device was downloaded into the system every 24 hours, however there are sometimes issues with connectivity. The technician indicated that the gel was released prior to a shock being delivered. A button can be pressed to delay the shock from being delivered. Five shocks are administered, then if more shocks are indicated they will be delivered based on the heart rhythm. The technician stated that if an abnormal heart rhythm was detected, the device emits a siren alarm which was loud and identifiable. If the device administered a shock, the blue gel was released onto the skin. The technician stated that if the device continuously sounded, the physician and the device manufacturer should be notified to check the equipment. A technician was available 24 hours per day 7 days per week to walk through issues with the device and if the technician was unable to resolve the issue via phone, a technician will come out within 24 hours to fix it or replace the device. Resident #119 was admitted on [DATE] with diagnosis which included ischemic cardiomyopathy (a condition that occurs when the heart muscle is damaged by lack of blood supply making it difficult for the heart to pump) requiring a LifeVest external defibrillator device, hypertensive heart disease, atrial fibrillation, coronary artery disease, chronic kidney disease with heart failure, acute on chronic systolic heart failure, and diabetes. Resident #119's electronic record revealed a physician order dated 10/17/24 which indicated LifeVest was to be worn at all times every shift. Resident #119's care plan dated 10/18/24 indicated that the resident had altered cardiovascular status related to cardiomyopathy and coronary artery disease and wore a LifeVest. The goal indicated that Resident #119 would be free from signs or symptoms of complications of cardiac problems through the next review date. Interventions included assess for chest pain every shift, enforce the need to call for assistance if pain starts, assess for shortness of breath and cyanosis every shift, monitor/document/report to MD changes in lung sounds, edema (swelling) and changes in weight, monitor/document/report to the physician as needed any signs or symptoms of coronary artery disease: chest pain or pressure especially with activity, heartburn, nausea and vomiting, shortness of breath, excessive sweating, dependent edema, changes in capillary refill, color or warmth of extremities. An additional care plan problem indicated that Resident #119 had a problem of atrial fibrillation (abnormal heart rhythm) with increased risk of stroke and or heart failure. Interventions stated that Resident #119 was to be assessed for chest pain or discomfort every shift and vital signs were to be obtained weekly per protocol. There were no interventions listed in the care plan for management of the LifeVest device, indications when the resident required medical attention or what to do after a treatment shock was delivered. Resident #119 was discharged from the nursing home to the hospital on 1/4/25. Resident #119 was diagnosed with lower gastrointestinal bleed and was readmitted on [DATE].Resident #119's physician order revealed an order dated 1/20/25 that indicated the LifeVest was to be worn at all times every shift. Resident #119's January and February 2025 Medication Administration Records (MAR) revealed the entry for the LifeVest to be worn at all times every shift was electronically signed for each shift. The MAR lacked directives for the LifeVest, including instructions to call the provider if the alarm sounded, remove the LifeVest for showers or baths, change and charge the battery every 24 hours, change and wash the garment every 1-2 days, manage post-treatment shocks, and download data weekly.Resident #119's quarterly Minimum Data Set (MDS) assessment dated [DATE] indicated resident was cognitively intact, had no behavior, and the presence of a heart assistive device. Resident #119 was dependent on staff for toileting, transfers and wheelchair mobility, required moderate assistance with bed mobility and was non ambulatory. A physician progress note dated 1/27/25 by Medical Director #3 indicated Resident #119 was recently readmitted to the facility following hospitalization due to gastrointestinal bleed. The progress note indicated Resident #119 was full code status, had a LifeVest in place, was to be monitored closely and facility staff were to alert the medical staff with changes in condition. Vital signs were recorded in Resident #119's record on 2/10/25 at 3:36 PM as blood pressure 108/65, pulse 87 beats per minute, respirations 18 breaths per minute, and temperature 97.0.An interview was conducted with Nurse Aide (NA) #2 on 8/6/25 at 10:06 AM. It revealed that she was assigned to Resident #119 on 2/10/25 from 11:00 PM to 7:00 AM. NA #2 stated that Resident #119 had a device that she thought was to kick start the heart. NA #2 stated that she recalled on the night of 2/10/25 Resident #119's LifeVest device from 11:00 PM to 7:00 AM was going off all night. NA #2 could not recall if the device was beeping or if it was another sound. NA #2 stated that she let Nurse #1 know that the device was sounding and she did not know what the nurse did about it or if the nurse went in to assess the resident. Attempts were made to interview Nurse #1 were unsuccessful with text messages sent on 8/7/25 at 2:16 PM and 8/8/25 at 12:31 PM with no return call received. Nurse #1 was an agency nurse who worked as needed at the facility and was assigned to Resident #119 on 2/10/25 from 7:00 PM to 7:00 PM. Nurse #1 no longer worked at the facility. An interview conducted with NA #4 on 8/6/25 at 2:45 PM revealed that she was assigned to Resident #119 on 2/11/25 from 7:00 AM to 3:00 PM. NA #4 stated that Nurse #5 asked her to assist with cleaning Resident #119 on the morning of 2/11/25. NA #4 stated she observed blue gel from the LifeVest all over Resident #119's upper