Issue 35 July 2012

Welcome to the July issue of the Human Tissue Authority’s (HTA’s) e-newsletter. The e-newsletter is the main way we communicate developments in regulatory policy and is essential reading if you work in one of the sectors we regulate or your work links to ours. We also use the e-newsletter to let you know about new advice and guidance and important updates to our website.

This special edition includes news of the arm's length bodies' review consultation; an update on our inspection pilot project; news on our new online portal and a brief look back at the work we have undertaken across the sectors over the last 12 months.

If you have any comments or queries about the issues raised in this e-newsletter, or any ideas for items that you would like to see in future, please email enquiries@hta.gov.uk.

Arm's length bodies' review consultation launched

The Department of Health's (DH) consultation on the possible future transfer of the HTA's functions was launched on 28 June and runs until 28 September 2012. It sets out three options for the HTA's functions. The first is to transfer them in their entirety to the Care Quality Commission; the second is to separate our functions and move them into several different organisations; the third is to keep the HTA as a separate entity and make further efficiencies. The DH's preference is for the first option. The HTA will continue working to ensure public and professional confidence in the use of human tissues and organs and any transfer is not likely to take place before 2015.

The HTA's position

We have long argued our functions should remain together, regardless of whether and where they transfer, for the benefit of professionals and the public. If the functions are transferred in 2014/15 we will seek assurances that these functions can continue to be carried out effectively and efficiently, and that the transfer will provide genuine benefits in terms of cost savings and accountability.

We will be discussing our response to this consultation at the public Authority meeting on 10 July. Meeting papers will be available on our website.

There are strong arguments in favour of keeping our functions together:

• Any proposals to separate the functions of the HTA risk losing hard won public and professional confidence.
• It is difficult to see how streamlining regulatory activity and reducing the burden on regulated sectors could be achieved by separating out each of the HTA's activities and identifying a different regulator for each. This would make it more complex and place a greater burden on regulated sectors. For example, if the HTA's research functions transferred to the Health Research Authority (HRA), some organisations with a HTA licence for all their human tissue activities, including storage for research, would then be regulated by two organisations. This could apply to 200 organisations across three sectors that also engage in research activities – the post mortem sector, the sector using tissue for patient treatment, and the anatomy sector.
• The HTA is the guardian of consent and splitting it up could risk different understanding and interpretation of consent, and create potentially lower or conflicting standards in different sectors over time.
• We have experience and knowledge that stretches far beyond the letter of the law and are viewed by many as a trusted source of insight into the complex legislation, as well as advice and guidance. Any attempt to separate our functions would fragment this knowledge and a valuable resource would be lost. For example, our response to the Nuffield Council on Bioethics' consultation on Give or take? Human bodies in medicine and research is a good example of where our broad knowledge and expertise meant we could provide a consistent, measured and informed response not only on organ and tissue donation, but also research and the use of tissue for patient treatment.
• We have expertise on the Board, and the executive, and have sector experts on specific groups, including the Histopathology Working Group and the Transplantation Working Group. The HTA Board is also responsible in law for approving complex organ donation cases. This expertise would be weakened if our functions were separated.
• Evidence shows that we are a highly effective specialist regulator commanding both professional and public confidence in the safe and ethical use of human tissue. The HTA licences some 800 organisations across five different sectors. We regulate under the Human Tissue Act 2004; we are also the Competent Authority for the EU Tissue and Cells Directive, and the Competent Authority designate for the EU Organ Donation Directive. The benefits of our proportionate regulatory approach and the positive feedback we receive from our stakeholders provide evidence of our positive, and increasing, impact at a low, and reducing, cost.

HTA's cross-sector work and collaboration

Collaboration continues to be a key theme in 2012/13 and we are committed to working with partners to reduce the burden on establishments and support public and professional confidence. By sharing information about common areas of risk and non-compliance we can reduce information requests to establishments and regulate in an even more proportionate manner; by working together on advice and guidance we can improve quality and safety; by understanding working practices and public concerns we can ensure our regulation is implemented practically.

