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.

BRIDGEPORT HOSPITAL 267 GRANT STREET BRIDGEPORT, CT 06610 May 25, 2017
VIOLATION: PATIENT RIGHTS Tag No: A0115
The Condition of Participation for Patient Rights has not been met. Based on clinical record review, review of hospital policies and documentation, and interviews with hospital staff and physicians for 1 of 10 patients reviewed for care in a safe setting (Patient #1), the hospital failed to ensure a safe environment during a surgical procedure when a flammable substance and electrical equipment were used simultaneously, resulting in a fire and subsequent burn to the patient's abdomen, which resulted in a finding of Immediate Jeopardy. The facility failed to ensure the folllowing;

That staff initiated and followed their fire protocol when a fire occurred in the operating room (OR);

That periodic evaluations of hazardous surgical procedures have been conducted as required by section 15.13 of NFPA 99, 2012 edition;

That the attending physician (MD #1) was readily available to fell ows #1 and #2 who were performing a surgical procedure and in accordance with policy and procedure, should be working under the supervision of MD #1, when MD #1 was involved in a concurrent surgical case involving Patient #10; and

That the circulating nurse was readily available during a critical point in the surgical procedure.




Please see A144
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**



1. Based on clinical record review, review of hospital policies and documentation, and interviews with hospital staff and physicians for 1 of 11 patients reviewed for care in a safe setting (Patient #1), the hospital failed to ensure a safe environment during a surgical procedure when a flammable substance and electrical equipment were used simultaneously, resulting in a fire and subsequent burn to the patient's abdomen, which resulted in a finding of immediate jeopardy. The findings include:


a. Patient #1 was admitted on [DATE] with the diagnosis of ovarian mass. The patient underwent an exploratory laparoscopy, a laparoscopic hysterectomy, a laparotomy, bilateral total pelvic lymphadenectomy, resection of the left ovary with tumor and retroperitoneal mass and supracolic omentectomy. The attending surgeon, MD #1 was assisted by fell ows #1 and #2. Interview with the MD #1 on 5/22/17 indicated that following the time out and initiation of the surgical procedure in operating room (OR) #9, MD #1 left OR room #9 to attend to another surgical patient in room #10. MD #1 identified that after he/she completed a procedure (unknown time) in room 10, he/she returned to assist with a conversion to an open laparotomy. While fell ow #1 or fell ow #2 (unclear who) was using the electrosurgical unit (ESU) to create an incision and/or stop a bleed in the transverse incision on Patient #1's abdomen, MD #1 began swabbing Patient #1's abdomen with a flammable surgical prep, Chloroprep (2% chlorhexidine gluconate and 70 % isopropyl alcohol). While swabbing the abdomen, MD #1 noted that his/her hands felt hot, noted a flame on the right lower abdominal quadrant trocar site, noted the prep applicator was on fire, dropped the prep applicator on the floor and stomped the fire out. At the same time, fell ow #2 noted a fire on Patient #1's abdomen, placed his/her hands down on top of the abdomen and extinguished the fire. While the surgical procedure was completed, a burn consultant evaluated Patient #1 at 6:50 PM and identified an abdominal, right lower quadrant, second degree, 3 cm x 3 cm burn which was treated with bacitracin and xeroform. The surgeons failed to ensure that the electrical surgical unit (ESU) was not used before communicating to the surgical team and failed to wait the required dry time for the Chloroprep before using the ESU.


b. Interview with MD #1 on 5/22/17 at 2:15 PM and 5/24/17 at 11 AM identified that the fell ows prepped the patient and completed the foley and trocar insertions. MD #1 indicated that he/she was present during the timeout (2:07-2:26 PM). MD #1 visualized the patient's abdomen through the laparoscope. Although MD #1 identified that he/she was in the room from the time he/she scrubbed in, MD #1 indicated that he/she left to go into another OR room to complete another procedure (unknown time) and instructed the fell ows to "take down the adhesions". MD #1 returned to complete the resection (? time) and supracolic omentectomy. MD #1 indicated that he/she replaced fell ow #1 on the right side of the patient, MD #1 reprepped the abdomen because the case was a long case and they had "gone back and forth through the vagina". MD #1 indicated that fell ow #1 completed the transverse incision. MD #1 reprepped with the Chloroprep after the incision was made and the patient was not redraped. MD #1 indicated that was not the usual practice to reprep after the incision and identified that he/she usually used betadine, not an alcohol based prep. Although interview with Surgical Technician #1 on 5/23/17 at 11:45 AM indicated that he/she said "3 minutes" for dry time when handing the Chloroprep applicator to MD #1, MD #1 indicated that he/she did not hear "3 minutes". MD #1 prepped the abdomen with the Chloroprep applicator, MD #1 felt heat on his/her hands, MD #1 saw a fire on the patient's abdomen and the applicator was on fire. MD #1 threw the applicator to the floor while pulling back from the OR table. MD #1 pulled off his/her gloves and gown. The record and hospital documentation failed to reflect the time of the fire, however, MD #1 believed the fire occurred sometime after 6:35 PM. MD #1 rescrubbed after the fire and returned to complete the surgery. MD #1 did not know who utilized the ESU. MD #1 indicated that the surgeons do not usually communicate ESU activation and did not communicate to each other when the ESU was activated in this case. MD #1 indicated that the prep must have pooled on the trocar site.


