**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on facility investigation, policy review, medical record review, observation, and interview, the facility failed to follow interventions to prevent falls and injury for 2 of 13 sampled residents (Resident #22 and #25) reviewed for accidents. The facility's failure to follow fall interventions resulted in Actual Harm when Resident #22 sustained a fall which resulted in a closed fracture (broken bone) of left distal femur (large upper bone of the leg), subarachnoid hemorrhage (bleeding in the space between the brain and the tissue covering the brain), cervical (neck) spine fracture, closed extensive facial fractures, rib fractures, closed fracture of distal end of the left humerus (long bone in the upper arm) and a chest wall hematoma (blood that has collected under the skin) and when Resident #25 sustained a fall which resulted in a fracture of his greater trochanter (bone in the hip). The findings include: Review of the facility's Accident Policy, approved 5/30/2018, revealed .Avoidable accident means that an accident occurred because a facility failed to identify environmental hazards, identify a Resident's individual risk for accidents, evaluate and analyze the hazard/risk, implement interventions and monitor the effectiveness of the interventions implemented .The definition of a fall is unintentionally coming to rest on the ground, floor, or other lower level .when a Resident is found on the floor, a fall is considered to have occurred .Resident Assessment .Each Resident will be assessed for fall risk coinciding with the Minimum Data Set schedule, admission, re-admission, quarterly and with significant change in status . Review of the facility's policy titled, .Resident Lift Policy, dated 5/2016, revealed .two staff members to be present during the use of Resident lifts . Review of the medical record, revealed Resident #22 was admitted to the facility on [DATE] and readmitted on [DATE] with diagnoses of Dementia, Dysphagia, Chronic Pain Syndrome, and Anxiety. Review of the .Nurse Aide's information Sheet dated 10/16/2020 (there were update dates of 9/9 and 10/14 but the year was not included), revealed .TRANSFERS .2 Person Assist . Review of the Fall Risk assessment dated [DATE], revealed Resident #22 was a high risk for falls with a score of 14. Review of the annual Minimum Data Set (MDS) assessment dated [DATE], revealed Resident #22 was assessed to have a Brief Interview Mental Status (BIMS) score of 7, which indicated Resident #22 was severely cognitively impaired, was totally dependent, and required two person assist with transfers. Review of the Care Plan dated 1/11/2022, revealed .at risk for fall .Use Hoyer lift with 2 staff assist with transfers . Review of the Progress Note dated 3/18/2022, revealed .Resident [Resident #22] had a fall in her room .Fall was witnessed by the CNA [Certified Nursing Assistant #7] .on night shift. CNA excitedly told RN [Registered Nurse #5] to come to house 2 as she wanted to show me something .When I entered the room, I observed resident faced-down on the floor outside of the bathroom in room .Resident was laying [lying] in a pool of blood that appeared to be coming from her head .she had a sizeable, deep laceration to her R [Right] eyebrow, a large hematoma above her L [Left] eyebrow, a R black eye with swelling, and bruising around the eye socket and R cheek, a small bruise to the L knee, and a large laceration to the R knee .call Dr [doctor] .contacted 911 .3/18/2022 .Son called and reported resident is being transferred to a .trauma center . Review of the facility's investigation dated 3/18/2022, revealed .resident [Resident #22] had a fall on 3-18-2022 and was sent to the ER [Emergency Room] .An agency CNA was alone in the room with the resident .She stated that she was using the lift to transfer the resident and it, 'buckled and tipped over' .resident fell face first onto the floor. When the nurse was called to the room, the resident was laying on the floor face down in a pool of blood .had multiple injuries .a fractured femur, knee, and eye socket requiring sutures .After the initial investigation by the facility .It appeared that the CNA tried to transfer this resident alone, without a lift .resident fell to the floor . Review of the Police Department Notes dated 3/18/2022, revealed .a resident was injured and had to be transported to the hospital .According to the incident details that [Named CNA #7] .was assisting the victim off the bed to use the restroom by herself with the lift. The policy is to have two personnel at all times and is required to use the lift for each assist .the victim fell off of the lift because it flipped and fell to the ground, striking her head on the floor .The [Named Facility] conducted their own internal investigation .