**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review, observation, review of the emergency department records, review of the weekly wound notes and skin assessments, review of the wound consultation notes, review of the National Pressure Ulcer Advisory Panel (NPUAP) wound stages, staff interviews and review of the facility policy, the facility failed to properly monitor a medical device resulting in a pressure ulcer. This resulted in actual harm when Resident #21 developed an unstageable pressure ulcer to the posterior of the left lower extremity. The facility also failed to ensure additional pressure relieving interventions were in place after Resident #34 developed an unstageable pressure ulcer. This resulted in actual harm when Resident #34's pressure injury further deteriorated. In addition, the facility failed to ensure pressure reducing interventions were in place and wound treatments were completed per physician orders for both (#21 and #34) residents. This affected two (#21, #34) of four residents reviewed for pressure ulcers. The facility identified six residents with pressure ulcers. The facility census was 43. Findings include: 1. Review of the medical record revealed Resident #21 had an admission date of 03/25/16. Diagnoses included unspecified fracture of shaft of left tibia, fracture of upper and lower end of left fibula, dementia without behavioral disturbance, depressive disorder, vascular dementia, peripheral vascular disease and osteoarthritis. Review of an emergency department note dated 05/19/21 at 5:05 A.M., revealed Resident #21 apparently fell out of bed this morning and was complaining of left lower extremity pain. The resident was noted with very limited motion at the left lower extremity because of pain. The resident was noted with a fracture of proximal end of tibia and fibula and a left tibial plateau fracture. After consult with orthopedics, the resident was noted as non-ambulatory and non-weight bearing and was placed in a well-padded knee immobilizer. The resident would follow up with orthopedics. Review of a nurses note dated 05/19/21 at 11:00 A.M., revealed the resident returned from the emergency department at 10:51 A.M. Review of a physician order dated 05/22/21, revealed to remove leg immobilizer to left leg every shift and check skin integrity every shift. Review of the treatment administration record (TAR) dated 05/22/21 through 06/24/21, revealed staff documented the leg immobilizer was removed each shift to monitor the resident's skin integrity. Review of Resident #21's weekly skin and wound total body skin assessments dated 06/07/21, 06/14/21, and 06/21/21, revealed no newly identified skin conditions. Review of a physician note dated 06/17/21, revealed Resident #21 had some general decline since her fall out of bed on 05/19/21, resulting in comminuted fractures of the proximal tibia and fibula being treating conservatively given age and advanced dementia with knee immobilizer. The physician noted the resident initially denied discomfort. The physician gently rotated the leg slightly and the resident complained of pain, more irritable and told the physician to stop. The physician noted an added bandage on the left heel, peeled back and the resident had a Stage II linear wound with no edema noted. Review of a nurses note dated 6/25/21 at 1:54 P.M., revealed Resident #21's immobilizer to the left leg was removed today to assess skin. A wound was noted to the left posterior lower leg; approximately 5.6 centimeters (cm) in length and 4.9 cm in width. Eschar was noted to the wound. There was a moderate amount of purulent drainage on the immobilizer. The physician ordered an antibiotic, Keflex 500 milligrams (mg) by mouth three times per day for ten days and to cleanse the area to the wound with normal saline, apply Santyl to eschar, cover with non-adherent dressing and wrap with Kerlix and paper tape. The physician ordered to discontinue the resident's leg immobilizer. Review of a physician order dated 06/25/21, revealed to administer Cephalexin 500 milligrams by mouth three times per day for the wound to left leg for ten days. Review of a skin and wound evaluation completed on 06/25/21 at 10:42 A.M., identified with a new facility acquired unstageable pressure ulcer to the left calf. The wound was unstageable due to slough and/or eschar. The wound measured 5.6 centimeters (cm) in length by 4.9 cm in width with no depth, no undermining and no tunneling. The wound bed was described as eschar with no percentage documented. There was redness/inflammation and increased pain with moderate purulent exudate. There was no documentation regarding odor or the periwound edges. The surrounding skin was noted as erythema. Pitting edema extending less than four centimeters around the wound. The new wound had suspected infection. The nurse practitioner was notified. Continued review of the wound note revealed the physician evaluated the wound and a treatment was in place. Review of a wound consult note dated 06/29/21, revealed the resident had history of fall in 05/2021, with immobilizer to the left leg. Nursing reported new wound to left posterior leg from immobilizer. The resident was noted on the antibiotic Keflex for a leg wound infection. The unstageable wound to the left posterior leg measured 5.2 cm in length by 5.1 in width by 0.4 cm in depth. The wound had moderate serous exudate with 100% slough/eschar. Debridement was completed to remove slough and eschar increasing depth to 0.5 cm. The wound practitioner ordered to cleanse with normal saline, pat dry, apply Santyl to wound bed, cover with 0.125% Dakins moist gauze, cover with abdominal pad (ABD) and gauze wrap, change daily and as needed. Review of the Treatment Administration Record (TAR) revealed the treatment to the left lower leg was not completed on 07/03/21, 07/14/21 and 07/18/21. Review of the wound nurse practitioner progress notes dated 07/09/21, revealed the wound to the posterior lower left extremity (LLE) measured 5.6 cm in length by 4.4 cm in width x 0.7 cm in depth. The wound was described as improving and had moderate serous exudate. The wound was 90% slough and eschar and 10% granulation tissue. Post debridement, the wound depth increased to 0.7 cm. Previous treatment orders were continued. Review of the wound nurse practitioner progress notes dated 07/20/21, revealed the unstageable wound to the posterior LLE measured 5.68 in length by 5.44 cm in width by 3.2 cm in depth. T he area was 30% slough/eschar and 50% granulation tissue with moderate serosanguinous drainage and 20% tendon noted with 30% adipose and eschar mixture. No new treatment orders were initiated. Review of a significant change Minimum Data Set (MDS) assessment dated [DATE], revealed Resident #21 had impaired cognition. The resident required the extensive assistance of two staff for bed mobility, toileting, transfers and personal hygiene. The resident was at risk for developing pressure ulcers. The resident was noted with three unstageable pressure ulcers. Review of a physician order dated 07/24/21, revealed to offload bilateral lower extremities by placing pillow under knees and calves, then noodle under ankles. Reposition frequently throughout shift on all three shifts. Review of the wound nurse practitioner progress notes dated 08/03/21, revealed the wound to the posterior LLE measured 7.5 cm in length by 7 cm in width by 1.5 cm in depth. The wound was 90% slough and eschar and 10% granulation tissue. The wound was described as a Stage IV with muscle and tendon exposed with a large amount of serous drainage. A new wound treatment was ordered to apply Santyl, nickel thick to wound bed, cover with Alginate dampened with Metronidazole solution for odor control, cover with four-by-four gauze, abdominal pad and gauze wrap, change daily and as needed. Review of the wound nurse practitioner progress note dated 08/10/21, revealed the posterior Stage IV LLE wound measured 9.5 cm in length by 7 cm in width by 2.4 cm in depth. Muscle and tendon exposed with a large amount of serosanguinous exudate. T he wound was 60% eschar/slough with 15% granulation tissue. Post debridement, the wound increased to 3.5 cm in depth. No new treatment orders were issued. Interview on 08/17/21 at 1:30 P.M., with Licensed Practical Nurse (LPN) #201, stated Resident #21 had a leg brace which caused her wounds. Two unsuccessful attempts were made to interview Wound Certified Nurse Practitioner (WCNP) #70 on 08/18/21 at 3:46 P.M. and on 08/19/21 at 1:42 P.M. Observation on 08/17/21 at 1:35 P.M., revealed the pool noodle ordered to elevate the resident's heels off the bed was incorrectly placed under her knees instead of her ankles. Further observations on 08/17/21 at 4:15 P.M., and 4:26 P.M., on 08/18/21 at 8:02 A.M., and 08/19/21 at 8:14 A.M., revealed the pool noodle was incorrectly placed under the residents knees or lower posterior legs. Observations and interview on 08/17/21 at 4:26 P.M. with State Tested Nursing Assistant (STNA) #122, revealed the resident had pool noodles to keep her heels off the bed. The pool noodle was located under the resident's knees and not under her heels per the physician order. STNA #122 stated the noodle was placed between the mattress and the bed sheet then pillows on top of noodles. STNA #122 was unaware the noodle placement was incorrect. Observation on 08/18/21 at 10:11 A.M. of Resident #21's wound care, revealed LPN #201 completed wound care to the resident's left posterior lower leg. The wound bed was deep, oblong, and red with slough present. Muscle, tendon, and bone were visible. LPN #201 completed the wound treatment per physician orders. Interview on 08/18/21 at 12:43 P.M. with LPN #201, stated when she removed the resident's leg immobilizer on 06/25/21, she lifted the resident's leg and noticed the wound underneath. LPN #201 stated during morning report, the previous shift had not reported any new skin areas. LPN #201 stated she measured the area. LPN #201 stated the wound had eschar and was dark. LPN #201 stated she notified the family, physician and the Director of Nursing. LPN #201 revealed the immobilizer skin integrity checks were not getting done correctly. LPN #201 revealed most likely the skin under the resident's leg was not getting checked as movement of the leg caused the resident discomfort. Interview on 08/18/21 at 1:12 P.M., with Registered Nurse (RN) #208, stated the resident had an unstageable pressure ulcer from her leg immobilizer. RN #208 could not recall any skin issues during the resident's skin checks. Interview on 08/18/21 at 2:37 P.M., with the Director of Nursing (DON), stated staff notified her of the wound. The DON stated she called the physician to assess the wound immediately. The DON stated the none of the nurses admitted to not checking the resident's skin. The DON stated some of the nurses stated the resident was agitated during the skin checks and they had not assessed the skin underneath the leg. The DON stated the nurses should have provided pain medication then completed the skin assessment. Continued interview with the DON, revealed prior to the wound discovery, the nurses had not reported they could not complete the skin inspections due to resident pain. The DON stated she educated the nurses regarding the immobilizer