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Based on interview and record review, the Governing Body (GB) failed to ensure quality of care and safety was provided for one of 25 sampled patients (Patient 10) when, the GB did not provide oversight of quality improvement measures were implemented , or ensure an effective safety and quality improvement program of the Operating Room (OR) staff for fire risk prevention during high fire risk surgical procedures. (Refer to A-0049)

The cumulative effect of this systemic problem resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview, and record review, the hospital failed to maintain an effective and ongoing hospital wide, data driven Quality Assessment and Performance Improvement (QAPI) program for one of 25 sampled patients (Patient 10), when the facility failed to identify opportunities for tracking and implementing safety care measures after a surgical fire resulted in patient sustaining 2nd and 3rd degree burns (burn to skin that results in blisters, disfigurement, pain and increased risk of infection). (Refer to A-0286)

The cumulative effects of these systemic problems resulted in the hospital's inability to identify problem prone areas and ensure the provision of quality health care in a safe environment.

Based on interview and record review, the facility failed to ensure that surgical services were provided in accordance with acceptable standards of practice for one of 25 sampled patients (Patient 10) when:

1. A "High Fire Risk" form was referenced in the facility's policy and procedure (P&P) was not utilized (Refer to A 951).

2. A monopolar cautery device (a surgical tool that uses electricity to cut and seal tissue, which flows an electrical current, from an electrode, through the tissue to a grounding pad) was used during a surgery on the face, next to an open oxygen source and oxygen was not discontinued or decreased prior to use of cautery device (Refer to A 951).

3. Sterile drapes did not allow for free airflow which caused tenting of oxygen from open air oxygen source (Refer to A 951).

4. A flammable skin prep was used to cleanse the surgical site prior to the procedure (Refer to A 951).

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Surgical Services and failure to provide care to their patients in a safe environment.

Based on interview and record review, the Governing Body (GB) failed to identify and ensure a safe environment was provided with quality of care for one of 25 sampled patients (Patients 10) when,:
Surgical Services did not implement safety policies and procedure in the operating room (OR) and fire risk and prevention protocols were not maintained (Patient 10) .

This failure resulted in the hospital's inability in identifying the problem prone areas and had the potential for adverse health outcomes such as inadequate patient monitoring, and inadequate therapy for treatment, which could negatively affect patients' health, safety, prolonged hospitalization, and/or lead up to death.


Findings:

During a review of Patient 10's clinical record titled, "Registration Admission" (a document that contains demographic information), the "Registration Admission" indicated, Patient 10's admission date was September 21, 2021, at 7:34 AM, and the discharge date was September 21, 2021, at 2:20 PM. Patient 10's admitting diagnosis was dysphasia (language disorder that affects speech and the comprehension of spoken language).

During a review of Patient 10's clinical record titled, "Consultation", dated September 21, 2021, at 12:23 PM, by Consult Physician 1, indicated ..."there was intraoperative flame fire in the operating field. Related to this, the patient sustained partial thickness burns (destruction of the top two layers of skin) to his face and upper chest measuring approximately 8% [percentage a number or rate in each hundred] to 10% of total body surface area (assessment of injury to skin). ...evidence of carbonaceous sputum (black mucus from smoke inhalation) to the tongue ...".

During a review of Patient 10's clinical record titled, "Discharge Summary", dated September 21, 2021, at 2:35 PM, by MD1, the "Discharge Summary" indicated, "Patient 10 was noted to have burns to ... the right face and possibly oropharynx (back of the throat) ...". Patient 10 was accepted at [Secondary Hospital] for burn treatment and a higher level of care. Patient 10 was transported via helicopter.

A review of the facility's document titled, "Board of Trustees Minutes October 7, 2021," the meeting minute under Section 17.3 Discussion indicated, " ...[Chief Quality Officer (CQO)] informed the Board of the incident that occurred in the OR on September 21st. A serious safety event occurred in the OR which involved a fire and a patient[Patient 10] being seriously injured. The patient was transferred to a burn unit for higher level of care ...a root cause analysis meeting had been conducted with the OR staff ...". The minutes did not identify what was discussed regarding the results or progress of the root cause analysis regarding this safety event. There was no documented evidence of what quality care measures were discussed, improvement opportunities identified, implementation of corrective actions, or monitoring of quality care.


