HospitalInspections.org

C5001


The hospital was found out of compliance with the Condition of Participation, Physical Environment (42 CFR 482.41), as evidenced by deficiency issued as a result of the Life Safety Code (LSC) inspection completed on August 9, 2012 during a substantial allegation investigation.

Findings include:

Refer to Life Safety Code deficiency - K48 for additional information.

Based on interviews and document review, the facility failed to provide care in accordance with acceptable standards of practice resulting in 1 of 15 patients (#1) who, while having a surgical procedure performed, sustained serious burns to her shoulders, neck, chin and face when a fire ignited while using cautery in an oxygen enriched environment. This immediate jeopardy has the potential to effect all patients who are undergoing surgery with oxygen and cautery use. This failure places the condition of surgical services out of compliance. See A0951.

The immediate jeopardy began on 8/2/2012 at 1:03 p.m. when patient #1 was undergoing a surgical procedure and a fire ignited which resulted in serious burns to patient #1. The hospital's Quality and Safety Director, the Vice President of Operations, and the Vice President of Medical Affairs, were notified of the Immediate Jeopardy findings on 8/7/2012 at 3:55 p.m.
The Immediate Jeopardy that began on 8/2/2012 at 1:03 p.m. was removed on 8/8/2012 at 1:00 p.m. when the hospital implemented a removal plan that included:
1. Prior to being assigned to a surgery, all staff are being trained in the fire safety and assessment. This was verified through interviews and document review.
2. Two surgeries were observed with different surgeons and different OR staff both observations verified the time out for the fire risk assessment, which included checking the O2 concentration and discussion of the need in regard to the O2, double checking the draping and assigning and discussion of a fire risk. All staff in the OR were involved in the process and much discussion took place.
3. A monitor plan of the process is in place and being conducted by the OR manager.

Based on interviews, observation and document review, the facility 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 15 patients (Patient #1) reviewed. Patient #1 underwent surgery with monitored anesthesia care, using oxygen and cautery. A fire ignited during the procedure resulting in first, second, and third degree burns to Patient #1's upper body. Findings include:

Patient #1's operative notes, dated 8/2/2012 were reviewed and revealed that Patient #1 was admitted to the facility for a scheduled surgery for bilateral Temporal Artery Biopsies. Patient #1 was brought to the operating room at 12:37 p.m. Both temples were prepped with betadine solution and draped by Physician (W) and Employee (Q)/Certified Surgical Technician. Oxygen was placed via a non-rebreather mask covering her mouth and nose. The non-rebreather mask was set at a flow rate of 100% oxygen at a rate of 10 liters per minute. Patient #1 was administered Propofol at a rate of 150 mcg/kg/minute, 2 mg of Midazolam and a total of 4 ml of Fentanyl under monitored anesthesia care (MAC). Physician (W) began the procedure on the left temporal site, and dissected a small segment of the left temporal artery with the use of an electrosurgical pencil. The artery was sutured, and the tissue and skin approximated, and steri-strips were placed. Physician (W) then moved over to the right side of the patient, and began the dissection to the right temporal artery with the use of the electrosurgical pencil, when a "sudden eruption of fire caught with the oxygen mask on face." The fire was put out, and burn treatment was initiated. Following the fire, Patient #1's was noted to have an adequate airway, with oxygen saturation in the 90's, and did not complain of shortness of breath or pain. Patient #1 sustained first, second, and third degree burns to her face, neck, and shoulders. A pulmonary consultation was ordered, and completed, and no airway burns were noted. She was stabilized, and transported to an another area hospital burn center for treatment.

Physician (W) was interviewed on 8/7/2012 at 2:20 p.m., and stated that Patient #1 was admitted on 8/2/2012 for bilateral temporal biopsies. She was brought to the operating room, and the anesthesia staff administered the oxygen via a non-rebreather mask on Patient #1. He stated that the anesthesia staff will administer the oxygen, and he is not always aware of what oxygen amount is given to a patient during the procedure. The patient was then prepped with a betadine prep, and the bilateral surgery sites were marked. Patient #1 was then draped by Physician (W) and Employee (Q) for the procedure. He stated that a towel was placed down the center of Patient #1's nose, on the right and left sides of her face, and across her forehead, with only the temporal sites of her face exposed. The drapes were placed over her oxygen mask. He then began the surgery on Patient #1's left temporal site, and completed the biopsy with the electrosurgical pencil. After approximately ten minutes, he moved over to the right side of her body, to complete the biopsy on the right temporal artery. He stated that he began to use the electrosurgical pencil, and noticed a spark and ignition on the right lower side of Patient #1's face. The fire appeared to travel from the right side of the oxygen mask, and across to the left side of the face and shoulders. He immediately began to pat at the fire, and then pulled the draping off of Patient #1. Employee (P)/nurse poured water on the fire, and the oxygen was disconnected from Patient #1.

