HospitalInspections.org

Based on hospital policy and procedure reviews, manufacture's product label review, worksheet for add on case form review, quality indicator report review, medical record review, staff and physician interviews the hospital's Governing Body failed to provide oversight and have systems in place to ensure the protection and promotion of Patients' Rights; ensure an organized Nursing Service; and to ensure Surgical Services were provided in accordance with acceptable standards of practice.

The findings include:

1. The hospital's surgical operating room staff failed to protect and promote Patients' Rights by failing to ensure care in a safe setting.

~Cross refer to 482.13 - Patients' Rights - Condition: Tag A0115.

2. The hospital's surgical operating room staff failed to have an organized Nursing Service providing oversight of day-to-day operations to ensure registered nursing staff supervised and evaluated patient care.

~Cross refer to 482.23 - Nursing Services - Condition: Tag A0385.

3. The hospital's surgical operating room staff failed to provide Surgical Services in accordance with acceptable standards of practice to ensure patient safety.

~Cross refer to 482.51 - Surgical Services - Condition: Tag A0940.

Based on hospital policy and procedure reviews, manufacture's product label review, worksheet for add on case form review, quality indicator report review, medical record review, staff and physician interviews, the hospital's surgical operating room staff failed to protect and promote Patients' Rights by failing to ensure care in a safe setting.

The findings include:

The hospital's surgical operating room staff failed to provide care in a safe setting for 1 of 1 patients (#1) who sustained second degree burns as a result of a fire during an emergency surgical procedure in an oxygen enriched environment.

~Cross refer to 482.13(c)(2) Patient Rights - Standard: Tag A0144.

Based on hospital policy and procedure reviews, manufacture's product label review, worksheet for add on case form review, quality indicator report review, medical record review, staff and physician interviews, the hospital's surgical operating room staff failed to provide care in a safe setting for 1 of 1 patients (#1) who sustained second degree burns as a result of a fire during an emergency surgical procedure in an oxygen enriched environment.

The findings include:

Review on 07/31/2013 of policy number: 7211-803 "Operating Room Fire Safety" revised April 2013 (version in effect on 06/27/2013 when fire occurred) revealed "POLICY: The surgical team will perform activities that contribute to the prevention of injury due to fire. These activities include application of the principles of fire prevention, perioperative environment assessment performed and documented prior to every case, and coordination with other members of the health care team. OUTCOME: The patient is free from fire injury. ...INTERPRETIVE STATEMENT: Fire prevention is a shared responsibility of the entire surgical team. Prevention of fire requires application of principles of fire safety, routine precautions, and knowledge of potential hazards. ...I. Risk Reduction A. The cornerstone of prevention is to reduce the risk associated with each of the three elements required for combustion. The OR is an oxygen enriched environment. The two major ignition sources are the Electrosurgical Unit (ESU) and lasers. ESU safety is covered in OR Policy 7211-805. ...Fuels includes, but is not limited to....prep agents....and the patient. 1. Conduct fire safety assessment with operative team, prior to incision. 2. Constantly monitor the patient environment for hazards. 3. Keep a bowl of sterile water or saline on the back table. ...9. Handle prep solutions properly. Prevent pooling, blot excess solution, allow sufficient time for prep solution vapors to dissipate. ..."

Review on 07/31/2013 of current policy number: 7211-805 "Electrosurgical Safety" revised April 2013 revealed "POLICY: In all cases involving the use of electrosurgical equipment, patients and personnel must be protected from hazards associated with electrosurgery. PURPOSE: To ensure the safe and proper functioning of the electrosurgical (ESU) equipment. To ensure the safety of the patient undergoing surgical intervention including use of electrosurgery. To ensure the protection of the operating room personnel from electrical hazards. Implementation: I. Preoperative Preparation ...B. Personnel who handle or operate ESU's must be familiar with operation of equipment and necessary safety precautions. ...II. Intraoperative Safety ...B. ...5. Avoid pooling of fluids...."

Review on 07/31/2013 of current policy number: 7211-1111 "Patient Skin Preparations" revised April 2013 revealed "POLICY: All patients undergoing surgical intervention will have appropriate preoperative skin preparation. ...INTRAOPERATIVE SKIN PREPARATION: 1. Approved Antiseptics: ...c. Dura Prep ...e. Chloraprerp [sic] f. alcohol ...2. General Considerations: ...b. Moisture proof pad should be placed around the prep site to prevent pooling of fluids. ...l. Prior to draping, prep solution must be allowed to dry. ..."

Review on 07/31/2013 of the manufacture's product label for a "ChloraPrep With Tint" 26 ml (milliliter) applicator revealed "WARNING FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME." Further review revealed "Active ingredients....Isopropyl alcohol 70%....". Review revealed "Warnings ...Flammable, keep away from fire or flames. To reduce risk of fire; PREP CAREFULLY: *do not use 26-ml applicator for head and neck surgery. ...*solution contains alcohol and gives off flammable vapors *avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. ...*do not drape or use ignition source (e.g. cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) * do not allow solution to pool *remove wet materials from prep area ...Directions ...*Do not use 26 -ml applicator for area smaller than 8.4 in. (inches) x (by) 8.4 in. Use a smaller applicator instead. *do not use 26-ml applicator for head and neck surgery ...*allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. ..."

Review on 08/01/2013 of a "Worksheet for Add-On Case" dated 06/27/2013 for Patient #1 revealed on Page 1 of 3, "OR room: OR02_A" and "PREP CHLORAPREP." Review revealed on Page 2 of 3, "SUPPLIES....11649 APPLICATOR CHLORAPREP 26 ML...." and " Qty (quantity) 1 EA (each)."

Review on 08/01/2013 of a "Quality Indicator Form" revealed, Date of the event: 06/27/2013, Time of event: 0900, Location of the event: OR #2. Review revealed "What happened?" with "- surgical fire with emergency tracheostomy - ChloraPrep used (handwritten)." Review revealed "What normally happens?" with "- ChloraPrep dries thoroughly before incision made (handwritten)." Review revealed "How/Why did it happen?" with "- prep did not dry - incision made with bovie (handwritten)." Review revealed "Patient....condition after event:" with "- 1st (first) degree burn on (R) (right) & (L) (left) posterior of shoulders & (R) (right) neck." Review revealed "Are there policies and/or procedures that apply to this situation?....Yes (with X handwritten in adjacent box)" with "Operating Room Fire Safety 7211-803 (handwritten)."

Closed medical record review on 07/31/2013 for Patient #1 revealed an 83 year old male who presented to the hospital's emergency department (ED) via ambulance on 06/27/2013 at 0806 with a chief complaint of allergic reaction. Review of triage nursing documentation at 0809 revealed "...Pt (patient) presents from group home with c/o (complaints of) tongue swelling and inability to speak after starting transdermal scopolamine patch yesterday evening. ..." Review revealed a past medical history of schizophrenia, Tardive Dyskinesia (a movement disorder characterized by repetitive, involuntary movement like lip smacking, protruding of the tongue, or grimacing), and "mental retardation" et al. Review of ED physician documentation at 0833 revealed "...Chief Complaint: Angioedema (allergic reaction where swelling occurs under the skin) ...Physical Exam: ...The patient has a large tongue that is protruding from the mouth about 2 inches and is largely swollen. There is some mild swelling of the lips. The patient is unable to breathe through the mouth. Patient is unable to speak. Patient is tripoding and appears mildly uncomfortable secondary to anxiety and mild difficulty breathing. Mental Status: Awake, Oriented times 3 (person, place, time). ...Lungs: Clear and equal to auscultation. ...Skin: Warm and dry. ...Psych: Anxious Affect. ...anesthesiology was immediately called. ...Patient was transported emergently to the operating room for definitive airway management. IMPRESSION: angioedema CONDITION: guarded DISPOSITION: OR." Continued review of nursing documentation at 0842 revealed "Transported by RN and MD accompanying to operating room via stretcher escorted by nurse..."

Review of an Intraoperative Record dated 06/27/2013 for Patient #1 revealed the patient entered OR 2-MRH-A at 0838 and exited at 0922. Review revealed Physician A was the surgeon, Physician B was the anesthesiologist, RN #1 was the circulator, CST #1 (certified surgical technologist) was the scrub technologist, and CRNA #1 (certified registered nurse anesthetist) was the anesthesia staff. Review revealed the procedure type was "Emergency." The procedure start time was 0845 and end time was 0908. Review revealed "INTRA-OP POSITIONING/COUNTS/PREP....Prep: CHLORAPREP....INTRA-OP CAUTERY AND GROUNDING SECTION Cautery Units: Y (yes) Cautery Types Aspen Excalibur Serial Number 03JGE010.... ." Further review revealed "FIRE RISK ASSESSMENT SECTION Surgical Site Above Xiphoid: Yes Open Oxygen Source: Yes Ignition Source: Yes Each Yes = (equals) 1 Total Score: 3 ...Score 3 - Initiate High Risk Fire Protocol Protocol Initiated By: (RN #1 name)... ." Further review revealed "...Irrigation Type: Saline..."

Review of an Anesthesia Record dated 06/27/2013 for Patient #1 revealed documentation by CRNA at 0838 "Anesthesia Start....Risks Discussed....Memo (pt sitting straight up on strecher [sic], tongue grossly swollen and hanging out of mouth, face mask oxygen given....Dr. [Physician A] at bedside.) ...At 0846 "Memo (small amt [amount] propofol [sedative/hypnotic] given followed by DL [direct laryngoscopy] with Glidescope x 2 [2 attempts], and DL x 1 with miller 2 x 1 per [CRNA #1], without success, procedure changed to emergent trach [tracheostomy - surgical airway], neck cleaned emergently, Dr. [Physician A] made incision and used bovie [cautery - electrosurgical unit] ). At 0846 Memo (immediately small fire noted to left chest, O2 d/c'd [oxygen discontinued], fire patted out, wet towels layed [sic] on pt., saline squirted to sheets beneath upper back, fire extinguished. Wet towels remain in place over upper neck and around upper chest). ..."