During an interview on March 13, 2025, at 10:30 AM, in the conference room, with two members of the Governing Board (GB): Board Member 1 and Board Member 2, both community member trustees. The GB stated, the Quality Assessment Improvement Committee (QAIC) reports to the board each meeting, which is monthly as noted in the GB minutes. Improvement opportunities and interventions are discussed at each GB meeting for each department presenting. Board Member 1 stated, the GB was made aware of the OR fire incident in 2021. Board Member 1 stated, it was hard to recall specifics from the incident. Board Member 1 could not recall a review of any other opportunities identified by QAIC or if safety interventions were implemented. Board Member 2 stated, he was not yet appointed to the "Board of Trustees" at the time. Board Member 2 stated, wound metrics are shared with the board when there is a notable increase or a new process is launched. Board Member 2 stated, reassessment after medication administration is discussed if the medication is for pain, not necessarily for blood pressure. Board Member 1 & 2 stated, it was the responsibility of the GB to provide oversight to the QAIC and ensure patient safety.

During a review of the facility's policy and procedure (P&P) titled," Organization-Wide Quality Assessment and Performance Improvement Program", dated March 2024, the P&P indicated, " ...7.B. Governing Board The Governing Board shall be responsible to ensure the provision of optimal quality care, safety, and organization-wide performance. The Board is ultimately accountable for the safety and quality and has legal responsibility and operational authority for hospital performance.

Based on interview, and record review, the hospital failed to track adverse patient events and take proactive steps to improve the safety and quality care ensuring an effective and ongoing Quality Assessment and Performance Improvement (QAPI) program for one of 25 sampled patients (Patient 10), when the facility failed to track and implement safety care measures after a surgical fire resulted in Patient 10 sustaining 2nd and 3rd degree burns(burn to skin that results in blisters, disfigurement, pain and increased risk of infection).

These failures resulted in the hospital's inability to identify problem prone areas and set priorities to improve quality nursing care and ensuring a safe environment for their patients.

Findings:

During a review of Patient 10's clinical record titled, "Registration Admission" (a document that contains demographic information), the "Registration Admission" indicated, Patient 10's admission date was September 21, 2021, at 7:34 AM, and the discharge date was September 21, 2021, at 2:20 PM. Patient 10's admitting diagnosis was dysphasia (language disorder that affects speech and the comprehension of spoken language).

During a review of Patient 10's clinical record titled, "Consultation", dated September 21, 2021, at 12:23 PM, by Consult Physician 1, indicated, "there was intraoperative flame fire in the operating field. Related to this, the patient sustained partial thickness burns (destruction of the top two layers of skin) to his face and upper chest measuring approximately 8% [percentage- a number or rate in each hundred] to 10% of total body surface area (assessment of injury to skin). ...evidence of carbonaceous sputum (black mucus from smoke inhalation) to the tongue ...".

During a review of Patient 10's clinical record titled, "Discharge Summary", dated September 21, 2021, at 2:35 PM, by MD1, the "Discharge Summary" indicated, "Patient 10 was noted to have burns to ... the right face and possibly oropharynx (back of the throat) ...". Patient 10 was accepted at [Secondary Hospital] for burn treatment and a higher level of care. Patient 10 was transported via helicopter.

During a concurrent interview and record review, on March 13, 2025, at 10:05 AM, with the Senior Director of Quality (SDQ) the facility's document titled, "[Name of Hospital] Quality Improvement Dashboard 2022 Indicators" (Dashboard), dated 3rd Qtr [quarter] 2021, was reviewed. The "Dashboard" indicated, there was no documented evidence of the surgical fire was tracked via the QAPI under the surgical services tab and there was no tracking of any adverse occurrences for any department in the facility. The SDQ stated, there was no adverse occurrence category for QAPI at that time. The SDQ further stated, there is no documented proof of monitoring for high-risk fire in the Operating Room (OR) or follow-up regarding the incident. The SDQ stated, there was a root cause analysis performed, but was unable to retrieve the data from the analysis and stated there was no documented evidence of what specifically happened or follow-up implementation of safety precautions. The DSQ stated, adverse events are to be reviewed and acted upon by QAPI.