skin check procedures. The DON stated the education had not included a demonstration on how to check the skin under the immobilizer device. Interview on 08/19/21 at 8:14 A.M. with LPN #202, verified the pool noodle was placed under the resident's knees. LPN #202 reviewed the physician order and revealed the pool noodle should be placed under the resident's ankles and not her knees. Interview on 08/19/21 at 9:04 A.M., with Physician #80, indicated the wound on the resident's posterior leg was consistent with the edge of the leg immobilizer. Physician #80 further revealed he had not removed the resident's leg immobilizer during a visit on 06/17/21. Physician #80 further revealed he had not assessed the wound on 06/25/21. Interview on 08/19/21 at 9:31 A.M. with Corporate Clinical Registered Nurse (CCRN) #300, verified there was no documentation in the nurses notes the resident had refused to allow staff to remove the leg immobilizer to check skin integrity. CCRN #300 also verified the wound treatments to the resident's left leg were not completed on 07/03/21, 07/08/21 and 07/18/21. Review of a physician progress note addendum dated 08/19/21 at 10:31 A.M., revealed the physician was informed by the Administrator of a wound to the left lower leg, pressure from immobilizer. The physician noted the resident was in bed, as usual, flat on back. Painful for patient to have leg moved, wound was posterior and freshly dressed, so elected to rely on nursing's description of wound at that time. Area compatible with lower edge of immobilizer. Treatment orders given and ordered a wound consult. Review of the National Pressure Ulcer Advisory Panel (NPUAP) wound staging definitions revealed a Stage IV pressure injury was full thickness skin and tissue loss with exposed or directly palpable fascia, muscle, tendon, ligament, cartilage or bone in the ulcer. Slough and/or eschar may be visible. An unstageable pressure injury was full thickness skin and tissue loss in which the extent of tissue damage within the ulcer cannot be confirmed as it obscured by slough or eschar. Review of the facility policy titled, Skin Management, dated 10/2019, revealed the facility should identify and implement interventions to prevent development of clinically unavoidable pressure injuries. 2. Review of the medical record for Resident #34 revealed a readmission date of 07/10/21. Diagnoses included chronic obstructive pulmonary disease, Type II diabetes, hypertension, major depression, anemia, and schizoaffective disorder. Review of the admission nursing assessment identified Resident #34 was admitted with a Stage I pressure ulcer to the coccyx and one unstageable pressure area to the left heel. No other pressure ulcers were noted. The resident had a pressure reducing device for the bed with nutrition and hydration to manage. Review of the physician orders for 07/18/21, identified an order for a Prevalon boot to left the foot at all times. Review of the plan of care dated 07/20/21, revealed the resident had a pressure ulcer injury due to recent hospitalization, decreased mobility, and incontinence. Interventions included pressure reducing mattress to bed, and Prevalon boots to bilateral lower extremities at all times, may remove for ambulation and hygiene. Review of the wound monitoring sheets with onset date of 07/20/21, revealed the resident had an inhouse acquired deep tissue pressure injury on the right heel. The wound measured 1.1 centimeters (cm) by 1.1 cm by 0.0 cm deep. The wound bed was a deep tissue injury persistent non blanchable deep red, maroon or purple discoloration. Review of the wound monitoring sheets dated 07/28/21, revealed the resident had an inhouse acquired deep tissue pressure injury on the right heel. The wound measured 0.7 centimeters (cm) by 0.9 cm by 0.0 cm deep. The wound bed was deep tissue injury persistent non blanchable deep red, maroon or purple discoloration. Review of the wound monitoring sheets dated 08/10/21, revealed the resident had an inhouse acquired deep tissue pressure injury on the right heel. The wound measured 0.9 centimeters (cm) by 0.9 cm by 0.0 cm deep. The wound bed was deep tissue injury persistent non blanchable deep red, maroon or purple discoloration and treatment normal saline, no dressing applied. Review of the wound clinic note date 08/17/21, revealed bilateral heel wounds and right heel unstageable. The wound measured 1.0 centimeters (cm) by 1.5 cm by 0.0 cm deep. No undermining 100% epithelial. Recommended treatment to off load heels at all times with heel boot or with pillow. Interventions included Prevalon boot to bilateral feet at all times may remove for ambulation and hygiene per physician order. Observation on 08/17/21 at 8:20 A.M., of Resident #34, lying in bed on back without heel protectors. Licensed Practical Nurse (LPN) #201, verified the bilateral heel protectors were not on and heels were not offloaded. Interview on 08/17/21 at 8:39 A.M. with Resident #34, reported she doesn't know when she got the area on the heel, but heels were sore when lying in bed. Interview on 08/17/21 at 8:25 A.M. with Licensed Practical Nurse (LPN) #201, revealed the heel protectors were to be on at all times and remove for ambulation and hygiene. Interview on 08/19/21 at 1:15 P.M., with Corporate Clinical Registered Nurse (CCRN) #300, revealed an order for the Prevalon boot for the right heel was not added to the MAR or TAR, as it was somehow missed. She also verified the wound measurement was not completed for the week of 08/01/21 to 08/07/21. Review of facility policy titled, Skin Management, dated 10/2019, revealed at risk heel suspension devices to be offloaded.