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Introduction to Panel Discussion Risk Assessment and Transplantation Guidelines

Introduction to Panel Discussion Risk Assessment and Transplantation Guidelines. Dr Cristina Baleriola BBV Laboratory Manager SEALS Prince of Wales Hospital. The Whole Picture. One person dies in the next year each time we miss two organ donors (Jeremy Chapman).

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Introduction to Panel Discussion Risk Assessment and Transplantation Guidelines

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  1. Introduction to Panel DiscussionRisk Assessment and Transplantation Guidelines Dr Cristina Baleriola BBV Laboratory Manager SEALS Prince of Wales Hospital

  2. The Whole Picture • One person dies in the next year each time we miss two organ donors (Jeremy Chapman). • Recognition of special risks for infectious complications will help to guide preventive, diagnostic and therapeutic steps in the control of donor-derived complications in individual patients. • The acceptability of risks for infectious complications depends also on the urgency of transplantation of a vital organ as well as the availability of organs.

  3. What are the key questions? • Do we know how often do clinically significant infections result from transmission of donor-derived pathogens in Australia?We do not know how often transmission occurs, with or without clinical signs.

  4. What are the key questions? • Which pathogens are important? • How good are the current approaches for screening of organ donors? • How can these be improved? • Bigger list? (more pathogens) • Better assays? (molecular vs. serologic) • Better communication of positive results? (Bio-Vigilance) • More flexibility? • New pathogens (outbreaks, H1N1) • Regional variability (endemic pathogens) • Donor epidemiologic history (travel, immigration)

  5. Current Guidelines for Donor Screening (TSANZ) • Lack of consistency in the formulation of testing guidelines between organs and in some organs virological donor screening is not mentioned at all. • Current guidelines do not define the tests to be performed for each virus. • Current guidelines do not formulate the interpretation of results or clinical interventions, based on evidence. • Apart from HIV, HCV and HBV, testing protocols for important agents which cause disease in large numbers of organ recipients, particularly CMV (IgG/IgM) and EBV are not defined.

  6. There is a marked organ shortage • Organs must be used in 4-24 hours after procurement . • Testing/screening must be available 24/7/365 • It requires highly specialized molecular laboratories • Need to close the “window period” of serologic testing and have the flexibility to provide assays for emerging pathogens and outbreaks (e.g., H1N1). • We cannot waste organs due to false (+) assays

  7. Window Period (WD) • WP is defined as the length of time after infection that it takes for a person to develop specific antibodies to be detected by current testing methods. • The infectious phase of window period has high risk (>90% of risk). • The risk of acquiring an organ-transmitted viral infection depends not only on the length of specific window period but also on the incidence of the infection (much higher in high-risk donors).

  8. Risk Assessment • What frequency of disease in the community or donor pool justifies testing? • Should data be collected from organ donors or general population? • What is the risk of infection transmission? • Is the infection organ specific? • Is the infection treatable/untreatable? • Do we have available testing platforms? • What is the incidence of false positives vs. false negatives in the testing population? • Should testing be prospective or retrospective?

  9. Risk Assessment • Why are bloods and tissues tested more rigorously than organs? Should the TGA regulate and certify all testing? • Do we want to test based on country of origin? Known risk factors? • What needs to be communicated from the NSW OTDS to clinical centers? And how?

  10. New Testing Algorithms • New pathogens can be detected using molecular and immunological techniques. • Sensitivity/specificity/availability not yet adequate for routine screening • Need assays designed for organ donors. • Development of list for testing must include consideration of the nature and severity of the disease and implications for therapy

  11. Bio-Vigilance • Need transparency of reporting to achieve safety for our patients. • Development of a secure internet based system that generates unique donor and tissue identifiers that can electronically track any tissue from donor to recipient • A system to track the final disposition of tissues including allograft description, surgeon, site/institution, tissue bank and recipient identifiers

  12. Bio-Vigilance . • A notification system for adverse events allowing clinical personnel to input patient and tissue identifiers, clinical institution, date, contact information and nature of the clinical event. • Notification of appropriate public health and tissue procurement authorities, other health professionals and patients. • Linkage of the data with existing databases, and stored specimens for later testing as appropriate.

  13. Welcome to our Panel Members • Professor Jeremy Chapman • Professor Michael Ison • Professor William Rawlinson • Dr Jonathan Gillis • Dr Patrick Coghlan • Dr Deepak Bhonagiri

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