Our regulatory approach aims to be right-touch and in line with the principles of better regulation and the Regulators’ Code. This means that we primarily focus our regulation and resources on areas that involve an inherently greater risk to patient safety and public confidence if standards are not maintained.
We employ a range of regulatory tools in order to ensure compliance with the legislative requirements, including licensing, inspection, reporting requirements and the provision of advice and guidance.
The legislation prescribes certain activities that can only be undertaken by a licensed establishment.
We license establishments across six sectors:
- Post Mortem, Public Display, Research, and Anatomy (under the Human Tissue Act 2004)
- Human application – tissues and cells used in patient treatment (under the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as amended)
- Organ Donation and Transplantation (under the Quality and Safety of Organs Intended for Transplantation Regulations 2012, as amended)
The establishments we license must adhere to our standards, which align to our core principles.
Inspections or audits
We conduct site visits of licensed establishments in order to assess whether our standards are being maintained. We schedule inspections based on a number of factors, including the legislative requirements, and according to the risk of the activities being carried out. We welcome the significant degree of trust that the vast majority of our licensed establishments have in us, as demonstrated by their openness and willingness to improve, which we believe is a key factor in the high level of compliance we see. As a result we only use significant regulatory action when it is appropriate and in the public interest.
We also undertake non-routine inspections, both announced and unannounced, when we have information which indicates that an inspection may be necessary due to the risks presented.
We require incidents and events which pose the highest risk to public confidence and patient safety to be reported to us by licensed establishments. This reporting, along with issues and complaints about licensed establishments that are raised with us by third parties, allows us to take action if required.
Advice and guidance
We provide advice and guidance to both the public and professionals, and recognise the value in supporting establishments to comply, rather than dealing solely with non-compliance. We publish a range of Codes of Practice and sector specific advice and guidance, as well as answering individual enquiries from establishments and members of the public. We share learning gained from inspections, incident reports and compliance updates through our newsletters and publications.
Living donation assessment
The HTA maintains a system to ensure that donations of organs or tissue for transplantation from living people are given without coercion or reward. The system relies on donor and recipient interviews, undertaken by a group of independent and accredited assessors. They are predominantly volunteers whom we train, accredit and support in order to fulfil our statutory functions. Complex cases are reviewed by panels, made up of HTA Authority Members.
Communication and engagement
We recognise communication as a key component of effective regulatory delivery. We utilise a range of channels to communicate with professionals, the public and key stakeholders to ensure that there is confidence in HTA regulation and in the services being regulated. We involve these groups to ensure we make decisions that take into account, as far as possible, the operational realities faced by professionals and the concerns of the public. Our formal groups, which report to the Authority include:
- Stakeholder and Fees Goup
- Histopathology Working Group
- Transplantation Advisory Group
We also engage virtually via our public panel and licensed establishment engagement programme, which provide fora for wider participation and further opportunities for those interested or affected by our work to be involved in, and inform, it.
Working with other organisations
Many of the establishments within our remit are also regulated or accredited by other bodies. We continue to see collaboration as a key tool for achieving benefits for professionals and the public that produces joined up results, reduces our costs or reduces regulatory burdens. The HTA has bilateral agreements with the following:
- 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.
- Deliver a right touch programme of licensing, inspection and incident reporting, targeting our resources where there is most risk to public confidence and patient safety.
- Deliver effective regulation of living donation.
- Provide high quality advice and guidance in a timely way to support professionals, Government and the public in matters within our remit.
- 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.
- 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 period covered by this strategy, we will:
- Ensure that new applications meet appropriate standards before issuing a licence.
- Further utilise our knowledge of risk in each sector to apply the right mix of regulatory tools to support compliance.
- Undertake a risk-based programme of site visits which provide assurance that standards are being maintained.
- Publish exception-based reports of inspections in the interests of transparency and to share learning.
- Take a proportionate and risk-based approach to non-compliance, and ensure that where there are shortfalls against standards, these are rectified within agreed timescales or escalated appropriately.
- Ensure decisions on living organ donation cases meet agreed service standards in a way that provides the necessary protections.
- Engage with, and involve, public and professional stakeholders in our work using a wide variety of channels.
- Use the results of our public evaluation to create awareness of what drives public confidence, what the public are most interested in, and why.
- Seek out opportunities to build new collaborations for the benefit of stakeholders.