The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

THE NEBRASKA MEDICAL CENTER 987400 NEBRASKA MEDICAL CENTER OMAHA, NE 68198 Dec. 1, 2016
VIOLATION: QAPI Tag No: A0263
On 11/22/16 an unannounced survey of the facility was conducted. During the entrance conference, the administration revealed that two adverse safety events of surgical fires on 9/8/16 and 11/19/16. Both fires involved the presence of a flammable skin prep product (Mastisol or Cavilon) used in the presence of an electrical cautery. After the fire on 9/8 and 11/19/16 the facility implemented preventative action plans with the operating room staff. The action plans failed to include Quality Assurance Activities and data collection to ensure the action plans were effective at preventing further errors. This failure placed all patients at risk of potential harm due to failure to include Quality Assurance activities to monitor and ensure action plans developed after adverse events were effective. The State Agency conferred with the Centers for Medicare and Medicaid Services (CMS) on 11/30/16. CMS determined the facility failed to be in compliance with the Condition of Participation for Quality Assessment and Performance Improvement Program with Immediate Jeopardy (IJ) to patients health and safety. The IJ conditions existed in the facility from 9/8/16 until 11/30/16. The administrator was informed of the determination of IJ conditions in the facility on 11/30/16 at 4:45 PM. The IJ was abated on 11/30/16 when the State Agency surveyors were able to verify an acceptable plan of correction. The facility census was 460. Findings are:
See also A0940.


A. Record review of facility document titled "Op [Operative] Note" for Patient #11 documented 9/8/16 at 9:51 AM reveals that during the operation on 9/8/16 a wound VAC (closure of a wound left open to heal using vacuum producing device) was to be applied to the surgical site. The notes state that prior to applying the wound VAC the skin was prepped around the wound with the "Elan Prep". The operative report states that after the skin prep was applied and after this was performed a "small bleeding vessel was found within the wound bed and the cautery [an electrical pen device used to cauterize blood vessels] was used to stop this bleeding. This ignited a spark of flame in the operating room which self put itself out without the aid of the team." There was no harm to the patient.

B. On 11/23/16 the facility self reported to the State Agency that they had a small fire in the Operating Room (OR). The report states that on 11/19/16 at 9:02 PM (Patient 12) a Raytec (gauze surgical sponge) ignited in the OR prior to the physician applying the Mastisol (a flammable skin preparation product used to help adhere dressings) to the patient. The Resident assisting with the procedure picked up the cautery to use and the Raytec ignited. The surgeon tossed it on the floor and it was extinguished with saline and by stomping on it. The report included a summary of the incident by the operating surgeon. The report by the surgeon states "I was standing at least a foot away from the bovie [another name for electric pen cautery device], not applying it (Mastisol) to the patient (hence why only the Raytec caught fire).The resident tried to slip in one last bovie but clearly direct contact of the bovie to the source is not needed to start the fire and distance is not enough to prevent fire."

C. Record review of the facility document titled "Summary/Additional Comments" identified the steps taken after each surgical fire.
After the 9/8/16 fire the plan notes that on 9/14/16 signage was added to the supply totes and carts to additionally warn staff of the flammability of the products. On 9/16/16 the skin prep policy and fire and other safety precautions and perioperative services policy was updated to reflect information and alerts.
After the second fire on 11/19/16 the cautery machine was inspected. Cautery disposable products , products from the fire were sequestered. Rounding frequency increased by OR Managers/ Coordinators and Educators for support and procedural questions. On 11/21/16 staff informed of second fire and reminded to be diligent in watching flammable liquids, 5 minute dry times and disabling ignition sources until the 5 minute wait (dry) time was completed. Implemented new procedures that there is to be no flammable liquid on the field until cautery tip is removed from cautery pen. After flammable adhesive applied a 5 minute wait time to dry and vapors dissipated will be implemented. The dressing is to be applied before the cautery is used again. Email sent and AM/PM staff huddles with sign off sheets for all OR staff regarding use of flammable substances in the OR and Fire Risk Scores. This was repeated again on 11/23 and 11/28/16. On 11/21 and 11/23/16 education was provided to Residents and staff on risks associated with the use of Cavilon/Mastisol as flammable products combined with cautery. On 11/22/16 morning and afternoon staff report included information on the fires to raise awareness and learning. The coordinators were going to investigate the process for using Mastisol on Neuro/General and Anesthesia draping procedures with dry times met before procedure starts and cautery used. On 11/23/16 a policy review was done for flammable liquid handling, cautery discontinuance before flammable product used. Managers pulled and reviewed all large bottles of flammable products used in the OR. They revised the annual Peri-op fire prevention competency to be used for staff and Residents before surgery rotation. Surgeons and surgical Residents were advised by email that OR staff have been instructed to not open onto the sterile field any of the adhesive (flammable) substances until all potential ignition sources have been disabled. A dry time of 5 minutes will be observed before proceeding with another part of the the procedure or bringing potential ignition sources back to the field.