body. NA #4 stated she and Nurse #5 cleaned Resident #119 and reapplied the LifeVest. A health status note dated 2/11/25 at 8:32 PM written by Nurse #5 was a summary note that described the events during the 7:00 AM to 7:00 PM shift. Nurse #5 stated in morning report that day, the off going nurse from the 7:00 PM to 7:00 AM shift (Nurse #1) reported that Resident #119's LifeVest was shocking Resident #119 all through the night. The note indicated that Nurse #1 stated that she changed the battery for the LifeVest, and Resident #119 was fine. The note indicated that Nurse #5 immediately went to check Resident #119 and observed the resident was lying in bed with brown dried emesis on her gown and around her mouth. The note did not indicate that the physician was notified and there were no vital signs recorded. The note stated that Nurse #5 observed that the pads of the electrodes for the LifeVest had leaked gel onto Resident #119's skin and her upper body was covered in gel. Resident #119 was cleaned, and the electrode pads were replaced. LifeVest was placed back on the resident. Resident #119 was alert, responsive but grunting. The note indicated that the LifeVest monitor was beeping with a message which stated to replenish the gel. Nurse #5 notified Support Nurse #1 of the situation. The note stated that the LifeVest support technician was notified of the issues with the LifeVest and the technician attempted to do a system check without success because of internet connection issues. The technician informed Nurse #5 that a technician would come to the facility to check the LifeVest equipment later that day or the next day. Resident #119 vomited again and did not eat during the shift. The oncoming nurse (Nurse #7) was informed of concerns with the LifeVest and that Resident #119 had vomited. On 2/11/25 at 12:29 PM Resident #119's vital signs were, blood pressure 123/78, pulse 94 beats per minute, respirations 18 breaths per minute, and temperature 97.0.An interview was conducted with Nurse #5 on 8/6/25 at 1:15 PM. Nurse #5 was assigned to Resident #119 frequently and was assigned to her on 2/11/25 from 7:00 AM to 7:00 PM. Nurse #5 indicated that Resident #119 had a LifeVest cardiac defibrillator device. Nurse #5 stated that she was familiar with the LifeVest device as she had worked with one at another facility in the past. Nurse #5 indicated that the LifeVest device provided an alert if an irregular heart rate was detected and the screen on the device indicated what to do. Nurse #5 stated that electrodes are applied and attached to the vest that the resident wears at all times. Nurse #5 stated that on the morning of 2/11/25, she received in report from the off going night shift nurse (Nurse #1) that Resident #119's LifeVest device was shocking the resident all night and that the device was sounding all night. Nurse #5 stated she asked the off going nurse (Nurse #1) if she had notified the provider or assessed Resident #119 and was told no, she had not. Nurse #5 stated she immediately went to the room and observed Resident #119 was soaked, her LifeVest device was soaked with the blue conducting gel that was released when a shock was received. Nurse #5 stated she and the Nurse Aide cleaned the resident, obtained vital signs and reapplied the electrodes and the LifeVest device. Nurse #5 stated that there was a message on the device that indicated that shocks were delivered. Nurse #5 indicated she informed Support Nurse #1 what was reported to her regarding Resident #119's condition and being shocked by the LifeVest. Nurse #5 indicated that the gel was all over the resident and that the gel released when the device delivered a shock. A follow up interview with Nurse #5 on 8/7/25 at 2:30 PM revealed that she did not notify the physician on 2/11/25 that Resident #119 was shocked by the LifeVest during the night shift. Nurse #5 stated that she reported to Support Nurse #1 that the off going nurse (Nurse #1) stated Resident #119 was shocked by the device, and she thought Support Nurse #1 was going to notify the physician. Nurse #5 stated that she did follow up with Support Nurse #1 to ensure that the physician was notified that Resident #119 was shocked. An interview with Nurse Aide (NA) #7 on 8/8/25 at 1:20 PM revealed that she was assigned to Resident #119 regularly on the 3:00 PM to 11:00 PM shift and that she was assigned to her (Resident #119) on 2/11/25, 2/12/25 and 2/13/25. NA #7 indicated that Resident #119 was alert at first when she was admitted but she had become increasingly weak. NA #7 stated that Resident #119 had stopped feeding herself, required 2-person assistance with bed mobility, and was bed bound. NA #7 stated Resident #119 was unable to manage the LifeVest device. NA #7 indicated that she did not know anything about the LifeVest or what it did until the night of 2/11/25 when the technician came to the facility to change out the equipment. NA #7 stated that the technician informed her on 2/11/25, that the LifeVest device was a defibrillator that shocked the resident's heart if an abnormal heart rate was detected. NA #7 stated she was surprised when she found out this information as she had no idea about the seriousness of this device. Until 2/11/25, NA stated she just knew that Resident #119 was to always wear the LifeVest. An interview with the Staff Development Director (SDD) on 8/7/25 at 3:00 PM revealed that she was informed on 2/11/25 that Resident #119 was noted with blue gel on her LifeVest indicating that a shock was delivered. The SDD stated that she was present on the evening of 2/11/25 when the representative from the manufacturer arrived. The SDD indicated that she did not conduct any orientation or any training regarding the LifeVest device with Nurse #1 who was an agency nurse who worked at the facility as needed. The SDD stated she was not aware of the directives for managing the LifeVest and was unable to explain why she