These terms of service (the “COVID West Hub TOS”) govern COVID-19 testing and related services (collectively the “Services”) provided by PerkinElmer Health Sciences, Inc. and its affiliates including PerkinElmer Genetics, Inc. (collectively, “PerkinElmer,” “we,” “us,” or “our” as applicable) pursuant to a contract with the U.S. Department of Defense and the U.S. Department of Health and Human Services (the “Program”). The Services may include:
- Provision of a sample collection kit (a “Collection Kit”);
- Shipping of samples from the collection site to a testing laboratory;
- Testing to detect the presence of SARS-CoV-2 COVID-19 (the “Test”);
- Reporting of the results of the Test to the patient or the patient’s guardian, the ordering healthcare provider, and all applicable governmental authorities;
- Use of or access to a website (the “Site”) maintained by Color Health, Inc. (“Color”), for the purpose of, for example, acceptance or viewing of the results of the Test.
Please note that unless expressly stated otherwise herein, these COVID West Hub TOS only apply to those Services that are performed by us; they do not apply to products and services provided by other individuals or entities in connection with the Test, which may include: Collection Kit component manufacturers and distributors, sample collection, testing performed by other laboratories or third parties, and any consultation, information or service provided by any healthcare professional. Refer to the applicable policies and terms and conditions from such other third parties for their terms of service.
PLEASE READ THE FOLLOWING COVID West Hub TOS CAREFULLY. BY ACCESSING AND USING THE SERVICE(S) OR BY OTHERWISE INDICATING CONSENT TO THESE TERMS OF SERVICE, the patient and the patient’s parent or legal guardian(s) (collectively, “You,” “Your” or the “Patient” as applicable) ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD AND AGREE TO BE BOUND BY THE FOLLOWING TERMS AND CONDITIONS (COLLECTIVELY, THE “TERMS”) . IF YOU ARE NOT ELIGIBLE OR DO NOT AGREE TO THESE TERMS, THEN PLEASE DO NOT USE THE SERVICE OR related PRODUCTS.
You must be at least eighteen (18) years of age to access the Site. You must be at least eighteen (18) years of age to submit a sample and use the Service, or a parent or legal guardian may agree to these terms and all related policies on behalf of their minor ward. By agreeing to these Terms, you represent and warrant to us that: (i) you are at least eighteen (18) years of age; (ii) your use of the Service on your own behalf or on behalf of your minor ward is in compliance with any and all applicable laws and regulations; and (iii) you have reviewed and agree to PerkinElmer’s, PerkinElmer Genetics’ and Color’s respective Privacy Policies, these COVID West Hub TOS, and any other applicable documentation with respect to the Services.
- Covid-19 Test Services
A) Ordering the Covid-19 Test
We do not order the Services. Under the Program, a governmental health official, or healthcare provider affiliated with the sample collection site will order the Test on your behalf. If you have any questions about the Test, you should discuss them with personnel at the collection site.
(B) About the Test
(i) Processing Laboratory: Your sample and PII (as that term is defined below) will be transferred to a laboratory performing the Test as part of the Program. All participating laboratories are CLIA-licensed and required by contract to comply with applicable law. Color will be providing a software interface. The participating laboratory that actually performed the Test shall be identified in the report from the Test.
(ii) Emergency Use Authorization: The Test is authorized by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA), or will be a Laboratory Developed Test (“LDT”) developed and validated under the Clinical Laboratory Improvement Amendments (“CLIA”), pursuant to applicable FDA regulations and guidances.
(iii) Molecular Testing: If you have received a Covid-19 test that is a molecular diagnostic test, you will receive one of the following potential Covid-19 test results:
- “Positive” indicates that SARS-CoV-2 (the virus that causes COVID-19) was detected in the submitted sample. It does not rule out bacterial infection or co-infection with other viruses.
- “Negative” indicates that the SARS-CoV-2 virus was not detected in the submitted sample. A Negative result does not preclude SARS-CoV-2 infection and should not be used as the sole basis for management decisions. Negative results must be correlated with clinical observations, personal history, and epidemiological information. COVID-19 virus may not be detected by the Test in early stages of infection when a person has no symptoms. Additionally, you must provide and return a sample in accordance with the instructions for use, collection procedures, and shipping procedures (including timelines for sample return) specified in your Covid-19 test kit and as otherwise instructed by your performing lab. If the sample is not properly collected, handled, or timely delivered to the testing laboratory, a false negative may result, which means that it is possible that no SARS-CoV-2 was detected in the sample, when it was present in your body.
