Business Plan2015-16

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Contents ……………………………………………………………………………………………..

Human Tissue Authority remit .................................................................................... 3

Aims, objectives and milestones 2015/16 .................................................................. 7

Human resources ..................................................................................................... 10

HTA in the wider context .......................................................................................... 12

Collaborative work .................................................................................................... 14

Budget 2015/16 ........................................................................................................ 17

An effective and efficient regulator ........................................................................... 18

Baseline Business Plan 2015/16 – Deliverables ...................................................... 20

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Human Tissue Authority remit ……………………………………………………………………………………………..

The HTA is an Executive Non-Departmental Public Body sponsored by the

Department of Health. We were established under the Human Tissue Act 2004 (HT

Act), which covers England, Wales and Northern Ireland, to regulate activities

relating to the removal, storage, use and disposal of human tissue.

In addition to our responsibilities for licensing under the HT Act, the HTA is the

Competent Authority in the UK under two sets of European legislation1, and is

thereby responsible for ensuring the safety of human tissue and cells used for

human application and organs used for transplantation.

In relation to organ donation, the HTA also regulates the donation of solid organs

from living people to ensure that valid consent has been given and that no reward is

sought or offered. This is done through an independent assessment process carried

out by trained professionals at clinical centres throughout the UK2. We fulfil a similar

role for living donation of bone marrow and peripheral blood stem cells from children

without competence and adults who lack the capacity to consent.

The HTA oversees the consent requirements of the HT Act for deceased organ

donation. From December 2015, the HTA will assume this duty for the Human

Transplantation (Wales) Act 2013, which will introduce an opt-out system of organ

donation in Wales.

Our overall strategic goal is to maintain and further enhance public confidence in

these activities by ensuring that they are undertaken safely and ethically, and with

proper consent.

We license 8523 premises that store and use human tissue and organs for purposes

such as research, human application, post-mortem examination, teaching, public

exhibitions and transplantation. We publish standards that licensed establishments

must meet on consent; governance and quality systems; premises, facilities and

equipment; and disposal. We also inspect and audit organisations to ensure that

they maintain good standards of practice and follow appropriate procedures.

1 The Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Quality

and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 respectively. 2 The HTA regulates living donation, in compliance with Scottish legislation, on behalf of the Scottish

Government. 3 Correct on 27 March 2015.

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The HTA has a number of statutory functions. We may restrict or prevent the

activities of an organisation which does not meet our standards. We also have a duty

to inform members of the public, professionals and the Secretary of State for Health

about issues within our remit. We do this by issuing Codes of Practice, which outline

our standards and provide clear guidance for licenced establishments. In addition,

information is provided on our website, and in response to enquiries, to help

members of the public make informed decisions.

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, one Member

appointed by the Welsh Minister and one by the Minister in Northern Ireland. The

Authority combines both lay and professional Members and donors and transplant

recipients.

The Authority’s primary role is to ensure that the HTA’s statutory responsibilities are

met and it achieves this by setting the HTA’s strategic direction, providing both

support and challenge to an Executive which is responsible for the discharge of

these responsibilities on a day-to-day basis.

This document should be read in conjunction with the Strategic Plan 2015/16 to

2017/18, which provides detail of the HTA’s strategic aims and high level business

objectives for he three years beginning 1 April 2015.

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Priorities 2015/16 ……………………………………………………………………………………………..

With the interests of both the public and those we regulate at the centre of our work,

our overall strategic goal is to maintain and further enhance confidence by ensuring

that activities involving human tissue are undertaken safely and ethically, and with

proper consent.

The confidence of professionals and the interested public in the regulation of human

tissue is central to our success: building it must shape our day-to-day work, and

protecting it is our first priority.

Key projects for 2015/16 will be to update our Codes of Practice to deliver a package

of clear, concise and accessible guidance to licensed establishments and interested

stakeholders, and to review the effectiveness of our policies and procedures relating

to licensing and inspection. Scoping for each of these projects began in 2014 and

work will commence in 2015.

The Human Transplantation (Wales) Act 2013 will be operational from 1 December

2015, changing the way in which people in Wales consent to organ donation. We will

continue to work with the Welsh Government throughout 2015/16 to support the

Parliamentary passage of the HTA’s Code of Practice for the Human Transplantation

(Wales) Act 2013 which was consulted on in 2014. We will be developing our

approach to superintending the new Act in 2015.

