**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview and document review, the facility failed to follow requirements to ensure safe use of a bed rail assist device resulting in a resident's neck becoming wedged between the assist bar and mattress while the rest of his body slid off the bed onto the floor preventing his ability to breathe for 1 of 4 residents (R1) reviewed for entrapment risk. This resulted in an immediate jeopardy (IJ) for R1. In addition, the facility failed to reduce the risk of bedrail entrapment when they did not attempt to use alternatives, ensure correct installation and maintenance, review risks and benefits, ensure bed dimensions were appropriate, and follow the manufacturers instructions resulting in the potential for harm for 57 of the 68 residents who utilized a bedrail assist bar for mobility. The immediate jeopardy began on 6/14/23, when R1 was found by family to have fallen off his bed with his neck and shoulder caught between the mattress and the assist bar while his bottom was on the floor. As a result R1 was having difficulty breathing. The IJ was identified on 6/27/23. The administrator, director of nursing (DON), regional clinical services director, administrator and senior director, and vice president of operations were notified of the immediate jeopardy at 5:49 p.m. on 6/27/23. The immediate jeopardy was removed on 6/28/23, but noncompliance remained at the lower scope and severity of a D which indicated no actual harm with potential for more than minimal harm that is not immediate jeopardy. Findings include: Food and Drug Administration (FDA) guidelines (Recommendations for Health Care Providers about Bed Rails) updated 2/27/23, provides the following guidance: Any decision regarding adult portable bed rail use or removal should be made based on the individual patient or resident assessments. If a bed rail has been determined to be necessary, steps should be taken to reduce the known risks associated with its use. To learn more about the patient or resident assessment, see the Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities and Home Care Settings. Before you install bed rails: Make sure the individual is an appropriate candidate for bed rails. Bed rails should not be used as a substitute for proper monitoring, especially for people at high risk for entrapment such as those with cognitive impairment. Follow the recommendations in the ASTM F3186-17: Standard Specification for Adult Portable Bed Rails and Related Products for home care facilities and long term care facilities. Only use bed rails that conform with ASTM F3186-17. Follow the recommendations in the FDA guidance Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment for health care facilities and the Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities and Home Care Settings. Be aware that not all bed rails, mattresses, and bed frames are interchangeable and not all bed rails fit all beds. Check with each manufacturer to make sure the bed rails, mattress, and bed frame are compatible, because most bed rails and mattresses are purchased separately from the bed frame. Bed rails should be selected and placed to discourage climbing over rails to get in and out of bed, which could lead to injury or death from falls. Avoid the routine use of adult bed rails without first conducting an individual patient or resident assessment. https://www.fda.gov/medical-devices/adult-portable-bed-rail-safety/recommendations-health-care-providers-using-adult-portable-bed-rails The FDA guidelines (Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment 2006, pp. 10-24) identified key body parts at risk for life-threatening entrapment the head, neck, and chest in the seven zones of a hospital bed system, focusing on the most common zones for risk of entrapment zones 1-4. Zone 1 - within the rail is any open space with the perimeter of the rail. Recommended space be less than 4 ¾ inches representing head breadth. Zone 2 - under the rail, between the rail supports or next to a single rail support. This space is the gap under the rail between a mattress compressed by the weight of a patient's head and the bottom edge of the rail at the location between the rail supports or next to a single rail support. Recommended space limit for entrapment in this space is less than 4 ¾ inches. Zone 3 - between the rail and the mattress. 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. Recommended space between the area between the inside surface of the rail and compressed mattress should be of less than 4 ¾ inches. Zone 4 - under the rail at the ends of the rail. This space poses a risk for entrapment of a patient's neck. In this space, a gap forms between the mattress compressed by the patient, and the lowermost portion of the rail, at the end of the rail. Recommended dimension for this zone measure both less than 60 mm in size and greater than 60 degrees in angle. Zone 5, 6, and 7 are identified as potential for entrapment with the least reporting. Zone 5 is the area between the split of bedrails, zone 6 is the between the end of rail and the side edge of the head or footboard, and zone 7 is between the head of footboard at the end of the mattress. Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. (2006). Retrieved from https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM072729.pdf During observation on 6/22/23 at 2:45 p.m., the facility assist bar was in the shape of a walking cane. The top part of the cane measured six inches before bending downward at an angle creating a 7-inch curved C shaped open space. Per the FDA, Zone 1 should measure 4 3/4 inches or less. The top of the assist bar measured 14 inches above the bed frame and 23 1/2 inches from the floor. During observation and interview on 6/27/23 at 12:32 pm., the DON and administrator demonstrated how R1 was found on 6/14/23. The DON stated he fell out of bed when his feet and the bolster slid off the foot of the bed pulling the rest of his body down to the floor. She added R1 had his back up against the side of the bed sitting on the bolster and floor. She stated R1's head was between the mattress and assist bar and she was able to untangle him. She added his neck was not entrapped by the assist bar, and she did not view the incident as an entrapment. When asked for a copy of her interviews with the staff involved during the incident, the DON stated she was sure she documented the interviews and would have to find them. R1's admission Record indicated R1 admitted to the facility on [DATE] with multiple diagnosis including cerebral arthrosclerosis, dementia, heart disease, dysphagia, anxiety, and adult failure to thrive. R1 was receiving hospice care. R1's MD Orders dated 3/20/23, identified an order for alternating pressure mattress (APM) to prevent pressure ulcers, and an assist device to aid with bed mobility. R1's Physical Device and/or Restraint Evaluation and Review form dated 3/21/23 indicated it was recommended/reviewed the device of an assist/grab bar for R1 for participation in bed mobility and identified the potential resident safety risks were evaluated and reviewed with R1 to include potential entrapment, accident hazards, potential negative outcomes, a Federal Drug Administration (FDA) brochure and policy packet, and R1 had cognitive learning barriers related to the educational material provided but was able to verbalize understanding. The box for family or other individuals who received education was not checked. The boxes for alternatives that have been attempted before the use of assist/grab bars were not checked. The boxes for care planning the use of physical devices were not checked. R1's admission Minimum Data Set (MDS) dated [DATE], identified R1 had severe cognitive impairment, anxiety, and received hospice care for a terminal disease. In addition, he required extensive assistance from two nursing staff for bed mobility. R1's progress note dated 6/14/23, indicated R1 fell off his bed at 4:16 p.m. when his family member (FM)-A yelled from R1's room, Help he is choking. R1 was found in a seated position on the floor facing the right where his neck and shoulder was caught between the mattress and the assist bar. In addition, R1 was tangled up in his sheets. FM-A was holding onto his right shoulder when the nurse was able to reposition him away from the assist bar. R1's nurse practitioner (NP) notification text dated 6/14/23 at 5:42 p.m. from the DON stated R1 fell out of bed and his head was caught on the assist bar. She added, Could have been bad! R1's progress note dated 6/15/23 indicated an incident meeting from fall on 6/14/23. The facility incident description indicated R1 was found sitting on the floor next to the bed with his head on the bed and his neck on the bedrail, tangled in his bedding, and wife in the room kneeling beside him holding his right shoulder. Contributing factors indicated R1 had severe cognitive impairment, can be restless with attempts to get out of bed. The facility plan was to implement new fall interventions for a high/low bed, safety sided mattress, floor mat, and soft touch call light. R1's NP-A visit dated 6/16/23, identified R1 was seen for an acute follow up related to neck pain. The note indicated R1 suffered a fall a couple days earlier out of his bed, where his head remained on the bed by the assist bar and his bottom was on the floor. R1 was confused and pointed towards his neck while appearing to be in pain. An order was placed for an ice pack four times a day to his neck and morphine 2.5 milligrams (mg) every hour as needed for pain and shortness of breath. R1's Physical Device and/or Restraint Evaluation and Review form dated 6/16/23 indicated R1's use of an assist/grab bar and bolsters cushion be discontinued for use because R1 did not use the grab bars for mobility and his head was hung up on the grab bar. There was no injury but a risk for injury. In addition, the air mattress with the bolsters cushions was also discounted due the R1's risk to slid off. The recommendation was for R1 to have a concave mattress to prevent him from sliding out of bed, a high/low bed to prevent injuries from falls out of bed. The concave mattress and high/low bed with its risk and benefits was reviewed with R1's representatives with no barriers to learning. The boxes of care planning were initiated. Email correspondence dated 6/26/23 at 11:31 a.m. with Hill-Rom representative (R)-A included Hill-Rom Siderail, Assist Bar, and Headrail Upgrade Kits Operation & Maintenance Manual dated 1/04 indicated new upgrades available to the bed assist devices in