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.

PARKRIDGE MEDICAL CENTER 2333 MCCALLIE AVE CHATTANOOGA, TN 37404 June 2, 2017
VIOLATION: PATIENT RIGHTS Tag No: A0115
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policy, review of The Joint Commission (TJC) Sentinel Event Alert, review of the Food and Drug Administration (FDA) guidelines, medical record review, review of facility documentation, observation, and interview, the facility failed to provide care in a safe setting for 1 patient (#2) of 5 patients reviewed for surgical services.

The findings included:

During the survey it was found one patient (#2) was admitted to the facility on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. During the patient's admission the staff were unable to gain Intravenous (IV) access. On 5/24/17 an attempt to place a central line into the patient's right jugular resulted in placement of the catheter into the patient's right carotid artery. On 5/25/17 the patient was taken to the Operating Room (OR) for an insertion of a femoral central line and ligation of a hole and right internal carotid artery repair. Prior to the surgery an Endotracheal tube (ETT) was inserted into the patient's tracheostomy site and the patient was placed on 100% oxygen with Continuous Airway Positive Pressure (CPAP), was given inhalation anesthesia, and ventilated with an ambu bag. During the surgical procedure a right femoral line was inserted by the surgeon and the patient remained on 100% oxygen (O2). A surgical incision was made to the patient's right carotid artery, which required the incision site to the previously placed central line site to be made larger. A cautery machine was used during the surgery and during use of the cautery device a flame was observed, resulting in burns to the patient's lips, neck, and singeing to the patient's facial hair. The flame was extinguished, the singed surgical drapes were removed, and the ETT was removed by anesthesia. The patient required reintubation with 100% supplemental oxygen. The surgical procedure was continued and the surgical wound was closed.

During a conference on 6/2/17 at 10:10 AM, in the Chief Nursing Executive's office, with the Administrator, the Chief Nurse Executive (CNE), and the Director of Regulatory Compliance, the facility was informed of the Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has cause, or is likely to cause injury, harm, or impairment, or death) at 42 CFR PART 482.13 Patient Rights (Condition).

Review of an Immediate Action Plan (MDS) dated [DATE] revealed the following actions were implemented:
1. Fire risk assessment for cases not identified prior to the procedure
(a) Implement fire risk scoring process to be completed by anesthesia provider and identified to the team during the timeout process. The circulating Registered Nurse (RN) will be the responsible party to communicate the score during the time out process.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, and Chief of Anesthesia.
(c) Implementation date: 6/2/17
(d) Prior to every OR procedure the fire risk score will be communicated during the time out process.
(e) Expected compliance: 100%
(f) Director or Manager of OR will complete direct observations on all regular scheduled cases and Nursing Supervisor will complete observations of emergent cases during the next 3 days and then 30 cases per month x (times) 3 months.
(g) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

2. Training- staff further need education regarding surgical site fire risk
(a) Staff will attend stand-up education sessions covering the risk assessment scoring tool and the measures to implement based on scores.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, and Chief of Anesthesia.
(c)Implementation date: 6/2/17. Completion date 6/7/17.
(d) Huddles to review surgical site fire risk tool with staff attestation of completing education. Huddles will provide time for staff to ask questions and seek any needed clarification.
(e) All full time (FT), part time (PT), and PRN (as needed) staff who participate in the time out process. Staff on family medical leave (FMLA) and vacation will receive education on return and prior to entering OR.
(f) 100% of staff will receive education prior to entering the OR.
(g) Director or Manager of OR will provide education to staff and obtain attestation.
(h) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

3. Anesthesia did not inform surgeon of difficulties of maintain O2 saturations and the need to increase O2 delivery.
(a) Implement a communication and documentation process for communicating high risk airway, high fractioned inspired oxygen (FIO2), and fire risk score prior to case by anesthesia provider and surgeon. Documentation of communication will be noted on anesthesia form.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, Chief of Anesthesia, Chief of Surgery.
(c) Implementation: 6/2/17. Completion 6/7/17.
(d) OR Director and Manager will meet with Anesthesia providers to review surgical site fire risk tool and new documentation process. All anesthesia providers will complete attestation that they have been informed.
(e) 100% of anesthesia providers will provide anesthesia services.
(f) OR Director and Manager along with Chief of Anesthesiology will provide education to the anesthesia providers and obtain attestation forms.
(g) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

4. Fire Drills did not include evaluation of surgical site fire risk assessment.
(a) Enhance current quarterly fire drills to include evaluation of surgical site fire risk assessment completion and communication prior to start of procedure during the time out process. Develop staff competency form which will be completed with initial drill and new hire orientation.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, Chief of Anesthesia, Chief of Surgery.
(c) Implementation date: 6/2/17
(d) First fire drill will be conducted on 6/7/17.
(e) Three drills to be completed prior to 7/15/17. Then quarterly.
(f) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

Review of recent changes to the facility policy "Safe Procedural and Surgical Verification" 6/2017, (as part of the allegation of compliance) revealed "...the verification process, which starts during the pre-procedure phase, will be conducted throughout all phases of procedural care, and will include the continuous sharing of information to include patient, procedure and site, and fire risk score..." Further review revealed "...a time out, which is led by the surgeon/proceduralist, will be performed prior to starting the procedure...surgical site fire risk score will be communicated to the team by the circulator..." Continued review revealed "...relevant documents...to be reviewed include...surgical site fire risk assessment guide..." Further review revealed "...if the patient will be moved to the surgical/procedural area, a final verification will be conducted prior to the transfer. Members of the Surgical/Procedure team will perform a reconfirmation of each of the following items...in addition, fire risk score will be calculated..." Continued review revealed "...safety concerns are addressed in relation to scheduled procedure. Safety concerns may include but are limited to...risk of fire associated with skin prep dry time [if alcohol based] and high risk airway..."

Review of a Surgical Site Fire Risk Assessment Guide (tool used to evaluate surgical fire risk) revealed the fire risk protocol addressed in the facility policy. Further review revealed the form will be used to score all surgical cases for surgical site fire risk of high, medium, or low risk. Continued review revealed fire risk protocols for each category of fire risk.

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

Based on review of facility policy, review of The Joint Commission (TJC) Sentinel Event Alert, review of The Food and Drug Administration (FDA) guidelines, medical record review, review of facility documentation, observation, and interview, the facility failed to provide care in a safe setting for 1 patient (#2) of 5 patients reviewed for surgical services.

The findings included:

Review of facility policy "Safe Procedural and Surgical Verification" last revised on 11/2015, revealed "...briefing: time-out and debriefing: once the patient is in the operating room or procedure area, team members will stop and respond through active verbal acknowledgement and confirmation to each question of the briefing, time-out, and debriefing...briefing/pre-anesthesia time out immediately before administration of any type of anesthesia and/or sedation...completion of safety check of anesthesia machine, if applicable...delineation of any specific anesthesia risk..." Further review revealed "...safety concerns are addressed in relation to scheduled procedure. Safety concerns may include...risk of fire associated with skin prep dry time..."

Review of a Sentinel Event Alert from The Joint Commission (TJC) " Preventing Surgical Fires" dated 6/24/03 revealed "...common ignition sources found in the OR [operating room] are electrosurgical or electrocautery [ESU's, ECU's]...recommendations include: staff should question the need of 100% O2 [oxygen] for delivery during facial surgery and as a general policy, use air or FIO2 [fractionated inspired oxygen] at < [less than] 30% for open delivery...informing staff members, including surgeons and anesthesiologist, about the importance of controlling heat sources by following laser and ESU safety practices; managing fuels by allowing sufficient time for patient prep; and establishing guidelines for minimizing oxygen concentration under the drape..."

Review of the Food Drug Administration (FDA) document "Preventing Surgical Fires: FDA Safety Communication" dated 10/31/11 revealed "...surgical fires can occur at any time all three elements of the fire triangle are present...[1] ignition source [lasers, electrosurgical units]...[2] fuel source [surgical drapes, alcohol based skin preparations agents]...[3] oxidizer [oxygen, nitrous oxide, room air]..." Further review revealed "...recommendations to reduce the risk of surgical fires: use supplemental oxygen safety...evaluate if supplemental oxygen is needed on each patient. Any increase in oxygen concentration in the surgical field increased the chance of fire...if supplemental oxygen is necessary, particularly for surgery in the head, neck, or upper chest area: deliver minimum concentration of oxygen needed to maintain adequate oxygen saturation for your patient...take additional precautions to exclude oxygen from the field if using an open delivery system...consider alternatives to using an ignition source for surgery of the head, neck, and upper chest if high concentrations of supplemental oxygen [greater than 30 percent] are being delivered...encourage communication among members of your surgical team...encourage the anesthesia professional delivering the gases is communicating with the surgeon controlling the ignition source and the clinician applying the skin preparation agent..."

