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Based on review of National Fire Protection Association (NFPA) 99 Health Care Facilities Code 2012 Edition, review of manufacturer's directions for use, policy review, medical record review and interview, the hospital failed to ensure patients received care in a safe setting by failing to appropriately use alcohol skin preparation and failing to perform timeouts prior to surgery for 2 of 3 (Patient #1 and 3) sampled patients in the Operating Room setting.

The findings included:

1. Review of NFPA 99 Health Care Facilities Code 2012 Edition 15.13.3.3-6 revealed, "15.13.3.3 Whenever the application of flammable liquid germicides or antiseptics is employed in surgeries where the usage of electrosurgery, cautery, or a laser is contemplated, time shall be allowed to elapse between application of the germicide or antiseptic and the following: (1) Application of drapes, to allow complete evaporation and dissipation of any flammable vehicle remaining (2) Use of electrosurgery, cautery, or a laser, to ensure the solution is completely dry and to allow thorough evaporation and dissipation of any flammable vehicle remaining 15.13.3.4 Any solution-soaked materials shall be removed from the operating room prior to draping or use of electrosurgery, cautery, or a laser. 15.13.3.5 Pooling of flammable liquid germicides or antiseptics shall be avoided; if pooling occurs, excess solution shall be wicked, and the germicide or antiseptic shall be allowed to completely dry. 15.13.3.6 A preoperative "time out" period shall be conducted prior to the initiation of any surgical procedure using flammable liquid germicides or antiseptics to verify the following: (1) Application site of flammable germicide or antiseptic is dry prior to draping and use of electrosurgery, cautery, or a laser. (2) Pooling of solution has not occurred or has been corrected. (3) Any solution-soaked materials have been removed from the operating room prior to draping and use of electrosurgery, cautery, or a laser."

2. Review of the "ChloraPrep With Tint" manufacturer's directions for use revealed, "...Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection...WARNING...FLAMMABLE...Keep away from fire or flame. To reduce the risk of fire, PREP [prepare] CAREFULLY...solution contains alcohol and gives off flammable vapors...do not drape or use ignition source (e.g. [for example], cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)...do not allow solution to pool...remove wet materials from prep area..."

3. Review of the hospital's "FIRE SAFETY AND EVACUATION PLAN FOR THE O.R. [Operating Room]" policy revealed, "...Fire Prevention: 1. Read all manufacturer labels before product usage. 2. Allow sufficient time for complete evaporation of flammable antiseptic agents (2-4 minutes) to reduce risk of fire..."

Review of the hospital's "Universal Protocol - Identification of Correct Patient, Procedure, Site/Side" policy revealed, "...Purpose: To outline the universal protocol and time-out process...The universal protocol and time-out process applies to invasive/surgical procedures performed in both inpatient and outpatient areas...The time-out is performed immediately prior to the invasive/surgical procedure or prior to incision/entry. The time-out process includes confirmation of the following: 1. Correct patient identity; 2. Agreement on the procedure to be done per consent documentation; and 3. Confirmation that the correct site/side is marked if applicable...The time-out is performed by a designated member of the procedural team and includes the following team members: The proceduralist who marks the site/side, and the immediate members of the procedure team (e.g., the individual performing the procedure, anesthesia provider, circulating nurse, operating room technician, and other active participants who will be participating in the procedure from the beginning). The proceduralist confirms the patient identity, procedure, site/side, and procedure immediately prior to procedural entry into the patient..."

4. Medical record review for Patient #1 revealed an admission date of 6/17/19 with diagnoses which included Malignant Neoplasm of the Right Breast and Pagets Disease of the Right Breast.