response to changing needs in health care. In addition, a Warning alert for owners to keep this manual with their existing service manual listing failure to do so could result in patient injury. Email correspondence dated 6/26/23 at 5:05 p.m. Hill-Rom technician (T)-A included Resident LTC Bed Brochure dated 12/6/17, indicated the special options available for this bed. The assist bar used at the facility was shown on the brochure installed at the foot of the bed and the open C space faced the foot of the bed. During interview on 6/22/23 at 1:16 pm. FM-A stated she found her husband sitting on the floor next to his bed, and his head was caught on the assist bar. She added he was a big guy, and she was unable to pull his neck away from the bar so he could breathe. She ran into the hall yelling, Help, help he is choking. She stated R1 was unable to communicate, and he was frightened. She added R1 was very restless and always trying to get out of bed or his wheelchair prior to his admission to the facility. She was afraid he would fall out of bed and told the facility staff about her concern when he was admitted to the facility. Now the facility provided a high-low bed capable of lowering to a few inches off the floor. In addition, the facility placed a thick fall mat next to the bed to catch him if he fell out of bed again. During interview on 6/26/23 at 9:05 a.m. the administrator stated the only bed operation and maintenance manual they could find was the Resident LTC Bed Service Manual for P870 model from Hill-ROM. The manual was originally issued on 12/1/1996. She stated the manual did not include the assist bars operator instructions or maintenance requirements for use. During interview on 6/26/23 at 11:11 a.m. Hill-Rom representative (R)-A stated the assist bars open C space should face the foot of the bed to prevent an entrapment. He said the facility would have installed the assist bars and must have placed them incorrectly facing the front of the bed. He added the facility could remove the assist bars and place them on the opposite side. During interview on 6/26/23, at 1:00 p.m. facility maintenance (M)-A stated the facility beds were the Resident LTC Bed from Hill-Rom model number P970, showing R1's bed now located at the facility garage. The assist bars were attached to the bed frame. The assist bar was capable of locking in the up position for use or stored in a locked position along the bed frame when not in use. He stated the assist bar came with the bed, and it was welded in place to be the frame preventing it from being switched to the other side of the bed so the open C area would face the foot of the bed. M-A confirmed he annually inspected each bed at the facility by shaking the bed to identify loose bolts and looking for frayed cords. During interview on 6/26/23, at 1:17 p.m. with M-A, R-A and the administrator, R-A said the assist bars were an accessory to the bed and would not have come installed. The facility must have installed the bars on the wrong side of the bed. He said all they would have to do was remove two bolts to remove and reinstall them on the other side of the bed. He reiterated the assist bars C space open must face the foot of the bed for safety. During interview on 6/26/23 at 3:00 p.m. the physical therapist (PT)-A stated one of his responsibilities included an assist bar evaluation for all the facility's residents upon admission, and after a change in condition. PT-A stated the assist bar is shaped like a cane, and the opening facing the head of the bed could be a potential risk for entrapment. PT-A stated prior to R1's falling out of bed he did not see the risk but now he could. PT-A stated he had no formal training on different assist devices for a nursing home bed, I just make sure it's on the bed appropriately and make sure the resident can use it. During interview on 6/26/23 at 3:35 p.m. the director of nursing (DON) stated what happened to R1 on 6/14/23, was not a case of entrapment because his neck was not caught in the assist bar's C shaped opening, and he was never choking. In addition, the shape and position of the assist bar did not pose a risk to any of their residents. She had worked at the facility for 42 years, and the assist bars on the beds had not changed. On 6/14/23, after R1's fall she arrived at the incident and found him sitting on the floor. She completed a head-to-toe skin evaluation and did not find any bruising or redness. She stated even though she did not feel there was an entrapment risk, she switched R1's bed to a high low bed because she did not want it to happen again. During interview on 6/26/23 at 5:00 p.m. Hill-Rom T-A stated the bed was manufactured with four side rails. As the bed became popular for nursing home use, the assist bar was developed for use. Later, after FDA regulations and changing guidance the original assist bar had too big of an opening and the company developed a conversation kit to eliminate the spacing created by the device. During interview on 6/27/23 at 2:01 p.m. administrator and senior director (SD)-A stated she spoke with T-B at Hill-Rom who told her the assist bars could face in any direction. During interview on 6/27/23 at 2:33 p.m. the DON confirmed R1's Physical Device and/or Restraint Evaluation and Review dated 3/21/23, did