During a concurrent interview and record review, on March 13, 2025, at 10:10 AM, with the SDQ, the facility's document titled, "[Name of Hospital] Quality Improvement Dashboard 2022 Indicators"(Dashboard), dated 4th Qtr [quarter] 2022, was reviewed. The "Dashboard" indicated, wound care management was a quality indicator being monitored by the facility, but there was no documented recommendations or actions documented, as the target not met for Quarters 1-3 of 2022. The "Dashboard" did not indicate data was collected and monitored for post medication administration reassessment. The SDQ stated, there was no documented evidence of interventions implemented with regard to wound care management and specific for reassessment after administration of medication in QAPI.

During a review of the facility's policy and procedure (P&P) titled, "Organization-Wide Quality Assessment and Performance Improvement Project" dated March 2024, the P&P indicated, " ...E. Quality Department The Quality department shall be responsible to support the organization's Quality Improvement principles, strategies, priorities, approach, and methodologies, which includes but is not limited to the following tasks 1. Working with the Medical Staff, patient care, and other hospital departments/services, and teams to effectively measure, assess, analyze, and improve the quality and safety of care and services ...Department Managers in collaboration with Quality Coordinator are responsible to collect data as appropriate, including ...Operative/invasive procedure review ...Adverse Events ...The Quality and Risk Management programs seek to reduce the frequency and severity of adverse events, thus minimizing loss and contributing to Quality Improvement through risk identification, evaluation, control and education ...".

Based on interview and record review, the facility failed to follow their Surgical Services policy and procedures (P&P) and ensure acceptable standards of fire safety were implemented in the Operating Room (OR) for one of 25 sampled patients (Patient 10) when:

1. A form referenced in the facility's policy and procedure was not utilized for a "High Fire Risk".

2. A monopolar cautery device (a surgical tool that uses electricity to cut and seal tissue, which flows through an electrical current, from one electrode, through the tissue to a grounding pad) was used during a surgery on the face, next to an open oxygen source and oxygen was not discontinued or decreased prior to use of cautery device.

3. Sterile drapes did not allow for free airflow which caused tenting of oxygen from open air oxygen source.

4. A flammable prep was used to cleanse the surgical site prior to surgery.

These failures resulted in Patient 10 sustaining a 2nd and 3 rd degree burns (burns resulting in blistered skin, disfigurement, increased risk of infection and severe pain through various thickness of the skin) to his face, neck and chest and resulted in immediate transfer to a higher level of care facility burn unit and prolonged the hospitalization

Findings:

1. During a review of Patient 10's clinical record titled, "Registration Admission" (a document that contains demographic information), the "Registration Admission" indicated, Patient 10's admission date was September 21, 2021, at 7:34 AM, and the discharge date was September 21, 2021, at 2:20 PM. Patient 10's admitting diagnosis was dysphasia (language disorder that affects speech and the comprehension of spoken language).

During a review of Patient 10's clinical record titled, "History and Physical Addendum" (H&P), dated September 21, 2021, the "H&P" indicated, Patient 10 had a history of type 2 diabetes (difficulty controlling blood sugar), headaches, and recent changes in speech. Patient 10 was admitted with concern for temporal arteritis (inflammation of blood vessels near the temples of the forehead) and was scheduled to undergo a temporal artery biopsy (procedure to remove a section of the artery for testing).

During a review of Patient 10's clinical record titled, "Operative Report", dated September 21, 2021, at 1:08 PM, by Medical Doctor 1 (MD1), the "Operative Report" indicated, " ...aborted procedure for temporal artery biopsy ...an incision was then made over the left temple ... a flame was noted in the operative field... Attempted manual suppression of the flame was not successful ... patient soaked with saline (sterile salt water) by circulating team (part of the surgical team that works outside of the sterile field) ...The anesthesia team (part of the surgical team that assists with medication administration) intubated (tube placed in the patient's airway to maintain the ability to oxygenate the body) the patient [Patient 10] ...".