Review of an Operative Report for Patient #1, dictated 06/27/2013 at 0928 by Physician A revealed the patient had an "Emergent Tracheostomy" performed on 06/27/2013. Review revealed a pre and postoperative diagnosis of upper airway obstruction with tongue edema from scopolamine. Review revealed "...Anesthesia: Local conversion to general. ..." Further review revealed "...COMPLICATIONS: Fire with the prep (preparation) and monopolar cautery with 100% oxygen. ..." Review revealed "...DESCRIPTION OF PROCEDURE: The patient was initially attempted to be intubated with a Glidescope and then followed by use of laryngoscope. There was no good view of the larynx. There was massive edema of the arytenoids and epiglottis. This was therefore evaluated and area was suctioned. An emergent airway, therefore, deemed necessary tracheostomy. A 15 blade scalpel was used to make an incision in the skin. The patient had been prepped with ChloraPrep. There was some oozing. Monopolar cautery was used and the prep was not dry and therefore there was fire around the airway of the skin. This was quickly dampened with wet towels. There were superficial injury to the right and left neck posteriorly where there was a 1st degree burn. The midline was divided. The thyroid was overlying the trachea. The thyroid was divided with monopolar cautery. There was a prominent vein which was treated with 3-0 silk ligature. The trachea was identified. The trachea was scored and the 3rd tracheal ring removed. The tracheal hook was used to elevate the trachea. This was followed by placement of a #6 trache [sic] tube which was in good position. 2-0 silk suture was then used for 4 quadrant suture securing of the tracheostomy. A tracheostomy sponge was placed and the patient returned to the care of anesthesia and oxygenated. He had no further troubles. There was silvadene which was placed onto the superficial burn areas."

Review of the Post Anesthesia Care Unit (PACU) record revealed the patient arrived in PACU from the OR at 0923 and was discharged at 1418 and transported to room 3712 (Intensive Care Unit).

Review of a Wound Consult note dictated 06/28/2013 at 0914 by a Family Nurse Practitioner (FNP) revealed "...REASON FOR CONSULTATION: Burns to the patient's neck and bilateral scapula areas. HISTORY OF PRESENT ILLNESS: ...He does have flash burns to his bilateral posterior shoulders as well as the right side of his neck. These are superficial. ...PHYSICAL EXAMINATION: ...SKIN/DERMATOLOGIC: To the right side of the neck he has an intact, flat blister which measures approximately 3 cm (centimeters) x (by) 2 cm. Below this at the base of the right neck he has an open blister which measures approximately 2.5 x 1.5 x 0.1 cm into the right posterior scapula. He has another intact, flat blister that measures over an area of about 4 cm x 2.5 cm. To the left scapula he has a flat blister which measure approximately 8 cm x 7 cm with intact skin and no erythema. No erythema to the other blisters. Minimal drainage with no fluctuance noted. There is no edema to the surrounding tissues. IMPRESSION: 1. Second-degree burns to the right neck and to the scapula areas bilaterally. ..."
Review of the Discharge Summary for Patient #1, dictated on 07/12/2013 at 0949 by a physician revealed date of admission 06/27/2013 and date of discharge 07/12/2013 (15 days later). Further review revealed "HOSPITAL COURSE: ....the patient developed severe swelling around his mouth, lips and throat and developed respiratory problems. He was taken to the Emergency Department on the day of admission where he was felt to be in acute angioedema. ...His airway was felt to be becoming compromised. Accordingly he was taken to the emergency operating room under the urgency of the situation. Preparation to the neck was quickly applied. The tracheostomy commenced. There was some bleeding present with bovie cauterization. Unfortunately an alcohol fire was ignited which resulted in some 2nd degree burns around the neck and shoulder blade areas. These were extinguished quickly and the tracheostomy was accomplished with otherwise excellent results and no further difficulties with breathing. ...DISCHARGE DIAGNOSIS: ...5. Second-degree skin burns which occurred this admission, resolving nicely. ...DISCHARGE DISPOSITION: Discharge this patient to....rehabilitation. ..."
Telephone interview on 07/31/2013 at 1635 with Physician A revealed he was the surgeon who performed the emergency tracheostomy on Patient #1 on 06/27/2013 and was present when the fire occurred in OR #2. Interview revealed he was in another OR preparing to perform a surgical procedure when he was called emergently by Physician B (anesthesiologist). Physician B explained a patient had presented with a difficult airway. He went to OR #2 and found Patient #1 in respiratory demise with a swollen tongue. An airway cart and two anesthesiology staff were present. Interview revealed Patient #1 was a difficult patient with a history of Tardive Dyskinesia, mental delay, and schizophrenia. Interview revealed anesthesiology staff had not tried a fiberoptic airway so a CRNA (CRNA #1) attempted to intubate the patient with a Glidescope (fiberoptic device) and was unsuccessful. Interview revealed the patient was declining and he told the OR staff to convert to an emergency tracheostomy. Interview revealed the emergency tracheostomy tray was already available in the room and some supplies were already open. Interview revealed he "called for someone" to prep the neck. Interview revealed a nurse (CST #2) with a ChloraPrep asked if he wanted the neck prepped with ChloraPrep, he said yes. Interview revealed the ChloraPrep was applied by CST #2. Interview revealed his "recollection of the fire" the nurse (CRNA #1) was bagging the patient with 100% oxygen. The ChloraPrep had recently been applied. "The prep was still moist and not dry." Interview revealed he made an incision into the neck with the scalpel and there was some bleeding. Interview revealed he used the cautery (Bovie - Electrosurgical unit) and it sparked a flame. Interview revealed he and the anesthesia staff put the fire out. Interview revealed the fire was put out with saline from a bowl on the back table. Once the fire was out he proceeded with the tracheostomy. Interview revealed "the prep solution must have pooled on the patient and the pillow." Interview revealed the fire burned the patient's neck and shoulders. Interview revealed the patient sustained first and second degree burns. Interview revealed the nurse used one ChloraPrep with one swipe down the neck. Interview revealed the patient was having increased airway complications and his condition was declining. Interview revealed "we did not wait the 3 minutes for the prep to dry." Interview revealed "there was an error in the type of prep used." Interview revealed non-alcohol based skin preparation solutions were available, but they were not opened or easily available. Interview revealed generally the OR staff prep and drape the patients. Interview revealed he has used ChloraPrep and/or DuraPrep before to prep patients. Interview revealed he is not included in hospital training regarding use of alcohol based skin prep solutions. Follow-up telephone interview on 08/01/2013 at 0855 confirmed he was aware that ChloraPrep was alcohol based. Interview revealed he can not recall having an inservice on ChloraPrep but "usually when a new product is rolled out, training and inservice are provided." Interview revealed the physician "normally does not get involved with the draping of the patient so I can not say for certain the physician receives the inservice." Interview confirmed the staff did not wait 3 minutes to allow the ChloraPrep solution to dry.
Interview on 08/01/2013 at 1255 with CRNA #1 revealed she was the anesthetist providing anesthesia services to Patient #1 on 06/27/2013 during his emergency tracheostomy and was present when the fire occurred in OR #2. Interview revealed she received a call from Physician B (anesthesiologist) about an ED patient having a swollen tongue. Interview revealed when the patient arrived to OR #2 he was sitting on the bed with his tongue hanging out of his mouth and panting. The patient was moved to the OR table with the head of the table elevated. The patient was placed on oxygen via mask. Physician B entered the room and a "Stores Brand scope, similar to a Glidescope" was used in an attempt to intubate the patient, but she was unable to visualize the vocal cords. At that time Physician A entered the OR and saw the view on the monitor screen and stated they needed to do an emergency tracheostomy. Interview revealed while Physician A went to scrub she attempted to intubate the patient with the Glidescope. She was able to visualize the cords but unable to pass the endotracheal tube. Interview revealed when Physician A returned, she was holding the face mask and Physician B was bagging the patient with 100% oxygen via bag valve mask. Interview revealed Physician A was made aware of the 100% oxygen in use prior to incision. Interview revealed Physician A told someone to prep the neck. The neck was prepped and Physician A made an incision. Interview revealed "all of a sudden there was fire. I threw the oxygen mask away. Fire was going up my arm and I began patting out the fire on myself." Interview revealed Physician A started patting out the fire on the patient's neck and back of shoulders. Interview revealed "(CRNA #2) started using saline (10 milliliter syringes) out of the top drawer of the anesthesia cart and squirting it on the patient. Someone got wet towels and placed them on the patient's shoulders, face, and chin." Interview revealed after the fire was out the patient was bagged with oxygen and Physician A proceeded with the tracheostomy. Interview revealed she does not recall who prepped the patient, but the patient was not fully draped when Physician A started the incision. Interview revealed there were no neck drapes to collect fluid from pooling. Interview revealed the patient still had his T-shirt on from the ED. Interview revealed after the procedure she noticed the right side of the patient's neck and both posterior shoulder areas were burned and there was a "charring" on the sheet under the patient. Interview revealed she is trained to know some skin prep solutions contain alcohol and can ignite. Interview revealed she does not recall any formal training on ChloraPrep. Interview revealed she is aware that staff must wait 3 minutes after application of ChloraPrep to let it dry. Interview confirmed the saline used to put the fire out was obtained from the anesthesia cart. Interview revealed the CRNAs used the 10 milliliter saline flush syringes.
Interview on 08/01/2013 at 0905 with CST #2 revealed she was on-duty when Patient #1 presented to the OR on 06/27/2013 and was present when the fire occurred in OR #2. Interview revealed when she entered OR #2 the patient was already on the OR table. Interview revealed the patient was sitting upright. Interview revealed staff were masking the patient and opening items for CST #1 to set up the case. Interview revealed CST #1 was assigned to scrub the case, and she was in the room helping. Interview revealed staff were getting ready for an emergency tracheostomy. Interview revealed there was "lots of people" and "lots of confusion." Interview revealed "Physician A was standing there with knife in hand and he says somebody prep the patient." Interview revealed "I was standing in the room and picked up the first thing I saw." Interview revealed she picked up a ChloraPrep applicator. Interview revealed she picked up the "big" ChloraPrep applicator (26 milliliters). Interview revealed she swiped the neck area once where the physician was going to make the incision. Interview revealed she "thinks" the patient was already draped with sterile towels and sheet, but is unsure. Interview revealed she turned around and then walked away and was picking up trash when the fire occurred. Interview revealed she did not visualize the physician making the incision or using the bovie. Interview revealed she did not witness the fire. Interview revealed the hospital has been using ChloraPrep for years. Interview revealed the skin preparation solutions are usually brought in to the OR for each case. Interview revealed the OR does have non-alcohol based skin preparation solutions available for use. Interview revealed staff receive annual training on the use of alcohol based skin preparation solutions. Interview revealed staff "normally" wait 3 minutes for the ChloraPrep to dry because it contains alcohol and is a "fire hazard." Interview revealed she was unsure if the 26 ml ChloraPrep applicator can be used on neck surgeries. Interview revealed ChloraPrep can not be used on the mucous membranes or face. Interview revealed "the staff did not wait 3 minutes for the prep to dry" on Patient #1. Interview revealed "the doctor was standing there and it was an emergency situation." Follow-up telephone interview at 1325 revealed she was not aware the manufacture's product label has directions and a warning not to use the 26 ml ChloraPrep applicator on head and neck surgeries.
Interview on 08/01/2013 at 0932 with CST #1 revealed she was the primary scrub tech for Patient #1's emergency tracheostomy on 06/27/2013 and was present when the fire occurred in OR #2. Interview revealed she heard the OR was receiving a patient from the ED for emergent intubation with a possible tracheostomy. Interview revealed she went into the back of the OR and CST #2 helped pull supplies for the case. She went back to OR #2 and the patient was already sitting up on the OR table. Interview revealed anesthesia was working with the patient. Interview revealed the patient had a swollen tongue and was struggling to breath. Interview revealed she was setting up the instrument table and asked Physician A what type of trach he wanted. Interview revealed Physician A stated "we're doing this trach." Interview revealed Physician A stated "somebody do a prep." Interview revealed she did not know who had performed the prep. Interview revealed she found out later that CST #2 performed the prep and used ChloraPrep. Interview revealed she did not visualize CST #2 applying the ChloraPrep to Patient #1. Interview revealed she is unsure of what size ChloraPrep applicator CST #2 used on the patient's neck. Interview revealed "in a controlled environment the tech would normally use a 26 ml ChloraPrep for a tracheostomy." Interview revealed the staff will usually drape the patient with crushed towels and block towels to collect pooling of fluids and use a three-quarter (3/4) sheet over the patient. The staff would prep the surgical site with ChloraPrep and allow it to completely dry for 3 minutes. Interview revealed the 3 minutes "allows the alcohol fumes to dissipate." Interview revealed a 3/4 sheet was placed over Patient #1. Interview revealed there was no crushed towels or block towels used to collect fluids from pooling. Interview revealed there was no other draping for Patient #1 other than the 3/4 sheet from the chest down. Interview revealed there was nothing around the neck. Interview revealed after the 3/4 drape was applied, she placed a bovie (cautery) and suction on top of the drape. Interview revealed the physician made an incision with the scalpel. Interview revealed she did not visualize the use of the bovie by Physician A. Interview revealed she turned towards the instrument table to get the trach tube ready when she heard someone yell "fire" and "I saw a flash in the corner of my eyes." Interview revealed she turned around and Physician A was holding the bovie in his hand. Anesthesia and Physician A started patting out the fire. Interview revealed the nurse was getting the saline when the fire occurred. The saline had not been poured into a sterile bowl yet. Anesthesia had saline syringes and used them on the pillow to put out the fire. Interview revealed she poured saline all over the patient's neck once the saline was poured into the sterile bowel by the nurse. Interview revealed once the fire was out Physician A proceeded with the tracheostomy. Interview revealed after the procedure she noticed the patient had burns to his neck and both shoulders. Interview revealed "the pillow had char on it." Interview revealed possible causes of the fire were "using ChloraPrep and not allowing 3 minutes for it to dry, it was an emergent situation, an oxygen enriched environment, bovie use, and not draping the patient to prevent pooling." Interview revealed there are other skin preparation alternatives that are alcohol free in the OR. Interview revealed when the hospital started using ChloraPrep, staff received an inservice and annually in competencies. Follow-up telephone interview at 1126 revealed she was not aware the manufacture's product label has directions and a warning not to use the 26 ml ChloraPrep applicator on head and neck surgeries, "until after the fire occurred."
Interview on 08/01/2013 at 1005 with RN #1 revealed she was the Circulator for Patient #1's emergency tracheostomy and was present when the fire occurred in OR #2. Interview revealed she received notification the ED had a patient that needed intubation with a possible emergency tracheostomy. Interview revealed when Patient #1 arrived in the holding area he was still wearing his T-shirt and pants. Interview revealed the patient was mentally challenged. Interview revealed the patient was in a sitting position, leaned over, and his tongue was swollen outside of his mouth. Interview revealed the patient was transported to OR #2 by her and CRNA #1. When in the OR the patient was moved over to the OR table. Interview revealed the patient remained in his T-shirt because of the emergent situation. Interview revealed blankets were placed behind the patient and the head of the table was elevated. Interview revealed the patient was secured to the OR table and medications were administered by the CRNA. The patient was laid back and CRNA #1 attempted intubation and was unsuccessful. Interview revealed Physician A entered and stated they would have to do a tracheostomy. Interview revealed "everything went fast forward." Interview revealed she did not visualize who prepped the patient with ChloraPrep. Interview revealed she did not see the fire occur. Interview revealed ChloraPrep was used because it was listed on the preference card for Physician A. Interview revealed she documented the high risk for fire assessment in the record. Interview revealed the patient scored a "3." Interview revealed if a patient scores a 3, staff must initiate the "high risk protocol." Interview revealed the protocol includes using towels for pooling, letting alcohol prep solutions dry for three minutes, use bipolar cautery, and have saline in a bowel on the table prior to incision. Interview revealed the staff used monopolar cautery, did not drape the patient with towels to collect pooling, did not have a bowel of saline on a table prior to incision, nor allowed the ChloraPrep to dry for 3 minutes prior to Patient #1's emergency tracheostomy. Interview revealed "there was no policy before - there is a policy now." Interview revealed she has received inservices on the use of ChloraPrep. Interview revealed staff should wait 3 minutes to let the solution dry completely and fumes evaporate due to alcohol. Interview revealed a 26 ml ChloraPrep was used during Patient #1 surgery. Interview revealed she visualized the package in the trash after the procedure. Interview revealed staff are not suppose to use the 26 ml applicator on neck and head surgeries. Interview revealed she does not know if there were any non-alcohol based skin prep solutions available in OR #2, but they are available in the OR suite.
Interview on 07/31/2013 at 1545 with OR Management Staff revealed the hospital does use alcohol based skin preparation solutions. Interview revealed the hospital uses ChloraPrep and DuraPrep. Interview revealed ChloraPrep is supplied in a 26 ml and 3 ml applicator. Interview revealed DuraPrep is supplied in a 26 ml applicator. Interview revealed the hospital has been using alcohol based skin preparation solutions for the past 5-10 years. Interview revealed staff receive training annually on alcohol based skin preparation solutions. Interview revealed the training is documented in the staff's training file. Interview revealed Physicians are not trained by the OR for use of alcohol based skin preparation solutions. Interview revealed in cases of emergency physicians may prep a patient using a alcohol based skin preparation solution. Interview revealed staff should not be using the 26 ml applicators on the neck, face, or vaginal areas due to pooling. Interview revealed the OR does not have a policy specifically for the use of alcohol based patient skin prep solutions. Interview revealed policy 7211-0803 Operating Room Fire Safety, was updated in July as a result of the fire on 06/27/2013 involving Patient #1. Interview revealed the policy was revised to include defined interventions for the fire risk assessment score; a minimum prep drying time of 3 minutes; and that all emergency surgical procedures should utilize non alcohol-based prep solutions unless non-alcohol based solution is contraindicated due to a know patient allergy to prep solution.
Consequently, the findings confirmed the hospital's surgical OR staff failed to maintain fire safety in an oxygen enriched environment; failed to follow established fire safety prevention policies and procedures; and failed to adhere to the manufacturer's product label directions and warnings for an alcohol based patient perioperative skin preparation solution.

