Pre-test Enrollment – Lifeline Health's Covid Clinic

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Please Review The Following Regarding Covid Clinic Tests

COVID Clinic may offer multiple types of testing dependent upon location and availability. Please carefully review the information below concerning the types of testing that may be available. If you have any questions concerning any of the information provided, please contact COVID Clinic at info@covidclinic.org.

Informed Consent for Antigen Testing

Consent for Sofia SARS Antigen FIA Test.

The Sofia SARS Antigen FIA test is used to test for the presence of the proteins from the virus that causes COVID-19 in respiratory specimens, such as a nasal swab. The tip of a cotton swab is inserted into one nostril. The swab is rotated in a circle around the entire inside edge of the nostril at least three times. You may experience some discomfort during the collection process. There is a small risk of minor nose bleeding. You may also experience a temporary runny nose or brief changes in taste. Test results are typically available within 60 minutes.

The possible risks of this test include (i) potential discomfort or other complications that can happen during specimen collection (for example, a minor risk of nose bleeding); and (ii) possible incorrect test result. Potential benefits of this test include: (y) the results, along with other information, can help your healthcare provider make informed recommendations about your care; and (ii) the results may help limit the spread of COVID-19 to your family and others in your community.

If you receive a positive test result for COVID-19, you understand that COVID Clinic is required to report this to various government agencies, including the local health department.

By signing below, you understand that:

– This test has not been Food and Drug Administration (FDA) cleared or approved;

– This test has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories;

– This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and

– The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

COVID Clinic makes no representations as to whether or not the testing services you receive will be reimbursable by your insurance provider.

Consent for Roche cobas SARS-CoV-2 (PCR Nasal Swab)

The nasal swab tests for the presence of COVID-19. The swab enters through the nose and is pushed to the back of your throat, just above the nasopharynx. The swab is then rooted to collect viral specimens. Upon obtaining the sample swab, it will be sent to an independent laboratory for testing. Results are typically available within 2 to 3 days and will be communicated to you.

The possible risks of this test include (i) potential discomfort or other complications that can happen during specimen collection (for example, a minor risk of nose bleeding or a runny nose); and (ii) possible incorrect test result. Potential benefits of this test include: (y) the results, along with other information, can help your healthcare provider make informed recommendations about your care; and (ii) the results may help limit the spread of COVID-19 to your family and others in your community.

Testing specimens using this test are collected by COVID Clinic and sent to an independent laboratory for testing. These laboratories may bill you directly for their services.

If you receive a positive test result for COVID-19, you understand that COVID Clinic is required to report this to various government agencies, including the local health department.

By signing below, you understand that:

– This test has not been Food and Drug Administration (FDA) cleared or approved;

– This test has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories;

– This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and

COVID Clinic makes no representations as to whether or not the testing services you receive from COVID Clinic or any third party laboratory will be reimbursable by your insurance provider.

Informed Consent for Antibody Testing

Consent for Antibody Test using Roche Elecsys Anti-SARS-CoV-2 test

The Roche Elecsys Anti-SARS-CoV-2 test measures the Igm and IgG “immunoglobin” or “antibody” in an individual’s blood for COVID. A sample of blood is obtained by venipuncture to perform this test. Venipuncture is the puncture of a vein to withdraw a blood sample. Upon obtaining the blood sample, it will be sent to an independent laboratory for testing. Results are typically available within 3 days and will be communicated to you.

The possible risks of this test include (i) potential discomfort or other complications that can happen during specimen collection (such as bruising or infection); and (ii) possible incorrect test result. Potential benefits of this test include: (y) the results, along with other information, can help your healthcare provider make informed recommendations about your care; and (ii) the results may help limit the spread of COVID-19 to your family and others in your community.

Testing specimens using this test are collected by COVID Clinic and sent to an independent laboratory for testing. These laboratories may bill you directly for their services.

If you receive a positive test result for COVID-19, you understand that COVID Clinic is required to report this to various government agencies, including the local health department.

By signing below, you understand that:

– This test has not been Food and Drug Administration (FDA) cleared or approved;

– This test has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories;

– This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens; and

COVID Clinic makes no representations as to whether or not the testing services you receive from COVID Clinic or any third party laboratory will be reimbursable by your insurance provider.