In relation to the public, we will continue to strengthen our relationships with public-

facing groups to ensure that advice and guidance appropriately reflects need.

With regard to better regulation, the HTA’s Regulatory Strategy4 considers the

inherent risks involved in the activities undertaken by individual establishments and

seeks to focus attention on those establishments most at risk of failing to meet the

required standards. In doing this, we draw on a wide range of information to identify

such establishments. This right-touch regulation is a key facet of the HTA’s success

and we will build on this in the coming year. The HTA has published its self-

assessment5 against the requirements of the Regulators’ Code and we have

committed to an action plan showing how we intend to improve further over the next

12 months.

4 http://www.hta.gov.uk/_db/_documents/HTA_Regulatory_Strategy_2013-17.pdf

5 http://www.hta.gov.uk/_db/_documents/HTA_response_to_the_Regulators'_Code.pdf

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To develop our collaboration, we will continue to strengthen our relationships with

Government, other regulators and third sector organisations. The HTA was

instrumental in the launch of the ‘One Stop Shop’ for life sciences in 2014, which has

been a considerable step forward for both stakeholders and sector regulators in the

human application sector. This initiative brings together expertise from the HTA, the

Human Fertilisation and Embryology Authority (HFEA), the Health Research

Authority (HRA) and the Medicines and Healthcare products Regulatory Authority

(MHRA) to provide regulatory advice on regenerative medicines to those working in

the life sciences industry. It was an outcome of the Government’s Regenerative

Medicine Expert Group and provides an excellent baseline for further joint working

throughout 2015/16.

We will be working on the implementation of two new pieces of European Union (EU)

legislation during 2015/16: one on coding for tissue products, which will improve

traceability of products, and the other regarding the import of tissues and cells into

the EU.

The HTA’s Stakeholder Group continues to provide valuable insight and advice on a

range of regulatory issues following its formation in 2013. The Histopathology

Working Group and the Transplant Advisory Group play significant roles in the

development of regulatory policy relating to the post-mortem and transplantation

sectors respectively.

The strategic aims, high level objectives and key milestones for 2015/16 are set out

in the next section. This information is supported by the ‘Baseline Business Plan

2015/16 – Deliverables’ information on page 20, which sets out the HTA’s key

performance indicators for this period.

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Aims, objectives and milestones 2015/16 ……………………………………………………………………………………………..

Strategic Aim One

To protect the public’s interests by delivering excellent regulation

High level objectives 2015/16:

a) 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 the public

b) To be 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

c) To deliver robust regulation of living donation

d) To monitor changes in our environment and act where these changes have

implications for maintaining public confidence

During 2015/16 we will:

Undertake at least 180 site visits, including inspections and audits

Ensure that, where there are shortfalls against standards, these are rectified

within agreed timescales

Reach decisions on living organ donation cases within five working days for

straightforward cases and 10 working days for panel cases

Undertake a review of the HTA’s Codes of Practice

Strategic Aim Two

To maintain strong relationships with stakeholders and the interested public to

improve the quality of our work

High level objectives 2015/16:

a) To maintain and build confidence and awareness in our work amongst

professionals and the interested public

b) To work collaboratively with others to reduce regulatory burdens and increase

the impact of our work

c) To engage with stakeholders on matters that are important to them and

influence them in matters that are important to us

d) To develop means to ensure the views of the interested public inform our

regulatory approach

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During 2015/16 we will:

Engage with patient groups and the public to improve confidence in HTA

regulation

Collaborate with others to reduce regulatory burdens on licensed

establishments

Engage with professional stakeholders and partner organisations to further

improve confidence in our work

Strategic Aim Three

To have a skilled and motivated team who are proud to work at the HTA and

are committed to achieving our objectives

High level objectives 2015/16:

a) To maintain the HTA’s positive working environment and culture, and uphold

the values of the organisation

b) To lead, motivate, involve and support colleagues to deliver excellent work

c) To attract and retain the right people with the right skills

d) To improve expertise and support delivery through high quality learning and

development

During 2015/16 we will:

