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UNITYPOINT HEALTH - DES MOINES IOWA METHODIST MEDI 1200 PLEASANT STREET DES MOINES, IA 50309 Aug. 5, 2014
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on review of hospital policies and procedures, hospital documents, medical records, and staff interviews, the hospital staff failed to follow the established policies and procedures during surgical procedures of 2 patients undergoing surgery where a cautery device was used during the procedure to stop bleeding that occurred (Patients #1 and #2). The hospital staff reported completing 210 surgeries a week using cautery.

The failure of surgical staff to furnish surgical services in accordance with the hospital's hospital's policy/procedure titled "Skin Preparation Agents" during a surgical procedure for Patient #1 resulted in fire in the operating room. The patient had an injury resulting in an open skull fracture and required surgery to repair an open wound on 7/16/14. The surgeon used an alcohol gauze pad to cleanse the patient's head wound when it began to bleed. The surgeon used a battery operated cautery pen to stop the bleeding from the wound without allowing sufficient time for an alcohol gauze to dry or be removed from the area and allow the alcohol vapor to dissipate. The use of the cautery ignited the gauze resulting in a fire that was extinguished by the surgeon and and a flash of flames across the patient's head that was immediately extinguished by the anesthesiologist. The alcohol gauze had not sufficiently dried and alcohol vapor had not sufficiently dissipated at the time of the fire. The patient and the surgical staff were not injured. Refer to A 951.

The failure of surgical staff to furnish surgical services in accordance with the hospital's policy/procedure titled "Electro Surgery Unit (ESU) (perioperative)" during a surgical procedure for Patient #2 resulted in burns to the patient's legs. This policy/procedure required that the cautery pen to be placed in a holster when not in use during surgery. The surgical staff failed to ensure the cautery pen was placed in the holster between uses resulted in burns to the patient's legs from cautery pen during the surgical procedure on 6/30/14. During the patient's open heart procedure, veins removed from the patient's leg were used to bypass arteries in the patient's heart. The surgeon used a cautery connected to a machine connected to an electrical power source. During the procedure, a clip used to hold the drape and cautery cord in place pierced through the cautery cord without staff knowledge. This caused a short which caused the cautery to remain on (hot) even when not in use during the procedure. Instead of placing the cautery pen in the holster as required, the surgeon placed the cautery pen between the patient's legs for easy access to the cautery pen between uses. The patient experienced burns from the cautery pen due to the short that occurred during that procedure. The patients wounds required debridement and closure of the burns on the right lower leg. Refer to A 951.

During the investigation, findings revealed "Fire Safety Training" was completed by all staff working in the OR on a yearly basis except surgeons and anesthesiologists. This was verified by staff interview. Refer to A 951.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure all surgical procedures were provided in a safe environment for patients and the surgical team.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on review of policies, procedures, facility documents, medical records, and staff interviews, the hospital staff failed to follow policies and procedures for 2 patients requiring surgery while using a cautery device (a device that emits heat and is used to stop bleeding) during the surgical procedures (Patients #1 and #2). The hospital staff reported completing 210 surgeries a week using cautery.

Failure to follow hospital policies and procedures during surgeries using a cautery device could potentially cause the cautery device to accidentally activate, a fire could occur during the surgery, and cause injury or death to the surgical patient.

Findings include:

1. Review of the surgery policy/procedure titled "Electro Surgery Unit (ESU) (Perioperative)", dated 2014, included in part "... Ensure active electrodes are not activated in the presence of flammable agents (e.g., skin preparation solution) until the agents are dry and vapors have dissipated. ... Ensure the ESU unit is securely mounted on a cart that is easily moveable around the OR. ... Ensure the ESU cables and cords are not twisted or placed in such a position that kinking or interference is possible. ... Return the electrode to the holster when not in use. Rationale: Returning the electrode to the holster helps prevent accidental activation, injury or fire. ..."

