Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and confirmed by interview with the Laboratory Operations Director at 2:00 pm on 09/26/2025, the laboratory failed to perform a self evaluation when the laboratory received 15 ungraded PT scores from five out of five PT testing events from 01/01/2024- 09/26/2025. The findings include: 1. For 2024 testing event 2, the laboratory received ungraded PT test scores for the following: *2024 Immunology/ Immunohematology- Anti-CCP (specimens CCP-03 and CCP-04) *2024 Immunology/ Immunohematology- C-reactive protein (specimen CRP-03) *2024 Immunology/ Immunohematology- Thyroglobulin Ab (specimens TA-03 and TA-04) *2024 Immunology/ Immunohematology- Anti-HIV-1/2 (specimen VM-08) 2. For 2024 testing event 3, the laboratory received ungraded PT test scores for the following: *2024 Immunology/ Immunohematology- Anti-CCP (specimens CCP-05 and CCP-06) *2024 Immunology/ Immunohematology- Anti-HIV-1/2 (specimen VM- 12) 3. For 2025 testing event 1, the laboratory received ungraded PT test scores for the following: *2025 Immunology/ Immunohematology- Anti-CCP (specimen CCP- 01) *2025 Immunology/ Immunohematology- Anti-HIV-1/2 (specimen VM-01) 4. For 2025 testing event 2, the laboratory received ungraded PT test scores for the following: *2025 Immunology/ Immunohematology- Anti-CCP (specimen CCP-03) *2025 Immunology/ Immunohematology- Anti-HIV-1/2 (specimen VM-10) 5. For 2025 testing event 3, the laboratory received ungraded PT test scores for the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- following: *2025 Chemistry Core- Folate (specimens IA-07 and IA-09) 6. At the time of the survey, the Laboratory Operations Director confirmed the laboratory did not take and document