Recent examples of effective collaboration

• Undertaking joint inspection visits with the Medicines and Healthcare products Regulatory Agency (MHRA) of the 12 establishments licensed by both organisations for development of medicinal products.
• Working with DH, regulatory agencies and others to develop the UK stem cell tool kit.
• Working with National Research Ethics Service (NRES) (part of the HRA) to ensure that 200 HTA-licensed tissue banks benefit from a streamlined process where RECs give generic approval for tissue collection, storage and release arrangements, so researchers do not need a HTA licence or REC approval themselves.
• Working with establishments to reduce regulatory and financial burdens by helping them to consolidate licences.

Further collaboration planned for 2012/13

• Close working with the HRA to provide a single point of access for researchers that retains all the strengths of the current systems and fully meets legal requirements.
• Supporting the implementation of recommendations from the Association of Chief Police Officers report into tissue retained by the police.
• Working with the Clinical Pathology Accreditation to develop a programme of information sharing and joint inspections in the post mortem sector.
• Working with NHS Blood and Transplant (NHSBT) to implement the requirements of the EU Organ Donation Directive (see below).
• Working with the Human Fertilisation and Embryology Authority (HFEA) to explore ways in which licensing arrangements for storage of ovarian and testicular tissue can be simplified.

Transplantation sector prepares for EU law on quality and safety of donated organs

We are helping the transplantation sector prepare for the European Union Organ Donation Directive (EUODD). The EUODD sets minimum standards that must be met across all Member States to ensure the quality and safety of human organs for transplantation. The HTA is the Competent Authority designate for implementing the EUODD in the UK. Domestic legislation, the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (the Regulations), brings the EUODD into force in August 2012.

Licensing requirements

The requirement to be licensed under the Regulations becomes law on Monday 27 August 2012. From that date you must have a licence to undertake activities described in the Regulations. Licensing applications must be made via the HTA website. This service will be live from Monday 9 July. The DH has confirmed that establishments applying for a licence will not be charged a licence fee for this business year. It is not yet confirmed whether this fee subsidy will continue into the following business year.

Advice and guidance

Following the HTA consultation on our 'framework' document, we have made significant revisions which address the majority of concerns raised by respondents. We have also developed a guidance document for reporting serious adverse events and reactions. Both documents are on our website. We have worked closely with DH, NHSBT, and the transplant community, to ensure our regulation is proportionate and risk-based. Most recently, we have held workshops in London and Birmingham to discuss implementation of the new framework.

In addition, we have worked with NHSBT develop a comprehensive suite of National Operating Procedures (NOPS) that will cover all procedures required to be documented by the new legislation. Establishments will be able to adopt or adapt the NOPs, or if preferred develop their own. Feedback from our workshop events suggests the NOPs will support establishments significantly in their preparations.

Themed inspection pilot project update

In February, we announced that we would be piloting a new 'themed' inspection model in a small number of establishments in the sector using tissue and cells for patient treatment, as part of our work to strengthen our regulatory processes and reduce the burden of regulation on those we licence.

We have now completed nine themed inspections, and feedback has been very positive. In particular, those in the pilot have said:

1. it has taken less time to prepare for the inspection
2. fewer staff have had to be involved, so the impact on operational activities has been reduced
3. it has provided an opportunity for establishments to showcase demonstrate their compliance with each HTA standard and allowed more time to discuss these in depth.

We have received other useful comments, including ways that we can improve our documentation.

Another two establishments will take part in the pilot before the end of July. We will continue to gather feedback so that a lessons learned exercise can be undertaken to inform the future inspection process. Establishments that have taken part will receive a summary of the findings. We are grateful to all those who are participating.

Please direct any questions to Allison Cummings, Regulation Manager by phone on 020 7269 1935 or via email at allison.cummings@hta.gov.uk.

Update on our new online portal

The HTA is developing a new Portal which will present a single, consistent interface for stakeholders to submit information to us. This will include licence application forms, licence variation requests (for example, change of Designated Individual (DI) or change of premises requests), licence enquiries, incident reports, annual compliance and activity reports and inspection feedback forms. In the longer term it is also envisaged that transplant approvals will be incorporated into the portal as well as providing an updated e-learning package for DIs.

