Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Ataraxis AI Inc on December 16, 2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited is as follows: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, review of the instrument manual, and interview, the laboratory failed to monitor and document temperatures and humidity of the room from 07/10 /2024 to 12/16/2025. Findings: 1. During a tour of the laboratory on 12/16/2025 at 9: 30 AM, the Motic Easy Scan Pro was seen in the laboratory. 2. Review of the Motic Easy Scan Pro Instruction Manual noted, "Environmental temperature: 5 degrees C 2 ~ +40 degrees C " and "Humidity: 30% to 75% (No condensation)." 3. On 12/16/2025 at 12:41 PM, the Laboratory Assistant stated they were not taking the temperatures or humidity of the laboratory. Key C - Celsius ~ means proportional to, similar to, or about 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 --