Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Virginia Urology Center- Prince George on October 12-13, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation, and interviews, the laboratory failed to ensure Core Chemistry Module PT test results for endocrinology Testosterone and Prostate Specific Antigen (PSA) analytes were returned to American Proficiency Institute (API) within the program's deadline for one of six events during the twenty-four month review timeframe (October 2021 -10/13/23). Findings include: 1. Review of the laboratory's API Core Chemistry PT documentation (2021 Event 3, 2022 Events 1-3, 2023 Events 1-2) revealed that the laboratory failed to submit PT results and received failure to participate scores for the following modules/analytes: 2021 Chemistry- Core Event 3: Testosterone and PSA challenges received zero percent (0%) scores for challenge samples IA 11-12. 2. An interview with the technical consultant and supervisor on 10/13/23 at approximately 10:15 AM confirmed the above finding. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --