Summary:
Summary Statement of Deficiencies D0000 An onsite initial survey was performed on 09/01/26. A standard-level deficiency was cited. 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 manufacturer's instructions, laboratory environmental records, and interview with the director of project management, the laboratory failed to document an environmental temperature for 1 of 2 days of patient testing. Findings included: 1. On 09/01/26 at 09:30 am, the director of project management confirmed the following: a. The laboratory performed urine drug screens on the Thermofisher Indiko Plus analyzer. b. The laboratory performed confirmatory drug testing on the Agilent 6400 Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). c. The analyzers were approved for patient testing on 05/05/26. 2. A review of the manufacturer's requirements revealed the following environmental operating conditions: a. Thermofisher Indiko Plus - "Ambient Temperature 18-30C" C=Celsius b. Agilent 6400 LC-MS/MS - " ....ambient temperature range of 15C to 35C" 3. A review of the laboratory's environmental records on 05/21/26 and 05/28/26 revealed no evidence the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory documented ambient temperatures on 05/21/26 for 1 of 2 days of patient testing. 4. An interview on 09/01/26 at 01:00 pm with the director of project management confirmed the findings above. -- 2 of 2 --