D. Record Review of the the facility's "Quality and Patient Safety Initiatives and Structure 2016" revealed The Quality Mission and purpose stated "To define, embrace, and advocate for a patient centered culture of exceptional quality care, patient safety, and patient experience." Quality Assessment and Performance Improvement Processes stated "Data collection is essential to ongoing and system measurement and assessment of performance improvement activities and sets the priorities for ongoing analysis." Record review of facility provided documents used for Root Cause Analysis revealed the facility uses the National Patient Safety Foundation Version 2 January 2016 process titled "RCA 2 Improving Root Cause Analysis and Actions to Prevent Harm". The process notes states that "Each Action should have a process or outcome measure identifying what will be measured, the expected compliance level, and the date it will be measured. An individual will be responsible for measuring and reporting on action effectiveness."

E. Interview with the Executive Director Peri Operative Services, Registered Nurse (RN) C on 11/29/16 at 3:58 PM revealed the product used in the 9/8/16 fire was Cavilon and in the 11/19/16 fire was Mastisol both are highly flammable products. An action plan was put in place after the first fire. After the second fire involving the flammable product in use with cautery additional measures were put in place. RN C confirmed that the action plans did not include quality assurance data collection/monitoring to ensure staff were adhering to the changes implemented in either of the action plans.

F. Interview with the Quality Assurance Registered Nurse (RN) D on 11/30/16 at 9:25 AM revealed that the Quality Assurance team was not included in the initial meeting regarding the surgical fire on 9/8/16.
The RN looked at the action items and made a list of questiions and then met with the leadership group 1-2 days later. RN D confirmed that at the time of the fire, the facility staff was unaware that Cavilon and Mastisol were flammable. The facility looked for other flammable products. RN D confirmed that the fire was a sentinel "never" event and root cause analysis was done after each fire and action plans developed. RN D confirmed quality assurance action plan audits to ensure staff were following the action plans were not developed or being done until 11/30/16.

G. The IJ was abated on 11/30/16 after the State Agency Surveyors observed staff appropriately handling a flammable skin prep in the OR from 11 AM until 2:50 PM. The OR's were observed to have red STOP signs telling staff to remove the cautery tip from the handpiece before applying flammable substances, observe a 5 minute dry time if the cautery tip is to be resumed. The entire OR team consisting of 1 Resident, 1 Surgeon, 1 Scrub Technician and 2 circulating RN's confirmed they had the education regarding fire safety/prevention. The Director of Peri operative services was present and supervising the procedure. RN C provided the completed Quality Tool for the 15 cases involving flammable prep and cautery demonstrating 100% observation by a manager or OR supervisor. The tool includes the steps in the action plan to ensure compliance. This ensures a manager is notified 100% of the time the flammable product is to be used and can ensure the 100% monitoring of the product use is done.
VIOLATION: PATIENT SAFETY Tag No: A0286
On 11/22/16 an unannounced survey of the facility was conducted. During the entrance conference, the administration revealed that two adverse safety events of surgical fires on 9/8/16 and 11/19/16. Both fires involved the presence of a flammable skin prep product (Mastisol or Cavilon) used in the presence of an electrical cautery. After the fire on 9/8 and 11/19/16 the facility implemented preventative action plans with the operating room staff. The action plans failed to include Quality Assurance Activities and data collection to ensure the action plans were effective at preventing further errors. This failure placed all patients at risk due to failure to include Quality Assurance activities to monitor and ensure action plans developed after adverse event were effective. The State Agency conferred with the Centers for Medicare and Medicaid Services (CMS) on 11/30/16. CMS determined the facility failed to be in compliance with the Condition of Participation for Quality Assessment and Performance Improvement Program with Immediate Jeopardy (IJ) to patients health and safety. The IJ conditions existed in the facility from 9/8/16 until 11/30/16. The administrator was informed of the determination of IJ conditions in the facility on 11/30/16 at 4:45 PM. The IJ was abated on 11/30/16 when the State Agency surveyors were able to verify an acceptable plan of correction. The facility census was 460. Findings are:
See also A0940.


A. Record review of facility document titled "Op [Operative] Note" for Patient #11 documented 9/8/16 at 9:51 AM reveals that during the operation on 9/8/16 a wound VAC (closure of a wound left open to heal using vacuum producing device) was to be applied to the surgical site. The notes state that prior to applying the wound VAC the skin was prepped around the wound with the "Elan Prep". The operative report states that after the skin prep was applied and after this was performed a "small bleeding vessel was found within the wound bed and the cautery [an electrical pen device used to cauterize blood vessels] was used to stop this bleeding. This ignited a spark of flame in the operating room which self put itself out without the aid of the team." There was no harm to the patient.

B. On 11/23/16 the facility self reported to the State Agency that they had a small fire in the Operating Room (OR). The report states that on 11/19/16 at 9:02 PM (Patient 12) a Raytec (gauze surgical sponge) ignited in the OR prior to the physician applying the Mastisol (a flammable skin preparation product used to help adhere dressings) to the patient. The Resident assisting with the procedure picked up the cautery to use and the Raytec ignited. The surgeon tossed it on the floor and it was extinguished with saline and by stomping on it. The report included a summary of the incident by the operating surgeon. The report by the surgeon states "I was standing at least a foot away from the bovie [another name for electric pen cautery device], not applying it (Mastisol) to the patient (hence why only the Raytec caught fire).The resident tried to slip in one last bovie but clearly direct contact of the bovie to the source is not needed to start the fire and distance is not enough to prevent fire."

C. Record review of the facility document titled "Summary/Additional Comments" identified the steps taken after each surgical fire.
After the 9/8/16 fire the plan notes that on 9/14/16 signage was added to the supply totes and carts to additionally warn staff of the flammability of the products. On 9/16/16 the skin prep policy and fire and other safety precautions and perioperative services policy was updated to reflect information and alerts.
After the second fire on 11/19/16 the cautery machine was inspected. Cautery disposable products , products from the fire were sequestered. Rounding frequency increased by OR Managers/ Coordinators and Educators for support and procedural questions. On 11/21/16 staff informed of second fire and reminded to be diligent in watching flammable liquids, 5 minute dry times and disabling ignition sources until the 5 minute wait (dry) time was completed. Implemented new procedures that there is to be no flammable liquid on the field until cautery tip is removed from cautery pen. After flammable adhesive applied a 5 minute wait time to dry and vapors dissipated will be implemented. The dressing is to be applied before the cautery is used again. Email sent and AM/PM staff huddles with sign off sheets for all OR staff regarding use of flammable substances in the OR and Fire Risk Scores. This was repeated again on 11/23 and 11/28/16. On 11/21 and 11/23/16 education was provided to Residents and staff on risks associated with the use of Cavilon/Mastisol as flammable products combined with cautery. On 11/22/16 morning and afternoon staff report included information on the fires to raise awareness and learning. The coordinators were going to investigate the process for using Mastisol on Neuro/General and Anesthesia draping procedures with dry times met before procedure starts and cautery used. On 11/23/16 a policy review was done for flammable liquid handling, cautery discontinuance before flammable product used. Managers pulled and reviewed all large bottles of flammable products used in the OR. They revised the annual Peri-op fire prevention competency to be used for staff and Residents before surgery rotation. Surgeons and surgical Residents were advised by email that OR staff have been instructed to not open onto the sterile field any of the adhesive (flammable) substances until all potential ignition sources have been disabled. A dry time of 5 minutes will be observed before proceeding with another part of the the procedure or bringing potential ignition sources back to the field.

