Consent and Authorized Release of My PacTox COVID-19 Test Results. No other tests will be performed on my sample.ĥ. Consent to Collection and Authorized Use of My Test Sample: I hereby agree to have my lab sample collected by PacTox and submitted to PacTox solely for performing and reporting the PacTox COVID-19 Test. I also understand that I should consult my usual healthcare provider after receiving my PacTox COVID-19 Test results and should not undertake any treatment measures prior to consulting with my usual healthcare provider.Ĥ. I further understand that I have the opportunity to ask the Physician questions regarding the purpose, reliability, limitations, and risks and benefits of the PacTox COVID-19 Test. PACTOX has contracted with an independent physician (the “Physician”) duly licensed and authorized under applicable laws to authorize PacTox to perform and report the PacTox COVID-19 Test for and on my behalf. PacTox COVID-19 Test results will indicate as positive, negative or inconclusive. EMPLOYER is seeking to make the COVID-19 Test available to all EMPLOYER’s employees during the COVID-19 public health emergency as one measure to help to prevent the spread of COVID-19 to the EMPLOYER workforce.ģ. Intended Purpose: The PacTox COVID-19 Test is a PCR test designed to detect the genetic material of the SARS-CoV-2 (COVID-19) virus in a sample from your respiratory system. pursuant to the Food & Drug Administration (FDA) Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, Section IV.A (PacTox has notified FDA it has validated the PacTox COVID-19 Test and started patient testing).Ģ. The PacTox COVID-19 Test was developed by Trax Management Services Inc. PacTox is certified to perform high complexity testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and California law. Description: The PacTox COVID-19 Test is performed at PacTox. PATIENT INFORMED CONSENT AUTHORIZATION FOR RELEASE, DISCLOSURE AND USE OF HEALTH INFORMATIONġ.
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