Removal of relevant material from deceased children

This guidance states the legal requirements of the HT Act with regard to consent for removal of relevant material from the deceased and licensing. It seeks to ensure that there is clarity about the circumstances in which removal can and can’t take place in order that licensed establishments can be advised correctly.

Licensing

The making of a post-mortem examination and the removal of material from a deceased person for certain purposes including determining the cause of death are licensable activities under the Human Tissue Act 2004.  Therefore, in compliance with the HT Act, removal of pathology specimens from deceased infants and children for microbiological, biochemical and toxicological testing must take place on licensed premises.  It is for NHS Trusts to establish whether activity carried out in any area of their premises is licensable under the HT Act and to seek guidance from the Human Tissue Authority where there is uncertainty. 

On receipt of a written request from a licensed establishment, the HTA will extend the Trust's pathology / post mortem licences to include the Accident and Emergency Department, provided that the department is located on the same premises as those specified on their licence. Where the removal takes place on other premises, for example on a children’s ward located in a different hospital within the Trust, then a satellite licence arrangement may be required.

It is important to note that the Designated Individual (DI) named on the HTA licence has statutory responsibility for ensuring that the premises are ‘suitable’ and that ‘suitable practices’ take place on those premises, as well as for complying with the conditions of the licence. Therefore, the Licence Holder will need to ensure that the DI is content for his remit to be extended to any new areas of responsibility and that he will oversee compliance with relevant HTA standards. This should be confirmed by the DI in writing to the HTA. Where this arrangement is not suitable, then it is recommended that removal of the specimens only takes place in the mortuary, which is licensed.

Consent

The HT Act 2004 is clear that removal of tissue from the deceased for the purpose of determining the cause of death can only take place under the authority of the coroner (or, in the case of hospital post mortems only, with appropriate consent).  Working Together to Safeguard Children (WTtSC) recommends that NHS Trusts secure 'general approval' from coroners; it is up to individual establishments to make their own arrangements. However, it is important to note that removal without such coronial authorisation would be unlawful. As mentioned earlier, where it is not a coroner’s post mortem case, appropriate consent (from a nominated representative if there is one or the person ranked highest in the qualifying relationship hierarchy – most often the parents) would be required for the removal of tissue to take place.

From information we have received, it appears there may be instances when samples are removed from a deceased child prior to the death being reported to the coroner. Where this is indicated, the guidance above should be re-iterated and it should be stressed that it is unlawful to remove material without the necessary consent or coronial authority or to remove material in these circumstances on unlicensed premises.

The status of the document as statutory guidance is defined in its Executive Summary, which specifies the chapters issued under s16 of the Children Act 2004. The guidance in these chapters must be taken into account and, if it is departed from, there must be clear reasons for doing so.