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 the Quality Manager (QM), the laboratory failed to evaluate and document the relationship between 2 of 2 Thermofisher ABI-7500 rt-q Polymerase Chain Reaction (PCR) for SARS-CoV-2 RNA test result at least twice in 2020 and 2021. Findings Include: 1. On the day of survey, 06/06/2022 at 12:55 pm, the laboratory could not provide documentation for the comparison of test results between 2 of 2 Thermofisher ABI-7500 rt-q PCR twice annually from 07/21/2020 to 12/31/2021. 2. The laboratory performed the following SARS-CoV-2 RNA examinations: - 07/21/2020 to 12/31/2020: 47,234 patient testing - 01/01/2021 to 12/31/2021: 9, 298 patient testing 3. The QM confirmed the findings above on 06/06/222 around 02:45 pm. 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 --