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Based on observation, interview and record review, it was determined the Condition of Participation: Physical Environment was not met. The facility failed to maintain the physical environment to ensure the safety and well-being of patients. The facility failed to ensure patient care equipment received preventative maintenance per policy. Refer to C222.

Based on observation, record review and interview, the facility failed to ensure patient care equipment was maintained in safe operation condition. A Electrosurgical Generator (used as a power source in conjunction with a hand held electrode to halt blood loss) was utilized during surgery for three (3) of ten (10) sampled patients (patient #1, #4 and #6) during the months of March and April 2013. The hospital's Preventative Maintenance and Electrosurgical Unit policies revealed the unit would be checked, cleaned, and a preventative maintenance inspection would be completed on this equipment on a semiannual basis. However, preventative maintenance and/or inspection had not been preformed on the Electrosurgical Generator since June 2012. The electrosurgical equipment was used during out-patient surgery on Patient #1 on 04/18/13. During the procedure, a fire occurred from a spark from the Cautery (electrosurgical equipment) that came into contact with oxygen that had accumulated underneath the surgical drape. Patient #1 sustained second degree burns to the face.

The findings include:

The facility policy titled "Preventive Maintenance" "Electrosurgical Unit," undated, revealed the unit would be checked, cleaned, and a preventative maintenance inspection would be completed on this equipment on a semiannual basis.

The facility policy titled "Anesthesia Awareness," dated January 2007, revealed all anesthesia equipment was on the preventive maintenance inventory rotation and would be thoroughly assessed by the Biomedical Engineer on a routine schedule.

Review of the manufacture's user guide for the Force 2 Electrosurgical Generator revealed the manufacture recommended that the Force 2 generator be inspected by qualified service personnel twice per year.

Interview with the Biomedical Staff on 04/29/13 at 3:40 PM revealed the facility no longer had a preventive maintenance program in place to monitor the Operating Room (OR) equipment. According to the Biomedical Staff, the contract was null after the facility filed bankruptcy in July 2012. The Biomedical Staff stated the last preventive maintenance conducted on the electrosurgical equipment Cautery equipment was in June 2012.

Documentation in the medical records of Patients #1, #4, and #6 revealed Surgeon #1 performed an electrosurgical procedure (a procedure that uses an electrical current to cut and/or to halt blood loss) for lesions on Patient #1's temple area, on Patient #4's neck, and on Patient #6's scalp.

Review of Patient #1's medical record, including the post-operative anesthesia report, revealed the patient underwent outpatient surgery (Temporal Artery Biopsy) on 04/18/13. Further review revealed during the surgical procedure, while closing the subcutaneous tissue with an electrosurgical instrument, a fire was encountered when electrical currents from the electrosurgical instrument mixed with the oxygen provided through a nasal cannula. The post-operative anesthesia documentation revealed 6 liters of nasal oxygen was in use during the operative process which ignited a fire that caused "slight" burns to Patient #1's face, hair, and eyebrows with no airway complications noted. Further review of the post-operative note revealed the oxygen was removed immediately by Surgeon #1 and Patient #1's burns were assessed by the surgeon. Review of the nursing notes dated 04/18/13 at 12:15 revealed Patient #1 was transported by ambulance to a regional trauma hospital for further evaluation.

Review of the medical record from the receiving hospital revealed Patient #1 sustained second-degree burns to 4 percent of the body.

A review of medical records revealed Patient #4 received outpatient surgery on 03/27/13. According to the medical record, electrosurgical equipment was used to remove a cyst from Patient #4's neck. Patient #6 received outpatient surgery on 04/16/13. According to patient #6's medical record, electrosurgical procedure was used to remove a cyst from the patient's scalp.

Interview with the Administrator on 05/02/13 revealed he had been employed at the facility a short time and was not aware of the facility's policies related to electrosurgical equipment/procedures. According to the administrator, the last preventative maintenance performed on the electrosurgical equipment was in June 2012.

Based on the survey findings it was determined the Condition of Participation for Organizational Structure, 42 CFR 485.627, was not met.
The facility failed to ensure Bylaws had been approved by the Governing Body before they were considered effective.

Refer to C0241.

Based on interview, and review of facility Bylaws it was determined the facility failed to ensure Bylaws had been approved by the Governing Body before they were considered effective.

The findings include:

Review of facility Bylaws revealed no evidence the bylaws had been approved by the Governing Body.

