Summary:
Summary Statement of Deficiencies D0000 An onsite special focused COVID-19 reporting survey was conducted on August 3, 2022 to August 9, 2022 at North Shore Medical Labs Inc, a clinical laboratory in Tampa, FL. North Shore Medical Labs Inc was not in compliance with Code of Federal Regulations (CFR), Part 493, requirements of 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 observation and interview, the laboratory failed to report Corona Virus Disease 2019 (COVID-19) test results as required by the Florida Department of Health (FDOH) from 04/16/2022 to 08/03/2022. Findings Included: On 03/10/2022, the laboratory was informed by an email from the Agency for Health Care Administration Lab Unit that "You have been authorized to perform COVID-19 testing. Please remember that if a laboratory performs COVID-19 testing, the test results must be reported to the Department of Health (DOH)." The mandatory reporting requirements outlined by FDOH Executive Order 20-013, section 381.0031, Florida Statutes, and Florida Administrative Code Chapter 64D-3, noted laboratories must report both negative and positive COVID-19 test results. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated on 08/09/2022 by the Chief Executive Officer, the laboratory listed they performed COVID-19 testing using the iHealth COVID-19 Antigen Rapid Test and the annual test volume was 100 tests. A tour of the laboratory on 08/03/2022 at 12: 30 PM, revealed the laboratory had three iHealth COVID-19 Antigen Rapid Test kits. Review of random Daily Specimen Log that were available for review showed the 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 -- earliest date the COVID-19 rapid tests were performed was on 04/16/2022. On 08/05 /2022 at 9:30 AM, the Chief Executive Officer stated they did not know they needed to report the COVID-19 test results to the Florida Department of Health. -- 2 of 2 --