Recruit the right people to fill our essential jobs

Deliver a high quality learning and development programme

Engage staff to further improve the HTA as a place to work

Strategic Aim Four

To seek continuous improvement in the way we run the HTA and our value for

money for licence holders and the public

High level objectives 2015/16:

a) To maintain governance arrangements which give appropriate oversight to

matters within the HTA’s legislative remit

b) To maintain high quality management skills and practices

c) To maintain and improve cost-effectiveness and quality by systematically

reviewing systems, processes and procedures, and by working with others

d) To ensure the continued financial viability of the HTA

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During 2015/16 we will:

Manage HTA finances to ensure that spend does not exceed £4.4m

Continue to deliver efficiencies, as appropriate

Continue to develop our quality management procedures and identify and

deliver quality improvement projects, including reviewing the content of the

HTA’s relationship management database

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Human resources …………………………………………………………………………………………….. Headcount 2015/16 Full time equivalents (FTEs)

Q1 Q2 Q3 Q4

Starting count – payroll 46 46 46 46

Starting count – non-payroll 0 0 0 0

Expected transfers in – payroll 0 0 0 0

Expected transfers out – payroll 0 0 0 0

Changes in non payroll staff 0 0 0 0

TOTAL at end quarter 46 46 46 46

There are no expected reductions from natural wastage and redundancy.

Human resources risks

The HTA manages a number of strategic risks, one of which is related to an inability

to carry out our statutory remit. The key factor underpinning this risk is the availability

of experienced staff to undertake our frontline regulatory work.

Staff turnover and maternity leave is an ongoing issue for the HTA. We have

introduced a range of measures to retain staff, including more flexible working and a

career development scheme which allows staff to apply for funding for additional

training on the agreement that they stay with the organisation for a specified period

following completion of the course. These steps have gone some way towards

mitigating the human resource risk, although the HTA remains subject to the

continued risk of staff turnover in the face of relatively limited career development

opportunities due to the small size of the organisation and public sector pay

constraints.

The HTA has reduced its workforce over the last four years to a level that provides

little scope for discretionary activity, and we have a range of contingency options in

place which cover both staff losses and other situations where risks are realised.

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During 2015/16 it is expected that:

the HTA will have 3.5 FTEs who are classified as very senior managers, within

the total of 46 FTEs

one of the HTA’s Directors will continue to have a joint role: our Director of

Resources holds this role for the HTA and the HFEA, spending two and a half

days per week with each organisation

none of the HTA’s staff will earn over £142,500 per annum

there will be one FTE Human Resources member of staff within the full

complement of 46 FTEs

the training budget will equate to around two per cent of the pay bill

there will be no non-payroll staff

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HTA in the wider context ……………………………………………………………………………………………..

The HTA is committed to supporting the Department of Health’s goals and priorities.

Although The HTA is not directly involved in the provision of patient care, the

Authority is responsible for ensuring the quality and safety of tissues and cells for

human application and organs for transplantation, contributing to a high standard of

care for patients needing these interventions and to successful clinical outcomes.

We continue to work with the research sector, supporting efforts to engage with the

public, and ensuring that there are no regulatory barriers to the donation and use of

tissue and organs for research into conditions such as dementia.

Our work in the post mortem sector gives primacy to the dignity of the deceased,

ensuring that the standard of care that they receive reflects that given in life.

We are a member of the National Information Board (NIB) which is charged with

developing the strategic priorities for data and technology in health and care to

deliver the maximum benefit for patients, and to make appropriate recommendations

for investment and action. In addition, we take into account the growth agenda when

making regulatory decisions.

The HTA ensures value for money for taxpayers by ensuring that we deliver high-

quality, right-touch regulation, while keeping costs to a minimum. The focus on

streamlining and increased efficiency from 2010 to the present day has made the

HTA a lean organisation, delivering a wide range of highly effective functions with

just 46 FTE staff.

The 2013 McCracken report noted that the specialist knowledge and expertise within

the HTA adds to the UK’s international competitiveness. We are considering how, as

a small health regulator, we can use this knowledge and expertise to contribute to

economic growth in the UK.

The HTA is part of the value chain in a number of areas of healthcare, including

living and deceased organ donation, the use of tissues and cells for human

application and care after death. By ensuring that we are an effective and efficient

organisation, we add to the resilience of the healthcare system, never forgetting our

key role in ensuring the safe and ethical use of human tissue and the importance of

valid consent.