I understand and agree to the above.

History & Consent Form

History and Consent Form

Information given on this form should be completed for the person being tested

First Name:

Last Name:

Phone Number:

Date of Birth:

Primary Address:

For testing efficiency, provide the license plate number of the car you will be tested from:

*License Plate Number

Is this Person a Minor?*

Yes

If this person is a minor, please complete the following information for the individual authorized to consent to the administration of the testing services:

Name of Consenting Adult

Address

City

State

Zipcode

Phone

Relationship to Minor

Insurance Information

TESTING SPECIMENS COLLECTED AT COVID CLINIC ARE SENT TO THIRD-PARTY LABS FOR PROCESSING. THESE LABS WILL BILL THE PATIENTS FOR THEIR SERVICES. COVID CLINIC STRONGLY ENCOURAGES ALL PATIENTS TO PROVIDE ANY INSURANCE INFORMATION SO PATIENTS MAY BE ABLE TO AVOID CHARGES FROM OUR LAB PARTNERS.

I understand that, in addition to Covid Clinic's testing service fee, I or my insurance provider will be billed by Covid Clinic's lab partners for lab work related to the COVID-19 nasopharyngeal test or antibody test conducted via blood draw. Since lab work is not required for obtaining a result for the rapid antibody test, there is no separate billing if only I only receive a rapid antibody test.

Please select your Insurance Status*

Insurance Company

Name of the Insured

Group Number

Policy Number

Upload Insurance Card Photo

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Disclosures and Patient Acknowledgement

Information for All Patients:

Families First Coronavirus Response Act (H.R.6201) requires private health insurance, Medicare, Medicare Advantage, CHIP, and other programs to cover testing for COVID-19. State Medicaid Programs may also cover COVID-19 testing and related visits for uninsured individual during the public health emergency declared on Jan 31, 2020. Additional Detail Regarding H.R.6201 can be found at https://www.congress.gov/bill/116th-congress/house-bill/6201.

Patient Acknowledgement and Irrevocable Assignment of Benefits

I am voluntarily submitting this specimen for analysis by my healthcare provider and/or third party lab outside the course and scope of my employment. I hereby request and authorize COVID Clinic to collect this sample for me or the person named above for whom I am the legal guardian. I hereby release COVID Clinic and its principals, directors, members, employees, affiliates, suppliers, providers, subcontractors, successors, agents, their respective insurance carriers, and the location sponsoring this clinic/program, its principals, directors, employees, affiliates, successors, or agents from any and all liability, injury or damage whatsoever arising from, or in any way connected with, this test or the administration of same including, but not limited to, acts of negligence. I authorize my medical information herein to be shared with my physician/insurance. I understand Covid Clinic will use and disclose my personal and health information to treat me, to receive payment for the care it provides, to public health agencies as required, and for its other health care operations which generally include those activities we perform to improve quality care. I authorize Covid Clinic’s lab partner(s) to process the tests I have ordered and to release the results of the tests I have requested to Covid Clinic. Covid Clinic’s lab partner(s) is/are authorized to bill my insurance provider, or any payer, whether fully insured or self-insured, and I will irrevocably assign any payment of benefits, claims, rights, and interests related to the services my healthcare provider performed against any payer. I further authorize Covid Clinic’s lab partner(s) and my healthcare provider to release to my insurance provider any medical information necessary to process this claim. I acknowledge that Covid Clinic’s lab partner(s) may be an out-of-network facility/provider with my insurance provider. I am also aware that in some circumstances my insurance provider may send the payment directly to me. I agree to endorse the insurance check and forward it to the lab within 15 days of receipt as payment towards the lab services provided by Covid Clinic’s lab partner(s). I acknowledge that I am responsible for any amounts not covered by my insurer including any deductibles and co-payments/co-insurance. I understand that Covid Clinic’s lab partner(s) may use my specimen and any testing performed on that specimen for research, development, or commercial purposes so long as the information has been de-identified pursuant to law.

