HTA Business Plan 2020/21

The HTA is an executive Non-Departmental Public Body sponsored by the Department of Health and Social Care, established by the Human Tissue Act 2004.

Our overall goal is to maintain public confidence by ensuring that the removal, storage and use of human tissue and organs are undertaken safely and ethically, and with proper consent, in accordance with the provisions of the Human Tissue Act 2004, Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended).

We also have a role in maintaining professional confidence; by assuring that human material being used by professionals has been obtained with the proper consent and is managed with appropriate care.

Our role

• We license organisations that remove, store and use human tissue for certain activities under the Human Tissue Act 2004. 
• We license organisations involved in preparing tissues and cells for use in patient treatment as required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
• We license organisations involved in organ donation and transplantation as required by the Quality and Safety of Organs Intended for Transplantation Regulations 2012.
• We monitor and inspect or audit organisations to ensure they comply with the requirements of the legislation and our Codes of Practice.
• We use our powers to take regulatory action where we identify non-compliance.
• We assess living organ donations to ensure donors are protected from duress or coercion, and that no reward is offered or given.
• We provide information, advice and guidance to the public and professionals about the nature and purpose of activities within our remit.
• We monitor developments relating to activities within our remit and advise Government on related issues.

In addition to our statutory role we are increasingly called upon to provide advice on areas related to, but not specified in, our legislation. This is particularly important in areas of emerging technology and cutting-edge research not originally envisaged when the Human Tissue Act was enacted.

Our remit

• Removal, storage and use of human tissue and organs for a number of activities and scheduled purposes as set out in the Human Tissue Act 2004, such as post mortem examination, anatomical examination, research, transplantation and public display.
• Procurement, testing, preservation, processing, storage, distribution, import and export of tissues and cells for use in patient treatment (human application).
• Donation, testing, characterisation, procurement, preservation, transport, transplantation and disposal of organs for transplantation.

Our remit under the Human Tissue Act 2004 extends to England, Wales and Northern Ireland; however, we also carry out some activities in relation to the approval of living organ donations on behalf of the Scottish Government. Our remit as the Competent Authority for the quality and safety of tissues, cells and organs used in transplantation extends to the whole of the UK.

We license over 800 premises across the six sectors that we regulate and publish standards and requirements that those working within these regulated fields must meet.

Whilst the HTA has a statutory duty to superintend compliance and an influential role in promoting good practice, public confidence in the use of human tissue cannot be safeguarded by the HTA alone. Public confidence is also dependent on the individuals and organisations that undertake activities within the HTA’s remit acting within the standards and requirements of the legislation.

Guiding principles

Four guiding principles continue to drive our work and underpin our regulatory framework. They should be followed in dealing with human bodies, tissue and organs:

• Consent  and the wishes of the donor (or in some cases, their nominated representatives or relatives) are the primary consideration when removing, storing and using human tissue.
• Dignity  is paramount in the treatment of human bodies and tissue.
• Quality  must underpin the management of human bodies and tissue.
• Honesty and openness  are the foundation of communications in matters pertaining to the use of human tissue and bodies.

Our values

Our values as an organisation in carrying out our role, expressed in all interactions are:

• Professionalism the high standards we apply in the conduct of our individual and collective responsibilities.
• Respect proper regards for the abilities and perspectives of others.
• Expertise the skills, knowledge and experience we apply for the benefit of our stakeholders and each other.
• Agility rapid and positive response to changes in the internal and external environment without losing momentum.

Key activities

We group our key activities into three themes:

• Delivery  how we achieve our strategic objectives today.
• Development  how we will improve in the future.
• Deployment  how we effectively use our people and resources.

Through these themes, our strategy sets out the ways in which we will strive to be a more resilient, sustainable and agile organisation. in order to meet the challenges ahead.

We are now in the third year of a multi-year strategy stemming from a review that took place in 2017. At this time, the HTA undertook a fundamental evaluation of the extent to which our strategic approach protects public and professional confidence in the proper use, and quality and safety of, human tissues, cells and organs. We based this evaluation on evidence and analysis from a variety of sources, including the views of those working in establishments we regulate, an evaluation of public opinion, analysis of the data we hold, and the views and opinions of HTA staff and Authority Members.&

An assessment of the evidence provided us with great reassurance that both the public and professionals think we are on the right track with our regulatory approach. However, the review identified opportunities and challenges relating to our operating environment that require us to adapt as an organisation. 

As a statutory body, our aim remains unchanged. As such, our review focused on evaluating our future operating environment and whether our resources are optimally aligned to where the risks are greatest. 

Our strategy therefore continues to focus on the steps we need to take in order to operate in a more sustainable way, building in greater resilience and agility in the face of increasing complexity and uncertainty in our external environment.   

