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NORTH OKALOOSA MEDICAL CENTER 151 REDSTONE AVE SE CRESTVIEW, FL 32539 Dec. 16, 2011
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on interview and record review, the facility failed to develop and implement policies and procedures, other than guidelines and recommendations, for fire safety in invasive procedural areas (including oxygen enriched atmosphere); and failed to ensure implementation of facility's policy and procedure for "Electrosurgical Cautery Unit Safety" for 1 of 6 sampled patients. (Patient #1)

Findings:

Closed record review for Patient #1 was conducted on 12/14/11. The record documented patient underwent surgical procedure for removal of 3 sebaceous cysts on back of head in the facility's outpatient surgery unit on November 29, 2011. Record review revealed the procedure was performed with patient in prone position with her head turned to the left side, anesthesiologist administering intravenous sedation , anesthesiologist administering 100% oxygen via simple vinyl oxygen mask at 10 liters/minute, and use of electrosurgical unit by the surgeon. The record revealed the patient sustained burns as a result of a "flash fire" during the procedure.



Review of facility's Policy & Procedure titled "Fire Safety in Invasive Procedural Areas (Including Oxygen Enriched Atmospheres), dated 9/29/09 with review date of 2/2011 documented PURPOSE: "to provide guidelines to prevent an operative and/or invasive procedure, fire, including those potentially involving oxygen-enriched atmospheres under sterile drapes and to react efficiently and effectively in the event of a fire. " Review of procedure, (Section III) Procedure for Prevention, (D) Strategies to reduce the risk of Oxidizers (Oxygen and Nitrous Oxide) documented the following: Recognize that oxygen and nitrous oxide-enriched atmospheres can vastly increase flammability of drapes, plastic and hair. Section (D)(2) During Head, Face, Neck, and Upper-Chest Surgery documented applicability of the following recommendations must be considered individually for each patient: Documented following recommendations are for surgery in which the patient's verbal responses may be required AND where open oxygen delivery is required to keep the patient safe: At all times (1) Deliver the minimum oxygen concentration necessary for adequate oxygenation, (2) Begin with a 30% delivered oxygen concentration and increase as necessary,(3) For unavoidable open oxygen delivery above 30%, deliver 5-10L/minute of air under drapes to wash out excess oxygen. (4) Documented to stop supplemental oxygen at least one minute before and during use of electrosurgery, electrocautery, or laser, if possible; procedure team communication is essential for this recommendation. (Section III) Procedures for Prevention, (B) Strategies to manage ignition source, (1) During Electrosurgery documented the following: If open oxygen sources are employed, use bipolar electrosurgery whenever possibly and clinically appropriate (such as for cauterization during head, face, neck and upper-chest surgery). Bipolar electrosurgery creates little or no sparking or arcing and according to ECRI (2009), has not been involved in starting any surgical fires. Documented to never use electrosurgery in close proximity to flammable materials in oxidizer-enriched atmospheres.

