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 

Maryland Medical Laboratory Permit 1118         

New York Clinical Laboratory Permit PFI 8091                

Pennsylvania Clinical Laboratory Permit 028753A    

Rhode Island Clinical Laboratory License LCO01563

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

NOTICE OF PRIVACY PRACTICES

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

COMMITMENT TO CONFIDENTIALITY

Eurofins Viracor is required by the Health Insurance Portability and Accountability Act of 1996 to maintain the privacy of your protected health information (PHI) and provide you with notice of our legal duties and privacy practices. Your PHI includes any information that identifies you and relates to your past, present or future health care or payment for your health care.  This notice describes how we may use or disclose your PHI to provide you with treatment, obtain payment for our services, operate our laboratory, and perform other activities. It also describes your privacy and access rights with respect to your PHI.

HOW EUROFINS VIRACOR MAY USE OR DISCLOSE YOUR PROTECTED HEALTH INFORMATION

The information below describes how Eurofins Viracor may use or disclose your protected health information.  If you have questions about any of the below uses and disclosures, contact our Privacy Officer at 1-800-305-5198.

• For Treatment.  We may use your PHI to provide you with clinical laboratory services.  For example, our laboratory scientists will use your PHI to perform the laboratory tests you requested. We may share your PHI with health care professionals involved in your medical care.  For example, we may share your test results with the physician who ordered your laboratory test.

• For Payment.  We may use and disclose your PHI in order to obtain payment for our laboratory services.  For example, we may share your PHI with your health plan in order to receive payment for performing a laboratory test.

• For Heath Care Operations.  We may use and disclose medical information about you to operate our laboratory and provide our services.  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.

• To Business Associates.  We may share your PHI with business associates who use PHI to perform certain functions or activities on our behalf.  For example, we may share your PHI with an outside billing company or collection agency who assists us in obtaining payment for our services. These business associates are required to maintain the privacy of your medical information.  As of February 17, 2010, business associates are also directly responsible for compliance with federal security standards and certain provisions of the federal privacy law, to further ensure the protection of your PHI.

• To Persons Involved In Your Care or Payment for Your Care.  Unless you object, we may disclose your PHI to people (such as a spouse, friend, or family member) who are involved in your care or payment for your care.

• As Required by Law.  We will disclose your PHI when required to do so by federal, state or local law.

• For Public Heath Activities.  When required by law, we may disclose your PHI to public health authorities so that they can perform certain public health activities, such as tracking the incidence of communicable diseases.

• For Abuse, Neglect & Domestic Violence.  If we have reason to believe that you are a victim of abuse, neglect, or domestic violence, we may disclose your PHI to the proper government authority.

• For Health Oversight Activities.  We may share your PHI with health oversight agencies that assure we are following certain laws in providing our services.  For example, we may share your PHI with Centers for Medicare & Medicaid Services when it is certifying our laboratory or making sure we were paid properly for our services.

• For Judicial and Administrative Proceedings.  We may disclose your PHI in response to a court or administrative order, or in response to a proper subpoena, discovery request, or other lawful process.

• For Law Enforcement Purposes.  We may disclose your PHI for law enforcement purposes such as reporting certain types of wounds, responding to a court order or other legal process, identifying or locating suspects, witnesses, and missing persons; identifying a victim of a crime, or responding to a suspicious death, suspected crime on our premises or certain other emergency situations.

• To Coroners, Medical Examiners and Funeral Directors. We may disclose PHI to a coroner, medical examiner or funeral director as may be necessary to identify a deceased person, determine the cause of death, or perform other legal duties.

• For Organ and Tissue Donation Purposes.  We may disclose PHI to organizations that engage in organ donation and transplantation activities.

• For Research Purposes.   We may use your PHI for research purposes if we have your permission, the information does not identify you, or an Independent Review Board finds that your permission is not necessary because certain other federally required protections have been met.

• To Avert A Serious Threat to Health or Safety.  We may disclose your PHI to certain persons in order to prevent a serious threat to the health and safety of yourself or others.

• For Specialized Government Functions.  We may disclose your PHI for specialized government functions, such as assisting in national security or protecting the President.  In certain situations, we may disclose the PHI of military personnel and veterans to military authorities and disclose the PHI of inmates to correctional institutions or law enforcement personnel.

• For Workers’ Compensation Purposes.  We may disclose your PHI for workers’ compensation purposes as appropriate under State workers’ compensation laws.

• Data Breach Notification.  We may use or disclose your PHI to provide legally-required notices of unauthorized access, acquisition or disclosure of your PHI.

OTHER USES AND DISCLOSURES OF YOUR PROTECTED HEALTH INFORMATION

• Before we use or disclose your PHI for any purpose other than those mentioned above, we will ask for your written authorization.  Certain federal and state laws may limit the information we are allowed to disclose under your authorization.  Uses and disclosures of your PHI for marketing require your authorization. You may revoke your authorization in writing at any time, except to the extent we have already relied upon it.

