Issues and Difficulties in follow up of TTI Pos Donors

1
Ethical Issues
and
Difficulties
in follow up
of TTI Pos Donors
Zarin S Bharucha
2
Ethical Responsibility of BTS

• Human origin of blood and blood products - basis
  of ethical rules
• Code of Ethics formulated by ISBT adopted by
  WHO
• Donor safety care before, during after
  donation is the main ethical requirement
• Rules and regulations ensuring blood
• safety are guided by basic principles of
  ethics

3
Advent of AIDS other Emerging Infections

• Increased testing requirements
• Increased activity of information counseling
• Increased donor deferrals / discards
• Prior to this
• Upto 1972 only Syphilis
• After 1972 Hepatitis B
• After 1984 HIV / AIDS
• After 1992 Hepatitis C

4
Objectives of Donor counseling information

• To fulfill ethical requirement
• To protect health of donor
• To maintain safety of blood supply
• To monitor effectiveness of donor selection

5
Pre Donation Counseling

• Privacy / difficult in many settings
• Assists donor to decide whether to
• donate or not (self deferral)
• Reduces seroprev in donated units

6
Pre Donation Issue

• Acceptance of donors
• Donors eager to know test result
• Alternate testing sites - VCTCs to be widely
  available, publicised and should be free or
  affordable
• Donors do not want to know test result
• Deferred in some countries

7
Ethical Responsibility of BTS

• Take Informed Consent
• Provide information to donors regarding their
  health from history, medical examination test
  results

8
Informed Consent Voluntary agreement given by
donors after understanding -

• the donor selection blood collection procedure
• tests carried out
• implications of test results
• options of knowing results
• potential adverse consequences
• need for blood

9
Responsibility of Donors

• To read understand information
• Give informed consent
• May be deferred
• - Receive test results
• - Blood may be discarded
• - Blood may be used for research

10
Responsibility of Donors

• To understand HIV infection and possibility of WP
  transmission
• To provide correct information regarding risk
  behaviour
• - should understand seriousness of endangering
  blood supply
• Legal responsibility in some countries -
  infection rate in donors has dropped
• Difficult to adopt in developing countries

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BTS expects truthful disclosure

• Healthy individuals
• Consider themselves fit to donate
• Not well informed
• Do not understand information provided

• Treated like other free pts
• Documentation is incomplete
• Lack of staff communication facilities

Reduces donor recruitment retention
12
Expectations of Donors

• Donors expect communication regarding their
  health
• 95 donors expect to continue being a donor
  (study in Denmark)
• Do not appreciate being deferred
• Increased cost for further tests treatment
• Affects lifestyle employment potential
• Difficulty in insurance, confidentiality, social
  stigma

13
Donor Rights

• Right to safety
• Right to be informed (process / tests /
  results)/RT not to know
• Right to choose to donate ( where when )
• Right to be heard
• Right to seek redressal
• Right to consumer education

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Post Donation Issues

• Right to know the report
• Report should be accurate and
• followed by counseling
• Report to be sent to correct person
• National testing policy whether
  encourages information

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Impact of tests

• Developing countries
• Sensitivity specificity of tests
• Initial reactive dispose blood unit
• Confirmation not required
• Confirmatory tests not available
• Difficult to make a donor understand need to be
  tested after 3 months

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Impact of tests - 2

• In developed countries
• In US FDA requires notification of HIV screening
  test result /EU confirmatory
• Only 10 of ELISA pos is confirmed by Western
  Blot
• Difficult to explain indeterminate results
• Less of a problem after introduction of NAT as
  less chances of false pos

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Impact of tests - 3

• False pos result leads to anxiety and
  psychosocial problems
• Donors undergo extensive follow-up testing at
  personal expense
• Increased confusion due to test results not being
  reproducible
• With discrepant test results donors may demand
  their names removed from deferral, request
  reimbursement of expenses threaten litigation

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Communication

• Letter confidentiality ?
• - nonspecific information
• - language barrier / literacy
• - leads to anxiety
• - feel such letters should not be
  sent / request copy of FDA requirement
• Telephone confidentiality ?
• Contact in person additional testing offered
• No staff to trace, contact follow up
• Inadequate data

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Unexpected Response

• Every effort made to trace
• Some do not respond
• Some claim to be busy
• Some respond but language barrier
• Some refuse referral for med assessment / cannot
  force
• Some refuse to inform partner at risk

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Post Donation Counseling

• For seropos donors is a challenge for blood
  service
• If counseling further management care not
  possible, donors should not be informed
  (time/interruption free/accessibility)
• Not necessary for BTS to function as primary
  health care center but can refer to other centers
  
• Referral links with existing
• counseling facilities important

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Post Donation Counseling involves

• Helping the donor to cope with the psychological
  impact of a pos test result
• Stressing the need to prevent further
  transmission
• Offering options regarding continued referral
  service for donors their family

22
Post donation Counseling

• IR test result h/o risk behavior indicates need
  for follow up to confirm WP seroconversion
• Lack of trained staff
• Liaison with other existing centers -NA
• Free testing treatment -NA

• Helps a donor -
• To benefit from prophylactic or
• therapeutic interventions
• To modify behaviour
• To limit the spread to 3rd party

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Legal Issues

• Erroneous notification of
• results mental anguish litigation
• Documentation of compliance of proper
• procedure - important for blood banks
• defence (Finland case)
• Insurance - compensation if donor
• suffers from any harm or loss

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Confidentiality

• Constitutional right to privacy requires
• protection of donors identity from
• disclosure to public
• Donor records need to maintain
• confidentiality during storage eventual
  disposal

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Confidentiality - 2

• Traceability - Donor Unit
• Recipient
• Important in case of donors with
• positive results or seroneg transmission
• Partner notification vis-à-vis
• confidentiality (permission from judge to
  overrule confidentiality)

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Conclusion

• Many ethical issues need to be considered in
  donor management
• Dilemmas are accentuated in resource -poor
  settings
• Ethically sound policies are the basis for
  public trust and a reliable donor base
• Need to integrate ethical considerations in
  national strategies, rules regulations

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Thank you
Any Questions ?