Arthritis Associates, Pllc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation of the laboratory, a review of the Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), final patient test reports, lack of documents, and staff interviews, the laboratory failed to verify the accuracy of the microscopic synovial fluid crystal identification test in 2024 and 2025, with approximately 26 patients reported annually. The findings include: 1. Observation of the laboratory on 02/06/2026 at 9:00 a.m. revealed a microscope used for patient testing. During the observation testing, person one stated that the microscope was used for urine sediment analysis and synovial fluid crystal identification. 2. A A review of the Form CMS-116 completed for the survey revealed that the laboratory listed synovial fluid crystal identification as a test it performed. 3. A review of final patient test reports revealed that the laboratory performed a synovial crystal identification (ID) on patient 230112 on 06/03/2025. 4. The laboratory could not provide documentation of verification of accuracy for the microscopic synovial fluid crystal identification test for 2024 or 2025. 5. An interview with testing person one on 02/06/2026 at 3:00 p.m. confirmed that the laboratory performed approximately 26 synovial fluid crystal identification patients annually and failed to verify accuracy in 2024 and 2025. 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 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the laboratory lead, the laboratory failed to include the test report date on final patient test reports in 2023 and 2024. The findings include: 1. Review of final patient test reports for patient numbers 47715 from 10.16.2023 and 58093 from 01.17.2024 revealed the test report date was not on the report. 2. A subsequent phone interview with the laboratory lead on February 28, 2024, at 9:00 a.m. confirmed that the laboratory failed to include the report date on final patient test reports in 2023 and 2024. 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 --