The Operative Report (for first part of the dual procedure) dated 6/17/19 revealed, "...OPERATIONS PERFORMED: 1. Injection of Lymphazurin blue dye to facilitate sentinel lymph node biopsy. 2. Right skin-sparing total mastectomy. 3. Right deep axillary sentinel lymph node biopsy...Surgeon: [Physician #1]...PROCEDURE IS AS FOLLOWS...She [Patient #1] underwent general anesthesia and endotracheal intubation without complication...Her neck, chest, and upper abdomen with the right upper extremity were all prepped and sterilely draped. A time-out was performed with participation of the entire OR team...the breast was taken off the underlying pectoralis major muscle along with its overlying fascia, dissecting superior to inferior and medial to lateral...The wound was irrigated with a copious amount of warm sterile water and packed with a warm moist laparotomy sponge..."

The Operative Report (for second part of the dual procedure) dated 6/17/19 revealed, "...PROCEDURES: 1. Placement of right tissue expander in reconstruction 2. Implantation of Alloderm [regenerative tissue matrix] Select RTU [ready to use] ..SURGEON: [Physician #2]...FIRST ASSISTANT: [Physician #3]...OPERATIVE DETAIL: The initial portion of the procedure consisted of mastectomy as dictated by [Physician #1]. Upon completion of her portion of the operation, our team was called to the operating room. As per standard protocol, the skin was reprepped with Chloraprep and new drapes were placed over old. A laparotomy sponge present within the pocket over the pectoralis muscle was removed to allow for prepping the pocket with antibiotic solution. At this point, per his report, [Physician #3] noted a small arterial bleeder and moved to control this with electrocautery. He reported that Chloraprep was dry on the skin surface, but a small flash was noted when electrocautery was first used, presumed to result from ignition of residual alcohol vapors. The field was immediately covered with a moist towel, less than 1 second after the flash...Initially, no apparent injury was observable, although some erythema would eventually be noted at 3 locations progressively during the case over approximately the next hour, consisting of an 8 x 1 cm [centimeters] area of erythema and superficial blistering transversely across the lower aspect of the left breast, and 2 areas of erythema without evident blistering in the right upper and lower breast measuring 3 X 1.5 and 3 x 1 cm...At the location of the burn erythema and blistering noted above, bacitracin [topical antibiotic] and Xeroform [petrolatum gauze] was placed, with overlying soft gauze dressings..." Physician #3 failed to wait the minimum 3 minutes after skin preparation with an alcohol-based skin prep before continuing with the procedure (removing the laparotomy sponge).

Patient #1 was taken to the Post-Anesthesia Care Unit (PACU) after her wounds were treated, and Physician #2 took photographs of the wounds. Physician #2 informed Patient #1 of what happened in surgery after she was fully awake and would be able to remember the details of the discussion while still in PACU.

Review of the pictures dated 6/17/19 revealed Patient #1 had a transverse reddened blistered area on the lower aspect of the left breast approximately 8 cm long by 1 cm wide and an irregularly shaped, reddened blistered area on the upper right breast approximately 3 cm by 1 ½ cm.

5. In an interview in the conference room on 7/2/19 at 11:00 AM, Nurse #1 stated the OR staff was to wait at least 3 minutes after the alcohol-based preparation was used before proceeding with the surgery. Nurse #1 stated the OR staff kept the drapes from the first procedure for Patient #1 but replaced the towels on top of the drapes. Nurse #1 stated Physician #3 asked her to get betadine, which was unavailable on Scrub Technician #1's table in the OR room, for the preparation of the Patient #1's skin prior to the start of the second procedure. Nurse #1 stated she returned to the OR room with the betadine (non-flammable) when Physician #3 used ChloraPrep (flammable) which was available on the table in the OR room. Nurse #1 stated she heard the "click" of the ChloraPrep stick and then heard Physician #3 scream a little bit soon afterward. Nurse #3 stated she saw a flash of flames when Physician #3 used the Bovie (electrocautery stick) to cauterize an artery in the existing surgical wound. Nurse #1 stated there was less than a minute from the time she heard the "click" of the ChloraPrep stick to the time she saw the flames. Nurse #1 stated Physician #3 quickly grabbed a towel and patted where the flames had been. Nurse #1 stated Scrub Technician #1 poured water on the surgical towel Physician #3 had placed on the patient.

