Organ and tissue donation - authorisation requirements: guidance

Chapter 9 - Retrieval

Conditions which must be satisfied before retrieval of organs and tissue can proceed

209. Section 11(1) and (4)(a) of the HTS Act set out the conditions which must be met before the removal of a body part can take place.

210. First, the removal of the body part must be carried out by a registered medical practitioner or a person (or category of person) authorised to do so in accordance with regulations made by the Scottish Ministers. The existing regulations are the Human Tissue (Removal of Body Parts by an Authorised Person)(Scotland) Regulations 2006.^[14] These outline that a registered medical practitioner can authorise someone who is not such a practitioner to undertake the removal of a body part, provided that they are sufficiently qualified and trained to perform the procedure competently. In practice, authorised persons are persons who are specially trained to retrieve tissue, for example tendons or eyes.

211. Second, a number of criteria need to be met before the retrieval is undertaken. Those are that:

• the life of the potential donor is extinct;
• if the consent of the procurator fiscal to the carrying out of the removal is required by section 5(1) of the HTS Act, the consent has been given; and
• the removal and use for the purpose in question is authorised in accordance with the relevant section of the HTS Act:
  • Section 6 - Express authorisation: adult
  • Section 6D - Deemed authorisation for transplantation: adult
  • Section 6E - Non-resident adult: authorisation for transplantation by nearest relative
  • Section 6F - Adult incapable of understanding deemed authorisation: authorisation for transplantation by nearest relative
  • Section 6G - Excepted body parts: authorisation for transplantation by nearest relative
  • Section 6H - Authorisation for purpose other than transplantation by nearest relative
  • Section 8 - Authorisation: child 12 years of age or over
  • Section 8D - Authorisation by person with parental rights and responsibilities: child 12 years of age or over
  • Section 10 - Authorisation by person with parental rights and responsibilities: child under 12 years of age
  • Section 10A - Authorisation by other persons: children

212. The person proposing to carry out the retrieval must satisfy themselves that the latter two criteria have been met. In terms of verifying that the life of the potential donor is extinct, where a registered medical practitioner is undertaking the retrieval, it is sufficient for that person to examine the donor's body to confirm the donor is deceased.

213. However, where the person undertaking the retrieval has been lawfully authorised to do so and is not a registered medical practitioner, then they must satisfy themselves that a registered medical practitioner has examined the donor's body to confirm the donor is deceased. In practice, this will usually be done by checking that there is a record of such an examination having taken place. It is not a requirement that a registered medical practitioner has to be present at the retrieval when it is being undertaken by an authorised person.

Checking authorisation is in place

214. To be satisfied that the removal and use of a body part is authorised in accordance with the HTS Act, the person undertaking the retrieval must consider that there is an appropriate record of authorisation in place. The record should reflect the inquiries undertaken by the SNOD/SR/TDC and should include confirmation that:

• there is an authorisation in place in relation to the potential donor under the relevant section of the HTS Act, which was given in accordance with the relevant section and which pertains to the removal and use of the relevant body part for the relevant purpose. Where authorisation is in place for a particular purpose, organs/tissue may only be used for that purpose. For example, an organ or tissue removed under authorisation for transplantation purposes cannot be used for research unless there is an authorisation in place for research.
• there is no opt-out declaration as respects removal and the use of the relevant part for the purpose in question.
• in the case where an adult who is deemed to have authorised donation, the deceased adult does not fall into one of the categories of individual that deemed authorisation does not apply to (i.e. a non-resident adult or an adult who lacks capacity).

215. As well as ensuring that there is an appropriate record of authorisation of donation, the person proposing to carry out the removal of a body part must also have no reason to believe that:

• authorisation for the removal and use of the potential donor's body part for the relevant purpose is not, in fact, in place or has not been properly given;
• the deceased person would be unwilling in the circumstances for the part to be removed and used for the purpose in question.

216. In practice, it will be rare for the person proposing to carry out the removal to have any reason to believe that authorisation is not in place or that the deceased person would be unwilling for the removal to be carried out. However, if there is any cause for them to doubt the position (for example, where it is suspected that there may be an error in the documents recording authorisation), this should be investigated before retrieval proceeds.

Cases involving the Procurator Fiscal

217. Where the circumstances of death require to be reported to the Procurator Fiscal, a person cannot remove a body part until the Procurator Fiscal has consented to the removal. Where consent has been given verbally, this should be confirmed in writing, for example by email, as soon as is reasonably practicable. See paragraphs 12-15 for more information.

Offences

218. Section 16(1)(a) of the HTS Act sets out that it is an offence for a person to remove or use a part of a person's body for a specific purpose if there is not an authorisation in place for removal or use for that purpose. The offence is committed if authorisation is not in place under the relevant section of the HTS Act. If a person is charged with this offence, it is a defence for them to show that at the time of carrying out the activity, the person reasonably believed that the removal and use for the purpose had been authorised in accordance with the HTS Act.

219. It is also an offence under section 16(1)(b) of the HTS Act to remove a body part or use a body part in Scotland which has been retrieved in Scotland if any of the requirements in section 11(1) or (4)(a) of the Act (as outlined above in paragraphs 210-215) are not satisfied. Again, it is a defence for a person charged with this offence to show that they reasonably believed that the requisite requirements were satisfied.