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

OWENSBORO HEALTH MUHLENBERG COMMUNITY HOSPITAL 440 HOPKINSVILLE STREET GREENVILLE, KY 42345 Sept. 3, 2015
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, record review, and review of the U.S. Food and Drug Administration (FDA) "Preventing Surgical Fires: FDA Safety Communication", it was determined the facility failed to provide safe surgical care by failing to follow nationally recognized guidelines and procedures to prevent surgical fires for one (1) of ten (10) sampled patients (Patient #1).

The findings include:

Review of the facility's policies revealed no reference to conducting a fire risk assessment prior to each surgical case.

Review of the U.S. Food and Drug Administration (FDA) "Preventing Surgical Fires: FDA Safety Communication" (issued [DATE]) revealed information on preventing fires in surgical environments. The first recommendation contained in this document stated, "Conduct a fire risk assessment at the beginning of each procedure. The highest risk procedures involve an ignition source, delivery of supplemental oxygen, and the operation of the ignition source near the oxygen (e.g., head, neck, or upper chest surgery)."

Review of Patient #1's medical record revealed he/she was admitted on [DATE] for an outpatient surgical procedure scheduled for 08/24/15. The surgical consent described the operation as "Incision and evacuation of left hand hematoma, biopsy of left skin lesion". Review of the surgeon's operative report, dated 08/24/15, revealed the procedure was performed under monitored anesthesia care (MAC) with local anesthetic infiltration to the surgical sites. The procedure to the hand was completed and the biopsy to the lesion to the face was initiated. During the procedure, the patient was receiving oxygen by way of a mask, which was shifted away from the surgical site. The surgeon documented an incisional biopsy to the face lesion was completed and an electrosurgical unit (ESU) was used to control a small amount of bleeding. A spark from the ESU led to a fire inside the face mask that was still attached to the patient's face. Although the fire was quickly extinguished, the patient suffered burns to the nose and "perioral" skin. There was no documented evidence a fire risk assessment had been completed prior to the beginning of this procedure. Further review of the record revealed Patient #1 was admitted to the hospital's intensive care unit and required total parenteral nutrition (TPN) and multiple doses of narcotic pain medication. On 08/28/15, the patient was transferred to the hospital's long term care unit.

Review of nine (9) additional patient records was completed for patients who underwent surgical procedures and had risk factors for surgical fires (Patients #2, #3, #4, #5, #6, #7, #8, #9, and #10). These risk factors included the use of oxygen, surgical procedures that occurred above the xiphoid process, use of an ESU, and use of an alcohol based skin preparation. None of these records contained evidence of a fire risk assessment completed prior to the procedure.

Observation of Patient #1 was conducted on 08/31/15 at 10:17 AM at the hospital long term care unit. The patient was in bed and did not respond to verbal stimuli. First (1st) and second (2nd) degree burns were noted to his/her distal nose, upper and lower lips extending to his/her chin, and an area left lateral of his/her mouth. Further observation revealed a mole-like lesion approximately four (4) millimeters (mm) in diameter in the crease between the patient's nose and left cheek. A review of the medication record revealed the patient had received a narcotic analgesic (morphine) at 9:45 AM.

On 08/31/15 at 11:53 AM, an interview was conducted with the Registered Nurse (RN) circulator who was involved with this incident. She stated prior to the start of the procedure a "time out" had been performed as a standard safety precaution. However, a fire risk assessment had not been included in this procedure. The RN was not aware of any hospital policy which required a fire risk assessment.