Medical record review revealed Patient #2 was admitted the facility on 5/21/17 at 12:13 PM with a chief complaint on a rash to his body. Further review revealed the patient was discharged from the facility on 6/1/17.

Medical record review of an Emergency Department (ED) Provider Report (ED physician documentation) dated 5/21/17 at 12:24 PM revealed "...chief complaint: chicken pox...33 y/o [year old] male with [DIAGNOSES REDACTED], ulcerative colitis [UC], presents with a rash. It is all over his body, it is itchy. He is non-verbal, his parents give most of the history. He gets Humira [anti-inflammatory medication] shots for UC, he had one last week as recently..." Further review revealed "...Immunocompromised with chicken pox. Need admission for IV [intravenous] Acyclovir [antiviral medication]. Further review revealed the patient received Acyclovir and Benadryl [medication used for itching] while in the ED. The patient was admitted to the hospital.

Medical record review of an Admission History and Physical dated 5/21/17 revealed "...[AGE] year old male with [DIAGNOSES REDACTED], who was taken to the emergency room by his parents for rash...minimally verbal...receives Humira, methotrexate [medication used to treat rheumatoid arthritis] and sulfasalazine [anti-inflammatory medication] for UC...developed rash on Thursday, 5/18/17 prior to admission. It started on the left lower abdomen and groin area and spread to his trunk and now spreading to his extremities. The patient did have a fever of 100.3 yesterday. The patient had a lot of itching. The parents gave Benadryl...parents called gastrointestinal doctor...who advised to come to the emergency room ..." Further review revealed "...initially the parents thought the patient had a reaction to the Humira, but the patient has been on Humira for over several years..." Further review revealed "...he has a tracheostomy and PEG [percutaneous gastrostomy] tube...all review of systems otherwise negative..." Further review revealed "...Assessment: immunosuppressed patient...UC...[DIAGNOSES REDACTED]..." Further review revealed "...Plan: we will admit the patient for IV Zovirax [antiviral medication]. [Named Infection Specialist] to see the patient in consultation. We will check pending admit labs. We will begin Lovenox [anticoagulant] for deep venous thrombosis prophylaxis..."

Medical record review of a Pulmonary Consult dated 5/24/17 at 11:45 PM revealed "...on Acyclovir, phone orders were given for administration of IV fluids and steroids but I was informed that we lost peripheral IV access. PICC [peripheral intravenous central catheter] but was unable to place midline or PICC..." Further review revealed "...patient needs CVC [central venous catheter] for IV fluid resuscitation, possible infusion of vasoactive agents, administration of IV medications, and access for phlebotomy [blood draws]..." Further review revealed "...CVC placed in the R [right] neck, intended for RIJV [right internal jugular vein]...ABG [arterial blood gases] from distal port compatible with ARTERIAL blood...vascular surgery consult requested, case discussed with [named surgeon] re: request for CVC removal/artery repair and placement of CVC in the operating theater..."

Medical record review of an Anesthesia Record dated 5/25/17 at 8:00 AM revealed "...transported from MICU [medical intensive care unit] monitored, ventilated per ambu with O2. Monitors connected in OR. Anesthesia induced via [by] inhalation..." Further review revealed "...8:38 AM: start procedure...8:48 AM: fire on field. Drapes and ETT [endotracheal tube] removed immediately. ETT replaced, patient vital signs stable throughout..." Further review revealed FIO2 during the surgical procedure was 0.9% [90%].

Medical record review of an Immediate Post-Procedure Note dated 5/25/17, with no time, revealed "...procedure: removal, insertion of central line R groin...ligation of hole and right internal carotid artery..." Further review revealed "...complications: flame during case..."

Medical record review of an operative report dated 5/25/17 at 9:47 AM revealed "...operation: insertion of right femoral vein CVP [central venous peripheral] line using [named ultrasound device], right neck exploration, removal of CVP line right internal carotid artery, ligation of hole in right internal carotid artery..." Further review revealed "...admitted to the hospital last night...could not get a routine line in place for intravenous therapy. Pulmonary medicine service was consulted for central line. Central line was placed last night. It was thought, after placement, to be in the carotid artery. This was confirmed with pressure transducer. I was asked to remove the line..." Further review revealed "...he [the] tracheostomy tube was then replaced with an endotracheal tube placed through the stoma [opening]...the right groin was prepped and draped in the usual sterile manner. [Named ultrasound device] was used to easily find the right femoral vein...[blank space] inserted through the right femoral vein. It was sutured into place and irrigated with heparinized saline..." Further review revealed "...I then changed my attention to the upper part of the right neck. A central line was going into the neck in this location. This area was prepped and draped in a sterile manner as possible. I initially started with a small neck incision, which had to be made larger on several occasions. We carefully dissected down to the catheter and down into the deeper layers of the neck. I then noticed a flame in the wound. This was immediately extinguished...the area was then reprepped with [named antiseptic cleanser]. We then continued the dissection deeper into the neck..." Further review revealed "...the case was then turned over to the pulmonary medicine service to do a bronchoscopy. The patient seemed to tolerate the procedure reasonable well considering everything. Intraoperative complications including the flame...I then went out and talked to the family and told them frankly all the details of the case including the flame. At this point in time, it appears that he patient had some...[blank space] but no other skin burn is seen at this point in time..."

Medical record review of a Physicians Anesthesia Clinical Note dated 5/25/17 at 11:04 AM revealed "...patient with interop surgical fire. Fire immediately extinguished and ET tube immediately removed. [Named pulmonary doctor] notified at surgery conclusion and performed bronchoscopy, which revealed no airway burns in trachea or bronchi. Burns noted on face and lips, however no burns noted inside lips or mouth. Plastic surgery is being consulted to evaluate burns. Will discuss with patient's parents..." Further review revealed "...cuffed ET tube used during surgery. Patient's trach replaced at the end of surgery..."

Medical record review of a Physicians Progress Note dated 5/25/17, with no time, revealed "...stable...burn seems to be limited to lips, facial hair...available as needed..."

Review of facility documentation dated 5/25/17 at 1:20 PM revealed "...5/25/17 at 8:48 AM...invasive procedure...burn...first aid treatment...refer to administration...seen by physician..." Further review revealed "...family notified...mother and father on 5/25/17 at 10:40 AM..."

Medical record review of a Hospitalist Progress Note dated 5/25/17 at 1:39 PM revealed "...events in OR noted and events surrounding tlc [triple lumen catheter]...s/p [status post] flash fire...looks better overall to me today...discussed with nurse continue aerosols and steroids..."

Medical record review of a Pulmonary Critical Care Progress Note dated 5/26/17 at 11:12 AM revealed "...no new respiratory complaints. Family is concerned about neck swelling/fullness...facial burns are superficial, wound care input is appreciated..."

Medical record review of a Skin/Wound/Ostomy consult dated 5/26/17 at 5:39 PM revealed "...consult placed for burns to the face received during surgerical [surgical] procedure...Pt. has dark red pustules over entire epidermis. Father points out raw place on right earlobe. This looks like burst of 3rd degree blister. Pt. also has red area to right jaw line with small amount of serous drainage. Pt. has swollen place flesh to left side upper lip and lower lip. Discussed with nurse the need to watch pt. closely for respiratory distress. Distress in the near future as internal swelling of esophagus may occur..."

