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9500 EUCLID AVENUE

CLEVELAND, OH 44195

GOVERNING BODY

Tag No.: A0043

Based on medical record review, staff interviews, documentation presented by Quality Assurance and Risk Management, the lack of monitoring of staff to ensure that manufacturer recommendations in the use of their products were followed; the lack of staff education in regard to what to do and who to notify in case of a fire; lack of monitoring of humidity levels in the operating rooms; the use of flammable preparations in the operating rooms; the lack of reporting to the proper authorities the instances of fire; and the lack of documentation in the medical record in regard to patient injury from fire, the Condition of Governing Body is NOT MET. The hospital has 89 operating rooms and the hospital's census was 988 patients at the time of the survey.

Findings include:

Review of documentation in regard to the instances of six fires in an 11 month period from April 2009 thru March 2010, with 3 of 6 patients (Patient #22, #54 and #55) involved being injured, revealed incomplete investigations were done; that there was a lack of information in regard to the patients' injuries documented in their medical records; and although education was provided there was no monitoring to ensure that staff were following and heeding the manufacturers' recommendation on the use of their products. This could affect all surgical patients at any time in any of the 89 operating rooms.

Please refer to A049, 482.12(a)(5) Ensure that the medical staff is accountable to the governing body for the quality of care provided to patients.

MEDICAL STAFF - ACCOUNTABILITY

Tag No.: A0049

Based on medical record review, staff interviews, documentation presented by Quality Assurance and Risk Management, the facility failed to monitor staff to ensure that manufacturer recommendations in the use of their products were followed; failed to ensure staff education in regard to what to do and who to notify in case of a fire; failed to monitor humidity levels in the operating rooms and the use of flammable preparations in the operating rooms; failed to report to the proper authorities the instances of fire; and failed to include documentation in the medical record in regard to patient injury from fire. The hospital has 89 operating rooms and the hospital's census was 988 patients at the time of the survey.

Findings include:

Review of documentation in regard to the instances of six fires in an 11 month period from April 2009 thru March 2010, with 3 of 6 patients (Patient #22, #54 and #55) involved being injured, revealed incomplete investigations were done; that there was a lack of information in regard to the patients' injuries documented in their medical records; and although education was provided there was no monitoring to ensure that staff were following and heeding the manufacturers' recommendation on the use of their products. This could affect all surgical patients at any time in any of the 89 operating rooms.

Interviews with the Quality Assurance staff (Staff L and CCCC) in regard to the fires revealed that although a root cause analysis was done on the first fire in April of 2009, the hospital continued to have fires caused by the same type of ignition. During one of the investigations, Quality Assurance asked the facility's engineering department if they monitor operating room humidity. The facility's engineering department stated that they did. The Quality Assurance staff person did not carry this part of the investigation any further. Interview with the facility's engineering department (Staff XX) revealed that in monitoring the humidity of the operating rooms, they did not inform the operating room staff when the humidity was too low, only when the humidity was too high. Further, there are different types of monitoring equipment and one such system only holds the information for 24 hours and then it is "dumped" and gone. A review of the humidity read outs revealed that many of the readings were lower than what is required by the National Fire Protection Association.

Interview with the Quality Assurance staff (Staff L and CCCC) revealed that they did the investigations and concluded that staff needed to be educated, which was done but during the time they were putting together the training components other fires took place. The Quality Assurance staff again concluded that the operating room staff needed re-education but even with the re-education fires occurred. Quality Assurance felt that they had done all that could be done. When asked about monitoring after the education was given, the Quality Assurance staff stated that monitoring was not part of the plan.

The Quality Assurance and Risk Management staff were aware of the fires from the onset in April of 2009, with the first meeting being held on 04/29/09. The education component was not completed until 08/31/09. At this point there was only discussion of making the educational piece part of an annual competency.

The fire timeframes were as follows: 04/06/09; 04/22/09; 09/30/09; 12/21/09; 02/15/10 and 03/16/10.

Please refer to A144, 482.13(c)(2) The Patient has the right to receive care in a safe setting.

Please refer to A285. 482.21(c)(1) The hospital must set priorities for performance improvement activities.

Please refer to A710, 482.41(b) The hospital must meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association.

Please refer to A714, 482.41(b)(7) The hospital must have written fire control plans that contain provisions for reporting fires; extinguishing fires; protection of patients, personnel and guests; evacuation; and cooperation with fire fighting authorities.

Please refer to A951, 482.51(b) Delivery of Service.

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on medical record review and staff interviews, the facility failed to ensure that patients received care in a safe setting. This affected 6 out of 6 patients reviewed who were in the operating rooms at the time of a fire. (Patient #22, #54, #55, #56, #57 and #58.)

Findings include:

1. Per medical record review on 04/26/10, Patient #22 was admitted to the hospital on 03/08/10 with short bowel syndrome for a small bowel transplant. The transplant was completed on 03/09/10 and additional surgeries were performed on 03/15/10 and 03/16/10. When Patient #22 was taken back to the operating room on 03/16/10, an exploratory laparotomy, takedown loop ileostomy, intestinal graft removal, suture of the aortic arterial graft insertion, suture jejunal enterostomy placement and abdominal wall reconstruction using AlloDerm mesh was performed. A hemorrhage from the aorta occurred and a hemoperitoneum resulted. The transplant team inspected the bowel and found it was not salvageable and their plan was to simply close over the proximal anastomotic area.

Per the summary of fire form there was, "application of benzoin spray to the abdomen in preparation for placement of a wound vac at the peri umbilical area". The operative report continued "After placing the benzoin spray, I addressed a dermal bleeding using Bovie (electrocautery device), while attempting to stop the bleeding with the Bovie, the dressing that was partially applied caught on fire and some of the fire seemed to involve the wound edges. We were able to control the fires immediately. The inspection of the skin right after the fact and at 1 hour after showed some erythema around the incision, which was still intact."

Review of the medical record of Patient #22 on 04/26/10 and 04/27/10, revealed that on "03/16/10 at 2247, patient admitted to the surgical intensive care unit. Ice to abdomen per physician. Abdomen red and swollen". A physician note written on 03/18/10 at 12:27 PM addressed the "hyperemic skin at the site of the burn. Appears only to be first degree".

On 03/24/10, a physician from plastics assessed the burn to the abdomen and described Patient #22's skin as" superficial second degree burns to abdomen- there are three patches on the left lower quadrant and right lower quadrant. All smaller than 5 centimeters by 5 centimeters. Apply Silvadene. Should heal by secondary intention."

Per medication administration record, the burn was treated with Silvadene daily starting 03/18/10 and this treatment continues as of 04/29/10, as Patient #22 remains in the hospital. Per review of medication administration records, Patient #22 was assessed to have abdominal pain after the 03/16/10 surgery, but the nursing notes do not differentiate between incisional pain and pain from the second degree burns.