[Named CNA #7] was attempting to lift the victim out of bed herself and appeared to have either dropped the victim or let her go causing her to fall on the floor . Review of Hospital #2 record dated 3/18/2022, revealed .88 y.o. [year old] .significant for dementia .presents to the ED [Emergency Department] .after patient fell from a Hoyer lift about 5 feet .patient is noted to have a left femur fracture and orbital floor [bones of the eye socket floor] fracture .CT [Computerized Tomography scan-a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body] head .contusion [bruise of the brain tissue] in the frontal lobes [of the brain] with extensive facial soft tissue injury with a laceration and hematoma with a right orbital medial wall [eye socket] and orbital floor fracture .major traumatic injury . Review of the Trauma Surgery Discharge Summary dated 3/29/2022, revealed .Diagnosis: Active Problems: Closed fracture of left distal femur .Fall from height of greater than 3 feet .subarachnoid hemorrhage [Bleeding in the space between the brain and the tissue covering the brain] .Cervical spine fracture .Closed extensive facial fractures .Rib fractures Closed fracture of distal end of left humerus with routine healing .Chest wall hematoma .Acute pain due to trauma .fall from Hoyer lift at nursing home . Observation in the resident's room on 4/4/2022 at 3:45 PM, revealed Resident #22 lying in bed, eyes closed, wearing a neck brace, stitches above the right eyebrow, and blue/purple bruising on the forehead and left and right side of the face area. During a telephone interview on 4/5/2022 at 7:13 PM, CNA #7 was asked about Resident #22's fall. CNA #7 stated, .put lift pad underneath her, pulled lift over her and made sure all 4 straps connected .as I was lifting her .lift made a noise and buckled and she [Resident #22] completely flipped .face forward .it was bad .I ran and got the nurse .told her what happened .she assessed her .blood on the floor .Hoyer lift tilted over . CNA #7 was asked if Resident #22 was a 1 or 2 person assist. CNA #7 stated, I'm not sure if she was a 1 or 2 person assist . CNA #7 confirmed she had used the Hoyer lift by herself to get Resident #22 out of bed. Observation in the resident's room on 4/6/2022 at 9:34 AM, revealed 5 staff using a Hoyer lift to move Resident #22 to a Geri-chair (a chair with high sides and reclines). During an interview on 4/6/2022 at 10:21 AM, Registered Nurse (RN) #5 was asked about Resident #22's fall. RN #5 stated, .I was told that the CNA was trying to transfer her by herself with the Hoyer lift and you don't do that you always need 2 .she was a 2 person transfer with Hoyer . During an interview on 4/6/2022 at 11:14 AM, the Director of Rehabilitation (DOR) confirmed Resident #22 had been totally dependent on staff for transfers since 11/2020, and a Hoyer lift had been used for transfers for about a year and half. The DOR confirmed the Hoyer lift always requires two persons for transfers and stated, .right now with her [Resident #22] .3 minimal [persons] or more [for transfers] . During an interview on 4/7/2022 at 8:14 AM, the Director of Nursing (DON) confirmed Resident #22 was a 2 person transfer and that CNA #7 had transferred Resident #22 by herself. During an interview on 4/7/2022 at 9:35 AM, the Administrator was asked about Resident #22's incident on 3/18/2022. The Administrator stated, .her statement was that she had put her in the lift by herself which was a violation of our policy .she said it bolted [moved] . The Administrator confirmed there should always be 2 persons using a Hoyer lift and stated, I don't think she used the lift .I think she just tried to transfer her by herself . The facility's failure to follow fall interventions resulted in Actual Harm when Resident #22 sustained a fall which resulted in a closed fracture of the left distal femur, subarachnoid hemorrhage, cervical spine fracture, closed extensive facial fractures, rib fractures, closed fracture of distal end of left humerus and a chest wall hematoma. Review of the medical record, revealed Resident #25 was admitted to the facility on [DATE] with diagnoses of Non-Displaced Fracture of Greater Trochanter of Left Femur, Repeated Falls, Dysphagia, Cerebral Infarction, Hemiplegia, Atherosclerotic Heart Disease, Hypertension, and Chronic Obstructive Pulmonary Disease. Review of the Nurse Aide's Information Sheet (initiated on admission and updated 12/6/2021) revealed, .Transfers .2 Person Assist [checked] . Review of the Fall Risk assessment dated [DATE], revealed Resident #25 was not a risk for falls with a score of 8. Review of the Physical Therapy and Plan of Treatment dated 6/8/2021, revealed .Clinical Impressions: Pt [Patient] [Resident #25] demonstrates decreased standing balance, decreased transfer status, decreased functional activity tolerance that presents him as a high risk for fall . The facility was unable to provide the quarterly Fall Risk Assessment for 9/2021. Review of the annual MDS dated [DATE], revealed Resident #25 was assessed to have a BIMS score of 14, which indicated Resident #25 was cognitively intact, required extensive assistance with his activities of daily living, and had functional limitations in range of motion with impairment in an upper extremity. Review of the Care Plan revised 10/25/2021, revealed Resident #25 had a self-care performance deficit with interventions of .TRANSFER: I need extensive/2 staff assist .TOILETING .I require 2 staff assistance with transfers to the toilet and incontinence care . Review of the Nurses Note dated 12/25/2021, revealed .At about 1553 [3:53 PM] the CNA [#6] came to nurse's station and stated that she needed this nurse right away. The CNA took this nurse to [Resident #25's] room where the resident was on the floor. This nurse stated that we needed to get the Hoyer lift to assist resident to [off] the floor. When this nurse asked what happened this resident stated, I fell hun [honey] and my leg just gave out. This nurse got the [NAME] [machine for vital signs] to obtain VS [vital signs] and another CNA sat with the resident until other staff returned. When this nurse returned to the room she and the other CNA was [were] trying to roll resident to put a brief on him but when turning the resident to the left side he was saying ouch. This was attempted twice then this nurse asked the CNA to call for Nurse supervisor. Once she arrived when assessing resident he continued to say ouch when the left hip was moved a certain way .Family, RN Supervisor notified. 911 called and EMS [Emergency Medical Services] arrived about 1630 [4:30 PM]. Resident transported by stretcher to [Named Hospital] for X-ray and evaluation about 1640 [4:40 PM] . Review of the Fall w [with]/injuries dated 12/25/2021, revealed .About 1553 [3:53 PM] the CNA came to the nurse's station and stated that she needed this nurse right away. The CNA took this nurse to [Resident #25's room] where the resident was on the floor. This nurse stated that we needed to get the Hoyer lift to assist resident to [off] the floor. This nurse got the [NAME] to obtain VS and another CNA sat with the resident. When this nurse returned to the room she and the other CNA was [were] trying to roll resident to put on a brief on him but as we turned to the left side he was saying ouch. This was attempted twice this nurse asked the CNA to call for the nurse supervisor. Once she arrived when assessing resident he continued to say ouch when the left hip was moved a certain way .Resident Description 'Hun I fell, my legs gave out and I just fell' . Review of the Hospital Emergency Documentation dated 12/25/2021, revealed .CT pelvis is indicated with left-sided greater trochanter [hip] fracture .no extension into the neck .range of motion is baseline .Orthopedics recommend weightbearing as tolerated . Review of the Hospital Emergency Department Discharge Instructions dated 12/25/2021, revealed .Discharge Diagnosis: Greater trochanter fracture . Review of the Fall Risk assessment dated [DATE], revealed Resident #25 was a high risk for falls with a score of 10. During an interview on 4/5/2022 at 1:06 PM, Resident #25 was asked if he had sustained any falls. Resident #25 stated, .the staff is no longer here .about 12 weeks ago [fell] .she [CNA #6] wanted to see if I could stand up and I couldn't stand up that long .she wouldn't use the lift . During an interview on 4/6/2022 at 9:15 AM, the DOR was asked if he was familiar with Resident #25. He stated, .yes .before his fall he was a 2-person transfer assist . The DOR was asked if Resident #25 should have been transferred on 12/25/2021 with 2 people. The DOR stated, .right .before his fall he was a 2 person assist .we didn't initiate the Hoyer lift until 12/27/2021 .the last day we saw him was 7/9/2021 and our recommendations at that time was 2 person transfer .they transferred him not following our recommendations .Minimum Assistance means the resident does 75% [percent] of the work, that's why we specify on