Review of Patient #1`s Anesthesia Record documented oxygen delivered at 10 liters via face mask. Anesthesia Record documented anesthesia start time of 9:03am and surgery start time of 9:16am with anesthesia stop time and surgery stop time not documented. The Anesthesia Record further documented fire from posterior scalp to face mask at 9:20am. Further review of record, in presence of Chief Quality Officer (CQO), failed to indicate percentage of oxygen as confirmed by the CQO. CQO stated she was informed the oxygen was being administered at 100% concentration from Fire Marshall's investigative interviews conducted.
Review of Patient #1's Intraoperative Record, dated 11/29/11, documented surgery start time of 9:16am with a time into Operating Room of 9:03am. Operative report documented use of Monopolar Bovie with cutting set at 35 and coagulation set at 35.
An interview was conducted with the Medical Director of Anesthesia on 12/14/11 at approximately 2:00pm. Facility's Policy and Protocol titled "Fire Safety in Invasive Procedural Areas (Including Oxygen Enriched Atmospheres) was reviewed by physician prior to interview. The Director stated open oxygen use is defined as not being closed to vacuum and includes nasal cannula and simple mask delivery. Stated to begin with a 30% delivered oxygen concentration , would need a Ventimask as not able to ensure this with a simple face mask. The Director further stated it is safe to say oxygen at 10 Liters delivered via simple mask would deliver an oxygen concentration greater than 30%. The Director stated a simple face oxygen mask is kept on the anesthesia carts for use in transporting patients from surgery area to recovery area; and that Nasal Cannula is commonly used to deliver oxygen during moderate conscious sedation. Anesthesia Director further stated the procedure for stopping supplemental oxygen at least one minute before and during use of electrocautery is practiced by him routinely with Ear, Nose, & Throat (ENT) cases through communication with the surgeon.
On 12/14/11 at approximately 2:40pm, an interview was conducted with the Circulating Nurse for surgical procedure of Patient #1. Nurse stated anesthesiologist wanted a simple oxygen face mask which is not typically kept in the Operating Room, so provided one obtained one from the recovery room. Further stated the Electrocautery Bovie setting was confirmed with the physician, but did not recall communication between the surgeon and anesthesiologist prior to use of the Bovie.
An interview was conducted with the Anesthesiologist administering oxygen to Patient #1 during incident on 12/15/11 at approximately 9:30am. During this interview, the Anesthesiologist stated the advantage with intravenous sedation was patient could position herself. The physician stated the patient was positioned on stomach with forehead supported on a blanket. The physician stated the patient was obese and undergoing heavy sedation and that was a determining factor for using a simple oxygen mask versus nasal cannula; and stated it is standard to use a mask. He stated oxygen was started at 10 Liters and did not recall if he turned down the oxygen or not, but "it was 10 or less." It was also stated "the surgeon started with cauterizing, might have been some arcing of the Bovie tip; and next thing he heard was "wait, smoke, fire" and whipped off the face mask to protect the patient from flames." The flames were noted to be visible from surgeon's angle from under the drape.
An interview was conducted on 12/15/11 at approximately 10:20 with Patient #1's surgeon. During this interview, the surgeon stated the type of anesthesia administered is whatever the anesthesiologist deems appropriate and didn't follow the method of oxygen administration as this is per anesthesia. Stated used a monopolar Bovie set on 35/35. Surgeon verbalized sequence of events of procedure from start to finish which did not include communication to anesthesiologist for when using Bovie. When surveyor asked the surgeon what the process was for communicating to anesthesiologist during electrocautery use, she replied she was taught that during neck surgery, communicate with anesthesia to turn off oxygen. When asked by this surveyor, surgeon stated she did not communicate to anesthesiologist that she was firing Bovie prior to doing so. The surgeon stated did not know, until after the fact, of the percentage of oxygen being delivered or that 10 liters of oxygen was being delivered into a non-rebreather mask; and stated she is not sure "off the top of her head" what concentration of oxygen would be delivered if 10 liters of is administered via a simple oxygen face mask.
The surgeon stated that during surgery, while using cautery, there were 2 incidents of little sparks and a little spark flame, which sometimes can get that with a piece of fat in between 2 pieces of metal and is a self limited event. Stated at beginning of case, electrosurgery unit set at 35/35, stated settings are determined from experience, and setting was appropriate to the amount of bleeding.
On 12/16/11 at approximately 9:45am, interviews were conducted with the Surgical Services Director (Main Operating Room and Outpatient Surgery Center) and the Operating Room (OR) Manager for Outpatient Surgery Center. The Outpatient Surgery Center OR Manager stated cautery is set according to the physician, and could not think of any cases right of hand that would use bipolar. It was further stated the mask used was a simple vinyl oxygen mask and that they don't keep that type of mask in the OR as it is something they just don't use for conscious sedation.

Survey process revealed a facility policy and procedure titled "Electrosurgical Cautery Unit Safety" documenting the following: PURPOSE: To provide for the safe operation of electrosurgical units, used for the purpose of cutting and coagulation of body tissue with a high frequently electrical current during surgical procedures. Section II. PROCEDURE, Section G documented the following: When using electrosurgical cautery around the face, head or neck with supplemental oxygen, discontinue oxygen delivery at least one minute before and during use of the electrosurgical cautery unit. Interviews conducted with the anesthesiologist and surgeon for Patient #1 revealed this procedure was not followed in accordance with facility's written policy and procedure.
Review of facilities Policy and Procedure manual failed to reveal additional policies and procedures for preventing surgical fires related to oxygen use in the surgical setting.
VIOLATION: OPERATIVE REPORT Tag No: A0959
Based on interview and record review, the facility failed to ensure an operative report describing techniques, findings, and tissues removed or altered was be written or dictated immediately following surgery and signed by the surgeon for 1 of 6 sampled patients. (Patient #4)

Findings:

Record review of six (6) surgical patients was conducted on 12/15/11 at approximately 10:00am. Patient #4's medical record failed to reveal an operative report for surgical procedure conducted on 12/6/11. The record included a document titled "physician progress/discharge note" which did include pre and post procedure diagnoses, addressed whether specimens obtained, and addressed whether there were complications, but record failed to include an operative report describing techniques. This finding was confirmed by the Chief, Quality Oficer (CQO) at approximately 10:45am. The CQO stated facility requirement is for surgeon to perform immediate postoperative note; and dictated operative note within 24 hours after procedure. The CQO checked to see if operative note had been dictated, but just not yet typed; and returned to inform this surveyor there was no indication the operative note had been dictated.

The Chief Quality Officer provided the surveyor a zeroxed copy of Medical Staff By-Laws, Article II, Medical Records, Section 2.5 documenting the following: Operative/Procedureal Reports shall include a preoperative diagnosis, a detailed account of the findings at surgery, name and the details of the surgical technique, postoperative diagnosis and tissue or specimens removed or altered. Operative/procedural notes shall be written or dictated immediately following surgery, and the report made a part of the patient's current medical record within twenty-four (24) hours after completion of surgery. An operative progress note must be entered immediately if the operative report is not placed in the record immediately after surgery.