2. The medical record for Patient #54 was reviewed on 04/27/10. The patient was admitted on 03/17/09 with pulmonary fibrosis and end stage respiratory failure. On 04/05/09 from 8:15 PM until 1:14 AM on 04/06/09, the patient was in the operating room receiving a bilateral lung transplant. The operative report stated there were no complications. The cardiothoracic intensive care unit admission note on 04/06/09 at 2:50 AM stated during the operative course, a first and second degree burn was sustained to the superior right shoulder secondary to a flammable skin prep. The medical record contained a plastic surgery consultation dated 04/06/09 at 11:00 AM to evaluate a burn to the right shoulder. The consultation stated the right shoulder burn was caused by a fire in the operating room on 04/05/09 that occurred during the double lung transplant surgery. The consultation also stated the flame occurred when the Bovie hit the Dura prep (surgical prep that contains alcohol), lasted two seconds, and was promptly controlled. A dressing was applied to the wound in the operating room. The burn to the right shoulder was 4 centimeters (cm) by 6 cm, triangular shaped, and located on the back of the right shoulder. The central aspect of the burn was 3 cm by 5 cm, leathery, pale, and a third degree burn. The outer 1 cm of the burn was a second degree burn. The burn was clean with no sign of infection noted. An order was written to apply Silvadene to the burn twice a day. The Skin Care Team assessed the burn to the right shoulder on 04/07/09 at 5:05 PM. The Skin Care Team documented the burn to the right shoulder was 7 cm by 7 cm by 0.2 cm, triangular in shape and caused by a flash burn from an alcohol prep that was ignited by the Bovie in surgery. A second plastic surgery note on 04/08/09 at 8:55 AM reiterated the first plastic surgery note, but added that the burn lacked redness or drainage and that plastic surgery would no longer follow the patient. A plastic surgery consultation was conducted on 05/13/09 at 8:00 PM. The 05/13/09 consultation note stated the burn to the right shoulder occurred at the end of the lung transplant surgery when an alcohol prep was inadvertently struck by electrocautery. The fire was extinguished within seconds and the burn had been treated over the previous six weeks with Silvadene. The plastic surgery consultation documented the burn was 4 cm by 4 cm and was a deep second degree burn. The plastic surgeon recommended a split thickness skin graft to expedite the wound healing, but the patient declined and would prefer to have the burn continue to heal with secondary intent and the Silvadene dressings were ordered to continue. The patient was discharged home on 05/18/09 with orders for the Silvadene dressings to continue twice a day to the right shoulder burn. This finding was verified with Staff DDDD at 1:05 PM on 04/27/10

The Safety Event Reporting System (SERS) for the operating room fire for Patient #54 was reviewed on 04/27/10. The SERS report stated the patient's right shoulder was re-prepped during the surgery with Dura prep and cautery was used in the area before the solution was dry. A flash of vapor was extinguished with a towel and saline. Anesthesia turned off the gas preventatively. The site of the flash flame had no apparent injury, but when the patient was undraped and turned, an area of sloughed off skin was noted on the posterior right shoulder. A dressing was applied and plastic surgery was consulted. The SERS report stated the event was in the category of temporary harm to the patient that required intervention and the category of permanent patient harm. The SERS report did not contain a summary of the findings of the investigation.

3. The medical record for Patient #55 was reviewed on 04/27/10. The patient was admitted on 09/14/09 for a cerebral hemorrhage. The medical record contained a Code Blue form dated 09/30/09 at 6:01 PM that stated the patient had a tracheostomy (trach) tube for ventilation, had loss of the surgical airway, and difficulty breathing. The Adult Medical Emergency Team that responded to the Code Blue included the thoracic surgeon and anesthesiologist. The thoracic surgeon placed an endotracheal tube and transferred the patient to the operating room for surgical management. The anesthesiology report dated 09/30/09 stated the emergency surgery to reestablish the patient's airway started at 6:23 PM and was completed at 7:26 PM.

The operative report for 09/30/09 stated that second degree burns occurred to the tracheostomy site. The operative report stated there were superficial blisters around the tracheostomy stoma, on the underside of the left chin, and on the left anterior chest wall. An endotracheal tube was inserted, a bronchoscopy was performed, and the airway was not involved with any burn. The endotracheal tube was sutured into place. A plastic surgery consultation was ordered and Silvadene cream and a dressing were applied. The operative report stated the patient would need additional surgery to replace the tracheostomy tube when the air trapped in the skin around the tracheostomy tube resolved.

The anesthesiology record dated 09/30/09 stated a brief one second airway fire occurred during Bovie use by the cardiothoracic staff during dissection of the trach site to re-secure the trach, the Bovie and oxygen use were discontinued immediately. The anesthesiology report also stated the patient sustained one to two percent body surface area second degree burns localized to the trach site.

The plastic surgery consultation on 10/02/09 at 1:35 PM stated there was a partial thickness/second degree burn to the neck, which had a couple of small areas of deeper burn, and prescribed Silvadene cream twice a day to be applied to the burn. The physician progress notes documented the patient was kept in a chemical induced paralysis for 48 hours to optimize healing to the trach area starting on 09/30/09. The surgery to redo the tracheostomy was performed on 10/05/09. The patient was discharged to a long term acute care hospital on 10/16/09 with orders to continue to apply Silvadene cream to the burn area.

The medical record for Patient #55 lacked documentation of wound measurements for the burn area. This was verified with Staff DDDD from 1:15 PM to 3:00 PM on 04/27/10. The SERS report for the operating room fire for Patient #55 was reviewed on 04/27/10. The SERS report stated the applicator used to apply the Dura prep was found to be the wrong size and the label specified this product was for below the neck use. The report stated the patient suffered temporary harm related to the surface burns and this incident extended the patient's hospital stay.

4. The medical record for patient #56 was reviewed on 4/27/10. The patient was admitted for combined heart liver transplant and repair of umbilical hernia on 4/21/10. The patient was discharged 5/20/10. The record revealed the patient was in OR Room #63. The operative report lacked evidence a 12 by 12 sponge gauze was singed during surgery from a Bovie device.

Interview with Staff CCCC and DDDD on 4/27/10 at 3:45 PM revealed the reported event of the singed sponge did not originate with a SERS report. The surveyor asked who reported this event. Staff CCCC and DDDD did not confirm who reported the event, however, it was stated that anyone could report a near miss event. Staff CCCC and DDDD stated there were no pictures taken of the sponge. Review of the summary of investigation of surgery fires revealed this event was recorded with an event number, action plan, and root cause analysis that resulted in training of the staff.