The following only applies to patients who receive a Nasal Swab Test

The test is designed to detect the virus that causes COVID-19 in respiratory specimens.

Potential risks include (a) possible discomfort or other complications that can happen during sample collection and (b) possible incorrect test result

Potential benefits include (a) the results, along with other information, can help your healthcare provider make informed recommendations about your care and (b) the results of this test may help limit the spread of COVID-19 to your family and others in your community.

What does it mean if I have a positive test result? If you have a positive test result, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positiveresult). Your healthcare provider will work with you to determine how best to care for you based on the test results along with other factors of your medical history, and your symptoms, possible exposures, and geographic location of places you have recently traveled.

What does it mean if I have a negative test result? A negative test result means that the virus that causes COVID-19 was not found in your sample. For COVID-19, a negative test result for a sample collected while a person has symptoms usually means that COVID-19 did not cause your recent illness. However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. It is important that you work with your healthcare provider to help you understand the next steps you should take.

Is this test FDA-approved or cleared? No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).

The following only applies to patients who receive a Rapid Antibody Test

FDA requires any medical-professional administering the COVID-19 qualitative screen test to ensure patients understand the following:

● This test has not been reviewed by the FDA

● Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with molecular diagnostic should be considered to rule out infection in these individuals.

● Results from antibody testing should not be used as the sole basis of diagnose or exclude SARS-CoV-2 infection or to inform infection status.

● Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This test is for informational purposes only and should be discussed with your health care professional. Please keep in mind that a positive result does not mean you are immune or cannot become re-infected. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test has been validated in accordance with the FDA’s Guidance Document (Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency) issued on April 20, 2020. FDA independent review of this validation is pending. This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The following only applies to patients who receive an Antibody Test Via Blood Draw

This test offers qualitative detection of anti-SARS-CoV-2 antibodies. This test detects and reports on the presence of high affinity antibodies to the SARS-CoV-2 virus.This test is recommended for individuals at least 10-14 days post symptom onset or at least 10-14 days following exposure to individuals with confirmed COVID-19.

I hereby acknowledge full and complete consent to and make request for a SARS-CoV-2 antibody test. I am physically able to have this blood draw and have never had an adverse reaction to any phlebotomy services. I agree to remain in the general area for at least 5 minutes after collection of samples. This test is for informational purposes only and should be discussed with your health care professional. Please keep in mind that a positive result does not mean you are immune or cannot become re-infected. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test has been validated in accordance with the FDA’s Guidance Document (Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency) issued on April 20, 2020. FDA independent review of this validation is pending. This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

*Signature (or Signature of Parent/Guardian)

If you are signing on behalf of a minor, by signing below you are representing that you are authorized to consent to the administration of the testing services on behalf of the minor.

I consent to review my results via text or personal email and to communicate with the office via text.

By signing this form I acknowledge, understand, and agree to Covid Clinic’s Terms of Service & Privacy Policy

*Date and Time ×

Health Track RX

AIT Laboratories
1500 Interstate 35 W
Denton, TX 76207
Phone: 940-383-2223
Fax: 940-295-1483
www.healthtrackrx.com
CLIA# 45D2009077
State LAB ID Number: CDS00800536
Medical Director: John K. Granger, MD

Date Collected:

Facility Name:

Covid Clinic

18800 Delaware St #800, Huntington Beach, CA 92648

Ordering Provider/ Faculty Phone: (949) 287-8191

Collected at:

Provider Information

Dr. Matthew Abinante DO

For HealthTrackRx Laboratory

Use Only

For HealthTrackRx Laboratory

Use Only

Patient Information

First Name:

Last Name:

Gender:

Date of Birth:

Address:

Phone:

Race:

Ethnicity:

Billing:

Client Bill

Billing Information

Insurance Information:

Insurance Company:

Name of Insured:

Group Number:

Policy Number:

Diagnosis (ICD-10) Codes

Z11.59

Test Ordered

COVID-19 CORONAVIRUS (SARS-COV-2)

Sample Type

Nasopharynx Specimen

Symptoms

Patient Acknowledgement

This specimen was provided voluntarily for analysis and I authorize AIT Laboratories, a HealthTrackRx company, to process, bill and provide results. I agree to the declarations and terms in the patient acknowledgment and irrevocable assignment of benefits on this form.