had not provided education to the staff regarding the device. Voice mail messages and text messages were sent to Nurse #7 on 8/6/25 at 11:25 AM, 8/7/25 at 12:24 PM, 8/8/25 at 12:35 PM. Nurse #7 was assigned to Resident #119 on 2/11/25 from 7:00 PM to 7:00 AM. Nurse #7 was an agency nurse who was no longer employed at the facility. A review of the facility staffing assignment sheet revealed that the on-call nurse, an administrative nurse designated to be called for any emergency situations for 2/10/25-2/11/25, was Support Nurse #1. An alert note (a note designation in a resident chart that includes important information and is used to notify care team members about the need for follow up) dated 2/12/25 at 8:16 AM written by the Support Nurse #1 indicated that Resident #119 refused meal. The note did not indicate a comprehensive assessment was completed, did not indicate that the physician was notified and did not include vital signs. An interview with Support Nurse #1 on 8/6/25 at 12:05 PM revealed she recalled that Resident #119 had a LifeVest device. Support Nurse #1 stated that the LifeVest device had a transmitter box that sounded a gong noise if it detected an abnormal rhythm. If a button was not pressed, a shock was administered. Support Nurse #1 stated that she talked to the technician at the manufacturer regarding the device on 2/11/25 and was informed that if the gel was released, a shock was administered. Support Nurse #1 stated that on 2/11/25, Resident #119 had gel on her chest which indicated that she received a shock. Support Nurse #1 stated the provider should have been notified that the LifeVest was sounding and a shock was administered. Support Nurse #1 stated that Resident #119 should have been assessed immediately including vital signs and monitored closely and stated that she thought that the floor nurse (Nurse #5 would have done this. Support Nurse #1 stated she did not notify a provider on 2/11/25 that Resident #119 received a shock from the LifeVest and explained that she thought Nurse #5 would have done this. Support Nurse #1 stated she should have followed up with Nurse #5 to be sure that she had assessed Resident #5 and notified the provider of the shock from the LifeVest. Support Nurse #1 stated the Cardiologist called the facility on 2/13/25 and was adamant that he speak with Medical Director #1 regarding Resident #119. A health status note dated 2/12/25 at 7:07 PM written by Nurse #8 indicated Resident #119 had been in bed resting with eyes closed most of the shift. The note indicated that Resident #119 had difficulty feeding herself, showed no interest in food when staff attempted to assist with feeding and was slow to respond to verbal stimuli. Staff attempted to keep Resident #119 engaged, but she showed no interest. Resident #119's urinary catheter was patent draining yellow urine with sediment. Resident #119 showed a lack of interest in any activities. The note did not indicate a comprehensive assessment was completed, did not indicate that the physician was notified and did not include vital signs. Review of Resident #119's medical record revealed no documentation of vital signs on 2/12/25.An interview conducted with Nurse #8 on 8/7/25 at 11:41 AM indicated that she was assigned to Resident #119 on 2/12/25 from 7:00 AM to 7:00 PM and was assigned to the resident frequently. Nurse #8 stated that she was familiar with the LifeVest device as she had personal experience with it. Nurse #8 stated she did not recall receiving in service education at the facility regarding the device. Nurse #8 stated that Resident #119 was unable to manage the device herself and that there were no directives for how to manage the device. Nurse #8 stated that she did not recall whether Resident #119 had any significant changes on 2/12/25 from 7:00 AM to 7:00 PM and stated that the resident had been demonstrating a gradual, slow decline. Nurse #8 was unable to explain why she did not complete a full assessment of Resident #119. An interview was conducted on 8/6/25 at 1:45 PM with the Nurse Aide (NA) #6 who stated she was assigned to Resident #119 on 2/11/25 and 2/12/25 from 11:00 PM to 7:00 AM. NA #6 stated Resident #119 had some type of LifeVest that she wore and she did not recall any issues with it. NA #6 stated she did not know much about the device but knew that it had something to do with resident's heart and if it beeped, she notified the nurse. NA #6 stated she had not received any instructions about the device. An interview with Nurse #6 on 8/7/25 at 2:20 PM indicated that she was assigned to Resident #119 on 2/12/25 from 7:00 PM to 7:00 AM. Nurse #6 stated she was familiar with the LifeVest device from working with residents at other facilities with this device. Nurse #6 stated there were no issues with Resident #119 on the night of 2/12/25. If the device had alarmed, she would have called for assistance, called Emergency Medical Services, the provider and the responsible party. An interview with the Resident Representative for the LifeVest manufacturer on 8/7/25 at 4:30 PM revealed she worked with the physician and shared information with the doctors and cardiologists. She indicated that she called the Cardiologist on 2/13/25 and informed him that Resident #119 had a sustained run of ventricular tachycardia (v tach) on 2/11/25. The representative indicated that if a resident had a run of v tach greater than 1 minute, a shock was delivered. The device can deliver up to five shocks. The representative stated that the LifeVest device does not provide continuous real time monitoring of the resident's heart rhythm meaning that there was not a medical professional viewing the information for each resident wearing a LifeVest, therefore if an alarm sounds on the device, it was imperative to respond to that alarm and inform the medical provider. If the monitor was not plugged in, then the information was stored and was downloaded when it was plugged in again. The representative stated that when the technician for the manufacturer came to the facility on 2/11/25 and serviced the equipment, then the monitor generated the stored information from the device. The representative stated that the strip from 2/11/25 just after midnight indicated that v tach was detected. The representative stated that there were multiple episodes of v tach from the night of 2/11/25 and when she received that information, she reached out to the Cardiologist. An interview with the Cardiologist on 8/6/25 at 3:36 PM revealed that the LifeVest device is designed to detect dangerous arrhythmias including ventricular tachycardia and ventricular fibrillation. The Cardiologist stated that the device can be disarmed to prevent a shock from being administered. If the resident is unable to disarm the device, a shock is delivered. The Cardiologist stated that the physician should be notified when the device delivered a shock and if unable to contact the physician, the resident should be sent to the hospital for evaluation. Following an electrical shock from the LifeVest device, evaluation is required to determine if the heart has returned to a regular rate and rhythm. The cardiologist stated that he received a call on 2/13/25 from the representative for the LifeVest manufacturer who stated that Resident #119 was shocked by the device due to the abnormal heart rhythm ventricular tachycardia. The Cardiologist stated he called the facility and recommended that Resident #119 be sent to the hospital for evaluation. A health status note dated 2/13/25 at 5:00 PM written by Support Nurse #1 indicated that the facility received a call from the cardiologist who stated that a remotely acquired EKG (electrocardiogram) strip received from the LifeVest manufacturing company showed severe episode of ventricular tachycardia (a dangerous rapid heart rhythm). The Cardiologist spoke with Medical Director #1 and upon cardiologist's recommendation due to the resident not being stable, an order was received to send Resident #119 to the emergency department for further evaluation. Emergency Medical Services was contacted, and Resident #119 was transported to the hospital. An interview was conducted with Support Nurse #1 on 8/6/25 at 12:05 PM. She said the Cardiologist was on the phone and requested to speak with the Medical Director. She immediately went and informed Medical Director #1, who was in the building at the time. After speaking with the Cardiologist, Medical Director #1 gave the order to send Resident #119 to the hospital due to a dangerous heart arrhythmia.An interview with Medical Director #1 on 8/6/25 at 3:52 PM revealed that he had started in the facility in early February 2025. Medical Director #1 stated he was not notified that Resident #119's LifeVest had alarmed or shocked her due to arrhythmia. Medical Director #1 stated if the LifeVest alarm sounded due to arrhythmia, the resident should be sent to the emergency room and then the provider should be notified. Medical Director #1 stated that if the device shocked the resident, the nurse should have immediately assessed the resident and sent her to the hospital for evaluation. When the LifeVest discharges an electrical shock to the resident, it means the person had an unstable arrythmia requiring immediate physician attention, or the device malfunctioned and administered a shock when it was not required. Both require evaluation. An Emergency Department (ED) report from hospital #1 dated 2/13/25 indicated that Resident #119 presented to the hospital with a LifeVest device on. Resident #119 presented after the LifeVest detected a cardiac arrhythmia and the cardiologist requested evaluation at the nearest emergency room. Resident #119 was somnolent, difficult to understand with closed eyes and was unresponsive on presentation to the ED. Resident #119 was noted to have 4+ pitting edema from toes to abdomen. The impression indicated that Resident #119 was evaluated due to a cardiac arrhythmia and was significantly fluid overloaded with severe congestive heart failure. Due to her severe and acute condition, Resident #119 was transferred to another hospital for further evaluation and monitoring. The discharge summary from hospital #2 dated 2/27/25 indicated that Resident #119 was admitted to the critical care unit on 2/13/25 and was deceased on 2/27/25. Discharge diagnoses included acute heart failure, cardiogenic shock, cardiac arrhythmia, acute hypoxic respiratory failure, acute kidney failure, and sustained ventricular tachycardia. The certificate of death dated 2/27/25 at 10:41 AM indicated the immediate cause of death was acute hypoxic respiratory failure and acute on chronic congestive heart failure with the approximate interval of onset to death for the immediate causes was 2 weeks. Other significant condition contributing to death was cardiogenic shock. An interview was conducted on 8/6/25 at 2:20 PM with the Director of Nursing (DON) and the Clinical Services Director. The DON stated that the facility had residents with a LifeVest in the past, and they usually came in with a booklet that provided instructions about the device and managed their own device. The DON did not recall if Resident #119 came in with a booklet about her device or if she was able to manage her own LifeVest when she was admitted . The DON and Clinical Services Director stated that they expected that if something occurred such as the LifeVest delivered a shock, the provider would be notified immediately for further instructions. The DON and Clinical Services Director stated that Resident #119 should have had a full assessment completed including vital signs and the physician should have been notified immediately for further instructions when the LifeVest alarmed during the night on 2/11/25. The DON stated that when the alarm on the device sounded, it indicated an abnormal heart rate was detected and this