c. Interview with fell ow #1 on 5/22/17 at 5/25/17 at 11:00 AM identified he/she was standing between the stirruped legs of the patient while MD #1 and fell ow #2 were standing on either side of the patient. fell ow #1 could not recall the time of the fire. fell ow #1 indicated that either MD #1 or fell ow #2 completed the transverse incision (fell ow #1 could not recall who did). fell ow #1 indicated that a bleeder was noted on the incision. fell ow #1 identified that he/she remembered holding a tonsil to grab a vessel. fell ow #1 indicated that either he/she or fell ow #2 used the ESU to coagulate the vessel, but could not remember who did. fell ow #1 did not remember the ESU settings utilized at the time. fell ow #1 identified that the surgeons did not communicate to each other when the ESU was activated. fell ow #1 indicated that MD #1 was reprepping with the Chloroprep applicator on the abdomen when the ESU was activated. fell ow #1 did not witness the fire on Patient #1"s abdomen but did see the Chloroprep applicator on fire when MD #1 threw it to the floor.



d. Interview with fell ow #2 on 5/23/17 at 10:45 AM identified that he/she was standing on Patient #1's left side at the time of the fire. fell ow #2 could not recall the time of the fire. fell ow #2 believed that fell ow #1 completed the transverse incision. fell ow #2 identified that MD #1 reprepped the patient's abdomen with the alcohol based skin prep, Chloroprep and the patient was not redraped. fell ow #2 did not hear anyone say "3 minutes". fell ow #2 identified that he/she never had the bovie (ESU). fell ow #2 indicated that he/she was standing, holding suction when he/she saw fire on the patient's abdomen. fell ow #2 placed his/her hands on the abdomen and extinguished the fire.


e. Interview with the circulating nurse, RN #2 on 5/23/17 at 10 am identified that the decision was made to convert to an open procedure and MD #1 requested a prep. RN #2 asked if MD #1 wanted "Chloroprep or Duraprep" and MD #1 indicated that it didn't matter. RN #2 opened a Chloroprep applicator stick to the scrub table and left the room to get a bookwalter retractor for the open procedure. RN #2 returned to OR room 10 after the fire had occurred. RN #2 identified that the room "smelled like fire". In addition, RN #2 identified that he/she had plugged the ESU into the power source but did not set/ regulate the settings.


Hospital policy for skin prepping and draping failed to address "reprepping" a surgical site. The Skin Prepping policy identified in part, that the selected prepping agent was based on patient assessment. During the prep, care should be taken to prevent pooling of the prep solution. In the case of flammable preps, additional time would be taken to ensure dissipation of vapors according to the manufacturer's written instructions.


Review of the Chloroprep manufacturer's written instructions identified in part, the following warnings: flammable keep away from fire or flame, solution contains alcohol and gives off flammable vapors, do not drape or use ignition source, e.g. cautery or laser, do not allow solution to pool, allow solution to completely dry- minimum of 3 minutes on hairless skin.


Hospital policy for use of an ESU identified that the electrosurgical unit generator must not be used in the presence of high concentrations of O2 or flammable agents such as alcohol.


Hospital policy for fire safety in a procedure area identified in part, that all prep solutions would be allowed to dry and time would be given to allow vapors to dissipate prior to draping per manufacture's guidelines. Pooled prep solution would be cleared prior to draping. The circulating nurse would announce to the team if the alcohol prep agent was used during the "time out". Fire management included removing and/or extinguishing burning materials from the patient. Cool the fire with wet towels. The flow of oxygen and anesthetic gases would be discontinued and the control desk and/or hospital personnel would pull the alarm to initiate system RACE protocol.





2. Based on review of hospital policies and documentation and interviews with staff, the hospital failed to ensure that staff initiated and followed their fire protocol when a fire occurred in the operating room (OR). The findings include:


a. Patient #1 was admitted on [DATE] and underwent an exploratory laparoscopy, a laparoscopic hysterectomy, a laparotomy, bilateral total pelvic lymphadenectomy, resection of the left ovary with tumor and retroperitoneal mass and supracolic omentectomy. The attending surgeon, MD #1 was assisted by fell ows #1 and #2 with a conversion to an open laparotomy. While fell ow #1 or fell ow #2 (unclear who) was using the electrosurgical unit (ESU) to create an incision and/or stop a bleed in the transverse incision on Patient #1's abdomen, MD #1 began swabbing Patient #1's abdomen with a flammable surgical prep, Chloroprep (2% chlorhexidine gluconate and 70 % isopropyl alcohol). While swabbing the abdomen, MD #1 noted that his/her hands felt hot, noted a flame on the right lower abdominal quadrant trocar site, noted the prep applicator was on fire, dropped the applicator on the floor and stomped the fire out. At the same time, fell ow #2 noted a fire on Patient #1's abdomen, placed his/her hands down on top of the abdomen and extinguished the fire. fell ow #1 saw the applicator was on fire and did not move. Surgical Technician #1 poured saline on the Chloroprep applicator (smoldering/glowing) on the floor. The circulating nurse, RN #2 was not in the room at the time of the fire.


