kean health terms of service

Lab Consent for Services

Kean Health

 

Lab Consent for Services

 

Last Modified: November 8, 2022

 

Introduction

 

This consent form (“Consent”) reviews the benefits, risks and limitations of you, as the person who has created an Account (referred to as “you” or “your”), utilizing the Services provided by Kean Health (referred to as “Kean Health”, “we”, “us” or “our”). It also explains how your information and sample(s) will be used after performance of the Services. Your sample(s) will not be processed unless you confirm that you have read and understood the contents of this form.

 

By clicking on the box, you indicate that this Consent is a binding agreement and that you have read and understood the following terms. Capitalized terms used but not defined in this Consent have the meaning given to them in our other policies.

 

By clicking your acceptance, you have chosen to use our Services and have given your informed consent to have your biological sample(s) tested for biomarkers and/or genes. Biological samples shall consist solely of human fluids and/or tissue samples, depending on the test purchased, that are intended to be analyzed for the individual’s sole use, and not for any other purpose, including but not limited to research, publications, commercial uses, or any other purpose other than to inform the purchaser’s health and/or wellness.

 

 

Voluntary Participation

Our Services are offered and available to users who are residents of the United States. Your use of Kean Heath’s Services is voluntary. It is your choice whether to utilize our Services or not. Prior to signing this Consent, you may wish to speak with a genetic counselor or your healthcare provider for further guidance about our Services.

 

 

Procedures and Protocol for Kean Heath Tests

When you create your Account, we will collect some information from you. We cannot perform the Services without collecting information from you but we will only collect information that will assist us in providing the Services that you have requested. In order for the Services to be provided as intended, you must provide accurate and correct information. Failure to provide required information or to execute required documents may result in your sample(s) not being tested.

All requests for tests will be reviewed by a licensed physician (“Health Consultant”) affiliated with a company that we have partnered with to provide review and authorization of testing, review of lab results, prescriptions and counseling where applicable. Services will not be provided to you if a Health Consultant does not authorize your request and order the applicable test(s). We will refund the applicable fees for such canceled tests.

You will collect the biological sample(s) (i.e., vaginal swab) that will be provided to and tested by our designated testing laboratory (“Lab”). You will send the sample(s) directly to the Lab where your sample(s) will be tested for a number of biomarkers (Including vaginal health and your vaginal type).

The results of your test(s) will be made available to you through our Site (https://www.keanhealth.com). In the event we determine that a biological sample is not suitable for testing due to the content of the sample or because we believe the sample to have been submitted in violation of this Consent or the User Agreement, we reserve the right to withhold the results and to not provide a refund. We will determine and establish normal ranges for all tests in

 conjunction with the Labs based on their validation and proficiency testing procedures. If your results are clinically significant or have a critical value that falls outside of our established normal ranges by at least a certain amount, a Health Consultant will make reasonable efforts to contact you.

 

 

Benefits

Utilizing our Services to discover what your biomarker say about you can help you gain a better perspective on your health. You may use this information to make more informed health care decisions and choices. A summary of the potential benefits of our tests is included below.

Product Name

Information

Kean V

Vaginal type, Bacterial balance, How vaginal type impacts health, Risk factors associated with vaginal disease

Kean V+

Vaginal type, Bacterial balance, How vaginal type impacts health, Risk factors associated with vaginal disease, Gonorrhea testing, Chlamydia testing, Mycoplasma genitalium testing, HPV testing

 

*If your results for these test panels identify a marker as detected or positive, a consult from a Health Consultant licensed in your state of residence will be offered to you at no additional cost. When appropriate and permitted by law, the Health Consultant may prescribe treatment for positive results.

 

More information about the specific benefits of our tests and Services are available on our Site.

 

 

Risks

In order to utilize our Services, you must collect the appropriate biological sample(s) for the test(s). Our tests require a vaginal swab; there are no risks associated with collecting a vaginal swab sample using the containers provided in our test kits.

 

Disclosing certain information may make you uncomfortable. Our Services include biomarker tests that may reveal sensitive information about your health. This information may be distressing.

 

Health information that you choose to share with your physician or other healthcare providers may become part of your medical record and through that route may be accessible to other healthcare providers and/or insurance companies in the future. Information that you share with family, friends or employers may also be used against your interests. Even if you share health information that has no or limited meaning today, that information could have greater meaning in the future as new discoveries are made.

 

Kean Heath, or the Health Consultant who reviews your results, may advise you to have a follow-up visit with your doctor after reviewing the results of your test. As a result, you may learn about health conditions and problems or potential health risks that you were not aware of before you utilized our Services. You may experience stress, anxiety, or emotional or physical discomfort when you learn about health problems or potential health problems. There may also be additional risks of utilizing our Services that are currently unforeseeable.

