Information for the public on post mortem facilities at University Hospital of Wales

Update from the HTA for members of the public

Issue date: 4 February 2010

How has the HTA been involved with events at the University Hospital of Wales?

In August 2009, the HTA suspended the licences authorising University Hospital of Wales, Cardiff, to carry out post-mortem examinations.

This followed our inspection of the post-mortem facilities on 30 July 2009. The inspection raised serious concerns about practices, procedures and the suitability of premises, which did not comply with HTA standards. On inspection, records could not be provided for some of the tissue that was being stored. In August 2009, we referred our findings to South Wales Police.

South Wales Police have confirmed that upon taking the advice of the Crown Prosecution Service (CPS), the circumstances do not raise a reasonable suspicion of criminality justifying further police involvement. The CPS and police agree that the HTA referral was necessary to ensure public confidence. The priority now is for the hospital to dispose of tissue where appropriate according to the HTA’s code of practice.

Since July we have worked closely with the hospital to help get the facilities up to standard. The hospital has invested significant time and resources and made great improvements. We are working with Cardiff and Vale University Health Board to build on the significant improvements that have already been made. The suspension of the licences was lifted on 18 September 2009.

What happens next?

This year we will prioritise inspections of establishments carrying out post-mortem examinations and are already working with the Department of Health, Welsh Assembly Government, Ministry of Justice, Home Office and professional bodies to improve compliance with our standards. The HTA has inspected 12 of the 18 establishments that hold an HTA licence for post-mortem examination in Wales. Those who have not been inspected so far are due to be inspected by the end of March 2011.

How might this affect me if a member of my family has previously had a post-mortem examination at the hospital?

Cardiff and Vale University Health Board has set up an information line for any families that think they may be affected. The number is 0800 952 0244. The information line number is freephone and is open 9am – 6pm Monday to Friday. The information line will be open until 8pm on Thursday 4 February, and over the weekend 6-7 February.

Background information

What is the role of the HTA?

The HTA is an independent watchdog that supports public confidence by licensing and inspecting organisations that store and use tissue for purposes such as research, patient treatment, post-mortem examination, teaching and public exhibitions. We also give approval for organ and bone marrow donations from living people through an independent assessment process.

We provide advice and guidance about two laws: the Human Tissue Act and the Quality and Safety Regulations. These laws ensure human tissue is used safely and ethically, with proper consent. Our aim is to set standards that are clear and reasonable, and in which both the public and professionals can have confidence.

The HTA works with organisations to help them comply with our standards. However, where there is serious non-compliance with our standards we must take the appropriate regulatory action.

What is a post-mortem examination?

A post-mortem examination is a detailed study of a body after death. It is also known as an autopsy. Post-mortem examinations are carried out by pathologists - medical professionals who specialise in the diagnosis of disease after death and identifying the causes of death. Post-mortem examinations are carried out for two main reasons:

• if the cause of a death is unknown, or when a death happens unexpectedly or suddenly, it is referred to a coroner who orders a post-mortem examination. By law, coroners' post-mortem examinations can take place without the consent of the family
• at the request of the doctors who looked after the deceased person before they died in order to obtain more information about their illness and the cause of their death. In these cases, consent should be obtained from the deceased's family

What role does the HTA have in post-mortem examination?

All post-mortem examinations, whether or not authorised by a coroner, must take place on premises licensed by the HTA. The HTA produces a code of practice to give professionals practical information on how to meet the statutory requirements and the HTA standards relating to post-mortem examination.

What standards are necessary for an establishment to hold an HTA licence for post-mortem examination?

To hold an HTA licence establishments must demonstrate compliance with HTA standards, including:

• staff must be appropriately trained
• consent is taken for any tissue or organs taken from the body to be used for purposes including research and training
• there is good record keeping, for example records are taken of each body coming into the mortuary and of any organs or tissue removed from the body
• premises are ‘fit for purpose' and provide an environment that preserves the safety and dignity of the deceased and the safety of staff and visitors
• systems are in place to ensure that establishments comply with relatives wishes for disposal of tissue or its use in research or training after the post-mortem examination

How has the Human Tissue Act made a difference?

Since the Human Tissue Act came into force in 2006, establishments have had to ensure post-mortem examinations take place in suitable facilities, and are undertaken by trained staff working to stringent procedures. During post-mortem examinations, tissue and organs may be taken to help establish the cause of death. After the Coroner has established the cause of death, tissue and organs that were removed can be returned to the body, respectfully disposed of or kept with consent for purposes such as research or training, depending on the wishes of relatives’. Post mortem establishments must keep accurate records of relatives’ wishes, and have clear systems to ensure they are carried out in a timely way.

Before the Human Tissue Act, post-mortem examinations were not regulated in law and this case demonstrates the importance of regulation. We want to reassure the public that we monitor compliance with our standards and will take regulatory action where necessary.