b. Review of the clinical record, review of hospital documentation and interviews with hospital personnel failed to reflect the time the fire occurred. Review of the Fire Safety in a Procedure Area Policy indicated that fire management included the flow of oxygen and aesthetic gases would be discontinued as per Anesthesia. Review of the Anesthesia Record and interview with the anesthesiologist, MD #2 identified that the CRNA did not turn the gases off at the time of the fire because it had happened so quickly. MD #2 indicated that the CRNA saw the burning applicator as it was thrown across the room. The Anesthesia Record failed to reflect when the fire occurred and MD #2 identified that he/she would expect the time of the fire to be documented on the anesthesia record.


c. The Fire Safety Policy indicated that fire management included the control desk and/or hospital personnel would pull the alarm to initiate the RACE protocol (Rescue, Alarm, Confine, Extinguish/Evacuate) and would notify the charge anesthesiologist and all other operating rooms. MD #2 was not notified of the fire and the fire alarm was not activated as per protocol.


d. The Fire Safety Policy indicated that the circulating nurse would unplug electrical devices and disconnect all equipment connected to the surgical field. The circulating nurse, RN #2 was not present when the fire occurred.


e. The local fire department was not notified of the fire and the policy failed to reflect notification of the local fire department.


f. The Fire Safety Policy identified that the supplies and equipment involved in the fire would be gathered and forwarded to Risk Management. The hospital failed to sequester the burnt prep applicator and/or sponge.


g. Review of hospital documentation and interviews with the Performance Improvement Director on 5/24/17 identified that OR personnel had received hospital fire safety education. Review of hospital documentation and interviews with the Performance Improvement Director and MD #5 on 5/26/17 identified that fell ows #1 and #2 received hospital fire safety education during orientation. The fell ows were sent a "packet" to read, however, no validation was documented that the fell ows had "read the packet". Although review of the hospital's fire safety content for employees indicated that general fire safety was included, the documentation failed to reflect OR specific fire safety training.






3. Based on review of hospital documentation and interviews with staff, the hospital facility failed to ensure that periodic evaluations of hazardous surgical procedures have been conducted as required by section 15.13 of NFPA 99, 2012 edition. The findings include:


a. On 05/30/17 at 10:00 AM the surveyor obtained information in a meeting with the facility Director of Performance Management and the facility Performance Management Coordinator that during a surgical procedure conducted on 05/10/17, facility surgical staff failed to let a flammable liquid germicide solution applied to a patient dry completely before using an electric cautery device, causing second (2nd) degree burns to the patient, not complying with the standard set forth by section 15.13.3.3 (2) of NFPA 99.


b. On 05/30/17 at 10:05 AM the surveyor obtained information in a meeting with the facility Director of Performance Management and the facility Performance Management Coordinator that during a surgical procedure conducted on 05/10/17, facility surgical staff failed to conduct a required preoperative "time out" after the application of a flammable liquid germicide prior to the initiation of a surgical procedure, not meeting the requirements of section 15.13.3.6 (1) (2) (3) of NFPA 99.


c. On 05/30/17 at 10:20 AM the surveyor obtained information in a meeting with the facility Director of Performance Management and the facility Performance Management Coordinator that a fire incident occurred during a surgical procedure conducted on 05/10/17, facility surgical staff failed to activate the facility fire alarm and enact equipment shutdown procedures as specified in the facility fire plan, not meeting the requirements set forth by section 15.13.3.9.2 of NFPA 99.


d. On 05/30/17 at 11:00 AM the surveyor obtained information in a meeting with the Clinical Nurse Specialist for Procedural Areas that all facility staff that work in the operating room suite have not been instructed on specific safety practices for the equipment and procedures they will use, not meeting the requirements of section 15.13.3.10.1 of NFPA 99.





4. Based on clinical record review, review of hospital policies and documentation and interviews with staff and physicians for 1 of 11 Patients (Patient #1), the hospital failed to ensure that the attending physician (MD #1) was readily available to fell ows #1 and #2 who were performing a surgical procedure and were supposed to be working under the supervision of MD #1, when MD #1 was involved in a concurrent surgical case involving Patients #10 and #11 (Triple-Booked). The findings include:


a. Review of the operating room (OR) schedule for 5/10/17 identified that MD #1 was scheduled with Patient #1 in OR room #9 at 1:00 PM for a laproscopic radical hysterectomy with bilateral total pelvic lymphadenectomy.

b. Review of the OR schedule for 5/10/17 identified that MD #1 was scheduled with Patient #10 in OR room #10 at 1:05 PM for an open partial radical vulvectomy with bilateral inguinofemoral lymphadenectomy.