the CNA [NAME] [Nurse Aide's Information Sheet] the number of people needed for transfers . During an interview on 4/6/2022 at 10:00 AM, the Staff Development Coordinator (SDC) was asked to describe the orientation process. She stated, .they [staff] get 2 days of orientation with me .we go over policies and procedures .and I give them 2 different folders .then they are placed with another CNA for 2 or 3 days . She was asked how the CNAs know what to do for their residents. The SDC stated, .the department heads come in on the first day and reviews the highlights .MDS [Nurse] go over the [NAME] notebook on the unit . During an interview on 4/7/2022 at 8:11 AM, CNA #6 stated, .He [Resident #25] told me he could stand holding the grab bar. I questioned him again to make sure. He had his gait belt on, and the wheelchair was placed behind him in case he gets tired and needed to sit down .without warning, he fell to the side. He denied having pain until he moved a little bit, and I got the nurse [Named Licensed Practical (LPN) #3] . The CNA was asked if she had checked his Care Plan. She stated, .No, I didn't at the time know where they were .[Named CNA #7] told me he was a one man assist .I had transferred by myself . During an interview on 4/7/2022 at 9:30 AM, LPN #3 stated, .I did show her [CNA #6] where the Aide's Care Plans were after the fall because she said she didn't know where they were. They [new hires] are usually shown during their orientation . The facility's failure to follow fall interventions resulted in Actual Harm when Resident #25 sustained a fall which resulted in a fracture of his greater trochanter.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of Brunner & Suddarth's Textbook of Medical-Surgical Nursing, Twelfth Edition, the Hydrocollator (HotPac) HEATING UNITS User Manual, medical record review, review of a facility investigation, medical equipment inspection reports, maintenance logs, Hydrocollator Temperature logs and interview, the facility failed to implement an effective policy for the application and use of HotPacs for 1 of 3 (Resident #35) sampled residents reviewed for the use of HotPacs (moist heat therapy device). The failure of the facility to prevent a Certified Nursing Assistant (CNA) from applying a HotPac (which was outside her scope of practice) without a physician order resulted in actual Harm when Resident #35 suffered a deep partial thickness burn from an unmonitored HotPac which required application of medication with dressing changes. The findings included: The Brunner & Suddarth's Textbook of Medical-Surgical Nursing Twelfth Edition, page 1720, Table 57-1 CHARACTERISTICS OF BURNS ACCORDING TO DEPTH defines an area that is Blistered, mottled red base, broken epidermis [the outer layer of the skin], weeping surface as a Deep Partial-Thickness (Similar to Second Degree) burn. The Hydrocollator [HotPacs] HEATING UNITS User Manual 120 Volt Units Chattanooga ISO 13485 CERTIFIED dated 2011, documented, .Constantly monitor HotPac application to ensure the skin is not becoming too hot .Damage to skin can occur from exposure to extreme heat .DO NOT apply over insensitive skin or in the presence of poor circulation . Medical record review revealed Resident #35 was initially admitted to the facility on [DATE] with diagnoses of Paraplegia, Peripheral Vascular Disease, Malignant Neoplasm of the Lung, Secondary Malignant Neoplasm of Nervous System, Pressure Ulcer of Right Buttock, Pressure Ulcer of Left Buttock, Pressure Ulcer of Left Ankle, Pressure Ulcer of Sacral Region, Major Depressive Disorder, Adjustment Disorder with Mixed Disturbance of Emotions and Conduct, Post-Traumatic Stress Disorder, Transient Ischemic Attack, Cerebral Infarction and Left Above the Knee Amputation. The annual Minimum Data Set (MDS) dated [DATE] documented a Brief Interview for Mental Status (BIMS) score of 15, which indicated no cognitive impairment, required extensive assistance of 2 staff members with bed mobility, dressing and personal hygiene and total assistance of 2 staff members with transfers, toileting and bathing, impaired Range of Motion (ROM) in the lower extremities on both sides, 1 Stage 2, 1 Stage 3, and 1 Unstageable Pressure Ulcer, and no burns or other wounds. Review of the facility's investigation revealed an incident report dated 7/10/18 at 11:39 PM which documented, .Tech [nursing technician] reported .that resident has a baseball sized blister to the lower part of his left shoulder .Resident stated the heating pad was his. Then later said he got it from therapy once this writer said to him, [Named Resident] I