Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of Centers for Medicare &. Medicaid Services(CMS) Form 209, review of testing personnel (TP) training and competency records, and review of 2022 and 2023 American Proficiency Institute (API) proficiency testing (PT) records 10/27 /23, the laboratory failed to ensure all testing personnel (TP) who performed patient testing participated in PT. Findings: Review of CMS Form 209, submitted at time of survey, revealed the laboratory employs 19 TP. Review of 2022 and 2023 API PT events for Chemistry Core, Hematology and Bacteriology revealed 1 TP tested all samples for all specialties for each event. For example: 2022 API 1st events for Chemistry Core, Hematology and Bacteriology, all PT samples for all 3 specialties were tested by TP #2. 2022 API 2nd events for Chemistry Core, Hematology and Bacteriology, all PT samples for all 3 specialties were tested by one TP, this TP is no longer employed. 2022 API 3rd events for Chemistry Core, Hematology and Bacteriology, all PT samples for all 3 specialties were tested by one TP, this TP is no longer employed. 2023 API 1st events for Chemistry Core, Hematology and Bacteriology, all PT samples for all 3 specialties were tested by TP #12. 2023 API 2nd events for Chemistry Core, Hematology and Bacteriology, all PT samples for all 3 specialties were tested by TP # 9. 2023 API 3rd events for Chemistry Core, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Hematology and Bacteriology, all PT samples for all 3 specialties were tested by TP # 6. Review of 2022 and 2023 API PT events for Chemistry Core, Hematology and Bacteriology and review of TP training and competency records revealed the following 12 TP were performing patient testing prior to June of 2023 and had not participated in PT: TP #1, TP #3, TP #4, TP #5, TP #8, TP #10, TP #11, TP #13, TP #14, TP #15, TP #16 and TP #18. -- 2 of 2 --