not include the requirements to try alternative approaches before using an assist bar, complete a risk verse benefits assessment and because R1 had severe cognitive impairment he was unable to give informed consent. In addition, she stated the nursing staff failed to update R1's bed mobility limitations and he was approved to use an assist bar in his care plan. R1's family did not receive the required Federal Drug Administration (FDA) brochure and policy resource packet. She stated after the 6/14/23 fall, she exchanged R1's bed with low-high bed and a fall mat next to his bed to prevent R1 from being trapped and choked again. She added after a fall the facility holds an incident meeting, fall review to determine the cause of the fall and any new practice to prevent future falls. She stated the incident meeting and fall review was held for the 6/11/23 fall but not for the 6/14/23 fall because they did not have time to do so. During interview on 6/27/23 at 4:42 p.m. spoke with Hill-Rom T-B regarding his conversation with SD-A. He stated he did not tell SD-A the assist bars could face in any direction. He said during the conversation he told her several times there was a left and a right assist bar and when placed correctly on the bed the open C space would face towards the foot of the bed. He even showed them the Resident LTC Bed Brochure picture of an assist bar facing the foot of the bed. T-B was unable to find the part number P00070848 for the assist bar listed in the Hill-Rom Siderail, Assist Bar, and Headrail Upgrade Kits Operation & Maintenance Manual because it was now obsolete. During interview on 6/28/23 at 9:07 a.m. NP-A stated she was contacted by someone at the facility regarding R1's fall on 6/14/23. She was told he did not suffer any injury, but she was unable to visualize how it happened. She asked the staff to describe how his neck was caught on the assist bar, but the staff told her at that time he did not get his neck caught on the assist bar, but it could have. She was updated on 6/16/23 after R1 was showing signs of neck pain. She assessed him at that time and did not find any deficit while he performed different range of motion exercises. She questioned why he would need an assist bar since he was an extensive assistance with two staff for bed mobility. During interview on 6/28/23 at 9:40 a.m. RN-B stated on 6/14/23, she found R1 sitting on the floor and leaning to the right towards the assist bar with his right shoulder tucked between the assist bar and the mattress. R1's neck was lodged in the C shape space causing his skin to turn blue and slow down his ability to breathe normally. His wife was trying to push him up so he could breathe. She said R1 was a large man, and his body weight made it difficult to reposition his neck and right shoulder away from the assist bar. R1 was incontinent of urine at the time and had a history of trying to climb out of bed. During interview on 6/28/23 at 11:00 a.m. SD-A stated all of the assist bars were removed from all the beds and reinstalled on the appropriate side to face the foot of the bed. During group interview on 6/28/23 at 12:29 p.m. with the administrator, DON, SD-A, and the regional clinical director (CD)-A call was placed to discuss the assist bars with a Hill-Rom technician and obtain the required maintenance and service manual for the assist bar. T-B stated Hill-Rom no longer had any maintenance and service manuals for their assist bar. In addition, the up-grade assist bar information is now obsolete. He was unable to tell when or why it became obsolete. SD-A stated she called Hill-Rom the day before and they told her they could be installed either way. Informed SD-A, T-B was interviewed and he denied telling the facility the assist bars could be installed in any direction. The facility policy Bed Safety Including: Bed Rails, Side Rails, Assist Bars-Rehab/Skilled, Therapy & Rehab dated 9/6/22 identified an entrapment would be any event involving a resident being caught, trapped, or entangled in the space between the bed and the bar. Review alternative devices before installing an assist bar. Only suitable residents who can grab the assist bar independently or with nursing staff and used for bed mobility would receive one. In addition, a risk verse benefit assessment would be reviewed with the resident or family along with a signed consent. The immediate jeopardy that began on 6/14/23, was removed on 6/28/23, when the facility removal plan was verified by observation, interview, and record review. Noncompliance remained at a lower scope and severity level of 2, D-isolated because the facility needs to document steps taken for substantial compliance. -The facility reviewed its policy titled Bed Safety including Bed Rails, Side Rails, Assist Bars-Rehab/Skilled, Therapy & Rehab and found it current. -A system was initiated for bed inspections following the policy title Bed Safety. -Educated all licensed nurses on assessing the use of assist/grab bar device. -All 57 resident currently using assist/grab bars were reassessed based on the on the assessment criteria, which when appropriate the grab bars were removed from resident use and/or applied according to manufacturing instruction. -Resident care plans were updated to reflect the use of assist/grab bar device.