During a review of Patient 10's clinical record titled, "Consultation", dated September 21, 2021, at 12:23 PM, by Consult Physician 1, indicated, "there was intraoperative flame fire in the operating field. Related to this, the patient sustained partial thickness burns (destruction of the top two layers of skin) to his face and upper chest measuring approximately 8% [percentage- a number or rate in each hundred] to 10% of total body surface area (assessment of injury to skin). ...evidence of carbonaceous sputum (black mucus from smoke inhalation) to the tongue ...".

During a review of Patient 10's clinical record titled, "Discharge Summary", dated September 21, 2021, at 2:35 PM, by MD1, the "Discharge Summary" indicated, "Patient 10 was noted to have burns to ... the right face and possibly oropharynx (back of the throat) ...". Patient 10 was accepted at [Secondary Hospital] for burn treatment and a higher level of care. Patient 10 was transported via helicopter.

During a concurrent interview and record review on March 13, 2025, at 8:30 AM, with Registered Nurse 1 (RN1), Patient 10's "Surgery Nursing Record", dated September 21, 2021, at 11:02 AM, was reviewed. The "Surgery Nursing Record" indicated, the surgical "Fire Risk Assessment" for Patient 10's surgery was a "#3 High Risk" (1=low risk, 2=low with potential for high risk, 3=high risk). RN1 stated, Patient 10's procedure was at high risk for fire because the procedure involved Patient 10's head which was in close proximity to oxygen, use of open oxygen (supplemental oxygen provided through a mask on patient's face), and use of an electrocautery device (a surgical tool that uses heat to cut during surgery, often used to stop bleeding). RN 1 further stated, the combination of these three factors caused the procedure to be at a high fire risk.

During a continued concurrent interview and record review on March 13, 2025, at 8:35 AM, with RN1, the facility's policy and procedure (P&P) titled, "Universal Protocol with Fire Risk Assessment," dated July 2017, was reviewed. The P&P indicated, " ...E. The Fire Risk assessment is to be completed by the procedure team prior to the time-out and results reported during the time-out process. Follow the Fire Risk Assessment tool on the back of the UP [Universal Protocol] Form or the 2nd page of the e-form ...A score of 3 indicates a high risk of fire and more precautions are taken such as wet sponges ...cautery hold used ...minimal settings on electrocautery or use of bi-polar, and oxygen turned off at least 1 minute prior to using cautery when oxygen is free flowing and may tent under the drapes ...". RN1 stated, the "UP Form" referenced in the policy was not used to assess the fire safety risk for Patient 10. RN1 further stated, the safety risk is notated on the "Surgery Nursing Record" in a check box and interventions recommended by the policy are referenced on a form hanging in the Operating Room. RN1 stated, the purpose of the document is to decrease the chance of a fire in the OR when there is oxygen, fuel and a heat source present. RN1 stated, there was not documentation regarding interventions initiated by the surgical team prior to Patient 10's high fire risk procedure. RN1 stated, the P&P was not followed.

During a concurrent interview and record review on March 13, 2025, at 9:10 AM, with the Director of Surgical Services (DSS), the facility provided the document referred to by RN1 during his interview titled, "Fire Risk Assessment Protocol" dated September 2013, and reference from the American Society of Anesthesiologists. The "Fire Risk Assessment Protocol" indicated, scoring for low fire risk-1 to high fire risk- 3 and included protocol each member of the surgical team was to initiate if there was a high fire risk. The DSS stated, this document was not part of the facilities P&P but is the standard of practice for fire risk recognition and prevention in the Operating Room (OR). The DSS stated, the interventions listed to prevent a fire should be followed and each intervention should be documented in the patient's chart by the responsible team member. The DSS stated, the form referenced in the "Universal Protocol with Fire Risk Assessment" was not used and interventions were not documented.

