Hospital Pathology
Pathology Practice
There are provisions in Part 3 of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024 shall only apply to post-mortem activities that take place in a hospital setting. The provisions of this Part do not apply to post-mortem activities initiated before the commencement. Post-mortems directed by the Coroner are exempt from the legislation subject to the amendments made to the Corners Acts.
Regulations apply to certain aspects of coronial post-mortems that take place in hospitals. The Minister for Health may make regulations to support the management and the respectful and appropriate conduct of post-mortem examinations. Among other things, the regulations may provide for managing the conduct of post-mortem examinations, with specific emphasis on the retention, storage and disposal of body parts, organs and tissues.
There are a number of bodies that the Minister will consult with as appropriate before making regulations, including the Minister for Justice and a number of other named stakeholders.
Consent and Post-mortem Activities I
There is a process for obtaining consent for the conduct of post-mortem activities that do not fall under the jurisdiction of the Coroner, including non-coronial post-mortem examinations. It details the information that must be provided to the person giving consent, stipulates requirements around record keeping in respect of consent and provides for consent to be limited to certain activities.
Post-mortem activities are defined, and it is an offence to carry out such activity without the appropriate consent. There are conditions applying to non-coronial post-mortem examinations. It includes provisions relating to maintenance of records and the conduct of the examinations while also prohibiting payment for organs or tissues removed during a non-coronial post-mortem examination. These provisions reinforce the necessity for appropriate consent for the removal of any organ or tissue while clarifying that consent need only be given once in respect of any particular post-mortem activity.
Any tissue sample removed prior to commencement of the Act may be retained for purposes associated with the post- mortem examination without appropriate consent although it prohibits the sale or use of such samples for commercial purposes unless there is appropriate consent.
The 2024 Act lists the purposes for which post-mortem activities may be undertaken. It identifies the medical professionals who can conduct a non- coronial post-mortem examination and allows for technical assistance to be provided to enable such an examination. For the purpose of the Act, post-mortems can be undertaken by a pathologist or a registered medical practitioner under the supervision of a pathologist.
A report must be prepared following a non- coronial post-mortem examination. The Act sets out what information shall be recorded in that report and how the report should be retained. There are conditions in relation to consent for post-mortem activities on a deceased adult. Consent may be given by the adult prior to their death, or it can be given by a designated family member.
Consent and Post-mortem Activities
There are conditions in relation to consent for post-mortem activities on a deceased child. Consent must be given by a parent or guardian of the child. If one parent or guardian should object, any consent that may previously have been given by the other parent or guardian is nullified. There are conditions in relation to consent for post-mortem activities on a foetus. It stipulates that consent must be given by the mother of the foetus or a person acting on her behalf.
The 2024 Act sets out the conditions under which material derived from non- coronial post-mortems can be used by a third party (such as pharmaceutical companies) for commercial purposes. It stipulates that such use must first be authorised by the person in charge of the hospital and that consent must then be sought from the appropriate person as identified (designated family member; parent or guardian; or mother).
Consent need only be given once in respect of any particular post-mortem activity and stipulates that agreements with any third party will be recorded and approved in writing by the person in charge of the hospital.
The Minister for Health may make an application to the High Court to allow a non-coronial post-mortem examination to be undertaken where consent has not been given. Such an application should only be made in exceptional circumstances, namely where it is required in the interests of public health or where there is a risk to public health if the post-mortem is not conducted.
Each hospital that conducts post-mortem activities must appoint a nominated person who will serve as the main contact point for the regulator as well as fulfilling other responsibilities as set out. It delineates the responsibilities of such “a nominated person” for the purposes of this Part.
HIQA Regulation
The Health Information and Quality Authority (HIQA) has the power to regulate aspects of the Act. Specifically, it provides that an authorised person appointed under the Health Act of 2007 shall be an authorised person under this Part and makes necessary amendments to the 2007 Act to support and enable HIQA’s role in this regard.
There are circumstances whereby an authorised person may issue a compliance notice and sets out the steps which such a person must follow in relation to the notice. The Act sets out the obligations that must be followed by the person on whom a compliance notice has been served. There are appeal procedures that are available to a person on whom a compliance notice has been served.
HIQA has the power to serve prohibition orders for egregious breaches of the provisions of this Part of the Act. There are procedures which must be followed in relation to issue of the order and details the appeals procedures available to the person on whom the order has been served.
Coroners Act
The 2024 Act amends the existing provisions in the Coroners Act to ensure that the family of a deceased person, subject to a coronial post- mortem examination is informed that material removed during the examination may be retained for the purposes of the death investigation and is informed of the location of the hospital or other facility. Where the post-mortem examination has been conducted in a hospital, any material removed from the body shall be preserved, stored and recorded by the registered medical practitioner in accordance with regulations made in that regard by the Minister for Health or by the Minister for Justice in respect of another facility.
The 2024 Act formalises the final interactions between a coroner and a designated person in a hospital or other facility where coronial post-mortems on the deceased person occur. It (Authorisation for disposition) will ensure that family members are made aware, as soon as practicable by the coroner, that any material retained following the post-mortem examination is no longer required. This notification will advise the family member to contact the nominated person to arrange for the authorisation for the final disposition of the material.
A coroner may direct disposal of material considered historic, which may have been stored for a long period and whose retention serves no further purpose. The Minister for Justice may make such regulations for the purpose of proper management and conduct of post-mortem examinations that are made in places other than hospitals.