Year-on-year, the HTA sets itself stretching targets to make sure that our

performance improves in ways which benefit those we serve, whether this be a

reduction in the time it takes for a living organ donation case to be assessed, or how

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quickly we respond to enquiries. As an organisation, we are clear about our aims

and objectives, and work together with colleagues at the Department of Health and

other Arm’s Length Bodies (ALBs) to reach and exceed these targets wherever

possible.

Whistleblowing

As a number of recent inquiries into NHS bodies have indicated, whistleblowing can

act as an important source of information about shortcomings in the delivery of public

services.

The HTA whistleblowing policy explains how concerns can be raised, both formally

and informally within the organisation, and reinforces the individual protection

provided by the Public Interest Disclosure Act 1998. More generally, we have made

it clear to all staff that we would expect them to raise any concerns they have, and

that we would be supportive of any individual deciding to do so. For those who

remain uncomfortable with raising concerns internally, we provide information about

external reporting options, including the Department of Health, the National Audit

Office, the whistleblowing helpline and the Freedom to Speak Up website.

In addition, we have a clear set of organisational values, which were agreed by our

staff. These values help to engender an organisational culture which delivers high

quality services, and which listens to the views and concerns of all members of staff.

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Collaborative work …………………………………………………………………………………………….. Collaboration has always been a key theme for the HTA and we are committed to

working with partners in the health sector and with the public as a whole. Here we

set out examples of our ongoing and planned future collaboration for 2015/16.

Regulation

Research sector: with HTA membership of the HRA’s Collaboration and

Development Forum, we will continue to work closely with the HRA to ensure that

those involved in research can be assured of consistency of approach and a high

degree of information-sharing between the two organisations. We will also

continue to work with the National Research Ethics Service (now part of the HRA)

through our Memorandum of Understanding to ensure that advice and guidance

on research regulation is clear, coordinated and consistent, and to ensure that

researchers using the circa 200 HTA-licensed tissue banks continue to benefit

from a streamlined process, where Research Ethics Committees give generic

approval for tissue collection, storage and release arrangements.

Post mortem sector: we will continue to work closely with the Royal College of

Pathologists and other professional stakeholders through our Histopathology

Working Group to ensure that our regulation is responsive to the needs of the

sector, whilst maintaining public confidence. We will work to develop further the

HTA’s relationship with Coroners and Coroners’ Officers to ensure that human

tissue samples are treated in line with the wishes of the family after Coroners’

post mortem examinations. We have strong links with the Forensic Pathology

Unit of the Home Office and will continue to include samples held under the

authority of the Police within the scope of our inspections. We will also continue

to collaborate with the United Kingdom Accreditation Service (UKAS),

undertaking joint inspections where opportunities are identified.

Organ donation and transplantation sector: we will continue to work with NHS

Blood and Transplant (NHSBT) to avoid duplication of reporting or information-

gathering to limit the burden on those working in this area.

Human application sector: we will continue to deliver joint inspections of the

small number of establishments co-regulated with the MHRA, including 15

establishments involved in translational research of regenerative therapies, and

deliver joint advice and guidance through a new Memorandum of Understanding.

We will also explore joint inspections of the five establishments involved in

embryonic stem cell research co-regulated by the HTA and the HFEA.

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We are working with the American Food and Drug Administration and the

American Association of Tissue Banks to identify, and where necessary act on,

any regulatory issues which have an impact on products imported into Europe.

Over the next year, the HTA, in collaboration with those agencies, will work

towards ensuring that US exporters are able to access and understand the

standards required for tissue products imported into the UK and other European

member states.

In October 2014, the HTA and other life sciences regulators launched a ‘One

Stop Shop’, which enables businesses and other organisations in the life

sciences industry to quickly and easily navigate the different regulators and allow

them to get the right advice more quickly.

We continue to work with the MHRA to streamline the regulation of Advanced

Therapy Medicinal Products (ATMPs). Our aim is to reduce the regulatory

burdens on those developing these products without increasing the risk to patient

safety.

Stakeholder and public engagement

We will review our joint working protocols and Memoranda of Understanding with the

Care Quality Commission (CQC) and the HFEA, which set out how we share

information, should concerns arise about establishments that are co-regulated by

these organisations. Where possible, we will seek to minimise the burden of

regulation for all our establishments, through methods such as joint inspections.

