Summary:
Summary Statement of Deficiencies D0000 An onsite complaint visit, complaint #2020018683, conducted on 02/04-05/21 at Spearhead Medical. The allegations were not substantiated 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 rapid nucleic acid detection of Coronavirus 2019 Disease (COVID-19) from 10/13/2020 to 11/19/2020 (positive and negative) and from 11/20/2020 to 02/04/2021 (negative) at such time and frequency as prescribed. Findings include: -Procedure Manual review revealed that the laboratory failed to have a policy to report all COVID-19 tested cases to the Florida Department of Health (FDH). -Patient log review revealed that the laboratory started performing patient testing on 10/13/2020 with the Abbot rapid point of Care ID NOW test for the rapid detection of nucleic acid of COVID-19. -The laboratory failed to report to the FDH all 478 results (positive and negative) from 10/13/2020 to 11/19/2020 and negative results from 11/20/2020 to 02/04/2021. During an interview on 02/04/2021 at 1:30 pm, the owner, confirmed that the laboratory failed to report to the FDH all cases from 10/13/2020 to 11/19/2020 and negative cases from 11/20/2020 to 02/04/2021 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 --