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CENTRACARE HEALTH - MONTICELLO 1013 HART BOULEVARD MONTICELLO, MN 55362 March 9, 2012
VIOLATION: SURGICAL SERVICES Tag No: C1140
Based on documentation and interviews the hospital failed to provide services in accordance with acceptable standards of practice for 1 of 10 surgical patients (patient #1) reviewed. Patient #1 was undergoing surgery on 2/27/12 at 10:17 a.m. in operating room #1 (removal of two growths from his head and back) and was under conscious sedation and on 100 percent oxygen via a non-rebreather mask and had an esophageal oral airway in place. Patient #1 sustained second degree burns on his scalp, face, neck, upper chest and his upper arms (20 percent of his body) after a spark from the cautery pen that surgeon (H) was using started a fire underneath the surgical draping that extended from patient #1's head to his chest. The noncompliance posed an immediate jeopardy to patient health and safety when patients are having surgery with oxygen and cautery being used. The hospital's Chief Executive Officer and Chief Nursing Officer were notified of the Immediate Jeopardy finding on 3/9/12 at 2:30 p.m., and the hospital exit conference was conducted at that time. The hospital was in the process of reviewing the causes of the incident, but policy changes and training had not been completed/implemented and surgery was continuing to be performed since the fire occurred on 2/27/12. The hospital did not have a policy pertaining to ventilation of oxygen when patients are draped and cauterization is being used in an oxygen rich environment. The fire occurred on 2/27/12 and prior to the onsite investigation on March 9, 2012 the hospital completed thirty-four surgeries (twenty-six of these had cautery used). The Immediate Jeopardy status remained in effect at the time of the exit. Findings include:

A 2/27/12 operative report for patient #1, completed by surgeon (H), was reviewed. It stated patient #1 had a mass on his left temporal area and his left upper mid back. The report stated the removal of the mass on his left temporal area (cautery pen was being used at this site) was interrupted by a fire in the operating room and no attempt was made to remove the lesion on his back. The report stated surgeon (H) had been using the electrocautery for 10-15 minutes without incident when "there was a flash and an obvious fire coming up through the drapes." The drapes were moved away from patient #1 within a couple of seconds and water and a fire extinguisher were used to put the fire out. Patient #1's hair was burned and there were some second degree burns on his face and upper chest.

A 2/27/12 anesthesia record for patient #1, completed by employee (G)/nurse anesthetist, was reviewed. It stated there was a fire at patient #1's surgical site and that employee (G) pulled the oxygen mask off of patient #1's face and pulled the drapes and blanket off of him. The report stated the fire was put out, and patient #1 was given oxygen via a mask and transferred to the hospital's ED.

Employee (E)/Surgical Tech was interviewed in person on 3/9/12 at 9:00 a.m. She stated she draped patient #1 and squared off the towels on his left temple prior to the surgery. She stated she cut the opening in the drape over the surgical site on patient #1's left temple and surrounded the area with towels. She stated patient #1's face, nose and eyes were protected by towels, and she stated she thought there was a towel covering his oxygen mask. She stated the hospital does not have a policy pertaining to ventilation of oxygen when draping and cautery are being used in an oxygen rich environment.

Employee (F)/Surgical Nurse was interviewed in person on 3/9/12 at 9:30 a.m. She stated there may have been a towel covering patient #1's oxygen mask during the 2/27/12 surgery. She stated the re-enactment photographs of the 2/27/12 fire, including the draping, are accurate. She stated the fire occurred because the oxygen rich environment under the surgical draping was ignited by a spark from the cautery pen.

Surgeon (H) was interviewed by phone on 3/9/12 at 1:05 p.m., and he stated he was performing surgery on the mass on patient #1's temple on 2/27/12 and using a cautery pen at the incision site when the fire occurred. He stated draping and towels were covering patient #1's face and head. He stated there was an oxygen rich environment under the drape, and he was using a cautery pen which caused a spark and the fire occurred. He stated the hospital does not have a policy pertaining to ventilation of oxygen when draping and cautery are being used in an oxygen rich environment.

Employee (G)/Nurse Anesthetist was interviewed in person on 3/9/12 at 10:15 a.m. He stated he was present in OR #1 on 2/27/12 when the fire occurred. Patient #1 had an oxygen mask on his face, and surgeon (H) was cauterizing the incision site when the fire occurred. He stated the draping was tented upward and towels were not covering patient #1's oxygen mask at the time of the fire. The hospital does not utilize any special devices or equipment to ventilate the oxygen when draping and cautery are being used in the operating rooms. In addition, he stated the hospital does not have a policy pertaining to ventilation of oxygen when draping and cautery are being used in an oxygen rich environment.

Fire marshal (D) was interviewed on March 8, 2012 at 9:00 a.m. The fire marshall stated he arrived at the hospital at 12:00 p.m. on 2/27/12 in response to a call he received from the hospital pertaining to the fire. When fire marshal (D) arrived at the scene, he asked the staff who were present in OR#1 at the time of the fire to re-create the fire scene. The re-enactment identified the location of items at the time of the fire. Fire marshal (D) also directed staff to re-enact the draping process on a mannequin and to demonstrate how patient #1 was draped at the time of the fire. Fire marshal (D) took forty-eight photographs of the re-enactment scene. Review of the photographs revealed that towels and draping material were covering the mannequin's face and head. The draping was modified over the mass on patient #1's left temporal area (site of fire) and an opening was cut in the draping fabric. The fabric did not create a positive seal around the opening that separated the top (surgical side) from the bottom (tented area) oxygen enriched atmosphere.

The following hospital policies/procedures were reviewed: Cautery Force II Electrosurgical Generator; Draping the Surgical Patient; Fire Plan; Patient Safety and Risk Assessment of Surgical Services; Shave/Skin Prep and Preparation of Surgical Patients and Staff in the Operating Room in the Event of a Fire. None of these policies addressed ventilation of oxygen when draping and cautery are being used in an oxygen rich environment.