Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was conducted on 03/03/2026, and standard level deficiencies were cited. 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. This STANDARD is not met as evidenced by: Based on direct observation, a review of the laboratory's policies and procedures, and an interview with Technical Consultant 1 (TC1), the laboratory failed to perform and document twice a year comparison for two of two years (2024-2025). a. On 03/03 /2026 at 1:08 PM, in the laboratory, the surveyor observed two CoaguChek XS Pro Systems with serial numbers 9812 and 3775. b. The laboratory was asked to provide documentation and evidence of twice-a-year instrument comparisons. No documentation was provided. c. An interview with TC1 on 03/03/2026 at 1:46 PM in the conference room confirmed that no comparison was made between the two instruments. 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 --