Deficiencies in a Cardiac Research Study at the VA St. Louis Health Care System, Missouri

The VA Office of Inspector General (OIG) conducted a healthcare inspection that assessed whether (1) a research study cardiologist provided follow-up cardiac care to a research patient; (2) a cardiology fellow failed to provide follow-up care and correctly interpret electrocardiograms; (3) the Subcommittee on Research Safety and Institutional Review Board failed to ensure adherence to a research plan; and (4) stress-test laboratory procedure instructions were inconsistent. A research patient had a positive stress-test result. Follow-up studies were ordered only as part of the research study. The research cardiologist failed to initiate cardiac follow-up care or notify the patient or primary care provider of positive stress-test results. The OIG found that the cardiology fellow provided follow-up care for patients with positive stress tests, but the OIG was unable to determine if the fellow had difficulty interpreting electrocardiograms. The OIG determined that supervising providers were involved with the fellow’s patient encounters. The Subcommittee on Research Safety and Institutional Review Board failed to ensure a research team’s adherence to the research plan related to notification of primary providers of their patients’ enrollment in the study. The OIG found that primary providers were inconsistently alerted. The OIG identified inconsistencies between instructions provided to cardiology fellows and the protocol used by facility staff for a stress-test laboratory procedure. The stress-test laboratory protocol did not include elements required by facility policy for establishing internal policy and standard operating procedures. The OIG made six recommendations related to ensuring research providers take action on stress-test results; conducting a retrospective review of enrolled patients’ result notifications and follow-up care; providing disclosure to the patient’s family; performing research oversight of the study plan to ensure communication of patient enrollment in the study to primary providers; and reviewing the stress-test laboratory educational material.