Quality & Compliance

Eurofins Viracor is committed to providing the highest quality service to its clients in compliance with all federal, state, and local laws and regulations, as well as, organizational policies and ethical standards. Regulatory compliance is essential in successfully bringing diagnostic testing platforms and new therapeutic agents to the marketplace. Our quality assurance and compliance efforts go beyond those required of a typical clinical laboratory (CLIA-88 and HIPAA) to incorporate features of Good Clinical Practices, Good Clinical Laboratory Practices and other regulatory standards: 

• Quality system compliance training for all laboratory staff
• Independent Quality Assurance Unit with dedicated internal auditing staff
• Experienced staff dedicated to the demanding environment of clinical trials testing and data management
• Secure archival of applicable records
• Computer system validation and security

Eurofins Viracor is committed to providing the highest quality service to its clients in compliance with all federal, state, and local laws and regulations.

In addition to holding accreditation with the College of American Pathologists (CAP) and certification with the Clinical Laboratory Improvement Amendments (CLIA) through the Centers for Medicare and Medicaid Services (CMS), Viracor holds current licensure or permits required by state or local regulations.

California Clinical Laboratory License CDS-00800151   

Clinical Laboratory Improvement Amendments (CLIA) Certificate of Accreditation 26D0983643   

College of American Pathologists (CAP) 7179041 

DC Health Out of State Testing Certificate HFD-OS72

Maryland Medical Laboratory Permit 1118         

New York Clinical Laboratory Permit PFI 8091          

Pennsylvania Clinical Laboratory Permit 028753A    

Rhode Island Clinical Laboratory License LCO01563

West Virgina DOH HIV/AIDS-Related Testing Certification

Eurofins Viracor is committed to compliance with the Health Insurance Portability and Accountability Act (HIPAA) Standards. Eurofins Viracor has implemented policies, processes, and procedures designed to ensure compliance with these standards which are continuously monitored and audited for effectiveness. Workforce HIPAA training is completed annually.

Please see our Privacy Policy in the section below. If you have any questions about our notice or our privacy practices in general, contact our Privacy Officer at 1-800-305-5198; email PrivacyOfficer@viracor.eurofinsus.com; or send a written request to:

Eurofins Viracor
Attn: Privacy Officer
18000 W 99th St., Ste.#10
Lenexa, KS 66219

THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW CAREFULLY.

Eurofins Viracor, LLC (“Eurofins Viracor”) is committed to protecting the privacy of your identifiable health information. This information is known as “protected health information” or “PHI”. PHI includes laboratory test orders and test results as well as invoices for the healthcare services that we provide.

Our Responsibilities

Eurofins Viracor is required by law to maintain the privacy of your PHI. We are also required to provide you with this Notice of our legal duties and privacy practices. It describes our legal duties, privacy practices and your patient rights as determined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). We are required to follow the terms of this Notice currently in effect. We are required to notify affected individuals in the event of a breach involving unsecured PHI. HIPAA requires us to safeguard your PHI regardless of the form in which we receive it (e.g., oral, written, or recorded in other media). PHI is stored electronically and is subject to electronic disclosure.

We reserve the right to amend the terms of this Notice to reflect changes in our privacy practices, and to make the new terms and practices applicable to all PHI that we maintain about you, including PHI created or received prior to the effective date of the Notice revision. Our Notice is displayed on our website and a copy is available upon request.

How We May Use or Disclose Your PHI

Not every use or disclosure is listed in this Notice, but all of our uses or disclosures of your PHI will fall into one of the categories listed below.

Uses and Disclosures We May Make Without Your Authorization

We may use and disclose your health information for the following purposes without your authorization:

Treatment

We may use or disclose your PHI for treatment purposes, including for laboratory testing and exchanging PHI with physicians and other healthcare professionals for such testing. Examples of treatment related purposes include disclosure to an ordering physician or to a pathologist to help interpret your test results.

Payment

Eurofins Viracor will use and disclose your PHI for purposes of billing and payment. For example, we may disclose your PHI to health plans or other payers to determine whether you are enrolled with the payer or eligible for health benefits or to obtain payment for our services. If you are insured under another person’s health insurance policy (for example, parent, spouse, domestic partner or a former spouse), we may also send invoices to the subscriber whose policy covers your health services.