He stated that he noted burns around Patient #1's mouth and upper chest. Her nose was charred, and her eyelashes were singed. A bronchoscopy was completed which showed no concerns regarding Patient #1's airway. He stated that he was not aware of a hospital policy regarding ventilation with the use of oxygen when draping a patient, or the use of cautery in an oxygen rich environment.

Employee (P) was interviewed on 8/6/2012 at 2:21 p.m. and stated that she was in the operating room during the fire on 8/2/2012. Patient #1 had monitored sedation, and was receiving oxygen via a non rebreather mask. When the fire erupted, she was charting on the computer. She turned around to see the fire. She grabbed a bowl of sterile water and poured it on Patient #1 and the fire. She then called security to alert them of the fire, and opened the operating room door, and told another staff to pull the fire alarm. The fire was distinguished quickly, (unsure exact time) and she noted Patient #1 had burns on her left neck area, and left ear. She noted soot on Patient #1 ' s right eye, and nares. Her lips were peeling, and she had burn spots on her face. She stated that she has participated in fire safety training, but did not have a specific training regarding the use of cautery in an oxygen rich environment at the hospital. Employee (U)/Certified Registered Nurse Anesthesist(CRNA) was interviewed on 8/7/2012 at 10:34 a.m. and stated that she received report from Employee (T)/CRNA on 8/2/2012, after Patient #1 was prepped and draped for the procedure. She received report that Patient #1 was on 100% oxygen via a non rebreather mask at ten liters. She was not able to see the oxygen mask, at this time, as the oxygen mask was placed underneath the draping. She stated that she was not aware of any special procedures that she needed to implement, when cautery is used in an oxygen rich environment.

Employee (Q)/Certified Surgical Technician was interviewed on 8/6/2012 at 2:40 p.m. and stated that he was in the operating room with Patient #1 when the fire started on 8/2/2012. He stated that he and Physician (W) draped Patient #1, with only her temporal sites exposed. Her oxygen mask was under the drapes, but he stated that both sides of the drape were open for ventilation.

Physician (V)/Chair of Surgical Services was interviewed on 8/7/2012 at 1:20 p.m. and stated that he arrived at the hospital on 8/2/2012, and was told of the fire in the operating room. He said that the hospital investigation determined that cautery was being used on Patient #1, and Patient #1 had her oxygen mask placed beneath the drapes. The fire occurred, as oxygen was allowed to accumulate beneath the drape, and the spark from the cautery equipment ignited a flame.

Physician (V) stated that he was not aware of a specific policy for the use of cautery with oxygen use. He stated that staff was trained in fire safety, but this did not include a fire safety time out prior to surgery.

The hospital administrative staff have, since the fire, initiated a review of the fire safety video, and have looked at creating new procedures for draping of a patient in an oxygen rich environment with the use of cautery, to maintain adequate ventilation of the oxygen and prevent a fire from occurring. These policies and procedures were not in effect at the time of the fire, and had not been initiated at the time of the on-site investigation.

Observations were completed on 8/6/2012 of two procedures preps for surgery, and the safety checks initiated by staff prior to the initiation of the procedure. The safety checks included right patient and procedure, but a discussion was not held in regard to oxygen use, or if a fire risk existed for the patient.

On 8/8/2012, after the Immediate Jeopardy had been identified, two additional observations were completed of surgery safety checks prior to the initiation of the procedures. The safety check included a discussion by all staff in the operating room, of the fire risk to the patient in regard to the scheduled surgery, and the equipment being used for the surgery.

The electrosurgical pencil used during the procedure was a Covidien E2515 Hand stitching Pencil. The Valleylab information sheet, dated 3/2012, documents multiple fire hazard warnings in regard to use of oxygen in conjunction with the electrosurgical pencil, including avoiding use in an oxygen enriched atmosphere, as "this may result in fires or burns to patients or other surgical personnel."