Summary:
Summary Statement of Deficiencies 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 review of Moh's testing cases, lack of cryostat temperature logs, and interview with the practice manager the laboratory failed to monitor and document cryostat temperatures on four out of four Moh's testing cases. Findings are: 1. Review of Moh's testing cases from 8/16/2024, 11/18/2024, 6/16/2025, and 7/10/2025 revealed Moh's testing was performed on 8/16/2025, 11/18/2024, 6/16/2025 and 7/10 /2025. 2. The laboratory did not have documentation of cryostat temperatures for 8/16 /2024, 11/18/2024, 6/16/2025, and 7/10/2025. 3. Interview with the practice manager on 11/17/2025 at 2:10 PM, confirmed the laboratory did not have documentation of cryostat temperatures for 8/16/2024, 11/18/2024, 6/16/2025, and 7/10/2025. 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 --