HTA Business Plan 2019 - 20

Who we are and what we do

The HTA is an executive Non-Departmental Public Body sponsored by the Department of Health and Social Care (DHSC), 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 provision of:

• the Human Tissue Act 2004 (and associated Regulations);
• the 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 (as amended);
• we license organisations involved in organ donation and transplantation as required by the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended);
• we monitor and inspect or audit organisations to ensure they comply with the requirements of the legislation and our standards;
• 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; and,
• 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 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 for the quality and safety of tissues, cells and organs used in human application and transplantation extends to the whole of the UK.

We license approximately 855 premises across the six sectors that we regulate and publish standards and requirements that those working within the regulated fields must meet.

Four guiding principles continue to drive our work and underpin our regulatory framework. They should be followed when 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.

The Authority – the HTA’s non-executive board – is made up of a Chair and nine Members who are appointed by the Secretary of State for Health and Social Care; one Member appointed by the Welsh Cabinet Secretary for Health and Social Services, and one by the Minister for Health in Northern Ireland. The professional Members of our board come from medical and scientific backgrounds linked to our work, and the lay Members bring a wide range of business, commercial and public sector experience.

The Authority’s primary role is to ensure that the HTA discharges its statutory responsibilities effectively. It achieves this by setting the HTA’s strategic direction and providing both support and challenge to our Executive Team, which is responsible for the delivery of these responsibilities on a day-to-day basis. Further details on our staff can be found in the Resources section of this business plan.

In line with government requirements, we produce this document annually. It should be read in conjunction with the HTA’s Strategy for 2019 – 2022, which outlines the HTA’s strategic approach and high-level objectives for the next three years.

Our essential activities remain grouped within three themes:

1. Delivery – to deliver the right mix of operational activity to maintain public and professional confidence in the safe and proper use of human tissue
    
2. Development – to make the right investment to continuously improve delivery and deployment
    
3. Deployment – to make the most effective use of people and resources in pursuit of our goals

This business plan sets out our ambitions for 2019/20. 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.

Organisational change and smarter working

In order to achieve our vision the HTA is embarking upon a Development Programme, which aims to see the organisation working in smarter ways to make most effective use of our people, business technology and information and data. Preparations for a move to a new office location in 2021 provide additional opportunity to improve how we operate.

The benefits to the HTA, and therefore its stakeholders, of this Programme are based around improvements to systems and processes that facilitate a more targeted, risk-based, approach to regulation. This will also lead to a streamlining of our interactions with the public and professionals ensuring the information needs of each audience is met in the timeliest and most appropriate manner and that the regulatory burden can reduce where possible. 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.

EU exit

As the Competent Authority for two sets of EU Directives covering the human application and organ donation and transplantation sectors, the HTA has worked closely with DHSC and its arm’s length bodies to prepare for the UK’s exit from the European Union. We will continue to do so, implementing any legislative changes into operational practice and providing advice and guidance for our licensed establishments to enable them to comply with amendments to the applicable Regulations.

We have the appropriate governance and accountability structures in place to monitor and assess the impact of EU Exit on the HTA, and resource has been allocated which can be redirected as required. 

Introduction of Deemed Consent in England

The Organ Donation (Deemed Consent) Act 2019 received Royal Assent on 15 March 2019; when the new law comes into force it will change the legal basis for consent for deceased organ donation in England. Close engagement with public and professional stakeholders will remain an important priority as we make amendments to our Codes of Practice to support the introduction of the new system form April 2020.

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.

For professionals, our focus over the next year and beyond will be on developing and improving our digital engagement channels, as well as continuing to work with our existing advisory groups. Over the last year we have been reviewing the content across our website, and the next phase in this programme of work will be to redevelop the site to improve the structure and design, whilst meeting new accessibility requirements.

For members of the public, we will focus on how we can best make information about the HTA and the areas we regulate accessible when they need them – this will include working with other organisations such as patient facing groups and professional bodies. We will continue to work with our public panel, a virtual group of the public who have volunteered to input into our work on an as needed basis, to ensure that the best quality and most accessible content is available online for the public.

Human Application (HA)

Alongside our core delivery, the focus in the HA sector this year will be further development 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. In parallel we will examine our licensing model as it applies to satellite sites and how we superintend activity carried out under the terms of third party agreements.

We will continue to review and adjust our inspection processes to ensure they are aligned with risks in the sector; a likely focus of the coming inspection cycle will be processing of tissues and cells. This year, greater emphasis will be placed on sharing learning from inspections to enable establishments to review, and if necessary amend, their working practices to ensure compliance with the legislative requirements.

