Improvements needed in post mortem sector, but good compliance elsewhere

The HTA is calling on organisations that carry out post-mortem examinations to raise standards, in response to a new report on compliance.

Issue date: 22 October 2009

The report is one of a set that describes how organisations that are licensed to store and use tissue for purposes such as research, patient treatment, post-mortem examination, teaching, and public exhibitions are complying with key HTA standards.

Last year (2007/08), the HTA produced its first set of compliance reports for each of the licensed sectors, and found that compliance with standards was good overall, although two sectors needed to make improvements - those carrying out post-mortem examinations and those using human tissue for patient treatment. This year (2008/09), the HTA saw some progress in compliance for organisations using human tissue for patient treatment, but no significant improvement for those carrying out post-mortem examinations.

Post mortem sector

In the post mortem sector the HTA found good practice at some establishments, in particular:

• documented evidence of consent training for staff
• nominated members of staff with expertise in consent to support clinicians
• proactively informing the HTA of serious incidents
• seeking feedback from funeral directors through questionnaires

However, there were other establishments that needed to make substantial improvements. The HTA found that, at some establishments:

• consent documentation did not reflect the Human Tissue Act 2004 (HT Act)
• training for staff taking consent for tissue to be removed was deficient
• there was not adequate communication between families, coroners and establishments carrying out post-mortem examinations, which could lead to tissue being retained after the coroner has completed their work
• tissue taken during post-mortem examination could not always be traced from removal through to the creation and storage of microscope slides

The HTA also saw an increase in the number of complaints about establishments carrying out post-mortem examinations, either from staff at the establishment or from members of the public. Receipt of information from complaints and other channels led to the HTA carrying out seven non-routine site-visit inspections out of a total of 37 site-visit inspections.

In light of the findings, the HTA will carry out more site-visit inspections in the next year to monitor compliance, and provide advice and guidance to help drive up standards. It has already allocated more resources. The HTA expects to see an increase in compliance over the next year.

Dr Sandy Mather, Director of Regulation at the HTA, said:

"The HTA has been regulating for over three years now and we would expect to see all licensed establishments fully complying with our standards. We are concerned that the post mortem sector has not shown improvements over the last year. While we found some establishments exemplify good practice, others are struggling to get up to standard.

"Most people who work in mortuaries want to meet HTA standards and comply with the Human Tissue Act, but there is a small minority who still do not accept the legislation. That small minority has a strong voice. However, an even stronger voice comes from the public who demand regulation of the post mortem sector, Parliamentarians who created the legislation, and those complying with our regulation who have seen the benefits.

"We think that the diversity of staff from different organisations who work together may be one reason why some organisations struggle. The legislation and professional guidelines that influence the work of one individual within the sector may differ from those that influence the work of another. When the duties of these individuals overlap and conflict, there is a potential for non-compliance. We are working hard to help post mortem establishments improve, for example by creating a flowchart of communication and individual responsibilities, and we will work with other bodies to help streamline regulation, but we need to see the establishments invest as well.

She continued:

"We are aware that the public might have concerns about standards following the regulatory action that we took at Cardiff and Vale NHS Trust (now Cardiff and Vale University Local Health Board) post mortem facilities in August. We would like to reassure members of the public that much has changed since the introduction of the HT Act; there are now stringent standards that those carrying out post-mortem examinations must comply with. Where we find poor compliance we will work with establishments to help them get back up to standard or, where compliance is a matter for serious concern, we will take proportionate regulatory action.

"Our regulation in the post mortem sector aims to support the confidence of public and professionals. The nature of mortuary work means that it has potential for significant distress to relatives and friends of the bereaved when things go wrong. It is, therefore, essential that organisations comply with our standards."

Tissue used as treatments

Some progress was made in the sector using human tissue for patient treatment (also known as human application) in the last year, but there remain areas where some establishments are not up to standard, including:

• under-development of quality management systems
• immature systems for reporting serious adverse events and reactions
• failure to meet all mandatory donor testing requirements
• deficits in standards for environmental monitoring during processing

In addition, since the HTA started regulating the collection of cells and tissues in July 2008, we have found that procurement organisations, in particular those collecting cord blood for private use, require a significant amount of support to enable them to fully comply with regulatory requirements. We also received a high number of enquiries from both members of the public and midwives wishing to know more about the regulation of cord blood collection.

Sandy Mather, Director of Regulation at the HTA, said:

"We have implemented this regulation in a way that puts patient safety first while making it as simple as possible for professionals to become compliant. We have given extensive advice and guidance to those in the sector and hope to see more progress in the coming year."

For more information please contact Claire Bithell, Senior Media Advisor at the Human Tissue Authority, on 020 7211 3439 or claire.bithell@hta.gov.uk

Notes to editors

• The summary of compliance reports are available on request.
• The HTA is an independent watchdog that protects 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. The Quality and Safety Regulations cover the whole of the UK, including Scotland.
• 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.
• Under the Quality and Safety Regulations, the HTA licenses organisations that treat patients with human tissue and cells, including stem cells, skin and heart valves. We refer to these organisations as having an HTA licence for ‘human application'. This means that the human tissue will be used to treat patients. This type of licence can be issued to a wide variety of organisations, including:
• eye banks that store corneas to treat people who have sight problems
• maternity units where umbilical cord blood is collected. The cord blood is then stored and may be used in the future to treat the child or another person. The HTA licenses the collection and storage of the cord blood, but not any treatment using stem cells taken from it.
• organisations that store skin and bone. These can be used in grafts, or example to treat burns or to repair bone injuries
• organisations that store heart valves which are used to treat people with heart disease or other conditions
• 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.