c. Review of the OR schedule for 5/10/17 identified that MD #1 was scheduled with Patient #11 in OR room #1 at 1:30 PM for an exploratory laparoscopy, mobilization of the colon and repair of a posterior colpotomy site.


d. fell ow #1 was a Post Graduate Year 5 (PGY5) working under a "Permit to Practice" fell owship Agreement and had a new Connecticut Physician/Surgeon license issued on 3/1/17. fell ow #2 was a Post Graduate Year 6 (PGY6) working under a "Permit to Practice" fell owship Agreement and had no Connecticut Physician/Surgeon license.


e. Patient #1's surgical record identified that MD #1 was present in the operating room for the laproscopic radical hysterectomy with bilateral total pelvic lymphadenectomy that ultimately converted to an open procedure from 2:07 PM until 8:38 PM. However, review of the surgical records of Patient's #10 and #11 identified that MD #1 was simultaneously in each of the 3 OR rooms performing surgical procedures.



f. Patient #10's surgical record identified that MD #1 was present in the operating room with Patient #10 for the open partial radical vulvectomy with bilateral inguinofemoral lymphadenectomy from 2:02 PM until 5:35 PM continuously (no breaks) per intra-operative documentation. Additionally, a resident physician was also present during Patient #10's surgical procedure from 2:02 PM until 5:59 PM for the surgery.



g. Patient #11's surgical record identified that an exploratory laparoscopy, mobilization of the colon and repair of a posterior colpotomy site was performed. Review of the surgical record identified that MD #1 was present in the room from 2:15 PM until 2:52 PM. Additionally, fell ow #2 was identified to be in this room from 2:00 PM until 3:16 PM.



Interview with the Chief Medical Officer and Physician Quality Officer on 5/25/17 at 4:45 PM identified that based on the hospital's operating room schedule dated 5/10/17, MD #1 was double booked for both cases, Patient #1 and Patient #10. Based on documentation in Patient #10's intra-operative record, MD #1 remained with Patient #10 from 2:02 pm until 5:35 PM, leaving Patient #1 unsupervised with fell ows #1 and #2 during that time frame. It wasn't until MD #1 completed Patient #10's case that he/she returned to Patient #1's OR room and began the conversion from laproscopic to open. However, Review of the clinical documentation provided during this interview it was identified that MD #1 had a third OR case (Patient #11) running concurrently to Patient #1 and Patient #10.


Review of the hospital policy identified that triple booking surgical cases was not permitted.


Interview with the Chief of Obstetrics and Gynecology, on 5/25/17 at 11:50 AM, identified that he/she was not aware that GYN surgeons (MD #1 specifically) were double booking procedures. He/she stated that only if a second surgeon was available could such booking be acceptable. Double Booking was only intended during the preparation phase prior to the surgery or when the patient was being finished or cleaned up post-surgery. He further stated that going forward, MD #1 was not allowed to book more than one patient/room at a time, and the attending must be present in one room only.





5. Based on review of hospital documentation and interviews with staff for 1 of 11 patients (Patient #1), the hospital failed to ensure that the circulating nurse was readily available during a critical point in the surgical procedure. The findings include:


Patient #1 was admitted on [DATE] with the diagnosis of ovarian mass. The patient underwent an exploratory laparoscopy, a laparoscopic hysterectomy, a laparotomy, bilateral total pelvic lymphadenectomy, resection of the left ovary with tumor and retroperitoneal mass and supracolic omentectomy. The attending surgeon, MD #1 was assisted by fell ows #1 and #2. Interview with the MD #1 on 5/22/17 indicated that following the time out and initiation of the surgical procedure in operating room (OR) #9, MD #1 left OR room #9 to attend to another surgical patient in room #10. MD #1 identified that after he/she completed a procedure (? time) in room 10, he/she returned to room 9 to assist with a conversion to an open laparotomy. While fell ow #1 or fell ow #2 (unclear who) was using the electrosurgical unit (ESU) to create an incision and/or stop a bleed in the transverse incision on Patient #1's abdomen, MD #1 began swabbing Patient #1's abdomen with a flammable surgical prep, Chloroprep (2% chlorhexidine gluconate and 70 % isopropyl alcohol). While swabbing the abdomen, MD #1 noted that his/her hands felt hot, noted a flame on the right lower abdominal quadrant trocar site, noted the prep applicator was on fire, dropped the applicator on the floor and stomped the fire out. At the same time, fell ow #2 noted a fire on Patient #1's abdomen, placed his/her hands down on top of the abdomen and extinguished the fire.