The HTA Portal will provide authorised stakeholders secure access to key information relating to HTA licences and reduce the time and administrative burden needed to maintain licences, manage incidents or simply make a licensing enquiry.

We aim to launch the portal initially to the sector applying for licences under the Quality and Safety of Organs Intended for Transplantation Regulations. Further developments for other sectors will be announced in due course

Use of HTA logo and branding policy

The HTA's brand is an important communication tool between the HTA and its stakeholders and an important part of our brand is our corporate identity – the visual representation of the HTA, including our logo.

We have published a new policy which provides clear guidance for stakeholders and establishments on how the HTA's logo can and cannot be used.

Authority public meeting, 10 July

We will be holding our annual authority public meeting on Tuesday 10 July in central London. The meeting provides an opportunity to observe the Authority as it discusses its business. Items on the agenda include our response to the arm's length bodies' review consultation; and our position on the Welsh Government's Bill to introduce an opt-out system for living and deceased organ donation. You can download the meetings papers from our website.

New appointments announced at CQC, and the Health Research Authority (HRA)

David Behan has been announced as the new Chief Executive of CQC. David, who is currently Director General for Social Care, Local Government and Care Partnerships at the Department of Health, will begin his role as Chief Executive in July and will replace Cynthia Bower who resigned in February this year.

Janet Wisely has been confirmed as Chief Executive of the Health Research Authority (HRA). Janet has been interim Chief Executive since the HRA was established in December 2011 and is currently also Director of the NRES.

In addition, Professor Jonathan Montgomery has been confirmed as the new Chair of the Health Research Authority. Professor Montgomery is currently a professor of Health Care Law at the University of Southampton, Chair of the Nuffield Council on Bioethics and Chair of Hampshire Primary Care Trust.

Licensing and inspections update

From 1 April 2012 - 31 May 2012, we completed 36 site-visit inspections Of these, 13 were in the sector using tissue and cells for treatment (five of these were pilot 'themed' inspections), 14 were in the post mortem sector, five in the research sector, with two each in the anatomy and public display sectors.

Inspections are usually scheduled according to assessed risk; however they may also be scheduled randomly or on a reactive basis following receipt of information. We continue to receive positive feedback about our inspections and we are keen to hear more of your views.

Further information about our inspection process including inspection reports can be found on our website.

Information for the tissue and cells for patient treatment sector

Definition of composite tissue – such as face and limb

The EU is still to confirm absolutely that composite tissue, such as face and limbs, will be categorised as organs, but as the definition of organ has been revised to remove the word 'vital' it appears to be the direction of travel. It therefore represents HTA's current policy. Any establishment planning to carry out such transplants will need to be licensed under the Quality and Safety of Organs Intended for Transplantation Regulations 2012.

Licensing requirements for tissue and cells removed with organs

The licensing requirements for tissue and cells removed at the same time as the retrieval of organs for transplantation depend on the purpose to which they are put. Consideration must be given to ensuring that they are dealt with appropriately. The HTA should be the definitive source of information on licensing requirements, so please get in touch if you are in any doubt.

Tissues and cells that directly support organ transplantation, e.g. accessory vessels, are essential to re-establishing functionality, so their retrieval is covered by the same licence as retrieval of organs for transplantation.

The storage of those tissues and cells for use in the recipient to support organ transplantation does not require an HTA storage licence. Currently, storage of those tissues and cells for less than 48 hours does not require an HTA licence. However, should those tissues and cells be stored for more than 48 hours for use in a patient other than the primary recipient, they must be stored under a storage licence issued under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

Organs, tissue and cells procured for transplantation, e.g. heart valves and kidneys from deceased donors, come under separate regulatory frameworks. Organs for transplantation must be procured under the Quality and Safety of Organs Intended for Transplantation Regulations 2012. Tissues and cells for patient treatment must be procured and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 or under a Third Party Agreement with an HTA - licensed tissue establishment.

