Donor hemovigilance: safety as the first priority of blood donor management

Background  The American Red Cross instituted a donor hemovigilance program (HVP) in its 35 regional blood centres in 2003 to document adverse events occurring at the time of donation or reported later. The aims are to describe and quantitate rare events using standard definitions, define risk factors, design specific interventions and to assess outcomes. In the 1990s, most US blood centres converted to 500 ml whole blood (WB) collection bags to maximize blood collection. The AABB (formerly known as the American Association of Blood Banks) instituted a standard (#5.4.1.A) to permit a maximum blood loss of 10·5 ml/kg and minimum donor weight of 50 kg (110 lb), allowing 525 ml of blood to be removed from the smallest donors. In the last decade, the majority of States have enacted legislation to allow 16‐year‐old donors to donate with parental consent. Methods  Standardized adverse event definitions and reporting were instituted in 2003, and adverse event data were collated and analysed at the National Medical Office. Standard database and statistical analytical methods were utilized. Estimated blood volume was calculated based on height, weight and gender, using the method of Nadler et al. Surgery 1962; 51:224–231. Results  Analysis of HVP data from 2002 to 2006 highlighted that young, first time, female donors were at risk for vasovagal reactions, injuries related to falls and the need for outside medical care. Multivariate analysis revealed young age, low estimated blood volume (<3·5 l) (EBV) and first‐time donation status as major independent risk factors. Calculation of EBV revealed that current AABB standards allow, and CFR limits do not prevent, 15–20% blood loss of EBV from short, low‐weight female donors. Interventions to reduce vasovagal reactions were piloted, starting in 2008, including: (i) a controlled environment through standardized work guidance, physical setup and staffing matrices; (ii) improved donor and parent educational material prior to donation; (iii) enhanced donor monitoring post donation; (iv) fluid intake encouraged within 30 minutes of donation; (v) distraction and muscle tension techniques; (vi) use of apheresis double red cell collection in eligible donors; (vii) enhanced post donation instructions to donors and patients; (viii) implementation of selective height and weight restrictions in donors <19 years old to avoid collection from donors with EBV <3·5 l. Conclusions  A national HVP has highlighted the issue of vasovagal syncope‐like reactions in young first‐time donors with low EBV leading to multiple interventions designed to reduce risk. Outcomes are being assessed and monitored. Current AABB standards do not adequately protect young donors with low height/weight from excess blood loss in the United States.