Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint survey, #2020018671 was conducted on January 27, 2021. Medfast Urgent Care Centers LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to report SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) test results for positive and negative Coronavirus Disease 2019 (COVID-19) for immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody test from 04/22/2020 to 01/27/2021. The laboratory failed to report SARS-CoV-2 for the COVID-19 antigen test results at such timing and frequency as prescribed. Findings: 1. Review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed by the Laboratory Director on 1/27/21 showed the laboratory was using the "Assure Tech FaStep COVID-19 IgG/IgM Antibody Fingerprick test." Review of an email received on 2/2/2021 from the Chief of Operations, the laboratory had performed 1,229 antibody tests. During an interview on 1/27/2021 at 12:50 PM, the Chief of Operations stated they were not reporting the results from the antibody tests to the Florida Department of Health. During a phone interview on 1/29/2021 at 3:30 PM, the Chief of Operations stated the lab started performing antibody testing on 4/22/20. 2. Review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed by the Laboratory Director on 1/27/21, showed the laboratory was currently using the "CareStart - Rapid Covid-19 Antigen Test" and the "Sofia SARS 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 -- Antigen FIA (Fluorescent Immunoassay)." Review of an email received on 2/2/2021 from the Chief of Operations, noted the laboratory had performed 5,745 antigen tests. During an interview on 1/27/2021 at 2:10 PM, the Chief of Operations stated they were currently working on reporting antigen testing from 1/21/21. During a phone interview on 1/29/2021 at 3:30 PM, the Chief of Operations stated the lab started performing antigen testing on 8/5/20. -- 2 of 2 --