5. The medical record for patient #58 was reviewed on 4/27/10. The patient was admitted on 2/15/10 to 2/19/10. The patient had a left open partial nephrectomy on 2/15/10 in OR Room #22. Both the operative and anesthesia report lacked evidence of a dry sponge fire with the use of a Bovie device.

The post anesthesia record revealed the nurse noted at 5:35 PM the patient's skin was warm, dry, and intact, with no wounds. Interview on 4/27/10 at 3:45 PM, Staff CCCC and DDDD confirmed a SERS report was recorded. Review of the summary of investigation of surgery fires revealed this event was recorded with an event number, action plan, and root cause analysis that resulted in training of the staff.

6. The medical record for patient #57 was reviewed on 4/27/10. The patient was admitted on 12/21/09 to 12/28/09. The operative report revealed the patient had a left thoracotomy and pleural decortications in OR Room #69. The surgeon reported when the pleurectomy and decortications were complete, the lung was inflated. Multiple small pleural air leaks resulted, and a transient flash fire occurred using electrocautery. This was rapidly identified and controlled within 1-2 seconds of the flash and from that point forward lower oxygen concentrations were used given the size of the air leak. Other than discoloration of a lap sponge, there appeared to be no significant injury created by a transient flash. Review of the summary of investigation of surgery fires revealed this event was recorded with an event number, action plan, and root cause analysis that resulted in training of the staff and education of the Anesthesiologist to drop the oxygen concentration when an ignition source was present.

QAPI

Tag No.: A0263

Based on observations, interviews, review of patient medical records and review of information presented in regard to the quality assessment and performance improvement program activities, the hospital failed to ensure that the quality assessment and performance improvement program ensured that all indicators for prevention and reduction of fires in the 89 operating room areas were implemented and monitored for their effectiveness to report and control fires.

Findings include:

Documentation in regard to the instances of six fires in an 11 month period from April 2009 thru March 2010, with 3 of the 6 patients (Patient #22, #54, #55) involved being injured, revealed incomplete investigations were done; that there was a lack of information in regard to the patients' injuries documented in their records; and although education was provided there was no monitoring to ensure that staff were following and heeding the manufacturers' recommendation on the use of their products.

Please refer to A285, 482.21(c)(1) The hospital must set priorities for its performance improvement activities for further information.

No Description Available

Tag No.: A0285

Based on observations, interviews, review of patient medical records and review of information presented in regard to the quality assessment and performance improvement program activities, the hospital failed to ensure that the quality assessment and performance improvement program ensured that all indicators for prevention and reduction of the fires in the 89 operating room areas were implemented and monitored for their effectiveness to report and control fires.

Findings Include:

Documentation in regard to the instances of six fires in an 11 month period from April 2009 thru March 2010, with 3 of the 6 patients involved being injured, revealed incomplete investigations were done; that there was a lack of information in regard to the patients' injuries documented in their records; and although education was provided there was no monitoring to ensure that staff were following and heeding the manufacturers' recommendation on the use of their products. This could affect all surgical patients at any time in any of the 87 operating rooms.

Interviews with the Quality Assurance staff (Staff L and CCCC) in regard to the fires revealed that although a root cause analysis was done on the first fire in April of 2009, the hospital continued to have fires with the same type of ignition. During one of the investigations, Quality staff asked the facility's engineering department if they monitor operating room humidity. The facility's engineering department stated that they did, however the Quality staff person did not carry this part of the investigation any further to determine if there were any problems.

Interview with the facility's engineering department on 04/23/10 at 10:30AM with Staff XX revealed that in monitoring the humidity of the operating rooms, they did not inform the operating rooms when a humidity level was too low, only when the humidity level was too high. Further, there are different types of monitoring equipment and one such system only holds the information for 24 hours and then it is "dumped" and gone. A review of the humidity read outs revealed that many of the readings were lower than what is required by the National Fire Protection Association.

Interview with the Quality Assurance staff (Staff L and CCCC) revealed that they did the investigations and concluded that staff needed to be educated, which was done, but during the time they were putting together the training components other fires took place. The Quality Assurance staff again concluded that the operating room staff needed re-education, but even with the re-education fires occurred. Quality Assurance felt that they had done all that could be done. When asked about monitoring after the education was given, the Quality Assurance staff (Staff L and CCCC) stated that monitoring was not part of the plan.

Quality Assurance and Risk Management were aware of the fires from the onset in April of 2009, with the first meeting being held on 04/29/09. The education was not completed until 08/31/09, four months later. At this point there was only discussion of making the educational piece part of an annual competency. The fire timeframes were as follows: 04/06/09; 04/22/09; 09/30/09; 12/21/09; 02/15/10 and 03/16/10.

During the course of the survey interviews of the surgical personnel (Staff OOOO, TT, PPPP, QQQQ, RRRR, SSSS, TTTT, AND UUUU) on Tuesday, 04/27/10, revealed that staff were unsure of their roles in a fire, did not know that there had been fires and were not aware of any training about fires. The following are the answers to questions from the operating room staff.

In an interview on 04/27/10 at 1:00 PM, Staff OOOO stated that there had been no fires in their operating room. Staff OOOO stated that they mainly worked with ENT, GI, and Ambulatory surgery and that they normally worked in two operating rooms per day. When asked what role they would take during an OR fire, Staff OOOO replied, " contain the fire and save the patient " . When asked where they would report a surgical fire Staff OOOO replied " to the control desk " .

In an interview on 04/27/10 at 1:15 PM, Staff TT stated that they had nine years of OR experience working with the clinic. Staff TT stated that they worked on a part time basis, two days per week. Staff TT stated that he/she knew nothing about fires in the OR, have had no in-servicing because they were not here on Wednesdays when the training had taken place. Staff TT stated that yearly they have a fire walk to look at fire exits and extinguishers. Staff TT stated that Comet, an online training program, was required to be completed annually by all staff and had an OR fire component. When asked what their role would be in the event of a surgical fire, Staff TT stated "grab the extinguisher which is located outside the room and ensure the patient is safe and remove the source of the fire".

In an interview on 04/27/10 at 1:30 PM, Staff PPPP stated that they had never been present during an OR fire but stated that they knew part of the problem related to the fires was that the prep was not dry before starting the case. Staff PPPP stated that education had been conducted in the auditorium with all staff and if the staff could not attend, the training was available on disks. During the interview, Staff PPPP stated that during a surgical fire the nurse's role would be to guide the Surgical Tech to extinguish the fire and keep the patient safe.

