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UNIVERSITY OF LOUISVILLE HOSPITAL 530 SOUTH JACKSON STREET LOUISVILLE, KY 40202 Feb. 6, 2014
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on interview, record review, and review of the facility's policy Event Reporting, Patient Care Orders, Manufactures recommendations, and the Mosby's Skills Protocol, it was determined the facility failed to follow their policy to ensure the safe use of a heating pad was implemented for one (1) of ten (10) sampled patients (Patient #1). In addition, the facility failed to complete a incident report as required per facility policy.

The findings include:

Review of the Manufacture's recommendation (operator's manual) for the T/Pump heat therapy system, revealed the device pumps warmed water through a pad. The staff was to monitor the patient's temperature and skin condition every twenty (20) minutes or as directed by a physician. Failure to adhere to these warnings could result in patient injury.

Review of the Mosby's Skills for Aquathermia and Heating Pads Quicksheet, revealed an alert, to staff to never position a patient to lie directly on the pad. This position prevented dissipation of the heat and increased the risk for burns. It further directed staff to refer to the practitioner's order for location of application and duration of therapy.

Review of the facility's policy regarding Patient Care Orders, reviewed March 2011, revealed orders were to contain all elements of an order, i.e., drug name, dose, route, frequency, indication and duration.

Review of the facility's policy regarding Event Reporting, revised date September 2013, revealed reporting of actual and potential safety events were the responsibility of all healthcare professionals and ancillary staff. The submission of the events would be facilitated by an electronic reporting system. Definitions revealed a safety event was any unusual or unexpected occurrence that resulted in injury or potential injury to patients, employees, or guests. Included were patient falls, injury, or unanticipated outcomes of care.

Review of the clinical record for Patient #1 revealed the facility admitted the resident on 01/15/14 with an admission diagnosis of Colovaginal fistula. The patient had a laparoscopic converted to open and colovaginal fistula with sigmoidectomy and primary end-to-end anastomosis. Review of the physician orders revealed a K-Pad (heating pad) was ordered for chronic back pain post operation. No duration was identified for the K-Pad. RN #5 documented, on 01/15/14 at 3:04 PM, that the patient had chronic back pain. The heating pad was placed to the lower back where the patient was complaining of the most pain. RN #6's nursing notes, dated 01/17/14 at 12:32 PM, revealed upon bathing the patient and removal of the K-Pad, there was noticeable redness, and quite possibly some blistering noted as well. Will consult with the wound care nurse. Review of the Wound Care Nurse's note (not timed or dated) revealed the patient had opened ulcerations and blisters on bilateral buttocks and on the right lower back. The areas Mirrored the pattern of the K-Pad he/she had been using. The wound presents as a partial thickness with some areas with open blisters and some areas with fluid filled. Will use Mediplex Border to cover and no present signs/symptoms of infection.

Review of the facility's incident reports for January 2014 revealed no incident report was initiated regarding the patient injury with use of the K-Pad.

Interview with Clinical Manager, RN #4, on 02/05/14 at 10:55 AM, revealed a patient had what appeared to be a burn across his/her lower back and the wound nurse had seen the patient. She stated the physician had ordered the K-Pad for the patient's back. She stated there had to be a physician's order for the K-Pad and the protocol was to be on for twenty (20) minutes and off for forty (40) minutes. She stated it was the nurses' responsibility to complete an incident report and the wound nurse could also put it in the computer. She stated she had pulled the pump and K-Pad and tagged it and placed it in the dirty utility room for biomed to pick up. She stated she had not completed an incident report regarding the incident; however, she had informed the patient's daughter and made sure the Wound Care Nurse and physician had seen the patient. She stated she was told by Maintenance staff that the K-Pad was functioning appropriately; however, she could not provide evidence of this report. She stated there was no specific protocol for the use of the K-Pad and used Mosby's as a resource. She stated she did not inservice the nursing staff on her unit of the safe use of the K-Pad specifically, but had discussed it informally in the "huddles".

Interview with RN #6, on 02/06/14 at 9:30 AM, revealed she was preparing to bathe Patient #1 when the patient stated, I feel warm. She state she saw the K-Pad beneath the draw sheet and removed it. She stated she assessed the patient's skin and saw two (2) pea sized blisters on the right buttock area and the area was reddened. She stated she place a wound consult request and kept the patient off the area. She stated she notified the charge nurse; however, she did not complete an incident report. She stated she was not sure if the blister was caused by the K-Pad or if the patient had a post operative reaction. She stated they used the Mosby's reference for heat/cold protocol, twenty (20) minutes on and twenty (20) minutes off. She stated she had been inserviced on the equipment and had never seen anyone burn with the use of the K-Pad. She stated they assessed the patient prior to the application and checked on them every thirty (30) minutes.

Interview with RN #5, on 02/06/14 at 9:10 AM, revealed the physician had ordered the K-Pad for chronic back pain per the patient's request. She stated there was no order for the duration of the K-Pad. She stated she admitted the patient to the floor and knew of the order for the K-Pad; however, she stated the K-Pad was not applied that day. She stated she did not place an incident report into the system because she did not know what caused the blisters. She stated she did not think about it at the time and she had reported the incident to the Wound Care Nurse or the Charge Nurse.

Interview with the Certified Wound Ostomy Continence Nurse (Wound Care Nurse), on 02/06/14 at 10:51 AM, revealed she received the wound consult on 01/20/14. She stated the patient had blisters and staff did not know if they were related to an allergic reaction or if it had been caused by the K-Pad. She stated the patient's burn blister was a partial thickness and she recommended Mediplex Border dressing to protect the blisters. She stated the area mirrored the K-Pad and most likely caused the blisters. She stated she spoke with the Clinical Manager (charge nurse) and ensured the K-Pad was pulled and sent to engineering to be checked. She stated she did not know the protocol for the use of the K-Pad; however, she stated the staff should had filled out an incident report.

Telephone interview with RN #7, on 02/06/14 at 1:50 PM, revealed the patient had complained of back pain the evening of admission; however, there was no K-Pad in use. She stated on 01/16/14 the K-Pad was provided for the patients back pain. She stated the patient reported relief for his/her back pain and declined to let her remove it. She stated she did not know how frequently to check the device; however, safety rounds were completed hourly on the patients, not specifically to assess the K-Pad. She stated they needed a physician's order to use a K-Pad, but was unsure of the duration. She stated she was told in shift report of the blisters and that they may have been caused by the K-Pad. She stated she thought the supervisor was aware and had filled out an incident report and since she was informed during shift change she thought the other staff would have completed the incident report.

Interview with the Clinical Risk Manager, on 02/05/14 at 5:05 PM, revealed she received a phone call message last week from the patient's daughter and she referred the call to the Clinical Manager for follow-up. She stated there was no event report made and there should have been. She stated the K-Pad was taken out of use to check for disfunction.

Interview with the Patient Safety Analyst, on 02/06/14 at 11:35 AM, revealed it was important to monitor all incidents to include malfunctioning equipment so they would be able to trend or determine if it was an isolated event. She stated there was no incident report made for unsafe condition. She stated the staff reported the incident to the Wound Care Nurse and the physician, and pulled the K-Pad from service; however, they did not report the incident as required.