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Based on record review, review of polices and interviews, the hospital fialed to provide surgical services that conformed to current standards of practice. Specifically, the hospital failed to follow interdepartmental policies and procedures to ensure patients are protected against operating room fires. This finding was noted in 1 (Patient #1, P1) of 11 patient records reviewed for fire safety risks.

On 12/14/2022 a 67-year-old female patient (P1) presented to the operating room (OR) for an elective bilateral blepharoplasty (surgical procedure to remove excess skin from the eyelids). The patient was consciously sedated and was receiving 4-6 liters of oxygen via a mask covering her nose and mouth (open oxygen system). A spark from an electrocautery device being utilized by the physician ignited and the open oxygen system accelerated the ignition causing a fire to erupt on the surgical drapes covering the patient's face and neck. The patient suffered partial thickness burns to her face and neck, burns to her right ear, superficial burns to upper and lower lips, 1st and 2nd degree burns to her tongue, 3rd degree burns within her right nasal vestibule (nostril) and nare (opening of the nose), 2nd degree burns on her left nasal vestibule and nare and a full thickness burn to her right shoulder. The patient was placed on a ventilator and transferred to the Intensive Care Unit (ICU).

Cross reference to Tag A 951 482.51 (b).

Based on staff interviews and review of medical records, hospital policies/procedures, and manufacturer recommendations, the facility failed to follow their policy to ensure safety practices were identified and implemented, failed to follow manufacturer recommendations as well as recommended standards of practice for one patient (P1) of 11 sampled patients to reduce the risk and prevent a fire from occurring in the operating room (OR) which resulted in harm occurring to the patient. This failure placed all patients who presented to this hospital at risk for injury or death from a fire. The hospital had 15 surgical cases scheduled on the day the fire occurred.

Patient #1 (P1) presented to the hospital on 12/14/24 for an elective outpatient surgical procedure. P1 was consciously sedated (a level of sedation in which a person is asleep but wakes when spoken to or touched) and was receiving 4-6 liters of oxygen via a mask covering her nose and mouth (open oxygen system). A spark from an electrocautery device being utilized by the physician during the surgical procedure ignited and the open oxygen system accelerated the ignition causing a fire to erupt on the surgical drapes covering the patient's face and neck and under the oxygen mask covering the patient's mouth and nose. The patient suffered partial thickness burns to her face and neck, burns to her right ear, superficial burns to upper and lower lips, 1st and 2nd degree burns to her tongue, 3rd degree burns within her right nasal vestibule (nostril) and nare (opening of the nose), 2nd degree burns on her left nasal vestibule and nare and a full thickness burn to her right shoulder.

Findings include:

Review of P1's Electronic Medical Record (EMR) showed the patient was admitted on 12/14/2023 at 9:28 AM, Admission Type: Elective. Admitting diagnosis: Dermatochalasis of right and left upper eyelid (removal of excess eyelid skin).

Review of P1's EMR showed the surgical staff conducted a "time out" prior to beginning the surgical procedure on 12/14/23 at 12:01 PM to determine fire safety. The assessment identified the surgical procedure being conducted was a level 3, indicating a "high risk for fire", based on the procedure site (above the xiphoid), an open oxygen source (face mask) and ignition source (electrocautery tool). Staff were to follow the HIGH protocol which included:

-If using alcohol-based solutions prep, use the minimal amount needed. Allow sufficient drying time to allow the dissipation of fumes.
-Do not allow pooling of a prep solution (including under the patient).
-Do not drape until the prep area is fully dry.
-Remove all bowls of volatile solutions from the field after use.
-Close open bottles of flammable agents.
-Utilize standard draping procedure.
-Check all electrical equipment before use.
-Protect all heat sources when not in use.
-Activate heat source only when active tip is in line of sight.
-De-activate heat sources before leaving the surgical site.
-Utilize appropriate draping techniques to minimize oxygen concentration.
-Minimize the electrical surgical setting, use wet sponges as appropriate.
-Have a basin of sterile saline and bulb syringe available for suppression purposes.
-Have a syringe full of saline available to anesthesia provider for oral cavity processes.
-Anesthesia personnel will follow guidelines for high-risk fire.