Interview with the circulating nurse, RN #2 on 5/23/17 at 10 am identified that the decision was made to convert to an open procedure and MD #1 had requested a surgical prep. RN #2 asked if MD #1 wanted "Chloroprep or Duraprep" and MD #1 indicated that it didn't matter. RN #2 opened a Chloroprep applicator stick to the scrub table and left the room to get a bookwalter retractor for the open procedure. RN #2 was not present during the time of the fire and had returned to OR room 10 after the fire had occurred. RN #2 identified that the room "smelled like fire". RN #2 notified the charge nurse.
VIOLATION: SURGICAL SERVICES Tag No: A0940
The Condition of Participation for Surgical Services has not been met. Based on clinical record review, review of hospital policies and documentation, and interviews with hospital staff and physicians for 1 of 10 patients reviewed for care in a safe setting (Patient #1), the hospital failed to ensure a safe environment during a surgical procedure when a flammable substance and electrical equipment were used simultaneously, resulting in a fire and subsequent burn to the patient's abdomen, which resulted in a finding of Immediate Jeopardy. The facility failed to ensure the folllowing;

That staff initiated and followed their fire protocol when a fire occurred in the operating room (OR);

That periodic evaluations of hazardous surgical procedures have been conducted as required by section 15.13 of NFPA 99, 2012 edition;

That the attending physician (MD #1) was readily available to fell ows #1 and #2 who were performing a surgical procedure and in accordance with policy and procedure, should be working under the supervision of MD #1, when MD #1 was involved in a concurrent surgical case involving Patient #10; and

That the circulating nurse was readily available during a critical point in the surgical procedure.



Please see A944 and A951
VIOLATION: OPERATING ROOM CIRCULATING NURSES Tag No: A0944
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of hospital documentation and interviews with staff for 1 of 11 patients (Patient #1), the hospital failed to ensure that the circulating nurse was readily available during a critical point in the surgical procedure. The findings include:


Patient #1 was admitted on [DATE] with the diagnosis of ovarian mass. The patient underwent an exploratory laparoscopy, a laparoscopic hysterectomy, a laparotomy, bilateral total pelvic lymphadenectomy, resection of the left ovary with tumor and retroperitoneal mass and supracolic omentectomy. The attending surgeon, MD #1 was assisted by fell ows #1 and #2. Interview with the MD #1 on 5/22/17 indicated that following the time out and initiation of the surgical procedure in operating room (OR) #9, MD #1 left OR room #9 to attend to another surgical patient in room #10. MD #1 identified that after he/she completed a procedure (? time) in room 10, he/she returned to room 9 to assist with a conversion to an open laparotomy. While fell ow #1 or fell ow #2 (unclear who) was using the electrosurgical unit (ESU) to create an incision and/or stop a bleed in the transverse incision on Patient #1's abdomen, MD #1 began swabbing Patient #1's abdomen with a flammable surgical prep, Chloroprep (2% chlorhexidine gluconate and 70 % isopropyl alcohol). While swabbing the abdomen, MD #1 noted that his/her hands felt hot, noted a flame on the right lower abdominal quadrant trocar site, noted the prep applicator was on fire, dropped the applicator on the floor and stomped the fire out. At the same time, fell ow #2 noted a fire on Patient #1's abdomen, placed his/her hands down on top of the abdomen and extinguished the fire.

Interview with the circulating nurse, RN #2 on 5/23/17 at 10 am identified that the decision was made to convert to an open procedure and MD #1 had requested a surgical prep. RN #2 asked if MD #1 wanted "Chloroprep or Duraprep" and MD #1 indicated that it didn't matter. RN #2 opened a Chloroprep applicator stick to the scrub table and left the room to get a bookwalter retractor for the open procedure. RN #2 was not present during the time of the fire and had returned to OR room 10 after the fire had occurred. RN #2 identified that the room "smelled like fire". RN #2 notified the charge nurse.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

1. Based on clinical record review, review of hospital policies and documentation, and interviews with hospital staff and physicians for 1 of 11 patients reviewed for care in a safe setting (Patient #1), the hospital failed to ensure a safe environment during a surgical procedure when a flammable substance and electrical equipment were used simultaneously, resulting in a fire and subsequent burn to the patient's abdomen, which resulted in a finding of Immediate Jeopardy. The findings include:


a. Patient #1 was admitted on [DATE] with the diagnosis of ovarian mass. The patient underwent an exploratory laparoscopy, a laparoscopic hysterectomy, a laparotomy, bilateral total pelvic lymphadenectomy, resection of the left ovary with tumor and retroperitoneal mass and supracolic omentectomy. The attending surgeon, MD #1 was assisted by fell ows #1 and #2. Interview with the MD #1 on 5/22/17 indicated that following the time out and initiation of the surgical procedure in operating room (OR) #9, MD #1 left OR room #9 to attend to another surgical patient in room #10. MD #1 identified that after he/she completed a procedure (unknown time) in room 10, he/she returned to assist with a conversion to an open laparotomy. While fell ow #1 or fell ow #2 (unclear who) was using the electrosurgical unit (ESU) to create an incision and/or stop a bleed in the transverse incision on Patient #1's abdomen, MD #1 began swabbing Patient #1's abdomen with a flammable surgical prep, Chloroprep (2% chlorhexidine gluconate and 70 % isopropyl alcohol). While swabbing the abdomen, MD #1 noted that his/her hands felt hot, noted a flame on the right lower abdominal quadrant trocar site, noted the prep applicator was on fire, dropped the prep applicator on the floor and stomped the fire out. At the same time, fell ow #2 noted a fire on Patient #1's abdomen, placed his/her hands down on top of the abdomen and extinguished the fire. While the surgical procedure was completed, a burn consultant evaluated Patient #1 at 6:50 PM and identified an abdominal, right lower quadrant, second degree, 3 cm x 3 cm burn which was treated with bacitracin and xeroform. The surgeons failed to ensure that the electrical surgical unit (ESU) was not used before communicating to the surgical team and failed to wait the required dry time for the Chloroprep before using the ESU.


