St Lukes Hospital

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 46816 Based on the seriousness of the non-compliance and the effect on patient outcome, the facility failed to substantially comply with this condition by failing to provide safe patient care during a procedure in which a fire ignited in the Operating Room (OR). Findings include: Review on November 1, 2023, of facility policy and procedures, “Fire Prevention and Patient Fire Risk Assessment and Attachment,” OR Manual, reviewed October 2022 revealed, A fire risk assessment (attachment 1) will be performed by the surgical team and be documented in the electronic medical record (EMR) as part of the Time Out prior to each surgical or other invasive procedure. The purpose of the fire risk assessment is to: Identify possible fire hazards ... Reduce the risk from these hazards to an acceptable level ... Identify actions needed for patient safety. Further review of the “Fire Prevention and Patient Fire Risk Assessment Attachment,” revealed the following strategies to manage the risks of oxygen ... Configure surgical drapes to allow sufficient venting of oxygen delivered to the patient via mask or nasal cannula ... Deliver 5L to 10L/min of air under the surgical drapes to flush out excess oxygen via a separate administration system, if oxygen is being administered via mask or nasal cannula. ... Titrate oxygen to the lowest percentage necessary to support the patient’s physiological needs. ... Stop supplemental oxygen for one minute before using electrosurgery, electrocautery or laser for head, neck or upper chest procedures ... Used cuffed endotracheal tubes when possible.” Review on November 1, 2023, of MR1 revealed the patient was admitted as an outpatient at the Saint Luke’s Hospital of Bethlehem, Pennsylvania on October 9, 2023, for excision of a lipoma at the posterior of the skull and was transferred to a higher level of care due to electrical burns that resulted during procedure. Further review of MR1 revealed the procedure was documented as a Fire Assessment Moderate Risk 2 - 3. Review on November 1, 2023, of facility document “Screen Shot” revealed an example of the Fire Risk Assessment Tool for 2 - 3 Moderate Risk of Fire that included check off boxes for interventions and did not include strategies to manage the risks of oxygen. Review on November 1, 2023, of Anesthesia Provider documentation for MR1 dated October 9, 2023, revealed the patient had normal cardiovascular and pulmonary exams and received General Anesthesia with monitors with 4L of oxygen during the procedure. Further review of MR1 revealed no Anesthesia provider documentation for managing the strategies for the use of oxygen. Interview on November 1, 2023, at 11:00 AM, with employee (EMP1), confirmed the patient suffered burns to face, left hand and left wrist during an elective procedure at the facility on October 9, 2023. Further interview confirmed the internal investigation revealed the electrocautery device (Bovie) may have sparked and ignited the oxygen that was pooling under the surgical drape on the head of the patient. Further confirmed it is the anesthesiologists’ responsibility to monitor oxygen use on patients during procedures. Interview on November 1, 2023, at 11:30 AM, with employee (EMP1), confirmed the “Fire Risk Assessment Tool “ does not list strategies to address, manage and decrease the fire risk, while utilizing oxygen on patients during a procedure. Interview on November 1, 2023, at 11:30 AM, with employee (EMP1), confirmed the facility has not had the employee Fire Safety and Prevention computer based annual training this year. The last employee training is dated October 2022. Interview on November 1, 2023, at 12:00 PM, with employee (EMP8), confirmed the facility did not have an Operating Room (OR) specific fire drill this year. A fire drill occurred in the OR hallway on August 31, 2023, which was not OR specific. Review of the Fire Drill attendance sheet revealed, four of fourteen OR staff attended the fire drill. EMP8 confirmed that only 4 of the 14 OR staff members were in attendance during the fire drill. Interview on November 1, 2023, at 2:51 PM, with employee (EMP11), confirmed the cause of the fire was “multifactorial”. The patient was positioned on their right side, patient had an oxygen mask with 100% FIO2 source, the surgical drape on the patients’ face trapped oxygen under the drape and the electrocautery sparked the fire. We need to be more vigilant during the “Time Out” procedure with an emphasis on the Fire Risk assessment and mitigation. The Fire Risk Assessment Tool does not address direct Oxygen (O2) delivery and the risk when procedure is performed above the xiphoid, with proximity to the airway. A discussion took place with the survey team and the facility’s administrative staff (EMP1, EMP2, EMP3, EMP4, EMP8, EMP11) regarding the survey team’s concerns related to Surgical Services on November 1, 2023, at approximately 2:24 pm.”

“FIRE CONTROL PLANS CFR(s): 482.41(b)(7) (5) The hospital must have written fire control plans that contain provisions for prompt reporting of fires; extinguishing fires; protection of patients, personnel and guests; evacuation; and cooperation with fire fighting authorities. This Standard is not met as evidenced by: 46816 Based on review of facility policy and procedures, review of facility documents, review of the medical record (MR) and interview with staff (EMP), it was determined the facility failed to ensure all members of the perioperative team responsible for preventing fires in the surgical environment participated in the annual fire education safety program and failed to ensure the Fire Drill was specific to the Operating Room (OR). Findings include: Review on November 1, 2023, of facility policy, “Fire Prevention and Patient Fire Risk Assessment,” Operating Room Manual, reviewed October 2022 revealed, “ ... II. Policy: Members of the perioperative team are responsible for preventing fires in the surgical environment and for participating in annual departmental fire safety education. Fire safety education will occur for staff annually and may include but not limited to participating in department mock drills, identification of evacuation routes, participation in fire extinguishing techniques, and identification of medical gas and electrical panel shut-off. Review on November 1, 2023, of facility documents, “Fire Drill Signature Page,” for the OR Fire Drill conducted on August 31, 2023, revealed documentation of attendance of four OR staff. Continued review of the Fire Drill Signature Page revealed the remainder of the attendees at the OR fire drill were from other departments of the facility. Review on November 1, 2023, of “Case Information” for MR1 revealed the four OR staff and two providers were in attendance during the procedure for MR1. There was no documentation for these staff and providers of attendance for the OR Fire Drill on August 31, 2023, or a subsequent OR Fire Drill. Review on November 1, 2023, of facility documents “Fire Drill Effectiveness Evaluation,” and “Supplementary Fire Drill/Alarm Evaluations”dated August 31, 2023, for the OR fire drill, revealed the fire drill was not specific to the OR. Review on November 1, 2023 of online facility education revealed “2022 OR Fire Safety” the last education was completed in October 2022. Interview on November 1, 2023, at 12:00 PM, with employee (EMP8), confirmed the facility did not have an OR specific fire drill this year. A fire drill occurred in the OR hallway on August 31, 2023, which was not OR specific. Review of the Fire Drill attendance sheet revealed, four of fourteen OR staff attended the fire drill. EMP8 confirmed that only 4 of the 14 OR staff members were in attendance during the fire drill. Further interview with EMP8 on November 1, 2023, at 12:00 PM confirmed the staffing for the OR included 4 -surgical techs and 2 surgical tech per diem, 7- RNs along with 1 RN part time and 2 RN per diem. Further interview with EMP8 confirmed four of the 16 members of the OR staff were in attendance at the OR Fire Drill conducted on August 31, 2023, due to the fact the remainder of the staff were involved in other cases at the time of the drill at 11:10 AM. EMP8 also confirmed the last OR Fire Safety Education was completed in October 2022 and the OR Fire Safety Education for 2023 has not yet been completed.”