National Online Heamovigilance Reporting System

Tender description

The Irish Blood Transfusion Service (IBTS) requirements for the tendering of a National Online Haemovigilance Management system. Haemovigilance is the process of monitoring the safety of blood and blood components from collection of the pre-transfusion sample to completion of the transfusion process. This system will be used to capture, collate, review, analyse and trend adverse events as reported by establishments, such as hospitals. The National Haemovigilance Office (NHO) was set up in 1999 by the Department of Health to operate a National Haemovigilance System. This service is staffed and administered by the IBTS. The NHO organise and administer a haemovigilance service for obtaining and assessing reports of unexpected or undesirable effects of transfusion of blood and blood components. Reporting establishments are legally obliged by legislation to notify the NHO of such reports. The Health Products Regulatory Authority (HPRA) has been designated as the Competent Authority for the purposes of the Blood Directive7.1 and related legislation7.2 and works closely with the NHO in this regard. The arrangements between the HPRA and NHO of the IBTS are set out in a memorandum of understanding and a technical protocol. In summary, the NHO collate, review, analyse and trend all reports received from reporting establishment. The NHO provide the HPRA support with the publication of an annual report to the European Commission as set out by EU Directive 2005/61/EC7.2. The HPRA maintains oversight of reports assessed by the NHO that are within scope of the EU Blood Directive, through quarterly reports and weekly submissions as well as through ANSARE submission7.1