Compliance Overview

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.

Compliance Committee

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.

Our Compliance

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.

Compliance Areas

Internal Operations

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

Clinical Operations

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

Security Safeguards

Virtual security measures in place, including safeguards for managing financial transactions
Various unique physical security measures implemented on-premises

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

Security Officer

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.

David Booth

Member

Lara Taubner, Ph.D.

Member

Legal & Compliance