D. Record Review of the the facility's "Quality and Patient Safety Initiatives and Structure 2016" revealed The Quality Mission and purpose stated "To define, embrace, and advocate for a patient centered culture of exceptional quality care, patient safety, and patient experience." Quality Assessment and Performance Improvement Processes stated "Data collection is essential to ongoing and system measurement and assessment of performance improvement activities and sets the priorities for ongoing analysis." Record review of facility provided documents used for Root Cause Analysis revealed the facility uses the National Patient Safety Foundation Version 2 January 2016 process titled "RCA 2 Improving Root Cause Analysis and Actions to Prevent Harm". The process notes states that "Each Action should have a process or outcome measure identifying what will be measured, the expected compliance level, and the date it will be measured. An individual will be responsible for measuring and reporting on action effectiveness."

E. Interview with the Executive Director Peri Operative Services, Registered Nurse (RN) C on 11/29/16 at 3:58 PM revealed the product used in the 9/8/16 fire was Cavilon and in the 11/19/16 fire was Mastisol both are highly flammable products. An action plan was put in place after the first fire. After the second fire involving the flammable product in use with cautery additional measures were put in place. RN C confirmed that the action plans did not include quality assurance data collection/monitoring to ensure staff were adhering to the changes implemented in either of the action plans.

F. Interview with the Quality Assurance Registered Nurse (RN) D on 11/30/16 at 9:25 AM revealed that the Quality Assurance team was not included in the initial meeting regarding the surgical fire on 9/8/16.
The RN looked at the action items and made a list of questiions and then met with the leadership group 1-2 days later. RN D confirmed that at the time of the fire, the facility staff was unaware that Cavilon and Mastisol were flammable. The facility looked for other flammable products. RN D confirmed that the fire was a sentinel "never" event and root cause analysis was done after each fire and action plans developed. RN D confirmed quality assurance action plan audits to ensure staff were following the action plans were not developed or being done until 11/30/16.

G. The IJ was abated on 11/30/16 after the State Agency Surveyors observed staff appropriately handling a flammable skin prep in the OR from 11 AM until 2:50 PM. The OR's were observed to have red STOP signs telling staff to remove the cautery tip from the handpiece before applying flammable substances, observe a 5 minute dry time if the cautery tip is to be resumed. The entire OR team consisting of 1 Resident, 1 Surgeon, 1 Scrub Technician and 2 circulating RN's confirmed they had the education regarding fire safety/prevention. The Director of Peri operative services was present and supervising the procedure. RN C provided the completed Quality Tool for the 15 cases involving flammable prep and cautery demonstrating 100% observation by a manager or OR supervisor. The tool includes the steps in the action plan to ensure compliance. This ensures a manager is notified 100% of the time the flammable product is to be used and can ensure the 100% monitoring of the product use is done.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on review of facility internal documentation and action plans, policies and procedures, education records, staff and Resident Physician interviews, the facility failed to implement monitoring and supervision of the operating room staff to ensure facility policies and procedures were followed to prevent the development of surgical fires. The facility administrative staff confirmed on entrance 11/22/16 that the facility had a surgical fire on 9/8 and 11/19/16 in their operating rooms. Both fires involved the presence of a flammable skin prep product (Mastisol or Cavilon) used in the presence of an electrical cautery. After the fire on 9/8 and 11/19/16 the facility implemented preventative action plans with the operating room staff. The action plans failed to include staff observations/monitoring to ensure the plans were effective. This failure placed all patients having surgical procedures in which Mastisol or Cavilon products were used in the presence of cautery at risk of injury or death from fire. Administrative staff confirmed the facility has performed 161 surgical cases in which Mastisol or Cavilon were used with electrical cautery since the first fire on 9/8 until 11/30/16. The State Agency conferred with the Centers for Medicare and Medicaid Services (CMS) on 11/30/16. CMS determined the facility failed to be in compliance with the Condition of Participation for Surgical Services with Immediate Jeopardy (IJ)to patients health and safety. The IJ conditions existed in the facility from 9/8/16 until 11/30/16. The administrator was informed of the determination of IJ conditions in the facility on 11/30/16 at 4:45 PM. The IJ was abated on 11/30/16 when the State Agency surveyors were able to verify an acceptable plan of correction. Findings are:

A. Record review of facility document titled "Op [Operative] Note" for Patient #11 documented 9/8/16 at 9:51 AM reveals that during the operation on 9/8/16 a wound VAC (closure of a wound left open to heal using vacuum producing device) was to be applied to the surgical site. The notes state that prior to applying the wound VAC the skin was prepped around the wound with the "Elan Prep". The operative report states that after the skin prep was applied and after this was performed a "small bleeding vessel was found within the wound bed and the cautery [an electrical pen device used to cauterize blood vessels] was used to stop this bleeding. This ignited a spark of flame in the operating room which self put itself out without the aid of the team." There was no harm to the patient.

B. On 11/23/16 the facility self reported to the State Agency that they had a small fire in the Operating Room (OR). The report states that on 11/19/16 at 9:02 PM (Patient 12) a Raytec (gauze surgical sponge) ignited in the OR prior to the physician applying the Mastisol (a flammable skin preparation product used to help adhere dressings) to the patient. The Resident assisting with the procedure picked up the cautery to use and the Raytec ignited. The surgeon tossed it on the floor and it was extinguished with saline and by stomping on it. The report included a summary of the incident by the operating surgeon. The report by the surgeon states "I was standing at least a foot away from the bovie [another name for electric pen cautery device], not applying it (Mastisol) to the patient (hence why only the Raytec caught fire).The resident tried to slip in one last bovie but clearly direct contact of the bovie to the source is not needed to start the fire and distance is not enough to prevent fire."

C. Interview with Resident Medical Doctor (MD) A on 11/29/16 at 11:56 AM. MD A was assisting the surgeon ( MD B) with the procedure on 11/19/16 being performed on Patient 12. The Mastisol was poured into a cup off to the side in the back of the room. The surgery tech brought it to the surgical table near the patient. The surgeon soaked the Raytec in the Mastisol and held the Raytec in a 8 inch forcep clamp. MD A recalled smelling the Mastisol in the air. MD A was "buzzing small bleeders [using electric cautery] and simultaneously the Mastisol was brought to the surgical field (area above and immediately around the patient). MD A noticed the fire first. MD A stated "it looked like a ball of fire - like a marshmallow on fire." There was no injury to the patient.

D. Record review of the facility document titled "Summary/Additional Comments" identified the steps taken after each surgical fire.
After the 9/8/16 fire the plan notes that on 9/14/16 signage was added to the supply totes and carts to additionally warn staff of the flammability of the products. On 9/16/16 the skin prep policy and fire and other safety precautions and perioperative services policy was updated to reflect information and alerts.
After the second fire on 11/19/16 the cautery machine was inspected. Cautery disposable products , products from the fire were sequestered. Rounding frequency increased by OR Managers/ Coordinators and Educators for support and procedural questions. On 11/21/16 staff informed of second fire and reminded to be diligent in watching flammable liquids, 5 minute dry times and disabling ignition sources until the 5 minute wait (dry) time was completed. Implemented new procedures that there is to be no flammable liquid on the field until cautery tip is removed from cautery pen. After flammable adhesive applied a 5 minute wait time to dry and vapors dissipated will be implemented. The dressing is to be applied before the cautery is used again. Email sent and AM/PM staff huddles with sign off sheets for all OR staff regarding use of flammable substances in the OR and Fire Risk Scores. This was repeated again on 11/23 and 11/28/16. On 11/21 and 11/23/16 education was provided to Residents and staff on risks associated with the use of Cavilon/Mastisol as flammable products combined with cautery. On 11/22/16 morning and afternoon staff report included information on the fires to raise awareness and learning. The coordinators were going to investigate the process for using Mastisol on Neuro/General and Anesthesia draping procedures with dry times met before procedure starts and cautery used. On 11/23/16 a policy review was done for flammable liquid handling, cautery discontinuance before flammable product used. Managers pulled and reviewed all large bottles of flammable products used in the OR. They revised the annual Peri-op fire prevention competency to be used for staff and Residents before surgery rotation. Surgeons and surgical Residents were advised by email that OR staff have been instructed to not open onto the sterile field any of the adhesive (flammable) substances until all potential ignition sources have been disabled. A dry time of 5 minutes will be observed before proceeding with another part of the the procedure or bringing potential ignition sources back to the field.