2. During an interview with MD1 on March 12, 2025, at 1:24 PM, MD1 stated, there is always a risk for fire in the OR and the goal is to minimize the risk. MD1 stated, a fire is possible if you have oxygen, fuel like the drapes and ignition. MD 1 stated he recalled Patient 10, and because of his comorbidities (medical conditions that can cause complications) he had decided to perform the procedure with a lighter sedation instead of under general anesthesia, therefore the patient was receiving oxygen via a non-rebreather (oxygen mask on patients face). MD1 stated, Patient 10 was draped and an electrocautery device (a surgical tool that uses electricity to apply heat to tissue to stop bleeding) was used to make the incision. MD 1 stated, after the second use of the electrocautery device, a flame was noted under the drape at Patient 10's face. MD1 stated, the fire was extinguished, Patient 10 was intubated to protect his airway and Patient 10 was transported to another hospital's burn unit. MD1 stated, the electrocautery device used was monopolar (an electrocautery device with an active electricity which flows through tissue to the grounding pad [located on the thigh]).

During a record review of Patient 10's "Anesthesia Note" dated September 21, 2021, the "Anesthesia Note" indicated, "Procedure Aborted due to Operating Room Fire. O2 [oxygen] at 4L [Liter-unit of measurement] and Air at 2L discontinued ...".

During a concurrent interview and record review on March 12, 2025, at 3:25 PM, with RN1, Patient 10's "Surgery Nursing Record", dated September 21, 2021, at 11:02 AM, was reviewed. The "Surgery Nursing Record", the "[Name of electrocautery device]" Settings (high-frequency electrical energy) was not documented. RN1 stated, the surgeon will request the settings, and the device will be checked to ensure the settings are correct. RN1 stated, the settings should have been documented on the record.

During a concurrent interview and record review on March 13, 2025, at 9:15 AM, with the DSS, Patient 10's "Surgery Nursing Record", dated September 21, 2021, was reviewed. The DSS stated the cautery settings should have been documented on the "Surgery Nursing Record" to ensure setting were correct. The DSS further stated, the purpose of documenting the settings is to make sure the device is set to it controls how much electricity is released at the surgical site and into surrounding tissue. It should have been documented in the patient's record on the nursing surgical notes.

During a concurrent interview and record review on March 13, 2025, at 9:55 AM, with Certified Registered Nurse Anesthetist (CRNA1), the facility's document, "Fire Risk Assessment Protocol" was reviewed. The "Fire Risk Assessment Protocol" dated September 2013, indicated, "Fire Risk Protocol Initiated with a Score of 3 = High Risk The nurse, surgeon/physician, and anesthesia providers take these precautions and communicate handoff ...Anes [Anesthesia]/Sedation Provider ...Notifies the physician and documents if O2 (oxygen) concentration > (greater than) 40% or risk of air leak ...Suction O2 prongs to 'scavenge' O2 ...Before ignition source is activated, reduce oxygen concentration < (less than) 40% if possible ...Surgeon/Physician: Before an ignition source is activated ...Verifies that the anes/staff provider has reduced the O2 concentration to the min [minute]., level for 1-3 minutes., before using ignition source ...". CRNA 1 stated the facility does not perform high risk for fire procedures often and does not document these interventions in his charting. The CRNA 1 stated, the best way to prevent a fire would be to reduce the oxygen to prevent tenting (buildup of oxygen under the draping [ used to keep area sterile]). The CRNA1 further stated, the oxygen could be turned off or decreased prior to use of the electrocautery device to decrease the risk of fire due to the open oxygen source and cautery device.

During a review of the facility's policy and procedure (P&P) titled, "Fire Safety in Invasive Procedural Areas (Including Oxygen Enriched atmospheres) Policy," dated July 2017, the P&P indicated, " ...B. Strategies to manage ignition source ...1. During Electrosurgery ...If open oxygen sources are employed, use bipolar electrosurgery whenever possible and clinically appropriate (such as for cauterization during head, face, neck, and upper-chest surgery). Bipolar electrosurgery created little or no spark or arcing ...Never use electrosurgery in close proximity to flammable materials in oxidizer-enriched atmospheres ...".

3. During an interview on March 13, 2025, at 8:40 AM with RN1, RN1 stated, he asked the Certified Registered Nurse Anesthetist 2 (CRNA 2) if he wanted the drapes up or down and the CRNA 2 stated, he wanted the drapes down. RN 1 stated, when the drapes are up, there is no tenting [area for O2 to get trapped when Pt has an O2 mask in place under the drapes). RN1 stated, he had seen the drape placed upright and down in various cases. RN1 stated, usually when the patient has on O2 mask on - the drape is lifted up, so there is no tenting (trapping of oxygen) with the O2 under the drape.

