Legal & Compliance
A Montana CLIA Lab
We are an accredited Clinical Laboratory Improvement Amendments (CLIA) licensed laboratory specializing in high-complexity diagnostic testing. We are committed to providing complete transparency in our compliance with relevant CLIA laws and regulations as determined by the FDA and related federal organizations. Learn more about our Compliance Committee and company policies below.
We have developed and implemented extensive internal guidelines to prevent, detect, and remediate violations of law, regulations, and company policies. We hold ourselves accountable and uphold the belief in doing good in everything we do.
We hold ourselves accountable and uphold our belief in doing good in everything we do. We are proud to offer complete transparency and total compliance across federal laws and regulations. We have developed and implemented extensive internal guidelines to prevent, detect, and remediate violations of law, regulations, and company policies.
FYR Diagnostics uses a Learning Management System (LMS) to train its team members, track certificates of completion, and schedule recurring training. FYR is committed to ensuring all team members have had proper training. A few examples of internal training include:
- Bloodborne Pathogen (BBP) for Healthcare Professionals
- Fair Labor Standards Act (FLSA)
- Health Insurance Portability & Accountability Act (HIPAA)
- Code of Conduct Essentials
- HR Compliance Essentials
- Information security
- Sexual Harassment Prevention
- Americans with Disabilities Act
FYR is committed to protecting the privacy of your protected health information or “PHI” in accordance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), its implementing regulations, and other applicable laws and regulations governing your PHI.
- Active CLIA Certification
- CLIA Number: 27D2190551
- Passed 2021 CLIA Inspection (May 4, 2021)
- Recurring Trainings for Clinical Lab Team Members provided through Learning Management System (LMS)
- Internal Documentation
- Compliance Handbook
- HIPAA Security and Privacy Documentation
- Virtual security measures in place, including safeguards for managing financial transactions
- Various unique physical security measures implemented on-premises
Other Links & Documentation
- Website Disclaimer
- Privacy Notice
- NIH Financial Conflict of Interest (FCOI)
- Other internal documentation
- Employee Handbook
- Board Meeting Compliance and Management Platform
- Labor tracking and management platform with approvals
Our Compliance Committee
We have instituted a five-member Compliance Committee to review company policies and to make changes as necessary to maintain compliance with applicable laws and regulations. The Compliance Committee is comprised of individuals with diverse backgrounds and roles within FYR. The Compliance Committee actively monitors compliance infractions. Please contact us to report any potential problems, or concerns, or to send questions to our compliance committee. The Compliance Committee reports directly to the FYR Board of Directors.
Please note, Grant Principal Investigators / Project Directors (PI/PDs) of FYR Diagnostics are not a part of the Compliance Committee. In the event a Compliance Committee member becomes a PI/PD on a grant, that individual will be removed from the Compliance Committee and replaced with another FYR team member.
Committed to Compliance
Brian Conway, MBA
Lead Compliance Officer
Brian is responsible for compliance of policies, and procedures, maintenance of records, monitoring adherence to the rules for the preservation of sensitive information, monitoring of changes in applicable laws and regulations, and the implementation of these regulations under the overall supervision of the Board of Directors of the Company.
Claire Seibold, MA
Claire oversees the development, implementation, maintenance, and adherence to privacy policies and procedures regarding the safe use and handling of protected health information (PHI) in compliance with federal and state HIPAA regulations.
Lara Taubner, Ph.D.