Patient Consent/Financial Responsibility Form

PATIENT CONSENT: I voluntarily consent to the collection and testing of my specimen and all future testing performed by American Research Labs, LLC (hereinafter ARL) or its affiliated laboratories, unless I give written notice that I have revoked my consent.

MINOR PATIENT RELEASE CONSENT FOR TESTING: I authorize that a test sample be taken for COVID-19 identification by American Research Labs or its affiliated Patient Service Centers. I do hereby consent to ARL for testing my minor child to use or disclose protected health information for reporting purposes. I consent that I have the legal authority, based on the relationship to the child as indicated pursuant to Florida Statute 743.0645, or any pertaining local/state laws to consent to this test administration for the child named above.

PATIENT CONSENT FOR DNA TESTING: I consent to the collection of whole blood or buccal swab specimens from myself or my minor child for the purpose of DNA testing (genotyping) to guide medication prescription. I understand despite the accuracy of DNA testing, there is a possibility for error. I understand genotyping will detect only certain DNA variants incorporated in the assays, which are performed by simultaneous (multiplex) detection in microarray chip or fluorescent bead analyzers. I understand ARL or its affiliated laboratories, will maintain my specimen and DNA only for the period required by law and will discard it afterwards. By submitting specimens to ARL, I agree to relinquish ARL, or its affiliated laboratories, from any and all injury, physical or psychological, which might arise from collecting and testing these specimens and from any effects or actions the results of these tests may have on me or any other individual. This agreement for testing is subject to and shall be construed and enforced in accordance with the laws of my state of residence. ARL’s limit of liability is not to exceed the cost of the testing.

DNA TEST RESULTS: I understand DNA testing measures DNA variants that impact my capacity to metabolize medications, and determine my body’s metabolizer status as Ultra-rapid, Function, Deficient, Poor or Null. I understand prescription drug regimens should not be altered without consulting a prescribing clinician. I understand these results are being collected and furnished by ARL or its affiliated laboratories and will be provided only to the clinician signing the requisition for test services. I understand genetic counseling is available from the signing clinician before and after the DNA testing, and further testing or clinician consultation may be warranted.

PAIN MANAGEMENT MONITORING: I understand that as part of my pain management program, my physician reserves the right to perform random or unannounced urine drug testing for compliance and to detect the presence of non-prescribed drug (s) or illicit drugs. I consent to the collection of urine or saliva specimens for therapeutic drug testing and monitoring. By submitting specimens to ARL or its affiliated laboratories, I understand that my insurance benefits may limit the number of specimens tested in a 30-day period and may not cover services provided. I accept full financial responsibilities for any specimen testing not covered by my insurer due to set limits.

ASSIGNMENT OF BENEFITS: I hereby authorize my insurance benefits to be paid directly to ARL or its affiliated laboratories for services provided. I acknowledge that ARL or its affiliated laboratories may be an out-of-network provider with my insurer. I am aware that in some circumstances my insurer will send the payment directly to me. I agree to endorse the insurance check and forward it to ARL within 30 days of receipt. I accept full financial responsibility and agree to pay in full those charges, for any co-pays, co-insurance, deductibles, or other charges defined as patient responsibility under my insurance plan. I also accept full financial responsibility and agree to pay in full those charges for all laboratory services provided for which I do not have coverage. I authorize my attending provider or treatment facility to release to ARL or its affiliated laboratories and all medical records of my treatment for the purpose of supporting medical necessity to my medical plan. This authorization and assignment includes all rights to collect benefits directly from my medical plan and all rights to proceed against my medical plan in any action, including legal suit, if for any reason my medical plan fails to make payment of benefits due. This assignment also includes all rights to recover attorney’s fees and costs for such action brought by the provider as my assignee.

ACKNOWLEDGEMENT OF FINANCIAL RESPONSIBILITY: My signature indicates that I voluntarily consent to the collection of testing of my specimen and all future testing for 12 months performed by American Research Labs, LLC or its affiliated laboratories. I have also read and agree to the patient assignment of benefits and financial responsibility section of this

HIPAA Rights and Patient Record of Disclosure

In general, the HIPAA privacy rule gives individuals the right to request a restriction on uses and disclosures of their protected health information (PHI). The individual is also provided the right to request confidential communications or that a communication of PHI be made by means such as sending correspondence to an address other than home.

The Privacy Rule generally requires healthcare providers to take reasonable steps to limit the use or disclosure of, and requests for PHI to the minimum necessary to accomplish the intended purpose. These provisions do not apply to uses or disclosures made pursuant to an authorization request by the individual.

HIPAA NOTICE OF PRIVACY PRACTICES PROTECTION OF PROTECTED HEALTH INFORMATION (PHI): Under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), American Research Labs, LLC, is required by law to maintain the privacy of your personal health information (PHI), and to provide you with notice of our legal duties and privacy practices regarding PHI. American Research Labs, LLC is committed to the protection of your PHI and will make reasonable efforts to ensure the confidentiality of your PHI, as required by statute and regulation.

USE AND DISCLOSURE OF PHI: As permitted under HIPAA, the following categories explain the types of uses and disclosures of PHI that American Research Labs, LLC. may make. Some of the uses and disclosures described may be limited or restricted by state laws or other legal requirements.

✓ FOR TREATMENT - American Research Labs, LLC. may use or disclose PHI for treatment purposes, including disclosure to physicians, nurses, medical students, pharmacies, and other health care professionals who provide you with health care services and/or are involved in the coordination of your care, such as providing your physician with your laboratory test results.

✓ FOR PAYMENT - American Research Labs, LLC. may use or disclose PHI to bill and collect payment for laboratory or genetic counseling services we provide.

✓ FOR HEALTH CARE OPERATIONS - American Research Labs, LLC. may use or disclose PHI for health care operations. These uses, and disclosures are necessary to evaluate the quality of our laboratory testing, accuracy of results,
accreditation functions and for operation and management purposes. American Research Labs, LLC. may also disclose PHI to other health care providers or health plans that are involved in your care.

✓ WORKER’S COMPENSATION - As authorized by applicable laws, American Research Labs, LLC. may use or disclose PHI to comply with workers' compensation or other similar programs established to provide work-related injury or illness benefits.

✓ DE-IDENTIFIED INFORMATION AND LIMITED DATA SETS - American Research Labs, LLC. may use and disclose health information that has been “de-identified” by removing certain identifiers making it unlikely that you could
be identified. American Research Labs, LLC. also, may disclose limited health information contained in a “limited data set”. The limited data set does not contain any information that can directly identify you.

OTHER USES AND DISCLOSURES OF PHI: For purposes not described above, including uses and disclosures of PHI for marketing or disclosures that would constitute a sale of PHI, American Research Labs, LLC. will ask for patient authorization before using or disclosing PHI.

PATIENT RIGHTS REGARDING PHI: Subject to certain exceptions, HIPAA establishes the following patient rights with respect to PHI:
✓ Right to Receive a Copy of the Notice of Privacy Practices
✓ Right to Request Limits on Uses and Disclosures of your PHI
✓ Right to Request Confidential Communications
✓ Right to See and Receive Copies of Your PHI

How to Contact Us If you have questions or comments regarding the American Research Labs’ Notice of Privacy Practices or have a complaint about our use or disclosure of your PHI, please email at compliance@arllabs.com.

Version Update/Effective: 05-26-2022