In an interview in the conference room on 7/2/19 at 12:01 PM, Physician #3 stated his team was called into surgery after the mastectomy was completed. Physician #3 stated he prepped the patient's skin and saw a gauze in the breast. Physician #3 stated he removed the gauze and saw an "arterial bleeder" on the pectoral muscle. Physician #3 stated when he tried to control the bleeder with the Bovie (electrocautery stick), there was a flash which he believed to be from the fumes from the ChloraPrep stick igniting. Physician #3 stated there were no signs of erythema on the patient's skin at first, but they began to develop as the case was continued. Physician #3 stated Patient #1 had a blister on the bottom side of the left breast. Physician #3 stated he knew to wait for at least 3 minutes after prepping the skin before using the Bovie, but the skin was dry. Physician #3 confirmed he did not wait 3 minutes after preparing the patient's skin before proceeding with the procedure. Physician #3 stated some of the prep may have gotten on the towel which was consistent with the blisters on the patient's skin. Physician #3 stated he reported the incident to the Attending Physician (Physician #2) and later discussed the case with the Plastic Surgery Department Chair. Physician #3 stated the Plastic Surgery Department Chair and Physician #2 decided the surgeons in the department would use only non-alcohol preparations to prepare the skin in dual step procedures.

In an interview in the conference room on 7/2/19 at 12:52 PM, Scrub Technician #1 stated she was the scrub technician for Patient #1 for both procedures. Scrub Technician #1 stated Physician #3 came into the OR room and asked for betadine which she did not have available. Scrub Technician #1 stated Nurse #1 left the OR room to get betadine, but Physician #3 used the ChloraPrep stick instead to prep the skin. Scrub Technician #1 stated the drapes and the towels under the drapes were not changed between the procedures, but she changed the towels on top of the drapes. Scrub Technician #1 stated she placed 4 towels (one of each side) made into a square around the surgical site and field on Patient #1's chest prior to Physician #3 prepping Patient #1's skin with the ChloraPrep. Scrub Technician #1 stated there was about 10 seconds from the time Physician #3 used the ChloraPrep stick and when he used the Bovie (electrocautery) stick.

In an interview in the conference room on 7/2/19 at 1:27 PM, Physician #2 (Attending Physician) stated that during these type of procedures (placement after mastectomy), a team would come in and reprep the skin and apply new drapes prior to the start of the second part of the procedure. Physician #2 stated Physician #3 reported to him that he used ChloraPrep (alcohol-based) to prepare Patient #1's skin. Physician #3 removed a sponge from the incision (made during the first part of the procedure) and saw an arterial bleeder on the surface of the pectoral muscle. Physician #3 used the electrocautery stick to cauterize the vessel and saw a flash of fire. Physician #2 stated the fire presumably resulted from the ignition of the alcohol.

In an interview in a conference room of the OR on 7/2/19 at 2:18 PM, the Director of the OR stated the OR staff should place new towels down around the operative site after the skin is prepped. The Director of the OR stated the Proceduralist (Physician) should wait at least 3 minutes after prepping the skin with an alcohol-based prep before continuing with the procedure.

6. The Immediate Post/Op [Operative] Note/Post-Procedure Note for Patient #1 for the first part of the procedure dated 6/17/19 revealed a Fire Safety Timeout was documented as performed at 10:41 AM and a Timeout (standard) was documented as performed at 10:47 AM and signed by Nurse #1.

The Immediate Post/Op Note/Post-Procedure Note for the second part of the procedure dated 6/17/19 revealed a Timeout (standard) was documented as performed at 1:45 PM and signed by Nurse #1. Three (Physician #3, Resident Anesthesiologist #1 and Scrub Technician #1) of the four OR staff members in the OR room who would have participated in the standard timeout stated in interview, they recalled the standard timeout for the first part of the procedure but not for the second part. There was no documentation a Fire Safety Timeout was performed prior to the start of the second part of the procedure.