In an interview on 04/27/10 at 1:45 PM, Staff QQQQ stated that they were currently completing a fellowship in pediatrics and congenital surgery. Staff QQQQ stated that he/she did overhear a nurse discuss that they needed to ensure the alcohol prep was dry before starting the case. Staff QQQQ stated that education was done online for fire safety in the Comet program and was required to be completed by all staff. In the event of a surgical fire, Staff QQQQ stated they would make sure no harm would come to the patient. Staff QQQQ stated that if the fire needed to be reported, they would tell the nurses because " nurses know everything".

In an interview on 04/27/10 at 2:00 PM, Staff RRRR stated that they were currently in orientation and had been employed with the clinic for the past six months. Staff RRRR stated that their job as an operating room technician was to maintain the sterile field, to do counts, to maintain equipment and to pass instruments. Staff RRRR stated that through their education, they knew that all liquids were flammable and that the prep must be completely dry. Staff RRRR stated that they had heard of one fire and following the incident they had an in-service. Staff RRRR stated that in the event of a surgical fire, they would douse the fire with saline.

In an interview on 04/27/10 at 2:15, Staff SSSS stated that they currently worked in the OR and had been employed with the clinic for six months. Staff SSSS stated that since their date of hire, they had completed online training regarding fire safety and walked through the area looking for extinguishers and fire pulls. Staff SSSS stated that they had also completed a power point with fire safety staff. Staff SSSS stated that they had never seen an OR fire, but knew that with the Betadine and alcohol prep you should wait for two minutes until starting the case.

In an interview on 04/27/10 at 2:30 PM, Staff TTTT stated that they had worked for the clinic for the past 12 years. Staff TTTT stated that they had heard of one surgical fire which was a year ago and stressed that no damage was done to the patient. When questioned regarding education, Staff TTTT stated that they had never attended any in-service regarding fire safety except the online computer training.

In an interview on 04/27/10 at 2:35 PM, Staff UUUU stated that they had never been present during a surgical fire in the J building. There were two phases to look at correcting this problem globally. Staff UUUU stated that as an institution they had worked at making a plan for a major fire in the hospital and had set up a command center across the street and had discussed the purchase of a walkie-talkie system if the phones and the paging system went down. Staff UUUU stated that within the Heart Vascular Institution they had discussed the evacuation in the event of a fire and were in possession of 10 driven beds and 44 evacuation sleds, that they had ensured that the required dry time of the alcohol preps were 3 minutes and that training was completed with 300 or more staff which included all RN and anesthesia staff. Staff UUUU also stated that as an institution, they had looked at doing away with alcohol prep, but they questioned if there would be an increase of sternal wound infections. Staff UUUU stated that the alcohol preps were not to be used around the neck and it was their understanding that anesthesia had stopped using the alcohol based preps. Staff UUUU stated that they were unsure of what anesthesia was currently using.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on observations/tour, interviews, and review of documentation presented by the hospital, the Condition of Physical Environment is NOT MET. There were six fires in the hospital's operating rooms resulting in injury to three patients, all of which occurred in an 11 month period; investigations were incomplete; education interventions to prevent further fires were not timely; no monitoring to ensure interventions were instituted and were effective; no monitoring to ensure that staff were following and heeding the manufacturers' recommendation on use of their products; lack of monitoring and reporting the humidity levels on the operating rooms and lack of notification to the appropriate authority to report the fires. This could affect all surgical patients at any time in any of the 89 operating rooms. The hospital's census was 988 patients at the time of this survey.

Findings include:

Please refer to A710, 482.41(b) The hospital must meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association in regard to the hospital's failure to ensure that the Life Safety Code requirements were followed. This affects the entire Main campus buildings and the off-site areas that were surveyed.

Please refer to A714, 482.41(b)(7) The hospital must have written fire control plans that contain provisions for reporting fires; extinguishing fires; protection of patients, personnel and guests; evacuation; and cooperation with fire fighting authorities in regard to the hospital's failure to ensure that the occurrence of fires were reported according to their fire plans for the fires that occurred in the "J" and "E" operating rooms from 04/2009 thru 03/10 that injured 3 of the patients involved in those operations.

Please refer to A724. 482.41(c)(2) Facilities, supplies and equipment must be maintained to ensure an acceptable level of safety and quality in regard to the hospital's failure to ensure that the operating rooms humidity levels were monitored and that they were in the acceptable parameters required by NFPA 99 for safety reasons.

LIFE SAFETY FROM FIRE

Tag No.: A0710

Based on documentation provided by the facility, interview of facility staff and tour of the entire hospital and off-site areas, the facility failed to ensure that the Life Safety Code was followed. This affects the entire Main campus buildings and the off-site areas that were surveyed. The hospital's census was 988 patients at the time of this survey.

Findings include:

Please see the Life Safety Code survey in the following areas:

For Building Q:

K 44 - the fire shutter did not close correctly

For Building J:

K 17 - open use areas without smoke detection

K 29 - unrated soiled utility room door

K 76 - improper storage of medical gases

K 130 - flammable liquid germicides in an anesthetizing area

For the Sleep Center - Elyria:

K 130 - improper locking mechanisms that require 2 hand motions to exit the room.

For Building E:

K 38 - delayed egress locks that did not work.

K 45 - exit discharges did not have secondary bulbs or fixtures

K 62 - dirty sprinkler heads and missing rings

K 76 - 2 e-tanks on floor unsecured

K 78 - operating room humidity

K 130 - flammable liquid germicides in an anesthetizing area

For Building U:

K 52 - smoke detectors not hooked up into the fire system

K 130 - exit discharges did not have secondary bulbs or fixtures; delayed egress locks not opening in the proper time frame; lack of directional signage for exit; no approval from authority having jurisdiction in regard to changing the timeframes for the delayed egress locks.

For Building R:

K 130 - delayed egress locks that did not open in the correct time frames and no approval for this from the authority having jurisdiction.

For the Sports Rehab. Building S. Woodland:

K 130 - no mechanical or electrical sprinkler system supervision tied into the fire alarm system.

For Building 1:

K 78 - improper humidity levels in the operating rooms

For Building 4:

K 78 - improper humidity levels in the operating rooms

K 130 - flammable liquid germicides in an anesthetizing area

For Building 5:

K 38 - exit egress not readily available

K 44 - horizontal exits not working correctly

FIRE CONTROL PLANS

Tag No.: A0714

Based on review of the documentation provided by the facility and staff interviews, the facility failed to ensure that the occurrence of fires were reported according to their fire plans for the fires that occurred in the "J" and "E" operating rooms from 04/2009 thru 03/10 that injured 3 of the patients involved in those operations. The hospital's census was 988 patients at the time of this survey.