Interviews with Administration staff (Risk Manager, Joint Commission Coordinator, and Director of Nursing) on 05/01/13 at 5:30 PM revealed no explanation why the Governing Body had not approved the facility's Bylaws.

Interviews were conducted with the Hospitalist on 05/01/13 at 5:00 PM and Chief of Staff on 05/02/13 at 12:45 PM and revealed they were members of the Medical Staff and Governing Body. The Hospitalist and the Chief of Staff stated the current Governing Body had not approved the facility's Bylaws. According to the Chief of Staff, the previous Governing Body/Owners took everything with them when they left. The Chief of Staff and Hospitalist both knew the Bylaws needed to be revised and approved by the Governing Body. Both stated the facility's financial issues had taken priority over the Bylaws.

The Administrator stated in interview on 05/02/13 at 11:00 AM that previous owners of the hospital "took everything" leaving the facility with nothing. The Administrator who had only been providing leadership for approximately two (2) months stated, "We're just trying to keep the doors open." The Administrator was not aware the Governing Body had not approved the Bylaws.

Based on the survey findings it was determined the Condition of Participation for Surgical Services, 42 CFR 485.639, was not met. The facility failed to provide surgical services in a safe manner for four of ten patients (Patients #1, #4, #6, and #10). According to facility policy, solutions, tinctures, and aerosols must dry completely; evaporate/dissipate before draping, and before the use of the electrosurgical equipment and/or Laser use. Further review of the Surgical Service Safety Policies revealed staff was to ensure that oxygen did not become trapped under the drape during surgical procedures.

Documentation in the medical records of Patients #1, #4, #6, and #10 revealed Surgeon #1 performed an electrosurgical procedure (a procedure that uses an electrical current to cut and/or to halt blood loss) for lesions on Patient #1's temple area, on Patient #4's neck, on Patient #6's scalp, and on Patient #10's lip. Based on documentation, each patient received oxygen via nasal cannula during the procedures.

During the electrosurgical procedure of a temporal artery lesion for Patient #1 on 04/18/13, the patient received 6 liters of continuous oxygen through a nasal cannula while surgically draped.

A review of the Electrosurgical Generator (used as a power source in conjunction with a hand held electrode to halt blood loss) guide and a telephone interview with a representative of the manufacturer of the instrument revealed 6 liters of nasal cannula oxygen should not have been used in close proximity to the surgical site when the electrosurgical procedure was in use. Staff interviews, medical record review, and review of the facility's Root Cause Analysis report revealed the oxygen under the drape ignited with the electrosurgical equipment which resulted in a fire to Patient #1's face which caused second-degree burns. Patient #1 was transferred to a regional trauma hospital for further treatment of the burns. Review of the medical record from the receiving hospital revealed Patient #1 sustained second-degree burns to 4 percent of the body.

Based on the findings, Immediate Jeopardy was identified on 05/03/13. The facility was out of compliance with the Conditions of Participation at 42 CFR 485.639 Surgical Services (C0320); and associated Standard, Designation of Qualified Practitioners (C0321). (Refer to C0321.)

The findings include:

Review of facility polices titled "Patient Safety in the Operating Room," dated July 1990, revealed the policy included the prevention of Burns/Fires. According to the policy, solutions, tinctures, and aerosols must dry completely; evaporate/dissipate before draping, and before the use of the electrosurgical unit and/or Laser. Further review of the policies revealed staff was to ensure that oxygen did not become trapped under the drape during surgical procedures.

The facility policy titled "Anesthesia Awareness," dated January 2007, revealed all anesthesia equipment was on the preventive maintenance inventory rotation and would be thoroughly assessed by the Biomedical Engineer on a routine schedule.

The facility policy titled "Preventive Maintenance" "Electrosurgical Unit," undated, revealed a preventive maintenance inspection would be completed semiannually. However, interview with the Biomedical Staff on 04/29/13 at 3:40 PM revealed the facility no longer had a preventive maintenance program in place to monitor the Operating Room (OR) equipment. According to the Biomedical Staff, the contract was null after the facility filed bankruptcy in July 2012. The Biomedical Staff stated the last preventive maintenance conducted on the electrosurgical equipment Cautery equipment was in June 2012.

Review of the manufacture's user guide for the Force 2 Electrosurgical Generator related to patient and OR safety revealed a warning for fire/explosion hazard if used in an oxygen-enriched atmosphere. According to the user guide, the sparking and heating associated with electrosurgery could provide an ignition source and staff should observe fire precautions at all times.

