**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observations, interviews, and record review conducted during the Recertification Survey from 10/28/2024 to 11/04/2024, the facility failed to ensure correct installation, use, and maintenance of bed rails (side rails) to ensure there were no entrapment zones (an event in which a resident was caught, trapped, or entangled in the spaces in or about the side rail, mattress, or hospital bed frame), or safety hazards for six (6) (Resident # 17, 29, 52, 71, 106, and 110) of 31 residents reviewed for bed rails. Specifically, Residents #29 and #52 were identified by the facility with bed rails that were loose, and that the residents' head, body, or extremities were small enough to pass between the bed rail bars or through gaps between the mattress and bed rails. Resident #110's bilateral bed rails were not in position as care planned for which created two entrapment zones. Resident #17's bed rails were observed loose and unsecured to the bed frame. For Residents #17, #29, #52, #71 and #106, the facility failed to provide evidence of routine inspections of the mattress and bed rails for areas of possible entrapment. Additionally, the facility did not evaluate alternatives to bed rails, did not review the risks and benefits of bed rails with the resident or resident representative and did not obtain informed consent prior to the installation of bed rails. This resulted in Immediate Jeopardy for Residents #29, #52 and #110 and placed the remaining 28 residents with bed rails at risk for the likelihood of serious injury, serious impairment, serious harm, or death. The evidence includes, but is not limited to the following: The facility's Bed Rail Use policy, revised 04/06/2022, documented a bed rail was a device attached to the bed frame that may assist in bed mobility. Bed rails include side rails, safety rails, grab bars, and assist bars. The use of bed rails may be necessary for resident safety, to assist with bed mobility and transfers, or may be requested by the resident. Bed rails could present a safety risk for entrapment if the rails have spaces or gaps that could cause injury or entrapment. Residents most at risk for entrapment were the frail or elderly or those who had conditions such as agitation, delirium, confusion, pain, or uncontrolled body movement. A Bed Rail Assessment would be completed by a Registered Nurse prior to the implementation of bed rail devices. The assessment would include an evaluation of the resident's preference related to bed rail use, the resident's mobility, safety, fall and injury risk. Alternatives to bed rail use must be considered prior to installation. A therapy evaluation may be needed to assess the resident's bed mobility and transfer status. The procedure documented: -Prior to installing a bed rail, the resident or resident representative would be informed of the risks and benefits of bed rail use, and alternatives attempted. The Registered Nurse would obtain informed consent for the use of bed rails and document this in the medical record. -The resident's bed mobility status would be assessed. If the resident had the potential to improve bed mobility or transfer skills, a referral for a therapy evaluation for the most appropriate bed rail/transfer device and determine if therapy services were warranted to optimize mobility status. -The resident's fall and injury risk would be assessed. If the resident had a risk for falls from the bed or had a history of attempting to get out of bed unsafely, a bed rail alternate should be considered. -The resident's risk for entrapment and to ensure the bed dimensions and bed rails were appropriate for the resident's size and weight, the bed rail has no spaces or gaps within the rail or between the rail and mattress that could cause injury or entrapment. -Bed rails would be installed and maintained in accordance with manufacturer's instructions to ensure proper fit. Ensure precautions with use of bed rails with specialty air filled mattress or therapeutic air-filled bed. -The resident's care plan would indicate the number and type of bed rails used. -Bed rail use would be re-evaluated quarterly by therapy to ensure continued appropriateness. The use of bed rails would be documented in the resident's care plan. The U.S. Food & Drug Administration (FDA) Bed Rail Safety, Recommendations for Health Care Providers about Bed Rails, updated 05/10/2016, documented to follow the recommendations in their guidance Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment dated March 2006, Dimensional limits for entrapment Zones 1- 4 to reduce the risk for entrapment. Specifically, Zone 3 was the space between the inside surface of the rail and the mattress compressed by the weight of a patient's head. The space should be small enough to prevent head entrapment when taking into account the mattress compressibility, any lateral shift of the mattress or rail, and degree of play from loosened rails. The recommendations were for a dimension of less than 4 3/4 inches because the head is presumed to enter the space before the neck. Zone 4 was the space under the rail at the ends of the rail. This space was the gap that formed when the mattress was compressed by the resident and the lowermost portion of the rail, at the end of the rail. Factors that could increase the gap size were mattress compressibility, lateral shift of the mattress or rail, and degree of play from loosened rails. This space poses a risk for entrapment of the resident's neck. The recommendations were for dimension of less than 2 3/8 inches to reduce the risk of neck entrapment. On 10/30/2024, the facility provided a list of 30 residents who had bed rails on their beds. One resident (Resident #22) was not identified on this list but was observed with raised bilateral bed rails in use during the survey. 