Summary:
Summary Statement of Deficiencies D0000 The initial survey was performed on 07/21/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. 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 and interview with the technical consultant, the laboratory failed to ensure one of one types of urine collection tubes were stored as required by the manufacturer in a room designated as the store room. Findings include: (1) Observation of the store room and interview with the technical consultant on 07/21 /2025 at 9:30 am, identified the following: (a) 900 Vacuette Urine (no additive) tubes, lot # A24043WM, storage temperature of 4-25 degrees (C) centigrade. (2) Interview with the technical consultant on 07/21/2025 at 9:30 am confirmed the laboratory was not monitoring the temperature of the store room. 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 --