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

UNIVERSITY OF MINNESOTA MEDICAL CENTER, FAIRVIEW 2450 RIVERSIDE AVENUE MINNEAPOLIS, MN 55454 Sept. 27, 2012
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation and interview, the hospital was found out of compliance with the Condition of Participation, Physical Environment (42 CFR 482.41), as evidenced by deficiencies issued as a result of the Life Safety Code (LSC) inspection completed on [DATE] during a substantial allegation investigation. This had the potential to affect all patients receiving services from the hospital.

Findings include:

Refer to Life Safety Code deficiencies - K11, K18, K20, K21, K25, K29, K43, K48, K56, K62, K69, K71, K72, K76 and K77 for additional information.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, interview and document review, the hospital was not in compliance with the Condition of Participation for Surgical Services (CFR 482.51) due to a failure to ensure the safe use of electrocautery devices. This resulted in a risk for fire in the operating room and/or risk for patient burns for 2 of 6 surgical patients observed (P1, P2), and an immediate jeopardy (IJ) situation for P1 and P2 when the surgeon and/or surgical staff failed to operate the electrocautery device as directed by hospital policy and the manufacturer's recommendations during a surgical procedure. The hospital also failed to ensure adequate investigation, surgeon and other appropriate staff training, and accurate reporting had occurred for 1 of 1 patient (P3) who had sustained a burn from use of an electrocautery device during a surgical procedure. These deficient practices had the potential to affect all patients undergoing surgery with cautery.

Findings include:

Refer to findings at A0951 regarding the use of electrocautery equipment in the surgical suite.

The IJ began when the improper use of an electrocautery device was observed on 9/25/12, during surgical procedures observed where the surgeon was not holstering the cautery device.

The manufacturer's recommendations in the user's guide for the Valley Lab cautery device used by the hospital was reviewed. The manufacturer's guide identified Warnings related to use. The cautery device was identified as having the potential to be a fire hazard. Under the topic Fire Hazard, the following was identified, "Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes), flammable gases, or high levels of oxygen. Electrosurgical accessories that are activated or hot can cause a fire. When not using active accessories, place them in a holster or in a clean dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns."

The IJ that began on 9/27/12, was removed on 9/27/12, when the hospital assured all surgeons, nurses and techs who worked in the surgical suites of the hospital had been re-educated to the hospital's safe surgical practices including safe use of cautery. The hospital had staff document attestations to confirm their knowledge. Staff not present were expected to review the current policy and sign an attestation of understanding prior to working in surgery through 10/1/12, when all staff were expected to have been educated. Surgical Services Managers began audits of surgeries to ensure safe surgical procedures including safe use of electrocautery were implemented beginning 9/27/12. All surgeons and operating room staff were informed that there would be consequences including suspension and/or termination for failure to follow the safe surgical practices including safe use of electrocautery devices on 9/27/12.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, interview and document review, the hospital failed to ensure the safe use of an electrocautery device for 2 of 6 surgical patients observed. This resulted in a risk for fire in the operating room and/or risk for patient burns for 2 of 6 surgical patients observed (P1, P2), and an immediate jeopardy (IJ) situation for P1 and P2 when the surgeon and/or surgical staff failed to operate the electrocautery device as directed by hospital policy and the manufacturer's recommendations during a surgical procedure. The hospital also failed to ensure adequate investigation, surgeon and other appropriate staff training, and accurate reporting had occurred for 1 of 1 patient (P3) who had sustained a burn from use of an electrocautery device during a surgical procedure. These deficient practices had the potential to affect all patients undergoing surgery with cautery.

Findings include:

The IJ began when the improper use of an electrocautery device was observed on 9/25/12, during surgical procedures observed where the surgeon was not holstering the cautery device.

