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. This STANDARD is not met as evidenced by: Based on lack of instrument comparison results from April 2024 through September 2025 and interview with the testing personnel (TP-1), the laboratory failed to perform instrument comparisons on three separate i-Stat instruments. Findings include: 1. The laboratory began patient testing on April 20, 2024 in the specialties of Chemistry and Hematology, with an annual test volume of 10,620. 2. The laboratory utilizes 3 separate i-Stat instuments to perform Chem8+, Protime (PT/INR), and Activated Clotting Time (ACT) testing. I-Stat serial numbers include 440365, 440368 and 440382. 3. The laboratory failed to provide evidence of instrument comparison activities for each i-Stat analyzer from 4/20/24 through the date of the survey, 9/24 /25. 4. TP-1 interviewed on 9/24/25 at 3:00 PM confirmed the laboratory failed to have a system that twice a year evaluates and defines the relationship between test results generated from each i-Stat analyzer. 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 --