Interview with the Patient Safety Director, on 6/1/17 at 9:30 AM, in the conference room, revealed "...the patient was admitted to the facility with chicken pox on May 21, 2017...he had a history of [DIAGNOSES REDACTED] and contractures ...he had a customized trach...the staff had a difficult time inserting an intravenous line and a central line was required to administer medications..." Further interview revealed "...a jugular central line was inserted that night but it was found to be in the carotid artery and needed to be surgically removed and repaired...while in the OR the patient required a high concentration of oxygen...an endotracheal tube was inserted through the trach site to administer the oxygen...they were going to insert a femoral central line while in surgery which was successfully inserted...when the surgeon removed the jugular carotid line he used a [named cautery device] to cauterize the area...the patient was on a high concentration of oxygen...the area was prepped and allowed to dry..." Continued interview revealed "...when the surgeon used the [named cautery device], anesthesia and the staff heard a pop...the CRNA [Certified Registered Nurse Anesthetist] stated he felt heat under the drape where he had his hand...the drapes were immediately removed and a saline sponge was thrown on the site...the drapes were singed to the upper part of the drape...the staff did not observe any burns at that time..." Further interview revealed "...the staff reported they immediately placed saline on the area, the endotracheal tube was removed and the patient was reintubated..." Continued interview revealed "...after the surgery procedure was completed a bronchoscopy was performed which revealed no airway burns...there were burns observed to the patient's mouth, lips, earlobe and nose...wound care was consulted..."

Interview with CRNA #1 on 6/1/17 at 10:20 AM, in OR room #2, revealed the CRNA provided anesthesia to the patient on 6/25/17. Further interview revealed "...the patient was brought to the OR without an IV access...we were going to use inhalation gases to put the patient to sleep...he had a customized trach with an inner cannula...we intubated the patient through the trach site with a 7.0 endotracheal tube and we were having a hard time in keeping his oxygen saturations up...we were using 100% oxygen via ambu and we had to use Continuous Positive Airway Pressure [CPAP-positive pressure ventilation to keep the alveoli open] to keep his oxygen saturations at 91-93%..." Further interview revealed "...the surgeon placed a femoral central venous line first...we had to turn the patient on to his left side for the surgeon to get to the right side to work on the carotid jugular line..." Continued interview revealed "...when the surgeon used the [named cautery device] to cauterize the area, we heard a pop and I felt heat around my hand where I was assisting the patient's ventilations with an ambu bag...we removed the drape and a saline sponge was thrown on the area...in addition the surgical technician used the saline which was located on the sterile tray and placed the saline on the area...we pulled the endotracheal tube immediately...we reintubated the patient immediately...the left side of the patient's face was singed...a bronchoscopy was performed after the surgical procedure which revealed no airway burns..." Further interview confirmed "...we were focused on maintaining the patient's airway and keeping his oxygen saturations up...again, the patient was on 100% oxygen with CPAP...we were overwhelmed with this patient so I do not remember having any conversation with the surgeon on the high oxygen percentage..." Further interview confirmed "...a time out procedure was done but we did not talk about the high oxygen percentage and the use of the [named cautery device]..."

Observation in the Surgical Intensive Care Unit (SICU) on 6/1/17 at 10:40 AM revealed the Patient #2 remained in the unit and was in respiratory isolation.

Telephone interview with Anesthesiologist #1 on 6/1/17 at 12:45 PM revealed he provided care to the patient on 5/25/17. Further interview revealed...we have talked about this patient's case...the CRNA had to use high concentration of oxygen to keep the patient's saturations up...in addition, the patient required CPAP...it was a high stressed situation..." Further interview revealed "...the oxygenated fraction of oxygen is normally decreased when a [named cautery machine] is used but it was not due to the patient's requirement for the increased oxygen need..." Further interview revealed "...the pulmonologist was notified and he performed a bronchoscopy after the surgical procedure to ensure no airway burns were present..."

Interview with Certified Surgery Technologist (CST) #1, on 6/1/17 at 12:55 PM, in the conference room, revealed the tech was the surgical assistant on the patient's case on 6/25/17. Further interview revealed "...we perform a time out on every patient but there was no conversation regarding the oxygen and the use of a [named cautery device]..." Further interview revealed "...I saw a flame when the [named cautery device] was used...there was a small flame from the hole where we were working...I immediately threw saline solution and a wet saline prep over the area...I used a Asetpo [hypodermic syringe with a bulb or slender nozzle used for injecting fluids or cleansing wounds] syringe to put the fire out...the drapes were removed from the area..."

Interview with CST #2, on 6/1/17 at 1:00 PM, in the conference room, revealed the technician assisted during the patient's case on 6/25/17. Further interview revealed "...the physician had just made an incision and the [named cautery device] was used to cauterize a few spots...there was a small flash which lasted for less than 5 seconds...[CST #1] placed a wet sponge pad on the area and poured the saline over the area...the drapes were removed immediately..." Further interview revealed "...I did not see any big burns to the patient at that time...the patient had chicken pox and it was hard to tell what was chicken pox and what was a burn...I did not smell anything...we re-draped the patient and the surgery continued..."

Telephone interview with Registered Nurse (RN) #1, on 6/1/17 at 1:10 PM, revealed the nurse was the circulating nurse assigned to the patient on 5/25/17. Further interview revealed "...the patient arrived in the OR...he had a prior permanent tracheostomy tube...the patient had to be intubated through the trach site with an endotracheal tube per anesthesia...he did not have an IV access and they had to give him inhalation anesthesia for induction..." Further interview revealed "...there were 2 CRNA's in the room, one holding the tube and the other one bagging the patient...it was somewhat stressful because they were trying to keep the patient oxygen saturations up...anesthesia had ventilation issues..." Further interview revealed "...the patient was complex. He had [DIAGNOSES REDACTED] and was very contracted...he came in with chicken pox..." Continued interview revealed "...[named surgeon] put a right femoral central line in first...I prepped both areas using Chlorhexidine and Chloraprep...they have a 3 minute dry time...the field was completely dried before we draped the patient..." Further interview revealed "...[named surgeon] was in the room...when he completed the femoral line he moved up to the neck area...a [named cautery device] was used and I heard someone say they heard a pop...the CRNA said he felt heat...we removed the drape...[CST #1] put a wet saline gauze on the site...the gases were turned off and the endotracheal tube was removed...the drapes were singed..." Further interview revealed "...once the fire was out, a new endotracheal tube was placed, the area was redraped and the surgery was completed...[named surgeon] was well aware of the patient's condition..." Further interview confirmed "...the patient had a burn to his right ear, left lip, and some facial hair singeing...a bronchoscopy was performed which revealed no oral, nasal or airway injuries..." Continued interview confirmed "...a time out was performed prior to the surgery but there was no discussion regarding the high concentration of oxygen prior to the use of the [named cautery device]..."

Telephone interview with the Chief of Anesthesia, on 6/1/17 at 1:50 PM, confirmed "...there should always be some conversation between anesthesia and the surgeon when high concentrations of oxygen are being used and when [named cautery device] would be used during a surgical procedure..." Further interview confirmed "...we do a time out but no fire safety checklist..."

Telephone interview with Surgeon #1 on 6/5/17 at 5:25 PM revealed the surgeon was called by the Pulmonologist after a jugular central line was inserted into the patient's right carotid artery. Further interview revealed "...the young man had multiple issues...he was contracted and had a history of [DIAGNOSES REDACTED]...he had spontaneous movements throughout his entire body...there had been multiple attempts to gain IV access which were unsuccessful...the patient had a permanent tracheostomy..." Further interview revealed "...I saw the patient the next morning and took the patient to the OR for a femoral central line insertion and repair of the carotid artery jugular line...I inserted the femoral line with difficulty and then moved up to the neck to repair the hole in the carotid artery..." Further interview revealed "...anesthesia had placed an endotracheal tube into the stoma site and were ventilating the patient with 100% oxygen...they were having problems keeping his oxygen saturations up..." Continued interview revealed "...I was using a cautery device to ligate the blood vessels when I felt a hot sensation and we saw a flash...we immediately put the fire out, removed the drapes and endotracheal tube, and placed gauze sponges on the surgical fire site...there did not appear to be any issues with that..." Further interview revealed "...the patient was reintubated and we continued on with the surgical procedure..." Continued interview revealed "...the patient did have some singeing of his facial hair, burns to his lips, and eyebrows...a bronchoscopy was performed after the surgery to ensure no airway injury was present..." Further interview confirmed "...I do not remember any discussion about the high oxygen concentration prior to the cauterization...but apparently he was on a high concentration of oxygen..." Continued interview confirmed the Surgeon and the CRNA did not discuss the increased fire risk associated with the administration of high oxygen during use of a cautery device.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policy, medical record review, and interview, the facility failed to ensure a consent form for a surgical procedure was timed for 1 patient (#2) of 5 records reviewed.

