Human Tissue (Authorisation) Act: consultation on Type A draft procedures

Annex A: Context of pre-death procedures

Practical context

49. During 2018/19, in Scotland, there were 30 DCD (donation following circulatory death) donors from a total of 98 deceased donors. DCD donation is where the donor has been pronounced dead following cessation of the heart and respiratory activity. Donation following diagnosis of death by neurological criteria (DNC), where the donor has been pronounced dead using neurological criteria (i.e. brain death) accounts for the rest of deceased donation.

50. In practice, to facilitate transplantation, organs have to be removed immediately after the death of a DCD donor and quickly transported to the transplanting hospital. This means there are significant time constraints and some of the vital tests which are necessary to ensure that the organs are likely to be successfully transplanted, and are a good match for the transplant recipient, need to be carried out shortly before death. These may include blood and urine tests, x-rays or tests on the heart such as an electrocardiogram or echocardiogram. All of these tests, or procedures, may be considered to be routine as part of the patient's care. For example, all patients in intensive care will have had a urinary catheter inserted, meaning that urine samples taken for the purposes of facilitating organ donation can be taken. Similarly, blood samples taken for the purposes of facilitating organ donation are likely to be taken from an existing line.

51. DCD donation had been carried out in Scotland and the rest of the UK since 2003. Before 2009/10 a far greater proportion of donation proceeded with DNC donors, however, there has been a significant increase in donors who have donated following circulatory death since that time. The increase in this type of donation is as a result of developments in clinical practice and processes and is now a very important element of deceased organ donation in Scotland.

52. DCD donation began to expand significantly after Guidance was issued by the former Chief Medical Officer in 2010 (CMO Guidance) which provided reassurance around the carrying out of some of these tests - including blood tests on a potential donor where it was clear that the person, or their family, were authorising donation. Similar Guidance was issued by the Department of Health for England and Wales in 2009, but this reflected the different legal regimes in those countries for people who are not capable of consenting to this type of medical procedure.

53. It was recognised in the 2010 CMO Guidance that the basis for medical consent to these tests and procedures for the purposes of transplantation should be considered further as practice develops.

54. The 2019 Act supports this consideration by setting out a clear and dedicated statutory provision for the completion of these tests that support DCD donation and transplantation.

Tissue

55. This matter does not directly affect tissue only donation as, for example, eyes can be retrieved from a donor up to 24 hours after the patient's death, while other forms of tissue can be donated up to 48 hours after death. This means the necessary tests can be carried out following the death of the patient. However, for completeness, the pre-death procedures framework in the 2019 Act makes no distinction between organs and tissues.

2019 Act - the framework

56. The Act sets out that to be considered a pre-death procedure, the medical procedure has to be:

• carried out for the purpose of increasing the likelihood of successful transplantation;
• not for the primary purpose of safeguarding or promoting the health of the person.

57. The Act also requires that a pre-death procedure, as defined above, may only be carried out where:

• in the view of the health worker primarily responsible for the person's medical treatment, for example the supervising consultant in ICU, the person is likely to die imminently (including as a result of withdrawing life sustaining treatment);
• where the person is receiving life sustaining treatment, the decision to withdraw that treatment has been taken by the person responsible for the person's medical treatment (i.e. supervising consultant);
• the carrying out of the procedure is necessary;
• the carrying out of the procedure is not likely to cause more than minimal discomfort to the person, and;
• the carrying out of the procedure is not likely to harm the person.^[4]

58. The Act explains that the carrying out of a procedure is necessary if either of the following apply:

• it is necessary to carry it out for the purpose of ascertaining whether a part of the person's body is suitable for transplantation,
• it is necessary to carry it out for the purpose of increasing the likelihood of successful transplantation of a part of the person's body.

59. The process and requirements set out above in the 2019 Act are intended to reflect current clinical practice in NHS Scotland.

60. Training and guidance will be provided to NHS staff in advance of the implementation of the new statutory framework for pre-death procedures, to support the delivery of the new deemed authorisation system for donation for autumn 2020. The intention is that this framework will strengthen the processes supporting DCD donation and ensure clarity for clinicians on the legal framework governing these medical procedures. It will also provide transparency for the public about what is involved in the wider donation and transplantation process.