The IJ that began on 9/27/12, was removed on 9/27/12, when the hospital assured all surgeons, nurses and techs who worked in the surgical suites of the hospital had been re-educated to the hospital's safe surgical practices including safe use of cautery. The hospital had staff document attestations to confirm their knowledge. Staff not present were expected to review the current policy and sign an attestation of understanding prior to working in surgery through 10/1/12, when all staff were expected to have been educated. Surgical Services Managers began audits of surgeries to ensure safe surgical procedures including safe use of electrocautery were implemented beginning 9/27/12. All surgeons and operating room staff were informed that there would be consequences including suspension and/or termination for failure to follow the safe surgical practices including safe use of electrocautery devices on 9/27/12.

Medical doctor (MD)-E was observed on 9/25/12, at 8:25 a.m. performing a cervical laminectomy with tumor removal on P1. The patient had received an alcohol based skin preparation prior to the surgical procedure and had an endotracheal tube in place. Although the certified surgical technologist (CST)-A had placed a cautery holster device on the patient's upper back, the surgeon did not place the electrocautery device in the holster following each use of the device. The surgeon made the incision at 9:15 a.m. using the electrocautery device, and then placed the electrocautery on the surgical drape covering the patient. MD-E used the electrocautery four times between 9:16 a.m. and 9:18 a.m. and placed the electrocautery on the drape versus the holster. MD-E again used the electrocautery eleven times between 9:22 a.m. and 9:27 a.m. and placed the device on the surgical drape covering the patient following each use of the device and did not place the device in the holster. CST-A was not observed to holster the electrocautery either.

MD-E, who performed P1's surgery, was interviewed on 9/27/12, at 8:55 a.m. She stated she was aware of the hospital policy related to the use of the electrocautery. She stated she did not always use the cautery holster when the surgery she was performing required frequent use of the electrocautery device

A telephone interview was conducted with the senior director of surgical services on 9/27/12, at approximately 10:30 a.m. The director stated the circulating registered nurse (RN)-L had been interviewed. The directed said RN-L had stated he had not observed the improper use of the electrocautery device due to other preparations he had been completing at that time in the operating room. In addition, the director stated that CST-A had been interviewed and was aware of the hospital policy which required the electrocautery be placed in the holster when not in use.





MD-A was observed on 9/25/12, from approximately 3:10 p.m. to 3:38 p.m. during a surgical procedure to perform a pulmonary valve replacement on P2. P2 received a Betadine based skin preparation prior to the surgical procedure and had an endotracheal tube in place. Although CST-B had placed a cautery holster device on the lower right side of the patient, the surgeon nor CST-B placed the electrocautery device in the holster following each use of the device. The surgeon made the incision at approximately 3:10 p.m., used the electrocautery device, and placed the electrocautery device on the surgical drape which was covering the patient. MD-A used the electrocautery more than 10 times between 3:10 p.m. and 3:37 p.m. and placed the electrocautery on the drape each time. CST-B did not always immediately holster the electrocautery device. During the observations, the electrocautery was holstered after 15 seconds of laying on the surgical drape four times, after 20 seconds one time, and after 25 seconds three times. The surveyor left the room at 3:38 p.m. and returned to the surgery suite approximately two minutes later. On the surveyor's return to the surgical suite, the electrocautery was observed laying on a dry gauze on top of the drape. The electrocautery remained on the dry gauze for 20 seconds, at which point CST-B picked it up and put it in the holster. MD-A placed the device on the surgical drape following each use and CST-B would inconsistently place the electrocautery in the holster as identified above.

The senior director of the surgical suite and the vice president of perioperative services were interviewed on 9/25/12, at 3:45 p.m. They stated the hospital policy required the electrocautery be placed in the holster when not in use.

The circulating registered nurse (RN)-A, present during P2's surgery, was interviewed on 9/25/12, at 3:55 p.m. RN-A stated she expected the scrub nurse to pick up the cautery and put it in the holster when not in use. She verified she had not visualized that being done.

The surgical nurse manager, RN-C, was interviewed on 9/25/12 at 3:58 p.m.. RN-C stated that although she had been in the surgical suite during P2's surgery, she was unable to see whether the cautery had been holstered because of equipment being in the way.

Another circulating nurse, RN-B, had also been in the operating room during P2's surgery. RN-B was interviewed on 9/26/12, at 10:00 a.m. RN-B also stated she expected the scrub nurse to place the cautery in the holster.