 

 

Limitations

 

OUR SERVICES DO NOT PROVIDE MEDICAL ADVICE. The information and content provided, including but not limited to text, graphics, images, videos, and other material contained on our Site and in the Services, are for informational purposes only and are not intended as a substitute for professional medical advice, help, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you have regarding your medical care, and never disregard professional medical advice or delay seeking it because of something you have read on or via our Site. Nothing contained in the Services is intended to constitute a medical diagnosis or treatment. Reliance on any information appearing in the Services, including but not limited to information provided by Kean Heath or by other users of the Services, is solely at your own risk. By clicking your acceptance, you understand and agree that your results are not a substitute for professional medical advice. You understand that Kean Heath does not provide medical services, diagnosis, treatment, or advice. You acknowledge that the Health Consultants are not employees of Kean Heath and are not providing services on behalf of Kean Heath, but instead are independent professionals solely responsible for the services each provides to you.

 

Kean Heath does not warrant the accuracy, completeness, timeliness or usefulness of the opinions, content, services or other information provided through the Services or on the Internet generally. Kean Heath and its affiliates, licensors, and suppliers have no control over and accept no responsibility for your compliance with the laws applicable to your state of residence.

 

Kean Heath implements several safeguards to avoid technical errors, but as with all medical tests, there is a chance of a false positive or a false negative result. A false positive result means a biomarker was detected, which is not in fact present. A false negative result means the test failed to identify biomarker that is in fact present. Other sources of error include sample mix-up, poor sample quality or contamination, inherent DNA sequence properties, and technical errors in the laboratory. Some biological factors, such as a history of bone marrow transplants or recent blood transfusions may limit the accuracy of the results or prevent the Services from being completed.

 

Results interpretation is based on currently available information in the medical literature and scientific databases. The field of genetics is constantly changing and our understanding of biomarkers is evolving. New information may replace or add to the information that we used to interpret your results. We are not obligated to notify you if there is a new understanding of biomarkers that might result in a change to the interpretation of your results. We reserve the right to contact you, at our option, in the future.

 

 

Retention and Use of Your Information

 

We are subject to multiple laws on the retention of data. Accordingly, we retain any information collected about you for as long as we are required to maintain it for regulatory and compliance purposes or for a legal or business necessity.

 

You will send your biological sample(s) directly to the Lab (Kean Health) that will conduct the test. The Lab testing your sample(s) is subject to multiple laws regarding the retention of data and samples and will maintain your data and sample(s) for as long as required for regulatory and compliance purposes or for legal or business necessity.

 

You understand that by providing any sample, having your sample processed, accessing your results, or providing information to us, you acquire no rights in any research or commercial products that may be developed by Kean Heath or its collaborating partners. You specifically understand that you will not receive compensation for any research or commercial products that include or result from your sample or information.

 

Your information and test results may be stored in a repository and used for validation, educational, and/or research purposes. By clicking your acceptance of this Consent, you acknowledge and agree that Kean Heath may de-identify the information that is obtained from our Services and that we may aggregate this information with de-identified information from other users. De-identification means that the personally identifiable information associated with your information will be removed. You understand that we will not disclose, sell and otherwise commercialize personally identifiable information but that we may disclose, sell and otherwise commercialize de-identified information and User Content without restriction.

 

We may incorporate different or additional technologies to test or analyze data in the future. We may, at our sole discretion, choose to test or analyze your data using such technologies. We are not obligated to notify you if we chose to conduct different or additional testing or analysis on your data. Your purchase of our Services does not automatically include any such different or additional technologies. You may have to pay additional fees in order to receive Services using any future or additional technologies or features.

 

 

Confidentiality

 

By clicking your acceptance of this Consent, you acknowledge that you have read and understand our Privacy Policy and HIPAA Privacy Authorization. You agree the Kean Heath is not liable for the unauthorized release of your results or information unless such unauthorized release was the result of gross negligence or willful misconduct on the part of Kean Heath.

 

 

Withdrawal of Consent

 

Your use of Kean Heath’s Services is voluntary. You may choose to withdraw your Consent or to stop using Kean Heath’s Services at any time. Such requests to should be sent to us by email at help@keanhealth.com or in writing at Kean Health, 21351 Gentry Drive Suite 125, Sterling, VA 20166.

 

Please note that while any such requests you make will be reflected in our databases within a reasonable period of time, we may retain your information in the ordinary course of business, for the satisfaction of our legal obligations, or where we otherwise reasonably believe that we have a legitimate reason to do so. Information that has already been de-identified, anonymized, or aggregated may not be retrievable or traced back for destruction, deletion, or amendment.