We will continue to seek to identify opportunities to work with public-facing

organisations to inform the public about the work of the HTA across the sectors we

regulate. In doing so, we will listen to concerns and seek to address these through

the development and dissemination of guidance and information for the public on

matters within our remit, as well as signposts to other organisations as appropriate.

The HTA Stakeholder Group will meet twice in 2015/16 and will play a continuing

role in fee setting for 2016/17.

Europe

We are the Competent Authority for the EU Directive on the quality and safety of

tissues and cells used in human application. We will be working on the following

projects in relation to this role during 2015/16:

the implementation of new EU legislation on coding for tissue products, which

will improve traceability of products

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the implementation of new EU legislation on the import of tissues and cells into

the EU

the development of guidance for novel therapies

the establishment of a framework for joint inspections between Member States

and in third countries, when a need for such inspections is identified

In addition to the above projects, we are working with the European Commission and

a small number of other Member States to develop proposals for improving

collaboration between Competent Authorities, with different but linked areas of

competence, such as Blood and Medicines. This work is intended to address some

of the regulatory issues arising from the emerging regenerative and ATMP sector.

Staff and shared services

The HTA has some strong collaborative links with other ALBs with regard to staffing.

These include the HTA’s Director of Resources and Head of Finance also having

these roles for the HFEA and the HFEA’s Legal Adviser meeting regularly with the

HTA to discuss emerging themes. There are more informal links with other ALBs and

the Department of Health to share expertise and good practice.

Representation

The HTA plays an active role in a number of groups and committees in order to

share the experience and knowledge we have gained through nine years of

regulation. These include the Government’s Regenerative Medicine Expert Group,

NHSBT’s 2020 Strategy Oversight Group, the Home Office’s Forensic Pathology

Specialist Group and the Health Research Authority’s Collaboration and

Development Forum. We also provide advice and guidance to organisations and

individuals on an ad-hoc basis.

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Budget 2015/16 ……………………………………………………………………………………………..

The HTA receives funding from two main sources. The majority (around 80 per cent)

comes from licence fees, with the balance coming from our sponsor, the Department

of Health. We also receive a small amount of income for undertaking activities on

behalf of the devolved administrations.

The licence fee income pays for a wide variety of activity associated with our

regulatory remit: from evaluating licence applications, making licensing decisions

and issuing licences, through to site visit inspections and providing advice and

guidance to licensed establishments.

We place great importance on ensuring that our finances are managed efficiently,

effectively and in a way which minimises risk.

The high level budget for 2015/16 is shown below:

Income £000s

Department of Health funding 740

Licence fees 3,384

Other income 291

Total income 4,415

Expenditure £000s

Operating costs

Staff costs 2,897

Other operating costs 1,284

Total operating costs 4,181

Capital charges 234

Total revenue expenditure 4,415

We have also indicated to the Department of Health a likely need for a capital budget

of £100k. This will help upgrade our Customer Relationship Management (CRM)

system, which is now five years old. Our CRM system supports all our regulatory and

business processes.

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An effective and efficient regulator ……………………………………………………………………………………………..

The Director of Resources is responsible for overseeing the procurement of goods,

services and contracts. HTA policies set out the procurement strategy and

governance arrangements, and the HTA uses centralised solutions for spend

wherever possible. During 2015/16, it is expected that the HTA will procure for IT

services. Any procurement that takes place would follow the necessary frameworks

and principles, including:

ensuring steps are in place to support the overall departmental target that at

least 18 per cent of procurement spend will be with small and medium-sized

enterprises (SMEs) by 2015

use of Government LEAN sourcing principles for all significant procurement

all but the most complex procurement are undertaken in less than 120 days

from advertisement to award

the Greening Government agenda and compliance with Government Buying

Standards

use of central contract solutions for procurement of common goods and

services

The HTA is aware of the Department of Health and Cabinet Office/Efficiency Reform

Group’s efficiency controls and procedures. These are understood and will be

followed.

The HTA will comply with data requests and publication of data arising from the

Government’s transparency agenda. All requests will be dealt with as rapidly as

possible, while ensuring quality.