Findings include:

During the tour of the operating rooms it was learned that there had been six fires in an 11 month period. When questioned about who the fires had been reported to, it was learned that none of the six fires had been reported to anyone. According to the fire plans for each building, the fires are to be reported to the Cleveland Clinic Police Department. When asked about the facility policy for reporting fires, on Wednesday, 04/28/10, at 9:30 AM, Staff A7 stated that there is no formal policy on the reporting of fires. At approximately 10:00 AM on Wednesday, 04/28/10, Staff A6 brought in the "fire plans" for each of the buildings. The fire plan stated that the Cleveland Clinic Police are to be notified of any fires. A request for documentation of the report of the fires to the Cleveland Clinic Police revealed that they had not received any reports of fires occurring in the 6 operating rooms. This was confirmed by Staff A7 on Wednesday, 04/28/10.

On Wednesday afternoon, 04/28/10, interviews of operating room staff took place consisting of anesthesia staff, operating room technicians and registered nurses. The interviews revealed that the operating room staff did not know who to report an operating room fire to.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on tour of the operating rooms, staff interviews and review of documentation presented by the facility, the facility failed to ensure that the operating rooms humidity levels were monitored and that they were in the acceptable parameters required by NFPA 99 for safety reasons. The hospital's census was 988 patients at the time of the survey.

Findings include:

During the tour of the operating rooms, various staff were interviewed in regard to the humidity levels of the operating rooms and asked who monitors the levels. Staff that were interviewed included registered nurses, operating room technicians, surgeons and anesthesiologists and certified registered nurse anesthetists (CRNA's). None of the staff that were interviewed knew the correct parameter for the humidity readings nor did they know who was responsible for the monitoring of them.

When the facility's engineering staff (Staff XX) was interviewed in regard to the humidity in the operating rooms, they stated that they did monitor the humidity levels of all of the operating rooms using three different types of systems to do so. The engineering staff further stated that it was not until the humidity was too high that the operating rooms were notified, never when it was low.

During the interviews conducted about the fires it was learned that although Quality Assurance asked if humidity was tracked in the operating rooms and was told that it was, it was not pursued further to determine whether the the humidity levels met the requirements or whether or not the humidity levels could have an impact on the prevention of fires. Interview with the Risk Management committee members (Staff L and CCCC) revealed that although they investigated the fires in the operating rooms, no one looked at the humidity levels in the operating rooms as perhaps a factor in the cause of the fires.

During the Life Safety Code portion of the survey in the monitoring areas for the humidity, copies of humidity readings were requested for the time frames of the six fires which occurred in the operating rooms. The facility engineering department staff (Staff XX) stated that one of the systems "dumps" all of the readings after 24 hours and they have not documented them any where else.

For more information in regard to this citation please see the deficiency under Life Safety Code, K78.

SURGICAL SERVICES

Tag No.: A0940

Based on interview, review of facility documentation, policy and procedure review and review of patient medical records, there was an occurrence of six operating room fires between 04/06/09-03/16/10 in 5 of 87 operating rooms in the hospital. During the course of the survey the hospital administrative staff was notified an Immediate Jeopardy was identified under the Condition of Surgical Services on Wednesday, 04/28/10 at 12:15 PM. The hospital failed to provide a policy addressing the responsibility of each staff member in an operating room fire; failed to implement the interventions to prevent future operating room fires; and failed to consistently monitor the effectiveness of the education provided to operating room staff. Three of the fires caused physical injury to three patients (Patients #54,
#55, and #22). These three fires involved the use of a surgical skin preparation and cautery equipment. The fires occurred in the "J" operating rooms #63 #64 and #69 on 04/06/09, 04/22/09, 09/30/09 and 12/21/09 and two fires occurred in the "E" operating rooms #16 and #22 on 02/15/10 and 03/11/10. The hospital's census was 988 patients at the time of this survey. The hospital has 89 operating rooms.

The Immediate Jeopardy was removed on Friday, 04/30/10, at 10:20 AM after the hospital provided and demonstrated immediate actions to correct the the conditions that led to the IJ.

Findings include:

Three of six fires that occured during surgical procedures in the hospital's operating rooms resulted in patient burns, including two patients with second degree burns (Patients
#22 and #55) and one patient with third degree burn (Patient #54). The four fires which occurred in 2009 on 04/06/09, 04/22/09, 09/30/09 and 12/21/09 all occurred in the "J" building.

Review of action taken by hospital staff included a root cause analysis of the incident involving Patient #54 which occurred on 04/06/09 and the 04/22/09 incident when
Patient #56, an orthotopic heart transplant patient, was on the operating room table when the surgeon noted some singeing of a 12 x12 (inch/centimeters not specified) sponge gauze from a Bovie (an electrocautery device). No harm to Patient #56 resulted.

The investigations of both fires were completed on 06/17/09 when a power point presentation was developed.

The next documented OR fire occurred on 09/30/09 when a 69 year old, Patient #55, experienced a second degree burn around the tracheostomy, left chin and left chest when a skin preparation pooled and electrocautery was used in the setting of high oxygen flow during an emergency tracheostomy.

On 12/21/09 a 52 year old, Patient #57, undergoing thoracotomy and lung decortification when a flash fire of a sponge occurred with no harm to the patient.

Per review of a summary of the OR fires, two fires occurred in the E building in 2010, one on 02/15/10 and one on 03/16/10.

In the incident occurring on 02/15/10 involving Patient #58, a dry sponge caught on fire while electrocautery was in use during a partial nephrectomy surgery on this 57 year. No harm resulted. Review of Patient 22's medical record revealed on 03/16/10 this 57 year old experienced an abdominal burn following application of benzoin aerosol spray to the abdomen in preparation for placement of a wound vac at the peri umbilical area. A Bovie was utilized to coagulate a surface vessel and a flash fire developed at the surgical site. Burns were described as second degree in three patches in the left lower quadrant and right lower quadrant.

Education provided through the use of a power point presentation and discussions between physicians did not ensure that staff were aware that the surgical skin preparations contained alcohol and were considered flammable; how to report a fire; and the ongoing need to monitor the use of skin preparations consistent with manufacturer's recommendations. Per interview with Staff L and Staff CCCC on 04/27/10 between 12:37 PM-1:15 PM, no matrix has been developed to audit the operating rooms for compliance with alcohol skin preparations.

Please refer to A951, 482.51(b) regarding Delivery of Service regarding the hospital's failure to review of hospital policies and procedures relating to the use of flammable skin prep in the operating rooms, reporting of operating room fires, cleanliness of all areas in the operating rooms, and to ensure patient safety in the operating rooms.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on review of hospital policies and procedures relating to the use of flammable skin prep in the operating rooms, reporting of operating room fires, cleanliness of all areas in the operating rooms, medical record review and staff interview, surgical services were not maintained to assure patient safety in the operating rooms. There are 89 operating rooms in this hospital with 1214 inpatient beds. Three patients including #22, #54 and #55 sustained burns during operating room fires and three patients were on the operating room table when a fire occurred with no harm to Patients #56, #57 and #58. Education of staff had begun on 06/17/09 after Patient #54 sustained a third degree burn and during Patient #56's heart transplant surgery on 04/22/09, a 12 x 12 sponge gauze was singed with no harm to Patient #56. On 09/30/09, Patient #55 sustained second degree burns around the tracheostomy, left chin and left chest when electrocautery was used after an alcohol based prep solution was used along with a high oxygen flow during an emergency tracheostomy. Patient #57 was undergoing thoracotomy and lung decortication when a flash fire of a sponge occurred with no harm to the patient. All of these fires occurred in the J operating rooms, with the last two fires (09/30/09 and 12/21/09) occurring in OR #69. In the E building operating rooms, two fires occurred in 2010. These include one on 02/15/10 when Patient #58 was undergoing a partial nephrectomy when a dry sponge caught on fire with no harm to the patient. The last fire occurred on 03/16/10 during a re-operation on a recent small bowel transplant patient. Patient #22 sustained a second degree burn on the abdomen following application of benzoin spray to the abdomen in preparation for placement of a wound vac at the peri umbilical area. A Bovie (electrocautery device) was utilized and a flash fire developed.

The safety event reporting system (SERS) report described the incident as relayed to a registered nurse in surgical intensive care unit by a staff physician that "Patient's abdomen caught on fire during surgery. Abdominal skin under vac dressing is bright red and tender to touch. Area covers almost entire abdomen."

Interviews were conducted with ten OR staff on 04/27/10 relating to awareness of OR fires, what each staff member would do in a fire, risk of using alcohol based skin preparations and to whom an OR fire should be reported. A variety of responses were received from Staff TT, OOOO, PPPP, QQQQ, RRRR, SSSS, TTTT, UUUU, VVVV and WWWW relating to the level of fire prevention knowledge. These staff members included two physicians, two anesthesiologists, a certified registered nurse anesthetist, four registered nurses and one surgical technician. Of these staff, three had not received training in fire prevention in the operating room, three displayed a knowledge deficit relating to the surgical preps and handling of an OR fire, three were unaware six OR fires that had occurred between 04/06/09-03/16/10 with three patients sustaining burns and one staff member who did not know to whom to report a fire to.

Findings include:

1. Per medical record review on 04/26/10, Patient #22 is a 57 year old who was admitted to the hospital on 03/08/10 with short bowel syndrome for a small bowel transplant. The transplant was completed on 03/09/10 and additional surgeries were performed on 03/15/10 and 03/16/10. When Patient #22 was taken back to the operating room on 03/16/10 , an exploratory laparotomy, takedown loop ileostomy, intestinal graft removal, suture of the aortic arterial graft insertion, suture jejunal enterostomy placement and abdominal wall reconstruction using AlloDerm mesh. A hemorrhage from the aorta occurred and a hemoperitoneum resulted. The transplant team inspected the bowel and found it was not salvageable and their plan was to simply close over the proximal anastomotic area. Per the summary of fire form , "application of benzoin spray to the abdomen in preparation for placement of a wound vac at the peri umbilical area". The operative report continued "After placing the benzoin spray, I addressed a dermal bleeding using Bovie (electrocautery device), while attempting to stop the bleeding with the Bovie, the dressing that was partially applied caught on fire and some of the fire seemed to involve the wound edges. We were able to control the fires immediately. The inspection of the skin right after the fact and at 1 hour after showed some erythema around the incision, which was still intact." Per medical record review on 04/26/10 and 04/27/10, on 03/16/10 at 2247, patient admitted to the surgical intensive care unit. Ice to abdomen per physician. Abdomen red and swollen". A physician note written on 03/18/10 at 12:27 PM addressed the "hyperemic skin at the site of the burn. Appears only to be first degree". On 03/24/10, a physician from plastics assessed the burn to the abdomen and described Patient 22's skin as" superficial second degree burns to abdomen- there are three patches on the left lower quadrant and right lower quadrant. All smaller than 5 centimeters by 5 centimeters. Apply Silvadene. Should heal by secondary intention." Per medication administration record, the burn was treated with Silvadene daily starting 03/18/10 and this treatment continues as of 04/29/10, as Patient #22 remains in the hospital. Per review of medication administration records, Patient #22 was assessed to have abdominal pain after the 03/16/10 surgery, but the nursing notes do not differentiate between incisional pain and pain from the second degree burns.

2. The medical record for Patient #54 was reviewed on 04/27/10. The patient was admitted on 03/17/09 with pulmonary fibrosis and end stage respiratory failure. On 04/05/09 from 8:15 PM to 1:14 AM on 04/06/09, the patient was in the operating room receiving a bilateral lung transplant. The operative report stated there were no complications. The cardiothoracic intensive care unit admission note on 04/06/09 at 2:50 AM stated during the operative course, a first and second degree burn was sustained to the superior right shoulder secondary to flammable skin prep. The medical record contained a plastic surgery consultation dated 04/06/09 at 11:00 AM to evaluate a burn to the right shoulder. The consultation stated the right shoulder burn was caused by a fire in the operating room on 04/05/09 that occurred during the double lung transplant surgery. The consultation also stated the flame occurred when the Bovie hit the Dura prep (surgical prep that contains alcohol), lasted two seconds, and was promptly controlled. A dressing was applied to the wound in the operating room. The burn to the right shoulder was 4 centimeters (cm) by 6 cm, triangular shaped, and located on the back of the right shoulder. The central aspect of the burn was 3 cm by 5 cm, leathery, pale, and a third degree burn. The outer one cm of the burn was a second degree burn. The burn was clean and had no signs of infection noted. An order was written to apply Silvadene to the burn twice a day. The Skin Care Team assessed the burn to the right shoulder on 04/07/09 at 5:05 PM. The Skin Care Team documented the burn to the right shoulder was 7 cm by 7 cm by 0.2 cm, triangular in shape and caused by a flash burn from an alcohol prep that was ignited by the Bovie in surgery. A second plastic surgery note on 04/08/09 at 8:55 AM reiterated the first plastic surgery note, but added that the burn lacked redness or drainage and that plastic surgery would no longer follow the patient. A plastic surgery consultation was conducted on 05/13/09 at 8:00 PM. The 05/13/09 consultation note stated the burn to the right shoulder occurred at the end of the lung transplant surgery when an alcohol prep was inadvertently struck by electrocautery. The fire was extinguished within seconds and the burn had been treated over the previous six weeks with Silvadene. The plastic surgery consultation documented the burn was 4 cm by 4 cm and was a deep second degree burn. The plastic surgeon recommended a split thickness skin graft to expedite the wound healing, but the patient declined and would prefer to have the burn continue to heal with secondary intent and the Silvadene dressings were ordered to continue. The patient was discharged home on 05/18/09 with orders for the Silvadene dressings to continue twice a day to the right shoulder burn. This was verified with Staff DDDD at 1:05 PM on 04/27/10.

