PATIENT INFORMED CONSENT AUTHORIZATION FOR RELEASE, DISCLOSURE AND USE OF HEALTH INFORMATION
[PER HIPAA, 45 C.F.R. § 164.508; AND CALIFORNIA CIVIL CODE § 56, et seq.]
1. Description: The PacTox COVID-19 Test is performed at PacTox. PacTox is certified to perform high complexity testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and California law. The PacTox COVID-19 Test was developed by Trax Management Services Inc. 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).
2. Intended Purpose: The PacTox COVID-19 Test is real-time RT-PCR-based designed to detect the genetic material of the SARS-CoV-2 (COVID-19) virus in a sample from your respiratory system and to meet the EUA statutory standard for COVID-19 testing.
3. Explanation of Test Results. PacTox COVID-19 Test results will indicate as positive, negative or inconclusive. I have had an opportunity to review the FACT SHEET FOR PATIENTS attached to this Informed Consent. 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. 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. 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.
4. 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. No other tests will be performed on my sample.
5. Consent and Authorized Release of My PacTox COVID-19 Test Results. I hereby request and authorize PacTox to disclose and transmit the results of my PacTox COVID-19 Test electronically in encrypted format to me. I understand and agree that PacTox is required by law to release my PacTox COVID-19 Test results to the applicable public health authority(ies).
6. Benefits and Risks of Consenting to the PacTox COVID-19 Test: SEE FACT SHEET FOR PATIENTS. I understand that even though the PacTox COVID-19 Test has received EUA authorization and has been properly validated there is a possibility of error in all labs testing including the PacTox COVID-19 Test.
My signature below indicates that I have received and read or had read to me the above information about the PacTox COVID-19Test, including the purposes and possible risks, and that I understand it and I have been provided an opportunity to ask questions. I have all the information I want and all my questions have been answered. I hereby authorize PacTox to test my sample to detect COVID-19 and to report my PacTox COVID-19 Test results to (a) the Physician, (b) me, and (c) the applicable public health authority(ies), as required by law.
AUTHORIZATION FOR RELEASE, DISCLOSURE AND USE OF HEALTH INFORMATION
This authorization applies to any information governed by the Health Insurance Portability and Accountability Act of 1996, 42 USC Section 1320d et seq., and 45 CFR Parts 160-164, as amended from time to time (“HIPAA”), and/or by California's Confidentiality of Medical Information Act, California Civil Code Section 56 et seq., as amended from time to time (“CMIA”). Specifically, this authorization complies with the valid authorization requirements of 45 CFR Section 164.508(c) and California Civil Code Section 56.11.
AUTHORIZATION: I authorize PacTox and the Physician to use and disclose the protected health information described below.
EXTENT OF AUTHORIZATION: I hereby authorize the release of the results of the COVID-19 Test and my personal information related to the COVID-19 Test performed on my lab sample. This medical information may be used by PacTox and the Physician for the Intended Purpose as set forth in Section 2 above. Any information I share through social media or otherwise that set forth herein is shared voluntarily, and I release PacTox and the Physician from liability under the HIPAA and the CMIA for the information I share.
RIGHT TO REVOKE AUTHORIZATION: I understand that I have the right to revoke this authorization, in writing, at any time. I understand that a revocation is not effective to the extent that any person or entity has already acted in reliance on my authorization or if my authorization was obtained as a condition of obtaining insurance coverage and the insurer has a legal right to contest a claim.
VOLUNTARY RELEASE: I understand that no treatment, payment, enrollment, or eligibility for benefits will be conditioned on whether I sign this authorization.
ACKNOWLEDGEMENT OF DISCLOSURE: I understand that information used or disclosed pursuant to this authorization may be disclosed by the recipient and may no longer be protected by federal or state law.