Review of Patient #1's medical record, including the post-operative anesthesia report, revealed the patient underwent outpatient surgery (Temporal Artery Biopsy) on 04/18/13. Further review revealed during the surgical procedure, while closing the subcutaneous tissue with an electrosurgical instrument, a fire was encountered when electrical currents from the electrosurgical instrument mixed with the oxygen provided through a nasal cannula. The post-operative anesthesia documentation revealed 6 liters of nasal oxygen was in use during the operative process which ignited a fire that caused "slight" burns to Patient #1's face, hair, and eyebrows with no airway complications noted. Further review of the post-operative note revealed the oxygen was removed immediately by Surgeon #1 and Patient #1's burns were assessed by the surgeon. Review of the nursing notes dated 04/18/13 at 12:15 PM revealed Patient #1 was transported by ambulance to a regional trauma hospital for further evaluation.

The medical record for Patient #1 was requested and received from the regional trauma hospital where Patient #1 was transferred on 04/18/13 for further evaluation. According to the medical record, Patient #1 had received second-degree burns on 4 percent of the body.

Operating Room (OR) Technician #1 stated in interview on 04/29/13 at 11:15 AM that she was present in the OR when the fire occurred. OR Tech #1 stated most of Patient #1's face and nose were under the surgical drape during the surgical procedure and confirmed the patient was receiving oxygen through a nasal cannula. OR Technician #1 stated the Surgeon was getting ready to close the surgical site and obtained the electrosurgical equipment to halt a bleed around an artery. According to OR Technician #1, the surgeon was using the electrosurgical equipment and she heard a "swoosh" sound. OR Technician #1 stated a fire had ignited on the patient's face and Surgeon #1 "patted" the fire under the drape but the fire didn't go out and, at that time, the Surgeon removed the drape off the patient and wiped the patient's face with saline. OR Technician #1 stated the patient's face looked "dark, scorched, burnt," and skin was peeling from the patient's nose and mouth. OR Technician #1 stated water was also poured on the patient's scorched hair.

OR Technician #2 stated in interview on 04/29/13 at 5:00 PM that she was present in the OR on 04/18/13 when Patient #1 was prepared for outpatient surgery for biopsy of a lesion on the patient's temporal artery. OR Technician #2 stated the patient received oxygen under the drape per nasal canal. According to OR Technician #2, Patient #1 began to arouse from sedation toward the end of the procedure, the Certified Registered Nurse Anesthetist administered additional sedative medications to Patient #1 and, at that time, Patient #1's oxygen saturation level began to decrease. The OR Technician stated she "heard" an increase in oxygen while the surgeon was using the electrosurgical equipment. OR Tech #2 stated "it all happened so fast" and the Surgeon tried to extinguish the fire by "patting" the fire under the drape on the patient's face. OR Technician #2 stated the fire on the patient's face continued and the surgeon removed the drape to extinguish the fire on the patient's face.

An interview was conducted with Registered Nurse (RN) #1 on 04/29/13 at 3:00 PM. RN #1 stated she was also present in the OR during Patient #1's surgical procedure on 04/18/13. RN #1 stated during the surgical procedure Patient #1 received oxygen by a nasal cannula and a fire had occurred. RN #1 confirmed the patient's face, including the nose, was draped when the fire stated. RN #1 stated she had turned her back to the patient to get her paperwork and when she turned back around, she saw the drape on fire and the surgeon "patting" the drape in an effort to extinguish the fire. RN #1 stated after the fire was extinguished, the surgeon cleansed Patient #1 with saline and applied ointment. RN #1 stated the patient was transported to recovery and then transferred to a regional trauma hospital. RN #1 stated the front of Patient #1's hair and his/her eyebrows were burned. RN #1 also stated, "I would say the patient will have facial scars."

A telephone interview was conducted with Certified Registered Nurse Anesthetist (CRNA) #1 on 04/30/13 at 12:15 PM. The CRNA stated Patient #1 was administered six liters of oxygen per nasal cannula during the entire procedure performed on 04/18/13. CRNA #1 stated the use of oxygen was necessary and stated, "No one would do this surgery without using oxygen." The CRNA did not want to continue the interview without his attorney present.

