Summary:
Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to compare two instruments, the Axcel and Piccolo chemistry analyzer instruments twice a year in 2018 and 2019 to compare the relationships between Comprehensive Metabolic Profile (CMP) test results using the different methodologies. The laboratory performed approximately 8834 CMP tests on the Axcel and 84 using the Piccolo method as the back up instrument. Findings include: 1. The laboratory failed to document they compared test results between the two CMP methods twice annually in 2018 and 2019. 2. In an interview conducted on 08/27/2019 at approximately 5:00 P.M., staff confirmed the laboratory did not compare CMP test results between the primary, Axcel, and back up, Piccolo, instruments for CMP tests. 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 --