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 2024 and 2025 American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation and interview with technical supervisor (TS) 06/30/25, the laboratory failed to perform and document a review of "not graded" PT results. Findings: Review of 2024 and 2025 API PT records revealed the following "Not Graded" PT sample results; 1. 2024 Immunology/Immunohematology - 3rd Event - Sample VM-12 for test "Anti-HIV-1/2 (VM) (screen). 2. 2025 Immunology/Immunohematology - 1st Event - Sample VM-01 for test "Anti-HIV-1/2 (VM) (screen). Review of 2024 and 2025 API PT records revealed no documentation of a review of the 2 "Not Graded" PT results. Interview with TS at approximately 10: 15 a.m. confirmed the laboratory had failed to perform and document a review of the 2 "Not Graded" PT results. 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 --