If at any point those tissues and cells are to be used for a purpose other than to support a specific donation, such as research, they will fall into the regulatory framework relevant to that use (see section on research below).

Preparation Process Dossier

A number of establishments originally licensed to procure specific tissue types, are beginning to expand their activities and the types of tissues they process e.g. cord tissue, teeth, adipose tissue and bone marrow. To meet EU requirements, the HTA is using the recently developed Preparation Process Dossier (PPD) to regulate the rapid expansion of this field. From April 2012, establishments wishing to introduce new or improved processes or make a change to tissues that are processed will be asked to submit a PPD. The PPD will enable robust judgements to be made on suitability of the process, materials and assays used, and confirm they have been fully validated and do not render the cells clinically ineffective or harmful. This new procedure will help the HTA in fulfilling its function of ensuring the safe use of tissues and cells for patient treatment. The HTA has assessed around 25 PPDs since April.

Influencing in Europe – HTLV testing

The HTA has successfully negotiated with the EU Commission an amendment to the wording of the testing requirements for HTLV. The current requirement is that donors living in or originating from 'high-incidence' areas must be tested. Establishments involved in donor testing have told us that this requirement is difficult to comply with due to the lack of reliable data on high incidence areas. The amendment will replace 'high-incidence' with 'high-prevalence', following a recommendation to the EU Commission by the European Centre for Disease Control (ECDC). The amendment will give greater clarity on the selection of donors and those that must be tested for HTLV. The UK will implement the amendments in 2013. In the meantime, we continue to work with the ECDC on the current requirements for repeat testing of HTLV, as we are aware that the requirement is not applied consistently in the UK and across Europe. This often because of significant difficulties in getting a second sample for testing 180 days after donation. With ECDC, we will consider whether the scientific evidence supports the requirement for repeat testing as a proportionate response to risk.

Influencing in Europe – Council of Europe Guide to the Safety and Quality Assurance for Tissues and Cells

The HTA is contributing to the first edition of the Council of Europe Guide to the Safety and Quality Assurance for Tissues and Cells, due to be published by mid-2013. The guide will provide guidance on the donation, procurement, donor testing, processing, preservation, storage and distribution of tissues and cells for patient treatment. The guide outlines general requirements for quality and safety, but includes guidance on specific tissues, so going beyond the HTA's own guidance. The draft version of the Guide will be released for consultation by the end of 2012.

Influencing in Europe – Vigilance and surveillance of substances of human origin project (SOHO V&S)

The HTA has been working with the EU commission on a three year project which aims to support EU Member States in establishing effective vigilance and surveillance systems for tissues and cells used in transplantation and assisted reproduction. The project will end in 2013 with a conference organised by the HTA but financed by the EU. The conference will be used to present the project outcomes, which comprise three guidance documents:

• Guidance on Investigation and Communication of Serious Adverse Events and Reactions
• Guidance on the investigation and management of illegal and fraudulent activity
• Guidance for clinical end-users

More information is on the HTA website

Information for the post mortem sector

Microscope slides

At the request of our Histopathology Working Group (HWG), we have reviewed how we regulate the storage of microscope slides.

To date, our focus has been on requiring evidence that microscope slides have been disposed of where no consent has been given for them to be kept. Some members of the HWG considered this to be disproportionate, especially given that slides from living patients, important for diagnostic purposes, are not subject to such rigorous requirements. The Group requested that we look again at our requirements in relation to the management of microscope slides to see if a more proportionate approach to traceability could be adopted.

We recognise that microscope slides are more difficult to keep track of because of their fragility and the number of times they move between locations, and as a result we are considering modifying our approach. This would not mean tolerating the retention of slides without consent, but rather changing the current focus on disposal to one of governance, assuring ourselves through review of policies, operating procedures, the establishment's own audit activities and any other evidence that it chooses to present, that systems are in place to prevent unauthorised retention and use of tissue, including microscope slides. This approach would seek to acknowledge the difficulties faced by the sector and respond to them in a proportionate fashion, without compromising our commitment to fulfilling our statutory responsibilities and providing assurance to the public.