required notification of the physician. The DON was unable to state why the physician was not notified other than that the nurse who worked on the night of 2/10/25 was an agency nurse who is no longer working at the facility. The DON further stated that when Resident #119 had a change in condition with emesis twice and lack of appetite the resident should have been assessed, and the provider should have been notified. The DON stated that the manufacturer provided an in-service to the administrative nursing staff following this incident, but it was not part of a plan of correction. The DON did not provide a plan of correction and stated a plan of correction was not implemented nor was an investigation of the incident completed. An interview with the Administrator on 8/7/25 at 4:00 PM revealed that when the facility admitted Resident #119 with the LifeVest device, the facility was responsible for managing the device. The Administrator stated that the facility staff as well as agency staff that were assigned to Resident #119 should have been aware of the seriousness of the LifeVest device and the directives for managing it. The Administrator was notified of immediate jeopardy on 8/11/25 at 12:10 PM.The facility provided the following credible allegation of Immediate Jeopardy removal: Identify those recipients who have suffered, or are likely to suffer, a serious adverse outcome as a result of the noncompliance.Resident #119 was placed at serious risk due to the facility's failure to recognize and respond appropriately to a critical change in condition. The resident wore a LifeVest, an external defibrillator prescribed due to a severely reduced left ventricular ejection fraction. This device is intended to detect and treat life-threatening arrhythmias.This failure in clinical judgment and timely notification to the physician, so that a comprehensive medical evaluation necessity determination could be made, created a high likelihood of serious harm or death, as the LifeVest's discharge indicates either an unstable arrhythmia or device malfunction, both requiring immediate medical evaluation.On 2/11/25, the LifeVest delivered multiple shocks beginning shortly after midnight. Nurse #1 witnessed these events but failed to assess the resident and to notify a physician, instead only informing the incoming shift nurse. No physician directives were in place regarding staff response to LifeVest discharges. The Cardiologist was only informed on 2/13/25 after the LifeVest manufacturer reported a severe episode of ventricular tachycardia, at which point the resident was sent to the hospital and did not return to the facility.The facility has not been able to contact Nurse #1, and she is no longer working in the facility. The Administrator and Director of Nursing attempted to contact Nurse #1 on 8/6/25, but the number was not operational.On 8/6/25, the facility initiated a comprehensive response to address the facility's failure to recognize and respond appropriately to a critical change in condition for Resident #119.The Director of Staff

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review and staff, Medical Director #1, Cardiologist, Resident Representative, LifeVest technician, and LifeVest patient representative interviews, the facility failed to ensure staff were trained and competent to care for a resident who wore a LifeVest (a device designed to detect certain life-threatening rapid heart rhythms and, if needed, automatically deliver a treatment shock to restore normal heart rhythm). Resident #119 received a treatment shock multiple times by the LifeVest she was wearing in the early morning hours (beginning shortly after midnight) on [DATE]. Nurse #1, an agency nurse assigned to Resident #119, observed the device deliver the treatment shocks to Resident #119 and took no action with the exception of notifying the oncoming first shift nurse (Nurse #5) that the LifeVest was shocking the resident all through the night. The 7 of 7 staff members that cared for Resident #119 from [DATE] through [DATE] that included Nurse #1, Nurse #5, Nurse #6, Nurse #8, Nurse Aide (NA) #2, NA #6, and NA #7 had not been trained on how to respond if the LifeVest alarmed or sounded or how to respond if the LifeVest delivered a treatment shock. Per the manufacturer instructions, if a treatment shock was delivered, the physician was to be called immediately, and an announcement was made by the device with this instruction. Resident #119's Cardiologist contacted the facility on [DATE] and recommended the resident be sent to the hospital for evaluation after being notified by the LifeVest's manufacturer that the resident had a severe episode of ventricular tachycardia (a life-threatening rapid heart rate). The emergency department at hospital #1 determined Resident #119 had significant fluid overload with severe congestive heart failure and she was transferred to another hospital for further evaluation and monitoring. The discharge summary from hospital #2 dated [DATE] indicated that Resident #119 was admitted to the critical care unit on [DATE] and was deceased on [DATE]. Discharge diagnoses included acute heart failure, cardiogenic shock, cardiac arrhythmia, acute hypoxic respiratory failure, acute kidney failure, and sustained ventricular tachycardia. The certificate of death dated [DATE] at 10:41 AM indicated the immediate cause of death was acute hypoxic respiratory failure and acute on chronic congestive heart failure with the approximate interval of onset to death for the immediate causes was 2 weeks. Another significant condition contributing to death was cardiogenic shock (medical emergency resulting from inadequate blood flow to the body's organ due to dysfunction of the heart). Immediate Jeopardy began for Resident #119 on [DATE] when Resident #119 received a treatment shock from LifeVest and the staff did not demonstrate competency for delivering care according to