**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and document review the facility failed to ensure safe mechanical lift transfers were completed along with following manufacturer guidelines for Med Care lift that expired, and ensuring correct sling/harness sizes for 7 of 7 residents (R4, R5, R6, R7, R8, R9, R10) who utilized this mechanical lifts. This resulted in an immediate jeopardy (IJ) for R1 who fell from the Med Care sit to stand lift resulting a fractured right femur (thigh bone) on 10/9/23. This had the likelihood for serious harm, impairment or death for R4, R5, R6, R7, R8, R9 and R10 who continued to use this Med Care sit to stand lift. In addition, the facility failed to ensure a preventive lift maintenance program was followed and staff had knowledge of using the correct size harness/sling size for their mechanical lifts. The IJ began on 10/9/23 at 9:05 p.m., when facility staff did not use two staff to transfer R1 in accordance with the care plan and follow manufacturer guidelines for Med Care lift that had expired. The regional director of operations (RDO), Administrator, the Interim director of nursing (DON) and regional nurse consultant (RNC) were notified of the IJ on 10/26/23 at 4:19 p.m. The IJ was removed on 10/27/23 at 12:30 p.m., but the deficiency remained at a lower scope and severity of a E with no actual harm with potential for more than minimal harm that was not immediate jeopardy. Findings include: R1's facility reported incident (FRI) dated 10/10/23, indicated nursing assistant (NA)-A transferred R1 via sit to stand to toilet. R1 became weak and fell from the lift. NA-A notified registered nurse (RN)-A immediately. RN-A assessed the resident noted to be in pain and called 911 for transfer to the emergency department (ED). R1's face sheet indicated diagnoses of dementia, right sided weakness from stroke, disorientation, restlessness, agitation, and fractured lower right femur (10/9/23). R1's quarterly Minimal Data Set (MDS) dated [DATE] indicated R1 required extensive assist of two staff for bed mobility, transfers, toileting, and dressing. R1 did not walk and used a wheelchair. No history of falls and no range of motion (ROM) impairments. The cognition section was not identified on this assessment, or 6/8/23 assessment. For the significant change MDS assessment dated [DATE], indicated R1 had intact cognition and had no behaviors. R1's care plan for transfers dated 7/23/22, indicated assist of two staff with mechanical lift. No indication of which lift or sling/harness size. Review of facility's Care Sheet (sheet for NAs to direct resident care) dated 10/24/23, after the fall, indicated R1 required assist of 3 staff and mechanical lift. Care sheet did not mention which mechanical lift or size of sling/harness to use. R1's progress note dated 10/9/23, identified the following: Review of R1's progress notes indicated on 10/9/23: -11:10 p.m. call placed to Mayo ER (emergency room) department and spoke with the ER nurse and stated resident did have a fractured right femur and was admitted to the hospital. -11:38 p.m. resident was being helped with bedtime cares by staff when this writer was called to resident's room. Upon arrival, resident was lying down on the floor on his back crying and stating I think I broke my leg it hurts so bad. Assessment done, resident was unable to move his right leg and with passive range of motion. Resident kept screaming stating it hurts. Right leg was warm to touch and slightly bent sideways. Nurse manager and agreed resident to send R1 to ER, family member informed of the incident. Emergency Medical Services arrived at the facility at 9:40 p.m. and left accompanied with paramedics at 9:56 p.m. to the ER. -10/10/23 at 1:40 a.m., above incident happened on 10/9/23 at 9:05 p.m. Facility incident report dated 10/9/23, did not identify a causal factor to the fall for R1. R1's hospital Discharge summary dated [DATE], indicated on 10/9/23 R1 had a fall from a hoyer lift and per x-ray was found to have a broken distal (bottom end) right femur (thigh bone) that also involved his right knee replacement. R1 had surgery to fix the fracture and returned to the facility on [DATE] with non-weight bearing (NWB) status to the right leg. During an observation of transfers with R1 on 10/24/23 at 4:29 p.m., R1 was assisted by three staff members to transfer from his wheelchair to a recliner in the commons area via EZ full body lift. The lift sling was already under him and the 3 staff members, one to support R1's right leg, one to pull R1 back into the recliner and one to run the lift. Sling loops were attached to the lift and double hooked. During the transfer the sling was incorrectly placed too high as a result R1's upper buttocks was hanging through the sling and his pants were sliding down. The sling should be two inches below R1's tail bone and the top of the