**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and record review, the facility failed to ensure five of five Residents (Residents 6, 8, 11, 16, and 55) were assessed for the risk of entrapment (resident caught, trapped, or entangled in the space in or about the bed and side rail) from bed (side) rails (adjustable metal or rigid plastic bars in various sizes that attach to the bed, and can be placed in a guard (raised) or lowered) prior to installation and had no consent (form signed by resident or family explaining the risks of side rail use), physician order, indication for use, and care plans prior to the use of side rails when: 1. Resident 6 had two bed rails raised up and had sustained an injury of unknown origin on 10/29/2021 prompting the facility to pad the bed rails. Prior to the use of the two bed rails, staff did not conduct an entrapment risk assessment; no consent, physician order and care plan were done prior to the use of the two bed rails for Resident 6. 2. Resident 16 had two bed rails on both sides of the bed in the guard position (A position that is intended to prevent an individual from inadvertently rolling out of bed). Resident 16 did not have a physician's order, consent, and plan of care prior to the use of the bed rails. 3. Resident 11 had two bed rails on both sides of the bed in the guard position and did not have a consent prior to use of bed rails. 4. Resident 8 had two bed rails on both sides of the bed in the guard position and did not have a physician's order, consent, entrapment risk assessment, and plan of care prior to use of the bed rails. 5. Resident 55 had two bed assist bed rails in the guard position and no entrapment risk assessment, consent, physician order and care plan were done prior to use. These failures had the potential to cause entrapment, serious harm, injury, or death to Residents 6, 8, 11, 16, and 55. Because of the serious potential harm such as injury and entrapment to Residents 6, 8, 11, 16, and 55 and the serious potential harm to all residents with bed rails used without an entrapment risk assessment, no consent, no physician order, no indication for use, and no care plans prior to use, an Immediate Jeopardy (IJ, a situation in which non-compliance with one or more regulatory requirements has caused or is likely to cause serious injury, harm, impairment, or death to a resident) situation was called., on 11/4/2021 at 6:07 p.m., under Code of Federal Regulations (CFR) 483.25 (F700) with the Administrator (ADM) and Director of Nursing (DON). The facility was provided the IJ template which indicated the need to submit an acceptable written Plan of Removal that addressed the need for immediate action for the IJ situation. The facility submitted a Plan of Removal (POR) on 11/8/21, at 11:02 p.m., to address the IJ situation. The IJ POR included: 1) immediately conduct entrapment risk assessments for affected Residents, obtain consents for all affected residents and obtain physician's order and develop and implement a care plan for each affected resident. 2) Develop immediate safety processes and monitoring steps to ensure the residents do not get entrapped and sustain injuries. 3) Implement processes regarding the difference between bedrolls and/or mobility aids, consents, physician orders, entrapment risk assessment, care planning, equipment monitoring & maintenance that would ensure all residents' safety. 4) Implement Training and Education and measure of competencies to all staff regarding Physical Restraints [Physical Restraint is defined as any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body]/Bedrails to ensure residents' safety at all times. The IJ Plan of Removal was accepted on 11/8/21 at 12:28 p.m. While onsite, the surveyors validated the POR implementation action items through observations, interviews, record reviews and confirmed that all POR action interventions to address the IJ situation were fully implemented. The IJ was removed on 11/8/21 at 5:50 p.m., with the ADM. Findings: 1. During an observation on 11/2/21, at 2:55 p.m., in Resident 6's room, Resident 6 was asleep in bed with two bed rails up and a soft, hallow piece of foam covered the top of the half bed rails. During an interview on 11/3/21, at 3:09 p.m., with the DON, the DON stated Resident 6 had an injury of unknown origin on 10/29/21. The DON stated Certified Nursing Assistants (CNAs) were doing last rounds on 10/29/21 and saw Resident 6's right hand was reddened, swollen and warm to touch. The DON stated Licensed Vocational Nurse (LVN) 1 called her to look at Resident 6's right hand. The DON stated Resident 6 said don't touch when the DON looked at her hand. The DON stated an x-ray (digital image of a part of the body) was done at the facility. The DON stated Resident 6's physician wanted the staff to place a soft splint (soft, padded material that is used to secure an injury by holding it in place ) on her right hand. The DON stated Resident 6 would not let staff put a splint on her hand. The DON stated Resident 6 was