Development of biovigil ance in theUnitedStatesB．i．WhitakerAmericanAssociation ofBloodBanks，MDUSAAbstractBackgroundHemovigilance systems have been in existence for over10 years，a consequence of the transmission ofHIV through the blood supply and the recognition of the im— pact of other serious adverse events associated with transfusion on the safety of blood transfusion．Hemo— vigilance systems now have been implemented globally in most developed countries，with a few exceptions，to monitor the adverse events and incidents associated with blood donation and transfusion．‘Biovigilance’ broadens the scope beyond blood to incorporate monito— ring of adverse events associated with tissue，organs and cellular components．In the"USA，while numerous sep— arate programs existed to ensure biological safety，there was no comprehensixre natioualHemovigilance or broa— der biovigilanee system．Beginning with the promulga— tion of the teml‘bim’igilanee’．the framework for a national biovigilance program began．MethodsIn2006．theDepartment ofHealth andHumanServ- ices’AdvisoD"Committee onBloodSafety andAvaila— bility recommended the establishment of a national bio— vigilance program to collect，analyze．and report on medieal errors and adverse reactions occurring during blood donation and transfusion to identify interventions that can improve patient care and donor heahh．Also， in2006，theAABB established a111ultiorganizafional task force，made up of both public and private organiza· tions，to help build a biovigilance network with three separate components addressing safety for transfusion recipients，blood donors and orgaw／tissue．Develop— ment of these systems has been through various public— private partnerships with funding from both government and private sectors．TheTransfusionRecipientSystem(Hemovigilance)llas been a collaboration between theCorrespondence：Barbee1．Whitaker．PlI．D，Director．Data andSpecialProgramsAABB，8101GlenblookRoad，Bethesda．MD，USAE· mail：bwhitake,’@aabb．orgP一09文章编号：1004—549X(2010)10-0762-02Centers forDiseaseControl andPrevention(CDC)andAABB．developed as a module inCDC7 sNationalHeahhcareSafetyNetwork(NHSN1．The blood donorHemovigilance system is a collaborative effort with theDepartment ofHealth andHumanServices．Omee ofPublicHealth andSafety．andAABB member blood do— nor programs．Under a cooperative agreement with theCDC，theUnitedNetwork forOrganSharing and other partners are developing a system to increase recognltlon of adverse events associated with organ and tissues，theTransplantationTransmissionSentinelNetwork(‘IrrSN)．Results’rhese systems have many features in common．The public—private collaborations are unique and designed to fit theUS environment providing tools for the private sector for use in quality improvement，putting data in the hands of local quality staff．The systems are volun— tary．non．punitive and confidential in order to encour— age pamelpatmn，and are expected to generate aggre— gate data in order to prompt policy changes，standards and procedural interventions to improve patient safety and outcomes．However，each system is slightly differ— ent in configuration，source of development，intended outputs and implementation challenges．For example， for a sentinel network such asTrSN．the additional in— tention is to improve comnmnications between organ and tissue agencies and to notify heahhcare providers when there is a risk associated with8 particular donor．ConclusionsThese biovigilance initiatives are heing developed sire— ultaneously through a unique public··private partner·- ship．As of2010，only the‘FransfusionRecipientNH—SN module has been implemented．TheBloodDonorHemovigilaneeSystem is being piloted and prepared for implementation．The third system，the qTSN，under— went pilot testing in2008 and is currently under review by theCDC．Although global hemovigilance efforts are more advanced in comparison to theUSA，there is much potential for growth and learning asUS hemovigi—