sling parallel to the base of the neck per manufactures recommendations. NAs did not stop the transfer or lower resident to reposition the sling. R1 stated, everyone can see my butt. Staff lowered R1 into the recliner, removed the loops from the EZ full body lift and raised the foot of the recliner and left the sling under R1. Review of the EZ Way Sling Sizing Chart (undated) identified the sling should be two inches below R1's tail bone and the top of the sling parallel to the base of the neck. During an interview on 10/25/23 at 10:23 a.m., NA-T stated he worked the day of R1's fall on 10/9/23 at 9:05 p.m. NA-T heard R1 scream and went to R1's room and saw R1 on the floor next the head of the bed with the Med Care sit to stand in front of him. NA-A was holding the harness. NA-T stated he had gone over the care sheets with NA-A making sure to let NA-A know that R1 was assist of two staff for all transfers, at the beginning of the shift and gave NA-A a radio to call and ask questions. He could not remember what size sling R1 was using at time of the fall. NA-T also stated the nurse manager assessed the resident to determine the correct harness size. If this was not on are the care sheet,he would ask the nurse or nurse manager. During interview on 10/25/23 at 11:24 a.m., RN-A stated she was working the shift of R1's fall. RN-A was at the nurses' station when NA-A came out of R1's room and asked for help. RN-A stated NA-A was transferring R1 from wheelchair to commode with the Med Care sit to stand lift by herself when R1 slid down to the floor. RN-A stated the care plan stated transfer with assist of 2 staff with sit to stand lift. RN-A could not articulate who decided what size sling/harness to use or what size harness R1 used at the time of the fall. During observation on 10/24/23 at 4:03 p.m., the facility identified they were using the following mechanical lifts for their current resident: -Med Care - Care Stand Total support Model number 400002, six lifts all with a large size harness hanging across the lift. Seven residents used these lift (the facility refers to this lift as EZ stand in their documentation). -EZ Lift total body lift, 3 lifts, slings located on residents or in their rooms, 14 residents used this lift. R4 R4's face sheet indicated the following diagnoses, dementia with behavioral disturbances, osteoporosis and history of falling. R4's quarterly MDS dated [DATE], indicated R4 had impaired cognition and required extensive assist of one for transfers, bed mobility and toileting. R4's had one fall without injury prior to assessment and used a wheelchair. R4's care plan therapy recommendations R4 was assist of 1 staff with EZ stand (Med Care Stand) for all transfers including toileting, dated 6/25/18. Care plan lacked identification of what size harness to use. Review of the R4's facility's care sheets 10/24/23 indicated transferred with EZ stand (Med Care Stand) and assist of one but did not identify the size of harness R4 required for safe transfer. R4's Lift and Mobility status form dated 6/20/23, indicated R4 was assist of one staff with EZ stand (Med Care lift). There was no harness size identified. R5 R5's face sheet indicated the following diagnoses of cervical disc disorder with myelopathy and severe sepsis with septic shock. R5's nursing assessment dated [DATE], indicated an intact cognition and transferred with physical assist of two staff, had ROM impairments to his lower extremities, used a wheelchair and no history of falls. R5's care plan dated 10/24/23, direct staff to transfer R5 with mechanical lift and max assist of two for bed mobility. Review of the facility's care sheets for R5 dated 10/24/23, indicated R5 transferred with mechanical lift and max assist of two for bed mobility. Care sheets did not indicate which mechanical lift or the size of sling/harness to use for R5. R5's record lacked a comprehensive assessment to determine which mechanical lift including sling/harness R5 required to ensure they were safe during these transfers. R6 R6's face sheet indicated the following diagnoses vertebrogenic low back pain, systemic lupus erythematosus, osteoporosis, and wedge compression fracture of fifth vertebra. There was no MDS available for R6. R6's alteration in mobility care plan indicated R6 transferred with mechanical lift and assist of two staff, start date of 10/17/23; TLSO (ridged back brace) to be worn when out of bed and when head of bed greater than 30 degrees, no bending, twisting or lifting greater than 10 pounds, start date of 10/18/23. Care plan did not indicate which mechanical lift to use for R6. Review of the facility's care sheet 10/24/23 indicated R6 transferred with EZ stand (Med Care) and assist of two staff. Care sheets lacked the size of harness R6 used for safe transfer. R6's lift and mobility status assessment dated [DATE], indicated R6 transferred with