The safety of COVID-19 convalescent plasma donation: A multi-institutional donor hemovigilance study.

BACKGROUND: Although the safety and therapeutic efficacy of COVID-19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi-institutional context. STUDY DESIGN AND METHODS: Nine blood collection organizations (BCOs) participated in a multi-institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity. RESULTS: The overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5-17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions. CONCLUSION: The safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.

A question of clarity: redesigning the American Association Of Blood Banks blood donor history questionnaire--a chronology and model for donor screening.

A new donor history questionnaire, introduced by the American Association of Blood Banks in 2004 and approved by Food and Drug Administration in 2006, is now in widespread use in the United States. The development of this questionnaire involved an in-depth look at the entire system of donor screening questions, and is notable for its use of survey design experts as well as blood banking experts, government agencies, and an ethicist who represented the public interest in developing the actual questions. The end result is a questionnaire that uses capture questions in a time bounded format, donor educational materials, and a medication deferral list. Detailed instructions for donor screeners include follow-up questions in easy-to-follow flow-charts. Most importantly, for the first time in the history of developing donor history questions, all materials were tested for donor comprehension using cognitive interview evaluation. This article discusses the development of the questionnaire, explains the methodology, and describes the thinking and rationale for decisions made during redesign of the questionnaire.