Healthcare Operations

Eurofins Viracor may use and disclose your PHI for activities necessary to support our healthcare operations, such as performing quality checks on our testing, internal audits, arranging for legal services or developing reference ranges for our tests. For example, we may use your PHI to evaluate the clinical performance of our laboratory scientists or to teach students entering the clinical laboratory sciences field. We may make incidental disclosures of limited PHI as permitted by law.

Business Associates

We may provide your PHI to other companies or individuals that need the information to provide services to us. These other entities, known as “business associates,” are required to maintain the privacy and security of PHI. For example, we may provide information to companies that assist us with billing for our services or to an outside collection agency to obtain payment.

As Required by Law

We may use and disclose your PHI as required by law. For example, we may disclose PHI about you to the U.S. Department of Health and Human Services if it requests such information to determine that we are complying with HIPAA.

Law Enforcement Activities

We may disclose PHI to law enforcement to report certain injuries, comply with court orders or warrants or similar process, to identify a suspect, fugitive, missing person or victim or to report a crime.

Legal and Administrative Proceedings

We may disclose your PHI as required to comply with a court or administrative order. We may disclose your PHI in response to a subpoena, discovery request or other legal process in the course of a judicial or administrative proceeding, but only if efforts have been made to tell you about the request or to obtain an order of protection for the requested information. If we receive records from substance use disorder treatment programs subject to federal privacy restrictions found at 42 CFR Part 2, such records or testimony about their content cannot be used or disclosed in civil, criminal, administrative, or legislative proceedings against the individual unless based on written consent or we receive a court order entered after notice and an opportunity to be heard is provided to the individual or us, as provided by 42 CFR Part 2. A court order authorizing use or disclosure must be accompanied by a subpoena or other legal requirement compelling disclosure before the requested substance use disorder record is used or disclosed.

Research

We may disclose PHI for research purposes when an Institutional Review Board or privacy board has reviewed the research proposal and established protocols to ensure the privacy of your PHI and determined that the researcher does not need to obtain your authorization prior to using your PHI for research purposes. We may also disclose information about decedents to researchers under certain circumstances.

Other Uses and Disclosures

As permitted by HIPAA, we may use and disclose your PHI:

• to a public health authority that is authorized by law to collect or receive such information including preventing or controlling disease, reporting deaths, reporting adverse effects of medications or problems with products, notification of communicable disease, and reporting abuse or neglect under certain circumstances
• to a family member, friend, or anyone else involved in your care or payment related to your care unless you object or if, in our professional judgment, the disclosure is in your best interest when you are not present or cannot agree or object because you are incapacitated and to those assisting in disaster relief efforts in an emergency
• to a health oversight agency for oversight activities authorized by law, including audits and inspections, and civil, administrative or criminal investigations, proceedings or actions
• to avert a serious threat to health or safety, so long as the disclosure is only to a person who is reasonably able to prevent or lessen such threat
• in a limited data set after removing most information that identifies you from a set of date for research, public health and health care operations, provided the recipients of the data set agree to keep it confidential or after de-identifying your PHI consistent with HIPAA for purposes permitted by law, including selling the de-identified information
• for military and veterans activities, correctional institutions and national security and intelligence activities consistent with applicable law
• to organ procurement organizations or similar entities for the purpose of facilitating organ, eye or tissue donation and transplantation to a coroner, funeral director or medical examiner to carry out their duties
• if we participate in Health Information Exchanges (HIEs), we may electronically share your PHI for treatment, payment, healthcare operations and other permitted purposes with other participants in the HIE
• to the extent necessary to comply with laws relating to workers' compensation and work-related injuries

Note Regarding Other Laws

For all the above purposes, when state or federal law (including the substance use disorder requirements at 42 CFR Part 2) is more restrictive than HIPAA, we are required to follow the more restrictive applicable law.

Uses and Disclosures with Your Authorization

We need your written authorization to use or disclose your health information for any purpose not covered by one of the categories above. Subject to compliance with limited exceptions, we will not use or disclose your PHI for marketing purposes or sell your PHI, unless you have signed an authorization. You may revoke any authorization you sign at any time. If you revoke your authorization, we will no longer use or disclose your health information for the reasons stated in your authorization except to the extent we have already taken action based on your authorization.

Your Patient Rights

You have the rights listed below. If you have given another individual a medical power of attorney, if another individual is appointed as your legal guardian or if another individual is authorized by law to make health care decisions for you (known as a “personal representative”), that individual may exercise any of the above rights listed for you.

