Donor eligibility determination has historically been one of the areas in the tissue industry to receive the most scrutiny by the FDA. There is a significant amount of data that can be difficult to collect and many changing variables that go into the decision making process that ultimately determine the acceptance of a donor. Incorrect donor eligibility determinations can result in tremendous liability risk and loss of revenue.
Reglera and ReproTech have teamed together to develop the first of its kind, automated web accessible system to assist in the donor eligibility determination process. This system is specifically designed to provide tissue organizations with the ability to fully automate the donor eligibility process in a way that is not only compliant with FDA 21 CFR 1271, but also speeds up eligibility determination and saves money.
The system takes input from numerous sources and manages the following areas:
Screening: An electronic questionnaire is built in the system to comply with FDA screening requirements. Companies with supplementary requirements for donor eligibility can add in customized questionnaires. The donor logs into the system and answers appropriate questions based on the donated tissue.
Testing: Appropriate testing panel results can be automatically fed (with Laboratory participation) or manually input into the system by appropriate personnel.
Physical Exam: Results are input into the system either during the exam or at the conclusion by appropriate personnel. Additional questions can be added as the client sees fit. Any additional medical records can be uploaded as an attachment to the donor file.
Relevant Medical History and Records: These data elements can be added to the file as attachments in their native document type or scanned to the system and added to the medical record. This information could include any and all relevant information about the donor to include medical history, autopsy report for non-living donors and genetics information for living donors.
Based on inputs at each step of the donor eligibility process, the system utilizes validated smart logic to automatically identify high risk areas and non compliances in the donor information, and helps you make the correct eligibility determination. Based on this determination, a compliant summary of records is created according to the requirements of 21 CFR 1271.55(b).
Built to support geographically diverse organizations through our web portal, the status of your donors can be easily monitored from any web enabled computer, and the system supports remote electronic approvals compliant with 21 CFR Part 11.
If you are looking for a way to reduce your regulatory risk and speed up your eligibility process, we welcome the opportunity to provide you a system demonstration.
