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UNIVERSITY OF MINNESOTA MEDICAL CENTER, FAIRVIEW 2450 RIVERSIDE AVENUE MINNEAPOLIS, MN 55454 Aug. 11, 2014
VIOLATION: ORGANIZATION OF MEDICAL STAFF Tag No: A0356
Based on interview and document review, the hospital failed to ensure the bylaws were followed when the Medical Executive Committee (MEC) did not provide oversight for the quality of patient care provided by practitioners, for 1 of 11 patients (P4) reviewed, who experienced a negative outcome during an interventional radiology (IR) procedure.
Findings include:

The hospital's Medical Staff By-laws, revised May 2012, indicated that the purpose of "the Medical Staff shall be to monitor the quality of medical care in the Hospital...the MEC is delegated authority to act on the primary responsibilities of the Medical staff...specific duties of the Medical Executive Committee shall include...to coordinate the activities and general policies of the Medical Staff; to provide oversight of the quality of patient care provided by practitioners privileged through the Medical Staff process; to provide leadership in performance improvement activities to improve quality care, treatment and services, and to improve patient safety."P4's history and physical indicated that P4 was admitted to the West bank ITC (intensive treatment center) psychiatric unit on 04/10/14 for worsening symptoms of mania, psychosis, aggression, and impulsive behaviors. P4 was not a voluntary admission. In addition to P4's psychiatric needs, P4 had a gastrostomy tube (g-tube) secondary to Parkinson's disease with resultant dysphagia.

P4's mental health progress notes indicated that P4's g-tube dislodged and fell out at 6:50 a.m. on 04/20/14. P4 was transported to IR for a g-tube replacement procedure at 12:45 p.m. on 04/20/14. An IR procedure for Tube Change, dated 04/20/14 at 1:39 p.m., indicated that P4's gastrostomy tube was inserted under fluoroscopic guidance by Physician/(F). No immediate complications were noted. Correct placement of the g-tube was confirmed under fluoroscopy.

P4's mental health progress notes, dated 04/20/14 indicated that P4 returned to the mental health unit at 1:50 p.m. following g-tube replacement. After P4 received medications, water flushes, and a tube feeding, P4 began complaining of abdominal pain at approximately 5:00 p.m. P4's abdominal pain did not subside despite interventions aimed at pain control. At 8:35 p.m., P4 was transported to Radiology for x-rays of the abdomen.

Radiology reports, dated 04/20/14 at 8:47 p.m., indicated that two views of P4's abdomen were imaged. X-ray results at 9:29 p.m. showed pneumoperitoneum. Stat labs were ordered. A subsequent CT of P4's Abdomen and Pelvis was imaged at 10:20 p.m. CT results at 10:50 p.m. confirmed a diagnosis of pneumoperitoneum, with a large amount of abdominal and pelvic fluid. An internal medicine progress note, dated 04/20/14 at 10:33 p.m., indicated that P4 emergently needed evaluation for possible gastrointestinal perforation and sepsis, which had occurred post g-tube replacement. Intravenous (IV) lines were established and P4 was given fluid boluses along with IV Vancomycin and Zosyn. Stat labs, including blood cultures, were obtained. At 12:33 a.m., P4 was transferred to Surgical Services on the East bank of the medical campus.
A surgical report, dated 04/21/14 at 4:40 a.m., indicated that P4 underwent an exploratory laparoscopy, abdominal washout, repair of gastric perforation, and upper endoscopy with replacement clip. The surgical report indicated that P4 had diffuse peritonitis with a large amount of intraperitoneal purulent fluid. There was a perforation identified posteriorly on the lesser curve of the stomach. The g-tube was noted to be in appropriate position. After surgery, P4 was transferred to the surgical Intensive Care Unit for postoperative care.