Based on hospital policy and procedure reviews, manufacture's product label review, worksheet for add on case form review, quality indicator report review, medical record review, staff and physician interviews the hospital's surgical operating room staff failed to have an organized nursing service providing oversight of day-to-day operations to ensure registered nursing staff supervised and evaluated patient care.

The findings include:

The hospital's surgical operating room nursing staff failed to supervise and evaluate patient care in an oxygen enriched environment to reduce the associated risk of fire with the use of alcohol-based skin preparation solutions for 1 of 1 patients (#1) who sustained second degree burns as a result of a fire during an emergency surgical procedure in an oxygen enriched environment.

~Cross refer to 482.23(b)(3) RN Supervision of Nursing Care - Standard: Tag A0395.

Based on hospital policy and procedure reviews, manufacture's product label review, worksheet for add on case form review, quality indicator report review, medical record review, staff and physician interviews, the hospital's surgical operating room nursing staff failed to supervise and evaluate patient care in an oxygen enriched environment to reduce the associated risk of fire with the use of alcohol-based skin preparation solutions for 1 of 1 patients (#1) who sustained second degree burns as a result of a fire during an emergency surgical procedure in an oxygen enriched environment.

The findings include:

Review on 07/31/2013 of policy number: 7211-803 "Operating Room Fire Safety" revised April 2013 (version in effect on 06/27/2013 when fire occurred) revealed "POLICY: The surgical team will perform activities that contribute to the prevention of injury due to fire. These activities include application of the principles of fire prevention, perioperative environment assessment performed and documented prior to every case, and coordination with other members of the health care team. OUTCOME: The patient is free from fire injury. ...INTERPRETIVE STATEMENT: Fire prevention is a shared responsibility of the entire surgical team. Prevention of fire requires application of principles of fire safety, routine precautions, and knowledge of potential hazards. ...I. Risk Reduction A. The cornerstone of prevention is to reduce the risk associated with each of the three elements required for combustion. The OR is an oxygen enriched environment. The two major ignition sources are the Electrosurgical Unit (ESU) and lasers. ESU safety is covered in OR Policy 7211-805. ...Fuels includes, but is not limited to....prep agents....and the patient. 1. Conduct fire safety assessment with operative team, prior to incision. 2. Constantly monitor the patient environment for hazards. 3. Keep a bowl of sterile water or saline on the back table. ...9. Handle prep solutions properly. Prevent pooling, blot excess solution, allow sufficient time for prep solution vapors to dissipate. ..."

Review on 07/31/2013 of current policy number: 7211-805 "Electrosurgical Safety" revised April 2013 revealed "POLICY: In all cases involving the use of electrosurgical equipment, patients and personnel must be protected from hazards associated with electrosurgery. PURPOSE: To ensure the safe and proper functioning of the electrosurgical (ESU) equipment. To ensure the safety of the patient undergoing surgical intervention including use of electrosurgery. To ensure the protection of the operating room personnel from electrical hazards. Implementation: I. Preoperative Preparation ...B. Personnel who handle or operate ESU's must be familiar with operation of equipment and necessary safety precautions. ...II. Intraoperative Safety ...B. ...5. Avoid pooling of fluids...."