Date:

Authorized Healthcare Provider Acknowledgement

I acknowledge that documentation to support medical necessity for all tests ordered is recorded in the patient’s chart. I have certified medical necessity in Section C and/or I have provided the appropriate diagnosis codes (ICD-10) to support medical necessity on this form and understand the Office of the Inspector General requires documentation in patient medical chart including date of service, tests ordered and documentation to support medical necessity.

Date:

PATIENT ACKNOWLEDGMENT AND IRREVOCABLE ASSIGNMENT OF BENEFITS

The information provided on this form and on the label affixed to the specimen is accurate. The specimen identified on this form is my own. I have not adulterated it in any way. I am voluntarily submitting this specimen for analysis by my healthcare provider and/or third party lab. I authorize the lab to release the results of this test to the ordering healthcare provider. The lab is authorized to bill my insurance provider, or any payer, whether fully insured or self-insured, and I will irrevocably assign any payment of benefits, claims, rights, and interests related to the services my healthcare provider performed against any payer. I further authorize the lab and my healthcare provider to release to my insurance provider any medical information necessary to process this claim. I acknowledge that AIT may be an out-of-network facility/provider with my insurance provider. I am also aware that in some circumstances my insurance provider may send the payment directly to me. I agree to endorse the insurance check and forward it to AIT within 15 days of receipt as payment towards the lab services provided by AIT. I acknowledge that I am responsible for any amounts not covered by my insurer including any deductibles and co-payments/co-insurance. I understand that AIT may use my specimen and any testing performed on that specimen for research and development so long as the information has been de-identified pursuant to law. I am aware that all AIT Privacy Practices can be found at www.healthtrackrx.com.

Labcorp

LabCorp

888-522-2677

www.labcorp.com

Acct Number:04118340

Acct Name: COVID Clinic

Acct Phone Number: 714-916-5210

Acct Fax Number: 714-916-5494

Collected at:

Provider Information

Dr. Matthew Abinante DO

NPI 1740685387

Patient Information

First Name:

Last Name:

Gender:

Date of Birth:

Address:

Phone:

Race:

Ethnicity:

Billing:

Client Bill

Billing Information

Insurance Information:

Insurance Company:

Name of Insured:

Group Number:

Policy Number:

Diagnosis (ICD-10) Codes

Z11.59

Sample Type

Whole Blood
Nasal Swab

Test Ordered

139900 – SARS-CoV-2, NAA
164068 – SARS-CoV-2 Antibodies ROCHE
164055 – SARS-CoV-2 Antibody, IgG

Symptoms

Patient Acknowledgement

This specimen was provided voluntarily for analysis and I authorize Labcorp, to process, bill and provide results. I agree to the declarations and terms in the patient acknowledgment and irrevocable assignment of benefits on this form.

Date:

Authorized Healthcare Provider Acknowledgement

Date:

Personal Information

Signature

Please Review The Following Regarding Covid Clinic Tests

History & Consent Form

History and Consent Form

Symptoms & Medical History

Underlying Conditions

Laboratory Test Completed By Patient

Insurance Information

Upload Insurance Card Photo

Disclosures and Patient Acknowledgement

The following only applies to patients who receive a Nasal Swab Test

The following only applies to patients who receive a Rapid Antibody Test

The following only applies to patients who receive an Antibody Test Via Blood Draw

*Signature (or Signature of Parent/Guardian)

Health Track RX

Patient Information

Client Bill

Billing Information

Diagnosis (ICD-10) Codes

Test Ordered

COVID-19 CORONAVIRUS (SARS-COV-2)

Sample Type

Patient Acknowledgement

Authorized Healthcare Provider Acknowledgement

PATIENT ACKNOWLEDGMENT AND IRREVOCABLE ASSIGNMENT OF BENEFITS

Labcorp

Acct Number:04118340

Patient Information

Client Bill

Billing Information

Diagnosis (ICD-10) Codes

Sample Type

Test Ordered

Patient Acknowledgement

Authorized Healthcare Provider Acknowledgement

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