Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an off-site CLIA special focused survey on 6/16/2022, 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. The findings and conclusions of any investigation 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 review of the State of Nevada laboratory licensing database and a remote survey by correspondence through electronic mail with the business manager, and lack of documented evidence of SARS-CoV-2 test results being reported to the State Authority, the laboratory failed to report the results as required. Findings include: 1. The laboratory was approved to test for SARS-CoV-2 by waived antigen testing on 3 /01/2021. 2. The business manager indicated in an email on 6/15/2022 that the school tested athletes for SARS-CoV-2 beginning in late August of 2021. The business manager indicated that there are no records of test results being reported to the State Authority due to the loss of data when the computer crashed. The data was not saved on the cloud. The school performed approximately 120 SARS-CoV-2 antigen tests to date. 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 --