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 the CMS-209 and review of 2019, 2020, and 2021 CAP (College of American Pathologists) proficiency testing records 9/29/21, the laboratory failed to ensure proficiency testing was rotated among personnel who routinely perform patient testing. Review of the CMS-209 Laboratory Personnel Report (CLIA) revealed 46 TP (testing personnel) were listed on the form. Review of 2019, 2020, and 2021 CAP proficiency testing records revealed proficiency samples for 3 of 12 events were tested by 1 TP who is no longer employed. Samples for 9 of 12 events were tested by 4 of the 46 testing personnel - TP #1, TP #2, TP #4, and TP #5. a. TP #1 tested all samples for the 2020 FH2-B hematology event, the 2020 AQI-C chemistry event, the 2021 FH2-B hematology event, and the 2021 AQI-B chemistry event. b. TP #2 tested all samples for the 2019 FH2-C hematology event, the 2020 AQI-B chemistry event, and the 2021 FH2-A hematology event. c. TP #4 tested all samples for the 2019 FH2-B hematology event. d. TP #5 tested all samples for the 2020 FH2-A hematology event. D5783