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 August 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 laboratory policy and procedure entitled, " First Person Care Clinic Lab Policies and Protocols, a review of patient records submitted between the dates of June 16, 2021, and July 29, 2021, and a telephone interview with the Laboratory Compliance Director on August 23, 2021, the laboratory failed to ensure that positive and negative CareStart and BD Veritor SARS-CoV-2 antigen test results, and positive and negative Abbott ID Now SARS-CoV-2 PCR test results were submitted to the public health authorities. Findings include: 1. The submitted laboratory policy and procedure entitled, "First Person Care Clinic Laboratory Policies and Protocols," in the section entitled, "Morbidity Reporting" stated "Reporting of communicable diseases required by the Southern Nevada Health District (SNHD) is mandatory, and must be reported the same day as the diagnosis day. Morbidity reports must be faxed accompanied with the lab results that confirm 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 -- the diagnosis. Once faxed, the morbidity report must be uploaded in the patients EMR documents." 2. A review of four submitted patient reports between the dates of June 16, 2021 and July 29, 2021 revealed that two of two negative patient results were not reported to the SNHD. 3. The findings were confirmed via email correspondence and a telephone conversation with the Laboratory Compliance Director on August 23, 2021 at approximately 3:00 PM. The laboratory has performed approximately 980 rapid SARS-CoV-2 Abbott ID Now PCR, BD Veritor and Care Start Antigen tests between the dates of May 26, 2020 and August 23, 2021. -- 2 of 2 --