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Intraoperative Radiofrequency Ablation and Other Surgical Service Concerns, Samuel S. Stratton VA Medical Center, Albany, New York

Report Information

Issue Date
Report Number
17-01770-188
VISN
State
New York
District
VA Office
Veterans Health Administration (VHA)
Report Author
Office of Healthcare Inspections
Report Type
Hotline Healthcare Inspection
Recommendations
9
Questioned Costs
$0
Better Use of Funds
$0
Congressionally Mandated
No

Summary

Summary
The VA Office of Inspector General (OIG) conducted a healthcare inspection regarding allegations that the Samuel S. Stratton VA Medical Center’s peer review processes did not follow Veterans Health Administration (VHA) policy; the surgeon performed intraoperative radiofrequency ablation (IORFA) surgery for hepatocellular carcinoma and “completely missed” tumors in patients; a surgeon told a patient there was a recurrence of a tumor although it was “completely missed” during IORFA surgery; the surgeon performed cancer surgery on patients who did not have cancer; and adverse events occurred during and after the surgeon’s other cancer surgeries. The OIG substantiated the facility’s peer review process did not follow VHA policy, and the facility did not meet credentialing and privileging requirements. The OIG substantiated the surgeon completely or partially missed tumors when performing IORFA in three patients and told patients they had residual tumors when tumors were not initially ablated. The OIG determined that facility leaders did not provide disclosures for the patients reviewed. The OIG did not substantiate the surgeon performed surgery on patients who did not have cancer or that adverse events occurred during cancer surgeries. The OIG made nine recommendations related to reviewing quality oversight and quality data for professional practice evaluations; improving peer review programs; including accurate performance data for Surgery Service’s professional practice evaluations; developing and implementing processes to document, report, and track discussed patient cases; implementing processes to track, monitor, and report IORFA outcomes; consulting with Office of General Counsel on patients with missed tumors to institutionally disclose if appropriate; assessing the Surgeon’s IORFA outcomes; performing external reviews of IORFA processes; and evaluating actions for relevant staff.

Open Recommendation Image, SquareOpenClosed and Implemented Recommendation Image, CheckmarkClosed-ImplementedNot Implemented Recommendation Image, X character'Closed-Not Implemented
No. 1
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The Veterans Integrated Service Network Director ensures that the Facility’s credentialing and privileging program is reviewed for integration of key functions of quality oversight, including the use of quality data for Focused Professional Practice Evaluation and Ongoing Professional Practice Evaluation processes and surgical Peer Review program.
No. 2
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The Facility Director ensures that the Facility Peer Review program meets all Veterans Health Administration requirements.
No. 3
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The Facility Director ensures that Surgery Service’s professional practice evaluations include performance data to support provider privileges and contain accurate data.
No. 4
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The Facility Director ensures that a process is developed and implemented to document, report, and track patient cases discussed in the Liver Tumor Board and that meeting minutes are completed and forwarded to oversight groups.
No. 5
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The Facility Director ensures that a process is implemented to track, monitor, and report intraoperative radiofrequency ablation outcomes to Facility and Quality Management leaders.
No. 6
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The Facility Director ensures that the Office of General Counsel is consulted on the three patients with missed or partially missed tumors after intraoperative radiofrequency ablation to determine if institutional disclosure might be appropriate.
No. 7
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The Facility Director ensures that the five additional intraoperative radiofrequency ablation patients the Office of Inspector General referred to the Facility, and any other patients who had intraoperative radiofrequency ablation done by Surgeon A, are reviewed by clinicians with qualifications to assess the outcome of these procedures and actions taken as appropriate.
No. 8
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The Facility Director ensures an external review of intraoperative radiofrequency ablation processes is obtained to identify possible causes of missed tumors and methods to improve practice and outcomes.
No. 9
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The Facility Director ensures that Human Resources and the Office of General Counsel are consulted to determine the appropriate actions, if any, including consideration for ethics review, for staff who were not forthcoming with patients on outcomes of intraoperative radiofrequency ablation.