thought you said the heating pad was your personal pad? This is from therapy he said, Yes I got it from there . Review of Physician's Orders from 7/6/18 through 8/6/18 revealed no order for HotPacs to Resident #35's left shoulder. A Physicians Telephone Order dated 7/11/18 documented, Clean L [left] shoulder blade [symbol for with] wound cleanser. Pat dry. Apply Silvadene 1% [percent] to Injured area to L Shoulder blade. Cover [symbol for with] oil Emulsion dsg [dressing] cut to fit area. May Cover [symbol for with] Foam dsg. On Mon [Monday], Wed [Wednesday] [symbol for and] Fri [Friday] and as needed x [times] 14 days then Re Eval [reevaluate] area. The Nurses Note dated 7/11/18 at 6:30 AM documented, .Resident doesn't have an order for the heating pad [HotPac] that he said he'd been using . The Nurses Note dated 7/11/18 at 7:09 AM documented, .Correction on the heating pad being a personal item. The pad came from therapy . The Skin/Wound Note dated 7/11/18 at 11:34 AM documented, Resident noted this morning with area to left shoulder blade .Entire area measures 7.5 cm [centimeters] L [length] X [by] 5 cmW [width] with redness surrounding area .non intact blister .measures 4.5 cmL X 4.5 cmW . Review of a Medical Equipment Services, Inc. [incorporated] invoice revealed the Hydrocollator was last inspected on 9/14/17. Review of the facility's maintenance logs revealed no other equipment inspection on the Hydrocollator Unit documented from 9/14/17 through 7/12/18. A facility Inspection of the Hydrocollator Unit report dated 7/12/18 documented, As a result of a reported burn to a resident after the use of HotPacs from the [named facility] Therapy Department Hydrocollator unit, the Hydrocollator heating unit was inspected by Maintenance .11:00 AM a water temperature check reached a high of 158 degrees .2:00 PM the hotpac was removed from the unit and showed a surface temperature of 145 . Review of the facility's Hydrocollator Temperature Log beginning 7/19/18 revealed that the Hydrocollator temperature was not monitored by staff prior to the burn incident for Resident #35 on 7/10/18. There were no temperature logs provided for the period of time prior to 7/19/18. The Rehabilitation Manager and the Director of Nursing (DON) confirmed there were no temperatures monitored until 7/19/18. The facility did not have a policy for nursing personnel to apply HotPacs to residents prior to resident # 35's burn incident. The Care Plan dated 6/6/18 and updated on 7/11/18, documented, .risk for the development of pressure ulcers and other skin impairment .related to I require assist with bed mobility .paraplegia .L [left] shoulder blade injury Date Initiated: 07/11/2018 . Resident #35 refused observations of his wound by the surveyor. Interview with the Director of Clinical Services on 8/8/18 at 1:16 PM, in the Director of Clinical Services office, the Director of Clinical Services confirmed that the facility has never had a nursing policy for the application of heating pads or pods. Interview with Certified Nursing Assistant (CNA) #1 on 8/9/18 at 10:30 AM, in the conference room, CNA #1 was asked what caused the burn to Resident #35. CNA #1 stated, It was a HotPac .he [Resident #35] requested it for his neck pain .I went to Physical Therapy and asked [named therapist] for it . CNA #1 was asked if she checked for a physician's order for the HotPac before obtaining it from therapy and applying it to Resident #35. CNA #1 stated, I didn't know you had to have a physician's order for a heating pad til this happened . CNA #1 was asked if a nurse was present when she applied the HotPac. CNA #1 stated, No. CNA #1 was then asked to what body part was the HotPac applied. CNA #1 stated, Around the back of the left neck and top of the shoulder. CNA #1 was asked, if at any point did she check on Resident #35 while he was wearing the HotPac. CNA #1 stated .at which time .I got it for him twice .the second time was close to the end of my shift. CNA #1 was asked what time she placed the HotPacs on resident #35. CNA #1 stated Around 8:00 the first time .the second time was around 2:45 PM. CNA #1 was asked if she reported to anyone on the oncoming shift that Resident #35 had a HotPac on, and what time it was placed, prior to leaving for the day. CNA #1 stated, .Maybe, maybe not .I couldn't say for sure. Interview with Licensed Practical Nurse (LPN) #1 on 8/9/18 at 12:11 PM, in the conference room, LPN #1 confirmed that she was Resident #35's nurse on 7/10/18. LPN #1 was asked if she was aware of the CNA applying a HotPac to Resident #35 that day. LPN #1 stated, No. Interview with