Review on 07/31/2013 of current policy number: 7211-1111 "Patient Skin Preparations" revised April 2013 revealed "POLICY: All patients undergoing surgical intervention will have appropriate preoperative skin preparation. ...INTRAOPERATIVE SKIN PREPARATION: 1. Approved Antiseptics: ...c. Dura Prep ...e. Chloraprerp [sic] f. alcohol ...2. General Considerations: ...b. Moisture proof pad should be placed around the prep site to prevent pooling of fluids. ...l. Prior to draping, prep solution must be allowed to dry. ..."

Review on 07/31/2013 of the manufacture's product label for a "ChloraPrep With Tint" 26 ml (milliliter) applicator revealed "WARNING FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME." Further review revealed "Active ingredients....Isopropyl alcohol 70%....". Review revealed "Warnings ...Flammable, keep away from fire or flames. To reduce risk of fire; PREP CAREFULLY: *do not use 26-ml applicator for head and neck surgery. ...*solution contains alcohol and gives off flammable vapors *avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. ...*do not drape or use ignition source (e.g. cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) * do not allow solution to pool *remove wet materials from prep area ...Directions ...*Do not use 26 -ml applicator for area smaller than 8.4 in. (inches) x (by) 8.4 in. Use a smaller applicator instead. *do not use 26-ml applicator for head and neck surgery ...*allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. ..."

Review on 08/01/2013 of a "Worksheet for Add-On Case" dated 06/27/2013 for Patient #1 revealed on Page 1 of 3, "OR room: OR02_A" and "PREP CHLORAPREP." Review revealed on Page 2 of 3, "SUPPLIES....11649 APPLICATOR CHLORAPREP 26 ML...." and " Qty (quantity) 1 EA (each)."

Review on 08/01/2013 of a "Quality Indicator Form" revealed, Date of the event: 06/27/2013, Time of event: 0900, Location of the event: OR #2. Review revealed "What happened?" with "- surgical fire with emergency tracheostomy - ChloraPrep used (handwritten)." Review revealed "What normally happens?" with "- ChloraPrep dries thoroughly before incision made (handwritten)." Review revealed "How/Why did it happen?" with "- prep did not dry - incision made with bovie (handwritten)." Review revealed "Patient....condition after event:" with "- 1st (first) degree burn on (R) (right) & (L) (left) posterior of shoulders & (R) (right) neck." Review revealed "Are there policies and/or procedures that apply to this situation?....Yes (with X handwritten in adjacent box)" with "Operating Room Fire Safety 7211-803 (handwritten)."

Closed medical record review on 07/31/2013 for Patient #1 revealed an 83 year old male who presented to the hospital's emergency department (ED) via ambulance on 06/27/2013 at 0806 with a chief complaint of allergic reaction. Review of triage nursing documentation at 0809 revealed "...Pt (patient) presents from group home with c/o (complaints of) tongue swelling and inability to speak after starting transdermal scopolamine patch yesterday evening. ..." Review revealed a past medical history of schizophrenia, Tardive Dyskinesia (a movement disorder characterized by repetitive, involuntary movement like lip smacking, protruding of the tongue, or grimacing), and "mental retardation" et al. Review of ED physician documentation at 0833 revealed "...Chief Complaint: Angioedema (allergic reaction where swelling occurs under the skin) ...Physical Exam: ...The patient has a large tongue that is protruding from the mouth about 2 inches and is largely swollen. There is some mild swelling of the lips. The patient is unable to breathe through the mouth. Patient is unable to speak. Patient is tripoding and appears mildly uncomfortable secondary to anxiety and mild difficulty breathing. Mental Status: Awake, Oriented times 3 (person, place, time). ...Lungs: Clear and equal to auscultation. ...Skin: Warm and dry. ...Psych: Anxious Affect. ...anesthesiology was immediately called. ...Patient was transported emergently to the operating room for definitive airway management. IMPRESSION: angioedema CONDITION: guarded DISPOSITION: OR." Continued review of nursing documentation at 0842 revealed "Transported by RN and MD accompanying to operating room via stretcher escorted by nurse..."

Review of an Intraoperative Record dated 06/27/2013 for Patient #1 revealed the patient entered OR 2-MRH-A at 0838 and exited at 0922. Review revealed Physician A was the surgeon, Physician B was the anesthesiologist, RN #1 was the circulator, CST #1 (certified surgical technologist) was the scrub technologist, and CRNA #1 (certified registered nurse anesthetist) was the anesthesia staff. Review revealed the procedure type was "Emergency." The procedure start time was 0845 and end time was 0908. Review revealed "INTRA-OP POSITIONING/COUNTS/PREP....Prep: CHLORAPREP....INTRA-OP CAUTERY AND GROUNDING SECTION Cautery Units: Y (yes) Cautery Types Aspen Excalibur Serial Number 03JGE010.... ." Further review revealed "FIRE RISK ASSESSMENT SECTION Surgical Site Above Xiphoid: Yes Open Oxygen Source: Yes Ignition Source: Yes Each Yes = (equals) 1 Total Score: 3 ...Score 3 - Initiate High Risk Fire Protocol Protocol Initiated By: (RN #1 name)... ." Further review revealed "...Irrigation Type: Saline..."

Review of an Anesthesia Record dated 06/27/2013 for Patient #1 revealed documentation by CRNA at 0838 "Anesthesia Start....Risks Discussed....Memo (pt sitting straight up on strecher [sic], tongue grossly swollen and hanging out of mouth, face mask oxygen given....Dr. [Physician A] at bedside.) ...At 0846 "Memo (small amt [amount] propofol [sedative/hypnotic] given followed by DL [direct laryngoscopy] with Glidescope x 2 [2 attempts], and DL x 1 with miller 2 x 1 per [CRNA #1], without success, procedure changed to emergent trach [tracheostomy - surgical airway], neck cleaned emergently, Dr. [Physician A] made incision and used bovie [cautery - electrosurgical unit] ). At 0846 Memo (immediately small fire noted to left chest, O2 d/c'd [oxygen discontinued], fire patted out, wet towels layed [sic] on pt., saline squirted to sheets beneath upper back, fire extinguished. Wet towels remain in place over upper neck and around upper chest). ..."

Review of an Operative Report for Patient #1, dictated 06/27/2013 at 0928 by Physician A revealed the patient had an "Emergent Tracheostomy" performed on 06/27/2013. Review revealed a pre and postoperative diagnosis of upper airway obstruction with tongue edema from scopolamine. Review revealed "...Anesthesia: Local conversion to general. ..." Further review revealed "...COMPLICATIONS: Fire with the prep (preparation) and monopolar cautery with 100% oxygen. ..." Review revealed "...DESCRIPTION OF PROCEDURE: The patient was initially attempted to be intubated with a Glidescope and then followed by use of laryngoscope. There was no good view of the larynx. There was massive edema of the arytenoids and epiglottis. This was therefore evaluated and area was suctioned. An emergent airway, therefore, deemed necessary tracheostomy. A 15 blade scalpel was used to make an incision in the skin. The patient had been prepped with ChloraPrep. There was some oozing. Monopolar cautery was used and the prep was not dry and therefore there was fire around the airway of the skin. This was quickly dampened with wet towels. There were superficial injury to the right and left neck posteriorly where there was a 1st degree burn. The midline was divided. The thyroid was overlying the trachea. The thyroid was divided with monopolar cautery. There was a prominent vein which was treated with 3-0 silk ligature. The trachea was identified. The trachea was scored and the 3rd tracheal ring removed. The tracheal hook was used to elevate the trachea. This was followed by placement of a #6 trache [sic] tube which was in good position. 2-0 silk suture was then used for 4 quadrant suture securing of the tracheostomy. A tracheostomy sponge was placed and the patient returned to the care of anesthesia and oxygenated. He had no further troubles. There was silvadene which was placed onto the superficial burn areas."

Review of the Post Anesthesia Care Unit (PACU) record revealed the patient arrived in PACU from the OR at 0923 and was discharged at 1418 and transported to room 3712 (Intensive Care Unit).

