Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at VCU Health / MCV Physicians -Warsaw on September 29, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The inspection also included an initial remote record review and interview with the primary testing personnel on 09/28/21. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to document remedial action taken for 6 unsatisfactory analyte challenged results (3 Lead Level, 2 Infectious Mononucleosis, 1 Hematocrit) during the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) proficiency documentation, a total of 6 events (2019 Event 3, 2020 Events 1-3, 2021 Events 1-2), revealed no evidence of remedial action for the following unsatisfactorily scored analytes: 2019 API Chemistry Core Event 3 - 0% Lead (LEA-11, LEA-12 scored unacceptable); 2019 API Immunology Event 3 - 0 % Infectious Mononucleosis (IM- 06, IM-07 scored unacceptable); 2020 API Chemistry Core Event 2 - 50% Lead (LEA- 07 scored unacceptable, long term performance unsuccessful); 2020 API Hematology Event 3 - 80% Hematocrit (HSY-12 scored unacceptable). 2. Review of available PT