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 technical supervisor (TS), the laboratory failed to evaluate twice a year the relationship between test results for 2 of 2 Atomic Absorption Spectrophotometers from 01/14/2021 to the day of the survey. Findings include: 1. On the day of the survey, 03/22/2023 at 11:00 am, the laboratory could not provide documentation of the biannual comparison of test results between 2 of 2 Perkin Elmer PinAAcle 900 Atomic Absorption Spectrophotometers for lead testing performed from 01/14/2021 to 03/22/2023. 2. The laboratory performed 14,760 lead examinations in 2022 (annual volume listed on CMS-116). 3. The TS confirmed the finding above on 03/22/2023 at 11:15 am. 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 --