sent to the hospital on [DATE] to get a splint on the right hand, and the hospital repeated the x-ray. The DON stated the x-ray at the hospital showed no fracture of the right hand. The DON stated the x-ray indicated degenerative joints (decrease in function of joints) of Resident 6's right hand. The DON stated the hospital placed a soft splint on Resident 6's hand. The DON stated staff or residents did not witness the injury. The DON stated Resident 6's injury could have occurred as a result of her hand hitting the bed rail. During an interview on 11/3/21, at 3:38 p.m., with LVN 1, LVN 1 stated CNA 3 asked her to look at Resident 6's right hand on 10/29/21 at 2:24 p.m. LVN 1 stated Resident 6's knuckles on her right hand were red, swollen, and warm to touch. LVN 1 stated staff had not reported any past falls for Resident 6. LVN stated the physician ordered x-rays of Resident 6's right hand. LVN stated the x-ray was done at the facility. LVN stated the x-ray results showed Resident 6 had a fracture. The physician ordered to put a splint on Resident 6's right hand. LVN 1 stated the staff was not able to get a splint on Resident 6's hand and Resident 6 was sent out to the hospital to get her right hand splinted. LVN 1 stated the second x-ray that was done at the hospital on [DATE] did not indicate a fracture. LVN 1 stated that after the injury Resident 6's side rails were padded to keep her from hurting her hand. LVN 1 stated Resident 6's injury could have been caused by her hitting the bed rail. During a concurrent interview and record review on 11/3/21, at 3:38 p.m. with LVN 1, Resident 6's Radiology Interpretation, dated 10/29/21, was reviewed. The X-ray indicated, .Impression: Impaction fractures age unknown, distal right second and third metacarpals (miniature long bone near the second and third finger of the right hand) . LVN 1 stated the first x-ray was done at the facility on 10/29/21. LVN 1 stated the second x-ray was done at the hospital on [DATE]. The second X-ray indicated, .Findings: . There is no acute fracture or dislocation. Advanced degenerative changes involving interphalangeal and first carpal metacarpal joints (first joint of the finger and is located between the first two bones of the finger). Soft tissues (supports internal bones) are unremarkable . During a concurrent observation and interview, on 11/4/21, at 9:40 a.m., with CNA 1 in Resident's 6 room, Resident 6's bed had two bed rails up. CNA 1 stated the bed rails were padded because Resident 6 had hurt her hand. CNA 1 stated they used two CNAs to get Resident 6 up because she sometimes hits at them. CNA 1 stated Resident 6's injury could have been a result of her hand hitting the bed rail. During a concurrent interview and record review, on 11/4/21, at 1:00 p.m., with LVN 3, Resident 6's electronic health record (EHR), dated between 10/1/21 and 10/30/21 was reviewed. LVN 3 stated she could not find the physician's order, no entrapment risk assessment, no consent, or care plan for the padded bedrails before the injury on 10/29/21. Resident 6's care plan indicated padded bed rails were initiated on 10/30/21. LVN 3 stated there should be a physician's order, an entrapment risk assessment, a consent form signed by Resident 6's responsible party and a care plan done before the bed rails were used for Resident 6. During an interview, on 11/4/21, at 2:37 p.m., with the CNA 2, the CNA 2 stated she had worked at the facility since September 2021 and was familiar with Resident 6. CNA 2 stated Resident 6 would swat at the staff and was confused at times. CNA 2 stated Resident 6 had bed rails up since she started working at the facility in 2021. During a concurrent interview and record review, on 11/4/21, at 2:43 p.m., with LVN 4, Resident 6's EHR, dated 10/1/21 to 11/4/21 was reviewed. LVN 4 stated there were no consent form, and physician orders for the bed rails for Resident 6. LVN 4 stated she did not recall how long Resident 6 had been using bed rails. During a concurrent observation and interview, on 11/4/21, at 3:15 p.m. with Director of Maintenance (DOM), in Resident 6's room, Resident 6's had two bed rails up. DOM stated the bed rails came with Resident 6's bed. DOM stated he put the padding on the bed rails. DOM was unable to provide a copy of the Resident 6's bed manufacturer's guidelines. DOM demonstrated how Resident 6 was supposed to lower the bed rails by pulling on a knob below the side rail. DOM stated Resident 6 could not remove the bed rail because she was unable to reach down to where the knobs were located on the bed. During a concurrent observation and interview on 11/4/21, at 3:34 p.m., with the Director of Rehabilitation (DOR) in Resident 6's room, Resident 6's bed rails were observed up. DOR stated there should be an entrapment risk assessment, and a consent form prior to use. DOR stated the bed rails were considered a restraint since Resident 6 was unable to remove it. DOR stated the importance of doing an entrapment risk assessment was to prevent entrapment injury. During an