b. Interview with MD #1 on 5/22/17 at 2:15 PM and 5/24/17 at 11 AM identified that the fell ows prepped the patient and completed the foley and trocar insertions. MD #1 indicated that he/she was present during the timeout (2:07-2:26 PM). MD #1 visualized the patient's abdomen through the laparoscope. Although MD #1 identified that he/she was in the room from the time he/she scrubbed in, MD #1 indicated that he/she left to go into another OR room to complete another procedure (unknown time) and instructed the fell ows to "take down the adhesions". MD #1 returned to complete the resection (? time) and supracolic omentectomy. MD #1 indicated that he/she replaced fell ow #1 on the right side of the patient, MD #1 reprepped the abdomen because the case was a long case and they had "gone back and forth through the vagina". MD #1 indicated that fell ow #1 completed the transverse incision. MD #1 reprepped with the Chloroprep after the incision was made and the patient was not redraped. MD #1 indicated that was not the usual practice to reprep after the incision and identified that he/she usually used betadine, not an alcohol based prep. Although interview with Surgical Technician #1 on 5/23/17 at 11:45 AM indicated that he/she said "3 minutes" for dry time when handing the Chloroprep applicator to MD #1, MD #1 indicated that he/she did not hear "3 minutes". MD #1 prepped the abdomen with the Chloroprep applicator, MD #1 felt heat on his/her hands, MD #1 saw a fire on the patient's abdomen and the applicator was on fire. MD #1 threw the applicator to the floor while pulling back from the OR table. MD #1 pulled off his/her gloves and gown. The record and hospital documentation failed to reflect the time of the fire, however, MD #1 believed the fire occurred sometime after 6:35 PM. MD #1 rescrubbed after the fire and returned to complete the surgery. MD #1 did not know who utilized the ESU. MD #1 indicated that the surgeons do not usually communicate ESU activation and did not communicate to each other when the ESU was activated in this case. MD #1 indicated that the prep must have pooled on the trocar site.


c. Interview with fell ow #1 on 5/22/17 at 5/25/17 at 11:00 AM identified he/she was standing between between the stirruped legs of the patient while MD #1 and fell ow #2 were standing on either side of the patient. fell ow #1 could not recall the time of the fire. fell ow #1 indicated that either MD #1 or fell ow #2 completed the transverse incision (fell ow #1 could not recall who did). fell ow #1 indicated that a bleeder was noted on the incision. fell ow #1 identified that he/she remembered holding a tonsil to grab a vessel. fell ow #1 indicated that either he/she or fell ow #2 used the ESU to coagulate the vessel, but could not remember who did. fell ow #1 did not remember the ESU settings utilized at the time. fell ow #1 identified that the surgeons did not communicate to each other when the ESU was activated. fell ow #1 indicated that MD #1 was reprepping with the Chloroprep applicator on the abdomen when the ESU was activated. fell ow #1 did not witness the fire on Patient #1"s abdomen but did see the Chloroprep applicator on fire when MD #1 threw it to the floor.



d. Interview with fell ow #2 on 5/23/17 at 10:45 AM identified that he/she was standing on Patient #1's left side at the time of the fire. fell ow #2 could not recall the time of the fire. fell ow #2 believed that fell ow #1 completed the transverse incision. fell ow #2 identified that MD #1 reprepped the patient's abdomen with the alcohol based skin prep, Chloroprep and the patient was not redraped. fell ow #2 did not hear anyone say "3 minutes". fell ow #2 identified that he/she never had the bovie (ESU). fell ow #2 indicated that he/she was standing, holding suction when he/she saw fire on the patient's abdomen. fell ow #2 placed his/her hands on the abdomen and extinguished the fire.


e. Interview with the circulating nurse, RN #2 on 5/23/17 at 10 am identified that the decision was made to convert to an open procedure and MD #1 requested a prep. RN #2 asked if MD #1 wanted "Chloroprep or Duraprep" and MD #1 indicated that it didn't matter. RN #2 opened a Chloroprep applicator stick to the scrub table and left the room to get a bookwalter retractor for the open procedure. RN #2 returned to OR room 10 after the fire had occurred. RN #2 identified that the room "smelled like fire". In addition, RN #2 identified that he/she had plugged the ESU into the power source but did not set/ regulate the settings.


Hospital policy for skin prepping and draping failed to address "reprepping" a surgical site. The Skin Prepping policy identified in part, that the selected prepping agent was based on patient assessment. During the prep, care should be taken to prevent pooling of the prep solution. In the case of flammable preps, additional time would be taken to ensure dissipation of vapors according to the manufacturer's written instructions.