The findings included:

Review of facility policy "Record of Care, Treatment and Services, Medical Record Documentation," last revised on 3/2016, revealed "...entires are made timely and each entry included the complete date of the entry, month, day, year and time of day and the signature [written or electronic] of the person making the entry..."

Medical record review revealed Patient #2 was admitted to the facility on [DATE] with a diagnosis of Varicella (Chicken Pox). Further review revealed the patient was discharged from the facility on 6/1/17.

Medical record review of a Consent for Surgical or Invasive Treatment to "Remove Central Venous Catheter Line from Neck. Insertion of New Central Venous Catheter Line" for Patient #2 dated 5/25/17 revealed the consent was not timed.

Interview with the Director of Quality Management on 6/1/17 at 2:30 PM, in the conference room, confirmed the consent form was not timed and the facility failed to follow policy.
VIOLATION: SURGICAL SERVICES Tag No: A0940
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policy, review of the Joint Commission (TJC) Sentinel Event Alert, review of the Food and Drug Administration (FDA) guidelines, medical record review, review of facility documentation, and interview, the facility failed to ensure surgical services were provided in accordance with acceptable standards of practice for 1 patient (#2) of 5 patients reviewed for surgical services.

The findings included:

During the survey it was found one patient (#2) was admitted to the facility on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. During the patient's admission the staff were unable to gain Intravenous (IV) access. On 5/24/17 an attempt to place a central line into the patient's right jugular resulted in placement of the catheter into the patient's right carotid artery. On 5/25/17 the patient was taken to the Operating Room (OR) for an insertion of a femoral central line and ligation of a hole and right internal carotid artery repair. Prior to the surgery an Endotracheal tube (ETT) was inserted into the patient's tracheostomy site and the patient was placed on 100% oxygen with Continuous Airway Positive Pressure (CPAP), was given inhalation anesthesia, and ventilated with an ambu bag. During the surgical procedure a right femoral line was inserted by the surgeon and the patient remained on 100% oxygen (O2). A surgical incision was made to the patient's right carotid artery, which required the incision site to the previously placed central line site to be made larger. A cautery machine was used during the surgery and during use of the cautery device a flame was observed, resulting in burns to the patient's lips, neck, and singeing to the patient's facial hair. The flame was extinguished, the singed surgical drapes were removed, and the ETT was removed by anesthesia. The patient required reintubation with 100% supplemental oxygen. The surgical procedure was continued and the surgical wound was closed.

During a conference on 6/2/17 at 10:10 AM, in the Chief Nursing Executive's office, with the Administrator, the Chief Nurse Executive (CNE), and the Director of Regulatory Compliance, the facility was informed of the Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has cause, or is likely to cause injury, harm, or impairment, or death) at 42 CFR PART 482.13 Patient Rights (Condition).

Review of an Immediate Action Plan (MDS) dated [DATE] revealed the following actions were implemented:
1. Fire risk assessment for cases not identified prior to the procedure
(a) Implement fire risk scoring process to be completed by anesthesia provider and identified to the team during the timeout process. The circulating Registered Nurse (RN) will be the responsible party to communicate the score during the time out process.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, and Chief of Anesthesia.
(c) Implementation date: 6/2/17
(d) Prior to every OR procedure the fire risk score will be communicated during the time out process.
(e) Expected compliance: 100%
(f) Director or Manager of OR will complete direct observations on all regular scheduled cases and Nursing Supervisor will complete observations of emergent cases during the next 3 days and then 30 cases per month x (times) 3 months.
(g) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

2. Training- staff further need education regarding surgical site fire risk
(a) Staff will attend stand-up education sessions covering the risk assessment scoring tool and the measures to implement based on scores.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, and Chief of Anesthesia.
(c)Implementation date: 6/2/17. Completion date 6/7/17.
(d) Huddles to review surgical site fire risk tool with staff attestation of completing education. Huddles will provide time for staff to ask questions and seek any needed clarification.
(e) All full time (FT), part time (PT), and PRN (as needed) staff who participate in the time out process. Staff on family medical leave (FMLA) and vacation will receive education on return and prior to entering OR.
(f) 100% of staff will receive education prior to entering the OR.
(g) Director or Manager of OR will provide education to staff and obtain attestation.
(h) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

3. Anesthesia did not inform surgeon of difficulties of maintain O2 saturations and the need to increase O2 delivery.
(a) Implement a communication and documentation process for communicating high risk airway, high fractioned inspired oxygen (FIO2), and fire risk score prior to case by anesthesia provider and surgeon. Documentation of communication will be noted on anesthesia form.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, Chief of Anesthesia, Chief of Surgery.
(c) Implementation: 6/2/17. Completion 6/7/17.
(d) OR Director and Manager will meet with Anesthesia providers to review surgical site fire risk tool and new documentation process. All anesthesia providers will complete attestation that they have been informed.
(e) 100% of anesthesia providers will provide anesthesia services.
(f) OR Director and Manager along with Chief of Anesthesiology will provide education to the anesthesia providers and obtain attestation forms.
(g) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

4. Fire Drills did not include evaluation of surgical site fire risk assessment.
(a) Enhance current quarterly fire drills to include evaluation of surgical site fire risk assessment completion and communication prior to start of procedure during the time out process. Develop staff competency form which will be completed with initial drill and new hire orientation.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, Chief of Anesthesia, Chief of Surgery.
(c) Implementation date: 6/2/17
(d) First fire drill will be conducted on 6/7/17.
(e) Three drills to be completed prior to 7/15/17. Then quarterly.
(f) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

Review of recent changes to the facility policy "Safe Procedural and Surgical Verification" 6/2017, (as part of the allegation of compliance) revealed "...the verification process, which starts during the pre-procedure phase, will be conducted throughout all phases of procedural care, and will include the continuous sharing of information to include patient, procedure and site, and fire risk score..." Further review revealed "...a time out, which is led by the surgeon/proceduralist, will be performed prior to starting the procedure...surgical site fire risk score will be communicated to the team by the circulator..." Continued review revealed "...relevant documents...to be reviewed include...surgical site fire risk assessment guide..." Further review revealed "...if the patient will be moved to the surgical/procedural area, a final verification will be conducted prior to the transfer. Members of the Surgical/Procedure team will perform a reconfirmation of each of the following items...in addition, fire risk score will be calculated..." Continued review revealed "...safety concerns are addressed in relation to scheduled procedure. Safety concerns may include but are limited to...risk of fire associated with skin prep dry time [if alcohol based] and high risk airway..."

Review of a Surgical Site Fire Risk Assessment Guide (tool used to evaluate surgical fire risk) revealed the fire risk protocol addressed in the facility policy. Further review revealed the form will be used to score all surgical cases for surgical site fire risk of high, medium, or low risk. Continued review revealed fire risk protocols for each category of fire risk.

Refer to A951
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policy, review of The Joint Commission (TJC) Sentinel Event Alert, review of The Food and Drug Administration (FDA) guidelines, medical record review, review of facility documentation, and interview, the facility failed to ensure safety checks were performed during a surgical procedure for 1 patient (#2) of 5 surgical patients reviewed.

The findings included:

Review of facility policy "Safe Procedural and Surgical Verification" last revised on 11/2015, revealed "...briefing: time-out and debriefing: once the patient is in the operating room or procedure area, team members will stop and respond through active verbal acknowledgement and confirmation to each question of the briefing, time-out, and debriefing...briefing/pre-anesthesia time out immediately before administration of any type of anesthesia and/or sedation...completion of safety check of anesthesia machine, if applicable...delineation of any specific anesthesia risk..." Further review revealed "...safety concerns are addressed in relation to scheduled procedure. Safety concerns may include...risk of fire associated with skin prep dry time..."

Review of a Sentinel Event Alert from The Joint Commission (TJC) " Preventing Surgical Fires" dated 6/24/03 revealed "...common ignition sources found in the OR [operating room] are electrosurgical or electrocautery [ESU's, ECU's]...recommendations include: staff should question the need of 100% O2 [oxygen] for delivery during facial surgery and as a general policy, use air or FIO2 [fractionated inspired oxygen] at < [less than] 30% for open delivery...informing staff members, including surgeons and anesthesiologist, about the importance of controlling heat sources by following laser and ESU safety practices; managing fuels by allowing sufficient time for patient prep; and establishing guidelines for minimizing oxygen concentration under the drape..."

