Report Summary

Title: Healthcare Inspection – Sterile Compounding Environment and Practices, Overton Brooks VA Medical Center, Shreveport, Louisiana
Report Number: 17-01542-273
Issue Date: 6/15/2017
City/State: Shreveport, LA
VA Office: Veterans Health Administration (VHA)
Report Author: Office of Healthcare Inspections
Report Type: Healthcare Inspections
Release Type: Unrestricted
Summary: OIG conducted a healthcare inspection at the Overton Brooks VA Medical Center, Shreveport, LA (facility) to determine whether deficient conditions in the compounding pharmacy placed patients at risk. We confirmed that the facility did not comply with key elements of United States Pharmacopeia (USP) <797> (which outlines safe sterile compounding requirements and practices) as initially identified in October 2016 by the Louisiana Board of Pharmacy. The Board’s findings included a lack of proper cleaning of the compounding rooms and incomplete air and surface testing and certification in compounding areas. During our January 2017 site visit, we found continuing noncompliance with USP <797> requirements, including: Cleaning logs from September 2016 through January 27, 2017, reflected 4 days where there was no evidence of appropriate cleaning and mopping of floors; Only 18 percent of applicable employees had all the training and competency documentation required as of January 27, 2017; Air and surface testing and certification had not been completed in July 2016 and January 2017 as required. Appropriate air and surface testing was completed on February 1, 2017. Pharmacy managers did not report the Louisiana Board of Pharmacy’s inspection findings to appropriate leaders or committees. Facility leaders learned of the Louisiana Board of Licensing reports after the OIG unannounced January 2017 site visit. In February 2017, Food and Drug Administration (FDA) investigators conducted an extensive and detailed review of the facility’s compliance with FDA guidance on compounded sterile preparations (CSPs). Facility and Veterans Integrated Service Network (VISN) leaders implemented interim measures to assure patient safety that included sending all chemotherapy CSP orders to the Alexandria, LA, VA Medical Center for compounding; outsourcing all routine compounding to a local pharmacy; and limiting CSP activities to immediate use (≤1 hour beyond use date). Facility and VISN officials implemented an extensive action plan to correct the identified USP <797> deficiencies before re-opening the onsite pharmacy compounding areas. We reviewed the electronic health records of hospitalized patients who were administered CSPs and who were diagnosed with selected types of infections subsequent to the CSP administration in FYs 2016–2017 through January 6, 2017. None of the patients developed infections after intravenous infusions or injections of compounded medications. We made two recommendations to the VISN Director focusing on the implementation of corrective actions and processes to fully comply with USP <797> requirements, and communication of external review results to facility leaders.