**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on staff interviews, review of the clinical record and facility documentation, it was determined the facility failed to ensure a resident was properly monitored and assessed during a hot pack treatment. This failure resulted in actual harm to Resident R302 who sustained a burn on the right shoulder (Resident R302). Findings include: Review of the facility's undated policy, Commercial Hot Packs/Thermal Agent Treatment, indicated the rehabilitation therapist will follow established techniques when applying commercial hot packs as a treatment modality. Further review of the policy indicated the packs are stored in a thermostatically controlled cabinet in water at a temperature of 150-170 degrees Fahrenheit. Continued review of the policy indicated that prior to the application of the commercial hot packs, a physician's order will be obtained and the resident will be evaluated for any contraindications or precautions, as well as all risk and benefits are clearly communicated to the resident. Continued review of the above policy stated the following: Check area every 5-10 minutes after moist heat pack has been applied j. Remove pack after treatment, dry gently and inspect area for any unusual signs k. Discard wet linen according to facility protocol and return moist heat pack to hydrocollator (stainless-steel therapeutic liquid heating device. It is used to heat bentonite-filled cloth heating pads, which are placed on patients to achieve rapid heat for specific body muscle groups. The hydrocollator heats the pads up to 175°F. The unit contains a wire rack to prevent contact of the packs with the bottom of the tank) l. Treatment time should be 15-25 minutes. Residents should be checked every 5-10 minutes for signs of skin irritation and burning. Consideration should be taken when using commercial hot packs with individuals who demonstrate: a) Sensory impairment (e.g., diabetes, CVA (cerebral vascular accident), neuropathies (damage to one or more nerves), nerve root impairment) b) Circulatory impairment (e.g., arteriosclerosis (the thickening and hardening of the walls of the arteries), venous insufficiency, phlebitis (inflammation of a vein) c) Cancer d) Very young/very old resident e) Skin rashes Review of the user manual for Hydrocollator M-2m Mobile Heating Unit utilized by the facility revealed under section titled Safety Precaution indicated, Treatment time should not exceed 30 minutes; Always wrap the HotPac with a towel or [NAME] cover before handling or applying to patient; Constantly monitor the HotPac application to ensure that the skin is not becoming too hot. The Safety Precaution' section also indicated that damage to an individual's skin can occur from exposure to extreme heat or cold, and that the individual applying the treatment should note instructions for proper use. Continued review of the Safety Precaution section indicated the HotPac should not be applied over sensitive skin or in the presence of poor circulation and that individuals with circulatory problems should consult with a physician before using this product. During observation conducted on February 25, 2025 at 2:30 p.m. the Hydrocollator was observed in a room in the therapy department. During the above observation accompanied by the Director of Rehabilitation (Employee E5), it was reported the rehabilitation department has not utilized the unit since November 2024. Review of Resident R302's November 2024 physician orders revealed the resident diagnoses of Anemia Hyperlipidemia (high cholesterol); Hypertension (high blood pressure), and Diabetes (disease characterized by high blood sugars). Review of Resident R302's physician documentation dated November 8, 2024 at 12:48 p.m. revealed Resident R302 was admitted into the facility on November 6, 2024, for rehabilitation services after being treated at a local hospital from [DATE] through November 6, 2024 for a right lower extremity hematoma. The resident was also treated for an elevated INR (International Normalized Ratio- a measure that of how long it takes for an individual's blood to clot). Review of Resident R302's nursing note dated November 22, 2024 at 3:03 p.m. revealed the resident was discharged home on the above referenced date. Review of information submitted to the State Survey Agency on November 13, 2024 revealed, on the morning of November 13, 2024, Resident R302 complained that his/hers shoulder was irritated. Continued review of the information submitted to the State Survey Agency indicated the resident notified the licensed nurse, (Employee E6), who found a burn-like area on (his/hers) right shoulder. The resident told the nurse that his/hers shoulder was stiff at therapy the day prior (November 12, 2024) and that he/she requested heat therapy, which was applied to him/her. Review of a