assist of two staff and EZ stand (Med Care lift). The lift harness size was not identified. R7 R7's face sheet indicated the following diagnoses acute kidney failure and weakness. R7's care plan indicated an alteration in mobility related to acute kidney injury, chronic obstructive pulmonary disease, major depressive disorder and atrial fibrillation as evidenced by needing assistance with cares, dated 10/19/23. The following interventions were in place: -assist of one staff for ambulation, start date 10/19/23, -assist of one staff with movement in and out of bed, start date 10/19/23, -maximal assist of two staff for transfers, use mechanical lift stand from low surfaces. Max assist of two staff for bed mobility, does not ambulate at this time. Transfers with assist of two staff and two wheeled walker in room. Can use EZ stand (Med Care) if patient is tired in evening, start date 10/19/23. There was no mention of the harness size. Review of the facility's care sheet indicated R7 transferred with assist of two and a two wheeled walker in and R7 could use the EZ stand (Med Care) if tired in the evening. There was no mention of harness size. R7's lift and mobility assessment dated [DATE], indicated R7 transferred with maximal assist of two and mechanical stand per therapy recommendations. Staff to continue to monitor for safety. There was no mention of which mechanical lift or harness size to use for R7. R8 R8's face sheet indicated the following diagnoses of spondylosis without myelopathy or radiculopathy, cervical region, weakness, osteoporosis, and spinal stenosis cervical and lumbar region. R8's quarterly MDS dated [DATE], indicated R8 required assist with transfers and did not walk. R8 used a wheelchair. Cognition section not filled out for this assessment, previous quarterly assessment dated [DATE], indicated intact cognition. R8 had no history of falls. R8's alteration in mobility care plan indicated R8 transferred with EZ stand (Med Care), assist of two with movement in bed and in/out of bed, dated 8/13/21. There was no mention of harness size for R8. Review of the facility's care sheet dated 10/24/23, R8 was assist of one with EZ stand (Med Care). There was no mention of harness size to use for R8. R8's record lacked a comprehensive assessment to determine which size sling/harness R8 required to ensure they were safe during these transfers. R9 R9's face sheet indicated the following diagnoses of stroke, and cervicalgia. R9's annual MDS dated [DATE], indicated an intact cognition and required maximal assist with transfers and did not walk. R9's alteration in mobility care plan indicated R9 transferred with assist of 1 and EZ stand (Med Care), did not ambulate, and assist of one with movement in bed and in/out of bed, start date of 10/5/20. Review of the facility's care sheet dated 10/24/23, indicated R9 transferred with EZ stand (Med Care) with assist of one staff with medium harness. Even though the facility only had large harnesses on the floor in use as a result of the observation on 10/24/23 at 4:03 p.m R9's record lacked a comprehensive assessment to determine which size sling/harness R9 required to ensure they were safe during these transfers. R10 R10's face sheet indicated the following diagnoses of weakness, and age-related disability. R10's quarterly MDS dated [DATE], indicated R10 was dependent on staff for transfers, no history of falls, did not walk and used a wheelchair. R10's fall risk care plan indicated R10 was assist of two staff and EZ stand (MedCare), start date 10/10/23. Transfer care plan indicated EZ stand (Med Care) and assist of one staff, dated 8/1/19. Review of the facility's care sheet dated 10/24/23, indicated R10 transferred with EZ stand and assist of two staff. Care sheet lacked what size of harness R10 needed to transfer. R10's record lacked a comprehensive assessment to determine which sling/harness size, R10 required to ensure they were safe during these transfers. During an interview on 10/25/23 at 9:31 a.m., NA-R stated staff follow the care plan/care sheets to transfer residents. NA-R looked at the care sheet and stated it did not state which harness size to use with the Med Care sit to stand lift. NA-R could not remember when she last had training on the lifts the facility used. NA-R stated the sit to stand lifts should say on the care sheet whether one or two staff needed and there are always two staff with the EZ lift. During an interview on 10/25/23 at 9:39 a.m. NA-S and NA-A stated they would look at the care sheets for how to transfer any resident, if not there they would ask the nurse manager. During an interview on 10/25/23 at 12:55 p.m., speech therapist (ST)-A, director of therapy, indicated therapy does an initial assessment of new admissions for proper transfer techniques for resident. Therapy would tell nursing which type of mechanical lift to use but