SAFETY, PRIVACY, NOTICES, & FACTS SHEETS

Fact Sheet for Healthcare Providers:
https://www.fda.gov/media/138293/download
Fact Sheet for Patients
https://www.fda.gov/media/138296/download

FDA NOTICE

No COVID-19 Test has been FDA approved yet, but our Test is FDA authorized.

• This test has not been FDA cleared or approved;

• This test has been authorized by the FDA under an EUA for use by the authorized labs;

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

• This 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 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.

HIPAA NOTICE

The Health Insurance Portability and Accountability Act (HIPAA) and supplemental legislation collectively referred to as the HIPAA rules (HIPAA) lay out privacy and security standards that protect the confidentiality of protected health information (PHI). The information that you  provide to Biotech Accelerated in the course of submitting your Test comprises PHI.

In the course of providing services to you and to enable HIPAA compliance to covered entities such as Curogram with respect to the processing of your Test submission, Biotech Accelerated complies with the provisions of HIPAA which are required and applicable to Biotech Accelerated in its capacity as a “Business Associate” under HIPAA. For more information with respect to the type of  privacy and security standards  observed by Biotech Accelerated regarding your PHI, please go to www.curogram.com/privacy. For complaints to the covered entity regarding HIPAA, contact us.

ORDERING PHYSICIAN NOTICE

Our PROVIDER authorizes our lab to perform COVID-19 (SARS- CoV-2) rRT-PCR testing for individual samples based on a medical necessity, only when a patient has met one of the criteria outlined by the CDC, and based on a need to test. This criteria is evaluated through Screening.

Our PROVIDER will provide the following services to patient: authorizing a non-patient specific order for patient to obtain saliva samples as appropriate to perform indicated COVID-19 testing.

It is the sole responsibility of the patient or patient’s legal guardian to contact their treating practitioner, insurance company, or PCP to obtain any medical care, reporting, follow-up, or reimbursement.

The patient agrees that the PROVIDER shall have no notification duty related to the test results and shall not provide any follow-up consultation or care to individuals tested pursuant to this consent. When patients receive their results, they will be provided with a Telemedicine link that will allow them to see a doctor if they receive a positive result or have questions regarding their result.

TESTING NOTICE

Your Test result and the product are not a substitute for professional medical advice. You should always seek the advice of your physician or other licensed healthcare professional for any questions you may have regarding any Test result or regarding the status of your health.