Sustainability 

By sustainable, we mean taking a new approach to recruiting, developing and retaining high-quality staff and working in new ways to reduce the growing pressures on the staff we have. 

Resilience 

By resilience, we mean adapting our operating model to retain staff for longer and developing strategic alliances with other organisations to put us in a better position to manage unexpected demands. 

Agility 

By agility, we mean providing a highly responsive regulatory framework that supports innovative uses of organs, tissues and cells, burnishes our reputation as an expert regulator and actively supports the Industrial Strategy for Life Sciences. 

Success will mean retaining alignment with core principles and values, whilst developing our staff in a flexible manner to lead and adapt to innovations in our area of regulation. 

In order to meet the challenges ahead we require continued focus on our: 

• people recognising our staff as our key asset, widening the pool of candidates for recruitment beyond the South East and investing in training and development;
• business Technology ensuring our systems are not reliant on location and making strategic choices about key business systems ;
• information and data meeting our obligations relating to data security and using information and data as a key strategic resource; and 
• finance being clear about managing our fee levels based on workload and regulatory effort, including longer term planning to ensure continued financial viability.

This business plan sets out our ambitions for 2020/21. The HTA operates a continuous business planning process - we maintain a pipeline of proposed business activities over a three-year period, which allows us to adapt and plan in response to changes in our operating environment.

Our overarching aim remains to protect public and professional confidence in the safe and ethical use of human tissue, as set out in our governing legislation. We do this by utilising a combination of regulatory tools, which we deploy according to risk across each of the sectors we regulate.  Our core delivery activities are centred on licensing, inspection, incident reporting, assessment of living organ donation, providing advice and guidance, and communicating and engaging with stakeholders.

We have a long-established culture of working with establishments to ensure that they meet our standards, targeting our resources at the areas of greatest risk to patient safety and public confidence.  We encourage improvement through the provision of high-quality advice and guidance and sharing best practice, publishing our inspection reports so we are transparent about our findings, and so that others can learn.  When things go wrong we ensure that establishments take appropriate action, including measures to prevent future incidents from happening.

Whilst the HTA has a statutory duty to superintend compliance and an influential role in promoting good practice, public confidence in the use of human tissue cannot be safeguarded by the HTA alone.  Public confidence is also dependent on the individuals and organisations that undertake activities within the HTA’s remit acting within the standards and requirements of the legislation. Our network of Designated Individuals and Persons Designate are vital partners in our regulatory framework, and we continue to engage and work with those in key roles across the sectors we regulate.

Office relocation

In 2020/21 we are undertaking a project to move offices to a new, shared space with other arm’s length bodies of DHSC. This will give us new opportunities to share learnings and improve the overall regulatory framework for organisations working across the healthcare spectrum. Our key aim for this business year is to maximise the opportunities this affords us while maintaining our core regulatory work and operational capability through this period of change.

Introduction of Deemed Consent in England

The Organ Donation (Deemed Consent) Act 2019 came into force on 20th May 2020, changing the legal basis for consent for deceased organ donation in England. We worked with stakeholders and government throughout 2019/20 to amend our Codes of Practice, and this year will be supporting the introduction of the new system as it is rolled out.

EU Exit Transition Period

Following the UK’s exit from the EU, we are continuing to work closely with DHSC and its arm’s-length bodies to understand the opportunities available to the UK and our health and care system. This includes supporting the cross-organisational work on the UK’s future relationships with the EU and the rest of the world.

We will work with the Department to contribute to delivering the future relationship with the European Union and implementing the Northern Ireland Protocol. We will also work closely with DHSC to ensure preparations are in place throughout the transition period and assess any implications this may have on the sectors we regulate.

We will continue to update our business continuity plans in line with the UK’s future relationships with the EU and the rest of the world, and continue to contribute to the post-EU Exit planning and coordination work undertaken by the DHSC.

Communications and engagement

We continue to engage with and involve both professionals and the public on our work, and provide timely advice and guidance on areas that affect them.

Our website redevelopment programme continues throughout 2020/21, improving the structure, design and content of our website and ensuring we meet new accessibility requirements by October 2020

 Our existing advisory groups and our public panel, a virtual group of the public who have volunteered to input into our work on an as needed basis, will help us ensure that the best quality and most accessible content is available online for both professionals and the public.

Organisational change and smarter working

We will maintain our focus on improving ways of working to make the most effective use of our people, business technology and information and data. In response to the COVID-19 pandemic we are adapting our oversight model to develop a remote form of assessment. We will build on this model over the coming months as we continue to target our resource to areas where risk is greatest. We have also responded effectively to the recent move to remote working, minimising the impact of the changes on our staff and their ability to deliver our regulatory functions. We will combine the learnings from this with existing work on improving our use of data to facilitate a more targeted, risk-based, approach to regulation.  The benefits include improved horizon scanning, better targeting of regulatory effort to risk and more innovative use of data and technology to improve regulatory outcomes.