Access PHI

You have the right to access your PHI that we maintain or request to send a copy of your PHI to another person designated by you in writing. You may call the Eurofins Viracor Client Services Team at (800) 305-1598. If your request for test information is denied, you may request that the denial be reviewed.

Amend PHI

You may request amendments to your PHI by making a written request. However, we may deny the request in some cases (such as if we determine the PHI is accurate). If we deny your request to change your PHI, we will provide you with a written explanation of the reason for denial and additional information regarding further actions that you may take.

Accounting of Disclosures

You have the right to receive a list of certain disclosures of your PHI made by us in the past six years from the date of your written request. Under the law, this does not include disclosures made pursuant to an authorization you signed or certain other purposes.

Request Restrictions

You may request that we agree to the restrictions on certain uses and disclosures of your PHI. We are not required to agree to your request, except for requests that limit disclosures to your health plan for purposes of payment or healthcare operations when you have paid us for the item or service covered by the request out-of-pocket and in full and when the uses or disclosures are not required by law.

Request Confidential Communications

You have the right to request that we send your PHI by alternative means or to an alternative address and we will accommodate reasonable requests.

Copy of this Notice

You have the right to obtain a paper copy of this Notice upon request even if you have received it electronically.

How to Exercise Your Rights

You may write or send an email to us with your specific request. Eurofins Viracor will consider your request and provide you a response.

Complaints/Questions

If you believe your privacy rights have been violated, you have the right to file a complaint with us. You also have the right to file a complaint with the Secretary of the U.S. Department of Health and Human Services, Office for Civil Rights. We will not retaliate against any individual for filing a complaint.

To file a complaint with us, or should you have any questions about this Notice, send an email to us at PrivacyOfficer@viracor.eurofinsus.com or write to us at the following address:

Eurofins Viracor

Attn: Privacy Officer
18000 W 99^th Street, Suite 10
Lenexa, KS 66219

You may also contact the Privacy Officer at is (816) 347-0113

Effective Date

This Notice is effective February 16, 2026.

Medicare Coverage of Laboratory Testing

1. Only those laboratory tests that are reasonable and necessary for the diagnosis or treatment of the patient will be covered by Medicare. A physician should carefully consider the medical need for each test ordered.

2. An individual who knowingly causes a false claim to be submitted to any of the Federal health care programs may be subject to civil, criminal, and administrative sanctions or remedies. The term “false claim” may encompass a variety of actions, including falsifying records, double-billing for items or services, submitting bills for services never performed or items never furnished, or knowingly or with deliberate disregard upcoding (billing for a more highly reimbursed service or product than the one provided).

3. Eurofins Viracor and client-customized panels should be billed to Medicare only when every component of the customized panel is medically necessary. Unless necessary for clinical or regulatory reasons, all tests may be ordered individually.

4. Medicare National Limitation Amounts for Current Procedural Terminology (CPT) codes are available through CMS or its contractors. Medicaid reimbursement will be equal to or less than the amount of Medicare reimbursement.

For reimbursement amounts for tests performed by Eurofins Viracor, please refer to the Medicare Clinical Laboratory Fee Schedule.

Medicare Coverage Database: Click Here

The Medicare Clinical Laboratory Fee Schedule: Click Here

5. Clients may contact Eurofins Viracor's Clinical Laboratory Director for information or questions about testing.

The Clinical Laboratory Director is Brock Neil who can be reached at Brock.Neil@viracor.eurofinsus.com or by calling client services at 1-800-305-5198.

6. The American Medical Association CPT codes published on Eurofins Viracor's Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually. CPT codes are provided only as guidance to assist clients with billing.  We strongly recommend that clients confirm CPT codes with their Medicare administrative contractor, as requirements may differ.  CPT coding is the sole responsibility of the billing party, and Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes published.

NOTICE OF PRIVACY PRACTICES for CALIFORNIA RESIDENTS\n

Effective Date: February 22, 2022

This Privacy Notice for California Residents supplements the information contained in Eurofins Viracor Notice of Privacy Practices and applies solely to all visitors, users, and others who reside in the State of California (\"consumers\" or \"you\"). We adopt this notice to comply with the California Consumer Privacy Act of 2018 (CCPA) and any terms defined in the CCPA have the same meaning when used in this Notice.