the manufacturer's instructions. Immediate Jeopardy was removed on [DATE] when the facility implemented an acceptable plan of Immediate Jeopardy removal. The facility will remain out of compliance at a lower scope and severity of D (no actual harm with potential for more than minimal harm that is immediate jeopardy) to ensure education is completed and monitoring systems are in place and are effective. Findings:This tag is cross referred to:F580: Based on record review and staff, Medical Director #1, Cardiologist, LifeVest Resident Representative and LifeVest Technician interviews, the facility failed to consult with Medical Director #1 when Resident #119's LifeVest (an external defibrillator designed to detect certain life-threatening rapid heart rhythms and, if needed, automatically deliver a treatment shock to restore normal heart rhythm) delivered treatment shocks to her multiple times in the early morning hours on [DATE]. The LifeVest Resident Representative contacted Resident #119's Cardiologist on [DATE] about Resident #119's severe episodes of ventricular tachycardia, a life-threatening rapid heart rate. The Cardiologist called the facility and requested to talk to the Medical Director. The Cardiologist recommended that the resident be sent to the hospital for evaluation. The emergency department at hospital #1 determined Resident #119 had significant fluid overload with severe congestive heart failure and she was transferred to another hospital for further evaluation and monitoring. The discharge summary from hospital #2 dated [DATE] indicated that Resident #119 was admitted to the critical care unit on [DATE] and was deceased on [DATE]. Discharge diagnoses included acute heart failure, cardiogenic shock, cardiac arrhythmia, acute hypoxic respiratory failure, acute kidney failure, and sustained ventricular tachycardia. The certificate of death dated [DATE] at 10:41 AM indicated the immediate cause of death was acute hypoxic respiratory failure and acute on chronic congestive heart failure with the approximate interval of onset to death for the immediate causes was 2 weeks. Other significant condition contributing to death was cardiogenic shock. This deficient practice occurred for 1 of 1 resident reviewed for notification of change (Resident #119). F684: Based on record review and staff, Medical Director #1, Cardiologist, LifeVest technician and LifeVest patient representative interviews, the facility failed to obtain physician directives for staff about what to do when the LifeVest delivered a shock, identify the seriousness of Resident #119's cardiac status and the need for a comprehensive medical evaluation when a LifeVest (an external defibrillator device designed to detect certain life-threatening rapid heart rhythms and, if needed, automatically deliver a treatment shock to restore normal heart rhythm) shocked the resident multiple times in the early morning hours (beginning shortly after midnight) of [DATE]. Nurse #1 observed the device deliver shocks to the resident and took no action with the exception of notifying the oncoming first shift nurse that the LifeVest was shocking the resident all through the night. From [DATE] through [DATE] the facility failed to consult with the physician regarding the LifeVest having delivered treatment shocks to the resident and provide ongoing nursing assessment. According to the manufacturer's instructions, a resident with a LifeVest is to be evaluated by a physician for potential arrhythmia once the vest delivers a treatment shock. On [DATE], Resident #119's Cardiologist contacted the facility and recommended the resident be sent to the hospital for evaluation after being notified by the LifeVest's manufacturer that the resident had a severe episode of ventricular tachycardia (a life-threatening rapid heart rate). The emergency department at hospital #1 determined Resident #119 had significant fluid overload with severe congestive heart failure and she was transferred to another hospital for further evaluation and monitoring. The discharge summary from hospital #2 dated [DATE] indicated that Resident #119 was admitted to the critical care unit on [DATE] and was deceased on [DATE]. Discharge diagnoses included acute heart failure, cardiogenic shock, cardiac arrhythmia, acute hypoxic respiratory failure, acute kidney failure, and sustained ventricular tachycardia. The certificate of death dated [DATE] at 10:41 AM indicated the immediate cause of death was acute hypoxic respiratory failure and acute on chronic congestive heart failure with the approximate interval of onset to death for the immediate causes was 2 weeks. Another significant condition contributing to death was cardiogenic shock. This deficient practice occurred for 1 of 1 resident reviewed for professional standards (#119). An interview with Resident #119's Resident Representative on [DATE] at 9:02 AM revealed that Resident #119 was not cognitively intact, was unable to manage the LifeVest device and was dependent on staff for all care. Resident Representative stated that when she visited Resident #119, she was unable to recall the exact dates, she observed that the extra battery for the LifeVest device was in a drawer or in a bag and was not charged and the transmitter (router) device was not plugged in. Resident Representative stated that when she asked the staff assigned to Resident #119 questions, she was unable to recall which staff members specifically, about the Life Vest device, the staff stated they did not know about it and to ask someone else. An interview was conducted with staff nurse Nurse #5 on [DATE] at 1:15 PM. Nurse #5 was assigned to Resident #119 frequently and was assigned to her on [DATE] from 7:00 AM to 7:00 PM. Nurse #5 indicated that Resident #119 had a LifeVest cardiac defibrillator device. Nurse #5 stated she had not received any training regarding the LifeVest device and there were no instructions for