Human Application

Alongside our core delivery, the focus in the Human Application sector this year will be further developed to improve and streamline our internal procedures and support those actively working in this sector. This will include issuing guidance on a range of emerging policy areas and licence variation procedures.

We will continue to review and adjust our inspection and assessment processes, particularly in view of COVID-19, to ensure they are proportionate and aligned with risks in the sector;

Organ Donation and Transplantation

We continue to work closely with the sector, particularly NHS Blood and Transplant (NHSBT), in the oversight of Serious Adverse Events and Reactions, ensuring that learning from these incidents is shared appropriately.

Research

Our partnership with the Health Research Authority (HRA) will continue throughout the 2020/21 business year, supported by our long-term secondment arrangement involving one of our Regulation Managers.

Post Mortem

We remain committed to working closely with the sector, providing guidance and support based on learning from inspections and incident investigations. We will continue to support efforts to build emergency mortuary capacity and any other licensing needed as part of the response to COVID-19.

We continue to maintain strong links with professional stakeholders within the sector and other groups, including the Association of Anatomical Pathology Technology, Royal College of Pathologists, Coroner’s Society for England and Wales and the Home Office Forensic Science Regulation Unit. The HTA’s Histopathology Working Group provides a platform for us to engage with these bodies and we will also continue to contribute to external training and engagement events where possible.

Anatomy

Providing advice and guidance about body donation remains an important and valued service to the public and will continue during the 2020/21 business year.

We continue to attend, and present at, sector-related events, maintaining strong links with professional bodies and the Anatomy Associations Advisory Committee (AAAC). We will also liaise with Coroners about the death certification requirements for body donation.

Public Display

The sector continues to be the smallest but with a diverse range of collections with varying degrees of risk and public interest.

Engagement continues with sector establishments to ensure that regulation in this sector remains proportionate.

The HTA’s high-level aims, objectives and high-level milestones and deliverables for 2020/21 are set out in this section.  This information is supported by our key performance indicators (KPIs) at the end of this Plan, which set out how we will measure whether we are achieving those aims.

Delivery

Delivery – To deliver the right mix of activity to maintain public and professional confidence in the safe and proper use of human tissue

Our Delivery objectives for 2020/21 are to:

• Deliver a risk-based, data-driven and proportionate 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 decisionmaking 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. 

During 2020/21, we will:

• Provide appropriate communications and advice and guidance to sectors and organisations we regulate to help them prepare for EU exit.
• Continue to use our knowledge of risk in each sector to inform the delivery of the right mix of regulatory tools to support and superintend compliance.
• Undertake a risk-based programme of assessments which provide assurance that standards are being maintained, working within the constraints of COVID-19.
• Take a proportionate and risk-based approach to non-compliance, and ensure there where there are shortfalls against standards, these are rectified within agreed timescales.
• Ensure that decisions on living organ donation cases meet agreed service standards in a way that provides the necessary protections.
• Engage with, and involve, public, Government and professional stakeholders in our work using a wide variety of channels.
• Provide high quality and timely responses to enquiries from professionals, the public and the media.

Development

Development - to make the right investment to continuously improve delivery and deployment

Our development objectives for 2020/21 are to:

• Use data and information to provide real-time analysis, giving us a more responsive, sharper focus for our regulatory work and allowing us to target resources effectively.
• Make continuous improvements to systems and processes to minimise waste or duplicated effort, or address areas of risk.
• Provide an agile response to innovation and change in the sectors we regulate, making it clear how to comply with new and existing regulatory requirements.
• Implement and embed a future operating model, which builds our agility, resilience and sustainability as an organisation.

During 2020/21, we will:

• Continue to advise and respond to DHSC, its arm’s length bodies and our licensed establishments to support the UK’s exit from the EU;
• Embed business technology changes made in 2019/20 to support continued high-quality delivery of our functions and further develop our business technology to provide seamless working with other arm’s length bodies when we move to our shared office;
• Develop the structure, design and content of our website to improve the user experience for professionals and the public, and ensure we meet new accessibility guidelines
• Further plan, develop, and implement an organisational change programme.
• Build new tools for evaluating and inspecting the organisations we licence, using the learnings from the changes we’ve needed to make as a short term response to COVID-19.
• Further develop the HTA’s risk-based approach to regulation and definition of associated data sets.

Deployment

Deployment – To make the most effective use of people and resources in pursuit of our goals

Our deployment objectives for 2020/21 are to:

• Manage and develop our people in line with the HTA’s People Strategy 
• Ensure the continued financial viability of the HTA while charging fair and transparent licence fees and providing value for money 
• Provide a suitable working environment and effective business technology, with due regard for data protection and information security 
• Plan and prioritise our resources to carefully balance activity across the organisation 

In 2020/21, we will:

• Focus on supporting and retaining staff through the disruption caused by COVID19 and up to and beyond the office move, including a shift to increased home and flexible working
• Work through the opportunities provided by the move to develop our organisational culture, resilience and capability
• Implement our revised induction and training programme based on a comprehensive training needs analysis;
• Review our current fees to ensure the costs to regulated establishments are fair and proportionate
• Further embed information governance and cyber security good practice within the organisation.