The HTA rents space in a Department of Business, Innovation and Skills-managed

building along with other ALBs. Current occupancy is 14 sqm per FTE, determined

by the space allocated to the HTA and reduced staffing arising from efficiencies. We

continue to seek opportunities to gain the greatest value for the space that we have

available and have an ongoing arrangement with our neighbours, the NHS Litigation

Authority, to provide them with 12 workstations in the HTA office space.

The HTA’s IT strategy is refreshed every year to ensure IT supports the HTA’s

business and the HTA has outsourced provision of IT services for some years. The

present contract has been extended to September 2015 while we consider the future

arrangements with the Department of Health.

With regards to information governance, the Director of Resources is the Senior

Information Risk Owner, and Information Asset Owners are in place. The HTA

assesses risk at least annually using the HMG Security Policy Framework.

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In March 2014, the Director of Resources post became a joint HTA and HFEA role.

The Head of Finance role is also shared with the HFEA. These arrangements, while

challenging at times due to simultaneous workload peaks, are now well-established

and benefits can be seen.

A key strategic aim for the HTA is “To seek continuous improvement in the way we

run the HTA and our value for money for licence holders and the public”. High level

objectives include: “To maintain and improve cost-effectiveness and quality by

systematically reviewing systems, processes and procedures, and by working with

others”.

Efficiencies

Grant-in-Aid reduced by 10 per cent in each of the three years from 2011/12 to

2013/14 and has reduced by a further five per cent since 2013/14. The Grant-in-Aid

funds our work on the assessment of living organ donations and bone

marrow/peripheral blood stem cell donations. It also funds those administrative and

support functions which are not directly associated with our work with licensed

establishments.

We have reduced licence fees over the same period by making further efficiencies

that enable us to manage with 36 per cent less income from licence fees. The HTA is

now a very lean organisation and there are only small opportunities to make further

savings, and these are largely offset by inflation increases.

We understand the importance of keeping licence fees as low as possible,

recognising that licensed establishments live in challenging financial times. At the

same time we must continue to be an effective regulator and we seek to strike the

right balance. Licence fees reflect the costs of activities associated with regulating

each sector and, while there are differences between sectors, the overall amount of

HTA activity on regulation remains the same for 2015/16. We ensure that reductions

in Grant-in-Aid are matched by reductions in the cost of activities funded by Grant-in-

Aid and that no cross-subsidisation takes place.

We continue to review our processes to streamline them as much as possible and

keep them effective. This should minimise any burden on our licensed

establishments, although it is unlikely to result in further savings for the HTA. We are

committed to working collaboratively with other regulators and organisations,

including the Department of Health, to be efficient and to realise benefits for those

we regulate, and to deliver better regulation.

Baseline Business Plan 2015/16 – Deliverables …………………………………………………………………………………………….. Key Performance Indicators (KPIs)

Reference number

Business Plan Objective Performance Indicators

KPI 1:1 To process licence applications and variations in accordance with SOPs.

At least 90% of completed applications to vary a licence are processed within 20 working days of receipt (reported quarterly).

KPI 1:2

To undertake a risk based inspection/audit programme for Human Tissue Act and Organ Donation and Transplant sectors.

At least 180 site visits to take place during the business year across all sectors.

KPI 1:3 To seek feedback from establishments after each inspection and analyse and report the results each quarter.

At least 80% of responding establishments rate the overall inspection process as either good or excellent (reported quarterly).

KPI 1:4 To take appropriate action for all regulatory non-compliances.

At least 90% of Corrective and Preventative Actions (CAPAs) implemented to address major shortfalls are completed within agreed timescales.

KPI 1:5 PROJECT: To deliver a project to implement EU Directives on Coding and Import/Export.

EU Directives on Coding and Import/Export implementation project red-amber-green (RAG) status remains amber or green during the course of the project.

KPI 1:6 PROJECT: To deliver a project to improve the HTA's Codes of Practice.

HTA Codes of Practice and Standards project red-amber-green (RAG) status remains green or amber during the course of the project.

KPI 1:7 To make appropriately evidenced decisions on executive cases to agreed quality standards.

100% of non-panel cases turned around within 5 working days. Average to be reported monthly.

KPI 1:8 To support appropriately evidenced decision making for panel cases to agreed quality standards.

100% of panel cases turned around within 10 working days. Average to be reported monthly.

KPI 2:1

To answer enquiries in a timely and accurate way, ensuring responses are of a high quality and enquiries are recorded in CRM. To ensure that advice and guidance is passed on to HTA staff when appropriate.