- “Inconclusive” means that the generated test data was internally inconsistent. This can occur due to a problem with the sample provided or the Test itself. An inconclusive result does not eliminate the possibility that you carry the virus.
- “Sample Unsatisfactory” means that the lab could not analyze your sample. If you receive this result, please contact Support to discuss resampling procedures.
(iv) Pooled or other Covid-19 surveillance testing: The Test may be surveillance testing (e.g., pooled testing). Surveillance testing for Covid-19 involves the testing of asymptomatic individuals who have no known exposures to infected individuals, with the intent to identify infected individuals before they develop symptoms so that appropriate measures can be taken to prevent further viral spread. Pooled testing is one method of surveillance testing. Pooled testing involves combining samples from a number of people together in a batch, so that only one laboratory test is performed on the entire batch instead of one laboratory test for each sample submitted. A pooled test detects whether at least one person whose sample that was combined in the batch was likely infected with SARS-CoV-2 at the time of testing, but not which person(s). If your sample is pooled and the pool tests positive, your sample will be tested individually. Also, while a negative pooled test result typically means no one who submitted a Sample in that batch was infected with SARS-CoV-2, pooled tests dilute the samples which could result in less viral genetic material able to be detected by the test, which increases the likelihood of false negative results. Accordingly, individuals who are experiencing symptoms are advised to isolate and contact their healthcare provider even if they were part of a pooled test with a negative result.
(v) General: If you have symptoms of illness (such as fever, cough, and/or shortness of breath), you should discuss your symptoms and the results of your Test with your doctor who can decide how to care for you. In some cases, if the COVID-19 virus is found in your sample, the COVID-19 viral sample may be further tested, analyzed, or sequenced one or multiple times in conjunction with efforts relating to COVID-19, including for research, scientific, public health, or related purposes. If your Test is positive, your sample may be sequenced to facilitate variant monitoring and spread. No individual results of sequencing will be returned.
C) Payment, Refunds, and Covid-19 Test Kit Replacements
There is no cost to you for the Test. The Test is being funded by the United States Government through the Program.
Under no circumstances will we issue a refund or any other monies to You.
E) INSTRUCTIONS AND DISCLAIMER
We or personnel at your sample collection site may provide you with instructions for use (IFU) of the Collection Kit (“Collection Instructions”). In order for the Test to perform as intended, and for your results to be timely provided, your sample must comply with such Collection Instructions. By using our Services, you acknowledge and agree that failure to collect your sample in strict compliance with such Collection Instructions and any delay in returning your sample to the processing lab may result in (1) sample failure or loss; (2) failure to receive timely results; (3) Test failure, or (4) any consequences of the foregoing.
We disclaim, and You hereby release and discharge Us from any and all liabilities directly or indirectly resulting from 1) a failure to comply with Collection Instructions, 2) any delays in shipment of your sample to the applicable testing laboratory, or 3) failure of any third party to perform their obligations in accordance with applicable law, regulation or contractual obligation. We are not responsible for delays or sample loss due to errors of shipping and transport vendors, or due to weather or other uncontrollable events.
PerkinElmer warrants that it will use commercially reasonable efforts to perform the Services as described in these COVID West Hub TOS. WE MAKE NO OTHER WARRANTIES OF ANY KIND WHATSOEVER, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY WITH RESPECT TO The SERVICES, WHICH WARRANTIES ARE EXPRESSLY DISCLAIMED.
- Required Patient Information and Access
- Additional Service Terms
Your use of the Services may be subject to additional terms, policies, rules or guidelines applicable to a particular Service. When you use such Service(s), you agree to be subject to such terms, policies, rules and guidelines applicable to that Service (“Service Terms”). If these Terms are inconsistent or conflict with those Service Terms, such Service Terms shall control.
COVID-19 has been designated a pandemic by the World Health Organization and is currently a public health crisis in the United States. The sample you provide for Covid-19 testing will be tested as described above so that we may share Results with you and, as applicable, the healthcare provider who ordered the Test, your school, congregant living setting or other facility where your sample was collected, and applicable health authorities, in part, to prevent the potential spread of the virus to others. Your information and information about your Test will be shared with state immunization registries and others in compliance with applicable law, rule, regulation, and order. By agreeing to these COVID West Hub TOS, you agree that your PII and Results will be made available to such parties, as set forth herein.