In practical terms, this would mean placing less emphasis on review of disposal records and modifying our tissue traceability audit so it excludes microscope slides. In turn, we would expect to see a documented policy that explicitly states that, when no longer needed for diagnostic purposes or by the coroner, PM tissue samples must be disposed of as expeditiously as possible and in line with relatives' wishes, unless consent is obtained for them to be stored for future use.

We are now in the process of finalising and agreeing these proposed changes. We would then seek to implement the change in approach by the end of the current business year.

Reducing regulatory burdens

When we moved to continuous licensing in 2009, we issued Directions to the PM sector requiring the annual submission of compliance information. Since then, establishments have provided two compliance assessments and completed an audit of tissue holdings. The information submitted has demonstrated a good level of compliance with HTA standards across the sector, which is borne out by the very small number of major or critical shortfalls we find on inspections. Committed to reducing regulatory burdens and working to principles of better regulation, we will not be asking for a submission this year, but instead will switch to a cycle of two-yearly updates, bringing the PM sector in line with the other sectors we regulate under the Human Tissue Act. Soon after Christmas we will be issuing reminders that your compliance update will be due for submission in June 2013. In the meantime, we advise that you undertake your own internal audits of compliance with HTA standards, in preparation for next year's submission.

Results of ACPO audit published

Following our post mortem audit in 2010, it became apparent that human tissue samples and specimens from historical homicide and suspicious death cases were being kept on HTA licensed premised on behalf of the police. A large proportion of these had been retained before the Human Tissue Act came into force, in some cases many years before. The Association of Chief Police Officers (ACPO), with the assistance of the National Policing Improvement Agency (NPIA), subsequently advised police forces in England, Wales and Northern Ireland to audit human tissue held by or on behalf of the police following post-mortem examinations. To guide and oversee the audit, a multi-agency national strategy group was established, which included HTA representation to provide advice, guidance and support as appropriate. ACPO and NPIA have since published their report.

There are two recommendations from the report that require action by the HTA.

• In cases where it is determined following post-mortem examination that a case is not suspicious and there is no further police investigation, a clear process should be followed between the police and the coroner to ensure material is suitably dealt with. To this end, ACPO and the Chief Coroner (when appointed) should agree the process to be followed in consultation with HTA.
• Review of police exhibits held on HTA licensed premises should be included within the regular HTA inspection process with a mechanism for reporting back to the police and the Home Office.

We will be taking these forward, although – in relation to the second recommendation - we have yet to agree with ACPO/NPIA the level of scrutiny of police holdings we will provide on inspection and how we would feed this information back to the police and the Home Office. We will also need to consider what, if any, changes will need to be made to our inspection process and the support and training that needs to be provided to our regulation team.

There are several further recommendations where we have offered to provide assistance, and we will continue to support ACPO in the forthcoming months as its recommendations are implemented.

Development of advice and guidance on post mortem examination of stillborn babies and infants.

We have been supporting the Sudden and Neonatal Death Society (SANDs) on the development of a national consent form and guidance on post-mortem examination of stillborn babies and infants, which will be issued in the autumn. SANDs hope that a simplified and unified consent form will help increase the number of post mortems, which provide invaluable information about the causes of stillbirths and infant deaths. The form has been developed in consultation with parents and healthcare professionals, and will be available on the HTA website, along with supporting information for clinicians and the public.

Reducing the burden of regulation – joint inspections with CPA

In response to requests from the sector, and as part of our ongoing commitment to reducing regulatory burdens, we are working with Clinical Pathology Accreditation (CPA) with a view to establishing a memorandum of understanding on how the two organisations will work together to share information and streamline inspection visits. This will include using CPA reports, with establishments' permission, to inform our themed inspection programme; and undertaking joint inspections where this is feasible and will provide clear benefits. We have completed a standards-mapping exercise, which will be tested throughout the summer, and have identified a small number of establishments that may be suitable for a pilot joint inspection in the fourth quarter of 2012/13 (between January and end March). We will be contacting these establishments in due course.