1. Resident #29 had diagnoses including schizoaffective disorder (mental health illness), muscle weakness, and dementia. The Minimum Data Set Resident assessment dated [DATE] documented the resident had moderately impaired cognition, had no behaviors, did not reject care, had no impairments to their upper or lower extremities, required substantial/maximum assistance with bed mobility (rolling right to left, sitting to lying, and sitting to standing) and partial to moderate assistance for transfers. The Comprehensive Care Plan revised 08/07/2024 and the current [NAME] (care plan used by the Certified Nursing Assistant for daily care) documented the resident had an activity of daily living self-care performance deficit related to disease process and weakness, was at risk for falls and unaware of safety needs. Interventions included to have two caregivers for all resident care, the use of bilateral bed rails for bed mobility, and staff should observe for injury or entrapment related to bed rails. In a Fall assessment dated [DATE], Documentation Coordinator Registered Nurse #3 documented Resident #29 was at high risk for falling. The Occupational Therapy Discharge summary dated [DATE] completed by Occupational Therapist #1 documented recommendations that Resident #29 required maximum assistance with bilateral side rails for bed mobility and a stand aide (specialized mechanical lift to assist individuals with limited mobility in transitioning from a seated to a standing position) for all functional transfers. In a Bed Rail Assessment, dated 10/22/2024 Clinical Leader Registered Nurse #1 documented per a therapy evaluation Resident #29 required an assistive device to turn and reposition in bed, and the resident's head, body, or extremities were small enough to pass between bed rail bars or through a gap between the mattress and bed rail. The assessment included that bed rails were indicated with two upper bed rails utilized, there was a 6-inch opening on them, the bed rails were loose, and maintenance was notified. The questions regarding if bed rail alternatives had been tried, if the resident or representative was informed of the medical need for the bed rails and risks and benefits, or a consent to bed rail usage obtained were all blank. Review of the Certified Nurse Task form (a tracking form in the resident's electronic medical record for the Certified Nursing Assistants to document daily that the bed rails were checked for safety) from 10/02/2024 to 10/31/2024 revealed on 10/19/2024 at 7:45 PM, 10/23/2024 at 11:56 PM, and 10/24/2024 at 9:26 PM, staff documented the mattress did not fit snug with the bed rails and on 10/27/2027 at 3:56 AM, staff had documented the resident's bed rails were loose or unstable. There was no documentation in the resident's medical record that the Certified Nursing Assistant's observations were followed up on. During observations on 10/29/2024 at 4:12 PM and 10/30/2024 at 9:30 AM, the resident's bed was against the wall with bilateral upper bed rails raised which were not securely fastened to the bedframe. During an observation on 10/30/2024 at 11:25 AM, the bilateral upper bed rails were raised, the bed rails were not securely fastened to the bedframe and the mattress was not snug between the bed rails and moved when light pressure was applied. During an observation and interview on 10/30/2024 at 1:55 PM, Resident #29 was in their chair in their room, both bed rails were up, and the bed was against the wall. The left bed rail had excessive movement when checked for a secure fit. There were no brackets on the bed frame to hold the mattress secure in place, Zone 3 measured 5.5 inches (versus the recommended 4 3/4 inches) and Zone 4 measured 3.5 inches (versus the recommended 2 3/8 inches). Review of Resident #29's electronic medical record revealed no documented evidence any alternatives were trialed prior to the use of bed rails. 2. Resident #52 had diagnoses including muscle weakness, age-related debility, and a pressure ulcer. The Minimum Data Set Resident assessment dated [DATE] documented the resident was cognitively intact and had no upper or lower extremity impairment. The resident required substantial/maximal assistance with bed mobility and chair to bed transfers, and partial/moderate assistance with sitting to standing. The Comprehensive Care Plan dated 10/16/2024 documented the resident had an activity of daily living self-care deficit and used a left side bed rail to assist with bed mobility. Staff were to monitor for injury related to bed rail use. In an Occupational Therapy Discharge summary dated [DATE] Occupational Therapist #1 documented Resident #52 required maximum assistance with rolling left to right, moderate assistance with sitting to lying, and supervision with lying to sitting using a left sided bed rail. In a Bed Rail assessment dated [DATE] Clinical Leader Registered Nurse #1 documented per therapy evaluation Resident #52 required an assistive device to turn and reposition in bed. Under Safety/Entrapment risk, the assessment included the resident's head, body, or extremities were small enough to pass between bed rail bars or