Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's test logs which contain both proficiency testing (PT) samples and patient samples) and interview with the laboratory director (LD), the laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples for five of five PT events in 2023 and 2024. Findings: 1. Review of the laboratory's test logs from 3/28/23 to date of survey revealed that patient's samples for throat culture were tested once. PT samples from the College of American Pathologists (CAP) are also included on this log. The PT samples were each tested twice on the following dates: a. Test date 3/30/23 samples TC1, TC2, TC3, TC4 and TC5. b. Test date 8/15/23 samples TC6, TC7, TC8, TC9 and TC10. c. Test date 12 /12/23 samples TC11, TC12, TC13, TC14 and TC15. d. Test date 4/1/24 samples TC1, TC2, TC3, TC4 and TC5. e. Test date 8/9/24 samples TC6, TC7, TC8, TC9 and TC10. f. Test date 12/12/23 samples TC11, TC12, TC13, TC14 and TC15. 2. The surveyor asked the LD why the PT samples were tested twice. The LD stated that CAP provided two sets of samples, so he believed he was supposed to test both sample sets. Interview with the LD on 10/21/24 at 2:05 p.m. confirmed the laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples for five of five PT events in 2023 and 2024. 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 --