The Safety Event Reporting System (SERS) report for the operating room fire for Patient #54 was reviewed on 04/27/10. The SERS report stated the patient's right shoulder was re-prepped during the surgery with Dura prep and cautery was used in the area before the solution was dry. A flash of vapor was extinguished with a towel and saline. Anesthesia turned off the gas preventatively. The site of the flash flame had no apparent injury, but when the patient was undraped and turned, an area of sloughed off skin was noted on the posterior right shoulder. A dressing was applied and plastic surgery was consulted. The SERS report stated the event was in the category of temporary harm to the patient that required intervention however, the final category was determined to be permanent patient harm. The SERS report did not contain a summary of the findings of the investigation.

3. The medical record for Patient #55 was reviewed on 04/27/10. The patient was admitted on 09/14/09 for a cerebral hemorrhage. The medical record contained a Code Blue form dated 09/30/09 at 6:01 PM that stated the patient had a tracheostomy (trach) tube for ventilation, had loss of the surgical airway, and difficulty breathing. The adult medical emergency team that responded to the code blue included the thoracic surgeon and an anesthesiologist. The thoracic surgeon placed an endotracheal tube and transferred the patient to the operating room for surgical management. The anesthesiology report dated 09/30/09 stated the emergency surgery to reestablish the patient ' s airway started at 6:23 PM and was completed at 7:26 PM. The operative report for 09/30/09 stated that second degree burns occurred to the tracheostomy site. The operative report stated there were superficial blisters around the tracheostomy stoma, on the underside of the left chin, and on the left anterior chest wall. An endotracheal tube was inserted, a bronchoscopy was performed, and the airway was not involved with any burn. The endotracheal tube was sutured into place. A plastic surgery consultation was ordered and Silvadene cream and a dressing were applied. The operative report stated the patient would need additional surgery to replace the tracheostomy tube when the air trapped in the skin around the tracheostomy tube resolved. The anesthesiology record dated 09/30/09 stated a brief one second airway fire occurred during Bovie use by the cardiothoracic staff during dissection of the trach site to re-secure the trach, the Bovie and oxygen use were discontinued immediately. The anesthesiology report also stated the patient sustained one to two percent body surface area second degree burns localized to the trach site. The plastic surgery consultation on 10/02/09 at 1:35 PM stated there was a partial thickness/second degree burn to the neck, which had a couple of small areas of deeper burn, and prescribed Silvadene cream twice a day to be applied to the burn. The physician progress notes documented the patient was kept in a chemical induced paralysis for 48 hours to optimize healing to the trach area starting on 09/30/09. The surgery to redo the tracheostomy was performed on 10/05/09. The patient was discharged to a long term acute care hospital on 10/16/09 with orders to continue to apply Silvadene cream to the burn area. The medical record lacked documentation of wound measurements for the burn area. This was verified with Staff DDDD from 1:15 PM to 3:00 PM on 04/27/10.

The SERS report for the operating room fire for Patient #55 was reviewed on 04/27/10. The SERS report stated the applicator used to apply the Dura prep was found to be the wrong size and the label specified this product was for below the neck use. The report stated the patient suffered temporary harm related to the surface burns and this incident extended the patient's hospital stay.

4. The medical record for patient #56 was reviewed on 4/27/10. The patient was admitted for combined heart liver transplant and repair of umbilical hernia on 4/21/09. The patient was discharged 5/20/09. The record revealed the patient was in OR Room 63. The operative report lacked evidence a 12 by 12 sponge gauze was singed during surgery from a Bovie device. Interview with Staff CCCC and DDDD on 4/27/10 at 3:45 PM revealed the reported event of the singed sponge did not originate with a SERS report. The surveyor asked who reported this event. Staff CCCC and DDDD did not confirm who reported the event, however, it was stated that anyone could report a near miss event. Staff CCCC and DDDD stated there were no pictures taken of the sponge. Review of the summary of investigation of surgery fires revealed this event was recorded with an event number, action plan, and root cause analysis that resulted in training of the staff.

5. The medical record for patient #58 was reviewed on 4/27/10. The patient was admitted on 2/15/10 to 2/19/10. The patient had a left open partial nephrectomy on 2/15/10 in OR Room #22. The operative report lacked evidence of a dry sponge fire with the use of a Bovie device. The anesthesia record lacked evidence of a dry sponge fire with use of a Bovie. The post anesthesia record revealed the nurse noted at 5:35 PM the patient ' s skin was warm, dry, and intact, with no wounds. Interview on 4/27/10 at 3:45 PM, Staff CCCC and DDDD confirmed a SERS report was recorded. Review of the summary of investigation of surgery fires revealed this event was recorded with an event number, action plan, and root cause analysis that resulted in training of the staff.

6. The medical record for patient #57 was reviewed on 4/27/10. The patient was admitted on 12/21/09 to 12/28/09. The operative report revealed the patient had a left thoracotomy and pleural decortications in OR Room #69. The surgeon reported when the pleurectomy and decortications were complete, the lung was inflated. Multiple small pleural air leaks resulted, and a transient flash fire occurred using electrocautery. This was rapidly identified and controlled within 1-2 seconds of the flash and from that point forward lower oxygen concentrations were used given the size of the air leak. Other than discoloration of a lap sponge, there appeared to be no significant injury created by a transient flash. Review of the summary of investigation of surgery fires revealed this event was recorded with an event number, action plan, and root cause analysis that resulted in training of the staff and education of the Anesthesiologist to drop the oxygen concentration when ignition source present.

In an interview on 04/27/10 at 1:00 PM, Staff OOOO stated there had been no fires in his/her operating room (OR). He/she stated he/she mainly worked with ENT, GI, and ambulatory surgery. He/she normally worked in two operating rooms per day. When asked what role he/she would take during an OR fire he/she replied, "contain the fire and save the patient". When asked where he/she would report a surgical fire he/she replied "to the control desk".

In an interview on 04/27/10 at 1:15 PM, Staff TT stated he/she had nine years of OR experience working with the clinic. He/she worked on a part time basis, two days per week. Staff TT stated he/she knew nothing about fires in the OR, has had no in-servicing done with him/her mostly because he/she was not here on Wednesdays when they have had training. Staff TT stated yearly they have a fire walk to look at fire exits and extinguishers. COMET, an online training program, was required to be completed annually by all staff and this annual training had an OR fire component. When asked what his/her role would be in the event of a surgical fire, he/she stated " grab the extinguisher which is located outside the room and ensure the patient is safe and remove the source of the fire " .

In an interview on 04/27/10 at 1:30 PM, Staff PPPP stated he/she had never been present during an OR fire. Part of the problem related to the fires was the prep was not dry before starting the case. Education had been conducted in auditoriums with all staff, and if the staff could not attend, the training was available on disks. During a surgical fire the nurse's role would be to guide the surgical tech to extinguish the fire and keep the patient first.

In an interview on 04/27/10 at 1:45 PM, Staff QQQQ was currently completing a fellowship in pediatrics and congenital surgery. He/she stated that he/she did overhear a nurse discuss that they need to ensure the alcohol prep was dry before starting the case. Education was done online for fire safety in the COMET program and was required to be completed by all staff. In the event of a surgical fire, Staff QQQQ stated he/she would make sure no harm would come to the patient. If it needed to be reported, he/she would tell the nurses because "nurses know everything".

In an interview on 04/27/10 at 2:00 PM, Staff RRRR stated he/she was currently in orientation and had been employed with the clinic for the past six months. His/her job as an operating room technician was to maintain the sterile field, to do counts, to maintain equipment, and to pass instruments. Through his/her education, he/she knew that all liquids were flammable and that the prep must be completely dry. Staff RRRR stated he/she had heard of one fire and following the incident they had an in-service within the past month. In the event of a surgical fire, he/she would douse the fire with saline.

In an interview on 04/27/10 at 2:15, Staff SSSS currently worked in the OR and had been employed with the clinic for six months. Since his/her date of hire, he/she had completed online training regarding fire safety and walked through the area looking for extinguishers and fire pulls. He/she also completed a power point with fire safety staff. He/she had never seen an OR fire but knew that with the Betadine and alcohol prep you should wait for two minutes until starting the case.

In an interview on 04/27/10 at 2:30 PM, Staff TTTT had worked for the clinic for the past 12 years. Staff TTTT discussed he/she had heard of one surgical fire which was a year ago and he/she stressed that no damage was done to the patient. When questioned regarding education, he/she had never attended any in-service regarding fire safety except the online computer training. chloroprep was used for the neck to prep for all lines placed in the neck 90% of the time.

In an interview on 04/27/10 at 2:35 PM, Staff UUUU had never been present during a surgical fire in the J building. Staff UUUU stated there were two phases to look at correcting this problem globally. As an institution, staff had worked on making an plan to implement in the event of a major fire in the hospital and setting up a command center across the street. Staff UUUU had discussed the purchase of a walkie-talkie system if the phones and the paging system go down. Within the Heart Vascular Institution they had discussed the evacuation in the event of a fire and were in possession of 10 driven beds and 44 evacuation sleds. Also they had ensured that the required dry time of alcohol prep is 3 minutes. Training was completed with 300 or more staff which included all RNs and anesthesia. As an institution, they had looked at doing away with alcohol prep but there would be an increase of sternal wound infections. Staff UUUU also discussed that alcohol prep was not to be used around the neck and it was his/her understanding that anesthesia had stopped using alcohol based prep. He/she was unsure of what they currently were using.

In an interview on 04/27/10 at 2:55 PM, Staff VVVV was present for one fire which was over a year ago. This was during a thoracic case reoperation for a dissection when a hole was created in the line, the electrocautery ( Bovie pad) ignited, and this anesthesiologist decreased the FiO2. Staff VVVV then used a fiber optic scope to evaluate the tracheostomy and extubation was not required. Staff VVVV reported this on the safety event reporting system (SERS) report and notified the quality department of the incident. Staff VVVV stated that during this incident, no patient was injured and no alcohol was ever used during prep of the lines placed in the neck. Instead, chloroprep or iodine is used. chlorprep contains 70% isopropyl alcohol according to manufacturer ' s product information. During an emergency, no alcohol prep was to be used. Annually the Anesthesia institute discussed fires in the OR, online computer training (COMET) is completed and recently a DVD relating to fire prevention was viewed.

In an interview on 04/27/10 at 3:05 PM, Staff WWWW had been employed with the clinic for over 25 years. He/she had never been present in any surgical fire. He/she knew that you should wait 3 minutes from the time you prep to drape and currently the facility was looking at preps that were not alcohol based. Two weeks ago, he/she was trained in the location of fire extinguisher.
According to the fire plans for each building, the fires are to be reported to the Cleveland Clinic Police Department. When asked about the facility policy for reporting fires, on Wednesday, 04/28/10, at 9:30 AM, Staff A7 stated that there is no formal policy on the reporting of fires. Please refer to A714, 482.41(b)(7) The hospital must have written fire control plans that contain provisions for reporting fires; extinguishing fires; protection of patients, personnel and guests; evacuation; and cooperation with fire fighting authorities.

Review of the facility policy for environmental control revealed the surgical services locations were to have humidity levels maintained between 30 and 60 percent for ideal conditions related to health and safety.



A tour of OR's in E on 04/20/10 at 2:54 PM revealed dust on a shelf holding equipment in OR #5 during surgery on Patient 6. This was confirmed by Staff D at the time of the observation. Additionally circular weights used to stabilize the intravenous pole bases were rusty.


Per observation in the E OR at 3:05 PM on 04/20/10, end of day cleaning was observed in OR #11. Rusty bases (circular weights) were observed on two intravenous poles.


Per interview with Staff NNNN on 04/20/10, the weights to stabilize the intravenous poles are the responsibility of the anesthesia department. When Staff NNNN was made aware of the dust found on the equipment shelf in room #5 she indicated cleaning of shelves is the responsibility of her environmental staff.

Per observation in OR #46 at 10:35 AM on 04/21/10 in the G building, dust was observed on shelving on the colorectal mobile cart next to the operating table. This was confirmed by Staff A and D.

Per observation in OR #39 in the H building on 04/22/10 at 1:05 PM, dust was observed on shelving holding equipment from the electrical tower near the operating room table. This observation was confirmed by Staff B at the time of the observation.

Per observation on 04/22/10 at 1:19 PM in OR #31 in the H building, dust was found on the shelf attached to the electrical tower. The dusty shelf was holding equipment needed in the operation. This was confirmed by Staff A at the time of the observation.




Please refer to A144, 482.13(c)(2) The Patient has the right to receive care in a safe setting.

Please refer to A285. 482.21(c)(1) The hospital must set priorities for performance improvement activities.

Please refer to A710, 482.41(b) The hospital must meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association.


Please refer to A951, 482.51(b) Delivery of Service.