Review of a Wound Consult note dictated 06/28/2013 at 0914 by a Family Nurse Practitioner (FNP) revealed "...REASON FOR CONSULTATION: Burns to the patient's neck and bilateral scapula areas. HISTORY OF PRESENT ILLNESS: ...He does have flash burns to his bilateral posterior shoulders as well as the right side of his neck. These are superficial. ...PHYSICAL EXAMINATION: ...SKIN/DERMATOLOGIC: To the right side of the neck he has an intact, flat blister which measures approximately 3 cm (centimeters) x (by) 2 cm. Below this at the base of the right neck he has an open blister which measures approximately 2.5 x 1.5 x 0.1 cm into the right posterior scapula. He has another intact, flat blister that measures over an area of about 4 cm x 2.5 cm. To the left scapula he has a flat blister which measure approximately 8 cm x 7 cm with intact skin and no erythema. No erythema to the other blisters. Minimal drainage with no fluctuance noted. There is no edema to the surrounding tissues. IMPRESSION: 1. Second-degree burns to the right neck and to the scapula areas bilaterally. ..."
Review of the Discharge Summary for Patient #1, dictated on 07/12/2013 at 0949 by a physician revealed date of admission 06/27/2013 and date of discharge 07/12/2013 (15 days later). Further review revealed "HOSPITAL COURSE: ....the patient developed severe swelling around his mouth, lips and throat and developed respiratory problems. He was taken to the Emergency Department on the day of admission where he was felt to be in acute angioedema. ...His airway was felt to be becoming compromised. Accordingly he was taken to the emergency operating room under the urgency of the situation. Preparation to the neck was quickly applied. The tracheostomy commenced. There was some bleeding present with bovie cauterization. Unfortunately an alcohol fire was ignited which resulted in some 2nd degree burns around the neck and shoulder blade areas. These were extinguished quickly and the tracheostomy was accomplished with otherwise excellent results and no further difficulties with breathing. ...DISCHARGE DIAGNOSIS: ...5. Second-degree skin burns which occurred this admission, resolving nicely. ...DISCHARGE DISPOSITION: Discharge this patient to....rehabilitation. ..."
Telephone interview on 07/31/2013 at 1635 with Physician A revealed he was the surgeon who performed the emergency tracheostomy on Patient #1 on 06/27/2013 and was present when the fire occurred in OR #2. Interview revealed he was in another OR preparing to perform a surgical procedure when he was called emergently by Physician B (anesthesiologist). Physician B explained a patient had presented with a difficult airway. He went to OR #2 and found Patient #1 in respiratory demise with a swollen tongue. An airway cart and two anesthesiology staff were present. Interview revealed Patient #1 was a difficult patient with a history of Tardive Dyskinesia, mental delay, and schizophrenia. Interview revealed anesthesiology staff had not tried a fiberoptic airway so a CRNA (CRNA #1) attempted to intubate the patient with a Glidescope (fiberoptic device) and was unsuccessful. Interview revealed the patient was declining and he told the OR staff to convert to an emergency tracheostomy. Interview revealed the emergency tracheostomy tray was already available in the room and some supplies were already open. Interview revealed he "called for someone" to prep the neck. Interview revealed a nurse (CST #2) with a ChloraPrep asked if he wanted the neck prepped with ChloraPrep, he said yes. Interview revealed the ChloraPrep was applied by CST #2. Interview revealed his "recollection of the fire" the nurse (CRNA #1) was bagging the patient with 100% oxygen. The ChloraPrep had recently been applied. "The prep was still moist and not dry." Interview revealed he made an incision into the neck with the scalpel and there was some bleeding. Interview revealed he used the cautery (Bovie - Electrosurgical unit) and it sparked a flame. Interview revealed he and the anesthesia staff put the fire out. Interview revealed the fire was put out with saline from a bowl on the back table. Once the fire was out he proceeded with the tracheostomy. Interview revealed "the prep solution must have pooled on the patient and the pillow." Interview revealed the fire burned the patient's neck and shoulders. Interview revealed the patient sustained first and second degree burns. Interview revealed the nurse used one ChloraPrep with one swipe down the neck. Interview revealed the patient was having increased airway complications and his condition was declining. Interview revealed "we did not wait the 3 minutes for the prep to dry." Interview revealed "there was an error in the type of prep used." Interview revealed non-alcohol based skin preparation solutions were available, but they were not opened or easily available. Interview revealed generally the OR staff prep and drape the patients. Interview revealed he has used ChloraPrep and/or DuraPrep before to prep patients. Interview revealed he is not included in hospital training regarding use of alcohol based skin prep solutions. Follow-up telephone interview on 08/01/2013 at 0855 confirmed he was aware that ChloraPrep was alcohol based. Interview revealed he can not recall having an inservice on ChloraPrep but "usually when a new product is rolled out, training and inservice are provided." Interview revealed the physician "normally does not get involved with the draping of the patient so I can not say for certain the physician receives the inservice." Interview confirmed the staff did not wait 3 minutes to allow the ChloraPrep solution to dry.
Interview on 08/01/2013 at 1255 with CRNA #1 revealed she was the anesthetist providing anesthesia services to Patient #1 on 06/27/2013 during his emergency tracheostomy and was present when the fire occurred in OR #2. Interview revealed she received a call from Physician B (anesthesiologist) about an ED patient having a swollen tongue. Interview revealed when the patient arrived to OR #2 he was sitting on the bed with his tongue hanging out of his mouth and panting. The patient was moved to the OR table with the head of the table elevated. The patient was placed on oxygen via mask. Physician B entered the room and a "Stores Brand scope, similar to a Glidescope" was used in an attempt to intubate the patient, but she was unable to visualize the vocal cords. At that time Physician A entered the OR and saw the view on the monitor screen and stated they needed to do an emergency tracheostomy. Interview revealed while Physician A went to scrub she attempted to intubate the patient with the Glidescope. She was able to visualize the cords but unable to pass the endotracheal tube. Interview revealed when Physician A returned, she was holding the face mask and Physician B was bagging the patient with 100% oxygen via bag valve mask. Interview revealed Physician A was made aware of the 100% oxygen in use prior to incision. Interview revealed Physician A told someone to prep the neck. The neck was prepped and Physician A made an incision. Interview revealed "all of a sudden there was fire. I threw the oxygen mask away. Fire was going up my arm and I began patting out the fire on myself." Interview revealed Physician A started patting out the fire on the patient's neck and back of shoulders. Interview revealed "(CRNA #2) started using saline (10 milliliter syringes) out of the top drawer of the anesthesia cart and squirting it on the patient. Someone got wet towels and placed them on the patient's shoulders, face, and chin." Interview revealed after the fire was out the patient was bagged with oxygen and Physician A proceeded with the tracheostomy. Interview revealed she does not recall who prepped the patient, but the patient was not fully draped when Physician A started the incision. Interview revealed there were no neck drapes to collect fluid from pooling. Interview revealed the patient still had his T-shirt on from the ED. Interview revealed after the procedure she noticed the right side of the patient's neck and both posterior shoulder areas were burned and there was a "charring" on the sheet under the patient. Interview revealed she is trained to know some skin prep solutions contain alcohol and can ignite. Interview revealed she does not recall any formal training on ChloraPrep. Interview revealed she is aware that staff must wait 3 minutes after application of ChloraPrep to let it dry. Interview confirmed the saline used to put the fire out was obtained from the anesthesia cart. Interview revealed the CRNAs used the 10 milliliter saline flush syringes.
Interview on 08/01/2013 at 0905 with CST #2 revealed she was on-duty when Patient #1 presented to the OR on 06/27/2013 and was present when the fire occurred in OR #2. Interview revealed when she entered OR #2 the patient was already on the OR table. Interview revealed the patient was sitting upright. Interview revealed staff were masking the patient and opening items for CST #1 to set up the case. Interview revealed CST #1 was assigned to scrub the case, and she was in the room helping. Interview revealed staff were getting ready for an emergency tracheostomy. Interview revealed there was "lots of people" and "lots of confusion." Interview revealed "Physician A was standing there with knife in hand and he says somebody prep the patient." Interview revealed "I was standing in the room and picked up the first thing I saw." Interview revealed she picked up a ChloraPrep applicator. Interview revealed she picked up the "big" ChloraPrep applicator (26 milliliters). Interview revealed she swiped the neck area once where the physician was going to make the incision. Interview revealed she "thinks" the patient was already draped with sterile towels and sheet, but is unsure. Interview revealed she turned around and then walked away and was picking up trash when the fire occurred. Interview revealed she did not visualize the physician making the incision or using the bovie. Interview revealed she did not witness the fire. Interview revealed the hospital has been using ChloraPrep for years. Interview revealed the skin preparation solutions are usually brought in to the OR for each case. Interview revealed the OR does have non-alcohol based skin preparation solutions available for use. Interview revealed staff receive annual training on the use of alcohol based skin preparation solutions. Interview revealed staff "normally" wait 3 minutes for the ChloraPrep to dry because it contains alcohol and is a "fire hazard." Interview revealed she was unsure if the 26 ml ChloraPrep applicator can be used on neck surgeries. Interview revealed ChloraPrep can not be used on the mucous membranes or face. Interview revealed "the staff did not wait 3 minutes for the prep to dry" on Patient #1. Interview revealed "the doctor was standing there and it was an emergency situation." Follow-up telephone interview at 1325 revealed she was not aware the manufacture's product label has directions and a warning not to use the 26 ml ChloraPrep applicator on head and neck surgeries.
Interview on 08/01/2013 at 0932 with CST #1 revealed she was the primary scrub tech for Patient #1's emergency tracheostomy on 06/27/2013 and was present when the fire occurred in OR #2. Interview revealed she heard the OR was receiving a patient from the ED for emergent intubation with a possible tracheostomy. Interview revealed she went into the back of the OR and CST #2 helped pull supplies for the case. She went back to OR #2 and the patient was already sitting up on the OR table. Interview revealed anesthesia was working with the patient. Interview revealed the patient had a swollen tongue and was struggling to breath. Interview revealed she was setting up the instrument table and asked Physician A what type of trach he wanted. Interview revealed Physician A stated "we're doing this trach." Interview revealed Physician A stated "somebody do a prep." Interview revealed she did not know who had performed the prep. Interview revealed she found out later that CST #2 performed the prep and used ChloraPrep. Interview revealed she did not visualize CST #2 applying the ChloraPrep to Patient #1. Interview revealed she is unsure of what size ChloraPrep applicator CST #2 used on the patient's neck. Interview revealed "in a controlled environment the tech would normally use a 26 ml ChloraPrep for a tracheostomy." Interview revealed the staff will usually drape the patient with crushed towels and block towels to collect pooling of fluids and use a three-quarter (3/4) sheet over the patient. The staff would prep the surgical site with ChloraPrep and allow it to completely dry for 3 minutes. Interview revealed the 3 minutes "allows the alcohol fumes to dissipate." Interview revealed a 3/4 sheet was placed over Patient #1. Interview revealed there was no crushed towels or block towels used to collect fluids from pooling. Interview revealed there was no other draping for Patient #1 other than the 3/4 sheet from the chest down. Interview revealed there was nothing around the neck. Interview revealed after the 3/4 drape was applied, she placed a bovie (cautery) and suction on top of the drape. Interview revealed the physician made an incision with the scalpel. Interview revealed she did not visualize the use of the bovie by Physician A. Interview revealed she turned towards the instrument table to get the trach tube ready when she heard someone yell "fire" and "I saw a flash in the corner of my eyes." Interview revealed she turned around and Physician A was holding the bovie in his hand. Anesthesia and Physician A started patting out the fire. Interview revealed the nurse was getting the saline when the fire occurred. The saline had not been poured into a sterile bowl yet. Anesthesia had saline syringes and used them on the pillow to put out the fire. Interview revealed she poured saline all over the patient's neck once the saline was poured into the sterile bowel by the nurse. Interview revealed once the fire was out Physician A proceeded with the tracheostomy. Interview revealed after the procedure she noticed the patient had burns to his neck and both shoulders. Interview revealed "the pillow had char on it." Interview revealed possible causes of the fire were "using ChloraPrep and not allowing 3 minutes for it to dry, it was an emergent situation, an oxygen enriched environment, bovie use, and not draping the patient to prevent pooling." Interview revealed there are other skin preparation alternatives that are alcohol free in the OR. Interview revealed when the hospital started using ChloraPrep, staff received an inservice and annually in competencies. Follow-up telephone interview at 1126 revealed she was not aware the manufacture's product label has directions and a warning not to use the 26 ml ChloraPrep applicator on head and neck surgeries, "until after the fire occurred."
Interview on 08/01/2013 at 1005 with RN #1 revealed she was the Circulator for Patient #1's emergency tracheostomy and was present when the fire occurred in OR #2. Interview revealed she received notification the ED had a patient that needed intubation with a possible emergency tracheostomy. Interview revealed when Patient #1 arrived in the holding area he was still wearing his T-shirt and pants. Interview revealed the patient was mentally challenged. Interview revealed the patient was in a sitting position, leaned over, and his tongue was swollen outside of his mouth. Interview revealed the patient was transported to OR #2 by her and CRNA #1. When in the OR the patient was moved over to the OR table. Interview revealed the patient remained in his T-shirt because of the emergent situation. Interview revealed blankets were placed behind the patient and the head of the table was elevated. Interview revealed the patient was secured to the OR table and medications were administered by the CRNA. The patient was laid back and CRNA #1 attempted intubation and was unsuccessful. Interview revealed Physician A entered and stated they would have to do a tracheostomy. Interview revealed "everything went fast forward." Interview revealed she did not visualize who prepped the patient with ChloraPrep. Interview revealed she did not see the fire occur. Interview revealed ChloraPrep was used because it was listed on the preference card for Physician A. Interview revealed she documented the high risk for fire assessment in the record. Interview revealed the patient scored a "3." Interview revealed if a patient scores a 3, staff must initiate the "high risk protocol." Interview revealed the protocol includes using towels for pooling, letting alcohol prep solutions dry for three minutes, use bipolar cautery, and have saline in a bowel on the table prior to incision. Interview revealed the staff used monopolar cautery, did not drape the patient with towels to collect pooling, did not have a bowel of saline on a table prior to incision, nor allowed the ChloraPrep to dry for 3 minutes prior to Patient #1's emergency tracheostomy. Interview revealed "there was no policy before - there is a policy now." Interview revealed she has received inservices on the use of ChloraPrep. Interview revealed staff should wait 3 minutes to let the solution dry completely and fumes evaporate due to alcohol. Interview revealed a 26 ml ChloraPrep was used during Patient #1 surgery. Interview revealed she visualized the package in the trash after the procedure. Interview revealed staff are not suppose to use the 26 ml applicator on neck and head surgeries. Interview revealed she does not know if there were any non-alcohol based skin prep solutions available in OR #2, but they are available in the OR suite.
Interview on 07/31/2013 at 1545 with OR Management Staff revealed the hospital does use alcohol based skin preparation solutions. Interview revealed the hospital uses ChloraPrep and DuraPrep. Interview revealed ChloraPrep is supplied in a 26 ml and 3 ml applicator. Interview revealed DuraPrep is supplied in a 26 ml applicator. Interview revealed the hospital has been using alcohol based skin preparation solutions for the past 5-10 years. Interview revealed staff receive training annually on alcohol based skin preparation solutions. Interview revealed the training is documented in the staff's training file. Interview revealed Physicians are not trained by the OR for use of alcohol based skin preparation solutions. Interview revealed in cases of emergency physicians may prep a patient using a alcohol based skin preparation solution. Interview revealed staff should not be using the 26 ml applicators on the neck, face, or vaginal areas due to pooling. Interview revealed the OR does not have a policy specifically for the use of alcohol based patient skin prep solutions. Interview revealed policy 7211-0803 Operating Room Fire Safety, was updated in July as a result of the fire on 06/27/2013 involving Patient #1. Interview revealed the policy was revised to include defined interventions for the fire risk assessment score; a minimum prep drying time of 3 minutes; and that all emergency surgical procedures should utilize non alcohol-based prep solutions unless non-alcohol based solution is contraindicated due to a know patient allergy to prep solution.
Consequently, the findings confirmed the hospital's surgical OR staff failed to maintain fire safety in an oxygen enriched environment; failed to follow established fire safety prevention policies and procedures; and failed to adhere to the manufacturer's product label directions and warnings for an alcohol based patient perioperative skin preparation solution.

Based on hospital policy and procedure reviews, manufacture's product label review, worksheet for add on case form review, quality indicator report review, medical record review, staff and physician interviews, the hospital's surgical operating room staff failed to provide surgical services in accordance with acceptable standards of practice.

The findings include:

The hospital's surgical operating room staff failed to design policies to assure the achievement and maintenance of high standards of medical practice and patient care to reduce the associated risk of fire with the use of alcohol-based skin preparation solutions for 1 of 1 patients (#1) who sustained second degree burns as a result of a fire during an emergency surgical procedure in an oxygen enriched environment.

~Cross refer to 482.51(b) Operating Room Policies - Standard: Tag A0951.

Based on hospital policy and procedure reviews, manufacture's product label review, worksheet for add on case form review, quality indicator report review, medical record review, staff and physician interviews, the hospital's surgical operating room staff failed to design policies to assure the achievement and maintenance of high standards of medical practice and patient care to reduce the associated risk of fire with the use of alcohol-based skin preparation solutions for 1 of 1 patients (#1) who sustained second degree burns as a result of a fire during an emergency surgical procedure in an oxygen enriched environment.

The findings include:

Review on 07/31/2013 of policy number: 7211-803 "Operating Room Fire Safety" revised April 2013 (version in effect on 06/27/2013 when fire occurred) revealed "POLICY: The surgical team will perform activities that contribute to the prevention of injury due to fire. These activities include application of the principles of fire prevention, perioperative environment assessment performed and documented prior to every case, and coordination with other members of the health care team. OUTCOME: The patient is free from fire injury. ...INTERPRETIVE STATEMENT: Fire prevention is a shared responsibility of the entire surgical team. Prevention of fire requires application of principles of fire safety, routine precautions, and knowledge of potential hazards. ...I. Risk Reduction A. The cornerstone of prevention is to reduce the risk associated with each of the three elements required for combustion. The OR is an oxygen enriched environment. The two major ignition sources are the Electrosurgical Unit (ESU) and lasers. ESU safety is covered in OR Policy 7211-805. ...Fuels includes, but is not limited to....prep agents....and the patient. 1. Conduct fire safety assessment with operative team, prior to incision. 2. Constantly monitor the patient environment for hazards. 3. Keep a bowl of sterile water or saline on the back table. ...9. Handle prep solutions properly. Prevent pooling, blot excess solution, allow sufficient time for prep solution vapors to dissipate. ..."

Review on 07/31/2013 of current policy number: 7211-805 "Electrosurgical Safety" revised April 2013 revealed "POLICY: In all cases involving the use of electrosurgical equipment, patients and personnel must be protected from hazards associated with electrosurgery. PURPOSE: To ensure the safe and proper functioning of the electrosurgical (ESU) equipment. To ensure the safety of the patient undergoing surgical intervention including use of electrosurgery. To ensure the protection of the operating room personnel from electrical hazards. Implementation: I. Preoperative Preparation ...B. Personnel who handle or operate ESU's must be familiar with operation of equipment and necessary safety precautions. ...II. Intraoperative Safety ...B. ...5. Avoid pooling of fluids...."

Review on 07/31/2013 of current policy number: 7211-1111 "Patient Skin Preparations" revised April 2013 revealed "POLICY: All patients undergoing surgical intervention will have appropriate preoperative skin preparation. ...INTRAOPERATIVE SKIN PREPARATION: 1. Approved Antiseptics: ...c. Dura Prep ...e. Chloraprerp [sic] f. alcohol ...2. General Considerations: ...b. Moisture proof pad should be placed around the prep site to prevent pooling of fluids. ...l. Prior to draping, prep solution must be allowed to dry. ..."

Review on 07/31/2013 of the manufacture's product label for a "ChloraPrep With Tint" 26 ml (milliliter) applicator revealed "WARNING FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME." Further review revealed "Active ingredients....Isopropyl alcohol 70%....". Review revealed "Warnings ...Flammable, keep away from fire or flames. To reduce risk of fire; PREP CAREFULLY: *do not use 26-ml applicator for head and neck surgery. ...*solution contains alcohol and gives off flammable vapors *avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. ...*do not drape or use ignition source (e.g. cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) * do not allow solution to pool *remove wet materials from prep area ...Directions ...*Do not use 26 -ml applicator for area smaller than 8.4 in. (inches) x (by) 8.4 in. Use a smaller applicator instead. *do not use 26-ml applicator for head and neck surgery ...*allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. ..."

Review on 08/01/2013 of a "Worksheet for Add-On Case" dated 06/27/2013 for Patient #1 revealed on Page 1 of 3, "OR room: OR02_A" and "PREP CHLORAPREP." Review revealed on Page 2 of 3, "SUPPLIES....11649 APPLICATOR CHLORAPREP 26 ML...." and " Qty (quantity) 1 EA (each)."

Review on 08/01/2013 of a "Quality Indicator Form" revealed, Date of the event: 06/27/2013, Time of event: 0900, Location of the event: OR #2. Review revealed "What happened?" with "- surgical fire with emergency tracheostomy - ChloraPrep used (handwritten)." Review revealed "What normally happens?" with "- ChloraPrep dries thoroughly before incision made (handwritten)." Review revealed "How/Why did it happen?" with "- prep did not dry - incision made with bovie (handwritten)." Review revealed "Patient....condition after event:" with "- 1st (first) degree burn on (R) (right) & (L) (left) posterior of shoulders & (R) (right) neck." Review revealed "Are there policies and/or procedures that apply to this situation?....Yes (with X handwritten in adjacent box)" with "Operating Room Fire Safety 7211-803 (handwritten)."

Closed medical record review on 07/31/2013 for Patient #1 revealed an 83 year old male who presented to the hospital's emergency department (ED) via ambulance on 06/27/2013 at 0806 with a chief complaint of allergic reaction. Review of triage nursing documentation at 0809 revealed "...Pt (patient) presents from group home with c/o (complaints of) tongue swelling and inability to speak after starting transdermal scopolamine patch yesterday evening. ..." Review revealed a past medical history of schizophrenia, Tardive Dyskinesia (a movement disorder characterized by repetitive, involuntary movement like lip smacking, protruding of the tongue, or grimacing), and "mental retardation" et al. Review of ED physician documentation at 0833 revealed "...Chief Complaint: Angioedema (allergic reaction where swelling occurs under the skin) ...Physical Exam: ...The patient has a large tongue that is protruding from the mouth about 2 inches and is largely swollen. There is some mild swelling of the lips. The patient is unable to breathe through the mouth. Patient is unable to speak. Patient is tripoding and appears mildly uncomfortable secondary to anxiety and mild difficulty breathing. Mental Status: Awake, Oriented times 3 (person, place, time). ...Lungs: Clear and equal to auscultation. ...Skin: Warm and dry. ...Psych: Anxious Affect. ...anesthesiology was immediately called. ...Patient was transported emergently to the operating room for definitive airway management. IMPRESSION: angioedema CONDITION: guarded DISPOSITION: OR." Continued review of nursing documentation at 0842 revealed "Transported by RN and MD accompanying to operating room via stretcher escorted by nurse..."

Review of an Intraoperative Record dated 06/27/2013 for Patient #1 revealed the patient entered OR 2-MRH-A at 0838 and exited at 0922. Review revealed Physician A was the surgeon, Physician B was the anesthesiologist, RN #1 was the circulator, CST #1 (certified surgical technologist) was the scrub technologist, and CRNA #1 (certified registered nurse anesthetist) was the anesthesia staff. Review revealed the procedure type was "Emergency." The procedure start time was 0845 and end time was 0908. Review revealed "INTRA-OP POSITIONING/COUNTS/PREP....Prep: CHLORAPREP....INTRA-OP CAUTERY AND GROUNDING SECTION Cautery Units: Y (yes) Cautery Types Aspen Excalibur Serial Number 03JGE010.... ." Further review revealed "FIRE RISK ASSESSMENT SECTION Surgical Site Above Xiphoid: Yes Open Oxygen Source: Yes Ignition Source: Yes Each Yes = (equals) 1 Total Score: 3 ...Score 3 - Initiate High Risk Fire Protocol Protocol Initiated By: (RN #1 name)... ." Further review revealed "...Irrigation Type: Saline..."

Review of an Anesthesia Record dated 06/27/2013 for Patient #1 revealed documentation by CRNA at 0838 "Anesthesia Start....Risks Discussed....Memo (pt sitting straight up on strecher [sic], tongue grossly swollen and hanging out of mouth, face mask oxygen given....Dr. [Physician A] at bedside.) ...At 0846 "Memo (small amt [amount] propofol [sedative/hypnotic] given followed by DL [direct laryngoscopy] with Glidescope x 2 [2 attempts], and DL x 1 with miller 2 x 1 per [CRNA #1], without success, procedure changed to emergent trach [tracheostomy - surgical airway], neck cleaned emergently, Dr. [Physician A] made incision and used bovie [cautery - electrosurgical unit] ). At 0846 Memo (immediately small fire noted to left chest, O2 d/c'd [oxygen discontinued], fire patted out, wet towels layed [sic] on pt., saline squirted to sheets beneath upper back, fire extinguished. Wet towels remain in place over upper neck and around upper chest). ..."

Review of an Operative Report for Patient #1, dictated 06/27/2013 at 0928 by Physician A revealed the patient had an "Emergent Tracheostomy" performed on 06/27/2013. Review revealed a pre and postoperative diagnosis of upper airway obstruction with tongue edema from scopolamine. Review revealed "...Anesthesia: Local conversion to general. ..." Further review revealed "...COMPLICATIONS: Fire with the prep (preparation) and monopolar cautery with 100% oxygen. ..." Review revealed "...DESCRIPTION OF PROCEDURE: The patient was initially attempted to be intubated with a Glidescope and then followed by use of laryngoscope. There was no good view of the larynx. There was massive edema of the arytenoids and epiglottis. This was therefore evaluated and area was suctioned. An emergent airway, therefore, deemed necessary tracheostomy. A 15 blade scalpel was used to make an incision in the skin. The patient had been prepped with ChloraPrep. There was some oozing. Monopolar cautery was used and the prep was not dry and therefore there was fire around the airway of the skin. This was quickly dampened with wet towels. There were superficial injury to the right and left neck posteriorly where there was a 1st degree burn. The midline was divided. The thyroid was overlying the trachea. The thyroid was divided with monopolar cautery. There was a prominent vein which was treated with 3-0 silk ligature. The trachea was identified. The trachea was scored and the 3rd tracheal ring removed. The tracheal hook was used to elevate the trachea. This was followed by placement of a #6 trache [sic] tube which was in good position. 2-0 silk suture was then used for 4 quadrant suture securing of the tracheostomy. A tracheostomy sponge was placed and the patient returned to the care of anesthesia and oxygenated. He had no further troubles. There was silvadene which was placed onto the superficial burn areas."

Review of the Post Anesthesia Care Unit (PACU) record revealed the patient arrived in PACU from the OR at 0923 and was discharged at 1418 and transported to room 3712 (Intensive Care Unit).

Review of a Wound Consult note dictated 06/28/2013 at 0914 by a Family Nurse Practitioner (FNP) revealed "...REASON FOR CONSULTATION: Burns to the patient's neck and bilateral scapula areas. HISTORY OF PRESENT ILLNESS: ...He does have flash burns to his bilateral posterior shoulders as well as the right side of his neck. These are superficial. ...PHYSICAL EXAMINATION: ...SKIN/DERMATOLOGIC: To the right side of the neck he has an intact, flat blister which measures approximately 3 cm (centimeters) x (by) 2 cm. Below this at the base of the right neck he has an open blister which measures approximately 2.5 x 1.5 x 0.1 cm into the right posterior scapula. He has another intact, flat blister that measures over an area of about 4 cm x 2.5 cm. To the left scapula he has a flat blister which measure approximately 8 cm x 7 cm with intact skin and no erythema. No erythema to the other blisters. Minimal drainage with no fluctuance noted. There is no edema to the surrounding tissues. IMPRESSION: 1. Second-degree burns to the right neck and to the scapula areas bilaterally. ..."
Review of the Discharge Summary for Patient #1, dictated on 07/12/2013 at 0949 by a physician revealed date of admission 06/27/2013 and date of discharge 07/12/2013 (15 days later). Further review revealed "HOSPITAL COURSE: ....the patient developed severe swelling around his mouth, lips and throat and developed respiratory problems. He was taken to the Emergency Department on the day of admission where he was felt to be in acute angioedema. ...His airway was felt to be becoming compromised. Accordingly he was taken to the emergency operating room under the urgency of the situation. Preparation to the neck was quickly applied. The tracheostomy commenced. There was some bleeding present with bovie cauterization. Unfortunately an alcohol fire was ignited which resulted in some 2nd degree burns around the neck and shoulder blade areas. These were extinguished quickly and the tracheostomy was accomplished with otherwise excellent results and no further difficulties with breathing. ...DISCHARGE DIAGNOSIS: ...5. Second-degree skin burns which occurred this admission, resolving nicely. ...DISCHARGE DISPOSITION: Discharge this patient to....rehabilitation. ..."
Telephone interview on 07/31/2013 at 1635 with Physician A revealed he was the surgeon who performed the emergency tracheostomy on Patient #1 on 06/27/2013 and was present when the fire occurred in OR #2. Interview revealed he was in another OR preparing to perform a surgical procedure when he was called emergently by Physician B (anesthesiologist). Physician B explained a patient had presented with a difficult airway. He went to OR #2 and found Patient #1 in respiratory demise with a swollen tongue. An airway cart and two anesthesiology staff were present. Interview revealed Patient #1 was a difficult patient with a history of Tardive Dyskinesia, mental delay, and schizophrenia. Interview revealed anesthesiology staff had not tried a fiberoptic airway so a CRNA (CRNA #1) attempted to intubate the patient with a Glidescope (fiberoptic device) and was unsuccessful. Interview revealed the patient was declining and he told the OR staff to convert to an emergency tracheostomy. Interview revealed the emergency tracheostomy tray was already available in the room and some supplies were already open. Interview revealed he "called for someone" to prep the neck. Interview revealed a nurse (CST #2) with a ChloraPrep asked if he wanted the neck prepped with ChloraPrep, he said yes. Interview revealed the ChloraPrep was applied by CST #2. Interview revealed his "recollection of the fire" the nurse (CRNA #1) was bagging the patient with 100% oxygen. The ChloraPrep had recently been applied. "The prep was still moist and not dry." Interview revealed he made an incision into the neck with the scalpel and there was some bleeding. Interview revealed he used the cautery (Bovie - Electrosurgical unit) and it sparked a flame. Interview revealed he and the anesthesia staff put the fire out. Interview revealed the fire was put out with saline from a bowl on the back table. Once the fire was out he proceeded with the tracheostomy. Interview revealed "the prep solution must have pooled on the patient and the pillow." Interview revealed the fire burned the patient's neck and shoulders. Interview revealed the patient sustained first and second degree burns. Interview revealed the nurse used one ChloraPrep with one swipe down the neck. Interview revealed the patient was having increased airway complications and his condition was declining. Interview revealed "we did not wait the 3 minutes for the prep to dry." Interview revealed "there was an error in the type of prep used." Interview revealed non-alcohol based skin preparation solutions were available, but they were not opened or easily available. Interview revealed generally the OR staff prep and drape the patients. Interview revealed he has used ChloraPrep and/or DuraPrep before to prep patients. Interview revealed he is not included in hospital training regarding use of alcohol based skin prep solutions. Follow-up telephone interview on 08/01/2013 at 0855 confirmed he was aware that ChloraPrep was alcohol based. Interview revealed he can not recall having an inservice on ChloraPrep but "usually when a new product is rolled out, training and inservice are provided." Interview revealed the physician "normally does not get involved with the draping of the patient so I can not say for certain the physician receives the inservice." Interview confirmed the staff did not wait 3 minutes to allow the ChloraPrep solution to dry.
Interview on 08/01/2013 at 1255 with CRNA #1 revealed she was the anesthetist providing anesthesia services to Patient #1 on 06/27/2013 during his emergency tracheostomy and was present when the fire occurred in OR #2. Interview revealed she received a call from Physician B (anesthesiologist) about an ED patient having a swollen tongue. Interview revealed when the patient arrived to OR #2 he was sitting on the bed with his tongue hanging out of his mouth and panting. The patient was moved to the OR table with the head of the table elevated. The patient was placed on oxygen via mask. Physician B entered the room and a "Stores Brand scope, similar to a Glidescope" was used in an attempt to intubate the patient, but she was unable to visualize the vocal cords. At that time Physician A entered the OR and saw the view on the monitor screen and stated they needed to do an emergency tracheostomy. Interview revealed while Physician A went to scrub she attempted to intubate the patient with the Glidescope. She was able to visualize the cords but unable to pass the endotracheal tube. Interview revealed when Physician A returned, she was holding the face mask and Physician B was bagging the patient with 100% oxygen via bag valve mask. Interview revealed Physician A was made aware of the 100% oxygen in use prior to incision. Interview revealed Physician A told someone to prep the neck. The neck was prepped and Physician A made an incision. Interview revealed "all of a sudden there was fire. I threw the oxygen mask away. Fire was going up my arm and I began patting out the fire on myself." Interview revealed Physician A started patting out the fire on the patient's neck and back of shoulders. Interview revealed "(CRNA #2) started using saline (10 milliliter syringes) out of the top drawer of the anesthesia cart and squirting it on the patient. Someone got wet towels and placed them on the patient's shoulders, face, and chin." Interview revealed after the fire was out the patient was bagged with oxygen and Physician A proceeded with the tracheostomy. Interview revealed she does not recall who prepped the patient, but the patient was not fully draped when Physician A started the incision. Interview revealed there were no neck drapes to collect fluid from pooling. Interview revealed the patient still had his T-shirt on from the ED. Interview revealed after the procedure she noticed the right side of the patient's neck and both posterior shoulder areas were burned and there was a "charring" on the sheet under the patient. Interview revealed she is trained to know some skin prep solutions contain alcohol and can ignite. Interview revealed she does not recall any formal training on ChloraPrep. Interview revealed she is aware that staff must wait 3 minutes after application of ChloraPrep to let it dry. Interview confirmed the saline used to put the fire out was obtained from the anesthesia cart. Interview revealed the CRNAs used the 10 milliliter saline flush syringes.
Interview on 08/01/2013 at 0905 with CST #2 revealed she was on-duty when Patient #1 presented to the OR on 06/27/2013 and was present when the fire occurred in OR #2. Interview revealed when she entered OR #2 the patient was already on the OR table. Interview revealed the patient was sitting upright. Interview revealed staff were masking the patient and opening items for CST #1 to set up the case. Interview revealed CST #1 was assigned to scrub the case, and she was in the room helping. Interview revealed staff were getting ready for an emergency tracheostomy. Interview revealed there was "lots of people" and "lots of confusion." Interview revealed "Physician A was standing there with knife in hand and he says somebody prep the patient." Interview revealed "I was standing in the room and picked up the first thing I saw." Interview revealed she picked up a ChloraPrep applicator. Interview revealed she picked up the "big" ChloraPrep applicator (26 milliliters). Interview revealed she swiped the neck area once where the physician was going to make the incision. Interview revealed she "thinks" the patient was already draped with sterile towels and sheet, but is unsure. Interview revealed she turned around and then walked away and was picking up trash when the fire occurred. Interview revealed she did not visualize the physician making the incision or using the bovie. Interview revealed she did not witness the fire. Interview revealed the hospital has been using ChloraPrep for years. Interview revealed the skin preparation solutions are usually brought in to the OR for each case. Interview revealed the OR does have non-alcohol based skin preparation solutions available for use. Interview revealed staff receive annual training on the use of alcohol based skin preparation solutions. Interview revealed staff "normally" wait 3 minutes for the ChloraPrep to dry because it contains alcohol and is a "fire hazard." Interview revealed she was unsure if the 26 ml ChloraPrep applicator can be used on neck surgeries. Interview revealed ChloraPrep can not be used on the mucous membranes or face. Interview revealed "the staff did not wait 3 minutes for the prep to dry" on Patient #1. Interview revealed "the doctor was standing there and it was an emergency situation." Follow-up telephone interview at 1325 revealed she was not aware the manufacture's product label has directions and a warning not to use the 26 ml ChloraPrep applicator on head and neck surgeries.
Interview on 08/01/2013 at 0932 with CST #1 revealed she was the primary scrub tech for Patient #1's emergency tracheostomy on 06/27/2013 and was present when the fire occurred in OR #2. Interview revealed she heard the OR was receiving a patient from the ED for emergent intubation with a possible tracheostomy. Interview revealed she went into the back of the OR and CST #2 helped pull supplies for the case. She went back to OR #2 and the patient was already sitting up on the OR table. Interview revealed anesthesia was working with the patient. Interview revealed the patient had a swollen tongue and was struggling to breath. Interview revealed she was setting up the instrument table and asked Physician A what type of trach he wanted. Interview revealed Physician A stated "we're doing this trach." Interview revealed Physician A stated "somebody do a prep." Interview revealed she did not know who had performed the prep. Interview revealed she found out later that CST #2 performed the prep and used ChloraPrep. Interview revealed she did not visualize CST #2 applying the ChloraPrep to Patient #1. Interview revealed she is unsure of what size ChloraPrep applicator CST #2 used on the patient's neck. Interview revealed "in a controlled environment the tech would normally use a 26 ml ChloraPrep for a tracheostomy." Interview revealed the staff will usually drape the patient with crushed towels and block towels to collect pooling of fluids and use a three-quarter (3/4) sheet over the patient. The staff would prep the surgical site with ChloraPrep and allow it to completely dry for 3 minutes. Interview revealed the 3 minutes "allows the alcohol fumes to dissipate." Interview revealed a 3/4 sheet was placed over Patient #1. Interview revealed there was no crushed towels or block towels used to collect fluids from pooling. Interview revealed there was no other draping for Patient #1 other than the 3/4 sheet from the chest down. Interview revealed there was nothing around the neck. Interview revealed after the 3/4 drape was applied, she placed a bovie (cautery) and suction on top of the drape. Interview revealed the physician made an incision with the scalpel. Interview revealed she did not visualize the use of the bovie by Physician A. Interview revealed she turned towards the instrument table to get the trach tube ready when she heard someone yell "fire" and "I saw a flash in the corner of my eyes." Interview revealed she turned around and Physician A was holding the bovie in his hand. Anesthesia and Physician A started patting out the fire. Interview revealed the nurse was getting the saline when the fire occurred. The saline had not been poured into a sterile bowl yet. Anesthesia had saline syringes and used them on the pillow to put out the fire. Interview revealed she poured saline all over the patient's neck once the saline was poured into the sterile bowel by the nurse. Interview revealed once the fire was out Physician A proceeded with the tracheostomy. Interview revealed after the procedure she noticed the patient had burns to his neck and both shoulders. Interview revealed "the pillow had char on it." Interview revealed possible causes of the fire were "using ChloraPrep and not allowing 3 minutes for it to dry, it was an emergent situation, an oxygen enriched environment, bovie use, and not draping the patient to prevent pooling." Interview revealed there are other skin preparation alternatives that are alcohol free in the OR. Interview revealed when the hospital started using ChloraPrep, staff received an inservice and annually in competencies. Follow-up telephone interview at 1126 revealed she was not aware the manufacture's product label has directions and a warning not to use the 26 ml ChloraPrep applicator on head and neck surgeries, "until after the fire occurred."
Interview on 08/01/2013 at 1005 with RN #1 revealed she was the Circulator for Patient #1's emergency tracheostomy and was present when the fire occurred in OR #2. Interview revealed she received notification the ED had a patient that needed intubation with a possible emergency tracheostomy. Interview revealed when Patient #1 arrived in the holding area he was still wearing his T-shirt and pants. Interview revealed the patient was mentally challenged. Interview revealed the patient was in a sitting position, leaned over, and his tongue was swollen outside of his mouth. Interview revealed the patient was transported to OR #2 by her and CRNA #1. When in the OR the patient was moved over to the OR table. Interview revealed the patient remained in his T-shirt because of the emergent situation. Interview revealed blankets were placed behind the patient and the head of the table was elevated. Interview revealed the patient was secured to the OR table and medications were administered by the CRNA. The patient was laid back and CRNA #1 attempted intubation and was unsuccessful. Interview revealed Physician A entered and stated they would have to do a tracheostomy. Interview revealed "everything went fast forward." Interview revealed she did not visualize who prepped the patient with ChloraPrep. Interview revealed she did not see the fire occur. Interview revealed ChloraPrep was used because it was listed on the preference card for Physician A. Interview revealed she documented the high risk for fire assessment in the record. Interview revealed the patient scored a "3." Interview revealed if a patient scores a 3, staff must initiate the "high risk protocol." Interview revealed the protocol includes using towels for pooling, letting alcohol prep solutions dry for three minutes, use bipolar cautery, and have saline in a bowel on the table prior to incision. Interview revealed the staff used monopolar cautery, did not drape the patient with towels to collect pooling, did not have a bowel of saline on a table prior to incision, nor allowed the ChloraPrep to dry for 3 minutes prior to Patient #1's emergency tracheostomy. Interview revealed "there was no policy before - there is a policy now." Interview revealed she has received inservices on the use of ChloraPrep. Interview revealed staff should wait 3 minutes to let the solution dry completely and fumes evaporate due to alcohol. Interview revealed a 26 ml ChloraPrep was used during Patient #1 surgery. Interview revealed she visualized the package in the trash after the procedure. Interview revealed staff are not suppose to use the 26 ml applicator on neck and head surgeries. Interview revealed she does not know if there were any non-alcohol based skin prep solutions available in OR #2, but they are available in the OR suite.
Interview on 07/31/2013 at 1545 with OR Management Staff revealed the hospital does use alcohol based skin preparation solutions. Interview revealed the hospital uses ChloraPrep and DuraPrep. Interview revealed ChloraPrep is supplied in a 26 ml and 3 ml applicator. Interview revealed DuraPrep is supplied in a 26 ml applicator. Interview revealed the hospital has been using alcohol based skin preparation solutions for the past 5-10 years. Interview revealed staff receive training annually on alcohol based skin preparation solutions. Interview revealed the training is documented in the staff's training file. Interview revealed Physicians are not trained by the OR for use of alcohol based skin preparation solutions. Interview revealed in cases of emergency physicians may prep a patient using a alcohol based skin preparation solution. Interview revealed staff should not be using the 26 ml applicators on the neck, face, or vaginal areas due to pooling. Interview revealed the OR does not have a policy specifically for the use of alcohol based patient skin prep solutions. Interview revealed policy 7211-0803 Operating Room Fire Safety, was updated in July as a result of the fire on 06/27/2013 involving Patient #1. Interview revealed the policy was revised to include defined interventions for the fire risk assessment score; a minimum prep drying time of 3 minutes; and all emergency surgical procedures should utilize non alcohol-based prep solutions unless non-alcohol based solution is contraindicated due to a know patient allergy to prep solution.
Consequently the findings confirmed the hospital's surgical OR staff failed to maintain fire safety in an oxygen enriched environment; failed to follow established fire safety prevention policies and procedures; and failed to adhere to the manufacturer's product label directions and warnings for an alcohol based patient perioperative skin preparation solution.

NC00090765