Organ Donation and Transplantation (ODT)

Living donation: The focus this year will be on the delivery and implementation of the remaining work to improve the sustainability of the Independent Assessor framework. The aim of this work is to ensure the independent assessment process is future-proofed as far as possible, maintaining a system that remains robust, effective and able to respond to sector demands. This includes streamlining processes and reviewing training to support Independent Assessors across the country.

Deceased donation: As outlined above, we will be drafting, consulting on, and publishing updates to HTA Codes of Practice A and F to reflect the introduction of deemed consent legislation in England.

We have committed to reviewing the assessment criteria used during on-site audits to ensure they remain robust and fit for purpose in an area of medicine that is rapidly evolving. This will include a review of our Quality and Safety of Organs Intended for transplantation: A documentary framework. 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 2019/20 business year, supported by our long-term secondment arrangement involving one of our Regulation Managers. Following the publication of the HRA/HTA public dialogue on ‘Consent to use human tissue and linked health data in health research’, we will further build on this work with HRA to improve our existing guidance and produce new guidance where it is needed.

Post Mortem

We remain committed to working closely with the sector, providing guidance and support based on learning from inspections and incident investigations.

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 2019/20 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. Within the last year, there have been two additional licence approvals, which have generated significant interest in the sector.

Engagement continues with sector establishments through our licensed establishment engagement programme and Stakeholder and Fees Group to ensure that regulation in this sector remains proportionate.

The HTA’s high-level aims, objectives and high-level milestones and deliverables for 2019/20 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

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 2019/20 are to:

1. 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;
2. deliver effective regulation of living donation;
3. provide high quality advice and guidance in a timely way to support professionals, Government and the public in matters within our remit;
4. 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;
5. 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; and,
6. maintain our strategic relationships with other regulators operating in the health sector.

During 2019/20, 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 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 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; and,
• provide high quality and timely responses to enquiries from professionals, the public and the media.

Development

To make the right investment to continuously improve delivery and deployment.

Our development objectives for 2019/20 are to:

1. Use our data and information to provide real-time analysis, giving us a more responsive, sharper focus for our regulatory work and allowing us to target our resources effectively;
2. make continuous improvements to our systems and processes to minimise waste or duplicated effort, or address areas of risk;
3. 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; and,
4. begin work on implementing a future operating model, which builds our agility, resilience and sustainability as an organisation.

During 2019/20, 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;
• draft, consult and publish updated Codes of Practice to support the introduction of deemed consent in England;
• develop and implement options for providing training for those at licensed establishments;
• plan and prioritise the necessary business technology changes to support continued high quality delivery of our functions; and,
• embark on a series of prioritised projects which will constitute the HTA’s Development Programme, including: further development of the HTA’s risk-based approach and definition of associated data sets; redevelopment of the HTA’s website; greater adoption of cloud based technologies to better support remote working. Any projects will be undertaken within existing resource allocations.

Deployment

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

Our deployment objectives for 2019/20 are to:

1. Manage and develop our people in line with the HTA’s People Strategy;
2. ensure the continued financial viability of the HTA while charging fair and transparent licence fees and providing value for money;
3. provide a suitable working environment and effective business technology, with due regard for data protection and information security; and,
4. plan and prioritise our resources to carefully balance activity across the organisation.

In 2019/20, we will:

• Implement our revised induction and training programme based on a comprehensive training needs analysis;
• explore, plan for and pilot more formal arrangements for home working;
• review our current fees model to ensure it supports and enables an agile approach to regulation;
• begin preparations for relocation to a Government hub by March 2021; and,
• further embed information governance and cyber security good practice within the organisation.

Our people

Total Staff costs	3,662
Estates costs	814
Administration costs	661
Non-cash costs	206
Total Costs	5,343
Total Income	5,343

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.

In line with our strategic vision to be operating in a more sustainable, resilient and agile way by 2021, and as part of our organisational Development Programme, we will introduce changes to our People Strategy in 2019/20. These will include being rigorous in assessing how vacancies should be filled, strengthening our framework to support remote working and taking action to ensure that the well-being of our staff is maintained.

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 one FTE Human Resources member of staff within the full complement of 51 FTEs;
• the training budget will equate to around 1.5 per cent of the pay bill; and,
• 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; and,
• 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 a 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 2019/20 is shown below:

Total Staff costs	3,662
Estates costs	814
Administration costs	661
Non-cash costs	206
Total Costs	5,343
Total Income	5,343

Efficiency and productivity

We understand the impact that licence fees have on the establishments we regulate.  However, after several years of making efficiencies, holding budgets steady and absorbing new work, in 2019/20 we limited our fees in line with the consumer price index.

