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 7, 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 telephone interview with the office manager, a review of the laboratory procedure for reporting SARS-CoV-2 test results to the Southern Nevada Health District (SNHD), a review of a patient result logs between the dates of April 26, 2021 and July 7, 2021, and a review of the SNHD Public Health Update entitled, "SARS- CoV-2 Testing Options and Reporting Positive Results" that was published on March 12, 2020, the laboratory failed to report positive and negative SARS-CoV-2 test results as required between the dates of July 15, 2020 to July 7, 2021. Findings include: 1. The office manager stated during a telephone conversation on July 7, 2021 at approximately 1:15 PM that the laboratory was not reporting negative SARS-CoV- 2 test results to the SNHD between the dates of July 15, 2020 and July 7, 2021. The manager also stated that the laboratory was not aware of the requirement to report all positive and negative SARS-CoV-2 results to the SNHD. 2. The SNHD Public Health 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 -- Update entitled, "SARS-CoV-2 Testing Options and Reporting Positive Results," published on March 12, 2020, in the section entitled, "Reporting Positive Lab Results" stated, "It is the responsibility of the healthcare provider to report ALL positive COVID-19 labs to SNHD." 3. The procedure entitled "Sofia SARS Antigen FIA" stated in step 5 "Per the Southern Nevada Health District, report all positive cases to SNHD." The laboratory performed approximately 700 Sofia SARS-CoV-2 antigen tests between the dates of July 15, 2020 and July 7, 2021. -- 2 of 2 --