Summary:
Summary Statement of Deficiencies 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 laboratory testing logs, American Proficiency Institute (API) proficiency testing (PT) reports, as well as interview with the Practice Manager (PM) the laboratory failed to test PT samples by testing personnel (TP) who routinely perform patient testing. FINDINGS: 1. Affirm VP III Lab Testing Logs documented TP who routinely perform patient testing yet API PT reports 2022-3, 2023-1, 2023-2, 2023-3, 2024-1, and 2024-2 PT reports indicated only two TP performing PT. 2. Confirmed findings by interview with PM on August 28, 2024, at approximately 11: 30 A.M. 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 --