On 08/31/15 at 2:30 PM, an interview was conducted with the Certified Registered Nurse Anesthetist (CRNA), who was providing care to Patient #1 at the time of the fire. The CRNA stated, at the beginning of the procedure, she moved the oxygen face mask to the side of the patient's face so it would be out of the operative field. The surgeon excised a specimen from the facial lesion and announced he had completed the procedure. The CRNA looked at the vital sign monitor to obtain a final recording for her anesthesia record. She heard the surgeon make an excited utterance and looked over to see a fire had erupted in the patient's oxygen face mask. The surgeon removed the mask, and at the same time, the CRNA discontinued the oxygen, and the RN removed the oxygen tubing from the anesthesia machine. At the time of the fire, the patient was receiving 100% oxygen at the rate of five (5) liters per minute (LPM). The CRNA stated she was not aware the surgeon was preparing to use the ESU. The CRNA stated had she been made aware the ESU was going to be used in close proximity to the oxygen mask, she would have discontinued the oxygen prior to the ESU's use. The CRNA stated a fire risk assessment had not been completed prior to the procedure.

On 09/02/15 at 11:48 AM, a telephone interview was conducted with the surgeon who performed the surgical procedure on Patient #1. The surgeon stated he was aware of safety precautions required to be taken relating to ESU units and oxygen. However, he inadvertently used the ESU during Patient #1's procedure due to an oversight. The surgeon stated a fire risk assessment had not been completed prior to Patient #1's procedure, but it was now routinely completed on all cases. A review of hospital training records revealed verification the operating room nursing staff and surgeons had been provided with information and procedures on conducting a fire risk assessment.

On 08/31/15 at 10:55 AM, an interview was conducted with the hospital Operating Room Director. She stated that, after the fire, the hospital conducted an investigation. After researching surgical fire hazards, it was determined the hospital lacked a fire risk assessment which needed to be conducted in conjunction with the surgical "time out". The hospital was in the process of updating its policies to include a fire risk assessment. This information was also verified in an interview with the Risk Manager on 09/02/15 at 11:25 AM.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observation, interview, and record review, it was determined the facility failed to promote and protect each patient's right to personal safety. The facility's failure led to the fire related injury for one (1) of ten (10) sampled patients (Patient #1), and created a potential for serious injury, harm, impairment, or death to all patients receiving surgical services. Immediate Jeopardy was determined to exist on 08/24/15 and was removed prior to exit on 09/03/15. The facility had incorporated a fire risk assessment into the surgical "time out" procedure, and had provided training on updated procedures to the nursing, anesthesia, and medical staff.

Refer to A 0144
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, record review, and review of the U.S. Food and Drug Administration (FDA) "Preventing Surgical Fires: FDA Safety Communication", it was determined the hospital failed to develop and implement policies and procedures consistent with recognized surgical standards governing fire safety in the operating room for one (1) of ten (10) sampled patients (Patient #1).

The findings include:

Review of the facility's policies revealed no reference to conducting a fire risk assessment prior to each surgical case.

Review of the U.S. Food and Drug Administration (FDA) "Preventing Surgical Fires: FDA Safety Communication" (issued [DATE]) revealed information on preventing fires in surgical environments. The first recommendation contained in this document stated, "Conduct a fire risk assessment at the beginning of each procedure. The highest risk procedures involve an ignition source, delivery of supplemental oxygen, and the operation of the ignition source near the oxygen (e.g., head, neck, or upper chest surgery)."

Review of Patient #1's medical record revealed he/she was admitted on [DATE] for an outpatient surgical procedure scheduled for 08/24/15. The surgical consent described the operation as "Incision and evacuation of left hand hematoma, biopsy of left skin lesion". Review of the surgeon's operative report, dated 08/24/15, revealed the procedure was performed under monitored anesthesia care (MAC) with local anesthetic infiltration to the surgical sites. The procedure to the hand was completed and the biopsy to the lesion to the face was initiated. During the procedure, the patient was receiving oxygen by way of a mask, which was shifted away from the surgical site. The surgeon documented an incisional biopsy to the face lesion was completed and an electrosurgical unit (ESU) was used to control a small amount of bleeding. A spark from the ESU led to a fire inside the face mask that was still attached to the patient's face. Although the fire was quickly extinguished, the patient suffered burns to the nose and "perioral" skin. There was no documented evidence a fire risk assessment had been completed prior to the beginning of this procedure. Further review of the record revealed Patient #1 was admitted to the hospital's intensive care unit and required total parenteral nutrition (TPN) and multiple doses of narcotic pain medication. On 08/28/15, the patient was transferred to the hospital's long term care unit.

Review of nine (9) additional patient records was completed for patients who underwent surgical procedures and had risk factors for surgical fires (Patients #2, #3, #4, #5, #6, #7, #8, #9, and #10). These risk factors included the use of oxygen, surgical procedures that occurred above the xiphoid process, use of an ESU, and use of an alcohol based skin preparation. None of these records contained evidence of a fire risk assessment completed prior to the procedure.

Observation of Patient #1 was conducted on 08/31/15 at 10:17 AM at the hospital long term care unit. The patient was in bed and did not respond to verbal stimuli. First (1st) and second (2nd) degree burns were noted to his/her distal nose, upper and lower lips extending to his/her chin, and an area left lateral of his/her mouth. Further observation revealed a mole-like lesion approximately four (4) millimeters (mm) in diameter in the crease between the patient's nose and left cheek. A review of the medication record revealed the patient had received a narcotic analgesic (morphine) at 9:45 AM.

On 08/31/15 at 11:53 AM, an interview was conducted with the Registered Nurse (RN) circulator who was involved with this incident. She stated prior to the start of the procedure a "time out" had been performed as a standard safety precaution. However, a fire risk assessment had not been included in this procedure. The RN was not aware of any hospital policy which required a fire risk assessment.

On 08/31/15 at 2:30 PM, an interview was conducted with the Certified Registered Nurse Anesthetist (CRNA), who was providing care to Patient #1 at the time of the fire. The CRNA stated, at the beginning of the procedure, she moved the oxygen face mask to the side of the patient's face so it would be out of the operative field. The surgeon excised a specimen from the facial lesion and announced he had completed the procedure. The CRNA looked at the vital sign monitor to obtain a final recording for her anesthesia record. She heard the surgeon make an excited utterance and looked over to see a fire had erupted in the patient's oxygen face mask. The surgeon removed the mask, and at the same time, the CRNA discontinued the oxygen, and the RN removed the oxygen tubing from the anesthesia machine. At the time of the fire, the patient was receiving 100% oxygen at the rate of five (5) liters per minute (LPM). The CRNA stated she was not aware the surgeon was preparing to use the ESU. The CRNA stated had she been made aware the ESU was going to be used in close proximity to the oxygen mask, she would have discontinued the oxygen prior to the ESU's use. The CRNA stated a fire risk assessment had not been completed prior to the procedure.

On 09/02/15 at 11:48 AM, a telephone interview was conducted with the surgeon who performed the surgical procedure on Patient #1. The surgeon stated he was aware of safety precautions required to be taken relating to ESU units and oxygen. However, he inadvertently used the ESU during Patient #1's procedure due to an oversight. The surgeon stated a fire risk assessment had not been completed prior to Patient #1's procedure, but it was now routinely completed on all cases. A review of hospital training records revealed verification the operating room nursing staff and surgeons had been provided with information and procedures on conducting a fire risk assessment.

On 08/31/15 at 10:55 AM, an interview was conducted with the hospital Operating Room Director. She stated that, after the fire, the hospital conducted an investigation. After researching surgical fire hazards, it was determined the hospital lacked a fire risk assessment which needed to be conducted in conjunction with the surgical "time out". The hospital was in the process of updating its policies to include a fire risk assessment. This information was also verified in an interview with the Risk Manager on 09/02/15 at 11:25 AM.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, interview, and record review, it was determined the facility failed to provide surgical services consistent with recognized standards of practice related to fire safety. The facility's failure led to the fire related injury for one (1) of ten (10) sampled patients (Patient #1), and created a potential for serious injury, harm, impairment, or death to all patients receiving surgical services. Immediate Jeopardy was determined to exist on 08/24/15 and was removed prior to exit on 09/03/15. The facility had incorporated a fire risk assessment into the surgical "time out" procedure, and had provided training on updated procedures to the nursing, anesthesia, and medical staff.

Refer to A 0951