Information for the anatomy sector

We received 1365 enquiries from the public in 2011/12 on body donation for medical science. We have had positive feedback on the work we have done to clarify the consent given in Wills or personal notes, and we are continuing to provide advice and guidance in the developing area of using cadaveric material for surgical training.

Information for the research sector

Removal of tissue from the deceased for research

Since it came into force, the Human Tissue Act 2004 (HT Act) has required that the removal of tissue from the deceased for research 'in connection with disorders, or the functioning, of the human body' must always be licensed by the HTA. There is no exception to this legal licensing requirement, even for research where the storage of material is exempt from licensing because a project has been approved by a recognised research ethics committee.

Over the last business year, we have continued to listen to researchers who have found this legal requirement to be a potential stumbling block, particularly transplant professionals who have wished to undertake research using material from deceased donors.

In November 2011, we issued a position statement explaining how existing post mortem removal licences can be extended to cover areas outside a typical hospital mortuary, such as operating theatres. To support organisations that cannot extend an existing licence, we launched a new licence in May that specifically covers the removal of tissue from the deceased for a range of scheduled purposes, including research, within the scope of the HT Act. Because we anticipate new removal activities to be taking place within robust governance frameworks – for example, health research projects approved by NHS Research Ethics Committees -– we have been able to reduce the new licence fees to levels we believe to be proportionate to the risks. It will still be possible to extend – at no cost – an existing removal licence to cover activities taking place on the same site.

We have also been providing information to the DH who are considering whether a change in the legal framework might offer an improved way forward in the future.

Information for the organ and bone marrow transplant sector

Living organ donation framework

The HTA has been working closely with NHSBT and the British Transplantation Society (BTS) to implement changes to HTA's living organ donation framework. Our collaborative approach has so far ensured that changes are well managed and clearly communicated.

Guidance document

The Guidance document for transplant Units and Independent Assessors will be re-issued in early August, and this will provide an up-to-date and comprehensive overview of the HTA's policies and requirements.

IA training

We have been exploring with a small number of Units different ways of delivering IA training and we will consider how we can roll this out more widely.

We are always keen to hear of ideas and suggestions from colleagues in the living organ donation community, and encourage people to get in touch.

Organ donations from living people

Between 1 April 2011 and 31 March 2012 the HTA approved 1215 reports from Independent Assessors (IAs).

Between 1 April 2011 and 31 March 2012, the HTA referred 118 reports to a panel of HTA Members for decision.

You can read more about organ donation on our website.

Bone marrow donations from children and adults who lack capacity to consent

Between 1 April 2011 and 31 March 2012, the HTA approved 69 reports from Accredited Assessors (AAs).

You can read more about bone marrow donation on our website.

Recent media stories about human tissue

April

The HTA was mentioned in a Telegraph article about a stem cell doctor who is working partnership with a British laboratory which is licensed by the HTA.

May

The HTA was referenced in some of the coverage on the ACPO Audit including: BBC News and Mail on Sunday and Ulster TV News. The HTA is mentioned in a Private eye piece relating to a paediatric pathologist.

We published a statement welcoming the appointment of first Chief Coroner of England and Wales.

June

The HTA was mentioned in a BBC story regarding a briefing by the State Pathologist for Northern Ireland, Dr Jack Crane, to the Stormont justice committee on the retention of human tissue and ACPO audit. Further coverage on the audit also appeared on the BBC News website.

There was also a HTA mention in an Evening Standard, article which is a follow up to a recent piece in Private Eye.

The HTA featured in two articles on the illegal trade in organs in the Sunday Times and Nursing Times. Information on this issue also appeared in a Q&A on NHS Choices website

There was a further HTA mention in a Camden New Journal story about a transplant between a living donor and a man with acute liver failure.

The Consultant Magazine published an article (see pages 8-9) about our role, achievements and upcoming issues.

A press release was issued on the how the HTA is helping the transplantation sector prepare for EUODD which comes into force later this year.

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