Review of the Food Drug Administration (FDA) document "Preventing Surgical Fires: FDA Safety Communication" dated 10/31/11 revealed "...surgical fires can occur at any time all three elements of the fire triangle are present...[1] ignition source [lasers, electrosurgical units]...[2] fuel source [surgical drapes, alcohol based skin preparations agents]...[3] oxidizer [oxygen, nitrous oxide, room air]..." Further review revealed "...recommendations to reduce the risk of surgical fires: use supplemental oxygen safety...evaluate if supplemental oxygen is needed on each patient. Any increase in oxygen concentration in the surgical field increased the chance of fire...if supplemental oxygen is necessary, particularly for surgery in the head, neck, or upper chest area: deliver minimum concentration of oxygen needed to maintain adequate oxygen saturation for your patient...take additional precautions to exclude oxygen from the field if using an open delivery system...consider alternatives to using an ignition source for surgery of the head, neck, and upper chest if high concentrations of supplemental oxygen [greater than 30 percent] are being delivered...encourage communication among members of your surgical team...encourage the anesthesia professional delivering the gases is communicating with the surgeon controlling the ignition source and the clinician applying the skin preparation agent..."

Medical record review revealed Patient #2 was admitted the facility on 5/21/17 at 12:13 PM with a chief complaint on a rash to his body. Further review revealed the patient was discharged from the facility on 6/1/17.

Medical record review of an Emergency Department (ED) Provider Report (ED physician documentation) dated 5/21/17 at 12:24 PM revealed "...chief complaint: chicken pox...33 y/o [year old] male with [DIAGNOSES REDACTED], ulcerative colitis [UC], presents with a rash. It is all over his body, it is itchy. He is non-verbal, his parents give most of the history. He gets Humira [anti-inflammatory medication] shots for UC, he had one last week as recently..." Further review revealed "...Immunocompromised with chicken pox. Need admission for IV [intravenous] Acyclovir [antiviral medication]. Further review revealed the patient received Acyclovir and Benadryl [medication used for itching] while in the ED. The patient was admitted to the hospital.

Medical record review of an Admission History and Physical dated 5/21/17 revealed "...[AGE] year old male with [DIAGNOSES REDACTED], who was taken to the emergency room by his parents for rash...minimally verbal...receives Humira, methotrexate [medication used to treat rheumatoid arthritis] and sulfasalazine [anti-inflammatory medication] for UC...developed rash on Thursday, 5/18/17 prior to admission. It started on the left lower abdomen and groin area and spread to his trunk and now spreading to his extremities. The patient did have a fever of 100.3 yesterday. The patient had a lot of itching. The parents gave Benadryl...parents called gastrointestinal doctor...who advised to come to the emergency room ..." Further review revealed "...initially the parents thought the patient had a reaction to the Humira, but the patient has been on Humira for over several years..." Further review revealed "...he has a tracheostomy and PEG [percutaneous gastrostomy] tube...all review of systems otherwise negative..." Further review revealed "...Assessment: immunosuppressed patient...UC...[DIAGNOSES REDACTED]..." Further review revealed "...Plan: we will admit the patient for IV Zovirax [antiviral medication]. [Named Infection Specialist] to see the patient in consultation. We will check pending admit labs. We will begin Lovenox [anticoagulant] for deep venous thrombosis prophylaxis..."

Medical record review of a Pulmonary Consult dated 5/24/17 at 11:45 PM revealed "...on Acyclovir, phone orders were given for administration of IV fluids and steroids but I was informed that we lost peripheral IV access. PICC [peripheral intravenous central catheter] but was unable to place midline or PICC..." Further review revealed "...patient needs CVC [central venous catheter] for IV fluid resuscitation, possible infusion of vasoactive agents, administration of IV medications, and access for phlebotomy [blood draws]..." Further review revealed "...CVC placed in the R [right] neck, intended for RIJV [right internal jugular vein]...ABG [arterial blood gases] from distal port compatible with ARTERIAL blood...vascular surgery consult requested, case discussed with [named surgeon] re: request for CVC removal/artery repair and placement of CVC in the operating theater..."

Medical record review of an Anesthesia Record dated 5/25/17 at 8:00 AM revealed "...ventilated per ambu with O2...Anesthesia induced via [by] inhalation..." Further review revealed "...8:38 AM: start procedure...8:48 AM: fire on field. Drapes and ETT [endotracheal tube] removed immediately..." Further review revealed FIO2 during the surgical procedure was 0.9% [90%].

Medical record review of a Physicians Anesthesia Clinical Note dated 5/25/17 at 11:04 AM revealed "...patient with interop surgical fire. Fire immediately extinguished and ET tube immediately removed. Burns noted on face and lips, however no burns noted inside lips or mouth..."

Medical record review of a Physicians Progress Note dated 5/25/17, with no time, revealed "...stable...burn seems to be limited to lips, facial hair...available as needed..."

Medical record review of a Hospitalist Progress Note dated 5/25/17 at 1:39 PM revealed "...events in OR noted and events surrounding tlc [triple lumen catheter]...s/p [status post] flash fire..."

Interview with the Patient Safety Director, on 6/1/17 at 9:30 AM, in the conference room, revealed "...the patient was admitted to the facility with chicken pox on May 21, 2017...he had a history of [DIAGNOSES REDACTED] and contractures ...he had a customized trach...the staff had a difficult time inserting an intravenous line and a central line was required to administer medications..." Further interview revealed "...a jugular central line was inserted that night but it was found to be in the carotid artery and needed to be surgically removed and repaired...while in the OR the patient required a high concentration of oxygen...an endotracheal tube was inserted through the trach site to administer the oxygen...they were going to insert a femoral central line while in surgery which was successfully inserted...when the surgeon removed the jugular carotid line he used a [named cautery device] to cauterize the area...the patient was on a high concentration of oxygen...the area was prepped and allowed to dry..." Continued interview revealed "...when the surgeon used the [named cautery device], anesthesia and the staff heard a pop...the CRNA [Certified Registered Nurse Anesthetist] stated he felt heat under the drape where he had his hand...the drapes were immediately removed and a saline sponge was thrown on the site...the drapes were singed to the upper part of the drape...the staff did not observe any burns at that time..." Further interview revealed "...the staff reported they immediately placed saline on the area, the endotracheal tube was removed and the patient was reintubated..." Continued interview revealed "...after the surgery procedure was completed a bronchoscopy was performed which revealed no airway burns...there were burns observed to the patient's mouth, lips, earlobe and nose...wound care was consulted..."

Interview with CRNA #1 on 6/1/17 at 10:20 AM, in OR room #2, revealed the CRNA provided anesthesia to the patient on 6/25/17. Further interview revealed "...the patient was brought to the OR without an IV access...we were going to use inhalation gases to put the patient to sleep...he had a customized trach with an inner cannula...we intubated the patient through the trach site with a 7.0 endotracheal tube and we were having a hard time in keeping his oxygen saturations up...we were using 100% oxygen via ambu and we had to use Continuous Positive Airway Pressure [CPAP-positive pressure ventilation to keep the alveoli open] to keep his oxygen saturations at 91-93%..." Continued interview revealed "...when the surgeon used the [named cautery device] to cauterize the area, we heard a pop and I felt heat around my hand where I was assisting the patient's ventilations with an ambu bag...we removed the drape and a saline sponge was thrown on the area...in addition the surgical technician used the saline which was located on the sterile tray and placed the saline on the area...we pulled the endotracheal tube immediately...we reintubated the patient immediately...the left side of the patient's face was singed...a bronchoscopy was performed after the surgical procedure which revealed no airway burns..." Further interview confirmed "...we were focused on maintaining the patient's airway and keeping his oxygen saturations up...again, the patient was on 100% oxygen with CPAP...we were overwhelmed with this patient so I do not remember having any conversation with the surgeon on the high oxygen percentage..." Further interview confirmed "...a time out procedure was done but we did not talk about the high oxygen percentage and the use of the [named cautery device]..."

Telephone interview with Anesthesiologist #1 on 6/1/17 at 12:45 PM revealed he provided care to the patient on 5/25/17. Further interview revealed...we have talked about this patient's case...the CRNA had to use high concentration of oxygen to keep the patient's saturations up...in addition, the patient required CPAP...it was a high stressed situation..." Further interview revealed "...the oxygenated fraction of oxygen is normally decreased when a [named cautery machine] is used but it was not, due to the patient's requirement for the increased oxygen need..."