interview on 11/4/21, at 5:37 p.m. with the DOM, the DOM stated he was responsible for installing bed rails on Resident 6's bed. The DOM stated he did not perform necessary measurements to ensure bed and bed rail compatibility for Resident 6 and other residents with bed rails. The DOM stated that he was unaware of the requirements for the measurements of the bed rails. During a review of the facility's policy and procedure (P&P) titled, Bed Rails, dated June 2020, the P&P indicated, .Maintenance/Designee will assess the bed dimensions no less than quarterly by utilizing Maintenance Inspection Checklist-Resident Rooms. Maintenance will also check bed rails regularly to ensure they are installed correctly, as rails may shift or loose over time . During a concurrent observation and interview on 11/4/21, at 5:53 p.m., with CNA 2, CNA 3, and the DON in Resident 6's room, CNA 3 stated the bed rails on Resident 6's bed was used as a mobility device. CNA 2 asked Resident 6 to grab the bed rails, Resident 6 did not follow commands and did not grab the bed rails. CNA 2 stated Resident 6 would not be able to remove the bed rails. During a concurrent interview and record review, on 11/5/21, at 9:15 a.m. with ADM, Facility Reported Event (Facility Reported Event), dated 10/30/21 was reviewed. The Facility Reported Event indicated, on 10/29/2021 .CNA notified the LVN that resident had redness, warm and swelling to her right hand .notified the physician and received and order for x-ray to right hand .All LVNs and CNAs were interviewed .Through an investigation of residents behaviors and interviews of staff .the Interdisciplinary Team (IDT-staff members of different expertise that work together toward a common goal for the resident) determined that redness and swelling of the hand was likely caused by accident by the resident . ADM stated that the staff determined that Resident 6 probably hit her hand on the bed rail causing her injury. ADM stated nobody actually witnessed the injury. During an interview on 11/5/21, at 2:50 p.m. with Resident 6's responsible party (RP), the RP was notified by the facility regarding Resident 6's injury of unknown origin on 10/29/21. RP stated Resident 6 had cracked bones in her right hand and thought Resident 6 was probably trying to grab something on her bedside table and hit her hand against the bed rail. During a review of Resident 6's Minimum Data Set (MDS- a resident assessment tool used to identify cognitive (mental processes) and physical functional level assessment were reviewed. MDS dated [DATE], indicated, .Resident 6's Brief Interview for Mental Status (BIMS - screening tool used to assess resident cognitive level) score was 3 out of 15 (0-7 indicated severe cognitive impairment - [memory loss, poor decision making-skills], 8-12 moderate cognitive impairment, and (13-15) cognitively intact) . MDS Section G (Function Status) indicated . B. Transfer how resident moves between surfaces including to or from: bed, chair, wheelchair, standing position . code 3 (two-person physical assist) . C. Walk in room how resident walks between locations in her room Code 8 (activity did not occur) . D. Walk in corridor how resident walks in corridor on unit . code 8 . 5. During an observation on 11/4/21, at 2:39 p.m., in Resident 55's room, Resident 55 was laying on his back in bed, with two assist bed rails attached to the midsection of the bed and was in the guard down position. Resident 55's bed was observed in the low position with two floor mats on both sides of the bed. During a concurrent observation and interview on 11/4/21, at 2:42 p.m., with CNA 2, in Resident 55's room, Resident 55 was laying in bed with both bed rails in the lowered position. CNA 2 stated, Resident 55 was not alert and required total assist for mobility. CNA 2 stated, Resident 55's bed rails were in place to prevent him from falling out of bed. During a review of Resident 55's Minimum Data Set and physical functional level assessment dated [DATE], the MDS indicated Resident 55's Brief Interview for Mental Status score was 0 out of 15, Section G indicated . B. Transfer how resident moves between surfaces including to or from: bed, chair, wheelchair, standing position . code 3 . C. Walk in room how resident walks between locations in her room Code 8 . D. Walk in corridor how resident walks in corridor on unit . code 8 . During a concurrent interview and record review on 11/4/21, at 3:01 p.m., with Minimum Data Set Coordinator (MDSC), MDSC reviewed Resident 55's clinical record. MDSC stated, he did not know when the bed rails were installed on Resident 55's bed. MDSC reviewed the clinical record and stated there was no physician order, no informed consent for bed rail use, no bed rail care plan, and no entrapment risk assessment. MDSC reviewed Section P of the MDS, dated [DATE] titled, Restraint and Alarms, indicated, .Physical Restraints .Physical restraints are any manual method, or physical or mechanical device, material or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body .Bed rail 0 . MDSC stated, the MDS section P was inaccurate because it was coded as 0 which meant not used. MDSC stated, he had worked with Resident 55 in the past and stated he was non-verbal and had limited mobility. During a concurrent observation and interview on 11/4/21, at 3:08 p.m., with MDSC, in Resident 55's room, Resident 55 was laying in bed with both bed rails in the guard down position. MDSC stated, the quick release knob was located on the bottom of the bed rail and Resident 55 would not be able to remove the bed rail independently. MDSC proceeded to move the bed rail from its guard down position into the assist up position (assisting the resident in standing or sitting in bed) and stated the assist bed rail should not be down because there was no order, consent, care plan, or entrapment risk assessment. MDSC stated, without an entrapment risk assessment the bed rails were an endangerment to Resident 55 and could cause more harm than good. During an interview on 11/4/21, at 3:38 p.m., with DOR, DOR stated when the therapy department makes a recommendation for bed rail use a resident or resident representative consent was required prior to use. DOR stated, if bed rails were installed just because a resident was a fall risk that would be considered a restraint. DOR stated, there should be an entrapment risk assessment and care plan interventions for the use of bed rails. During an interview on 11/4/21, at 5:45 p.m., with DON, DON stated, the facility had different bed rail sizes. DON stated, there was no determination of which residents' bed had longer or shorter bed rails, the bed rails were installed based on whatever fit the bed. During a review of the facility policy and procedure titled Bed Rails dated 11/2021 was reviewed. The policy indicated .Decisions to use or discontinue the use of a bed rail will be made in the context of an individualized resident assessment using an Interdisciplinary Team (IDT) and will take into account the resident's medical needs, comfort, and freedom of movement .The Assessment of whether to use bed rails should include an evaluation of the alternatives to the use of bed rail that were attempted and how these alternatives failed to meet the resident's assessed needs. If bed rails are to bed used, the assessment Bed Rail Utilization [would be conducted] by a Licensed Nurse and/or the IDT. The Licensed Nurse and/or the IDT may refer to the Bed Rail Decision Tree during the assessment. Before installing a bed rail, the Facility must: Assess the resident for risk for entrapment from bed rails; and Ensure the bed's dimensions are appropriate for the resident's size and weight. If the bed rail is used as a restraint, the Facility will refer to Policy Restraints, for informed procedures. If a bed rail is used as an enabler, the resident/resident representative's informed consent will be obtained by a Licensed Nurse or the physician. The resident's plan of care will be updated to reflect the use of bed rails. The plan of care should also include documentation of the type of specific direct monitoring and supervision provided during the use of the bed rails and the identification of how needs will be met during the use of bed rails . During a review of the facility's P&P titled, Restraints, dated June 2020, the P&P indicated, .Physical Restraint is defined as any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body. This may include bed rails, .if underlying causes of medical symptoms cannot be eliminated, alternative measures must be tried before a restraint is used .if the Facility is utilizing bed rails, the assessment Bed Rail Entrapment Risk Assessment .will be completed by a Licensed Nurse prior to the installation of bed rails .if a bed rails is being used as an enabler, the resident must be able to easily and voluntarily get in and out of bed when the equipment is in use. If the resident cannot easily and voluntarily release the bed rails and/or use the bed rails to reposition, the use of the bed rails may be considered a restraint . During a review of the manufactured guidelines titled Assist Rails retrieved from http://www.invacare.com/doc_files/1130185.pdf dated 1/26/2017 indicated, .The assist rails have three positions: Guard (Down) A: This position is intended to prevent an individual from inadvertently rolling out of bed. Assist (Up) B: Assist the user in the standing or sitting in bed. Transfer (Back) C: Allows unimpeded access to user. When changing position of the assist rail, hold and raise the rail with one hand while pulling the adjustment knob outward with the other hand . During a review of professional reference from the FDA- Food and Drug Administration, titled A Guide to Bed Safety Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts retrieved from https://www.fda.gov/medical-devices/hospital-beds/guide-bed-safety-bed-rails-hospitals-nursing-homes-and-home-health-care-facts dated 12/11/17, indicated, . Today there are about 2.5 million hospital and nursing home beds in use in the United