Reporting of Serious Adverse Events and Reactions RENAL - - PowerPoint PPT Presentation

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Reporting of Serious Adverse Events and Reactions RENAL - - PowerPoint PPT Presentation

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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

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RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013

Sue Falvey

Reporting

  • f

Serious Adverse Events and Reactions

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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 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’.

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RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013

Sue Falvey

SAR - DEFINITION

‘an unintended response, including a communicable disease, in the living donor

  • r 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,

  • r prolongs, hospitalisation or morbidity’.
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RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013

Sue Falvey

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

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RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013

Sue Falvey

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
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RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013

Sue Falvey

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

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RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013

Sue Falvey

SAE/SAR INVESTIGATION

  • Incident investigation managed through

ODT Clinical Governance processes

  • HTA may oversee investigation where

NHSBT involved in incident

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RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013

Sue Falvey

SAE/SARS

SAE/SARs reported 27/8/12 – 31/12/12:

  • SAEs = 2
  • SARs = 4
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RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013

Sue Falvey

SAEs Examples

  • Kidney retrieval damage – kidney deemed

un-transplantable

  • Malfunction of perfusion machine resulting

in loss of donor lungs

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RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013

Sue Falvey

SARs Example

  • Donor transmitted CMV in recipient
  • Kidney retrieval damage – resulting in intra

and post operative complications

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RENAL TRANSPLANT SERVICES MEETING (RTSM) JANUARY 2013

Sue Falvey

Conclusion

  • ODT confirm SAE/SAR prior to reporting to

HTA, where possible

  • Timely reporting of SAE/SARs
  • Conclude investigation within 90 days