E. Review of the facility policy titled "Fire and Other Safety Precautions in Perioperative Services" with last revised date of 9/16 states under the section titled "Intra Operative Precautions" that "Whenever the application of alcohol based skin adhesives (Mastisol,Cavilon, Derabond [sic Dermabond), Indermil, Benzoin) are employed in surgeries where the use of electrosurgery, laser, or any type of ignition source is contemplated, sufficient time (5 minutes) is allowed to elapse to permit complete evaporation and dissipation of any flammable vehicle remaining." The policy under "Precautions" states that the cautery tip from the electrosurgery handpiece is removed for the remainder of the case once flammable substances including but not limited to Collodion, Mastisol, Cavilon are introduced onto the operative field. A five minute dry time is to be observed once a flammable skin product is applied before cautery can resume."

F. Interview with the Executive Director Peri Operative Services, Registered Nurse (RN) C on 11/29/16 at 3:58 PM revealed the product used in the 9/8/16 fire was Cavilon and in the 11/19/16 fire was Mastisol both are highly flammable products. An action plan was put in place after the first fire. After the second fire involving the flammable product in use with cautery additional measures were put in place. RN C confirmed that the action plans did not include quality assurance data collection/monitoring to ensure staff were adhering to the changes implemented in either of the action plans. RN C stated that they were currently moving the Mastisol/Cavilon to the Pyxis ( medication dispensing machine) and only the charge nurses and leads (supervisory staff) could obtain it. RN C was unable to confirm all staff were adhering to the fire preventative action plans placing the patients at risk for further OR fires.

G. The IJ was abated on 11/30/16 after the State Agency Surveyors observed staff appropriately handling a flammable skin prep in the OR from 11 AM until 2:50 PM. The OR's were observed to have red STOP signs telling staff to remove the cautery tip from the handpiece before applying flammable substances, observe a 5 minute dry time if the cautery tip is to be resumed. The entire OR team consisting of 1 Resident, 1 Surgeon, 1 Scrub Technician and 2 circulating RN's confirmed they had the education regarding fire safety/prevention. The Director of Peri operative services was present and supervising the procedure. RN C provided the completed Quality Tool for the 15 cases involving flammable prep and cautery demonstrating 100% observation by a manager or OR supervisor. The tool includes the steps in the action plan to ensure compliance. In addition on 12/1/16 RN C stated that the decision was made to remove the flammable products (Cavilon/Mastisol) from the OR Pyxis and lock the product up in the OR manager office. This ensures a manager is notified 100% of the time the flammable product is to be used and can ensure the 100% monitoring of the product use is done. Staff training records regarding OR Fire drills and confirmation of education regarding use of flammable substances in the OR was also verified.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on review of facility internal documentation and action plans, policies and procedures, education records, staff and Resident Physician interviews, the facility failed to implement monitoring and supervision of the operating room staff to ensure facility policies and procedures were followed to prevent the development of surgical fires. The facility administrative staff confirmed on entrance 11/22/16 that the facility had a surgical fire on 9/8 and 11/19/16 in their operating rooms. Both fires involved the presence of a flammable skin prep product (Mastisol or Cavilon) used in the presence of an electrical cautery. After the fire on 9/8 and 11/19/16 the facility implemented preventative action plans with the operating room staff. The action plans failed to include staff observations/monitoring to ensure the plans were effective. This failure placed all patients having surgical procedures in which Mastisol or Cavilon products were used in the presence of cautery at risk of injury or death from fire. Administrative staff confirmed the facility has performed 161 surgical cases in which Mastisol or Cavilon were used with electrical cautery since the first fire on 9/8 until 11/30/16. The State Agency conferred with the Centers for Medicare and Medicaid Services (CMS) on 11/30/16. CMS determined Immediate Jeopardy to patients health and safety conditions existed in the facility from 9/8/16 until 11/30/16. The administrator was informed of the determination of IJ conditions in the facility on 11/30/16 at 4:45 PM. The IJ was abated on 11/30/16 when the State Agency surveyors were able to verify an acceptable plan of correction. Findings are:

