Loading...

Informed Consent

COVID-19 Testing

The person listed at the bottom of this form (“you” “I” or “patient”) is receiving one of the three tests for the 2019 novel coronavirus (“COVID-19”) described below from Olympus Health & Performance (“OHP” or “we”). Please read this form carefully as it has important information regarding the tests.

Depending upon the type of test you are receiving, the test results are intended to either (i) determine if you have an active COVID-19 infection (Rapid Antigen and PCR Tests) or (ii) have previously had a COVID-19 infection (Antibody Test).

The United States Food and Drug Administration (“FDA”) has made these COVID-19 tests available through an emergency use authorization process. The FDA requires that OHP provide you with a Fact Sheet regarding the test (the “Fact Sheet”). Links to each Fact Sheet are included below.  Please carefully read the Fact Sheet for the particular test you are receiving as it will provide further information about the test, its benefits and risks, and the meaning of your test results. By reference, the content of the Fact Sheets is fully incorporated herein. 

1. COVID-19 Antibody Test:  OHP uses the SiennaTM-Clarity COVIBLOCK™ COVID-19 lgG/lgM Rapid Test Cassette manufactured by Salofa Oy, Salo, Finland (the “Antibody Test”). This test is performed by obtaining a small amount of blood from the patient, which is tested for the presence of antibodies that may indicate the patient has previously had a COVID-19 infection.  Patients should obtain an Antibody Test no less than 7 days after a suspected active COVID-19 infection as it takes time (7-21 days) for antibodies to be present following infection. Additionally, the Antibody Test is not intended to diagnose or detect an active COVID-19 infection. Patients with active COVID-19 symptoms should receive a PCR or Rapid Antigen Test.  COVID-19 Antibody Test Fact Sheet

Potential risks include: possible discomfort or other complications that can happen during blood collection; and a possible incorrect test result. 

Potential benefits include: the results, along with other information, can help the patient and their healthcare provider make informed recommendations about the patient’s care.

2. COVID-19 Rapid Antigen Test:  OHP uses the CareStartTM COVID-19 Antigen test manufactured by Access Bio, Inc. (the “Rapid Antigen Test”). OHP will use a swab to collect specimen from the patient’s nose or mouth to perform the Rapid Antigen Test, which is intended to determine if the patient has an active COVID-19 infection. COVID-19 Rapid Antigen Test Fact Sheet

 

Potential risks include: possible discomfort or other complications that can happen during sample collection; and a possible incorrect test result.

Potential benefits include: the results, along with other information, can help the patient’s healthcare provider make informed recommendations about the patient’s care; the results of this test may help limit the spread of COVID-19 to the patient’s family and others in the patient’s community.

3. COVID-19 PCR Test: OHP uses the Logix Smart COVID-19 kit manufactured by Co-Diagnostics, Inc. (the “PCR Test”). OHP will use a swab to collect specimen from patient’s nose or mouth to perform the PCR Test, which is intended to determine if the patient has an active COVID-19 infection. COVID-19 PCR Test Fact Sheet

Potential risks include: possible discomfort or other complications that can happen during sample collection; and a possible incorrect test result.

Potential benefits include: the results, along with other information, can help the patient’s healthcare provider make informed recommendations about the patient’s care; the results of this test may help limit the spread of COVID-19 to the patient’s family and others in the patient’s community.

____________________________________________________________________________

By affixing your signature below, you agree to the following:

Limitations of the tests: I understand that (i) the tests are not FDA-approved but are authorized for use pursuant to an FDA emergency use authorization process, (ii) the tests are not 100% accurate, (iii) the tests can produce false negative or false positive results, and (iv) the tests should not be used as the sole basis for establishing whether the patient currently has or has had a COVID-19 infection. Accordingly, I understand that the patient may contract COVID-19 or infect others, even though the test results are negative. Accordingly, the patient agrees to and accepts responsibility for continuing to practice social distancing, hand-washing, and other preventative measures recommended by his/her healthcare providers and the CDC. See https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/index.html.   

Following CDC and Medical Guidance: I understand that If the test is positive, the patient develops symptoms, or the patient is  exposed to others with COVID-19, they should immediately initiate self-isolation, contact their primary healthcare provider, and comply with recommendations from their healthcare provider and/or the CDC. See https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/index.html.  I also agree that if the patient experiences severe symptoms, including but not limited to, difficulty breathing, they should immediately contact their primary healthcare provider, emergency medical services or go to the local hospital emergency department.  

Medical Appropriateness and/or Necessity: Except for those receiving testing in anticipation of travel or as a requirement of employment, I understand that the patient is being tested based on their medical provider’s clinical decision, recommendation, and order that such testing is medically appropriate and/or medically necessary, in accordance with current accepted standards of medical practice. This clinical decision may include testing of individuals with signs or symptoms compatible with COVID-19, as well as asymptomatic individuals with known or suspected recent exposure to COVID-19.  

Risk of Exposure: I understand that, although OHP has put in place reasonable preventative measures aimed to reduce the spread of COVID-19, COVID-19 is highly contagious and there is a risk of becoming infected with COVID-19 by virtue of the close contact required to perform this procedure. I understand all the potential risks and benefits, and I would like to proceed with testing.

