Alert issued to post mortem sector following serious adverse events

The HTA has issued a regulatory alert to all establishments that carry out post-mortem examinations in England, Wales and Northern Ireland following notification of incidents where tissue and organs were kept without consent.

Issue date: 8 December 2009

The alert states that establishments are required to complete an audit of all tissue and organs from the deceased on their premises and submit the results in writing to the HTA by September 2010. It also requires establishments to complete a compliance assessment report for submission by June 2010.

The alert has been issued because: 

• there is lower than expected compliance in the sector
• in some cases tissue blocks and slides are being retained without consent
• the HTA has been notified of five incidents where brains have been kept without consent following a post-mortem examination.

Dr Sandy Mather, Director of Regulation at the HTA, said:
“We understand, from speaking to the bereaved, that these events cause a great deal of additional distress. We take this very seriously and want to do everything we can to reduce the risk of this happening in the future. When something goes wrong it is important to share information about what happened and why so that lessons can be learnt.

“The HTA has committed significant resources to raising standards in the post mortem sector over the last two years and has been working closely with the sector and professional bodies. We are taking further action to improve compliance by asking those carrying out post-mortem examinations to audit tissue on their premises and complete a compliance assessment. This will enable us to understand if there are any establishments at particular risk of non-compliance.

She continued: “In the post mortem sector we have seen many examples of good practice and a genuine commitment by staff to care for the deceased and bereaved families. However, the nature of mortuary work means that there is the potential for significant distress to relatives and friends of the bereaved when things go wrong. This is why it is essential that post-mortem examination establishments comply with our standards.

HTA regulation focuses on mortuaries and the systems that are in place to ensure post mortems take place in appropriate facilities by trained staff working to exacting but essential procedures. The Human Tissue Act requires that tissue can only be kept after a post-mortem examination, when the Coroner’s authority has ended, with consent of relatives (or close friends of the deceased person, where there are no relatives).

The HTA monitors compliance in the sectors that it regulates and has identified a shortfall in compliance from post-mortem examination establishments over the last two years. As a result, the HTA has been engaged in an ambitious programme of work to help improve standards that include providing extensive advice and guidance, training events and working closely with stakeholders and professional bodies including the Department of Health, devolved assembly governments, the Royal College of Pathologists, Ministry of Justice, the Home Office and the Association of Anatomical Pathology Technologists.

ENDS

For further information, please contact Dr Claire Bithell, Senior Media Advisor at the HTA, on 020 7211 3439 or email claire.bithell@hta.gov.uk

Notes to editors:

• The full text of the regulatory alert can be found on our website
• 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 transplants from living people through an independent assessment process.
• The HTA provides advice and guidance about two laws: the Human Tissue Act (HT Act) and the Quality and Safety Regulations. These laws ensure human tissue is used safely and ethically, with proper consent. The HT Act applies to England, Wales and Northern Ireland.
• 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. Under the HT Act, all post-mortem examinations must take place on premises licensed by the HTA. Post-mortem examinations of some tissue and organs may take several weeks. The family can decide either to delay the funeral so that the tissue or organs can be replaced in the body, or to hold the funeral, in which case the tissue and organs will be sensitively and respectfully disposed of. Alternatively, a family may decide to consent to the tissue or organs being kept for research.
• The regulatory alert issues General Directions:

Designated Individuals should be on notice that the HTA will issue General Directions in April 2010 requiring them to undertake a full and complete audit of all material from the deceased stored on the premises, the results to be submitted to the HTA in writing by September 2010. 

Additional General Directions will be issued in April 2010 requiring DIs to complete a compliance assessment report against core HTA standards for submission by June 2010.

• The HTA monitors the compliance of those holding an HTA licence. HTA summary compliance reports can be found on our website 
• The HTA produces codes of practice that give professionals practical guidance on human tissue legislation. On 15 September 2009, the HTA's revised codes of practice came into force.