Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an off-site CLIA special focused survey of laboratories with a Certificate of Waiver (CoW) for the purpose of determining compliance with the new CLIA Condition-level regulation (42 CFR 493.41) pertaining to COVID-19 reporting requirements on July 23, 2021. The findings and conclusions of any investigations by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions, or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 a review of the established laboratory procedure for reporting SARS-CoV-2 test results to the Southern Nevada Health District (SNHD), a review of 223 patient test records between the dates of July 23, 2020 and July 12, 2021, and a telephone interview and email correspondence with the office manager, the laboratory failed to ensure that all positive and negative SARS-CoV-2 test results were reported to the public health authorities as required. Findings include: 1. The laboratory policy entitled "Policy for Reporting SARS-CoV-2 for Point of Care Testing" stated, "Patient testing with the Quidel Sofia SARS Antigen in office MUST have ALL results reported to the Southern Nevada Health District (SNHD) using the State of Nevada Confidential Morbidity Report Form." The office manager confirmed that the policy was established during the month of July, 2020 during a telephone interview conducted on July 23, 2021 at approximately 3:00 PM. 2. A review of 223 records of 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 -- patients tested for SARS-CoV-2 antigen between the dates of July 23, 2020 and July 12, 2021 revealed that 178 of 179 negative results obtained between the dates of July 23, 2020 and July 12, 2021 were not reported to the SNHD. 3. A review of 223 records of patients tested for SARS-CoV-2 antigen between the dates of July 23, 2020 and July 12, 2021 revealed that 28 of 44 positive results obtained between the dates of July 23, 2020 and June 28, 2021 were not reported to the SNHD. 4. The office manager confirmed the findings via email correspondence, and a telephone interview conducted on July 23, 2021. The laboratory has performed approximately 3000 SARS- CoV-2 Sofia antigen tests between the dates of July 23, 2020 and July 12, 2021. -- 2 of 2 --