7. In an interview in the conference room on 7/2/19 at 11:00 AM, Nurse #1 stated the OR staff was supposed to conduct a fire safety timeout and a regular timeout prior to the beginning of any surgery. Nurse #1 stated the fire safety timeout included checking if an alcohol-based preparation was used to prepare the skin and making sure it was dry before draping. Nurse #1 stated the OR staff was to wait at least 3 minutes after the alcohol-based preparation was used before proceeding with the surgery. Nurse #1 stated she was not used to the dual step procedure (surgery with 2 concurrent procedures) and confirmed the OR staff did not perform a fire safety check prior to the second part of the procedure. Nurse #1 confirmed she documented the regular timeout prior to the beginning of the second part of the procedure.

In an interview in the conference room on 7/2/19 at 12:01 PM, Physician #3 stated his team was called into surgery after the mastectomy was completed. When asked if a fire safety timeout or regular timeout had been performed prior to the second procedure, Physician #3 stated a fire safety timeout had not been performed. Physician #3 stated he knew a standard timeout had been documented, but he did not remember the timeout being performed.

In an interview in the conference room on 7/2/19 at 12:52 PM, Scrub Technician #1 stated she was the scrub technician for Patient #1 for both procedures. Scrub Technician #1 stated she remembered the standard timeout done prior to the first part of the procedure but did not remember the OR staff conducting a standard timeout prior to the second procedure. Scrub Technician #1 stated the Fire Safety Timeout performed by Nurse #1 prior to the first procedure consisted of her stating the patient was a fire risk of 3. Scrub Technician #1 stated she did not know what the score meant and confirmed Nurse #1 did not go through a fire safety check list. Scrub Technician #1 stated the OR staff did not conduct a fire safety timeout prior to the second procedure.

In an interview in the conference room on 7/2/19 at 1:27 PM, Physician #2 (Attending Physician) stated he would expect the OR team to perform a standard timeout and fire safety timeout prior to the start of the second part of the procedure. Physician #2 stated he could not recall a fire safety timeout being done or documented prior to the start of the second part of the procedure.

In an interview in a conference room of the OR on 7/2/19 at 2:18 PM, the Director of the OR stated the OR team should perform a standard timeout and fire safety timeout prior to the start of the first and second part of a dual procedure. The Director of the OR stated the fire safety timeout should include all parts of the list for the fire safety risk being read out loud. The Director of the OR confirmed the OR staff did not follow the hospital's protocol by reading out the list for the fire safety risk during the first part of the procedure and was not performed during the second part of the procedure for Patient #1.

During a phone interview on 7/2/19 at 3:34 PM, Resident Anesthesiologist #1 stated she remembered a standard timeout performed for the first part of the procedure for Patient #1 but did not remember a standard timeout or fire safety timeout for the second part of the procedure.

8. Medical record review for Patient #3 revealed an admission date of 6/25/19 with diagnoses which included Malignant Neoplasm of Overlapping Sides of the Left Breast.

The Operative Report (for the first part of the dual procedure) dated 6/25/19 revealed, "...PROCEDURE PERFORMED: 1. Bilateral skin-sparing total mastectomies. 2. Left intraoperative lymphatic mapping and deep axillary sentinel lymph node biopsy. 3. Placement of right anterior chest wall central venous port under ultrasound and fluoroscopy guidance..."

The Operative Report (for the second part of the dual procedure) dated 6/25/19 revealed, "...OPERATION: Bilateral immediate breast reconstruction with subpectoral dual plane tissue expanders with Alloderm..."

The "Case Information" dated 6/25/19 revealed there was no documentation for the fire safety timeout prior to the second part of the dual procedure.