At least 95% of enquiries are answered within 10 working days of receipt, excluding body donation enquiries.

KPI 2:2 PROJECT: To maintain up to date content on website, including content review, and ensure regular updating.

Digital (website and newsletter) survey takes place in January/February 2016. 80% of all those responding say that they find the website easy to use and the content useful.

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Reference number

Business Plan Objective Performance Indicators

KPI 3:1 To lead on the implementation of all employee initiatives and oversee the effective administration of these.

Target rate of no more than 18% for attrition rate measured monthly on a rolling annual basis. 80% of staff have more than one year length of service.

KPI 3:2 To lead and advise on best recruitment procedures.

Target of no more than two vacancies at any one time.

KPI 3:3

To manage all development options offered to staff and evaluate courses to ensure quality delivery and learning effectiveness.

80% of staff attending training courses agree that the skills and knowledge gained will be useful for knowledge, performance, career development or general wellbeing. Training statistics to be completed on an quarterly basis.

KPI 4:1

To fulfil the role specified for the Governance and Quality Manager in the HTA's Freedom of Information governance documents and respond to all requests in accordance with the Freedom of Information and Data Protection Acts.

All requests under the Freedom of Information Act responded to within 20 working days; all requests under the Data Protection Act responded to within 40 calendar days, where this applies.

KPI 4:2 PROJECT: To deliver a project to review the HTA’s licensing and inspection processes

HTA’s licensing and inspection processes review project red-amber-green (RAG) status remains amber or green during the course of the project.

KPI 4:3

To review fee structure by October 2015. To review fee levels required for 2016/17 by November 2015. To communicate fee levels to stakeholders by December 2015.

Average fee to increase by no more than 3% from 2015/16 level or fees set to generate no more than £3.4m in revenue.

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Performance Indicators (PIs)

Reference number

Business Plan Objective Performance Indicators

PI 1:1 To authorise preparation processes for tissues and cells for human application

A decision is reached on at least 90% of preparation process dossiers within 20 working days of receipt of the completed dossier or any additional information requested by the HTA.

PI 1:2 PROJECT: To collect compliance updates for all sectors regulated under the Human Tissue Act.

Compliance updates project red-amber-green (RAG) status remains amber or green during the course of the project.

PI 1:3

To undertake an inspection programme for Human Application sector establishments that meets EU legislative requirements.

100% of required Human Application sector inspections are undertaken during the business year (reported quarterly against the adjusted yearly total of required inspections).

PI 1:4 To issue inspection reports within agreed timeframe.

At least 90% of draft inspection/audit reports are sent to the DI/LH for a factual accuracy check within 20 working days of the end of the inspection/audit.

PI 1:5 To publish inspection reports on the HTA website.

At least 90% of inspection reports are finalised and published on the HTA website within 10 weeks of the end of the inspection.

PI 1:6 To seek feedback from establishments after each inspection and analyse and report the results each quarter.

At least 80% of responding establishments agree with the post inspection survey question "Has the inspection/audit process helped improve the ways in which your organisation works?" (reported quarterly).

PI 1:7

To provide professionals with up to date advice and guidance. To ensure coordination of communication with our stakeholders.

Content review of 100% of policies/guidance on the website. Assign each with an owner.

PI 1:8

PROJECT: To contribute to the review and revision of the HTA's Codes of Practice and Standards, as set out in the project managed by the Strategy and Quality Directorate.

Project red-amber-green (RAG) status remains amber or green during project implementation stage of approved project.

PI 1:9 To take appropriate action for all regulatory non-compliances

At least 90% of Corrective and Preventative Action (CAPA) plans are reported in published inspection reports as completed within 20 working days of completion.

PI 1:10 To take appropriate action for all regulatory non-compliances

100% of audited corrective and preventative action (CAPA) plans have sufficient evidence provided to ensure that the shortfall has been addressed.

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Reference number

Business Plan Objective Performance Indicators

PI 1:11

PROJECT: To produce Codes or Handbooks relating to organ donation and bone marrow and peripheral blood stem cell (PBSC) donation.

Codes of Practice relating to organ donation, bone marrow and PBSC donation project red-amber-green (RAG) status remains green or amber during the course of the project.