The Services are performed in the United States and/or its territories (“US”) and are subject to applicable US laws, rules, and regulations. If you provide us with any suggestions, recommendations, or other feedback regarding the Services (“Feedback”), you agree that we may use such Feedback in any way and for any purpose, without compensation or acknowledgment.
- Indemnification and Release
You agree that you will be responsible for your use of the Site and the Service, and you agree to defend, indemnify and hold harmless PerkinElmer and its third-party subcontractors (including Color), and their respective officers, directors, employees, consultants, affiliates, subsidiaries, and agents (collectively, the “Color Entities“) from and against any and all claims, liabilities, damages, losses, and expenses, including reasonable attorneys’ fees and costs, arising out of or in any way connected with: (i) your access to, use of, or alleged use of the Site, Service, and results; or (ii) your violation of these COVID West Hub TOS or any representation, warranty, or agreements referenced herein, or any applicable law or regulation. We reserve the right, at our own expense, to assume the exclusive defense and control of any matter otherwise subject to indemnification by you (and without limiting your indemnification obligations with respect to such matter), and in such case, you agree to cooperate with our defense of such claim.
By taking the Test, accessing the Site, using the Service, or otherwise indicating your assent to these COVID West Hub TOS, you hereby release, discharge, and covenant not to sue us, our subsidiaries and affiliates, and/or all of our present or former representatives, administrators, officers, employees, volunteers, agents, sponsors, directors, shareholders, partners, predecessors, successors, purchasers, and assigns, or any other persons whom you may claim to be responsible for any alleged damages (each considered a “Releasee”) from all liability, claims, demands, losses, or damages on your account caused or alleged to be caused in whole or in part by the actions of the Releasees, in negligence or otherwise, to the fullest extent permitted by law. You understand that you are giving up substantial rights by agreeing to these terms and have done so freely and without any inducement or assurance of any nature and intend it to be a complete and unconditional release of all liability to the greatest extent allowed by law. Furthermore, if any portion of this release is held to be invalid, the remainder of shall continue in full force and effect.
- Disclaimers; No Warranties
THE SERVICE AND ALL MATERIALS AND CONTENT AVAILABLE THROUGH THE SITE AND SERVICE ARE PROVIDED “AS IS” AND ON AN “AS AVAILABLE” BASIS, WITHOUT WARRANTY OR CONDITION OF ANY KIND, EITHER EXPRESS OR IMPLIED. We SPECIFICALLY (BUT WITHOUT LIMITATION) DISCLAIM ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, RELATING TO THE SERVICE AND ALL MATERIALS AND CONTENT AVAILABLE THROUGH THE SERVICE AND SITE, INCLUDING, BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
We CANNOT PROVIDE medical advice or TREATMENT FOR COVID-19 OR YOUR SYMPTOMS, AND YOU ARE AND WILL REMAIN RESPONSIBLE FOR SEEKING APPROPRIATE MEDICAL CARE. YOU ACKNOWLEDGE AND AGREE THAT, AS FURTHER SPECIFIED HEREIN, we DO NOT PROVIDE ANY MEDICAL SERVICES OR ADVICE AND DO NOT MAKE ANY REPRESENTATIONS, WARRANTIES, GUARANTEES OR ENDORSEMENTS REGARDING ANY MEDICAL SERVICES OR ADVICE THAT YOU MAY OBTAIN THROUGH THE SITE AND/OR THE SERVICES. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM THE SERVICE OR ANY MATERIALS OR CONTENT AVAILABLE ON OR THROUGH THE SERVICE (INCLUDING, WITHOUT LIMITATION, ANY CONSULTS WITH our SUPPORT STAFF, GENETIC COUNSELORS, OR THIRD PARTY VENDORS) OR SITE WILL CREATE ANY WARRANTY REGARDING us OR THE SERVICE THAT IS NOT EXPRESSLY STATED IN THESE TERMS. YOU ASSUME ALL RISK FOR ALL DAMAGES THAT MAY RESULT FROM YOUR USE OF OR ACCESS TO THE SERVICE AND SITE. BY USING THE SERVICES AND SITE, YOU FURTHER ACKNOWLEDGE AND AGREE THAT YOU WILL NOT TAKE ANY MEDICAL ACTION, OR FAIL TO TAKE ANY MEDICAL ACTION, WITHOUT CONSULTING WITH A HEALTHCARE PROVIDER.