 

 

Legal Agreement

You give permission for Kean Heath, its representatives, affiliates, staff, agents, and designees to perform the requested Services on the sample(s) you provide and to disclose your information and results in accordance with our Privacy Policy and your HIPAA Privacy Authorization. You are not an insurance company or an employer attempting to obtain information about an insured person or an employee.

 

 

Dispute Resolution

 

  1. ARBITRATION NOTICE: UNLESS YOU OPT-OUT OF ARBITRATION WITHIN 30 DAYS OF THE DATE YOU FIRST AGREE TO THESE TERMS BY FOLLOWING THE OPT-OUT PROCEDURE SPECIFIED IN THE ARBITRATION SECTION BELOW, YOU AGREE THAT DISPUTES BETWEEN YOU AND PSOMAGEN WILL BE RESOLVED BY BINDING, INDIVIDUAL ARBITRATION AND YOU ARE WAIVING YOUR RIGHT TO A TRIAL BY JURY OR TO PARTICIPATE AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS ACTION OR REPRESENTATIVE PROCEEDING.
  2.  

(i) Agreement to Arbitrate: You and Psomagen agree that any dispute, controversy or claim arising out of or relating to these Terms or the breach, termination, enforcement, interpretation or validity thereof or the use of the Services or Content (collectively, “Disputes”) will be settled by binding arbitration, except that each party retains the right; (i) to bring an individual action in small claims court and (ii) seek injunctive or other equitable relief in a court of competent jurisdiction to prevent the actual or threatened infringement, misappropriation or violation of a party’s copyrights, trademarks, trade secrets, patents or other intellectual property (IP) rights. Without limiting the preceding sentence, you will also have the right to litigate any other Dispute if you provide Psomagen with written notice of your desire to do so by email or regular mail at help@keanhealth.com, 21351 Gentry Drive Suite 125, Sterling, VA 20166, within thirty (30) day period, you will be deemed to have knowingly expressly set forth in clauses (i) and (ii) above. The exclusive jurisdiction and venue of any IP protection action or, if you timely provide Psomagen with an Arbitration Opt-out Notice, will be the state and federal courts located in the State of Maryland and each of the parties hereto waives any objection to jurisdiction and venue in such courts. Unless you timely provide Psomagen with an Arbitration Opt-out Notice, you acknowledge and agree that you and Psomagen are each waiving the right to a trial by jury or to participate as a plaintiff or class member in any purported class action or representative proceeding. Further, unless both you and Psomagen otherwise agree in writing, the arbitrator may not consolidate more than one person’s claims, and may not otherwise preside over any form of any class or representative proceeding. If this specific paragraph is held unenforceable, the entirety of this “Dispute Resolution” section will be deemed void. Except as provided in the preceding sentence, this “Dispute Resolution” section will survive any termination of these Terms.

 

(ii) Arbitration Rules: the arbitration will be administered by the American Arbitration Associate (“AAA”) in accordance with the Commercial Arbitration Rules and the Supplementary Procedures for Consumer Related Disputes (the “AAA” Rules) then in effect, except as modified by this “Dispute Resolution” section. (The AAA Rules are available at www.adr.org/arb med or by calling the AAA at 1-800-778-7979.) The Federal Arbitration Act will govern the interpretation and enforcement of the Section.

 

(iii) Arbitration Process: A party who desires to initiate arbitration must provide the other party with a written Demand for Arbitration as specified in the AAA Rules. The arbitrator will be selected by the parties from the AAA’s roster or arbitrators (either a retired judge or an attorney licensed to practice law). If the parties are unable to agree upon an arbitrator within seven (7) days of delivery of the Demand for Arbitration, then the AAA will appoint the arbitrator in accordance with the AAA Rules.

 

(iv) Arbitration Location and Procedure: Unless you and Psomagen otherwise agree, the arbitration will be conducted solely on the basis of the documents that you and Psomagen submit to the arbitrator. If you or Psomagen requests a hearing the rights to a hearing will be determined by the AAA Rules. If the arbitrator determines that a hearing is necessary, the arbitrator will direct a reasonable exchange of information by the parties, consistent with the expedited nature of the arbitration.

 

(v) Arbitrator’s Decision: The arbitrator will render an award within the time frame specified in the AAA Rules. The arbitrator’s award of damages must be consistent with the terms of the “Limitation of Liability” section above as to the types and amounts of damages for which a party may be held liable. The Arbitrator’s decision shall be final.

 

(vi) Arbitration Fees: Your responsibility to pay any AAA filing, administrative and arbitrator fees will be solely as set forth in the AAA Rules. However, if your claim for damages does not exceed $75,000, Psomagen will pay all such fees unless the arbitrator finds that either the substance of your claim or the relief sought in your Demand for Arbitration was frivolous or was brought for an improper purpose (as measured by the standards set forth in Federal Rule of Civil Procedure 11(b)).