Review of the Chloroprep manufacturer's written instructions identified in part, the following warnings: flammable keep away from fire or flame, solution contains alcohol and gives off flammable vapors, do not drape or use ignition source, e.g. cautery or laser, do not allow solution to pool, allow solution to completely dry- minimum of 3 minutes on hairless skin.


Hospital policy for use of an ESU identified that the electrosurgical unit generator must not be used in the presence of high concentrations of O2 or flammable agents such as alcohol.


Hospital policy for fire safety in a procedure area identified in part, that all prep solutions would be allowed to dry and time would be given to allow vapors to dissipate prior to draping per manufacture's guidelines. Pooled prep solution would be cleared prior to draping. The circulating nurse would announce to the team if the alcohol prep agent was used during the "time out". Fire management included removing and/or extinguishing burning materials from the patient. Cool the fire with wet towels. The flow of oxygen and anesthetic gases would be discontinued and the control desk and/or hospital personnel would pull the alarm to initiate system RACE protocol.





2. Based on review of hospital policies and documentation and interviews with staff, the hospital failed to ensure that staff initiated and followed their fire protocol when a fire occurred in the operating room (OR). The findings include:


a. Patient #1 was admitted on [DATE] and underwent an exploratory laparoscopy, a laparoscopic hysterectomy, a laparotomy, bilateral total pelvic lymphadenectomy, resection of the left ovary with tumor and retroperitoneal mass and supracolic omentectomy. The attending surgeon, MD #1 was assisted by fell ows #1 and #2 with a conversion to an open laparotomy. While fell ow #1 or fell ow #2 (unclear who) was using the electrosurgical unit (ESU) to create an incision and/or stop a bleed in the transverse incision on Patient #1's abdomen, MD #1 began swabbing Patient #1's abdomen with a flammable surgical prep, Chloroprep (2% chlorhexidine gluconate and 70 % isopropyl alcohol). While swabbing the abdomen, MD #1 noted that his/her hands felt hot, noted a flame on the right lower abdominal quadrant trocar site, noted the prep applicator was on fire, dropped the applicator on the floor and stomped the fire out. At the same time, fell ow #2 noted a fire on Patient #1's abdomen, placed his/her hands down on top of the abdomen and extinguished the fire. fell ow #1 saw the applicator was on fire and did not move. Surgical Technician #1 poured saline on the Chloroprep applicator (smoldering/glowing) on the floor. The circulating nurse, RN #2 was not in the room at the time of the fire.


b. Review of the clinical record, review of hospital documentation and interviews with hospital personnel failed to reflect the time the fire occurred. Review of the Fire Safety in a Procedure Area Policy indicated that fire management included the flow of oxygen and aesthetic gases would be discontinued as per Anesthesia. Review of the Anesthesia Record and interview with the anesthesiologist, MD #2 identified that the CRNA did not turn the gases off at the time of the fire because it had happened so quickly. MD #2 indicated that the CRNA saw the burning applicator as it was thrown across the room. The Anesthesia Record failed to reflect when the fire occurred and MD #2 identified that he/she would expect the time of the fire to be documented on the anesthesia record.


c. The Fire Safety Policy indicated that fire management included the control desk and/or hospital personnel would pull the alarm to initiate the RACE protocol (Rescue, Alarm, Confine, Extinguish/Evacuate) and would notify the charge anesthesiologist and all other operating rooms. MD #2 was not notified of the fire and the fire alarm was not activated as per protocol.


d. The Fire Safety Policy indicated that the circulating nurse would unplug electrical devices and disconnect all equipment connected to the surgical field. The circulating nurse, RN #2 was not present when the fire occurred.


e. The local fire department was not notified of the fire and the policy failed to reflect notification of the local fire department.


f. The Fire Safety Policy identified that the supplies and equipment involved in the fire would be gathered and forwarded to Risk Management. The hospital failed to sequester the burnt prep applicator and/or sponge.


g. Review of hospital documentation and interviews with the Performance Improvement Director on 5/24/17 identified that OR personnel had received hospital fire safety education. Review of hospital documentation and interviews with the Performance Improvement Director and MD #5 on 5/26/17 identified that fell ows #1 and #2 received hospital fire safety education during orientation. The fell ows were sent a "packet" to read, however, no validation was documented that the fell ows had "read the packet". Although review of the hospital's fire safety content for employees indicated that general fire safety was included, the documentation failed to reflect OR specific fire safety training.






