Human Tissue Authority

The regulator for human tissue and organs

Delivery

To deliver the right mix of activity to maintain public and professional confidence

Our aim at the HTA is to be a right-touch regulator. 

This means we primarily focus our regulation on establishments that carry out activities that involve an inherently greater risk to public confidence if standards are not maintained, and establishments that we assess as being at the greatest risk of non-compliance.

We license establishments – as required by legislation – to a set of standards, which are aligned with our principles, and designed to promote public confidence. Assurance that those standards are being met is achieved through a variety of mechanisms, including inspections, reporting requirements and the provision of advice and guidance.

We also continue to embed the principles of better regulation in our work, both day-to-day and specifically by:

  • reducing our regulatory burden where possible (you can see the HTA Burden Reduction Plan on our website here);
  • ensuring there is even greater transparency around the impact of regulation on business; and
  • reporting against the Government’s Business Impact Target (BIT).

HTA inspections – Inspections take place in each sector – according to the legislative requirements – and the regulatory risk of each sector, as well as the risk specific to each establishment. We work with establishments to schedule inspections at mutually convenient times. We recognise the significant level of compliance and transparency across our sectors, and believe that this approach enables us to reduce the burden of the inspection without increasing the risk of non-compliance.

We also undertake non-routine inspections, both announced and unannounced, when we have information which indicates that a site visit is required, for example if we receive intelligence on non-compliance, or from our analysis of data received from compliance reports between inspections.

Reporting requirements – We do place reporting requirements on licensed establishments, to inform us of incidents and events posing the highest risk to public confidence and patient safety. This allows us to take appropriate action, should things go wrong, and to ensure that any lessons learnt can be shared across the system.

Some examples of how experience is shared can be seen in some of our recent reports, including:

You can read more on our website here.

Advice and guidance – We have a statutory duty to provide advice and guidance to establishments. We place a great emphasis on this, so we can work with establishments to achieve compliance in partnership, rather than dealing solely with non-compliance. This approach has enabled us to develop strong links with representatives in each sector that we regulate. It means we are able to engage with them about issues across the sector, and gain a better understanding of the challenges they face and this in turn informs our regulatory policy development. Similarly, it gives them a better understanding of our requirements. It also means that we only use significant regulatory action when it is appropriate and in the public interest.

Living donation assessment – Under the HT Act, it is an offence for a reward to be sought or offered for a human organ or tissue for transplantation. The Act also provides independent protection to donors, in the rare cases where a donor is pressured to act against his or her wishes. The living donation assessment acts as a deterrent to donors and recipients entering the living donation programme with reward as a motivation. The system relies on donor and recipient interviews, undertaken by a group of independent and accredited assessors. They are predominantly volunteers who we train, accredit and support in order to fulfil our statutory functions, and to whom we offer our thanks and appreciation. Complex cases are reviewed by panels, made up of HTA Authority Members.

Communicating with professionals and the public – We have structured communication with professionals, the public, and our strategic partners to ensure that there is confidence in HTA regulation and in the services being regulated. Our approach is to provide relevant, high quality information, available on demand to these groups via our website, and to target information to specific audiences via a range of other channels. We involve these groups to ensure we make decisions that reflect, as far as is possible, the operational realities faced by professionals and the concerns of the public.

The groups, which report to the Authority include:

  • the Stakeholder Group;
  • the Histopathology Working Group; and
  • the Transplantation Advisory Group.

They are made up of stakeholders, Authority Members and Executive staff. They are used to seek stakeholder views and advise the HTA on the impact of its regulatory activity.

We also provide the public with the information that they need to understand what they should expect from the services we regulate, and to allow them to make informed decisions about using these services.

This work is underpinned and directed by a programme of monitoring and evaluation, to ensure our messages are up to date, relevant, and meaningful for the audience – addressing their interests and any concerns.

Working with other regulators – Many HTA licensed establishments are also regulated or accredited by other bodies. The HTA recognises the impact that this can have on an establishment, so structured collaborative working with other bodies is also an important feature of our strategic approach to minimise regulatory burdens. The HTA has bilateral agreements with:

  • the Care Quality Commission;
  • the Health Research Authority;
  • the Human Fertilisation and Embryology Authority;
  • the Medicines and Healthcare products Regulatory Agency; and
  • the United Kingdom Accreditation Service. 

Objectives for 2017/18

Our Delivery objectives remain, to:

  • Deliver right-touch regulation and high quality advice and guidance, targeting our resources where there is most likelihood of non-compliance and greatest risk to public confidence.
  • Be consistent and transparent in our decision-making and regulatory action, supporting those licence holders who are committed to achieving high quality and dealing firmly and fairly with those who do not comply with our standards.
  • Deliver effective regulation of living donation.
  • Inform and involve people with a professional or personal interest in the areas we regulate in matters that are important to them and influence them in matters that are important to us.
  • Maintain our strategic relationships with other regulators operating in the health sector.

In the remaining period covered by this Strategy, we will:

  • Undertake and publish reports on a programme of site visits and inspections which meet the aims of the HTA, and licensed establishments, and which provide assurance to the public that standards are being maintained.
  • Take a proportionate approach to our regulation, and ensure that where there are shortfalls against standards, these are rectified within agreed timescales.
  • Ensure decisions on living organ donation cases meet agreed service standards in a way that provides the necessary protections.
  • Engage with, and involve, the public and professional stakeholders in our work, seeking feedback and comment using a wide variety of channels on and offline.
  • Conduct a public evaluation to measure what areas of our work the public are most interested in being involved in, and why.

Last updated on: 6 Apr 2017