Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were 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 surveyor observation, and confirmed in interview, the laboratory failed to ensure storage temperatures were within manufacturer's specifications for one of one reagent in February 2026. Findings included: 1. During a tour of the facility on 02/18 /2026 at 09:35 AM, the surveyor observed one flammable cabinet in the laboratory storage area. Upon further inspection, the flammable cabinet contained the following two bottles: XZ Formic Acid Lot Number: 252749 Manufacturer temperature requirements: 15-25 C The laboratory was asked to provide room temperature documentation of the laboratory storage area. No documentation was provided. 2. In an interview on 02/18/2026 at 09:37 AM in the laboratory storage area, the general supervisor (GS-1) confirmed the laboratory failed to ensure storage temperatures were within manufacturer's specifications for one of one reagent in February 2026. Word Key C-Celsius D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policy, Liquid Chromatography Mass Spectrometry (LCMS) establishment study performed in 2025, and confirmed in interview, the laboratory failed to document all performance characteristics for test performance of a laboratory developed test (LDT), to include column specifications for one of one FDA-modified test system performed in March 2025. Findings included: 1. During a tour of the facility on 02/18/2026 at 09:35 AM, the surveyor observed one LCMS analyzer available for patient testing (Serial Number: B121621304). 2. Review of laboratory policy, "Method Development Standard Operating Procedure" (Approved by the Laboratory Director on 03/25/2025) revealed the following: "Summary Standardizing LCMS/MS method validation is critical for ensuring the accuracy, reliability, and reproducibility of analytical results, particularly in clinical and diagnostic laboratories. ...5. Equipment and Materials ...5.3 LCMS/MS Materials ...LCMS Column and Guard Column" 3. Review of laboratory LCMS toxicology establishment summary, "Pain Panel LCMS/MS Validation Study" (Approved by the Laboratory Director on 03/25/2025) revealed the laboratory failed to document LCMS column performance characteristics in the establishment study. 4. Review of LCMS column manufacturer's instructions revealed the laboratory performed toxicology patient testing with the Restek LC Column (Serial Number: 919035396). The laboratory was asked to provide documentation of the established Restek LCMS Column performance characteristics, and none were provided. 5. In an interview on 02/18/2026 at 10:48 AM, the general supervisor (GS-1) confirmed the laboratory failed to document all performance characteristics for test performance of a laboratory developed test (LDT), to include column specifications for one of one FDA- modified test system performed in March 2025. Word Key FDA- Food and Drug Administration D5785