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EU ORGAN DIRECTIVE

EU ORGAN DIRECTIVE. Reporting SAEs and SARs to NHSBT. INCIDENT REPORTING. Single portal for reporting Visibility of all incidents Mandatory requirement to report SAEARs Analysis, trending etc. Reporting SAEARs. NHSBT web based incident reporting system

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EU ORGAN DIRECTIVE

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  1. EU ORGAN DIRECTIVE Reporting SAEs and SARs to NHSBT

  2. INCIDENT REPORTING • Single portal for reporting • Visibility of all incidents • Mandatory requirement to report SAEARs • Analysis, trending etc

  3. Reporting SAEARs • NHSBT web based incident reporting system • Mandatory time frame for reporting SAEARs • NHSBT responsible for onward reporting to HTA on behalf of reporter

  4. INVESTIGATION OF SAEARs • NHSBT will lead/facilitate investigation on behalf of HTA • Incident investigation should conclude within set timeframe • Incident not formally closed until all actions complete • HTA must agree incident can be closed

  5. INVESTIGATION OF SAEARs Governance Assurance: • HTA member of ODT CGMG • HTA will advise on investigation of SAEARs involving NHSBT • SAEARs monitoring reports to HTA

  6. INCIDENT REPORTING • IT system being sourced • Framework tender process on-going • Need for user engagement in development of reporting tool • External access for reporting purposes only • EUODD requirement to publish SAEARs Annual Report

  7. INCIDENT REPORTING Benefits: • All incidents reported to single organisation • Visibility of all incidents • IT System will enable robust monitoring of: activity, trends, enable detailed analysis, shared learning, benefits patients

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