A. Record review of facility document titled "Op [Operative] Note" for Patient #11 documented 9/8/16 at 9:51 AM reveals that during the operation on 9/8/16 a wound VAC (closure of a wound left open to heal using vacuum producing device) was to be applied to the surgical site. The notes state that prior to applying the wound VAC the skin was prepped around the wound with the "Elan Prep". The operative report states that after the skin prep was applied and after this was performed a "small bleeding vessel was found within the wound bed and the cautery [an electrical pen device used to cauterize blood vessels] was used to stop this bleeding. This ignited a spark of flame in the operating room which self put itself out without the aid of the team." There was no harm to the patient.

B. On 11/23/16 the facility self reported to the State Agency that they had a small fire in the Operating Room (OR). The report states that on 11/19/16 at 9:02 PM (Patient 12) a Raytec (gauze surgical sponge) ignited in the OR prior to the physician applying the Mastisol (a flammable skin preparation product used to help adhere dressings) to the patient. The Resident assisting with the procedure picked up the cautery to use and the Raytec ignited. The surgeon tossed it on the floor and it was extinguished with saline and by stomping on it. The report included a summary of the incident by the operating surgeon. The report by the surgeon states "I was standing at least a foot away from the bovie [another name for electric pen cautery device], not applying it (Mastisol) to the patient (hence why only the Raytec caught fire).The resident tried to slip in one last bovie but clearly direct contact of the bovie to the source is not needed to start the fire and distance is not enough to prevent fire."

C. Interview with Resident Medical Doctor (MD) A on 11/29/16 at 11:56 AM. MD A was assisting the surgeon ( MD B) with the procedure on 11/19/16 being performed on Patient 12. The Mastisol was poured into a cup off to the side in the back of the room. The surgery tech brought it to the surgical table near the patient. The surgeon soaked the Raytec in the Mastisol and held the Raytec in a 8 inch forcep clamp. MD A recalled smelling the Mastisol in the air. MD A was "buzzing small bleeders [using electric cautery] and simultaneously the Mastisol was brought to the surgical field (area above and immediately around the patient). MD A noticed the fire first. MD A stated "it looked like a ball of fire - like a marshmallow on fire." There was no injury to the patient.