management or when to notify the provider regarding the device on Resident #119's Medication Administration Record (MAR). Nurse #5 stated that she had some knowledge of the LifeVest and how it functioned from working with one at another facility. Nurse #5 indicated she had not asked for training regarding the LifeVest device. Attempts were made to interview Nurse #1 were unsuccessful with text messages sent on [DATE] at 2:16 PM and [DATE] at 12:31 PM with no return call received. Nurse #1 was an agency nurse that worked as needed at the facility and was assigned to Resident #119 on [DATE] from 7:00 PM to 7:00 PM. Nurse #1 no longer worked at the facility. An interview with Support Nurse #1 (who was assigned as the on-call administrative nurse designated to be called for emergencies on [DATE]-[DATE]) on [DATE] at 12:05 PM revealed she did not know anything about the device prior to Resident #119 being admitted with a LifeVest device and had received no training regarding the device. Support Nurse #1 indicated that she had not asked for training or information regarding the LifeVest. Support Nurse #1 stated that the facility had admitted residents with LifeVest devices in the past, but the residents had managed the device themselves, so she had not learned about the device or the management of it. Support Nurse #1 stated Nurse #5 informed her on [DATE] that Resident #119's LifeVest device had a message on the monitor that stated the gel was depleted. Nurse #5 requested that Support Nurse #1 call the LifeVest support help line. Support Nurse #1 stated that after speaking with the LifeVest technician on [DATE], she learned that the blue gel observed on Resident #119's chest and upper body indicated that an electrical shock was administered due to an abnormal heart rhythm. An interview conducted with Nurse Aide (NA) #2 on [DATE] at 10:06 AM revealed that she was assigned to Resident #119 on [DATE] from 11:00 PM to 7:00 AM. NA #2 stated she had not received any training regarding the LifeVest device. An interview with Nurse #6, an agency nurse that worked at the facility as needed, was conducted on [DATE] at 2:20 PM. Nurse #6 indicated that she was assigned to Resident #119 on [DATE] from 7:00 PM to 7:00 AM. Nurse #6 stated she knew what a LifeVest device was from working with residents at other facilities with this device. Nurse #6 stated that she did not receive any training regarding the LifeVest device or how to manage it. Nurse #6 stated that she did not ask for training regarding the device since she only worked at the facility as needed and she worked the 7:00 PM to 7:00 AM shift when there was no administrative staff available. An interview with the Staff Development Director (SDD) on [DATE] at 12:25 PM revealed that she did not know much about the LifeVest Device when Resident #119 was admitted with the device in [DATE]. The SDD stated that she researched the device to find out more about it. The SDD stated she briefly reviewed some of the things to know about the device with a few of the nurses and nursing assistants, she could not recall which ones. The SDD stated that information regarding managing the device should have been entered on the Medication Administration Record (MAR) by the admitting nurse so that all nurses were aware of the management of the device. The SDD stated she did not know how an agency nurse or facility nurse would know how to manage the LifeVest device or the response to an alarm. The SDD stated she did not complete any training on the LifeVest or orientation to the facility or procedures with agency Nurse #1 that was assigned to Resident #119 on the night of [DATE]. The SDD was unable to explain why she had not conducted any training regarding the LifeVest device with the staff. The SDD stated she had not consulted with the physician regarding management of the LifeVest device. An interview with Medical Director #1 on [DATE] at 3:52 PM revealed that he had just started in the position at the facility in early February 2025 and prior to the incident with Resident #119's LifeVest on [DATE], he was not aware that the facility had an external defibrillator device in the facility. Medical Director #1 stated that the nursing staff should have been trained in the management of the LifeVest device due to the seriousness of the device and the potential for complications. An interview was conducted on [DATE] at 2:20 PM with the Director of Nursing (DON) and the Clinical Services Director. The DON stated that the facility had residents with a LifeVest in the past, and they usually had a booklet about the device and managed their own device. The DON did not recall if Resident #119 had a booklet or if she was able to manage her own LifeVest when she was admitted . The DON revealed that staff training about the LifeVest was not completed prior to Resident #119's admission in [DATE] with the physician order for the LifeVest device nor was staff training completed upon Resident #119's readmission in [DATE]. The DON stated that training regarding the LifeVest was not provided at any time during Resident #119's stay at the facility. The DON did not provide a plan of correction and stated a plan of correction was not implemented nor was an investigation of the incident completed. The DON indicated that the staff should have been trained in management of the LifeVest and emergency procedures. There were no other residents at this time that had LifeVest in the facility.An interview with the Administrator on [DATE] at 4:00 PM revealed that when the facility admitted Resident #119 with the LifeVest device, the facility was responsible for managing the device. The Administrator stated that the facility staff as well as agency staff that were assigned to Resident #119 should have been trained regarding the seriousness of the LifeVest device and the directives for managing it. The Administrator did not recall if she was aware that Resident #119 