written statement from licensed nurse, Employee E6 dated November 13, 2024 revealed the resident reported to the nurse that his/hers should has [sic] something irritating him. Employee E6 reported that he/she unsnapped the resident's gown and that she saw open skin area to his/hers right shoulder. Employee E6 reported in her statement that the resident told her that while he/she was at therapy the towel was to hot. Employee E6 statement indicated that she notified the wound nurse, unit manager and therapy. Made wound nurse UM (unit manager) Therapy aware. Review of Resident R302's nursing note by licensed nurse, Employee E6 dated November 13, 2024 at 12:38 p.m. indicated Nurse came to residents room to give morning medication today. Resident reported to nurse that (his/hers) right shoulder is irritated. Nurse asked to look at the shoulder. Upon unsnapping the hospital gown the nurse noticed open area to right shoulder and small blister side by side of each other. Resident explained yesterday 11/12/24 (he/she) felt a draft in his/her room while sitting in the recliner in (his/hers) room by the window, which made (his/hers) shoulder (right) achy. (He/she) goes on to explain (he/she) had therapy yesterday around 2pm where (he/she) rec'd heat to the right shoulder and that the towel was put on (his/hers) shoulder for the shoulder pain. Nurse ask was the towel hot. Resident said the towel was wet and started to get hot. Nurse said ok. Wound nurse, Unit manager and Therapy made aware. During an interview with licensed nurse, Employee E6 on March 3, 2025 at 12:45 p.m. Employee E6's statement and nursing notes regarding the incident were reviewed and confirmed. Review of a nursing note from the wound nurse, Employee E7 dated November 13, 2024, at 10:48 a.m. indicated that she was notified by nurse of injury to right shoulder. Resident was in therapy yesterday receiving heat therapy to right shoulder, nurse noted this morning a burn-like area. Area presents 2.5cm (centimeters) x 2.0cm, 100% pale pink tissue, no drainage, periwound intact, adjacent intact blister 0.3cm x 0.5cm, no drainage. Appears as scar tissue that experienced sensitivity to heat source and had mild reaction when heat was applied. Cleansed area with NSS (normal saline solution), applied Vaseline and covered with foam dressing. All appropriate parties notified. Orders and care plan updated. During an interview with the wound nurse, Employee E7 on March 3, 2025, at 12:39 p.m. Employee E7's notes, including the treatment provided, description of the injured areas, including the size of the injured areas, was reviewed and confirmed with the wound nurse. Review of an undated written statement from Employee E9 (Physical Therapy Assistant-PTA) indicated the resident requested the hot pack treatment to (his/hers) right shoulder at the end of physical therapy treatment due to pain, and the PTA attended to and observed the resident during the treatment. The PTA wrote in his statement that he asked the resident multiple times if the heat felt ok, and the resident reported that it felt fine and that (resident) was without complaints. The PTA reported the resident had two layers of clothing on (his/hers) shoulder and that the hot packs were covered in wrap plus one folded towel and one extra towel. Physical Therapy Assistant, Employee E8 was terminated on November 13, 2024, the day after the incident occurred, and was not available for an interview. During an interview with the physical therapist (Employee E10) on February 28, 2025 at 1:32 p.m. it was confirmed the incident occurred on November 12, 2024 and the treatment utilizing the hotpack took place in the therapy department. When asked if the treatment the resident received from Employee E9 was an authorized treatment, Employee E10 reported the treatment modality was not authorized in the resident's plan of care with the therapy department, and the PTA did not ask a physical therapist if it was permitted to provide Resident R302 with this treatment modality. Resident's plan of care was reviewed with the physical therapist and it did not include the use of the hotpacks. Continued interview with physical therapist, Employee E10 revealed the PTA did not document the treatment modality with the hotpacks, as required by therapy department. There was no documentation the PTA observed the skin areas that were being treated during the treatment or after the treatment, or how long the treatment actually occurred, due to the absence of clinical documentation. The facility failed to ensure that Resident R302 was properly monitored and assessed by physical therapist staff during the administration of a hot pack treatment which resulted in actual harm to Resident R302 who sustained a burn on the right shoulder. 28 Pa. Code 201.14(a) Responsibility of licensee 28 Pa. Code 201.18(b)(1) Management