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
Licenses & Certificates
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.
Lab Bldg 951 California Clinical Laboratory License COS-90002245
Lab Bldg 1001 California Clinical Laboratory License CDS-00800151
Lab Bldg 1001 Clinical Laboratory Improvement Amendments (CLIA) Certificate of Accreditation 26D0983643
Lab Bldg 951 Clinical Laboratory Improvement Amendments (CLIA) Certificate of Accreditation 26D2189478
College of American Pathologists (CAP) 7179041
Maryland Medical Laboratory Permit 1118
New York Clinical Laboratory Permit PF18091
Pennsylvania Clinical Laboratory Permit 028753A
Lab Bldg 1001 Rhode Island Clinical Laboratory License LCO00595
Lab Bldg 951 Rhode Island Clinical Laboratory License LCO01401
Eurofins Viracor is committed to compliance with the Health Insurance Portability and Accountability Act (HIPAA) Standards. Viracor Eurofins 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.
Attn: Privacy Officer
1001 NW Technology Drive
Lee's Summit, MO 64086
Notice of Privacy Practices
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 Viracor Eurofins 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@Eurofins-Viracor.com ; or send a written request to Viracor Eurofins, Attn: Privacy Officer, 1001 NW Technology Drive, Lee’s Summit, Missouri, 64086.
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@Eurofins-Viracor.com; or send a written request to Eurofins Viracor, Attn: Privacy Officer, 1001 NW Technology Drive, Lee’s Summit, Missouri, 64086.
- 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@Eurofins-Viracor.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@Eurofins-Viracor.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:
Attn: Client Services
1001 NW Technology Drive
Lee’s Summit, Missouri 64086
- 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@Eurofins-Viracor.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@Eurofins-Viracor.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 https://www.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@Eurofins-Viracor.com; or send a request to Eurofins Viracor, Attn: Privacy Officer; 1001 NW Technology Drive, Lee’s Summit, MO 64086.
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@Eurofins-Viracor.com; or send a complaint to Viracor Eurofins, Attn: Privacy Officer; 1001 NW Technology Drive, Lee’s Summit, MO 64086. Eurofins Viracor will not retaliate against anyone filing a complaint.
Notice to Test Orderers
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:
The Medicare Clinical Laboratory Fee Schedule:
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 BrockNeil@Eurofins-Viracor.com or by calling client services at 1-800-305-5198.
6. The American Medical Association CPT codes published on Viracor Eurofins 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.