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Doctor told she can't do research
Her recordkeeping endangered VA patients in a stroke study, officials said.
By JEAN HELLER
Published January 25, 2007
ST. PETERSBURG - A staff doctor at Bay Pines VA Medical Center has been suspended from research projects there after officials determined her faulty record-keeping had endangered the health care of several patients involved in a stroke study. The administration discovered the violations six months ago, imposed the two-year suspension and then reported the incident. The Office of the Inspector General issued a report Wednesday concluding that the hospital's actions were appropriate and justified. The doctor's actions endangered patient care by failing to provide a full accounting of their participation in the clinical trial, thereby depriving other VA doctors of information they might have needed in treating the same patients, the report said. The doctor also conducted research on individuals who had not been approved. As recently as a year ago, the report said, the VA official in charge of making sure the research complied with all rules and regulations was the doctor's husband. There was no indication that any of the 13 patient participants were harmed. The doctor, who was not identified except as a woman, also violated patient protections under federal regulations governing human medical experimentation. Those regulations, which cover clinical trials of new medications and procedures, require that everyone who takes part be fully informed of what will be done to them and their privacy guaranteed. In this case, the report said, the doctor permitted "individually identifiable patient information" to be seen by unauthorized personnel. The doctor remains on the Bay Pines staff treating patients. "The problems with the research protocols have nothing to do with her clinical practice of medicine," Wallace M. Hopkins, Bay Pines director, said. "But she can no long enroll her patients in research." The study, which was sponsored by an unidentified pharmaceutical company, involved comparisons of the effectiveness of medications in the prevention of stroke. Bay Pines currently conducts more than 125 research projects.
[Last modified January 25, 2007, 00:42:22]
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