Introduction to Panel Discussion Risk Assessment and Transplantation Guidelines

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Introduction to Panel DiscussionRisk Assessment
and Transplantation Guidelines

• Dr Cristina Baleriola
• BBV Laboratory Manager
• SEALS
• Prince of Wales Hospital

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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.

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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.

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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)

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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.

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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

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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 (gt90 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).

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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?
•  

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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?

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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

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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

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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.

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Welcome to our Panel Members

• Professor Jeremy Chapman
• Professor Michael Ison
• Professor William Rawlinson
• Dr Jonathan Gillis
• Dr Patrick Coghlan
• Dr Deepak Bhonagiri