Informed Consent for Infection Testing Services

Description: MedLab2020, Inc., Covid Clinic, Inc., Rume Medical Group, Inc. and other Laboratory Service Providers (individually “LSP”) is certified to perform waived and/or non-waived testing in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and state law, pursuant to a CLIA certificate of compliance. CLIA defines “waived testing” as simple testing with relatively low risk of incorrect result, and “non-waived testing” as moderate to high complexity testing that must meet certain standards of federal law. Healthy Campus, LLC (“Healthy Campus”) has appointed a physician duly licensed under state law (the “Healthcare Provider” or “HCP”) to authorize LSP (or a duly licensed and qualified “Reference Lab”, on behalf of LSP) to perform and report, for and on your behalf, at such times and frequency as the HCP shall direct, one or more of the COVID-19 or other infection tests (or equivalent) that have received FDA Authorization or Emergency Use Authorization (EUA) under the Food & Drug Administration (FDA) Policies such as Clinical Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories (collectively, the “Testing”) — as set forth in the addendum to this Consent (below) and which shall be updated from time to time on this site as new tests become available.

  1. Intended Purpose: The District is making the Testing available to District students, teachers, volunteers, and employees during and after the COVID-19 public health emergency as one measure to help to prevent the spread of COVID-19 and other infectious diseases to District students and employees (and their families) pursuant to federal CDC and state Department of Public Health or Health Authority (“DPH”) guidelines.
  2. Explanation of Test Results: The Testing results will be specified as “detected”, “not detected” or “indeterminate”. I have had an opportunity to review the pertinent PATIENT FACT SHEET(S) linked to this Informed Consent. I further understand that, prior to consenting to this document, I may ask the HCP questions regarding the purpose, reliability, limitations, and risks and benefits of the Testing. I also understand that I should consult my usual healthcare provider after receiving my Testing results and should not undertake any treatment measures prior to consulting with my usual healthcare provider.
  3. Consent to Collection and Authorized Use of My Test Sample: I hereby agree to have my lab sample collected by LSP (or under its direction) solely for the purpose of LSP or the Reference Lab’s performing and reporting the Testing at such times and frequency as the HCP shall direct. I also agree that test pooling may be used, which means that specimens from multiple people may be combined and tested for infection together. With the exception of quality assurance testing by LSP using wholly de-identified patient samples in accordance with federal law, no other tests will be performed on my test sample.
  4. Consent and Authorized Release of My Testing Results: I hereby request and authorize LSP to disclose and transmit the results of my Testing to the HCP; and, to help to prevent the spread of infection to District students and employees, to the District. I understand and agree that upon receiving the results of my Testing, as hereby authorized by me, the District will follow applicable CDC and public health authority guidance with respect to such information. I also understand and agree that LSP is required by law for certain tests to release my Testing results to applicable public health authorities.
  5. Benefits and Risks of Consenting to the Testing: I understand that even though the Testing has received EUA authorization or FDA authorization and has been properly validated, there is a possibility of error in all lab testing, including the Testing.

I have received and read or had read to me the above information about the Testing, 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 authorize LSP (or Reference Lab) to test my test sample to detect infection, to report my Test results to (a) the HCP; (b) the applicable public health authorities, as required by law; and (c) to the District.


Addendum (To be updated from time to time and shared with you as new tests become available)


EUA Instructions for Use Patient Fact Sheet
COVID-19 PCR Testing

(one of the PCR tests listed here or EUA authorized equivalent)

Bio-Speedy Direct RT-qPCR SARS-CoV-2 IFU Patients
TaqPath COVID-19 Combo Kit IFU Patients
TaqPath COVID-19 RNase P Combo Kit 2.0 IFU Patients
 TaqPath COVID-19 Fast PCR Combo Kit 2.0 IFU Patients
Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit IFU Patients
TaqPath COVID-19 Pooling Kit IFU Patients
LumiraDx SARS-CoV-2 RNA STAR Complete IFU Patients
COVID-19 Antigen Testing (one of the antigen tests listed here or EUA authorized equivalent) CareStart COVID-19 Antigen test IFU Patients
QuickVue SARS Antigen Test IFU Patients
INDICAID COVID-19 Rapid Antigen Test IFU Patients
COVID-19/Flu A/Flu B/RSV BioCode CoV-2 Flu Plus Assay  IFU Patients