D. Record review of the facility document titled "Summary/Additional Comments" identified the steps taken after each surgical fire.
After the 9/8/16 fire the plan notes that on 9/14/16 signage was added to the supply totes and carts to additionally warn staff of the flammability of the products. On 9/16/16 the skin prep policy and fire and other safety precautions and perioperative services policy was updated to reflect information and alerts.
After the second fire on 11/19/16 the cautery machine was inspected. Cautery disposable products , products from the fire were sequestered. Rounding frequency increased by OR Managers/ Coordinators and Educators for support and procedural questions. On 11/21/16 staff informed of second fire and reminded to be diligent in watching flammable liquids, 5 minute dry times and disabling ignition sources until the 5 minute wait (dry) time was completed. Implemented new procedures that there is to be no flammable liquid on the field until cautery tip is removed from cautery pen. After flammable adhesive applied a 5 minute wait time to dry and vapors dissipated will be implemented. The dressing is to be applied before the cautery is used again. Email sent and AM/PM staff huddles with sign off sheets for all OR staff regarding use of flammable substances in the OR and Fire Risk Scores. This was repeated again on 11/23 and 11/28/16. On 11/21 and 11/23/16 education was provided to Residents and staff on risks associated with the use of Cavilon/Mastisol as flammable products combined with cautery. On 11/22/16 morning and afternoon staff report included information on the fires to raise awareness and learning. The coordinators were going to investigate the process for using Mastisol on Neuro/General and Anesthesia draping procedures with dry times met before procedure starts and cautery used. On 11/23/16 a policy review was done for flammable liquid handling, cautery discontinuance before flammable product used. Managers pulled and reviewed all large bottles of flammable products used in the OR. They revised the annual Peri-op fire prevention competency to be used for staff and Residents before surgery rotation. Surgeons and surgical Residents were advised by email that OR staff have been instructed to not open onto the sterile field any of the adhesive (flammable) substances until all potential ignition sources have been disabled. A dry time of 5 minutes will be observed before proceeding with another part of the the procedure or bringing potential ignition sources back to the field.

E. Review of the facility policy titled "Fire and Other Safety Precautions in Perioperative Services" with last revised date of 9/16 states under the section titled "Intra Operative Precautions" that "Whenever the application of alcohol based skin adhesives (Mastisol,Cavilon, Derabond [sic Dermabond), Indermil, Benzoin) are employed in surgeries where the use of electrosurgery, laser, or any type of ignition source is contemplated, sufficient time (5 minutes) is allowed to elapse to permit complete evaporation and dissipation of any flammable vehicle remaining." The policy under "Precautions" states that the cautery tip from the electrosurgery handpiece is removed for the remainder of the case once flammable substances including but not limited to Collodion, Mastisol, Cavilon are introduced onto the operative field. A five minute dry time is to be observed once a flammable skin product is applied before cautery can resume."

F. Interview with the Executive Director Peri Operative Services, Registered Nurse (RN) C on 11/29/16 at 3:58 PM revealed the product used in the 9/8/16 fire was Cavilon and in the 11/19/16 fire was Mastisol both are highly flammable products. An action plan was put in place after the first fire. After the second fire involving the flammable product in use with cautery additional measures were put in place. RN C confirmed that the action plans did not include quality assurance data collection/monitoring to ensure staff were adhering to the changes implemented in either of the action plans. RN C stated that they were currently moving the Mastisol/Cavilon to the Pyxis ( medication dispensing machine) and only the charge nurses and leads (supervisory staff) could obtain it. RN C was unable to confirm all staff were adhering to the fire preventative action plans placing the patients at risk for further OR fires.

G. The IJ was abated on 11/30/16 after the State Agency Surveyors observed staff appropriately handling a flammable skin prep in the OR from 11 AM until 2:50 PM. The OR's were observed to have red STOP signs telling staff to remove the cautery tip from the handpiece before applying flammable substances, observe a 5 minute dry time if the cautery tip is to be resumed. The entire OR team consisting of 1 Resident, 1 Surgeon, 1 Scrub Technician and 2 circulating RN's confirmed they had the education regarding fire safety/prevention. The Director of Peri operative services was present and supervising the procedure. RN C provided the completed Quality Tool for the 15 cases involving flammable prep and cautery demonstrating 100% observation by a manager or OR supervisor. The tool includes the steps in the action plan to ensure compliance. In addition on 12/1/16 RN C stated that the decision was made to remove the flammable products (Cavilon/Mastisol) from the OR Pyxis and lock the product up in the OR manager office. This ensures a manager is notified 100% of the time the flammable product is to be used and can ensure the 100% monitoring of the product use is done. Staff training records regarding OR Fire drills and confirmation of education regarding use of flammable substances in the OR was also verified.