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.

Fee development work

We will be reviewing the framework under which we charge establishments for the regulation we undertake.  Over recent years we have seen a gradual decline in overall receipts, partly as a result of restructuring by organisations we licence.  We will aim to ensure that the mechanism we use to recover fees is based on the risk and effort required to oversee the sectors and organisation types we regulate.  We expect to conclude the initial phase of this work in the first quarter of the business year in order to consult with stakeholders ahead of our usual fee setting process in quarter three.

Shared services

We continue to operate our resources function as part of a shared directorate with the HFEA. This continues to operate well and we will consider how we might enhance this relationship in the short to medium term.  A significant part of this will be dependent on the expected co-location of both organisations in one of the outer London Government hubs, planned for the end of the 2020/2021 business year. Over this business year, we will be working with the DHSC project team to develop the plans for the new accommodation to ensure it provides for the specific needs of the organisation. In addition we will be engaging staff in an internal project to look at the cultural 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 2019/20 our DDaT priorities will include:

• support for remote working by design and in preparation for an office move by early 2021;
• better use of information and data, in particular in relation to risk; and,
• designing better interfaces and digital content for public and professional stakeholders and staff.

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).

Strand	Objective	Activity	Performance indicator
Delivery	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.	Undertake a risk based inspection / audit programme	180 site visits to take place during the business year across all sectors (year-to-date) *the total number of inspections will be dependent on resources required to be redeployed for other activity
Delivery	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.	Take appropriate action for all regulatory non-compliances	100% of Corrective and Preventative Actions (CAPAs) implemented to address critical and major shortfalls are completed to the HTA's satisfaction within agreed timescales or further regulatory action implemented (reported monthly)
Delivery	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.	Make appropriately evidenced decisions to agreed quality standards	100% of non-panel cases turned around in line with the quality criteria set out in the standard operating procedure, and within five working days (average reported monthly)
Delivery	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.	Make appropriately evidenced decisions within agreed timeframes	100% of panel cases turned around in line with the quality criteria set out in the standard operating procedure, and within ten working days (average reported monthly)
Delivery	Provide high quality advice and guidance in a timely way to support professionals, Government and the public in matters within our remit;	Respond to enquiries in a timely way	At least 95% of enquiries are answered within ten working days of receipt, excluding body donation enquiries (reported monthly)
Development	Make continuous improvements to our systems and processes to minimise waste or duplicated effort, or address areas of risk	PROJECT: Implementation of improvements to target areas of risk in the HA sector	Project RAG status remains amber or green during the course of the project (reported monthly)
Development	Further plan, develop and implement an organisational change programme	PROGRAMME: Develop and implement a series of business cases for projects which will form the HTA’s organisational change programme	Individual project RAG status remains amber or green during the course of the project (once approved)
Development	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	PROJECT: Develop a revised Code of Practice to provide practical guidance on the implementation of deemed consent for organ donation.	Project RAG status remains amber or green during the course of the project (reported monthly) Completion of drafting (Q1) Stakeholder consultation (Q2) Parliamentary approval (Q3)
Deployment	Manage and develop our people in line with the HTA’s People Strategy	Reduce attrition rates through improved selection and targeted retention measures to retain staff	Attrition rate measured monthly on a rolling annual basis (high risk if more than 18%) (reported quarterly)
Deployment	Manage and develop our people in line with the People Strategy.	Lead and advise on best recruitment procedures to maintain organisational capacity and capability	Number of vacancies reported monthly (high risk if more than three vacancies) (reported quarterly)
Deployment	Ensure the continued financial viability of the HTA while charging fair and transparent licence fees and providing value for money.	Ensure that the HTA has sufficient financial resources to fund its regulatory and policy activity, whilst continuing to provide value for money to license fee payers through limiting growth in licence fees	Actual income versus budgeted income (reported monthly) Actual spend versus budgeted spend (reported monthly); Actual cash reserves versus required reserve of £1.8m (high risk if deficit is more than 10%) (reported monthly)
Deployment	Ensure the continued financial viability of the HTA while charging fair and transparent licence fees and providing value for money.	Ensure that the HTA has sufficient financial resources to fund its regulatory and policy activity, whilst continuing to provide value for money to license fee payers through limiting growth in licence fees	Annual fees are calculated to recover no more than the net cost of HTA activity (total costs less Department of Health Grant-in-Aid and devolved governments income) (reported quarterly) Revisions to fees issued to stakeholders at least three months prior to implementation (reported quarterly)