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Based on staff interview and record review from 10/10-10/12/2022, the Aurora St Luke's Medical Center South Shore failed to construct, install, and maintain the building systems to ensure safety of patients.

Findings include:

The facility was found to contain the following deficiencies.

K711 - Evacuation and Relocation Plan
K911 - Electrical Systems - Other

As a result of these deficiencies, 42 CFR Subpart CFR 482.41 Condition of Participation: Physical environment was NOT MET

See K-tags for details of the specific findings.

Based on staff interview and record review from 10/10/2022-10/12/2022, the Aurora St Luke's Medical Center South Shore failed to construct, install, and maintain the building systems to ensure safety of patients.

Findings include:

The facility was found to contain the following deficiencies.

K711 - Evacuation and Relocation Plan
K911 - Electrical Systems - Other

As a result of these deficiencies, 42 CFR 482.41(b) Standard: Safety from Fire was NOT MET

See K-tags for details of the specific findings.

Based on record review and staff interview, the facility failed to take measures to minimize the concentration of oxygen to prevent fires in an oxygen-enriched environment while using electrosurgical equipment in 1 of 1 departments (Surgery department), the facility failed to provide training to medical staff on electrosurgical equipment used in 1 of 1 departments (Surgery department); resulting in a fire in the Surgery department, and the facility failed to activate the fire alarm pull system for automatic transmission of fire alarm signal to alert local fire departments, team members, patients, and other building occupants of a fire notification per facility policy (AAH FIRE SAFETY) for 1 of 1 fire events reviewed.

Findings include:

The facility failed to ensure policies were designed and implemented to minimize the concentration of oxygen at the surgical site to prevent possible fire when using electrosurgical equipment. See Tag A-0951

The facility failed to ensure policies were designed and implemented for staff competency/training on the use of electrosurgical equipment. This failure has the potential to affect all surgical patients requiring oxygen and electrosurgical equipment during their surgical procedures. See Tag A-0951

The facility failed to ensure a safe setting by failing to follow facility policy to activate the fire alarm pull station for a fire notification. See Tag A-0951

Based on record review and interview, the facility failed to minimize the concentration of oxygen at the surgical site to prevent possible fire when using electrosurgical equipment in 1 of 1 departments (Surgical Department) in 1 of 1 patients reviewed (#1) where burn injury occurred, the facility failed to ensure staff competency/training on the use of electrosurgical equipment in 1 of 1 departments (Surgical Department), and the facility failed to activate the fire alarm pull system for automatic transmission of fire alarm signal to alert local fire departments, team members, patients, and other building occupants of a fire notification per facility policy (AAH FIRE SAFETY) for 1 of 1 fire events reviewed.

Findings:

A review of the facility's protocol titled, "Fire Safety Tool", resource by AORN (Association of PeriOperative Registered Nurses) recommendations, effective date: 2017-2018, revealed: "Interventions when using an ESU (electrosurgical unit)...Keep the ESU active electrode away from oxygen, nitrous oxide, or combustible anesthetic gas source if possible...Use according to the manufacturer's in instructions for use and applicable professional guidelines..."

During an interview on 10/10/2022 at 11:45 AM with Surgical Services Director C, when asked about the fire risk associated with the procedure Pt.(Patient) #1 underwent on 10/05/2022, Director C stated "It will show in EPIC [electronic medical health record] that the procedure had a fire risk rating of '3' which is increased fire risk; during the time-out the Circulating Nurse announces the fire risk." When asked what a fire risk of 3 means, Director C stated that there is a protocol list in EPIC that the Circulating Nurse needs to go through to check-EPIC requires that all boxes are checked before moving on."

A review of Pt. #1's electronic medical record revealed a "Routine Protocol for Fire Risk Score 3 Procedure has the HIGHEST risk of fire. Follow HIGH protocol" form was completed by the Circulating Nurse (H) and all boxes were electronically checked during a time out before the procedure started; the following checks were done: "Minimize amount if prep is used to cover body area, Dry time followed per manufacturer's instructions, Draping not performed until prep solution dried, No pooling allowed, Check electrical equipment before use, Protect all heat sources when not in use, Activate heat source only when active tip in line of sight, De-activate heat source before tip leaves surgical site, Utilize appropriate draping techniques to minimize oxygen concentration, Minimize the Electrical Surgical unit (ESU) settings, Use wet sponges as appropriate, Have basin of sterile water/saline immediately available, Remove prep soaked linens/drapes/towels."

