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RIVERSIDE MEDICAL CENTER 350 N WALL ST KANKAKEE, IL 60901 July 13, 2012
VIOLATION: SURGICAL SERVICES Tag No: A0940
A. Based on a review of policy and procedure, the Hospital's draft RCA, medical records, staff training records, the Hospital's "Actions Taken and Action Plan," and staff interview, it was determined that the Hospital failed to ensure it provided surgical services in accordance with acceptable standards of practice as related to the use of a FRA tool to decrease/prevent the risk of a surgical fire. The cumulative effect of not using a FRA tool resulted in 1 of 1 (Pt. #1) an outpatient surgical patient receiving burns to the face, neck, shoulder, and hand and subsequent transfer to another facility for specialized care. The changes in the Hospital policy and procedures, implemented 7/13/12, related to surgical fires did not adequately address system wide processes that would decrease or eliminate the possibility of another surgical fire.

An Immediate Jeopardy (IJ) was identified on 7/13/12 at 9:55 AM with the Senior VP, VP of Clinical Operations, Director of Quality Improvement, and the Director of Risk Services present. Due to the Hospital's lack of corrective measures to prevent another surgical fire, the IJ remains in effect as of survey exit date 7/13/12 at 1:00 PM.

Findings include:

1. The Hospital failed to ensure the standards of practice for fire prevention were implemented. Please see the deficiency cited at A-951A.

2. The Hospital failed to ensure that all OR staff were trained in the prevention of OR fires. Please see the deficiency cited at A-951B.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

A. Based on medical record review, a review of policy and procedure, review of the Hospital's RCA, and staff interview, it was determined that in the hospital failed to follow standards of practice resulting in a surgical fire 1 of 1 (Pt. #1) causing an outpatient to receive burns to the face, neck, shoulder, and hand and subsequent transfer to another facility for specialized care, and 6 of 9 (Pts #2, #3, #4, #5, #6, #7) medical records reviewed in which the patient had surgery performed above the xiphoid process, the Hospital failed to ensure the recommended practices for fire prevention were implemented.

Findings include:
1. The medical record of Pt #1 was reviewed on 7/12/12 at 1:35 PM. It indicated Pt #1 was admitted to outpatient surgery on 7/9/12 for removal of a lesion on the forehead under conscious sedation with 8L of oxygen per mask. Documentation in the consultation report, dated 7/9/12, indicated "In listening to the report given by..." Pt #1's nurse "the procedure was apparently virtually complete when by report..." Pt #1's surgeon "noted one area of lesion and/or bleeding requiring cautery..." Pt #1 was inadvertently set on fire causing first to third degree burns to Pt #1's face, right hand, back of shoulders, and into hair. Pt #1 was intubated and arrangements were made for immediate transfer to a tertiary burn unit at another hospital. There was no documentation of stoppage/titration of the oxygen flow rate for Pt #1 while the cautery device was being used. There was no documentation that indicated a FRA was done on Pt #1, that a FRA was announced during the time out, or that specific actions directly related to the prevention of a surgical fire were implemented.

2. On 7/12/12 at 10:30 AM, the VP of Clinical Operations verbalized that the Hospital followed the AORN guidelines for surgical procedures. The AORN guidelines titled, "Perioperative Standards and Recommended Practices For Inpatient and Ambulatory Settings" (the 2012 Edition) were reviewed on 7/12/12 at 2:00 PM. In the guidelines there is a "Fire Risk Assessment Tool" with instructions for use. According to the Fire Risk Assessment Tool, Pt #1 would have been identified as a "B" risk (the surgical procedure being performed above the xyphoid process) which would have caused the following actions to be implemented; "1. Coat head and facial hair near the surgical site with water-soluble surgical lubricant to decrease flammability. 2. Use an adhesive incise drape." and also a "C" risk (Is open oxygen or nitrous oxide being administered?" The actions to be taken are, "1. Use the following strategies to manage the risks of both oxygen and nitrous oxide. 2. Configure surgical drapes to allow sufficient venting of oxygen delivered to the patient via mask or nasal cannula. 3. Deliver 5L to 10 L/min of air under the surgical drapes to flush out excess oxygen via a separate administration system, if oxygen is being administered via mask or nasal cannula. 4. Titrate oxygen to the lowest percentage necessary to support the patient's physiological needs. 5. Stop supplemental oxygen for one minute before using electrosurgery, electrocautery, or laser for head, neck, or upper chest procedures., etc"

3. The Hospital's draft RCA, dated 7/9/12, was reviewed on 7/13/12. It indicated under "Analysis Summary: ...Action - Use fire proof gel on hairline and eyebrows on cases above the xiphoid process with cautery." There was no documentation to implement the actions for the venting of oxygen and the stoppage/titration of supplemental oxygen as per the AORN guidelines.

