Summary:
Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to verify the accuracy of the PT results obtained for 6 of 6 API Microbiology testing events in 2023 and 2024. Findings Include: 1. On the day of survey, 02/11/2025 at 12:41 pm., review of the laboratory's API Microbiology PT records revealed that the laboratory did not verify the accuracy for the following analytes (UTI panel) that were not graded by the PT agency in 2023 and 2024: 2023 1st event: Molecular Mycology - Candida tropicallis (UTI-01) Molecular Resistance Genes - CTX-M Group 1 (UTI-01 through UTI-04) - dfrA, KPC, NDM, qnr, sul (UTI-01, UTI-03, UTI-04) - mecA (UTI- 01, UTI-02, UTI-03, UTI-05) - vanA/B (UTI-01 through UTI-05) 2023 2nd event: Molecular Resistance Genes - CTX-M Group 1, dfrA, KPC, NDM, qnr, sul (UTI-07, UTI-09) - mecA (UTI-06 through UTI-10) - vanA and vanB (UTI-06, UTI-08 through UTI-10) 2023 3rd event: Molecular Resistance Genes - AmpC , CTX-M, CTX-M Group 1, CTX-M Group 2 (UTI-12 through UTI-14) - dfrA, sul (UTI-12 through UTI- 15) - mecA (UTI-11, UTI-12, UTI-14, UTI-15) - qnr (UTI-12, UTI-13) - vanA (UTI- 11, UTI-12, UTI-14) - vanB (UTI-11 through UTI-14) 2024 1st event: Molecular Resistance Genes - CTX-M Group 1, dfrA, qnr, sul (UTI-02, UTI-03) - mecA, vanA, vanB (UTI-01 through UTI-05) 2024 2nd event: Molecular Resistance Genes - CTX- M Group 1, dfrA, KPC, NDM, sul (UTI-06, UTI-07, UTI-09, UTI-10) - mecA, vanA, vanB (UTI-06 through UTI-10) - qnr (UTI-06, UTI-08 through UTI-10) 2024 3rd event: Molecular Resistance Genes - CTX-M Group1, dfrA, KPC, NDM, qnr, sul (UTI-11, UTI-13 through UTI-15) - mecA (UTI-11 through UTI-15) - vanA (UTI-12 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 -- through UTI-14) - vanB (UTI-11 through UTI-14) 2. The API Proficiency Testing performance Evaluation form states "Laboratories are responsible for documenting and performing