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Reporting of Serious Adverse Events and Reactions RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey SAE - DEFINITION any undesired and unexpected occurrence associated with any stage of the chain from donation to

  1. Reporting of Serious Adverse Events and Reactions RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

  2. SAE - DEFINITION ‘any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity’. RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

  3. SAR - DEFINITION ‘an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity’. RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

  4. HTA SAE/SAR GUIDANCE • http://www.hta.gov.uk/_db/_documents/Gui dance_-_SAEARs.pdf • http://www.organdonation.nhs.uk/useful_lin ks/categories/incident_reporting.asp RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

  5. REPORTING INCIDENTS • Urgent incidents must initially be reported to duty office for immediate corrective action • All incidents, including SAE/SARs, reported via NHSBT on-line portal • Automated response with occurrence number • Aim to close incidents within 90 days RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

  6. REPORTING TIMEFRAMES • Licensed establishments must report SAE/SARs to NHSBT within 24 hrs of identification • NHSBT must report SAE/SARs to HTA the next working day RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

  7. SAE/SAR INVESTIGATION • Incident investigation managed through ODT Clinical Governance processes • HTA may oversee investigation where NHSBT involved in incident RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

  8. SAE/SARS SAE/SARs reported 27/8/12 – 31/12/12: • SAEs = 2 • SARs = 4 RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

  9. SAEs Examples • Kidney retrieval damage – kidney deemed un-transplantable • Malfunction of perfusion machine resulting in loss of donor lungs RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

  10. SARs Example • Donor transmitted CMV in recipient • Kidney retrieval damage – resulting in intra and post operative complications RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

  11. Conclusion • ODT confirm SAE/SAR prior to reporting to HTA, where possible • Timely reporting of SAE/SARs • Conclude investigation within 90 days RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013 Sue Falvey

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