Our people

As a small, expert regulator, the HTA has long recognised a strategic risk related to staff recruitment and retention – in particular, our vulnerability to the loss of experienced staff undertaking our frontline regulatory work. In response to this risk, we implemented our People Strategy, which has made good progress in mitigating our human resource risk through initiatives such as flexible working and a career development scheme. However, the ability to recruit high-quality candidates, and retain and develop staff expertise, remain significant areas we need to address to improve our resilience and sustainability. Retention is a particular concern throughout the period of change caused by COVID-19 and the office move.

In 2020/21 we will continue to strengthen our framework to support remote working and will focus on ensuring that the well-being of our staff is maintained. We will also use the COVID-19 period of disruption and the office move as an opportunity to strengthen our organisational culture with new ways of working being developed, and develop tools for longer-term planning for staff capacity and capability once the office move is complete.

During 2019/20, it is expected that:

• The HTA will have 3.5 Full-Time Equivalents (FTEs) who are classified as executive senior managers, within the total of 51 FTEs;
• there will be 1.5 FTE Human Resources members of staff within the full complement of 51 FTEs;
• the training budget will equate to around 1.5 per cent of the pay bill.

Any non-payroll staff will be subject to defining programme requirements for the organisational transformation and will likely be limited in their duration of engagement.

Finances

The HTA receives funding from two main sources.  The majority (80 per cent) comes from licence fees, with the remainder provided as grant-in-aid from our sponsor, the Department of Health and Social Care.  We also receive a small amount of income for undertaking activities on behalf of the devolved administrations and from sub-letting part of our office space.

The licence fee income pays for a range of activities associated with our licensed establishments:

• Evaluating licence applications;
• making licensing decisions and issuing licences;
• processing variations to licences;
• conducting site visits and following-up shortfalls;
• taking regulatory action;
• providing advice and guidance to licensed establishments.

Grant-in-aid funds our role in assessing living organ donations and bone marrow / peripheral blood stem cell donation cases and a proportion of our overheads that are not directly associated with our work with licensed establishments

We place great importance on ensuring that our finances are managed efficiently, effectively and in a way that minimises risk. As an arm’s length body, we continue to monitor developments in the wider public sector financial environment and are committed to implementing best practice. We have robust financial procedures and policies in place and strict controls in relation to authorisation of expenditure.

The high-level budget for 2020/21 is shown below:

Efficiency and productivity

As an organisation, we remain committed to seeking benefits from continuous improvement initiatives and delivering value for money for both the public and the establishments who we licence. We also recognise that following many years of making efficiencies, we are a very lean organisation.  We remain committed to delivering our core functions to a high standard, finding further efficiencies in the way we work where possible, and the importance of focusing on outcomes that really matter to the public and professionals.

Shared services

We continue to operate our resources function as part of a shared directorate with the HFEA. The office move will bring us into the same shared space along with other arm’s length bodies and will offer opportunities to enhance this and other relationships. We are working jointly with the other arm’s length bodies to develop the plans for the new accommodation, and the cultural and technological elements of the move, embracing new technology and new ways of working in keeping with the overarching ethos of the Government hubs programme.

Digital, Data and Technology

In 2018 we set out our new digital, data and technology (DDaT) strategy. Successfully achieving the outcomes of this strategy will contribute significantly towards achieving the HTA’s strategic development and deployment objectives and enable colleagues to achieve the delivery objectives, and is an essential part of our Development Programme.

In 2020/21 our DDaT priorities will include:

• Support for remote working in response to COVID-19 and in preparation for the office move;
• Embedding the tools available as a result of investment in technology in 2019/20, in particular the move to Office 365
• better use of information and data, in particular in relation to risk;

These priorities will be balanced alongside a background of continuous improvement to ensure that we continue to capitalise on more efficient and effective ways of working.

Capital

Our capital investment plans for 2019/20 are based on our cyclical refresh of Information Technology equipment.  As a result we will limit our expenditure to our normal delegation of Capital Funds from the Department of £100k (which has not yet been confirmed at the time of publication).

Monitoring and measuring performance

The COVID situation has made our usual methods of tracking performance and our KPIs less relevant. We are using the opportunity presented by this situation to review what we track and measure, to strengthen our management information and assurance information reporting. We account for our performance quarterly to the Board and to DHSC. The information we use to demonstrate our performance can be found in the Authority Meetings section of our website.