Issue 31 October 2011
Welcome to the October issue of the Human Tissue Authority’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 now have more than 7,000 subscribers. We also use the e-newsletter to let you know about new advice and guidance and important updates to our website.
This issue includes an update on the EU Organ Donation Directive, the launch of a brief survey of the post mortem sector, and an update on the HTA’s serious untoward incident reporting system.
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 contact us at: firstname.lastname@example.org.
Arm’s-length bodies review
The Public Bodies Bill continues through the parliamentary process and last week saw the completion of the House of Commons committee stage, where there was further debate about the inclusion of the HTA in the Bill and around plans to transfer the HTA’s functions to the Care Quality Commission (CQC). You can read more of this debate on Hansard. The Bill will now return to the House of Lords to consider any amendments.
As part of the arm’s-length bodies review, we are still expecting the Department of Health to consult on the options for transferring the HTA’s functions by the end of the year. As we have highlighted in previous editions of the newsletter, the Department’s preferred option is to transfer the HTA’s functions to the CQC. The Authority’s ambition of keeping all our functions (including research) together appears to be supported which is good news for public confidence in the safe and ethical use of human tissues and organs.
We will continue to keep stakeholders regularly updated on the Bill and the Department’s consultation in our e-newsletter. For more information, visit our ALB webpage or read the papers from our July and September Authority meetings.
Authority meeting, 27 September
The HTA held an Authority meeting 27 September in London. Issues discussed included updates on plans to implement the EU Organ Donation Directive, an update on the proposed framework for living organ donation assessment, planned revisions to the HTA codes of practice, a summary of the position to date on the arm’s-length bodies review and shared services, and a report on the introduction of presumed consent in Wales. You can download the papers for the meeting from our website.
The HTA is currently reviewing the level of licence fees and aims to announce the new fee rates for 2012/13 in December. We are not expecting these to be any more than present fees.
Fees for 2012/13 will be charged on the same basis as in 2011/12 and take account of the same factors (i.e. number of satellites and, in human application, licensed activities). The costs of delivering licensed activities for 2012/13, following the efficiencies being made, will be determined and fees set to recover these.
More information about HTA fees is available on our website.
Licensing and inspections update
To date in 2011/12, we have completed 95 site-visit inspections (37 tissue and cells for treatment, 35 post mortem, 18 research, four anatomy and one public display). There have been ten desk-based assessments completed this business year – five tissue and cells for treatment and five research.
We consistently score highly on the quality of our inspections and the approach of our front-line staff. During the last quarter (July/August/September), more than 95% of the establishments we inspected across all sectors (which responded to our questionnaire) answered ‘Yes’ to the question “Has the inspection process helped improve the way you work?”
You can read our latest summary report of performance against HTA standards for all sectors on our website.
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 are keen to hear more of your views via: email@example.com.
Further information about our inspection process including inspection reports can be found on our website.
Information for the research sector
Changes to the remit of research ethics committees
A harmonised edition of the Governance Arrangements for Research Ethics Committees (GAfREC) came into effect from 1 September, replacing the 2001 edition. The new edition sets out the requirements for review of research by research ethics committees within the UK Health Departments’ Research Ethics Service and contains some changes to the remit of committees.
Although ethical approval remains outside the remit of the HTA, researchers can be reassured that the new edition does not change either NRES’s or the HTA’s interpretation of the Human Tissue Act’s consent and licensing exemptions which apply by obtaining ethical approval from a recognised research ethics committee.
NRES has produced an algorithm to help researchers to determine whether their project requires ethical review by a REC either to comply with legislation or under the policy of the UK Health Departments.
Information for the post mortem sector
Post mortem sector survey
Today (Mon 17) we have launched a short survey to the post mortem sector inviting their comments on our involvement with the sector over the last 12 months. The aim is to evaluate the sector to see if levels of confidence in the HTA have changed since the Ipsos MORI evaluation in summer 2010.
HTA Chair Diana Warwick has written to Designated Individuals (DIs) in the post-mortem sector inviting them to take part in the survey and we have also written to key stakeholders and opinion leaders in the sector to seek their comments.
We have thought carefully about the timing of this poll because we value our stakeholders’ time and do not want to overburden the sector with information requests.
The evaluation will be analysed objectively and the results from DIs are anonymous, so we encourage all DIs in the post mortem sector to take part. We will report on the findings of the survey to a future Authority meeting and will provide further information in future editions of the e-newsletter. For more information about how we regulate the post mortem sector visit our website.
Histopathology Working Group update
On 13 September, the HTA hosted the second meeting of its newly constituted Histopathology Working Group, which includes representatives from the Royal College of Pathologists, Association of Anatomical Pathology Technology, the Coroners Society, the British Medical Association, the Home Office and the Institute of Biomedical Science.