Review of the surgery policy/procedure titled "Skin Preparation Agent", dated 2009, included in part "... Upon completion of the skin preparation, remove any linen that has become dampened with the preparation solution. Replace any cuff or positioning device padding that may have become dampened with the preparation solution. ... Additionally, alcohol-based preparation agents remain flammable until completely dry. ...Rationale: Pooled preparation agents require a longer time for evaporation. Soaked linens do not dry adequately. There is increased risk for fire with the use of heat and ignition sources (e.g., lasers, fiber optic cords, electro surgery). ..."

2. Review of the medical record for Patient #1 revealed the patient was admitted to Iowa Methodist Medical Center on 7/16/14 with a preoperative diagnosis of left frontal open skull fracture. The patient went to the operating room (OR) to have an incision with elevation and debridement of open skull fracture with cranial mesh covering the defect. The medical record indicated the patient did not experience any complications during the surgery.

a. The hospital submitted a self-report of the incident to the State Agency. The OR staff used a flammable disinfectant, failed to allow it to fully dry, and then used cautery. The cautery ignited the disinfectant which resulted in a small fire in the operating room during the preparation for this patient. The hospital reported that no injuries occurred to the patient or hospital staff.

b. During an interview on 8/4/14 at 12:50 PM, Staff A, Registered Nurse (RN) stated she was helping count instruments when she heard the fire occurred. Staff A said she observed 4x4 gauze pads on fire in Practitioner A's (MD) hand. RN A reported Practitioner A threw the gauze pads to the floor. Practitioner B (Anesthesiologist) attempted to put the fire out with his feet when the pant leg caught on fire. The OR staff threw water and towels on the fire to put it out. Staff A did not think the fire made contact with the patient.

c. During an interview on 8/4/14 at 1:40 PM, Practitioner A (surgeon) stated he used alcohol soaked gauze pads to cleanse the patient's head and wound prior to using the betadine (antiseptic) skin preparation and draping the head wound before performing surgery. Practitioner A stated the wound area started bleeding. Practitioner A reported using the cautery to stop the bleeding. A nurse retrieved a hand held cautery pen, operated by battery, for this procedure. Practitioner A began the cautery procedure approximately 5 minutes after using the alcohol scrub to the affected area. Practitioner A explained the alcohol soaked gauze pads were on a table located near the patient's head when he used the cautery device to stop the bleeding. Practitioner A reported a spark from the cautery pen ignited the alcohol fumes on the gauze pads and he threw them onto the floor. The nurses extinguished the fire on the floor and an evaluation showed the patient did not experience any adverse outcomes or burns. Practitioner A stated it was his fault for leaving the alcohol soaked gauze pads on the table during cauterization and that caused the alcohol soaked gauze pads to ignite.

d. During an interview on 8/5/14 at 6:30 AM, Staff B, RN stated she was standing behind Practitioner A when the fire occurred. Practitioner A had cleansed the wound on the patient's head with alcohol soaked gauze pads and then the wound started to bleed. Practitioner A asked for a cautery pen to stop the bleeding. Staff B said it was approximately 1 minute between the alcohol scrub and Practitioner A using the cautery device. Staff B reported Practitioner A held the alcohol soaked gauze pads in his hand while using the cautery to stop the bleeding. The cautery pen ignited the alcohol soaked gauze pads and Practitioner A threw them onto the floor. The OR staff extinguished the fire immediately. Staff B said it appeared the patient had a flame on his/her head. Staff extinguished the flames on the patient and then evaluated the patient. No burns or injuries were identified by the OR staff.

e. During an interview on 8/5/14 at 6:45 AM, Staff C, RN stated she stood across from Practitioner A and next to the patient during this incident. Practitioner A used alcohol soaked gauze pads to cleanse the patient's wound and scalp. The patient's wound started bleeding and Practitioner A asked for a cautery pen to stop the bleeding. Practitioner A held pressure on the wound while the nurse retrieved the cautery pen. Staff C was not sure if these were the alcohol soaked gauze pads or or dry gauze pads. Practitioner A had gauze pads in his hand while cauterizing the wound. The gauze pads that Practitioner A held caught on fire and Practitioner A threw them onto the floor. The OR staff extinguished the flames immediately. Staff C saw a flash of flames move across the patient's head. Staff C thought these were caused by the alcohol vapors. The flames on the patient's head were extinguished and the patient was evaluated for any injuries. The OR staff did not observe any patient burns or injuries.