Financial Responsibility: 

For Patients Receiving COVID-19 Antibody Tests and COVID-19 Rapid Antigen Tests: OHP may bill insurance for COVID-19 Antibody Tests to insurance companies with which it has a contract or other arrangement.  However, for most Antibody Tests and all COVID-19 Rapid Antigen Tests, OHP does not bill insurance. Except in the limited circumstances described above, payment in full is due from the patient at the time of testing. Following testing, you are free to submit the claim to your insurance carrier, to try and obtain reimbursement. However, most insurance companies are not covering these tests. Thus, there is no guarantee that you will be reimbursed, in part or in whole, for the cost of testing.  The specific cost of the tests are described on OHP’s website.

For Patients Receiving COVID-19 PCR Tests: Payment will be due at time of testing for (1) uninsured patients, (2) patients insured by  companies with which  OHP does not have an arrangement or contractual relationship, (3) asymptomatic patients, including testing solely for surveillance, and (4) patients receiving testing in anticipation of travel. For such situations, patient will be responsible for full payment at the time of testing. Thereafter, those patients with insurance can submit the claim to their insurance carrier for possible reimbursement. In such case, patient will be fully responsible for negotiations with their insurance carrier related to reimbursement. Reimbursement, in part or in whole, is not guaranteed. For those insurance plans with which OHP has an arrangement or contractual relationship, we will bill such insurance on behalf of patients. However, payment of the claim by the insurance company, in whole or in part, is not guaranteed.  Should the patient’s insurance deny payment of the claim, in whole or in part, patient will be financially responsible for any balance. The specific insurance companies for which OHP accepts insurance, and to whom OHP will submit claims, are described on OHP’s website. The specific cost of each test is also described on OHP’s website.

Communication: I authorize OHP to communicate with me, including providing the results of the test(s), via email, phone, or text message at the email address and phone number I provided on the OHP intake form(s).  

WAIVER OF CLAIMS:  BY SIGNING BELOW, I WAIVE AND DISCHARGE OHP, ITS PROVIDERS AND EMPLOYEES AND AFFILIATES FROM ANY AND ALL CLAIMS RELATED TO THE TEST AND PATIENT’S DECISIONS, ACTS OR OMISSIONS BASED UPON THE TEST RESULTS. IN THE EVENT THAT TESTING IS ADMINISTERED IN CONJUNCTION WITH A THIRD PARTY OR OFFSITE LOCATION, LIABILITY IS ADDITIONALLY WAIVED FOR THE THIRD PARTY OR OFFSITE LOCATION.

BY SIGNING BELOW I ATTEST AS FOLLOWS: I AM THE PATIENT OR PERSONAL REPRESENTATIVE OF THE PATIENT WITH AUTHORITY TO CONSENT TO MEDICAL TREATMENT UNDER APPLICABLE LAW; I HAVE READ AND UNDERSTAND THE INFORMATION IN THIS FORM; ALL OF MY QUESTIONS REGARDING TESTING HAVE BEEN ANSWERED; I CONSENT TO THE TEST(S) I AM REQUESTING FOR PATIENT.

 

Today's Date: October 26, 2021

 

First Patient's Name

First Name*

Last Name*

Phone*
First Patient's Date of Birth*
First Patient's Signature*
Second Patient's Name

First Name*

Last Name*
Second Patient's Date of Birth*
Third Patient's Name

First Name*

Last Name*
Third Patient's Date of Birth*
Fourth Patient's Name

First Name*

Last Name*
Fourth Patient's Date of Birth*
Fifth Patient's Name

First Name*

Last Name*
Fifth Patient's Date of Birth*
Sixth Patient's Name

First Name*

Last Name*
Sixth Patient's Date of Birth*
Seventh Patient's Name

First Name*

Last Name*
Seventh Patient's Date of Birth*
Eighth Patient's Name

First Name*

Last Name*
Eighth Patient's Date of Birth*
Ninth Patient's Name

First Name*

Last Name*
Ninth Patient's Date of Birth*
Tenth Patient's Name

First Name*

Last Name*
Tenth Patient's Date of Birth*
Parent or Guardian's Email Address

Email*

Confirm Email*
Check to receive information, news, and discounts by e-mail.
Parent(s) or court-appointed legal guardian(s) must sign for any participating minor (those under 18 years of age) and agree that they and the minor are subject to all the terms of this document, as set forth above.
Parent or Guardian's Name

First Name*

Last Name*

Phone*
Parent or Guardian's Date of Birth*
Parent or Guardian's Signature*
Electronic Signature Consent*
By checking here, you are consenting to the use of your electronic signature in lieu of an original signature on paper. You have the right to request that you sign a paper copy instead. By checking here, you are waiving that right. After consent, you may, upon written request to us, obtain a paper copy of an electronic record. No fee will be charged for such copy and no special hardware or software is required to view it. Your agreement to use an electronic signature with us for any documents will continue until such time as you notify us in writing that you no longer wish to use an electronic signature. There is no penalty for withdrawing your consent. You should always make sure that we have a current email address in order to contact you regarding any changes, if necessary.


One or more problems exist. Please scroll up.




Powered by  Smartwaiver - TRY IT FREE!