had the LifeVest device prior to the incident on [DATE]. The Administrator revealed that the DON and SDD were responsible for ensuring that staff were trained on medical devices or equipment prior to the resident's admission. The Administrator was notified of Immediate Jeopardy on [DATE] at 12:10 PM.The facility provided the following credible allegation of Immediate Jeopardy removal: Identify those recipients who have suffered, or are likely to suffer, a serious adverse outcome as a result of the noncompliance. Resident #119 was admitted on [DATE] with a physician-prescribed LifeVest. The clinical staff did not receive adequate training or demonstrate competency in the operation, monitoring, and emergency response procedures associated with the device. This lack of preparedness created a significant risk for serious adverse outcomes for Resident #119. Resident #119 was shocked by her LifeVest multiple times in the early morning hours (beginning shortly after midnight) of [DATE]. Nurse #1 observed the device deliver shocks to the resident and took no action with the exception of notifying the oncoming first shift nurse that the LifeVest was shocking the resident all through the night. On [DATE] Resident #119's Cardiologist contacted the facility and recommended the resident be sent to the hospital for evaluation after being notified by the LifeVest' s manufacturer that the resident had a severe episode of ventricular tachycardia.Nurse #1 no longer works for the facility. The Administrator and the Director of Nursing attempted to contact Nurse #1 on [DATE], but the number was not operational.Resident #119 did not return to the facility after discharge on [DATE].As of [DATE], a review conducted by the Director of Nursing confirmed that there have been no residents with a LifeVest residing in the facility since [DATE]. Specify the action the entity will take to alter the process or system failure to prevent a serious adverse outcome from occurring or recurring, and when the action will be complete. To prevent recurrence, a new protocol has been established requiring documented training and competency validation for any wearable cardiac device (e.g., cardioverter defibrillator) prior to resident admission.On [DATE], the Director of Admissions was instructed by the Administrator that any prospective resident with a wearable cardiac device must undergo a clinical review to ensure staff competency before acceptance. On [DATE], a LifeVest manufacturer representative came to the facility to complete a hands-on review of the care and function of the LifeVest, utilizing a demo vest, with the Director of Nursing and the Director of Staff Education. Instruction manual with several resource documents were provided. On [DATE], the Director of Nursing created a LifeVest quick reference guide for each nursing station. Contents of the manual included a patient checklist, a quick reference guide for trouble shooting, an educational overview for patients and families on use of the LifeVest, and the manufacturers manual for the LifeVest. The 24- hour help line number is also located on the outside and inside of the manual. Beginning [DATE], all Registered Nurses (RNs) and Licensed Practical Nurses (LPNs) are required to complete education and competency validation prior to providing care to any resident with a wearable cardiac device.All licensed nurse new hires, including agency staff, must complete mandatory training and competency checks before being assigned to residents using these devices.Training for licensed nursing staff began on [DATE] and includes viewing the 26-minute LifeVest instructional video designed for both patients and caregivers. Following the video, the Director of Staff Education utilized a competency checklist to validate staff understanding. This competency checklist includes verbalization of understanding of the knowledge of the LifeVest purpose and function, application and maintenance, emergency response, communication and education as well as the location and contents of the quick reference guide for LifeVest. On [DATE], all Certified Nursing Assistants received education from the Director of Nurses, Director of Staff Education, and the Minimum Data Set Nurse Coordinator on the need to immediately report to the staff nurse when a resident utilizing a LifeVest receives a shock treatment or expresses any other concerns. Staff who do not complete the training by [DATE] will not be permitted to work until the training is completed. The Director of Nursing and the Director of Staff Development will do a daily reconciliation of the schedule to ensure all licensed staff have completed the training and competency validation and all Certified Nursing Assistants received education as indicated above. This in-service training indicated above in addition to the competency validation for licensed staff has been incorporated into the orientation program for all new facility and agency staff. The in-service training indicated above for the Certified Nursing Assistants has been incorporated into the orientation program for all new facility and agency staff.No staff shall work without this training after [DATE]. Alleged date of Immediate Jeopardy removal: [DATE]The removal plan of the Immediate Jeopardy was validated on [DATE]. A sample of staff including the Administrator, the DON, Support Nurse #1, SDD, nurses, and nurse aides were interviewed regarding in-services they received related to the deficient practice. All staff interviewed stated they received in-service training regarding the LifeVest purpose and function, application, maintenance and emergency response. Validation indicated that licensed nurses had completed a competency checklist regarding the LifeVest device and the indications to notify the physician. A LifeVest reference manual was created and was observed at the nurses' station. The immediate jeopardy removal date of [DATE] was validated.