Compliance

Background

FYR Diagnostics is committed to being in compliance with relevant laws and regulations. FYR's team has developed and implemented extensive internal guidelines to prevent, detect, and remediate violations of law, regulations, and company policies.

The FYR Diagnostics’ Compliance Program, implemented and monitored by the FYR Compliance Committee, is intended to promote a culture of quality and transparency and the prevention of improper financial incentives and transactions, actual or apparent conflicts of interest, and to ensure FYR Diagnostics’ business practices comply with applicable laws and regulations.

FYR's Compliance Committee

FYR has 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 . Please use this email 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.

Grant Principal Investigators / Project Directors (PI/PD's) 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.

Brian Conway, MBA
Brian Conway, MBALead Compliance Officer
Brian is responsible for compliance of policies, 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 Seibold, MAPrivacy and 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 regulation.

David Booth
Member

Vikas Ghai

Vik Ghai, PhD
Member

Aurora Krebs
Member

Links, Documents and More

Internal Operations

  • FYR Diagnostics uses a Learning Management System (LMS) to train its team members, track certificates of completion, and schedule recurring trainings. FYR is committed to ensuring all team members have had proper training. A few examples of internal trainings 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

Security Safeguards

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

Clinical Operations

  • Notice of Privacy Practices
    • 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)
  • College of American Pathologists (CAP) Proficient
  • Recurring Trainings for Clinical Lab Team Members, both hand-on and trainings provided through Learning Management System (LMS)

Other