FDA EIR - Rocky Mountain Lions Eye Bank - September 27, 2024

An FDA inspection of Rocky Mountain Lions Eye Bank (RMLEB) in Aurora, CO, occurred from September 23-27, 2024, to assess its compliance with regulations for human tissue products, specifically Good Tissue Practices. John B. Lohmeier, Executive Director, was identified as the most responsible person for overall operations and compliance. The inspection identified several issues. A primary concern was the lack of established training requirements for both Medical Directors and Infectious Disease Consultants regarding their essential roles in donor screening and determining eligibility for relevant communicable diseases. Deficiencies were also noted in donor screening protocols. For sepsis, the firm's assessment only considered clinical signs within a narrow timeframe prior to death and did not fully evaluate all available clinical data. Additionally, recent internal updates to sepsis consultation procedures, intended to ensure all medical records are provided to consultants, had not been consistently implemented. The eye bank also lacked records for West Nile Virus follow-up worksheets for 2023 and 2024. Furthermore, for Zika Virus screening, the firm did not utilize the recommended addendum for eye-only donors, failed to routinely collect six months of hospital records as an alternative, and its internal screening steps were not formalized in approved written procedures. These findings highlight the need for RMLEB to strengthen its quality management system, particularly in personnel training, comprehensive donor risk assessment, and ensuring adherence to established and updated screening protocols, to meet FDA regulatory requirements, including 21 CFR 1271.50 and 1271.265.