Express Gene Molecular Diagnostics Laboratory

Summary Statement of Deficiencies D0000 A recertification survey conducted on 06/21/2022 found the EXPRESS GENE MOLECULAR DIAGNOSTICS LABORATORY clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2061 VIROLOGY CFR(s): 493.831(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to submit the proficiency results for the subspecialty of Virology for the third event of 2021. Findings include: Review of American Proficiency Institute (API) proficiency testing (PT) records revealed that the laboratory had zero percent score for SARS-CoV-2 molecular test resulting in a zero percent score in Virology in the third event of 2021. During an interview on 06/21/2022 at 02:05 PM, the laboratory director explained that the laboratory failed to submit the results because the laboratory was not in operations at the time of the event of reference. 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 An initial survey conducted on 09/10/2020 found that the Express Gene Molecular Diagnostics Laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. Cited the following Condition level deficiency: -D3000 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). This CONDITION is not met as evidenced by: Based on record review and staff interview the laboratory failed to follow the Florida Emergency Rule 64DER20-18 (64D-3.029) to report all COVID 19 tests results immediately to the Florida Department of Health (DOH) from 6/05/2020 to 09/10 /2020 . See 3009 D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to meet the Florida Emergency Rule 64DER20-18(64D-3.029). The laboratory failed to report Coronavirus 19 (COVID-19) negative results from 6/5/2020 to 9/10/2020. Findings include: -Record review revealed that the laboratory received EUA for their method 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 -- on 5/22/2020. -The laboratory started reporting real Time Polymerase Chain reaction (RT-PCR) COVID-19 results on 6/5/2020. -Review of FDOH Emergency Rule 64DER20-26 (64D-3.029) of April 10th 2020, revealed for COVID-19; the timeframe is immediately and had special reporting requirements. Results should be reported and accompanied by any testing conducted (positive and negative). For laboratories performing electronic laboratory reporting as described in subsection 64D-3.031 (5). F. A.C., all test results (positive and negative) are to be submitted, including screening test results (positive and negative). -Review of reports sent to the Department of Health from 8/4/2020 to 9/09/2020 revealed that the laboratory reported 137 RT-PCR COVID-19 positive cases but failed to report 1367 RT-PCR COVID-19 negative cases for the period of reference. During an interview on 09/10/2020 at 1:30 PM, the laboratory director confirmed that the laboratory only sent the COVID-19 positive results, he explained that during phone conversation with County Health personnel, he received instructions over the phone, to report only positive cases, he could not provide documentation of this instruction. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of