YOU UNDERSTAND AND AGREE THAT we are NOT RESPONSIBLE AND SHALL NOT BE HELD LIABLE FOR ANY PRODUCTS AND SERVICES PROVIDED BY OTHER INDIVIDUALS OR ENTITIES AS PART OF THE Test or the Program, OR IN CONNECTION WITH ANY OF THE OTHER SERVICES, WHICH MAY INCLUDE COVID-19 TEST COLLECTION KIT COMPONENT MANUFACTURERS AND DISTRIBUTORS, sample collection and TESTING SITES, HEALTHCARE PROFESSIONALS, CLINICAL LABORATORIES, RELEVANT PUBLIC HEALTH AUTHORITIES, AND OTHER GOVERNMENTAL FUNCTIONS; YOU SHOULD REFER TO THE APPLICABLE POLICIES AND TERMS AND CONDITIONS FROM SUCH OTHER THIRD PARTIES FOR THEIR TERMS OF SERVICE.
SOME JURISDICTIONS MAY PROHIBIT A DISCLAIMER OF WARRANTIES AND YOU MAY HAVE OTHER RIGHTS THAT VARY FROM JURISDICTION TO JURISDICTION.
- Limitation of Liability; Waiver
IN NO EVENT WILL WE BE LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES ARISING OUT OF OR RELATING TO YOUR ACCESS TO, RELIANCE ON, OR USE OF, OR YOUR INABILITY TO ACCESS, RELY ON, OR USE, THE SERVICE, RESULTS OF THE SERVICE, OR ANY MATERIALS OR CONTENT ON THE SITE OR OBTAINED IN CONNECTION WITH THE SERVICE, WHETHER BASED ON WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE), STATUTE OR ANY OTHER LEGAL THEORY, WHETHER OR NOT THE WE ENTITIES HAVE BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGE. THE TEST RESULTS AND SERVICES ARE INTENDED TO BE USED BY A HEALTHCARE PROVIDER FOR THE QUALITATIVE DETECTION OF SARS-COV-2 (SUBJECT TO THE METHODS AND LIMITATIONS OF THE TEST), AND YOU AGREE THAT YOU WILL NOT SOLELY RELY ON our SERVICES, the TEST RESULTS, OR INFORMATION OBTAINED FROM us FOR ANY PURPOSE, INCLUDING BUT NOT LIMITED TO, A DETERMINATION THAT YOU ARE SAFE OR ABLE TO TRAVEL, ATTEND EVENTS, OR CONGREGATE WITH OTHER INDIVIDUALS. YOU AGREE THAT our AGGREGATE LIABILITY TO YOU FOR ANY AND ALL CLAIMS ARISING OUT OF RELATING TO THE USE OF OR ANY INABILITY TO USE THE SITE AND/OR SERVICE (INCLUDING ANY MATERIALS OR CONTENT AVAILABLE THROUGH THE SITE AND/OR SERVICE), OR OTHERWISE UNDER THESE TERMS, WHETHER IN CONTRACT, TORT OR OTHERWISE, IS LIMITED TO THE PRICE YOU PAID OR THAT WAS PAID FOR YOU FOR THE SERVICE GIVING RISE TO LIABILITY. IN JURISDICTIONS THAT DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY.
For the Test, your results are based on currently available information in the medical literature and scientific databases, as well as laboratory informatics and algorithms that may be subject to change. You understand and agree that we may, at our sole discretion, amend or modify your Test report based on any such changes. This may result in a change in your result. You hereby irrevocably waive any and all claims against us for any amendment or modification of the Test report in accordance with Color’s standard operating procedures.
If you provide a Nasopharyngeal (NP) or Oropharyngeal (OP) sample for Covid-19 testing, you understand that your sample collection involves risks including mild pain or discomfort, a little gagging and/or a minor nosebleed, and in very rare situations, infection, serious injury, or death. By submitting a sample, you expressly waive and release any and all claims against us on account of pain, injury, or death arising from your sample collection.