States. Between 1985 and January 1, 2009, 803 incidents of patients* caught, trapped, entangled, or strangled in beds with rails were reported to the U.S. Food and Drug Administration. Of these reports, 480 people died, 138 had a nonfatal injury, and 185 were not injured because staff intervened. Most patients were frail, elderly or confused . Patients who have problems with memory, sleeping, incontinence, pain, uncontrolled body movement, or who get out of bed and walk unsafely without assistance, must be carefully assessed for the best ways to keep them from harm, such as falling. Assessment by the patient's health care team will help to determine how best to keep the patient safe . Potential risks of bed rails may include: Strangling, suffocating, bodily injury, or death when patients or part of their body are caught between rails or between the bed rails and mattress. More serious injuries from falls when patients climb over rails. Skin bruising, cuts, and scrapes. Inducing agitated behavior when bed rails are used as a restraint. Feeling isolated or unnecessarily restricted. Preventing patients, who are able to get out of bed, from performing routine activities such as going to the bathroom or retrieving something from a closet . During a review of professional reference from the FDA- Food and Drug Administration, titled FDA Entrapment Zones and Guidelines undated, indicated, . This product [bed rail] in not [is not] recommended for individuals with cognitive problems (difficulty in understanding their surroundings) . 2. During an observation on 11/4/21, at 2:38 p.m., in Resident 16's room, Resident 16 was asleep in bed. Resident 16 had a half beds rail on the upper left and upper right side of the bed in the guard position; the right side of the bed was next to the wall. During a concurrent interview and record review, on 11/4/21, at 3:38 p.m., with LVN 5, Resident 16's EHR as reviewed. LVN 5 stated Resident 16 did not have a physician's order, Care Plan, and consent prior to the use of bed rails. Resident 16's Enabler [a bed rails used to facilitate movement /Restraints-Physical [a device used to impede movement] initial evaluation) was reviewed. The Enabler/Restraint-Physical (initial evaluation), dated 6/1/18, indicated, .Reason for use of physical restraint . No restraints in use . History/Alternatives Attempted . No restraints in use .Communication . Family/POA [Power of Attorney], Decision Maker notified . No . Restraint Order . No . During an interview on 11/4/21, at 3:38 p.m., with LVN 5, LVN 5 stated there should be a physician's order, entrapment assessment, consent, and care plan prior to use of bed rails for Resident 16. During a review of Resident 16's MDS and physical assessment dated [DATE], the MDS indicated Resident 16's BIMS score was 4 which indicated severe cognitive impairment. Resident 16's functional status assessment indicated Resident 16 required two-person extensive assistance from staff with bed mobility. 3. During an observation on 11/4/21, at 2:42 p.m., in Resident 11's room, Resident 11 was asleep in bed. Resident 11 had a half bed rail on the upper right and upper left side of the bed. During a concurrent interview and record review, on 11/4/21, at 3:21 p.m. with LVN 5, Resident 11's Physician's Order, dated 2/13/19 was reviewed. Resident 11's physician's order indicated, .side rail/enabler bed mobility . Resident 11's Enabler/Restraint-Physical (initial evaluation), dated 1/11/19 was reviewed. The Enabler/Restraint-Physical (initial evaluation) indicated, .Reason for use of physical restraint . No restraints in use . History/Alternatives Attempted . No restraints in use . Communication . Family/POA [Power of Attorney], Decision Maker notified . No . Restraint Order . No . Resident 11's Care Plan, dated 1/30/19 was reviewed. Resident 11's care plan indicated, .I have physical functioning deficit related to: limited assistance need with ADL's [Activities of Daily Living] . I will improve or maintain my current level of physical functioning. Assistive devices (assist bar [a bed rail used to facilitate movement] to one side of the bed) . LVN 5 stated Resident 11 had no consent prior to the use of the half bed rails . During an interview on 11/4/21, at 3:38 p.m., with LVN 5, LVN 5 stated there should be a physician's order, entrapment risk assessment, consent, and care plan prior to the use of bed rails for Resident 11. 4. During an observation on 11/4/21, at 2:50 p.m., in Resident 8's room, Resident 8 was asleep in bed. Resident 8 had a half upper bed rails on both side of the bed in the guard position. During a concurrent interview and record review, on 11/4/21, at 3:13 p.m., with LVN 5, Resident 8's EHR was reviewed. LVN 5 stated Resident 8 did not have a physician's order, care plan, and entrapment risk assessment prior to use of bed rails . During an interview on 11/4/21, at 3:38 p.m., with LVN 5, LVN 5 stated there should be a physician's order, entrapment assessment, consent, and care plan prior to use of bed rails for Resident 8.