nursing would have to identify the sling/harness size to use as part of their nursing assessment. There is no formal assessment kept in our therapy notes for the lift they are to use, we just recommend the lift type to nursing staff. During an interview on 10/25/23 at 2:40 p.m., NA-T stated nurse managers indicated the size of harness used for the EZ stand (Med Care ) and there was a chart on the EZ lift to determine what sling to use. During an interview on 10/25/23 at 2:56 p.m., licensed practical nurse (LPN-B) who was the nurse manager, stated sling/harness sizes should be in the therapy orders as therapy does the transfer assessment. If not, they would base it off resident weight in their chart and put on the care sheet. NAs could look at therapy notes as well. During an interview on 10/25/23 at 3:00 p.m., RN-C stated she would rely on the NA's as they are competent on knowing what size of sling/harness to use. RN-C would check therapy notes as therapy does an assessment when residents admitted . If residents are on the LTC side then the nurse assessment should show which size to use. The facility's copy of the manufacture's operation manual, revised date 9/2010, page 9 - 11, informed reader how to operate the Med Care - Care Stand, but there was no sizing guide for harnesses even though the facility had other sizes. The facility also did not use a guide or any reference to determine harness size for each resident who used Med Care lift. Preventative Maintenance During an interview on 10/26/23 at 8:15 a.m. MM-A indicated preventative maintenance (PM) was completed monthly on all the lifts. Review of facility's form labeled, Weekly audit for functionality for all facility lifts and stand wear/tear on slings. The form had four areas labels: stand/lift number, location, functioning properly yes/no and slings in good working condition yes/no. Under stand lift identified the stand number (Med Care) and lifts (EZ Lift). The location was identified as east, west or north wing. Functioning properly column identified a yes or no. The column slings in good working condition only identified the stands (Med Care) as yes, there were no notion if the EZ lift slings were reviewed. MM-A stated he would test the buttons of the lift so they would go up and down, tested the emergency stop button and made sure the lifts rolled well by rolling it around in a circle. MM-A was not able to articulate the manufactures recommendations for PM and did not use manufactures provided check list for PM. MM-A completed PM on 10/10/23 on all lifts per his checklist and was unsure if the lift involved in R1's incident was removed from the floor until MM-A performed PM on it before returning it to the floor for use. He was unable to articulate the age of the lifts in use or other specific about the required maintenance by the manufacturer. Review of the Med Care's manufacture's operation manual model number 400002, revised 9/2010, on page 24-25 indicated the routine maintenance was a vital component to keeping the equipment in safe operating condition. A machine that is not properly maintained could create potentially hazardous situations for nursing staff and patients. Check list were to used for PM. The PM checklist had two column, pass or fail. Under general maintenance indicated the following: -Actuator and connections- check the operation of the actuator. Remove bolts and check for lithium grease. If none present, apply and re-insert. Use of a thread locker is recommended when re-attaching nut to bolt. -Actuator- check the up and down movement. If it makes noise or wobbles, it should be inspected. -Actuator cover- clean and check for wear and tear. -Base cover- clean and check for cracks and sharp edges. -Boom/arm pivot pins and bushings- check the area where the arm or boom meets the mast. Be sure the nut and bolt are securely attached. If not operating smoothly, remove bolt and apply lithium grease. Re-insert the bolt; apply thread locker, and secure nut. -Front casters- clean debris from casters and test for smooth rolling. -Hand control- check for smooth operation. -Leg covers- clean and check for sharp edges- -Leg bolts- remove base cover and check to make sure bolts are flush with the base. If not, tighten. Periodically remove bolts, apply lithium grease, and re-insert using thread locker on the threads. -Leg spreader pivot bar- check the bolt on the base and make sure the nut is at least 2 threads inside the end. This nut may be adjusted to your preferred tension. -Mast/base bolts- check bolts to make sure they are re tight. If not, remove, apply thread lock and re-tighten. -Rear casters- clean and remove debris. Check to make sure the brakes are working properly and that the wheels are firmly attached. -Receiver box- clean and check for operation. Check that the on/off switch is functioning properly. Try out the toggle switch, and