Review of the hospital's "Fire Safety HIGH Protocol" showed no guidance to address safety measures with the use of electrocautery tools and an open oxygen system to reduce the risk and prevent a fire from occurring.

Review of P1's EMR "Anesthesia Event" document dated 12/14/23 showed at:
- 12:01 PM anesthesia had been started.
- 12:09 PM P1 began receiving 4-6 liters of oxygen via a simple mask and:
- 12:22 PM the surgical procedure started.

Review of P1's EMR document "OR Nursing notes" dated 12/14/23, showed RN-A documented "at 12:27 PM, this nurse was documenting and attempt to notify the patient's family of start of procedure when MD-A said, "there's a fire." This nurse went to the patient and removed burning drapes and materials from the patient. Surgical tech poured saline on the flames. The fire was extinguished."

Review of P1's EMR document "Description of Procedure" dated 12/14/23, showed "The patient was brought to the operating room and placed supine. Intravenous (IV) sedation was administered, the facial area was prepped with betadine and draped in a sterile fashion. The right eyelid was addressed initially. Upper lid incisional marks were placed on the eyelid approximately 10 millimeters (mm) above the eyelid margin. Using electrocautery, a wedge of skin was elevated lateral to medial and the redundant skin was excised. As cauterization was being performed on the most medial aspect of the site, a flash and subsequent flame was noted involving the mask and drapes. The mask was removed immediately as were all the drapes, oxygen was discontinued, and the area was doused with sterile normal saline extinguishing the fire." "Complications: Fire following the facial mask, and drapes, resulting in apparent partial thickness burns to the perioral region, nasal tip and tears, upper and lower lips, tip of the tongue, scattered areas on the anterior neck and small areas on the bilateral shoulders."

Review of P1's EMR document "Operating Room Note" dated 12/14/23, showed physician MD-B was called to the operating room emergently. As he entered the OR he noted P1 with no drapes around her head and the obvious smell of smoke around the P1 and evidence of facial burns. He stated he was told that the electrocautery tool had ignited under the mask P1 was using for oxygen supplementation during the procedure. "Findings: Apparent second and possibly third degree burns within the right nasal vestibule and nare, second-degree burns of the left nasal vestibule and nare, scattered first to second-degree perioral, perinasal, neck and shoulder burns, first to second-degree burn of the right greater and left dorsal anterior tongue, mild edema and erythema (redness) of the uvula (soft piece of flesh that hangs down in the back of the mouth) and posterior oropharynx (the middle part of the throat behind the mouth)."

Review of P1's EMR document "Operative Note" dated 12/14/2023, showed MD-A documented MD-B was immediately available and presented to the room at which point intubation was performed. The patient was stabilized, the procedure was completed, and the patient was transferred to the ICU intubated but in stable condition."

Review of P1's EMR document "Consultation Note, dated 12/14/2023, showed MD-D documented "Physical Examination: Face is edematous. Inside nares are white and black. Lips are swollen and part of tongue hanging out is black. Pink burn areas to face and down neck. Posterior should burn, right has some white discoloration."

Review of the policy "Fire Safety in Perioperative Setting" approved 03/2021 showed:
-A fire risk assessment will be completed and communicated to the perioperative team before beginning a surgical procedure.
-Ignition sources (lasers, electrocautery devices, fiber-optic light cords) will be used according to manufacturer guidelines for use and
-The Association of Perioperative Registered Nurses (AORN) recommended practices.
-Fuel sources will be managed to prevent contact with ignition sources.
-Use the lowest possible concentration of oxygen that provides adequate oxygen saturation.
-Drapes will be placed over the head in a manner that allow oxygen to flow freely and prevents accumulation under the drapes.

The facility failed to follow their policy "Fire Safety in Perioperative Setting" by failing to manage the fuel source to ensure contact with the ignition source did not occur, failed to follow manufacturer guidelines and AORN recommended practices to prevent a fire from occurring.

Review of the Force Triad Energy Platform (electrocautery device used) service manual, effective date 1/2006, identified the following:

-"Patient and Operating Room Safety: The safe and effective use of electrosurgery depends to a large degree upon factors solely under the control of the operator. There is no substitute for a properly trained and vigilant surgical team. It is important that the operating instructions supplied with the or any electrosurgical equipment be read, understood, and followed."
-"Warning: Fire Hazzard, Sparking and heating associated with electrosurgery can be an ignition source. Keep gauze and sponges wet. Keep electrosurgical electrodes away from flammable materials and oxygen enriched environments. Use of electrosurgery in oxygen rich environments increase the risk of fire. Take measures to reduce the oxygen concentration at the surgical site. Take measures to reduce the oxygen concentration at the surgical site. If possible, stop supplemental oxygen at least one minute before and during use of electrosurgery."

The facility failed to follow the manufacturers recommendations for the Force Triad Energy Platform and take measures to reduce the oxygen concentration at the surgical site to ensure patient safety and prevent harm from occurring.

Review of "The Association of Perioperative Registered Nurses (AORN)" "3 Risks for Fire in the OR & the Interventions You Need to Protect Patients" identified the following safety interventions to implement when open oxygen is being administered, published 10/11/2023, showed:
-Cover hair near the surgical site with water-soluble gel and use water-based ophthalmic lubricant in the eyes.
-Configure drapes to allow oxygen to flow freely and not accumulate under the drapes.
-Use moistened radiopaque sponges near oxidizers and ignitions sources.
-Notify the anesthesia professional before using an ignition source.

Review of "The American Society of Anesthesiologists (ASA) Practice Advisory for the Prevention and Management of Operating Room Fires", Feb 2013, recommended "surgeons should inform anesthesiologists before using a potential ignition source, and anesthesiologists should inform surgeons if there is a potential for an ignition source to be exposed to an oxygen-enriched environment."

Review of the Joint Commission's (organization that accredits healthcare organizations) Sentinel Event Alert document (identifies specific types of adverse events and high-risk conditions, describes underlying causes and recommends steps to reduce the risk and prevent future occurrences) titled "Updated Surgical Fire Prevention for the 21st Century", dated 10/18/2023, recommended: " Stop or reduce the delivery of supplemental oxygen or nitrous oxide to the minimum required to avoid hypoxia for at least one minute before the use of electrosurgical devices; battery-powered, hand-held cautery units; or lasers for head, neck, or upper chest procedures."

Review of P1's Electronic Medical Record (EMR) showed no documentation fuel sources were stopped or reduced to prevent a fire from occurring.

The facility failed to follow the recommendations of the Joint Commission to reduce the risk and prevent a fire from occurring.

During an interview on 12/14/23 at 12:40 PM, RN-A stated she was unsure if the surgeon tells the anesthesia provider when a cautery tool is being used.

During interview on 12/19/23 at 1:30 PM, MD-A stated "I cannot tell you for sure I told the anesthesia provider I was using a electrocautery tool, but I always do." He stated the oxygen should have been shut off and allowed to dissipate before using the electrocautery tool. He stated mitigating risks would include "turning the oxygen on and off when using the electrocautery device, talk with the anesthesia provider and drape the patient so that more of their face is exposed.

During interview on 12/19/23 at 1:42 PM, MD-B stated it wasn't dictated how anesthesia providers administered oxygen in surgical procedures as long as they were turning it off while using a cautery tool.

During an interview on 12/19/23 at 4:06 PM, MD-C was unable to validate if surgeons and anesthesia providers communicate regarding the use of the cautery tool during surgical procedures.








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