Physician (F)/Interventional Radiology was interviewed on 08/11/14 at 7:05 a.m. Physician/(F) stated she was the Interventional Radiologist on-call on 04/20/14. The internal medicine physician contacted her on the morning of 04/20/14 and indicated that P4's g-tube had come out and needed to be replaced as soon as possible because P4 received all medications and food via g-tube. P4 came to Radiology around 1:30 p.m. on 04/20/14 for the procedure, which she performed. G-tube insertion is a short procedure. Lidocaine, a local anesthetic, is used for insertion of the g-tube. The procedure was completed under fluoroscopy, which is a live x-ray. After the g-tube was inserted, correct position of the g-tube was confirmed by fluoroscopy. Contrast media was injected to view the inside and outside of the stomach. No contrast media was seen outside P4's stomach. P4 tolerated the procedure without difficulty and returned to the mental health unit after the procedure was completed. Later during the evening of 04/20/14, the internal medicine physician contacted her again to report that P4 had sustained a possible gastrointestinal perforation following insertion of the g-tube. P4 needed emergent surgery. The next day on 04/21/14, she spoke to the Surgeon who performed P4's emergent surgery. The Surgeon reported that although P4's g-tube was noted to be in the correct position during surgery, a small perforation was identified on the posterior wall of P4's stomach. P4 had developed peritonitis, which required cleaning out P4's peritoneal cavity and closing the perforation. She stated that a perforation of this nature is a known complication of g-tube insertion procedures, but is not one of the three most common complications. On 04/21/14, she completed an Occurrence report regarding the outcome of P4's IR procedure. She forwarded the Occurrence report to Risk Management and to the IR Medical Director.

Physician (G)/Interventional Radiology Medical Director was interviewed on 08/08/14 at 2:00 p.m. Physician/(G) stated he received an Occurrence report on 04/21/14 regarding P4's negative outcome following g-tube insertion by Physician/(F). Typically, perforations that occur on the posterior wall of the stomach during g-tube insertion are caused during insertion of the guidewire, which directs the position of the g-tube. All patient procedures or surgeries that result in negative patient outcomes are reported to Risk Management. Risk Management then coordinates the appropriate review process for a root cause analysis of the occurrence. Risk Management sends Occurrence reports involving physician care to the MEC. Physician/(F) followed the process for occurrences by completing an Occurrence report regarding P4's perforation and sending the Occurrence report to Risk Management and the Department Chairperson, which is Physician/(G). In addition to the oversight process of physician practice by Risk Management and the MEC, the Department of Radiology conducts a monthly Quality meeting to monitor physician practice and identify any areas necessary to improve patient care. P4's perforation was reviewed a few days after the event at the Departmental Quality meeting, at which time concerns regarding any suboptimal practice by Physician/(F) were considered. The Department determined there were no problems with infrastructure and that P4's procedure was performed in accordance with expected standards of procedural practice.

Physician (D)/Vice President of Medical Affairs was interviewed on 08/08/14 at 1:00 p.m. Physician/(D) stated that the hospital's oversight of physician practice related to patient harm is the responsibility of the MEC, which Physician/(D) oversees. When patients experience a negative outcome as the result of physician care, an Occurrence report is generated regarding the event. The Occurrence report is forwarded to Risk Management. Risk Management then sends the Occurrence report to the MEC, where it is reviewed and determined if peer review is warranted. Although the Occurrence report regarding P4's perforation was sent to Risk Management, Risk Management did not send the Occurrence Report to the MEC for review. As a result, the MEC did not review the perforation P4 sustained during the 04/20/14 IR procedure, which was a breach in the hospital's process to ensure safe physician care of patients. Risk Management Director/(E) was interviewed on 08/08/14 at 1:00 p.m. Risk Management Director/(E) stated that all Occurrence reports are directed to Risk Management for coordination and distribution to the appropriate Departments or committees for review. Due to a communication failure, the Occurrence report pertaining to P4's IR procedure did not get recognized and was not forwarded to the MEC for review in accordance with the hospital's usual process.The hospital's policy on Occurrence Reporting, revised March 2012, defined an occurrence as a "situation or event that is not consistent with routine patient care or operations of the care setting and resulting in, or with the potential for, injury to the person or property. Occurrences may be the result of system failure and/or human error, at-risk behavior, or reckless behavior." The policy indicated that "Occurrences are reported to the attending or covering physician. Immediate reporting to the attending or covering physician is required for any occurrence which: has harmed the patient...all occurrences involving unanticipated death, serious physical or psychological injury will be reported immediately to the area manager/supervisor and Risk Management...the manager/supervisor assigned to review the occurrence should be the manager/supervisor most accountable for the system/process that failed and/or the supervisor of the people involved in the occurrence...managers/supervisors review and investigate occurrence reports routed to their attention to identify contributing or causal factors that could have been prevented...aggregate data will be analyzed by the appropriate groups, committees, and departments to identify opportunities for prevention and/or improvement."

A review of the MEC committee meeting minutes for May 2014, June 2014, and July 2014, indicated that the MEC reviewed a total of ten Occurrence reports during these three months. P4's perforation sustained during an IR procedure on 04/20/14 was not among the ten reports reviewed by the MEC.