f. During an interview on 8/5/14 at 9:45 AM, Practitioner B, (Anesthesiologist) stated Practitioner A cleansed the patient's wound and scalp with alcohol soaked gauze pads to remove blood and debris from the wound. The wound began to bleed and Practitioner A requested a cautery pen to stop the bleeding. The nurse went to get the cautery pen and it was approximately 2 to 3 minutes following the alcohol scrub prior to Practitioner A using the cautery pen. Practitioner A had the alcohol soaked sponges in his hand while using the cautery pen. The alcohol soaked sponges ignited, and Practitioner A threw them onto the floor. The OR staff extinguished the flames immediately. Practitioner B said he placed his hand on the patient's scalp, felt no heat, and evaluation of the patient's scalp showed no burns or patient injury.

3. Review of the medical record for Patient #2 revealed the patient was admitted to Iowa Methodist Medical Center on 6/30/14 with a preoperative diagnosis of severe coronary artery disease. The patient went to the OR for heart surgery that required taking veins from the patient's leg and using those veins in the heart to allow oxygenated blood to get to the heart. The patient experienced burns from a cautery pen, operated by an electrical power source, during that procedure and subsequently required debridement and closure of right lower extremity burns.

a. Review of patient/family grievances revealed documentation that the patient sustained burns to the leg from a cautery device placed on the table by the patient's leg during a surgical procedure.

b. During an interview on 8/5/14 at 12:00 PM, Staff D, RN stated during the surgery, staff heard a humming noise. Following an investigation, the OR staff determined the noise came from the cautery pen. The OR staff determined the penetrating clip used to hold the drape and cautery cord in place had pierced the cautery cord. The pierced cautery cord caused a short, causing the cautery to stay on all the time. The practitioner laid the cautery pen between the patient's legs. Placing the cautery pen between the patient's legs allowed easy access to the cautery pen between uses.

c. During an interview on 8/5/14 at 1:00 PM, Staff E, Surgical Technician stated she was helping the practitioner harvest a vein in the patient's leg to use on his/her heart. The practitioner used cautery during this procedure. The practitioner laid the cautery pen between the patient's legs following each use. Staff E reported the procedure required using cautery multiple times, however, cautery pen holster was available to hold the cautery pen between use. Staff E reported practitioners only use the holster approximately 50% (percent) of the time. Following the surgical procedure,Staff E noticed a burn to the patient's leg. Staff thought the cautery pen caused the burn. Staff identified the penetrating clip used to hold the drape and cautery cord had pierced the cord, causing a short in the cautery pen, causing it to stay on.

d. During an interview on 8/5/14 at 1:40 PM, Practitioner C, (surgeon) stated staff heard a beep/buzzing noise during the operation. After harvesting the vein from the patient's leg, the OR staff determined it was the cautery pen unit causing the noise. The OR staff noticed 2 to 3 burns on the patient's leg following the drape removal. The OR staff thought the penetrating clip used to hold the drape and cautery cord in place had pierced the cord. The pierced cord then caused a short in the cautery pen, causing it to stay on all the time. The practitioners generally laid the cautery pen between the patient's legs during the vein harvest procedures because it is used multiple times. The cautery pen holster was available to hold the cautery pen in when not in use and the OR staff did not utilize the holster at all times when not using the cautery pen in accordance with the policy and procedure.

3. Operating Room Meeting minutes revealed "Fire Safety Training" was completed by all staff working in the OR on a yearly basis except surgeons and anesthesiologists. During an interview with Staff F, RN on 8/4/14 at 1:15 PM, the RN verified Surgeons and Anesthesiologists are not involved in this annual training.