through a gap between mattress and bed rail. Bed rails were indicated, one upper bed rail utilized, there was a 6-inch opening on the bed rail, the bed rail was loose, and maintenance was notified. The questions regarding if bed rail alternatives had been tried, if the resident or representative were informed of the medical need for the bed rails, the risk and benefits, or if consent had been provided prior to bed rail usage, were all blank. Review of Certified Nurse Task for monitoring bed rails for safety in the electronic medical record dated 10/14/2024 -10/30/2024 revealed staff had documented the mattress did not fit snug with the bed rails on 10/19/2024 at 7:54 PM, 10/23/2024 at 11:59 PM and on 10/24/2024 at 9:37 PM. There was no documented evidence maintenance was notified. During observations on 10/28/2024 at 11:03 AM and 10/29/2024 at 9:00 AM and 4:18 PM, Resident #52 was seated in their chair in their room. Their bed was against the wall, had one bed rail raised that was not securely fastened to the bedframe and there was an alternating pressure reducing mattress on the bed. During an observation on 10/30/2024 at 11:27 AM, the resident remained in their chair, their bed was against the wall with one bed rail raised which was not securely fastened to the bedframe. The bed had an alternating pressure reducing mattress on that did not fit snug against the bed rail and moved when light pressure was applied. At 3:05 PM, the resident remained in their chair. Their bed remained against the wall with one rail up. There were no brackets on the bed frame to hold the mattress secure in place, Zone 3 measured 5.5 inches (versus the recommended 4 3/4 inches) with nothing in place to prevent the mattress from moving and Zone 4 measured 4 inches (versus the recommended 2 3/8 inches). Review of Resident #52's electronic medical record revealed no documented evidence the risk and benefits of side rail usage were discussed with the resident, that informed consent regarding the usage of side rail had been obtained or that any alternatives had been trialed prior to the installation of the side rail. 3. Resident #110 had diagnoses that included Huntington's disease (affects a person's movements, thinking ability and mental health), muscle weakness, and chronic pain. The Minimum Data Set Resident assessment dated [DATE] documented the resident was cognitively intact, had no upper or lower extremity impairment, required supervision/touching assistance with bed mobility and transfers. The Physical Therapy Discharge summary dated [DATE] documented recommendations for one-person assist and a walker with transfers. The summary did not document the use of any bed rails. The Comprehensive Care Plan revised on 10/02/2024 and the current Certified Nursing Assistant [NAME] documented Resident #110 had an activity of daily living deficit related to limited physical mobility and used bilateral bed rails to maximize independence with turning and repositioning in bed. Additionally, staff were to monitor bed rail use for injury. Review of Certified Nurse Task for in Resident #110's electronic medical record from 10/03/2024 -10/31/2024 revealed the task for checking bed rails for safety was checked off as completed and no issues were identified. In an observation on 10/28/2024 at 1:41 PM, both upper bed rails were up. In an observation on 10/30/2024 at 2:54 PM, the right upper side rail was raised. There were no brackets on the bedframe to hold the mattress securely in place. When observed at 3:03 PM, Resident #110 was lying in bed and the right upper side rail remained raised. Entrapment zone 3 measured 5 inches (recommended was 4 3/4 inches) and entrapment zone 4 measured 3.5 inches (recommended was 2 3/8 inches). The full extent could not be tested as the resident was in bed and did not engage with surveyors. There was no documented evidence a Bed Rail Assessment had been completed for Resident #110. 4. Resident #17 had diagnoses including major depressive disorder, muscle weakness, and seizures. The Minimum Data Set Resident assessment dated [DATE] documented the resident had moderately impaired cognition, had no upper or lower extremity impairments and was dependent on staff for bed mobility and transfers. The Comprehensive Care Plan revised on 10/08/2024 documented the resident had a self-care deficit related to limited physical mobility, impaired balance, and weakness. Interventions included two-person assist and the use of bilateral upper bed rails to assist with bed mobility. Additionally, staff were to observe for injury or entrapment risk related to the bed rail usage. The resident was at high risk for falls and the bed should be in a low position against the wall. The Occupational Therapy Functional Assessment Quarterly Screen dated 06/27/2024 completed by Occupational Therapist #1 documented the resident remained appropriate to use bilateral upper bed rails. In a Bed Rail assessment dated [DATE], Clinical Leader Registered Nurse #1 documented per therapy evaluation, Resident #17 required assistive devices to turn and reposition in bed, had a history of falls from bed and the side rails were stable and secure to the bed frame. The questions regarding if bed rail alternatives had been tried, if the resident or representative were informed of the medical need for the bed rails, the risk and benefits, or if consent had been provided prior to bed rail usage, were all blank. The current [NAME] documented Resident #17's bed should be in a low position