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FAIRVIEW LAKES HEALTH SERVICES 5200 FAIRVIEW BOULEVARD WYOMING, MN 55092 Feb. 21, 2012
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on interview and document review the facility failed to provide services in accordance with acceptable standards of practice related to the fire hazards of alcohol-based skin preparation, draping with delivery of oxygen and cautery, for 1 of 10 operative patients (Patient #1) reviewed.

Findings Include:

Patient #1 was undergoing surgery on 2/15/2012 and sustained burns when a flash fire erupted near his head. The noncompliance posed an immediate and serious threat to patient health and safety to any patient having surgery with oxygen use and cautery and/or alcohol based skin preparing agents. The hospital's Vice President of Quality Systems and Vice President of Patient Care were notified of the Immediate Jeopardy finding on 2/17/2012 at 5:10 p.m. The hospital exit was conducted on 2/21/2012 at 5:30 p.m. At the time of the exit the hospital had not completed a written plan for the removal of the immediate jeopardy. The hospital was in the process of implementing a policy, but training had not been completed and surgery was continuing to be performed. The Immediate Jeopardy status was not removed at the time of the exit. Refer to findings at A 951.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on document review and interview the facility failed to have policies in place to assure surgical services were provided consistent with needs and resources. The hospital failed to have policies and procedures in place to assure the achievement and maintenance of high standards of medical practice and patient care for 1 of 10 patients (Patient #1) reviewed. Patient #1 underwent surgery under conscious sedation while utilizing alcohol-based skin preparation agents, oxygen and cautery. A fire ignited during the procedure when cautery was used resulting in first and second degree burns to the patient. Findings include:

Patient #1's physician operation notes dated 2/15/2012 were reviewed and revealed he was admitted on [DATE] for surgery under conscious sedation for bilateral temporal artery biopsy. Approximately 10 minutes into the surgery a flash fire was noted when the surgeon was cauterizing on Patient #1's left side which spread to his face and neck.

The operative notes dated 2/15/2012 were reviewed and revealed Patient #1 sustained the following injuries: minimal orbital edema, superficial burns to the face and neck, some nostril hair loss, brow hair loss, and a 3cm x 2 cm palmar aspect blister to the right hand. A flexible laryngoscopy was performed through each side of the nose and after the nasal sill there was mostly first-degree burn. No sign of [DIAGNOSES REDACTED] or char and no sign of any first-degree or second-degree burn was noted intraorally. The nasopharynx was noted to appear clear. The hypopharynx and larynx appeared normal without char, [DIAGNOSES REDACTED] or mucosal change. Patient #1 was noted to have an adequate airway.

Physician A was interviewed on 2/17/2012 at 4:20 p.m. and stated that Patient #1 was admitted on [DATE]. At approximately 12:30 p.m. Patient #1's surgery was started. Physician A stated that she usually did this procedure in her office under local anesthetic, but chose to do it in the hospital this time due to Patient #1 having a pacemaker and she wanted increased monitoring of the patient's condition during the procedure. Patient #1 was receiving oxygen via a mask with the oxygen tubing on the left side of his body. Physician A stated that the operation did not start immediately because she was having trouble locating the artery, which took about 10 minutes. Physician A stated that Patient #1 was draped for surgery so that the oxygen mask was covered by a drape, allowing oxygen to accumulate under the drapes. Physician A stated that when she began cauterizing Patient #1, a flash fire ignited on Patient #1's left side, near his neck. Physician A stated that the oxygen tubing started on fire, then the fire moved below his chin to his right side. Physician A stated that the oxygen was turned off by staff and she tried to pat out the fire without success and normal saline was used to put out the fire. In addition, Physician A stated that Patient #1 attempted to push the oxygen mask away with his right hand during the fire. Physician A stated that Patient #1 sustained blistering to his right hand, singed skin to his nostrils, lips, eyebrows, the right side of his chin, right side of his forehead, down to the clavicle, however Patient #1 exhibited no difficulty swallowing or breathing after the fire. The oxygen mask and tubing were charred. Patient #1 was transferred to a burn unit in another hospital, where he was discharged that same day.

Physician A stated that, prior to this fire on 2/15/2012, she was not aware of a hospital policy regarding ventilation of oxygen when draping patients, or use of cauterization in an oxygen rich environment.

The anesthesia record dated 2/15/2012 was reviewed and revealed Patient #1 received oxygen at 8 liters per minute starting at approximately 11:30 a.m. via a mask.

Employee J/Registered Nurse Surgical Services was interviewed on 2/21/2012 at 11:05 a.m. and stated that she was in the operating room with Patient #1 when the fire started on 2/15/2012. Employee J stated that she prepared Patient #1's skin, bilateral forehead to the ear, for surgery using an alcohol-based skin preparation fluid. Within approximately 1 minute she draped the patient's skin. When queried she stated she did not allow Patient #1's skin to dry before draping him for surgery. Employee J stated that she was facing away from Patient #1 when the fire started, but heard screaming and turned to see Patient #1 flailing his arm. She stated she then saw a ball of flames about 8 to 12 inches off the bed, near Patient #1's head. She stated there were flames shooting from the oxygen tubing and it "sounded like a torch." When the oxygen mask was found under the drape after the fire, it was near Patient #1's neck and black and crumpled. Employee J stated that she got several bottles of sterile water and poured them on the fire and the flames went out.

Employee J stated that, prior to this fire on 2/15/2012, she was not aware of any hospital policy regarding the use of oxygen and cautery, nor was she aware of any hospital policy in regard to allowing the alcohol-based skin preparation to dry before draping the patient.

Employee C/Vice President of Quality Systems was interviewed on 2/17/2012 at 12:30 p.m. and stated that the hospital had no policies regarding the safety concerns of cauterization use near the head in an oxygen-rich environment prior to the fire on 2/15/2012. Employee C stated that the hospital root cause analysis was not complete, but they had conducted a debriefing with the staff involved and thought the cause of the fire was due to a build-up of oxygen under the draped material on Patient #1.

Employee F/Registered Nurse/Operating Room Manager was interviewed on 2/17/2012 at 12:50 p.m. and stated that after the fire the hospital staff contacted risk management for a policy for cauterization in an oxygen-rich environment. Employee F stated that they had no policy, but follow the AORN/Association of Operating Room Nursing guidelines. Employee F stated that they received a copy of the policy in use at a sister hospital, but were in the process of getting it approved for use in their hospital, and the education on the new policy was not complete at the time of this interview.

When policies for cauterization use with oxygen were requested Employee C provided pages 225 and 226 from the 2010 Perioperative Standards and Recommended Practices (Identified by the hospital staff as AORN guidelines). Recommendation IX which included the following: "Potential Hazards associated with fire safety in the practice setting should be identified, and safe practices should be established." IX. d.5. "Drapes should not be applied until prep solutions are dry, to prevent the accumulation of volatile fumes beneath them." IX e.1. "oxygen and nitrous oxide should be used with caution in the presence of any ignition or fuel source." IX.e.8. "Oxygen concentration under drapes should be minimized by tenting of drapes and using the lowest possible oxygen concentration that provides adequate patient oxygen saturation."

Additionally Employee C provided the policy received from their risk management department after the fire in surgery on 2/15/2012 titled Patient Fire Safety: Oxygen Enriched Environment effective date 9/09, (in use by another hospital) but not yet adopted by this hospital. This policy included a fire risk assessment of each patient based on a 3-point scale and included III. "Allow Duraprep or alcohol based prepping solutions a minimum of 3 minutes drying time... Prior to the start of the procedure configure surgical drapes to allow sufficient venting of oxygen delivered to the patient."