6.2 Professional Associations

Much of the work relating to identification of adverse occurrences has been carried out through professional associations. For example, the World Marrow Donor Association (WMDA) is an organization, which fosters international collaboration to facilitate the exchange of high quality haematopoietic stem cells for clinical transplantation worldwide and to promote the interests of donors. Its Clinical Working Group not only produces guidelines, recommendations and standards involving clinical aspects related to the donation of bone marrow and peripheral blood stem cells (PBSC) but also maintains the adverse events registry, S (P)EAR - the central reporting system for adverse events in
unrelated donors. S(P)EAR is in fact comprised of two registries 1) SEAR - the serious events and adverse effects registry, and 2) SPEAR – the serious product events and adverse effects registry.

The SEAR registry compiles donor data related to: life-threatening disease, death, those who required in-patient hospitalization or considerable prolongation of existing hospitalization, and those who are facing persistent or significant disability / incapacity. It also compiles data on events related to an anaesthetic, cardiac complications, infective complications, mechanical injury, haemostasis and (late) malignancies / autoimmune complications.

The SPEAR registry compiles data covering impairment of the quality of the graft (clots), damage or loss of (part-of) the graft, infusion of the wrong product, serious transportation problems, serious unpredicted transmissible infection risk (e.g. hepatitis B), serious unpredicted non-infection transmissible risk (e.g. malignancy), and bacterial infection (only if the patient becomes unwell).

In the field of Cornea transplantation, the Eye Bank Association of America (EBAA) initiated an adverse reaction reporting system in 1990 and in 2004 the Online Adverse Reaction Reporting System (OARRS). With respect to eye bank adverse reaction reporting, the EBAA Medical Advisory Board requires that recipients be tracked and that they seek a 3 – 12 month follow-up. Reporting, which is part of the accreditation process, was redesigned in 2004 for online submission.

In the field of Tissue Banking, the American Association of Tissue Banks (AATB) has produced a Guidance Document that aims to educate end users/clinicians by providing them with direction on how to: define proper recognition of suspected allograft-caused adverse outcomes (reactions and graft failures); describe reporting responsibilities (communication); detail expectations of cooperation during investigation through closure; and promote the non-punitive concept. The document also gives tissue banks advice on how to; ensure compliance with their communication responsibilities; define their expectations for investigation protocols and timelines; develop outcome terms and definitions in coordination with EUSTITE; and list and describe international implications. Completion of the guidance document is anticipated in 2011 with consideration being given to a focus on V&S for tissue allograft types that pose the most risk. The document will be widely disseminated to all stakeholders in order to optimize recognition, reporting and investigation.