and against the wall and the resident was able to use bilateral bed rails to assist with bed mobility. Staff were to observe for injury or entrapment related to bed rail use. Review of Certified Nurse Task for monitoring bed rails for safety in the electronic medical record dated 10/06/2024 -10/30/2024 revealed on 10/24/2024 at 1:20 AM and at 9:57 PM, staff documented the mattress was not snug against the bed rails and on 10/27/2024 at 4:00 AM, staff documented the bed rails were loose or unstable. During observations on 10/28/2024 at 11:57 AM and on 10/29/2024 at 8:57 AM Resident #17 was in bed with bilateral upper side rails raised, their bed against the wall and an alternating pressure mattress in place. The bilateral upper side rails were not secure to the bed frame. During observations and interviews on 10/30/2024 at 11:59 AM, Resident #17 was seated in their wheelchair with their family member present in the room. The resident's bed was against the wall, had bilateral upper side rails raised and had an alternating pressure mattress in place. The bilateral upper rails were not secure to the bed frame. When interviewed at this time, a family member stated the resident has had both upper rails for a while and no one had ever discussed the risks or benefits of the bed rail usage with them. At 3:07 PM the resident was in bed and both bed rails raised. The resident stated the bed rails were loose and wobbly. There were no entrapment zones identified at the time and both bed rails had excessive movement and were not securely fastened to the bed frame. During an interview on 10/31/2024 at 10:58 AM, Registered Nurse Unit Manager #2 stated therapy staff assessed the residents for bed mobility and the need for bed rails, and if recommended, they communicated this to the nursing staff who would enter a work order so maintenance could install the bed rails. The resident's care plan should be updated to include the usage of bed rails and a Registered Nurse would complete the Bed Rail Assessment form prior to installation. The assessment should be completed quarterly, annually, and as needed with any changes and would determine if there was any risk for entrapment or safety concerns. The Registered Nurse who completed the assessment should provide education regarding the risk and benefits of bed rail usage, obtain informed consent and it should be documented in their care conference note. The Certified Nursing Assistants checked the bed rails every shift and documented in the electronic medical record. If any issues with a bed rail were observed, staff should alert the nurse so maintenance could be notified and address the issue. Registered Nurse Unit Manager #2 stated if bed rails were loose, it could pose a safety risk such as entrapment. During an interview and observation on 10/31/2024 at 10:58 AM, Clinical Leader Registered Nurse #4 stated Resident #29's bed side rails moved slightly, and the mattress was not secure. During an interview on 10/30/2024 at 3:06 PM, Certified Nursing Assistant #2 stated they had not received any training regarding bed rail use, and they did not inspect the bed rails but were supposed to check the rails each shift for movement. If any issues with the rails, they were supposed to let the nurse know who would alert maintenance. During an interview on 10/30/2024 at 3:11 PM, Licensed Practical Nurse #2 stated they were assigned to the hallway where Residents #29 and #52 resided. If the Certified Nursing Assistants observed any issues with the bed rails, they should notify the nurse so maintenance could be notified to fix the issue, including if they observed the mattress not fitting snug. Licensed Practical Nurse #2 stated it was important to monitor the bed rails for safety issues and none of the Certified Nursing Assistants had alerted them today to any issues with loose bed rails or mattresses not fitting snug. Licensed Practical Nurse #2 added the nurses did not check the bed rails. During an interview on 10/30/2024 at 3:30 PM, the Maintenance Supervisor and Maintenance Technician #2 both stated the maintenance department installed and removed bed rails from a resident's bed if a work order was placed. Once placed the maintenance staff would review the order to determine the severity of the issue and address accordingly. They were unsure if clinical staff were assessing the residents for appropriateness or entrapment zones. They stated maintenance staff had not been educated on how to check for entrapment zones, did not know what the entrapment zones were and did not check for entrapment zones. All beds should have brackets on them to hold the mattress in place and if they were missing, a work order should be placed. They added maintenance staff did not do routine inspections on beds. The facility's electronic work orders from October 1, 2024, to October 29, 2024, did not include any work orders regarding any issues with loose bed rails. During an interview on 10/31/2024 at 10:53 AM, Clinical Leader Registered Nurse #1 stated they completed the Bed Rail Assessments and Therapy would evaluate the resident to determine if they were appropriate to use the bed rails. A Bed Rail Assessment would then be completed by a Registered Nurse and maintenance would install the bed rails as indicated on the work order. Clinical Leader Registered Nurse #1 stated when they completed the bed rail assessment, they checked to see if bed rails were loose or if there were any gaps (between rails or between rails and mattress). If