Interview with Certified Surgery Technologist (CST) #1, on 6/1/17 at 12:55 PM, in the conference room, revealed the tech was the surgical assistant on the patient's case on 6/25/17. Further interview revealed "...we perform a time out on every patient but there was no conversation regarding the oxygen and the use of a [named cautery device]..." Further interview revealed "...I saw a flame when the [named cautery device] was used...there was a small flame from the hole where we were working...I immediately threw saline solution and a wet saline prep over the area...I used a Asetpo [hypodermic syringe with a bulb or slender nozzle used for injecting fluids or cleansing wounds] syringe to put the fire out...the drapes were removed from the area..."

Interview with CST #2, on 6/1/17 at 1:00 PM, in the conference room, revealed the technician assisted during the patient's case on 6/25/17. Further interview revealed "...the physician had just made an incision and the [named cautery device] was used to cauterize a few spots...there was a small flash which lasted for less than 5 seconds...[CST #1] placed a wet sponge pad on the area and poured the saline over the area...the drapes were removed immediately..." Further interview confirmed "...I do not remember any conversations regarding the use of high concentrations of oxygen and the use of the cautery device..."

Telephone interview with Registered Nurse (RN) #1, on 6/1/17 at 1:10 PM, revealed the nurse was the circulating nurse assigned to the patient on 5/25/17. Further interview revealed "...the patient had to be intubated through the trach site with an endotracheal tube per anesthesia...he did not have an IV access and they had to give him inhalation anesthesia for induction...they were trying to keep the patient's oxygen saturations up...anesthesia had ventilation issues...I prepped both areas using Chlorhexidine and Chloraprep...they have a 3 minute dry time...the field was completely dried before we draped the patient...a [named cautery device] was used and I heard someone say they heard a pop...the CRNA said he felt heat...we removed the drape...[CST #1] put a wet saline gauze on the site...the gases were turned off and the endotracheal tube was removed...the drapes were singed..." Further interview revealed "...[named surgeon] was well aware of the patient's condition..." Further interview confirmed "...the patient had a burn to his right ear, left lip, and some facial hair singeing...a bronchoscopy was performed which revealed no oral, nasal or airway injuries..." Continued interview confirmed "...a time out was performed prior to the surgery but there was no discussion regarding the high concentration of oxygen prior to the use of the [named cautery device]..."

Telephone interview with the Chief of Anesthesia, on 6/1/17 at 1:50 PM, confirmed "...there should always be some conversation between anesthesia and the surgeon when high concentrations of oxygen are being used and when [named cautery device] would be used during a surgical procedure..." Further interview confirmed "...we do a time out but no fire safety checklist..."

Telephone interview with Surgeon #1 on 6/5/17 at 5:25 PM revealed "...anesthesia had placed an endotracheal tube into the stoma site and were ventilating the patient with 100% oxygen...they were having problems keeping his oxygen saturations up...I was using a cautery device to ligate the blood vessels when I felt a hot sensation and we saw a flash...we immediately put the fire out, removed the drapes and endotracheal tube, and placed gauze sponges on the surgical fire site...there did not appear to be any issues with that..." Further interview revealed "...the patient was reintubated and we continued on with the surgical procedure..." Continued interview revealed "...the patient did have some singeing of his facial hair, burns to his lips, and eyebrows...a bronchoscopy was performed after the surgery to ensure no airway injury was present..." Further interview confirmed "...I do not remember any discussion about the high oxygen concentration prior to the cauterization...but apparently he was on a high concentration of oxygen..." Continued interview confirmed the Surgeon and the CRNA did not discuss the increased fire risk associated with the administration of high oxygen during use of a cautery device.
VIOLATION: ANESTHESIA SERVICES Tag No: A1000
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policy, review of the Joint Commission (TJC) Sentinel Event Alert, review of the Food and Drug Administration (FDA) guidelines, medical record review, review of facility documentation, and interview, the facility failed to ensure anesthesia services were provided in a safe setting for 1 patient (#2) of 5 patients reviewed for surgical services.

The findings included:

During the survey it was found one patient (#2) was admitted to the facility on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. During the patient's admission the staff were unable to gain Intravenous (IV) access. On 5/24/17 an attempt to place a central line into the patient's right jugular resulted in placement of the catheter into the patient's right carotid artery. On 5/25/17 the patient was taken to the Operating Room (OR) for an insertion of a femoral central line and ligation of a hole and right internal carotid artery repair. Prior to the surgery an Endotracheal tube (ETT) was inserted into the patient's tracheostomy site and the patient was placed on 100% oxygen with Continuous Airway Positive Pressure (CPAP), was given inhalation anesthesia, and ventilated with an ambu bag. During the surgical procedure a right femoral line was inserted by the surgeon and the patient remained on 100% oxygen (O2). A surgical incision was made to the patient's right carotid artery, which required the incision site to the previously placed central line site to be made larger. A cautery machine was used during the surgery and during use of the cautery device a flame was observed, resulting in burns to the patient's lips, neck, and singeing to the patient's facial hair. The flame was extinguished, the singed surgical drapes were removed, and the ETT was removed by anesthesia. The patient required reintubation with 100% supplemental oxygen. The surgical procedure was continued and the surgical wound was closed.

During a conference on 6/2/17 at 10:10 AM, in the Chief Nursing Executive's office, with the Administrator, the Chief Nurse Executive (CNE), and the Director of Regulatory Compliance, the facility was informed of the Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has cause, or is likely to cause injury, harm, or impairment, or death) at 42 CFR PART 482.13 Patient Rights (Condition).

Review of an Immediate Action Plan (MDS) dated [DATE] revealed the following actions were implemented:
1. Fire risk assessment for cases not identified prior to the procedure
(a) Implement fire risk scoring process to be completed by anesthesia provider and identified to the team during the timeout process. The circulating Registered Nurse (RN) will be the responsible party to communicate the score during the time out process.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, and Chief of Anesthesia.
(c) Implementation date: 6/2/17
(d) Prior to every OR procedure the fire risk score will be communicated during the time out process.
(e) Expected compliance: 100%
(f) Director or Manager of OR will complete direct observations on all regular scheduled cases and Nursing Supervisor will complete observations of emergent cases during the next 3 days and then 30 cases per month x (times) 3 months.
(g) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

2. Training- staff further need education regarding surgical site fire risk
(a) Staff will attend stand-up education sessions covering the risk assessment scoring tool and the measures to implement based on scores.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, and Chief of Anesthesia.
(c)Implementation date: 6/2/17. Completion date 6/7/17.
(d) Huddles to review surgical site fire risk tool with staff attestation of completing education. Huddles will provide time for staff to ask questions and seek any needed clarification.
(e) All full time (FT), part time (PT), and PRN (as needed) staff who participate in the time out process. Staff on family medical leave (FMLA) and vacation will receive education on return and prior to entering OR.
(f) 100% of staff will receive education prior to entering the OR.
(g) Director or Manager of OR will provide education to staff and obtain attestation.
(h) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

3. Anesthesia did not inform surgeon of difficulties of maintain O2 saturations and the need to increase O2 delivery.
(a) Implement a communication and documentation process for communicating high risk airway, high fractioned inspired oxygen (FIO2), and fire risk score prior to case by anesthesia provider and surgeon. Documentation of communication will be noted on anesthesia form.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, Chief of Anesthesia, Chief of Surgery.
(c) Implementation: 6/2/17. Completion 6/7/17.
(d) OR Director and Manager will meet with Anesthesia providers to review surgical site fire risk tool and new documentation process. All anesthesia providers will complete attestation that they have been informed.
(e) 100% of anesthesia providers will provide anesthesia services.
(f) OR Director and Manager along with Chief of Anesthesiology will provide education to the anesthesia providers and obtain attestation forms.
(g) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

4. Fire Drills did not include evaluation of surgical site fire risk assessment.
(a) Enhance current quarterly fire drills to include evaluation of surgical site fire risk assessment completion and communication prior to start of procedure during the time out process. Develop staff competency form which will be completed with initial drill and new hire orientation.
(b) Responsible Party: The Director of Patient Safety, Director of Surgical Services, CNE, Chief of Anesthesia, Chief of Surgery.
(c) Implementation date: 6/2/17
(d) First fire drill will be conducted on 6/7/17.
(e) Three drills to be completed prior to 7/15/17. Then quarterly.
(f) Oversight: Patient Safety Committee, Medical Executive Committee, and the Board of Governance (BOG)

Review of recent changes to the facility policy "Safe Procedural and Surgical Verification" dated 6/2017, (as part of the allegation of compliance) revealed "...the verification process, which starts during the pre-procedure phase, will be conducted throughout all phases of procedural care, and will include the continuous sharing of information to include patient, procedure and site, and fire risk score..." Further review revealed "...a time out, which is led by the surgeon/proceduralist, will be performed prior to starting the procedure...surgical site fire risk score will be communicated to the team by the circulator..." Continued review revealed "...relevant documents...to be reviewed include...surgical site fire risk assessment guide..." Further review revealed "...if the patient will be moved to the surgical/procedural area, a final verification will be conducted prior to the transfer. Members of the Surgical/Procedure team will perform a reconfirmation of each of the following items...in addition, fire risk score will be calculated..." Continued review revealed "...safety concerns are addressed in relation to scheduled procedure. Safety concerns may include but are limited to...risk of fire associated with skin prep dry time [if alcohol based] and high risk airway..."