This Notice does not apply to employment-related personal information collected from California-based employees, job applicants, contractors, or similar individuals

Where noted in this Notice, the CCPA temporarily exempts personal information reflecting a written or verbal business-to-business communication (\"B2B personal information\") from some its requirements.

Information We Collect

We collect information that identifies, relates to, describes, references, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular consumer, household, or device (\"personal information\"). Personal information does not include:

• Publicly available information from government records.

• Deidentified or aggregated consumer information.

• Information excluded from the CCPA's scope, like:

• health or medical information covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Confidentiality of Medical Information Act (CMIA) or clinical trial data;

• personal information covered by certain sector-specific privacy laws, including the Fair Credit Reporting Act (FCRA), the Gramm-Leach-Bliley Act (GLBA) or California Financial Information Privacy Act (FIPA), and the Driver's Privacy Protection Act of 1994.

In particular, we have collected the following categories of personal information from its consumers within the last twelve (12) months:

We obtain the categories of personal information listed above from the following categories of sources:

• Directly from you. For example, from forms you complete or products and services you purchase.

• Indirectly from you. For example, from observing your actions on the Website.

Use of Personal Information

We may use or disclose the personal information we collect for one or more of the following purposes:

• To fulfill or meet the reason you provided the information. For example, if you share your name and contact information to request a price quote or ask a question about our products or services, we will use that personal information to respond to your inquiry. If you provide your personal information to purchase a product or service, we will use that information to process your payment and facilitate delivery. We may also save your information to facilitate new product orders or process returns.

• To provide, support, personalize, and develop the Website, products, and services.

• To create, maintain, customize, and secure your account with us.

• To process your requests, purchases, transactions, and payments and prevent transactional fraud.

• To provide you with support and to respond to your inquiries, including to investigate and address your concerns and monitor and improve our responses.

• To personalize the Website experience and to deliver content and product and service offerings relevant to your interests, including targeted offers and ads through our and/or affiliates’ websites (with your consent, where required by law).

• To help maintain the safety, security, and integrity of the Website, products and services, databases and other technology assets, and business.

• For testing, research, analysis, and product development, including to develop and improve the Website, products, and services.

• To respond to law enforcement requests and as required by applicable law, court order, or governmental regulations.

• As described to you when collecting your personal information or as otherwise set forth in the CCPA.

• To evaluate or conduct a merger, divestiture, restructuring, reorganization, dissolution, or other sale or transfer of some or all of our assets, whether as a going concern or as part of bankruptcy, liquidation, or similar proceeding, in which personal information held by us about the Website users is among the assets transferred.

We will not collect additional categories of personal information or use the personal information we collected for materially different, unrelated, or incompatible purposes without providing you notice.

Sharing Personal Information

We may disclose your personal information to a third party for a business purpose. When we disclose personal information for a business purpose, we enter a contract that describes the purpose and requires the recipient to both keep that personal information confidential and not use it for any purpose except performing the contract. We share your personal information with the following categories of third parties:

• Service providers.

• Data aggregators.

Disclosures of Personal Information for a Business Purpose

In the preceding twelve (12) months, Company has disclosed personal information for a business purpose with the following categories of third parties:

• Service providers.

• Data aggregators.

Sales of Personal Information

In the preceding twelve (12) months, Company has not sold personal information. We will not sell your personal information in the future.

Your Rights and Choices

The CCPA provides consumers (California residents) with specific rights regarding their personal information. This section describes your CCPA rights and explains how to exercise those rights.

Access to Specific Information and Data Portability Rights

You have the right to request that we disclose certain information to you about our collection and use of your personal information over the past 12 months. Once we receive and confirm your verifiable consumer request (see Exercising Access, Data Portability, and Deletion Rights), we will disclose to you:

• The categories of personal information we collected about you.

• The categories of sources for the personal information we collected about you.

• Our business or commercial purpose for collecting or selling that personal information.

• The categories of third parties with whom we share that personal information.

• The specific pieces of personal information we collected about you (also called a data portability request).

• If we sold or disclosed your personal information for a business purpose, two separate lists disclosing:\n
  
  • sales, identifying the personal information categories that each category of recipient purchased; and
  
  
  • disclosures for a business purpose, identifying the personal information categories that each category of recipient obtained.

We do not provide these access and data portability rights for B2B personal information.

