Creating a uniform donor medical history questionnaire

Area of Science:

• Transfusion Medicine
• Public Health
• Medical Device Development

Background:

• Blood Centers of California (BCC), a consortium of 19 blood centers, collects approximately 800,000 units of whole blood annually.
• Existing donor medical history questionnaires varied among member institutions.
• There was a need for a standardized approach to donor screening to meet regulatory requirements and address member concerns.

Purpose of the Study:

• To develop and implement a Uniform Donor Medical History Questionnaire (UDMHQ) for all BCC member blood centers.
• To ensure compliance with regulatory standards from the FDA, State of California, and American Association of Blood Banks.
• To enhance the quality and consistency of donor medical history collection.

Main Methods:

• A committee of medical and nursing directors from BCC member institutions was formed.
• The committee developed a 42-question UDMHQ.
• The questionnaire was designed to meet all relevant regulatory requirements and specific member needs.

Main Results:

• The UDMHQ was successfully developed and implemented across BCC member blood centers.
• Standardization of the donor medical history questionnaire led to an improvement in its content.
• Consistent messaging to donors and potential legal protection for blood centers were identified as potential, unproven benefits.

Conclusions:

• The implementation of a Uniform Donor Medical History Questionnaire significantly improved the content of donor medical histories.
• Standardization offers benefits beyond content improvement, including consistent donor communication and enhanced legal protection for blood centers.
• The UDMHQ serves as a model for standardized donor screening in transfusion medicine.