Summary:
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: A. Based on review of patient test reports, the Laboratory Test List & Annual Volume form, and confirmed by laboratory personnel #4 (refer to the Laboratory Personnel Report) at 10:30 am on 2/06/19, the laboratory failed to include the name and address of the testing facility for three out of three patient test reports (Patient identifiers A, B and C) from August 2018. The findings include: 1. The test report for Patient A indicated the laboratory performed the following patient testing on 8/09/2018: antinuclear antibody 9 panel (ANA9), anticardiolipin antibodies (ACL), 25-hydroxy vitamin D, rheumatoid factor panel (RF3), cyclic citrullinated peptide (CCP), antinuclear antibody (ANA) screen, antinuclear antibody titer, C-reactive protein (CRP), thyroid stimulating hormone (TSH) and comprehensive metabolic panel (CMP). 2. The test report for Patient B indicated the laboratory performed the following patient testing on 8/23/18: 25-hydroxy vitamin D, erythrocyte sedimentation rate (ESR), albumin, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and complete blood cell count. 3. The test report for Patient C indicated the laboratory performed the following patient testing on 8/27/18: RF3, CCP, uric acid, ANA screen, CRP, CMP, ESR, CBC, joint fluid culture, joint fluid cell count, and joint fluid aspiration exam. 4. Review of the Laboratory Test List 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 -- & Annual Volume form indicated the laboratory performed the following non-waived testing: CBC, joint fluid aspiration exam, albumin, AST, ALT, creatinine, ANA9, RF3, ACL, CCP, and 25-hydroxy vitamin D. 5. Laboratory personnel #4 confirmed that the laboratory sent additional testing to a reference laboratory. 6. Test reports for Patients A, B, and C did not include the name and address of the reference laboratory. In addition, the test reports did not distinguish which tests the laboratory performed and which tests the reference laboratory performed. B. Based on review of patient test reports, analyzer printouts and confirmed by laboratory personnel #4 (refer to the Laboratory Personnel Report) at 10:30 am on 2/06/19, the laboratory failed to include the correct test report date for one out of three patient test reports (Patient identifier A) from August 2018. The findings include: 1. The test report for Patient A indicated the laboratory performed the following patient testing on 8/09/2018: antinuclear antibody 9 panel (ANA9), anticardiolipin antibodies (ACL), 25-hydroxy vitamin D, rheumatoid factor panel (RF3), cyclic citrullinated peptide (CCP) antinuclear antibody (ANA) screen, antinuclear antibody titer, C-reactive protein (CRP), thyroid stimulating hormone (TSH) and comprehensive metabolic panel (CMP). 2. Analyzer printouts confirmed that Patient A had ANA 9 testing performed on 8/15/18, 25-hydrox Vitamin D testing performed on 9/4/18, and RF3 testing performed on 8/28/2018. 3. Laboratory Personnel identifier #4 confirmed the test report indicated the date of specimen collection, not the date of testing. -- 2 of 2 --