Healthcare Inspection – Alleged Transcatheter Aortic Valve Replacement Program Issues, VA Palo Alto Health Care System, Palo Alto, California

OIG conducted a healthcare inspection to assess allegations of delays in patients receiving transcatheter aortic valve replacement (TAVR) procedures at the VA Palo Alto Health Care System (system) Palo Alto, CA, due to Veterans Health Administration (VHA) policy requirements. We received complaints alleging: Patient A’s TAVR was delayed; VHA’s requirement that TAVR procedures occur in a hybrid operating room (HOR) is too stringent and not the community standard; patients were “affected” by the HOR requirement for the TAVR procedure; the system requested and was denied a waiver of the HOR requirement for TAVR procedures; HOR construction delays prevented system TAVR program implementation; and to avoid delays in patient care, the system enrolled patients in research studies so they could undergo TAVR procedures. We did not substantiate Patient A experienced a delay in obtaining the TAVR procedure. Once Patient A was recommended for a TAVR, the procedure was completed within a timeframe consistent with his medical needs. We substantiated VHA requires TAVR procedures be performed in a HOR. VHA reviewed best practices and obtained expert consensus to establish this requirement. We substantiated patients were affected by VHA’s requirement that TAVR procedures be performed in a HOR as the system did not have a HOR and was unable to perform non-research TAVR procedures. However, we found the system referred patients for care. We substantiated that construction on a TAVR HOR was not completed on the projected date and affected the system’s program. Patients obtained the TAVR procedure through other services during that time. We substantiated that system providers enrolled patients in TAVR procedure research studies. We were unable to determine if by doing so, they avoided delays in care. We identified lapses in the documentation necessary to maintain accurate records including communication and continuity of care. We made one recommendation.