During an interview on 10/10/2022 at 11:55 AM with Director of Quality B, when asked about any investigation done regarding the fire event on 10/05/2022 involving Pt. #1, Quality B stated, "There was an RCA [root cause analysis] done, we were not able to come up for sure with a root cause other than due to a pocket of oxygen under the drape over the patient's face; the drape was tented for Anesthesia to get in there, flame was observed under the cloth. Tenting of oxygen under the drape is the plausible explanation. The flames were observed under the drape where the Anesthesiologist was holding the oxygen mask on the patient, the patient was obese and the Anesthesiologist had to hold the mask on the patient's face. Anesthesia turned the oxygen off immediately, then someone in the room threw water on the patient, and then the fire department was called."

During an interview with Surgical Services Director C on 10/10/2022 at 12:20 PM, Director C stated that Anesthesiologist (O) was under the surgical drape during Pt. #1's procedure, he/she had his/her hands holding on the patient's face mask due to "obesity."

During an interview with Surgical Services Director C on 10/10/2022 at 5:30 PM, Director C stated "There was oxygen pooling under the tent." When asked if there are different sized masks for obese patients to prevent leaking and/or pooling of oxygen under surgical drapes, "No, but I can check with the manufacturer and supplier to see if there are different sized masks."

During an interview with Director of Quality B on 10/10/2022 at 5:34 PM, when asked if the oxygen mask Pt. #1 was wearing during the procedure was considered a possible factor during investigation discussions after the fire event, Quality B stated "No, this did not come up in discussions."

During an interview with Surgical Services Director C on 10/11/2022 at 10:26 AM, when asked if Surgical/OR staff are trained/educated on fire risk ratings (such as high-risk 3 ratings) and protocols to implement, Director C stated "I don't think so, we have all been educated in EPIC about the fire ratings used-but other than yearly fire training, nothing specific on high-risk fire ratings."

During an interview with Surgeon M on 10/11/2022 at 10:35 AM, Surgeon M confirmed he/she was the Surgeon who performed the removal of a right-sided scalp mass with a Bovie device on Pt. #1 on 10/05/2022 that involved a fire during the procedure. When asked about Anesthesiologist (O) holding onto Pt. #1's oxygen mask during the procedure, Surgeon M stated, "Anesthesiologist [O] was holding onto the patient's mask on and off, Anesthesia's arm was under the drape-assumed he/she was holding onto the mask." When asked if the band attached to the oxygen mask was fastened around the patient's head, Surgeon M stated, "I don't remember clearly." When asked about actions taken when the patient's fire risk of 3 was announced by the Circulating Nurse (H), Surgeon M stated "I lowered the Bovie energy to 30-35, I don't recall exactly what number it was set at-but I do recall looking at the machine and seeing it was at an acceptable number." When asked what he/she recalled regarding the fire incident, Surgeon M stated, "I saw a little bit of burning hair on the patient, one second later I saw the fire under the drape. I then called for water and put water on the patient's face, then grabbed the drape off the patient; I saw the oxygen mask was black and charred." When asked if there were wet sponges or towels around the surgical area, Surgeon M stated, "It's not typical to have wet towels around the surgical area, usually those are used for laser surgeries." When asked about the amount of oxygen being delivered to the patient and if the oxygen was stopped at any time, Surgeon M stated, "Six liters of oxygen is used in most cases (which is low), the only time I would stop oxygen would be a Tracheostomy (surgical incision into windpipe)." When asked if oxygen pocketing under the drape was the cause of the fire, Surgeon M stated "Yes, the oxygen tent contributed."

During an interview with Physician Assistant/First Assist K on 10/11/2022 at 2:49 PM, when asked about draping techniques used to minimize oxygen concentration in a fire risk 3 patient procedure, Physician Assistant/First Assist K stated that "tenting off of drapes" is used. When asked if drape tenting was used during the procedure involving Pt. #1 on 10/05/2022, Physician Assistant/First Assist K stated that he/she doesn't remember if the drape was connected on the IV (intravenous) poles to tent.

A review of Pt. #1's Operative Note on 10/05/2022 by Surgeon M revealed, "...Procedure: EXCISION OF RIGHT HEAD MASS 1 CM Anesthesia Type: MAC Complications: Encounter intraoperative fire, patient's [sig] suffered from 2nd degree face burnt [sig] and potential smoke inhalation. Description of procedure:...Patient's head was turned to the left and right temporal area were prepped and draped in sterile fashion. Small amount of hair was clipped with scissors to expose the area of concern. Local anesthetic was injected. 1 cm elliptical incision transversely was made and subcutaneous tissue cut down with sharp and cautery. Small amount of bleeding was cauterized. the thickened skin was removed. The specimen was placed in formalin. Small skin bleeding encounter and cauterize was used again. Sudden onset of spike noted and found fire started underneath the sterile drapes immediately. Drape was removed quickly and room temperature sterile saline water was pulled [sig] onto patient's face to put out fire at the same time the oxygen mask was quickly removed. Cold moist towel was placed on to patient's face while prepping for intubation. Additional staff was called. Her/his hospital gown was removed. Assessment was performed show secondary burn to patient's face, possible small amount of third-degree burn at the eyebrow out and nose area. And 1st-2nd degree burn to 5 cm upper chest from skin of the mid left to right clavicle region. No neck or scalp movement..."

A review of the facility policy titled, "AAH Competency Assessment", effective date: 06/01/2022, revealed: "PURPOSE To provide a measurable process for the assessment of a team member's knowledge (critical thinking), skills (technical), abilities and behaviors (interpersonal) necessary to fulfill their role...Competence: A person's ability to fulfill their professional role safely and effectively; the possession of knowledge, skills, abilities, and behaviors necessary to practice in a designated role under the varied circumstances in a clinical setting...C. Ongoing Competence 1. Annual/ongoing competencies are established at department level based on risk/need assessment data...2. A competency documentation tool is to be created for each competency, clearly identifying the purpose, methods, performance expectations, and critical behaviors necessary..."

A review of the current Manufacturer's Instructions for Use (IFU) for the Bovie electrosurgical unit used in the incident on 10/05/2022 revealed, "This guide and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed...Warnings and Precautions for Patient and Operating Room Safety The safe and effective use of 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 this or any electrosurgical equipment be read, understood, and followed...Fire/Explosion Hazards Fire Hazard...Sparking and heat associated with electrosurgery can be an ignition source...Use of electrosurgery in Oxygen (O2) rich environments increases the risk of fire. Therefore, take measures to reduce O2 concentration at the surgical site...Prevent the accumulation of flammable or oxidizing gases or vapors under surgical drapes or near the surgical site..."

During an interview with Surgeon M on 10/11/2022 at 10:35 AM, when asked about training that he/she received from the facility regarding the use and manufacturer's safety guidelines on the Bovie device used at the facility, Surgeon M stated that he/she did not receive training from the facility on manufacturer's safety guidelines and usage requirements on operation of the Bovie electrosurgical unit. Surgeon M stated that she last received training on the Bovie device in his/her residency in 2008.

A review of the facility policy titled, "AAH Patient Rights and Responsibilities", last dated 12/12/2019 revealed: "...E. Patient Safety 1. [Facility Name] supports the right of patients and families to be in a safe environment. 2. Team members will follow current standards of practice and existing policies and procedures for patient environmental safety, infection control, and security, and will protect vulnerable patients, including newborns and children. These protections include the patient's emotional health and safety as well as his/her physical health..."

A review of the facility policy titled, "AAH FIRE SAFETY", effective date: 02/18/2022, revealed: "...A. Fire Notifications 1. Fire alarms will be activated for all unexpected occurrences of smoke, flames or burning odors. 2. Fire notifications occurs when building fire alarm pull stations are activated which alerts local fire departments, team members, patients, and other building occupants..."

During an interview with Director of Quality B on 10/10/2022 at 11:55 AM, Director B stated, "The fire alarm should have been pulled and wasn't, staff observed the fire and put it out in 2-3 seconds with sterile water that was on the Tech's [technician's] back table."

A review of Intra-operative (operating room) Fire Drill Reports for 2022 revealed, last simulated patient fire drill was performed on 06/27/2022 at 9:30 AM-10:15 AM and was documented, "Staff able to identify where pull alarms and fire extinguishers were."

During an interview with Circulating Nurse H on 10/10/2022 at 3:39 PM, when asked what he/she recalled from the fire event that happened after the procedure started, Nurse H stated, "The doc [doctor] said 'there's a fire, get water'; then doc was peeling the drape back to feet, the doc put fluid over the patient and I went to get more water outside the room." When asked if the fire alarm was pulled, Nurse H stated, "No, it was not pulled."