MD-A, who performed P2's surgery, was interviewed on 9/26/12, at 2:30 p.m. He stated it was not his practice to holster the cautery during that type of surgery due to the intricate procedure required. He stated he had to be concerned with infection control and accuracy and could not remove his eyes from the field when performing a pulmonary valve surgery. He stated that with an open chest surgical procedure he expected the scrub nurse to holster the electrocautery. He further indicated that at one time during the surgery observed, the electrocautery was not holstered because the scrub nurse needed to hand him supplies in a hurry due to a bleed. He confirmed he was aware of the hospital's policy related to the use of the electrocautery.

During interview at 9:30 a.m. on 9/27/12, with certified scrub tech (CST)-B, who had assisted with P2's surgery, CST-B stated she did not think there was a specific policy for holstering the cautery. However, stated the requirement was part of the hospital's fire safety policy. CST-B stated she had been visualizing the cautery during P2's surgery and did not think it was ever on the drape for longer than 15 seconds. She stated she had tried to pick it up as soon as she could.




A review of variance reports indicated one patient had received a burn related to the use of an electrocautery device in the past year.

A Patient Variance Report provided by the hospital dated 8/13/12, indicated P3 had sustained a burn on the lower right abdomen. The burn was noted during a surgical procedure in which an electrocautery device had been used. The event occurred in the hospital based surgical suite. The facility's I CARE (incident report documentation) indicated the burn had been excised with cautery, and closed with suture and dermabond. An I CARE follow up note by a Surgical Services Nurse Manager dated 8/27/12, included: "...documentation correct and reflects that surgeon stated he would inform family. Holster for cautery was not utilized correctly by surgeon. It is difficult for ST [surgical tech] to monitor for this as they are busy passing instruments and are not always near the field to not [sic] if this happens. They do replace the pencil in holster if they see it is not in. ST and RN educated surgeon in the moment that the pencil needs to be returned to the holster after each use."

During further investigation, it was determined this variance had not been investigated in a timely and thorough manner. During interview with the Vice President (VP) of Medical Affairs on 9/27/12, at 2:30 p.m. the VP of Medical Affairs stated the surgeon involved in this incident had been flagged for Dyad (partnership between a physician and administrative partner) review, and review by the peri-operative safety committee. In addition, he stated the Dyad leader had communicated concern and remediation (specifics not provided), since the provider's notice of this issue. The VP of Medical Affairs stated every I-Care report that names a provider or trainee is supposed to go across his desk, however, he acknowledged this report had not made it to his desk yet. He verified the process for review of this incident could have been conducted in a more timely manner.

During interview with the hospital's President/CEO, at 3:00 p.m. on 9/27/12, she stated they had been able to follow up with the surgeon involved in P3's surgery on 8/13/12, where the patient received a burn from the cautery pen. She stated the surgeon had reported the incident had not been as a result of his failure to holster the cautery, but had been due to his body movement and human error. The CEO stated the surgeon had indicated he had been tired after a long surgery, had been holding the cautery in his hand, had bumped the patient and caused a burn. She verified the variance should have been followed up with a more thorough and timely investigation.

The hospital's policy, Fire Safety in the Operating Room last revised May 2012, indicated the use of an ignition source or any device that generated heat (e.g. electrosurgical unit) increased the fire risk factor. The policy also indicated the active electrode of an electrosurgical unit should be place in a holster when not in use.

The hospital's policy, Patient Fire Safety: Oxygen Enriched Environment last reviewed October 2011, indicated ESU (electrosurgery electrode units) were to be placed in a holster when not in use.

The manufacturer's recommendations in the user's guide for the Valley Lab cautery device used by the hospital was reviewed. The manufacturer's guide identified Warnings related to use. The cautery device was identified as having the potential to be a fire hazard. Under the topic Fire Hazard, the following was identified, "Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes), flammable gases, or high levels of oxygen. Electrosurgical accessories that are activated or hot can cause a fire. When not using active accessories, place them in a holster or in a clean dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns."