Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Piedmont Family Practice, PLC on February 4, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records, and interviews, the laboratory failed to rotate PT among the three (3) personnel who performed Hematology, and Chemistry patient testing in calendar year 2018 and up to the date of the survey, on February 4, 2020. Findings include: 1. Review of the CMS 209 form revealed 3 testing personnel (TP) listed as having performed/reported patient testing during the twenty four (24) months reviewed. 2. Review of the laboratory's American Proficiency Institute (API) PT documentation (Core Chemistry 2018 Events 1-3 and 2019 Events 1-3; Hematology/Coagulation 2018 Events 1-3 and 2019 Events 1-3; Miscellaneous Chemistry 2018 Evens 1-2 and 2019 Events 1-2 ) revealed that TP A signed as testing personnel on the following attestation statements: 2018 Core Chemistry Events 1-3; 2019 Core Chemistry Events 1-3; 2018 Hematology /Coagulation Events 1-3; 2019 Hematology/Coagulation Events 1-3; 2018 Miscellaneous Chemistry Events 1-2; and 2019 Miscellaneous Chemistry Events 1-2. TP A performed sixteen (16) of sixteen (16) events reviewed. (See Personnel Code Sheet.) 3. In an exit interview with Testing Personnel A at approximately 12:30 PM on February 4, 2020, the findings were confirmed. 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 --