The CRNA Supervisor stated in interview on 04/30/13 at 11:00 AM that CRNA #1's employment had been terminated on 04/18/13. The CRNA Supervisor stated in his practice, 6 liters of oxygen with Cautery would not have been used. The CRNA Supervisor did not want to continue the interview without a lawyer present.

An interview conducted with a representative of the manufacturer of the electrosurgical equipment that was used during the surgical procedure for Patient #1 revealed the use of oxygen at 6 liters per nasal cannula while using the equipment would be considered a "user error."

Surgeon #1 was out of the country and not available for interview during the course of the investigation.

Review of the facility's investigation dated 04/22/13 and the facility's the Root Cause Analysis report, revealed the fire that occurred on 04/18/13 during Patient #1's surgical procedure occurred from a spark from the Cautery (electrosurgical equipment) that came into contact with oxygen that had accumulated underneath the surgical drape. Further review revealed additional meetings would be planned to review the investigation and to discuss the facility's plan of action. There was no evidence that the facility had a plan of action in place as of 05/03/13.

In addition, Medical Record reviews were conducted on nine other similar cases performed by Surgeon #1. Three of the additional medical records reviewed revealed Surgeon #1 performed electrosurgical procedures while oxygen was being administered per nasal cannula. A review of medical records revealed Patient #4 received outpatient surgery on 03/27/13. According to the medical record, Patient #4 received six (6) liters of oxygen per nasal cannula while electrosurgical equipment was used to remove a cyst from the patient's neck. Patient #6 received outpatient surgery on 04/16/13. According to patient #6's medical record, the patient received 6 liters of oxygen per nasal cannula while an electrosurgical procedure was used to remove a cyst from the patient's scalp. Patient #10 received outpatient surgery on 8/15/12. According to the medical record, patient #10 received 6 liters of oxygen while an electrosurgical procedure was in use to remove a lesion from the patient's lip.

Interview with the Administrator on 05/02/13 revealed he was not aware of the facility's policies related to electrosurgical equipment/procedures and the use of oxygen. The Administrator stated he had been employed at the facility a short time and was not aware of the surgical procedures for Patient # 4, #6, and #10; and had not been involved in the review/investigation of the surgical procedure when a fire had occurred in the OR during a procedure by Surgeon #1 on Patient #1.

Based on interview, record review and review of facility bylaws it was determined the facility failed to ensure surgical privileges were designated for one of three physician's selected for review (Surgeon #1). Surgeon #1 performed a Temporal Artery Biopsy on Patient #1 during an outpatient surgical procedure on 04/18/13. However, it could not be determined by interview and a review of Surgeon #1's personnel file that the facility had approved the physician to perform the procedure.

The findings include:

Review of facility bylaws revealed the facility had a system in place to ensure clinical privileges and functions had been granted for every practitioner permitted by law and by the Board to provide patient care services independently in the hospital. According to the bylaws, practitioners were entitled to exercise only those clinical privileges granted in accordance with the bylaws.

Review of patient #1's medical record revealed the patient underwent outpatient surgery on 04/18/13 for a Temporal Artery Biopsy performed by Surgeon #1. Further review of the medical record revealed an electrosurgical procedure was utilized to perform the surgery and, while a surgical drape covered the patient's nose and oxygen cannula, a fire occurred when the electrosurgical equipment came into close proximity to the patient's nasal oxygen. According to the operative note, the surgical drape and the nasal cannula/oxygen were removed from the patient's face and the fire was extinguished. Further review revealed Patient #1 received superficial burning of the facial region.

Review of the credentials file revealed no evidence that Surgeon #1 had been designated to perform Temporal Artery Biopsies.

Interviews with the Risk Manager, the facility's Joint Commission Coordinator, and Director of Nursing on 05/01/13 at 5:30 PM revealed no explanation as to why Surgeon #1's credential file did not include privileges to perform the Temporal Artery Biopsy, or that the surgeon had been permitted to perform the procedure for Patient #1 on 4/18/13.

Interviews were conducted with the Administrator on 05/02/13 at 11:00 AM; the Hospitalist on 05/01/13 at 5:00 PM; and the facility's Chief of Staff on 05/02/13 at 12:45 PM. The Administrator stated he had been employed at the facility for a short time and did not know Surgeon #1 had not been designated the privilege to perform the Temporal Artery Biopsy. The Hospitalist and the Chief of Staff offered no explanation why Surgeon #1 had not been approved to perform a Temporal Artery Biopsy procedure and was allowed to perform the procedure on Patient #1 on 04/18/13.