Review of a Surgical Site Fire Risk Assessment Guide (tool used to evaluate surgical fire risk) revealed the fire risk protocol addressed in the facility policy. Further review revealed the form will be used to score all surgical cases for surgical site fire risk of high, medium, or low risk. Continued review revealed fire risk protocols for each category of fire risk.

Refer to A1002
VIOLATION: PRE-ANESTHESIA EVALUATION Tag No: A1002
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policy, review of The Joint Commission (TJC) Sentinel Event Alert, review of the Food and Drug Administration (FDA) guidelines, medical record review, review of facility documentation, and interview, the facility failed to ensure anesthesia was administered in a safe setting for 1 patient (#2) of 5 surgical patients reviewed.

The findings included:

Review of facility policy "Safe Procedural and Surgical Verification" last revised on 11/2015, revealed "...briefing: time-out and debriefing: once the patient is in the operating room or procedure area, team members will stop and respond through active verbal acknowledgement and confirmation to each question of the briefing, time-out, and debriefing...briefing/pre-anesthesia time out immediately before administration of any type of anesthesia and/or sedation...completion of safety check of anesthesia machine, if applicable...delineation of any specific anesthesia risk..." Further review revealed "...safety concerns are addressed in relation to scheduled procedure. Safety concerns may include...risk of fire associated with skin prep dry time..."

Review of a Sentinel Event Alert from The Joint Commission (TJC) " Preventing Surgical Fires" dated 6/24/03 revealed "...common ignition sources found in the OR [operating room] are electrosurgical or electrocautery [ESU's, ECU's]...recommendations include: staff should question the need of 100% O2 [oxygen] for delivery during facial surgery and as a general policy, use air or FIO2 [fractionated inspired oxygen] at < [less than] 30% for open delivery...informing staff members, including surgeons and anesthesiologist, about the importance of controlling heat sources by following laser and ESU safety practices; managing fuels by allowing sufficient time for patient prep; and establishing guidelines for minimizing oxygen concentration under the drape..."

Review of the Food Drug Administration (FDA) document "Preventing Surgical Fires: FDA Safety Communication" dated 10/31/11 revealed "...surgical fires can occur at any time all three elements of the fire triangle are present...[1] ignition source [lasers, electrosurgical units]...[2] fuel source [surgical drapes, alcohol based skin preparations agents]...[3] oxidizer [oxygen, nitrous oxide, room air]..." Further review revealed "...recommendations to reduce the risk of surgical fires: use supplemental oxygen safety...evaluate if supplemental oxygen is needed on each patient. Any increase in oxygen concentration in the surgical field increased the chance of fire...if supplemental oxygen is necessary, particularly for surgery in the head, neck, or upper chest area: deliver minimum concentration of oxygen needed to maintain adequate oxygen saturation for your patient...take additional precautions to exclude oxygen from the field if using an open delivery system...consider alternatives to using an ignition source for surgery of the head, neck, and upper chest if high concentrations of supplemental oxygen [greater than 30 percent] are being delivered...encourage communication among members of your surgical team...encourage the anesthesia professional delivering the gases is communicating with the surgeon controlling the ignition source and the clinician applying the skin preparation agent..."

Medical record review revealed Patient #2 was admitted the facility on 5/21/17 at 12:13 PM with a chief complaint on a rash to his body. Further review revealed the patient was discharged from the facility on 6/1/17.

Medical record review of an Emergency Department (ED) Provider Report (ED physician documentation) dated 5/21/17 at 12:24 PM revealed "...chief complaint: chicken pox...33 y/o [year old] male with [DIAGNOSES REDACTED], ulcerative colitis [UC], presents with a rash. It is all over his body, it is itchy. He is non-verbal, his parents give most of the history. He gets Humira [anti-inflammatory medication] shots for UC, he had one last week as recently..." Further review revealed "...Immunocompromised with chicken pox. Need admission for IV [intravenous] Acyclovir [antiviral medication]. Further review revealed the patient received Acyclovir and Benadryl [medication used for itching] while in the ED. The patient was admitted to the hospital.

Medical record review of an Admission History and Physical dated 5/21/17 revealed "...[AGE] year old male with [DIAGNOSES REDACTED], who was taken to the emergency room by his parents for rash...minimally verbal...receives Humira, methotrexate [medication used to treat rheumatoid arthritis] and sulfasalazine [anti-inflammatory medication] for UC...developed rash on Thursday, 5/18/17 prior to admission. It started on the left lower abdomen and groin area and spread to his trunk and now spreading to his extremities. The patient did have a fever of 100.3 yesterday. The patient had a lot of itching. The parents gave Benadryl...parents called gastrointestinal doctor...who advised to come to the emergency room ..." Further review revealed "...initially the parents thought the patient had a reaction to the Humira, but the patient has been on Humira for over several years..." Further review revealed "...he has a tracheostomy and PEG [percutaneous gastrostomy] tube...all review of systems otherwise negative..." Further review revealed "...Assessment: immunosuppressed patient...UC...[DIAGNOSES REDACTED]..." Further review revealed "...Plan: we will admit the patient for IV Zovirax [antiviral medication]. [Named Infection Specialist] to see the patient in consultation. We will check pending admit labs. We will begin Lovenox [anticoagulant] for deep venous thrombosis prophylaxis..."

Medical record review of a Pulmonary Consult dated 5/24/17 at 11:45 PM revealed "...on Acyclovir, phone orders were given for administration of IV fluids and steroids but I was informed that we lost peripheral IV access. PICC [peripheral intravenous central catheter] but was unable to place midline or PICC..." Further review revealed "...patient needs CVC [central venous catheter] for IV fluid resuscitation, possible infusion of vasoactive agents, administration of IV medications, and access for phlebotomy [blood draws]..." Further review revealed "...CVC placed in the R [right] neck, intended for RIJV [right internal jugular vein]...ABG [arterial blood gases] from distal port compatible with ARTERIAL blood...vascular surgery consult requested, case discussed with [named surgeon] re: request for CVC removal/artery repair and placement of CVC in the operating theater..."

Medical record review of an Invasive Procedure History and Physical dated 5/25/17 at 6:39 AM revealed "...neck exploration central line...[DIAGNOSES REDACTED]...contractures of BLE [bilateral lower extremities...ASA Classification: 4 [indicating severe systemic disease-constant life threat...will try MAC [monitored anesthesia care] if possible...may need ETT...without cuff or obturator [fits inside the tracheostomy tube and provides smooth surface]..."

Medical record review of an Anesthesia Record dated 5/25/17 at 8:00 AM revealed "...transported from MICU [medical intensive care unit] monitored, ventilated per ambu with O2. Monitors connected in OR. Anesthesia induced via [by] inhalation..." Further review revealed "...8:38 AM: start procedure...8:48 AM: fire on field. Drapes and ETT [endotracheal tube] removed immediately. ETT replaced, patient vital signs stable throughout..." Further review revealed FIO2 during the surgical procedure was 0.9% [90%].