- Dispute Resolution and Arbitration
11.1 Generally. You agree that any and all legal action, proceeding, or disputes arising in connection with these Terms, your use of the Service and/or Site, and your acceptance and use of the Results shall be resolved by binding arbitration governed by the Commercial Dispute Resolution Procedures and the Supplementary Procedures for Consumer Related Disputes (collectively, “AAA Rules“) of the American Arbitration Association (“AAA“), as modified by these Terms, and will be administered by the AAA. Any arbitration hearings will take place at a location to be agreed upon in Boston, Massachusetts. Our agreement to arbitrate disputes includes, but is not limited to all claims arising out of or relating to any aspect of these Terms, the Service, the Site, and the results, whether based in contract, tort, statute, fraud, misrepresentation, or any other legal theory, and regardless of whether the claims arise during or after the termination of these Terms. If the arbitrator finds that either the substance of your claim or the relief sought is frivolous or brought for an improper purpose (as measured by the standards set forth in Federal Rule of Civil Procedure 11(b)), then the payment of all fees will be governed by the AAA Rules. In such case, you agree to reimburse us for all monies previously disbursed by it that are otherwise your obligation to pay under the AAA Rules. YOU UNDERSTAND AND AGREE THAT, BY ENTERING INTO THESE TERMS, YOU AND US ARE EACH WAIVING THE RIGHT TO A TRIAL BY JURY OR TO PARTICIPATE IN A CLASS ACTION, AND INSTEAD ARE ACCEPTING THE USE OF ARBITRATION. You understand and agree that this agreement to arbitrate binds you and anyone else who may have a claim arising out of or related to all products and services provided to you by us, or persons employed or engaged by us.
11.2 Exceptions. Notwithstanding subsection 11.1, we and you agree that nothing herein will be deemed to waive, preclude, or otherwise limit either of our right to: (i) bring an individual action in small claims court; (ii) pursue enforcement actions through applicable federal, state or local agencies where such actions are available; (iii) seek injunctive relief in a court of law; or (iv) to file suit in a court of law to address intellectual property infringement claims.
11.3 No Class Actions. YOU AND WE AGREE THAT EACH MAY BRING CLAIMS AGAINST THE OTHER ONLY IN YOUR OR ITS INDIVIDUAL CAPACITY AND NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS OR REPRESENTATIVE PROCEEDING. Further, unless both you and we agree otherwise, the arbitrator may not consolidate more than one person’s claims, and may not otherwise preside over any form of a representative or class proceeding.
11.4 Modifications. In the event that we makes any future change to this arbitration provision, you may reject any such change by sending us written notice within thirty (30) days of the change in which case your account with Color shall be immediately terminated and this arbitration provision as in effect immediately prior to the amendments you reject shall survive.
11.5 Enforceability. If the entirety of this Section 11 is found to be unenforceable, then the entirety of this Section 11 shall be null and void and, in such case, the parties agree that the exclusive jurisdiction and venue described in Section 13 shall govern any action arising out of or related to these Terms.
- Modification of the Terms
We reserve the right to update or modify these COVID West Hub TOS at any time without prior notice, and such changes will be effective immediately upon being posted through the Service or on the Site, except as set forth below. These COVID West Hub TOS will identify the date of last update. Your use of the Service and/or the Site following any such change constitutes your agreement to be bound by the modified COVID West Hub TOS. In the case of material changes to the COVID West Hub TOS, we will make reasonable efforts to notify you of the change, such as through sending an email to any address you may have used to register for an account, through a pop-up window on the Site, or other similar mechanism. Material changes to these COVID West Hub TOS will be effective upon the earlier of: (i) your first use of the Service and/or Site with actual notice of such change, or (ii) thirty (30) days from posting of such change. Disputes arising under these COVID West Hub TOS will be resolved in accordance with the version of the COVID West Hub TOS in place at the time the dispute arose. We encourage you to review these COVID West Hub TOS frequently to stay informed of the latest modifications. Without limiting the generality of the foregoing, no modification to the terms of our agreement to arbitrate disputes will be effective without your express consent, provided that if we propose a change to the terms of our agreement to arbitrate and you do not consent to the change, you must terminate your use of the Service.
These COVID West Hub TOS shall continue to have full force and effect unless and until terminated by us. We may terminate, suspend, or restrict any provision of these COVID West Hub TOS and the Service and/or Site at any time in its sole discretion and without notice to you.
- Third-Party Beneficiaries
Nothing contained in these COVID West Hub TOS is meant or intended to confer any rights, remedies, or benefits upon any third party.
- Electronic Signatures
By using the Site or Services you consent to transact business with us electronically.