During an interview on March 13, 2025, at 10:00 AM, with CRNA 1, CRNA 1 stated, tenting taps oxygen, which is flammable. CRNA 1 stated, it is important to allow the oxygen to disperse, and not gather in one spot and be concentrated. CRNA 1 stated, when a patient has an open oxygen device and surgery is being performed near that source of oxygen, such as the head, the drapes should be placed in a way that will promote the flow of air under the drape to prevent concentration of oxygen under the drape to prevent a fire. The drapes should not be draped over the head in a downward fashion, which can trap oxygen and lead to starting a fire.

During a review of the facility's P&P titled, "Universal Protocol with Fire Risk Assessment,". dated July 2017, the P&P indicated, " ...E. The Fire Risk assessment is to be completed by the procedure team prior to the time-out and results reported during the time-out process ...A score of 3 indicates a high risk of fire and more precautions are taken such as wet sponges, basin or bowl of sterile water on the field, syringe full of saline for cases in the mouth, cautery holder used, laser and fiber-optic cord on stand-by when not in use, oxygen mixed with room air, minimal settings on electrocautery or use of bi-polar , and oxygen turned off at least 1 minute prior to using cautery when oxygen is free flowing and may tent under the drapes ...recognize that oxygen ...can vastly increase flammability of drapes ... During Head, Face Neck, and Upper-Chest Surgery: Use only air for open delivery to the face if the patient can maintain a safe blood oxygen saturation without supplemental oxygen ... Stop supplemental oxygen at least one minute before and during use of electrosurgery electrocautery, or laser, if possible ... Arrange drapes to minimize oxygen buildup underneath (such as from an uncuffed tracheal tube or laryngeal mask airway_ and to direct gases away from the operative site. This recommendation has limited potential effect in minimizing an oxygen-enriched surgical fire but nevertheless remains as a complement to the other recommendations from controlling open oxygen delivery ...".

4. During a concurrent interview and record review on March 12, 2025, at 3:10 PM, with RN1, Patient 10's "Surgery Nursing Record", dated September 21, 2021, at 11:02 AM, was reviewed. The "Surgery Nursing Record" indicated, [Name of Alcohol based Prep] (sterile solution used to reduce bacteria- highly flammable) was used to prepare the skin for surgery (left side of forehead). RN1 stated, he recalls [Name of Alcohol-Based Prep] was used on Patient 10. RN1 stated, he asked MD1 what kind of surgical prep he wanted to use for the surgery and MD1 instructed the operating room team to use [Name of Alcohol-Based Prep]. RN 1 further stated, alcohol based prep solutions are flammable.

During a continued concurrent interview and record review on March 12, 2025, at 3:15 PM, with RN1, the [Name of Alcohol-Based Prep] insert titled, "[Name of Alcohol-Based Prep] 26 ml (Milliliter -unit of measurement) Applicator", indicated, "Flammable, keep away from fire or flame. To reduce risk of fire, ... Do not use 26 ml applicator for head and neck surgery .... flammable vapors ... Do not drape (put up a barrier) or use ignition source (eg. Cautery [instrument that uses heat to remove tissue or seal blood vessels], laser) until solution is completely dry ..." RN1 stated, it was large prep, the 26 ml orange package. RN1 stated, that size [Name of Alcohol-Based Prep] was used, because that was the only kind they stocked in the Operating Room at the time of this surgery. RN1 further stated, he was aware that [Name of Alcohol Based Prep] is flammable and stated the packaging does state not to use on the face.

During a review of the facility's Policy and Procedure (P&P) titled, "Fire Safety in Procedural Areas (Including Oxygen Enriched Atmopheres) Policy," dated July 2017, the P&P indicated, " ...C. Strategies to Manage Fuel 1. During Prep: Be aware that alcohol-based preps are flammable. Avoid pooling, spilling, or wicking of flammable liquid preps ...".