Donor Eligibility System

The Donor Eligibility System is an automated, web-accessible platform designed to streamline the donor eligibility determination process for tissue organizations. It ensures compliance with FDA 21 CFR 1271, accelerates eligibility decisions, reduces costs, and allows clinicians to focus more on patient care.

Key benefits include a 40% reduction in time spent managing donor eligibility data and a 60% average reduction in costs compared to proprietary solutions. The system has supported over 120 successful FDA inspections and has been operational for 15 years, providing reliable client support.

Donor eligibility determination is a critical area in the tissue industry, often scrutinized by the FDA due to the complexity and variability of data involved. Incorrect determinations can lead to significant liability risks and revenue loss. The system integrates data from multiple sources, using validated logic to identify high-risk areas and non-compliance, ensuring accurate eligibility determinations. It generates compliant summaries of records per 21 CFR 1271.55(b).

Key Features

• Easy-to-use customer interface and comprehensive dashboard for tracking donors.
• Customizable questionnaires for donors before clinic appointments.
• Configurable workflows that align with individual processes.
• Management of donor records across multiple locations.
• Seamless updates and software validation reflecting FDA regulatory changes.

The system is cloud-based, requiring zero capital cost, and operates on a subscription model, eliminating the need for software purchases. It includes support from experienced IT administrators, quality assurance, and ongoing software validation compliant with 21 CFR Part 11.

Clinics benefit from automated workflows that ensure all required steps are completed, reducing errors. The system offers peace of mind by constantly updating to reflect FDA regulatory changes, allowing clinics to focus on patient care. Implementation is efficient, with minimal operational impact and training included, often completed in four weeks or less.

With permission-based control, users can access records based on their roles, ensuring HIPAA compliance. The system provides full access to surveys, questionnaires, and records from any location with internet connectivity, removing the need for manual document management.