Igenomix Slu

Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted 07/22/2024. Standard level deficiencies were cited and the laboratory did not meet the following condition: 42 CFR 493.1487 Testing Personnel High Complexity Testing D5305 Based on written procedures, patient final test reports, patient test requisitions, and interview with the general supervisor, the laboratory failed to ensure 2 of 3 test requisitions included the specimen date of collection for the sperm aneuploidy test (stability of 3 days). Findings included: 1. Review of the written procedure for sperm aneuploidy test (SAT) for specimen labeling, storage, and collection referred to "SAT Instructions." Review of the SAT instructions (provided to clients) stated, "After sample collection: ...We recommend shipping samples as soon as possible, preferably within 3 days of the sample collection in order to guarantee the quality of the sample." 2. Review of patient #75123976 final test report and the test requisition did not include a specimen collection date. The specimen was received 01/02/2024 and test results reported 01/08/2024. Review of patient #PAT-000387552 final test report and the test requisition did not include a specimen collection date. The specimen was received 09/14/2023 and test results reported 09/20/2023. The laboratory did not ensure a specimen collection date was documented for monitoring specimen stability (received within 3 days collection). 3. During an interview on 07/22/2024 at 4:27 pm, the general supervisor for SAT confirmed there were no specimen collection dates in the above test requisitions from 2023 and 2024. D5801 Based on review of final test reports, test requisition forms, written procedures, and in interview with LabSamples staff, the laboratory failed to ensure the accurate specimen collection date was on the final test report for 1 of 3 reports reviewed. Findings included: 1. Review of patient #CGS-24J003 final test report included a specimen collection date of 06/14/2024 and a specimen received date of 06/14/2024 (specimen type: saliva; test: In vitae 569 gene panel). Review of patient #CGS-24J003 test requisition form for the above test included a specimen collection date of 06/09/2024. 2. Review of the laboratory's written "Sample Transportation, Reception and Handling 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 -- Procedure" on page 18 stated "C. How to create cases in Navision that are outsourced by the affiliates (igenomix group). See internal document harboured [sic] on the LabSamples departmental folder." The document was not available for review. 3. During an interview on 07/22/2024 at 4:10 pm, the individual from the LabSamples department stated since the patient specimen was an outsourced case, their affiliate group in Miami completed the patient registration and most likely used the date of receipt as the date of collection (06/14/2024). The laboratory failed to ensure the specimen collection date was accurately transcribed on the final test report for patient #CGS-24J003. D6168 Based on review of the CMS-209 form, personnel records, and in interview with the general supervisor (GS), the laboratory failed to ensure individuals qualified to perform high complexity testing. The laboratory failed to ensure 1 of 43 testing persons (TP) qualified to perform high complexity testing (carrier genetic testing). Refer to D6171. D6171 Based on review of the CMS-209 form, personnel records, and in interview with the general supervisor (GS), the laboratory failed to ensure 1 of 43 testing persons (TP) qualified to perform high complexity testing (carrier genetic testing). Findings included: 1. Review of the CMS-209 form included TP-29 listed as an individual who performs high complexity testing. 2. Review of personnel records for TP-29 included a bachelor's and master's degree that was not in a chemical, physical, biological or clinical laboratory science. In addition, TP-29 bachelor's degree did not include enough science courses per CFR 493.1489(b)(2)(ii). 3. During an interview on 07/22 /2024 at 9:28 am, the GS of carrier genetic testing department confirmed that TP-29 began testing 08/16/2023. -- 2 of 2 --

Summary Statement of Deficiencies D5775 Based on a record review and email communication with Quality Assurance (QA) staff, the laboratory failed to have a system in place to document the comparison of test results using different instruments since July 2020 for Next Generation Sequencing (NGS) testing for Carrier Genetic Test (CGT), Endometrial Receptivity Analysis (ERA), Products of Conception (POC), and for Fluorescent In Situ Hybridization (FISH) testing for Sperm Aneuploidy Test (SAT). The laboratory performs approximately 250,000 tests annually. Findings: 1. A review of laboratory records revealed that the laboratory failed to perform instrument comparisons for seven thermal cyclers for CGT testing, Biometra Trio 48 serial # 3626156, Biometra TProfessional TRIO serial # 2701229, Biometra Tone serial # 3931268, Biometra 96 Gradient serial # 3021548, Biometra TOne 96 serial # 3804179, Bio-Rad C1000 Touch serial # CT01435, Bio-Rad C1000 Touch 96 serial # CT024998; and for two sample preparators Qiagen QIAsymphony SP serial # 35680 and # 35055. 2. A review of laboratory records revealed that the laboratory failed to perform instrument comparisons for two automated electrophoresis instruments for CGT and ERA testing, Agilent 4200 TapeStation System serial # DEDAA01390 and DEDAA00696; and for two Real Time-PCR instruments Thermofisher QuantStudio 5 serial # 272531158 and 272530364. 3. A review of laboratory records revealed that the laboratory failed to perform instrument comparisons for two thermal cyclers for ERA testing, Bio-Rad C1000 serial # CT028319, and # CT049881. 4. A review of laboratory records revealed that the laboratory failed to perform instrument comparisons for three automated template preparators for ERA, CGT, and POC testing, Thermofisher Ion Chef System serial # 242470664, # 242470711, and # 242471185. 5. A review of laboratory records revealed that the laboratory failed to perform instrument comparisons for two next-generation sequencers for ERA and POC testing, Thermofisher Ion S5 XL System serial # 245723900245 and # 2772816080057; and for three reporter software Thermofisher Ion Reporter Server System serial # 2XVVR22, DPZQKD3, and 4JLHW52. 6. A review of laboratory records revealed that the laboratory failed to perform instrument comparisons for two denaturation and hybridization system for SAT testing, Abbott Molecular ThermoBrite System serial # 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 -- 815S01563, and # 102402958. 7. A review of laboratory records revealed that the laboratory failed to perform instrument comparisons for two thermal cyclers for POC testing, Biometra Tprofessional serial # 2810130, and # 2501229. 8. Email from QA staff not listed on the CMS-209 on 08/17/2022 at 03:51 AM, confirmed the laboratory failed to have a system that twice a year evaluates and defines the relationship between test results using different instruments. D6168 Based on a review of personnel records and email communication with Quality Assurance (QA) staff, the laboratory did not have the education equivalency documentation required to qualify 2 of the 29 testing personnel for the specialty of clinical cytogenetics for high complexity testing. ( Refer to D6171). D6171 Based on a review of personnel records and email communication with Quality Assurance (QA) staff, the laboratory failed to have education equivalency documentation to qualify 2 of the 29 testing personnel. Findings: 1. A review of personnel records revealed that 2 of the 29 testing personnel designated on the Laboratory Personnel Report (CMS-209), did not have foreign education equivalency documentation to qualify them as testing personnel. 2. Email from QA staff not listed on the CMS-209 on 08/05/2022 at 05:56 AM, confirmed the laboratory failed to have education equivalency documentation for the 2 testing personnel. -- 2 of 2 --