Genova Diagnostics Inc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 14, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to ensure protection from physical, chemical, and biochemical hazards as required. Findings include: 1. Observation of the safety shower logsheets in the Molecular Chemistry hallway during the laboratory tour on 10/14/2020 at approximately 12:45 p.m. revealed required weekly function checks were not documented for the following time periods: 2018 (July -- 2 out of 5 weeks; September and November -- 3 out of 4 weeks); 2019 (April -- 3 out of 4 weeks; May and October -- 4 out of 5 weeks); 2020 (January and February -- 3 out of 4 weeks). 2. An interview with the Senior Quality Assurance Manager in the Molecular Chemistry hallway on 10/14/2020 at approximately 1:00 p. m. confirmed the lack of safety shower function check documentation for the aforementioned dates. 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 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 6, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to test the PT samples with the laboratory's regular patient workload by testing personnel (TP) who routinely perform the laboratory tests. Findings include: 1. College of American Pathologists (CAP) PT document review revealed Staff #10 (CMS 209) tested the PT samples for all 3 Chemistry (Ferritin) PT events in 2017. 2. An interview with the quality systems manager on 3/6/18 in a conference room at approximately 3 p.m. confirmed Staff #10 (CMS 209) performed all 3 Chemistry (Ferritin) PT events in 2017. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and maintenance logs and staff interview, the laboratory failed to follow the written procedures for all tests, assays, and examinations as required. Findings include: 1. SOP review and high performance liquid chromatography-mass spectrometry (HP /LCMS) 2017 and 2018 guanosine maintenance logs revealed the analytical column was not changed monthly as required in the SOP. 2. An interview with the quality systems manager on 3/6/18 in a conference room at approximately 3 p.m. confirmed the HP/LCMS analytical column was not changed monthly for 2017 and 2018 as required in the laboratory SOP. -- 2 of 2 --