PI 1:12 To answer queries relating to living donation

To answer 100% of enquiries within 10 working days.

PI 1:13

PROJECT: To seek clarity on the HTA's role in the assessment and approval of bone marrow and peripheral blood stem cell (PBSC) donations from children who lack competence and adults who lack capacity.

Project to clarify the HTA's role in the assessment and approval of bone marrow and PBSC donations from children who lack competence and adults who lack capacity red-amber-green (RAG) status remains green or amber during the course of the project.

PI 1:14 To monitor the quality of reports submitted by Independent Assessors (IAs) and act on any shortfalls.

90% of Independent Assessor reports are fit for purpose on submission (reported quarterly).

PI 1:15 To complete annual Independent Assesor (IA) re-accreditation

Independent Assessor re-accreditation completed in March 2016.

PI 1:16 To deliver annual panel training to Authority Members.

All Authority Members undertake panel training in January 2016.

PI 2:1 To publish a regular Feedback Report to SMT and the Authority and/or DH upon request.

All complaints are acknowledged within 3 working days and investigated and responded to within 20 working days.

PI 2:2 PROJECT: To ensure quality enquiry responses are sent and develop a database of enquiry responses.

Survey conducted in 2015 - 70% say that the quality of enquiry response was good or very good.

PI 2:3 PROJECT: To organise the HTA's 10 year review event and and produce the annual review publication

Annual review event and publication completed on time and in budget and 100% of the respondents (to event feedback) feel that events such as the review of the year are a good way to engage with people affected by HTA regulation.

PI 3:1 To upgrade the CRM system and consolidate the data it holds.

CRM upgrade and data consolidation project red-amber-green (RAG) status remains amber or green during the course of the project.

PI 3:1 To clean and improve the Sharepoint system.

Sharepoint system clean and improvement project red-amber-green (RAG) status remains amber or green during the course of the project.

PI 3:2 To clean the Exchange system and fileshares.

Exchange system and fileshares clean project red-amber-green (RAG) status remains amber or green during the course of the project.

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Reference number

Business Plan Objective Performance Indicators

PI 3:3 To advise on and provide reliable IT that supports effective working.

No unplanned outages.

PI 3:4

To manage IT contracts and maintain adequate contract arrangements with key suppliers including: BCC, WebCurl and BBD.

Supplier assurances including the standard assurance template. A smooth transition to, and satisfaction with, new IT contract(s) for IT services and portal. Quarterly meetings with suppliers.

PI 3:5

To ensure all existing policies meet the needs of the HTA and are up to date with good practice and current legislation.

Current policies are reviewed in line with expiry dates and new ones implemented in time for external change requirements.

PI 3:6 To monitor equal opportunities data and develop systems to capture required information.

The HTA has a diverse workforce, as evaluated by regular equal opportunities reports, which are to be produced on an annual basis. An equal pay audit to be carried out in Q3.

PI 3:7 To create, implement and oversee progress on the action plan.

2015/16 Staff survey action plan signed off by end of Q3 and 2016/17 Staff survey completed during Q4.

PI 3:8 To ensure staff understand the performance management process and that new staff receive training.

100% of performance assessments completed by 31 May 2015.

PI 4:1 To maintain acceptable levels of internal audit recommendations, i.e. "low - medium".

90% of audit recommendations are either Medium or Low in severity.

PI 4:2 To manage all HTA phone and email enquiries as the HTA's main and first point of contact.

80% of all feedback on performance surveys is positive.

PI 4:3 To pay all suppliers within 5 working days, in accordance with Government's Best Payment Practice (BPP) Code.

90% of payments made within 5 days of receipt of undisputed invoice.

PI 4:4

To manage the HTA's finances to ensure sufficient funds are in place to meet payments required; appropriate spending; appropriate levels of reserves; debtor management.

90% of licence fees received within 56 days of invoicing.

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Human Tissue Authority

151 Buckingham Palace Road

Victoria

London

SW1W 9SZ

Tel 020 7269 1900

Fax 020 7269 1999

Email enquiries@hta.gov.uk

Web www.hta.gov.uk

Twitter: http://twitter.com/HTA_UK

Facebook: https://www.facebook.com/HumanTissueAuthority

LinkedIn: http://www.linkedin.com/company/human-tissue-authority

Published on 27 March 2015.