• To request an Authorization form, contact the Eurofins Viracor 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

YOUR RIGHTS REGARDING YOUR PROTECTED HEALTH INFORMATION

• Right To Receive a Copy of this Notice.  You have the right to receive a paper copy of this Notice even if you have already received it electronically.  To receive a paper copy of this Notice, contact the Eurofins Viracor 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.

• Right To Request Restrictions.  You have the right to request that we restrict how your PHI is used or disclosed.  For example, you may ask us not to share your PHI with a certain person or company.  We will carefully consider your request, however we have the right to deny your request.  We must agree to your request if the disclosure is to a health plan for purposes of payment or health care operations and the disclosure relates to a health care expense for which you have already paid.  If we agree to your request, we will honor it except when the PHI is needed to provide you with emergency treatment.  If you would like to request a restriction on how your PHI is used or disclosed, contact our Privacy Officer at 1-800-305-5198 or at PrivacyOfficer@viracor.eurofinsus.com.  The Privacy Officer will provide you with our Restriction Request form.

• Right To Request “Confidential Communications”.  You have the right to request that we contact you about your PHI at a specific address or in a specific time, place, or manner.  We will grant all reasonable requests.  If you would like to request a “confidential communication,” contact our Privacy Officer at 1-800-305-5198 or at PrivacyOfficer@viracor.eurofinsus.com. The Privacy Officer will provide you with our Confidential Communications Request form.

• Right To Access Your PHI.  You have the right to inspect and receive copies of PHI that we use to make decisions about your care and payment for your care, or to designate another person to receive a copy of your PHI.  As of February 17, 2010, you have the right to request an electronic copy of your PHI if it is maintained in an electronic health record (“EHR”).  All requests to inspect or receive copies must be written and sent to:

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

• Right To Amend Your PHI.  You have the right to request that we amend your PHI if you feel that it is inaccurate or incomplete.  In certain circumstances, we are not required to grant your request.  If we do not grant your request, we will provide you with the reasons why your request was denied.  If you would like to request that your information be amended, contact our Privacy Officer at 1-800-305-5198 or at PrivacyOfficer@viracor.eurofinsus.com. The Privacy Officer will provide you with our Amendment Request form.
• Right To an “Accounting of Disclosures”.  You have the right to receive a list of certain disclosures we have made of your protected health information.  This list will not include disclosures we have made for treatment, payment, or health care operations purposes, or certain other types of disclosures.  However, as of January 1, 2014, you will have the right to receive an accounting of all disclosures of your PHI made through an EHR.  Requests for an accounting of disclosures through an EHR will only go back for three years. To request an Accounting of Disclosures, contact our Privacy Officer at 1-800-305-5198 or at PrivacyOfficer@viracor.eurofinsus.com.  The Privacy Officer will provide you with our Request for Accounting of Disclosures form. 

REVISIONS TO THIS NOTICE

We reserve the right to change the terms of this Notice and the right to make the new notice provisions effective for all PHI we maintain, regardless of when it was created or received.  We will keep our current Notice posted on our website at Eurofins-Viracor.com, and we are required to follow the terms of the notice currently in effect.  If you would like a paper copy of a revised notice contact our Privacy Officer at 1-800-305-5198; email PrivacyOfficer@viracor.eurofinsus.com; or send a request to Eurofins Viracor, Attn: Privacy Officer; 18000 W 99th St., Ste.#10, Lenexa, KS 66219  

COMPLAINTS

If you believe your privacy rights have been violated, you may file a complaint with Eurofins Viracor or with the Secretary of the Department of Health and Human Services.  To file a complaint with Eurofins Viracor, contact our Privacy Officer at 1-800-305-5198; email PrivacyOfficer@viracor.eurofinsus.com; or send a complaint to Eurofins Viracor, Attn: Privacy Officer; 18000 W 99th St., Ste.#10, Lenexa, KS 66219. Eurofins Viracor will not retaliate against anyone filing a complaint.

NOTICE OF PRIVACY PRACTICES for CALIFORNIA RESIDENTS

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:
  • 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.
2. Detect security incidents, protect against malicious, deceptive, fraudulent, or illegal activity, or prosecute those responsible for such activities.
3. Debug products to identify and repair errors that impair existing intended functionality.
4. Exercise free speech, ensure the right of another consumer to exercise their free speech rights, or exercise another right provided for by law.
5. Comply with the California Electronic Communications Privacy Act (Cal. Penal Code §1546 et. seq.).
6. 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.
7. Enable solely internal uses that are reasonably aligned with consumer expectations based on your relationship with us.
8. Comply with a legal obligation.
9. 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

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.