4. The medical record of Pt #2 was reviewed on 7/12/12 at 1:50 PM. It indicated Pt #2 was admitted for surgery with a procedure for excision of multiple skin nevi from right head and left head and face on 7/11/12. There was no documentation that indicated a FRA was done for Pt #2, that a FRA was announced during the surgical time out, or that specific actions directly related to the prevention of a surgical fire were implemented.

5. The medical record of Pt #3 was reviewed on 7/13/12 at 8:45 AM. It indicated Pt #3 was admitted on [DATE] for surgery with a procedure for the removal of a right nasal tip [DIAGNOSES REDACTED]. There was no documentation that indicated a FRA was done for Pt #3, that a FRA was announced during the surgical time out, or that specific actions directly related to the prevention of a surgical fire were implemented.

6. The medical record of Pt #4 was reviewed on 7/13/12 at 9:00 AM. It indicated Pt #4 was admitted for surgery with a procedure for removal of left nasal tip squamous cell [DIAGNOSES REDACTED] on 7/10/12. There was no documentation that indicated a FRA was done for Pt #4, that a FRA was announced during the surgical time out, or that specific actions directly related to the prevention of a surgical fire were implemented.

7. The medical record of Pt #5 was reviewed on 7/13/12 at 9:30 AM. It indicated Pt #5 was admitted on [DATE] for a surgical procedure for removal of [DIAGNOSES REDACTED]#5, that a FRA was announced during the surgical time out, or that specific actions directly related to the prevention of a surgical fire were implemented.

8. The medical record of Pt #6 was reviewed on 7/13/12 at 10:00 AM. It indicated Pt #6 was admitted on [DATE] for a surgical procedure for removal of [DIAGNOSES REDACTED].

9. The medical record of Pt #7 was reviewed on 7/13/12 at 10:15 AM. It indicated Pt #7 was admitted on [DATE] for a surgical procedure for removal of [DIAGNOSES REDACTED]]. There was no documentation that indicated a FRA was done for Pt #7, that a FRA was announced during the surgical time out, or that specific actions directly related to the prevention of a surgical fire were implemented.

10. During an interview with the Vice President of Clinical Operation, conducted on 7/13/12 at 10:45 AM, it was verbalized that there should have been documentation in the charts that indicated a FRA was done, that a fire risk score was announced during the surgical time out, and that the actions required by the FRA were implemented.

B. Based on a review of Mandatory OR Training, the Hospital's "Actions Taken and Action Plan," OR staff training records, and staff interview, it was determined that the Hospital failed to ensure that all OR staff were trained in the prevention of OR fires as per the AORN guidelines for fire safety, that the Hospital stated they were to follow, and in addition received updated training since the adverse event on 7/9/12. This has the potential to affect all patients who receive surgical services at the Hospital.

Findings include:

1. The Mandatory OR Unit Meeting "Record of Staff Training for 3/1/12 for OR employees was reviewed. The training consisted of "Patient on Fire" video, Fire Department Demo, deploy of water mist, and the use of the Paraslide. The "Fire Drill Conductor Evaluation" indicated a "simulated situation: Pt Fire in Airway in OR Suite" the training consisted of what to do when a fire occurs. There was no documentation to indicate that staff were trained on assessing and minimizing the risk of OR fires as per the AORN guidelines.

2. The Hospital's "Actions Taken and Action Plan - July 12, 2012" was reviewed. It indicated "Revised Surgical Time Out Checklist in every OR and staff educated - Completed 7-12-2012...Surgeon educational review utilizing AORN guidelines on fire prevention in ORs initiated immediately on 7-9-12 and ongoing, Formal review of AORN guidelines on fire prevention in ORs will be conducted with surgeons at next Department meetings...Reviewed AORN guidelines on fire prevention immediately with all staff in morning huddles-Completed 7-10-12 and ongoing, All staff not present at AORN review on fire prevention on 7-10-12 will receive review prior to working next shift..." None of the measures related to the education of the OR staff and implementation of preventive fire measures were implemented as of the survey exit date of 7/13/12 and OR procedures were still being performed.

