Ethical, Legal and Professional Framework for UK Organ Donation

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Royal College of Paediatrics and Child Health, 2015
Guidance on diagnosing death using neurological criteria in neonates.

AoMRC (2008) applies from 37 weeks gestation to 2 months, with additional cautions:
  1. a defined 24 hours observation if aetiology is contributed to by hypoxia
  2. a stronger hypercarbic stimulus is required (Starting PaCO2 of at least 5.3 kPa, seek rise > 2.7 kPa resulting in an end PaCO2 > 8.0 kPa)
  3. ancillary testing not advised (full clinical diagnosis or can’t be safely diagnosed)

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Human Transplantation (Wales) Act 2013
  • From mid 2015 the Organ Donor Register will change for all in the UK will change to allow for the first time a mechanism for individuals to register a wish NOT to donate.
  • Introduces deemed consent into Wales from December 2015. Only in Wales for Welsh residents over 18 years of age. Families will still be approached to ascertain if the potential donor may have objected to donation.
From Mid 2015
Change in the ODR (for all of the UK)
Register YES All organs
Register YES Specify organs
Register NOMINATE a representative
Register NO

Not Registered
- Wales = Deemed
- Rest UK = Status Quo
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Quick Reference Guide
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Full Guidance
NICE 2011
1. Triggered Referral
  • Plan to withdraw life-sustaining treatment
  • Plan to perform brain stem testing
  • Catastrophic brain injury (early referral)
2. While assessing the patient’s best interests clinically stabilise the patient in an appropriate critical care setting.

3. Collaborative Approach
  • SN-OD
  • Local faith representative
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Independent UK Donation Ethics Committee (UK DEC) 2011
- hosted by AoMRC

Guidance on roles and responsibilities, conflicts of interest:
  • Referral to SN-OD before withdrawal decision is acceptable.
  • SN-ODs not to give physical care to the patient before death.
  • Two senior clinicians to make the decision that life sustaining treatment should be withdrawn.
  • Clinical Lead for Organ Donation may act as treating clinician.
  • After death acceptable for treating clinician to take actions necessary to facilitate donation (eg re-intubation).
There are two guiding principles behind the work of the UK Donation Ethics Committee: Principle 1: Where donation is likely to be a possibility, full consideration should be given to the matter when caring for a dying patient; and Principle 2: If it has been established that further life-sustaining treatment is not of overall benefit to the patient, and it has been further established that donation would be consistent with the patient’s wishes, values and beliefs, consideration of donation should become an integral part of that patient’s care in their last days and hours.
UK DEC 2011
Joint professional statement from the Intensive Care Society and the British Transplant Society 2010
  • Professional support for DCD
  • Professional support for admission to ICU purely for organ donation
  • Suitability criteria for donation outlined
  • Guidance for treatments before and after death, including outline of he special requirements for lung DCD (reintubation and reinflation).
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GMC 2010
Treatment and Care Towards the End of Life: good practice in decision making

  • Establishes a duty on doctors to explore donation and follow national procedures.

Organ donation 81 If a patient is close to death and their views cannot be determined, you should be prepared to explore with those close to them whether they had expressed any views about organ or tissue donation, if donation is likely to be a possibility. 82 You should follow any national procedures for identifying potential organ donors and, in appropriate cases, for notifying the local transplant coordinator. You must take account of the requirements in relevant legislationxv and in any supporting codes of practice, in any discussions that you have with the patient or those close to them. You should make clear that any decision about whether the patient would be a suitable candidate for donation would be made by the transplant coordinator or team, and not by you and the team providing treatment.
GMC 2010
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Legal Guidances on Donation after Circulatory Death 2009, 2010, 2011
In someone who wanted to donate, donation might be in the Person’s Interests / Benefit
  1. By maximising the chance of fulfilling the donor’s wishes about what happens to them after death
  2. By enhancing the donor’s chances of performing an altruistic act of donation
  3. By promoting the prospects of positive memories of the donor after death
Not in the Person’s Interests / Benefit
“Anything that places the person at risk of serious harm.”
Harms might include worsening of the patient’s medical condition; shortening of the patient’s life; pain from an invasive procedure; and distress to family and friends.
Legal
  • Delay withdrawal
  • Change patient's location
  • Maintain physiological stability
Not Legal
  • Systemic heparinisation
  • Cardio-pulmonary resuscitation
  • Femoral cannulation for organ recovery reasons
While registration on the ODR provides consent for donation after death for the purposes of the HTA, the Department of Health does not consider that registration can be viewed as advance consent to steps to facilitate NHBD. It would, however, be important evidence of a person’s wish to donate.
Department of Health 2009
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AoMRC 2008
A Code of Practice for the Diagnosis and Confirmation of Death
  • Successor to the first 1976 Code (1979, 1983, 1998)
  • No mention of organ donation
  • Does not use the term 'brain death' or 'brainstem death' - only, diagnosing death in coma
  • First time UK criteria for diagnosing any death following cardio-respiratory arrest.
“The definition of death should be regarded as the irreversible loss of the capacity for consciousness, combined with irreversible loss of the capacity to breathe… therefore irreversible cessation of the integrative function of the brain-stem equates with the death of the individual.”
AoMRC 2008
MCA 2005 (Code of Practice 2007)
  • Best interests are broader than ‘medical’ best interests.
  • When a patient lacks capacity - duty to consult with those close to the patient to ascertain knowledge of the patient’s wishes, preferences, feelings, beliefs and values.
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Human Tissue (Scotland) Act 2006
  • Established a duty on the Scottish government to promote organ donation.
  • Uses the term authorisation, which in the Scottish legislation is stronger than the respective consent legislation in the HTA 2004.
HTA 2004 (Code of Practice 2009)
  • The Act and its associated codes of practice unequivocally establish the primacy of consent for the control of organs and tissues during life or after death.
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Adults with Incapacity (Scotland) Act 2000
  • There shall be no intervention in the affairs of an adult unless the person responsible for authorising or effecting the intervention is satisfied that the intervention will benefit the adult and that such benefit cannot reasonably be achieved without the intervention.
  • The present and past wishes and feelings of the adult with incapacity should be accounted for, including seeking the views of the nearest relative and the primary carer of the adult, when deciding if an intervention is of benefit.
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