the Rehab [rehabilitation] Manager on 8/9/18 at 12:52 PM, in the conference room, the Rehabilitation Manager was asked how often a HotPac should be checked after it is applied. The Rehabilitation Manager stated, Every 5 minutes while it is applied .and it should be on no longer than 20 minutes at a time. The Rehabilitation Manager was asked if therapy had a policy on HotPacs. The Rehabilitation Manager stated, No, we have never had a written policy .the class or course I took is how I know to use this heating pad .It is my scope of practice to be able to use it .I was told by the past Director of Nursing [DON] [named former DON] that we were to allow nursing to apply heating pads because it was in their scope of practice .we only asked who the patient was to find out if it was on our case load. If the patient was on our case load we would tell them we would take care of it for them . Telephone interview with CNA #2 on 8/9/18 at 2:25 PM, CNA #2 was asked if she was the CNA who found the burn on Resident #35 on 7/10/18. CNA #2 stated, Yes .I went into the room and he [Resident #35] asked me to turn around and placed his hand on my back and told me to scratch his back where he had placed his hand on mine .I did and I noticed my glove was wet. I told him, your shirt is wet and I pulled it up to look at his back and saw a blister. He [Resident #35] said, 'I had a heating pad on there today.' CNA #2 was asked if she had ever placed a heating pad or HotPac on a resident. CNA #2 stated, No. CNA #2 was asked what she would do if a resident requested a HotPac. CNA #2 stated, I would go to the nurse and tell her the resident was requesting a heating pad. Interview with the DON on 8/9/18 at 2:27 PM, in the conference room, the DON confirmed that she was unaware of the nursing staff applying HotPacs to residents prior to this incident. The DON was asked if she considered this a safe practice. The DON stated, No. Telephone interview with Resident #35's physician on 8/9/18 at 2:48 PM, the physician confirmed that he was familiar with Resident #35. The physician was asked if he had any knowledge about Resident #35's burn. The physician stated, Not much, I believe it came from a heating pod. The physician was then asked if he had given orders for nursing to apply HotPacs. The physician stated, No, ma'am I don't .I don't think that is in their privy [scope of practice]. Interview with CNA #3 on 8/9/18 at 2:50 PM, in the conference room, CNA #3 was asked if she worked in House 5 [Resident #35's assigned unit] on 7/10/18. CNA #3 stated, Yes. CNA #3 was asked if she received report prior to starting her shift that Resident #35 was wearing a HotPac. CNA #3 stated, .I got report but did not receive in report about the heating pad .I saw the heating pad under Resident #35's shoulder sitting in the wheelchair .nobody knew where it came from. CNA #3 was asked if she put Resident #35 back to bed. CNA #3 stated, Yes. CNA was asked if she removed the heating pad when putting Resident #35 back to bed. CNA stated, Cannot remember what happened to the heating pad. Interview with the Administrator on 8/9/18 at 6:25 PM, in the conference room, the Administrator was asked when he was notified of the burn to Resident #35's shoulder. The Administrator stated, Either that day or the morning after .I am not real sure. The Administrator was asked if he was aware how the burn occurred. The Administrator stated, Yes . The Administrator was asked if he was aware that a CNA obtained a HotPac from therapy and applied it to a resident without notifying the nurse and without a physician's order. The Administrator stated, .Yes, it came out in the investigation . The Administrator was asked if he was aware that the CNA was not practicing within her scope of practice. The Administrator stated, .with the investigation it came out . The Administrator was asked whose responsibility it should be to ensure the CNAs are practicing within their scope of practice. The Administrator stated, .the charge nurse and the DON and on up to myself. The Administrator was then asked whose responsibility it is to ensure that the DON is holding everyone accountable for working within their scope of practice. The Administrator stated, .it would be me and then the clinical director . The failure of the facility to prevent a Certified Nursing Assistant (CNA) from applying a HotPac (which was outside her scope of practice) without a physician order resulted in actual Harm when Resident #35 suffered a deep partial thickness burn from an unmonitored HotPac which required application of medication with dressing changes.