Softcell L-Form Laboratories Llc

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE 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 review of the laboratory document "Summary Report for TaqMan Genotyping and TaqMan Copy Number Variation Assays on the QuantStudio 5 Platform on 384 Block" and interview with laboratory staff, the laboratory failed to verify analytical specificity to include interfering substances, reference intervals, and any other performance characteristics required for test performance for the Pharmacogenomic profiling/Express PGx Assay. The laboratory tested approximately 1000 patient samples annually. _ Findings include: 1. Review of the document "Summary Report for TaqMan Genotyping and TaqMan Copy Number Variation Assays on the QuantStudio 5 Platform on 384 Block" (validation summary) failed to find establishment of the performance characteristics of interfering substances and reference intervals for the Pharmacogenomic profiling/Express PGx Assay. 2. Review of the validation summary found that it stated that "assay to assay contamination from neighboring wells" could be a potential source of error for the Express PGx Assay. No establishment of performance characteristics for carryover were found in the validation summary. 3. Interview with the general supervisor on 04/24/2025 at 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 -- approximately 3:30 PM it was discussed that several performance characteristics were not established for the Pharmacogenomic profiling/Express PGx Assay. -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on laboratory record review and interview with the technical supervisor (TS), the laboratory failed to ensure the twice a year evaluation of two Kingfisher Flex Systems, two Ion Chef Instruments, and two Ion GeneStudio S5 Plus Systems that compared the relationship between instruments in 2022 and 2023. The laboratory performed approximately 8,000 molecular tests per year. Findings Include: 1. Laboratory record review failed to produce instrument to instrument comparison for the two KingFisher Flex Systems, two Ion Chef Instruments, and two Ion GeneStudio S5 Plus Systems twice a year in 2022 and 2023. 2. In an interview conducted on 11/03 /2023, at 11:20 AM, the TS confirmed the laboratory has not performed an evaluation that defines the relationship between two KingFisher Flex Systems, two Ion Chef Instruments, and two Ion GeneStudio S5 Plus Systems. 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 --