  1.  
  2. B. Governing Law

These Terms and any action related thereto will be governed by the laws of the State of Maryland without regard to its conflict of law’s provisions.

 

 

Preliminary Equitable Relief and Intellectual Property Claims

 

Either party may bring a claim related to intellectual property rights, or seek temporary or preliminary specific performance or temporary or preliminary injunctive relief, in any court of competent jurisdiction, without the posting of bond or other security.

 

 

Miscellaneous

 

  1. a. Class Action Waiver
  2.  

Any proceedings to resolve or litigate any dispute in any forum will be conducted solely on an individual basis. Neither you nor we will seek to have any dispute heard as a collective or class action or in any other proceeding in which either party acts or proposes to act in a representative capacity, and each party hereby waives any right to assert consolidated claims with respect to any disputes subject to arbitration under the User Agreement. No arbitration or proceeding will be combined with another without the prior written consent of all parties to all affected arbitrations or proceedings.

 

  1. b. Limitation of Time to File Claims
  2.  

Any action, claim or dispute you have against us must be filed within one year, unless prohibited by applicable law. To the extent permitted by law, any claim or dispute under this agreement must be filed within one year in an arbitration proceeding. The one-year period begins when the claim or notice of dispute first could be filed. If a claim or dispute is not filed within one year, it is permanently barred.

 

  1. c.Notices
  2.  

You agree that we may provide you with notices by email to the address you provided at the time of registration or as changed in your member profile on the Site.

 

  1. d. No Affiliation with Kean Health 
  2.  

You agree not to hold yourself out as in any way sponsored by, affiliated with, endorsed by, in partnership or venture with, nor as an employee or employer of Kean Health, any of our affiliates or service providers.

 

  1. e. Entire Agreement
  2.  

This Agreement, including the other documents referenced and referred to herein, constitutes the entire agreement between you and us with respect to the Site and the Services and supersede all prior or contemporaneous understandings and agreements, whether written or oral, with respect thereto. No failure to exercise, and no delay in exercising, on the part of either party, any right or any power hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right or power hereunder preclude further exercise of that or any other right hereunder. In the event of a conflict between this Agreement and any applicable purchase or other terms, the terms of this Agreement shall govern. If any provision of this Agreement is illegal or unenforceable under applicable law, the remainder of the provision will be amended to achieve as closely as possible the effect of the original term and all other provisions of this Agreement will continue in full force and effect. The headings of sections and paragraphs in this Agreement are for convenience only and shall not affect its interpretation.

 

 

Special Notice for COVID-19 Testing in Connection with Employment for Work Safety Purposes 

 

If COVID-19 testing is being provided by your employer for work safety testing purposes on either a voluntary or mandatory basis, then the following additional statements apply and supersede other provisions in this consent form. Your signature on this Consent means you have read, understood and agree to the following:

 

This COVID-19 testing is for public health and work safety purposes in connection with your employment, is not a health benefit and is not part of a health plan or wellness plan. You are an employee undergoing testing in connection with your employment.

 

Results from the COVID-19 testing, as well as information you provide during registration, will be shared by Kean Health and the Labs with your employer as well as the vendor(s) who provides services to your employer in support of the employer’s business related to these results, including your employer’s franchisor and/or affiliate company. Signing this Consent is required in order to receive the COVID-19 testing services provided by your employer.

 

Although this form mentions other tests provided by Kean Health, the specimen you provide will ONLY be tested to diagnose COVID-19.

 

This COVID-19 testing is an at-home self-collection kit which uses a nasal swab. Wording regarding blood, urine or saliva does not apply and should be disregarded.

 

This COVID-19 testing is provided at no cost to you. Wording about fees, insurance, refunds, and reimbursement do not apply and should be disregarded.

 

Any resulting research studies, publications or commercial uses conducted by or for Kean Health or the Labs will not identify you, your employer, your employer’s franchisor or your employer’s affiliate company.

 

You can opt out of receiving marketing communications from Kean Health through “unsubscribe” links available on all marketing communications.

 

This COVID-19 testing does not involve medication or treatment for COVID-19. Physician consultation provided as part of this COVID-19 testing are physician services necessary to perform the COVID-19 testing, such as education provided to you regarding the test result and a telehealth consult. These services do not involve medication or treatment. As with other types of lab testing, there may be false positives and false negatives. If you have a positive test result, you should follow up with your personal health care provider.

 

This COVID-19 test is a point in time snapshot about your current status at this time; a person could still contract COVID-19 or test positive for COVID 19 in the future even if he/she has a negative result now.

 

 

Contacting Kean Health

 

If you have questions or comments about our Services or this Consent, please contact us by email at help@keanhealth.com, by phone at (301) 251-1007 or in writing at Kean Health., 21351 Gentry Drive Suite 125, Sterling, VA 20166.

 

 

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