Medical record review of an operative report dated 5/25/17 at 9:47 AM revealed "...operation: insertion of right femoral vein CVP [central venous peripheral] line using [named ultrasound device], right neck exploration, removal of CVP line right internal carotid artery, ligation of hole in right internal carotid artery..." Further review revealed "...admitted to the hospital last night...could not get a routine line in place for intravenous therapy. Pulmonary medicine service was consulted for central line. Central line was placed last night. It was thought, after placement, to be in the carotid artery. This was confirmed with pressure transducer. I was asked to remove the line..." Further review revealed "...he [the] tracheostomy tube was then replaced with an endotracheal tube placed through the stoma [opening]...the right groin was prepped and draped in the usual sterile manner. [Named ultrasound device] was used to easily find the right femoral vein...[blank space] inserted through the right femoral vein. It was sutured into place and irrigated with heparinized saline..." Further review revealed "...I then changed my attention to the upper part of the right neck. A central line was going into the neck in this location. This area was prepped and draped in a sterile manner as possible. I initially started with a small neck incision, which had to be made larger on several occasions. We carefully dissected down to the catheter and down into the deeper layers of the neck. I then noticed a flame in the wound. This was immediately extinguished...the area was then reprepped with [named antiseptic cleanser]. We then continued the dissection deeper into the neck..." Further review revealed "...the case was then turned over to the pulmonary medicine service to do a bronchoscopy. The patient seemed to tolerate the procedure reasonable well considering everything. Intraoperative complications including the flame...I then went out and talked to the family and told them frankly all the details of the case including the flame. At this point in time, it appears that he patient had some...[blank space] but no other skin burn is seen at this point in time..."

Medical record review of a Physicians Anesthesia Clinical Note dated 5/25/17 at 11:04 AM revealed "...patient with interop surgical fire. Fire immediately extinguished and ET tube immediately removed. [Named pulmonary doctor] notified at surgery conclusion and performed bronchoscopy, which revealed no airway burns in trachea or bronchi. Burns noted on face and lips, however no burns noted inside lips or mouth. Plastic surgery is being consulted to evaluate burns. Will discuss with patient's parents..."

Review of facility documentation dated 5/25/17 at 1:20 PM revealed "...5/25/17 at 8:48 AM...invasive procedure...burn...first aid treatment...refer to administration...seen by physician..."

Medical record review of a Hospitalist Progress Note dated 5/25/17 at 1:39 PM revealed "...events in OR noted and events surrounding tlc [triple lumen catheter]...s/p [status post] flash fire...looks better overall to me today...discussed with nurse continue aerosols and steroids..."

Medical record review of a Skin/Wound/Ostomy consult dated 5/26/17 at 5:39 PM revealed "...consult placed for burns to the face received during surgerical [surgical] procedure...Pt. has dark red pustules over entire epidermis. Father points out raw place on right earlobe. This looks like burst of 3rd degree blister. Pt. also has red area to right jaw line with small amount of serous drainage. Pt. has swollen place flesh to left side upper lip and lower lip..."

Interview with the Patient Safety Director, on 6/1/17 at 9:30 AM, in the conference room, revealed "...the patient was admitted to the facility with chicken pox on May 21, 2017...he had a history of [DIAGNOSES REDACTED] and contractures ...he had a customized trach...the staff had a difficult time inserting an intravenous line and a central line was required to administer medications..." Further interview revealed "...a jugular central line was inserted that night but it was found to be in the carotid artery and needed to be surgically removed and repaired...while in the OR the patient required a high concentration of oxygen...an endotracheal tube was inserted through the trach site to administer the oxygen... when the surgeon removed the jugular carotid line he used a [named cautery device] to cauterize the area...the patient was on a high concentration of oxygen... when the surgeon used the [named cautery device] anesthesia and the staff heard a pop...the CRNA [Certified Registered Nurse Anesthetist] stated he felt heat under the drape...the drapes were singed to the upper part of the drape...there were burns observed to the patient's mouth, lips, earlobe and nose...wound care was consulted..."

Interview with CRNA #1 on 6/1/17 at 10:20 AM, in OR room #2, revealed the CRNA provided anesthesia to the patient on 6/25/17. Further interview revealed "...the patient was brought to the OR without an IV access...we were going to use inhalation gases to put the patient to sleep...he had a customized trach with an inner cannula...we intubated the patient through the trach site with a 7.0 endotracheal tube and we were having a hard time in keeping his oxygen saturations up...we were using 100% oxygen via ambu and we had to use Continuous Positive Airway Pressure [CPAP-positive pressure ventilation to keep the alveoli open] to keep his oxygen saturations at 91-93%..." Further interview revealed "...the surgeon placed a femoral central venous line first...we had to turn the patient on to his left side for the surgeon to get to the right side to work on the carotid jugular line...when the surgeon used the [named cautery device] to cauterize the area, we heard a pop and I felt heat around my hand where I was assisting the patient's ventilations with an ambu bag...we removed the drape and a saline sponge was thrown on the area...in addition the surgical technician used the saline which was located on the sterile tray and placed the saline on the area...we pulled the endotracheal tube immediately...we reintubated the patient immediately...the left side of the patient's face was singed...a bronchoscopy was performed after the surgical procedure which revealed no airway burns..." Further interview confirmed "...we were focused on maintaining the patient's airway and keeping his oxygen saturations up...again, the patient was on 100% oxygen with CPAP...we were overwhelmed with this patient so I do not remember having any conversation with the surgeon on the high oxygen percentage..." Further interview confirmed "...a time out procedure was done but we did not talk about the high oxygen percentage and the use of the [named cautery device]..."

Telephone interview with Anesthesiologist #1 on 6/1/17 at 12:45 PM revealed he provided care to the patient on 5/25/17. Further interview revealed...we have talked about this patient's case...the CRNA had to use high concentration of oxygen to keep the patient's saturations up...in addition, the patient required CPAP...it was a high stressed situation..." Further interview revealed "...the oxygenated fraction of oxygen is normally decreased when a [named cautery machine] is used but it was not due to the patient's requirement for the increased oxygen need..." Further interview revealed "...the pulmonologist was notified and he performed a bronchoscopy after the surgical procedure to ensure no airway burns were present..."

Telephone interview with Registered Nurse (RN) #1, on 6/1/17 at 1:10 PM, revealed the nurse was the circulating nurse assigned to the patient on 5/25/17. Further interview revealed "...the patient arrived in the OR...he had a prior permanent tracheostomy tube...the patient had to be intubated through the trach site with an endotracheal tube per anesthesia...he did not have an IV access and they had to give him inhalation anesthesia for induction..." Further interview revealed "...there were 2 CRNA's in the room, one holding the tube and the other one bagging the patient...it was somewhat stressful because they were trying to keep the patient oxygen saturations up...anesthesia had ventilation issues..." Further interview revealed "...the patient was complex. He had [DIAGNOSES REDACTED] and was very contracted...he came in with chicken pox..." Continued interview revealed "...a [named cautery device] was used and I heard someone say they heard a pop...the CRNA said he felt heat...we removed the drape...[named surgeon] was well aware of the patient's condition..." Further interview confirmed "...the patient had a burn to his right ear, left lip, and some facial hair singeing..." Continued interview confirmed "...a time out was performed prior to the surgery but there was no discussion regarding the high concentration of oxygen prior to the use of the [named cautery device]..."

Telephone interview with the Chief of Anesthesia, on 6/1/17 at 1:50 PM, confirmed "...there should always be some conversation between anesthesia and the surgeon when high concentrations of oxygen are being used and when [named cautery device] would be used during a surgical procedure..." Further interview confirmed "...we do a time out but no fire safety checklist..."

Telephone interview with Surgeon #1 on 6/5/17 at 5:25 PM revealed "...anesthesia had placed an endotracheal tube into the stoma site and were ventilating the patient with 100% oxygen...they were having problems keeping his oxygen saturations up...I was using a cautery device to ligate the blood vessels when I felt a hot sensation and we saw a flash...we immediately put the fire out, removed the drapes and endotracheal tube, and placed gauze sponges on the surgical fire site...the patient did have some singeing of his facial hair, burns to his lips, and eyebrows...a bronchoscopy was performed after the surgery to ensure no airway injury was present..." Further interview confirmed "...I do not remember any discussion about the high oxygen concentration prior to the cauterization...but apparently he was on a high concentration of oxygen..." Continued interview confirmed the Surgeon and the CRNA did not discuss the increased fire risk associated with the high oxygen administered during anesthesia during the use of a cautery device.