Guidance for the Anatomy sector on evidencing medical certification of cause of death
In England and Wales, section 1(2) of the Human Tissue Act 2004 (‘the Act’) sets out that the storage of a body of a deceased person for use for anatomical examination is lawful if done with appropriate consent and after a medical examiner has either confirmed the cause of death on the certificate provided by the attending practitioner, or issued their own certificate confirming the cause of death. However, the Act does not specify the type of documentary evidence that should be obtained by an organisation proposing to accept a donation to demonstrate that the requirements of Section 1(2) of the Act have been met. The HTA has not mandated any single approach and local practices vary. Consistent with our approach in other matters, our expectation is that establishments are able to assure themselves, and demonstrate to us when requested, that they are compliant with the law.
In response to questions raised following the introduction of changes to death certification, the HTA’s position is that written confirmation that the relevant certificate has been completed and sent to the registrar by the medical examiner is satisfactory documentary evidence that the requirements of Section 1(2) of the Act have been met. Obtaining this written confirmation will allow organisations to proceed to storage and timely preservation of a body donated for anatomical examination pending registration of the death.
Written confirmation may be sought from the medical examiner’s office. Through liaison with representatives for the National Medical Examiner system, the HTA has clarified that while medical examiners are not legally obliged to provide written confirmation to establishments wishing to accept body donations, they want to support the donation process where they can. We encourage establishments to work with medical examiners to facilitate the donation process.
If information cannot be obtained from the medical examiner’s office, it may be possible to obtain it from a contact of the deceased donor. Medical examiners have a statutory duty to discuss the cause of death with the relevant contact and notify them when a certificate has been given to the registrar. If confirmation has been provided to a relevant contact of the deceased donor in the form of a letter or an email, this could be forwarded to the establishment, along with the provision of any other information requested by the establishment (for example, information about the cause of death). The copy of the notification would be sufficient documentary evidence that the requirements of Section 1(2) of the Act have been met.
Finally, when the death is registered, a certified copy of the registered entry may be obtained by the relevant contact and forwarded to the organisation as further documentary evidence that the requirements of Section 1(2) of the Act have been met and that anatomical examination can proceed lawfully. There is a small fee to purchase copies of a registered entry.
If an organisation is unable to obtain written confirmation that certification of cause of death has been completed lawfully, Designated Individuals should assess the risks of storing the body; for example, while awaiting confirmation in the form of a certified copy of the registered entry. Based on this assessment, Designated Individuals may decide to accept or decline the donation and should document the decision.
We will update our Code of Practice when it is next revised.