3. The training of the OR staff involved with the incident on 7/9/12 were reviewed. There was no documentation in the training records that the surgeon, circulating nurse, nor the scrub nurse had received any specialized training in the prevention of OR fires prior to the incident of 7/9/12 or since 7/9/12.

4. The surgeon, who was present during the OR fire on 7/9/12, was interviewed on 7/13/12 at 8:30 AM. The surgeon stated that he had performed surgeries at the Hospital since 1976. The surgeon verbalized that he had not received any training in the prevention of OR fires during that time. The surgeon did not know what FRA tool the Hospital followed, could not identify who was to complete the FRA, when it was to be announced, or the actions that would be utilized to decrease the risk of a surgical fire.

5. The CRNA #1, who was present during the OR fire on 7/9/12, was interviewed on 7/13/12 at 8:45 AM. CRNA #1 stated that he had been providing anesthesia services at the Hospital since 2005. CRNA #1 verbalized that he had not received any training in the prevention of OR fires during that time. CRNA #1 did not know what FRA tool the Hospital utilized, could not identify who was to complete the FRA, nor what actions that would be utilized to decrease the risk of a surgical fire. CRNA #1 did know that the FRA was to be announced during the surgical time out but verbalized that he had learned that only this morning.

6. The circulating nurse (RN #1), who was present during the OR fire on 7/9/12, was interviewed on 7/13/12 at 9:00 AM. The circulating nurse stated she had worked at the Hospital since 2004. The circulating nurse verbalized that she had not received any training in the prevention of OR fires during that time. The circulating nurse did not know what FRA tool the Hospital followed, could not identify who was to complete the FRA, when it was to be announced, or the actions that would be utilized to decrease the risk of a surgical fire.

7. On 7/13/12 at 10:12 AM CRNA #2 was interviewed. CRNA #2 stated she has worked at the Hospital since June 2008. CRNA #2 verbalized that the only fire training she received was through the Hospital online course and that only covered regular fires. It did not cover fire prevention in the OR. CRNA #2 also stated that she was not aware of any FRA tool used in the past. CRNA #2 was receiving training on the Hospital's new FRA today.

8. On 7/13/12 at 10:21 AM, RN #3 was interviewed. RN #3 stated that she was the OR Educator and was currently implementing training on the new FRA. When asked to be shown the new FRA, RN #3 provided a FRA that deviated from the AORN FRA tool. RN #3's FRA used numbers to determine if the surgical patient was at high risk or low risk for a surgical fire. The AORN FRA tool does not determine the amount of risk. The FRA addresses the procedure, equipment used, and gasses utilized to indicate what actions will reduce the likely hood of a surgical fire.

9. On 7/13/12 at 10:35 AM, CRNA #3 was interviewed. CRNA #3 stated that she has worked at the Hospital since 1/2012. CRNA #3 verbalized that her fire training was during orientation and on the Hospital's online training system. CRNA #3 stated that none of the fire training included training specifically to the prevention of surgical fires.

10. On 7/13/12 at 10:45 AM RN #4 was interviewed. RN #4 stated that she often work as a scrub tech and has been working in surgery in the Hospital since 2004. RN #4 verbalized that a FRA had never been used prior to 7/9/12. RN #4 stated that on 7/10/12 some fire risk assessment was covered in the morning meetings.

11. During an interview on 7/13/12 at 9:30 AM with the Senior Vice President, (who was present during all the interviews), the Senior Vice President verbalized that the OR staff that were interviewed, should have known the answers to the questions posed during the interviews. The Senior Vice President also verbalized that of the 53 physicians with surgical privileges, 9 had been talked to about fires in the OR since 7/9/12. However, the documentation presented indicated that these surgeons were educated on, "...how to prevent surgical fires, which included the three components of a fire in the OR: delivery of oxygen, draping and use of cautery. Surgical preps and drying times were also discussed." There was no documentation that indicated they received any training on a FRA tool, how the tool was to be used, and what actions were to be implemented related to the score of the patient on the FRA tool.

12. During the above interviews, the VP of Clinical Operations was present. At the conclusion of the interviews, on 7/13/12 at 11:00 AM, the VP of Clinical Operations stated that the process for FRA in the OR that was implemented was confusing.