Deletion Request Rights

You have the right to request that we delete any of your personal information that we collected from you and retained, subject to certain exceptions. Once we receive and confirm your verifiable consumer request (see Exercising Access, Data Portability, and Deletion Rights), we will delete (and direct our service providers to delete) your personal information from our records, unless an exception applies.

We may deny your deletion request if retaining the information is necessary for us or our service provider(s) to:

1. Complete the transaction for which we collected the personal information, provide a good or service that you requested, take actions reasonably anticipated within the context of our ongoing business relationship with you, fulfill the terms of a written warranty or product recall conducted in accordance with federal law, or otherwise perform our contract with you.

1. Detect security incidents, protect against malicious, deceptive, fraudulent, or illegal activity, or prosecute those responsible for such activities.

1. Debug products to identify and repair errors that impair existing intended functionality.

1. Exercise free speech, ensure the right of another consumer to exercise their free speech rights, or exercise another right provided for by law.

1. Comply with the California Electronic Communications Privacy Act (Cal. Penal Code §1546 et. seq.).

1. Engage in public or peer-reviewed scientific, historical, or statistical research in the public interest that adheres to all other applicable ethics and privacy laws, when the information's deletion may likely render impossible or seriously impair the research's achievement, if you previously provided informed consent.

1. Enable solely internal uses that are reasonably aligned with consumer expectations based on your relationship with us.

1. Comply with a legal obligation.

1. Make other internal and lawful uses of that information that are compatible with the context in which you provided it.

We do not provide these deletion rights for B2B personal information.

Exercising Access, Data Portability, and Deletion Rights

To exercise the access, data portability, and deletion rights described above, please submit a verifiable consumer request to us by either:

• Calling us at (800-305-5198).

• Emailing us at PrivacyOfficer@viracor.eurofinsus.com

Only you, or someone legally authorized to act on your behalf, may make a verifiable consumer request related to your personal information. You may also make a verifiable consumer request on behalf of your minor child.

You may only make a verifiable consumer request for access or data portability twice within a 12-month period. The verifiable consumer request must:

• Provide sufficient information that allows us to reasonably verify you are the person about whom we collected personal information or an authorized representative.

• Describe your request with sufficient detail that allows us to properly understand, evaluate, and respond to it.

We cannot respond to your request or provide you with personal information if we cannot verify your identity or authority to make the request and confirm the personal information relates to you.

Making a verifiable consumer request does not require you to create an account with us. We will only use personal information provided in a verifiable consumer request to verify the requestor's identity or authority to make the request.

Response Timing and Format

We endeavor to respond to a verifiable consumer request within forty-five (45) days of its receipt. If we require more time (up to 45 days), we will inform you of the reason and extension period in writing.

If you have an account with us, we will deliver our written response to that account. If you do not have an account with us, we will deliver our written response by mail or electronically, at your option.

Any disclosures we provide will only cover the 12-month period preceding the verifiable consumer request's receipt. The response we provide will also explain the reasons we cannot comply with a request, if applicable. For data portability requests, we will select a format to provide your personal information that is readily useable and should allow you to transmit the information from one entity to another entity without hindrance.

We do not charge a fee to process or respond to your verifiable consumer request unless it is excessive, repetitive, or manifestly unfounded. If we determine that the request warrants a fee, we will tell you why we made that decision and provide you with a cost estimate before completing your request.

Personal Information Sales

We do not sell the personal information of consumers.

Non-Discrimination

We will not discriminate against you for exercising any of your CCPA rights. Unless permitted by the CCPA, we will not:

• Deny you goods or services.

• Charge you different prices or rates for goods or services, including through granting discounts or other benefits, or imposing penalties.

• Provide you a different level or quality of goods or services.

• Suggest that you may receive a different price or rate for goods or services or a different level or quality of goods or services.

Changes to Our Privacy Notice

We reserve the right to amend this privacy notice at our discretion and at any time. When we make changes to this privacy notice, we will post the updated notice on the Website and update the notice's effective date. Your continued use of the Website following the posting of changes constitutes your acceptance of such changes.

Contact Information

If you have any questions or comments about this notice, the ways in which Clinical Enterprise collects and uses your information described here and in the Privacy Policy your choices and rights regarding such use, or wish to exercise your rights under California law, please do not hesitate to contact us at:

Phone: (800) 305-5198

Website: www.eurofins-viracor.com

Email: PrivacyOfficer@viracor.eurofinsus.com