the resident was able to answer, they would ask them to see if they understood why they had the bed rail and if they wanted them. If they identified any issues with the bed rails, they notified the nurse manager or whoever was available to place a work order. Clinical Leader Registered Nurse #1 stated if bed rails were loose by pulling on them it was an issue that needed to be fixed. Many of the residents at the facility have had bed rails for a long time and they thought education and informed consent had been completed prior to installing the bed rails and that the Bed Rail Assessment form should be completed quarterly, annually, and as needed and that many residents used the bed rails for positioning and mobility in bed. Clinical Leader Registered Nurse #1 stated they were unsure who maintained the bed rails for safety and during their recent audit, they did find that some of the bed rails were loose and there were some gaps. The Registered Nurse Manager had not been available, so they took the audit results to the Administrator the day they completed the audit (10/22/2024). Residents #29 and #52 had loose bed rails and there were gaps identified and this was noted on the audit provided. They did not enter a work order but had documented in the assessments that maintenance was notified as the facility's Administrator told them it would be taken care of. Clinical Leader Registered Nurse #1 stated any issues with loose bed rails or gaps could pose a safety risk such as injury or entrapment and should be corrected. Their 10/22/2024 audit was completed for safety reasons, and they did not review all residents to determine if informed consent had been obtained or alternate interventions trialed prior to installing the bed rails. They were concerned with the bed rail issues identified and informed the Administrator of their findings. They were under the assumption the issues were fixed. During an interview on 10/31/2024 at 11:35 AM, the Administrator stated bed rail use was determined by an assessment and therapy evaluation and installed by the maintenance department. Clinical Leader Registered Nurse #1's audit was completed as part of quality assurance and if any issues were identified on the audit regarding any loose bed rails or gaps, they should have completed a maintenance request to have the issues corrected. They would want to be made aware of any safety issues that could possibly result in imminent concern and they had not been made aware of any risk for entrapment when Clinical Leader Registered Nurse #1 completed their audit. When asked if any corrective action had been initiated following the audit's identified potential risk for entrapments prior to survey starting on 10/28/2024, no answer was given. During a follow up interview at 12:28 PM, the Administrator stated Clinical Leader Registered Nurse #1 identified an issue and provided them with the audit last week and if they recalled the conversation correctly, no entrapment issues were identified. If any issues were discussed, they would have had them corrected. During an observation and interview on 11/01/2024 at 2:12 PM, Clinical Leader Registered Nurse #4 examined Residents' #29, #52, and #110 beds (beds identified with entrapment issues) and stated they were all the same type of bed and referred to them as the crank style. During an interview on 11/04/2024 at 9:50 AM, the Director of Nursing stated it was important to monitor the bed side rails for safety reasons and if staff identified any issues a nurse should be made aware so a work order could be placed. They were not aware of any issues identified when Clinical Leader Register Nurse #1 completed their audit the previous week regarding safety concerns over possible entrapment issues. During an interview on 11/04/2024 at 11:09 AM, the Medical Director stated they did not provide input regarding bed rail usage at the facility. They had not been made aware of any issues identified with Clinical Leader Registered Nurse #1's audit and would want to be made aware if the facility did not act upon any entrapment issues immediately. They expected the entrapment zones to be assessed for safety purposes and were not aware this was not being done. ***************************************************************** Immediate Jeopardy was identified, and the Administrator was notified on 10/31/2024 at 6:35 PM. Prior to survey exit the Administrator was notified on 11/01/2024 at 8:50 PM that Immediate Jeopardy was lifted effective 11/01/2024 at 8:45 PM based on the following corrective actions: -Six residents (#17, 29, 52, 71, 106, 110) beds were reviewed and observed for loose rails and mattress-rail gaps, with no safety concerns being identified. Additionally, the Administrator provided an attestation that the remaining 24 residents with devices attached to their beds would be inspected and deemed free from loose rails or gaps. -The facility audit was provided and reviewed. There is a therapy recommendation for the residents to have the bed rails and a care plan is in place for all bed rails. -Bed rail assessments for 6 of 6 residents were provided and reviewed. Education completed and consents were obtained and documented alternatives being attempted. -Manufacturer information pertaining to bed rails was provided and reviewed. -The preventative maintenance program, which consisted of a monthly bed inspection audit form and a preventative maintenance bed inspection policy were provided and reviewed. 10 NYCRR 415.12(h)(1)