verify both the up and down motion of the actuator. -Batteries- check for damage to plug, and check voltage. -Slings/harness and belts- inspect slings/harness and belts for wear and tear before every use. Immediately remove any damaged slings/harness and belts from service and replace. Under the stand maintenance it indicated the following: -Foot platform- remove the platform and clean. Be sure to remove the plastic footplate cover and clean underneath. Pay attention to the plastic and check for sharp edges. -Knee pad assembly- check for tears and clean the leg strap and surface of pad. -Padded hand grips- clean hand grips, and check that they are pushed all the way on. -Arm pads- clean and check for wear and tear. -Foot pedal- check for smooth operation. In addition, the manufacture recommended replacement of the following: -Actuators to be replaced after 4 years of use -Support bar on lifts replace when excessive wear is apparent -Slings to be replaced after 2 years of use. During an interview on 10/25/23 at 4:38 p.m., Med Care representative (CSR-A) stated the harness sizing was based on the resident's waist measurements. The Med Care lift, model number 400002 (the lift the facility used) were manufactured in 2009 was discontinued in 2015. All the facilities that had this lift received a Tech Bulletin identifying the manufacture would continue to supply parts for 7 years after the discontinuation date (2021). The unit should not be used longer than this date, they could not ensure the safety of the resident during transfers with these lifts. CSR-A identified Med Care's expectation is the facility would report any incident involving their equipment to them. During an interview on 10/25/23 at 1:04 p.m., DON could not state the Med Care sit to stand lift R1 fell from was removed from the floor until the next morning when MM-A inspected it. DON also stated that the facility did not have a mechanical lift policy but followed the manufactures recommendations. During a clarification interview on 10/26/23 at 8:35 a.m., DON confirmed that all Med Care harness were size large that were on the floor. Other sizes were stored in the basement and available if needed. DON was not able to identify how the harness or sling size was determined for each resident. She was also unaware the Med Care- Care Stand Total support, model number 400002 was retired in 2015 and no longer supported by the company. During an interview on 10/26/23 at 10:11 a.m., RDO and Administrator both acknowledged they did not know there was a life span to lifts or that the Med Care- Care Stand Total support lift the facility was using was discontinued in 2015. Further more, they were not aware the facility did not have a system in place for harness sizing for safe transferring of residents with the Med Care- Care Stand Total support, model number 400002. During an interview on 10/26/23 at 1:37 p.m., the food and drug administration (FDA), stated the Med Care Stand, model number 400002 was no longer registered with the FDA. If the facility continued to use the unregistered device, the facility needed to have someone that supported the product to render it safe to use. The FDA further stated that if the expired device was involved in an incident that may have resulted in serious harm or death, the device would need to be reported to the FDA by the manufacturer under 42 CFR 803.3, it did not matter if the incident was caused by operator error or equipment failure. During an interview on 10/25/23 at 3:31 p.m., with EZ Way Lift representative stated the sling sizes was based on the sizing charts that are on each lift. The slings are color coded per size based on weight. The chart also explains and shows how to place the slings properly for a safe transfer of the resident. The immediate jeopardy that was identified on 10/26/23 at 4:19 p.m., was removed on 10/27/23 at 12:30 p.m., when it was verified, the facility implemented the following corrective actions: -Review manufacture's recommendations in conjunction with their mechanical lift transfer policy and procedures -Revise policy/procedure to ensure they are being used according to manufacture guideline -Remove all Med Care standing lifts that are not supported by manufacturer from the floor -Inspect all lifts for safe operation according to manufactures recommendations -Develop and educate nursing/physical therapy (PT)/ occupational therapy (OT) on completing comprehensive harness/sling assessments in accordance with manufacture's recommendations and develop/revise care plans as appropriate -Educate staff on appropriate positioning of the slings/harness and immediately removing equipment from service following an incident -Complete a return demonstration after education on all staff who use the mechanical lift, to ensure they are following facility policy and manufacture guidelines for a safe transfer.