3. Based on review of hospital documentation and interviews with staff, the hospital facility failed to ensure that periodic evaluations of hazardous surgical procedures have been conducted as required by section 15.13 of NFPA 99, 2012 edition. The findings include:


a. On 05/30/17 at 10:00 AM the surveyor obtained information in a meeting with the facility Director of Performance Management and the facility Performance Management Coordinator that during a surgical procedure conducted on 05/10/17, facility surgical staff failed to let a flammable liquid germicide solution applied to a patient dry completely before using an electric cautery device, causing second (2nd) degree burns to the patient, not complying with the standard set forth by section 15.13.3.3 (2) of NFPA 99.


b. On 05/30/17 at 10:05 AM the surveyor obtained information in a meeting with the facility Director of Performance Management and the facility Performance Management Coordinator that during a surgical procedure conducted on 05/10/17, facility surgical staff failed to conduct a required preoperative "time out" after the application of a flammable liquid germicide prior to the initiation of a surgical procedure, not meeting the requirements of section 15.13.3.6 (1) (2) (3) of NFPA 99.


c. On 05/30/17 at 10:20 AM the surveyor obtained information in a meeting with the facility Director of Performance Management and the facility Performance Management Coordinator that a fire incident occurred during a surgical procedure conducted on 05/10/17, facility surgical staff failed to activate the facility fire alarm and enact equipment shutdown procedures as specified in the facility fire plan, not meeting the requirements set forth by section 15.13.3.9.2 of NFPA 99.


d. On 05/30/17 at 11:00 AM the surveyor obtained information in a meeting with the Clinical Nurse Specialist for Procedural Areas that all facility staff that work in the operating room suite have not been instructed on specific safety practices for the equipment and procedures they will use, not meeting the requirements of section 15.13.3.10.1 of NFPA 99.





4. Based on clinical record review, review of hospital policies and documentation and interviews with staff and physicians for 1 of 11 Patients (Patient #1), the hospital failed to ensure that the attending physician (MD #1) was readily available to fell ows #1 and #2 who were performing a surgical procedure and were supposed to be working under the supervision of MD #1, when MD #1 was involved in a concurrent surgical case involving Patients #10 and #11 (Triple-Booked). The findings include:


a. Review of the operating room (OR) schedule for 5/10/17 identified that MD #1 was scheduled with Patient #1 in OR room #9 at 1:00 PM for a laproscopic radical hysterectomy with bilateral total pelvic lymphadenectomy.

b. Review of the OR schedule for 5/10/17 identified that MD #1 was scheduled with Patient #10 in OR room #10 at 1:05 PM for an open partial radical vulvectomy with bilateral inguinofemoral lymphadenectomy.


c. Review of the OR schedule for 5/10/17 identified that MD #1 was scheduled with Patient #11 in OR room #1 at 1:30 PM for an exploratory laparoscopy, mobilization of the colon and repair of a posterior colpotomy site.


d. fell ow #1 was a Post Graduate Year 5 (PGY5) working under a "Permit to Practice" fell owship Agreement and had a new Connecticut Physician/Surgeon license issued on 3/1/17. fell ow #2 was a Post Graduate Year 6 (PGY6) working under a "Permit to Practice" fell owship Agreement and had no Connecticut Physician/Surgeon license.


e. Patient #1's surgical record identified that MD #1 was present in the operating room for the laproscopic radical hysterectomy with bilateral total pelvic lymphadenectomy that ultimately converted to an open procedure from 2:07 PM until 8:38 PM. However, review of the surgical records of Patient's #10 and #11 identified that MD #1 was simultaneously in each of the 3 OR rooms performing surgical procedures.



f. Patient #10's surgical record identified that MD #1 was present in the operating room with Patient #10 for the open partial radical vulvectomy with bilateral inguinofemoral lymphadenectomy from 2:02 PM until 5:35 PM continuously (no breaks) per intra-operative documentation. Additionally, a resident physician was also present during Patient #10's surgical procedure from 2:02 PM until 5:59 PM for the surgery.



g. Patient #11's surgical record identified that an exploratory laparoscopy, mobilization of the colon and repair of a posterior colpotomy site was performed. Review of the surgical record identified that MD #1 was present in the room from 2:15 PM until 2:52 PM. Additionally, fell ow #2 was identified to be in this room from 2:00 PM until 3:16 PM.



Interview with the Chief Medical Officer and Physician Quality Officer on 5/25/17 at 4:45 PM identified that based on the hospital's operating room schedule dated 5/10/17, MD #1 was double booked for both cases, Patient #1 and Patient #10. Based on documentation in Patient #10's intra-operative record, MD #1 remained with Patient #10 from 2:02 pm until 5:35 PM, leaving Patient #1 unsupervised with fell ows #1 and #2 during that time frame. It wasn't until MD #1 completed Patient #10's case that he/she returned to Patient #1's OR room and began the conversion from laproscopic to open. However, Review of the clinical documentation provided during this interview it was identified that MD #1 had a third OR case (Patient #11) running concurrently to Patient #1 and Patient #10.


Review of the hospital policy identified that triple booking surgical cases was not permitted.


Interview with the Chief of Obstetrics and Gynecology, on 5/25/17 at 11:50 AM, identified that he/she was not aware that GYN surgeons (MD #1 specifically) were double booking procedures. He/she stated that only if a second surgeon was available could such booking be acceptable. Double Booking was only intended during the preparation phase prior to the surgery or when the patient was being finished or cleaned up post-surgery. He further stated that going forward, MD #1 was not allowed to book more than one patient/room at a time, and the attending must be present in one room only.