The Chair of the meeting, Caroline Browne, HTA Head of Regulation, provided a report on serious untoward incident reporting and on plans for collaboration with Clinical Pathology Accreditation, whilst Alan Clamp, HTA Chief Executive, gave an update on the arm’s-length bodies review and proposed transfer of HTA functions to the Care Quality Commission.
Agenda items also included sudden cardiac death in young people, Home Office post mortems and tissue retention, storage of tissue as part of the medical record, public information about post mortem services and recording and traceability of microscopic slides. The Group discussed at length the challenges faced by the post mortem sector in meeting HTA requirements relating to the logging, tracking and disposal of microscopic slides.
It was noted that slides from living patients, important for diagnostic purposes, are not subject to such rigorous requirements, and also that the requirements of the HTA are considered by some to be costly and resource intensive. It was argued that a culture of disposing of slides is developing, once the Coroner’s authority has ended and that this could have a negative impact on future criminal proceedings and on resources for trainee histopathologists. The HTA agreed that standards on disposal and traceability would benefit from review and undertook to develop a proposal for the Group to consider. For more information about how we regulate the post mortem sector visit our website.
Changes to HTA serious untoward incident reporting system
Following an internal review of the HTA serious untoward incident (SUI) reporting system, there will be a number of changes, which will take effect from January 2012. These changes were endorsed at the recent HTA Histopathology Working Group meeting as noted above. Designated Individuals (DIs) and licensed establishments will be notified, via the e-newsletter, when these system changes come into effect. A summary of the changes is outlined below:
• Amendment to some incident classifications.
• Addition of two new incident classifications.
HTA inspectors will ask to see your incident reporting processes when they visit, and will expect to see reporting to the HTA included as part of your standard operating procedures. Guidance should be given to staff on:
• What incidents are reportable (in general, and specifically to the HTA);
• The timeframe within which incidents should be reported to the HTA which is within five working days of the incident occurring or being discovered;
• Who should be informed about incidents (DIs, Persons Designated, etc); and
• What documentation should be completed.
Please do not hesitate to contact the HTA should you have any questions regarding the reporting of incidents on 020 7269 1900 or by email firstname.lastname@example.org.
Information for the organ and bone marrow transplant sector
Nuffield report on the donation of human bodily material for medicine and research
On 11 October, the Nuffield Council on Bioethics published a report on the donation of human bodily material for medicine and research, following an 18-month consultation.
The report considers how far we should go as a society in encouraging and supporting people to donate bodily material to benefit others. The report considers many different forms of material, and covers donation both during life and after death.
The report concludes that altruism should continue to be central to the approach to all types of donation as it underpins important community values, but this does not exclude the possibility of allowing some form of reward in some circumstances, one proposal is the offer of payment of funeral expenses for donors signing up to the organ donor register.
The HTA responded to the Council’s initial consultation and you can view this on our website. The HTA has welcomed the Nuffield Council of Bioethics report and we will be reviewing the report in detail and considering the recommendations. We will issue a formal response in due course.
You can view more information about the report and download copies from the Nuffield Council on Bioethics’ website.
EU Organ Donation Directive update
The HTA has been appointed as the Competent Authority (CA) designate for England, Wales, Scotland and Northern Ireland for the European Union Organ Donation Directive (EUODD).
The HTA has put in place a project with various work packages to ensure that we are ready for full implementation of the Directive on August 27 2012. In particular, over the last few months we have been working with the Department of Health on drafting the Statutory Instrument that will transpose the EU Directive into UK law.
In parallel with the work on the Statutory Instrument we have been working towards ensuring that we are compliant with the obligation of the Directive that Members States put in place a ‘Framework’ for quality and safety. The Framework will be published in a document which will explain to establishments how to fulfil the new regulatory requirements.
The Department of Health is finalising the draft Statutory Instrument and associated Impact Assessment, which will need to be scrutinised by the relevant government committees. Only when the Statutory Instrument, Impact Assessment and consultation package has been approved by the above committees will it be ready to go out to consultation.
The Department of Health and the HTA will be running parallel consultations. The Department of Health will consult on the Statutory Instrument and the HTA on the Framework document. The date for going out to consultation is dependent on the Statutory Instrument’s clearance by the relevant committees and so it is not possible at this point to give an exact date for opening the consultations; however, we consider it likely that consultation will start towards the end of October. You can respond at any time during the consultation period and the HTA encourages all transplant centres and other interested parties to do so.
Aside from the work on the Statutory Instrument and the Framework document, over the next few months the HTA will be working on a range of activities to facilitate a smooth and efficient transition to full implementation of the Directive.
In particular, we will be planning the delivery of training workshops for potential licence applicants to ensure that prior to applying for a licence, applicants have had an opportunity to learn about the licensing framework and the standards against which a licence application will be assessed. The workshops will also be an opportunity for the HTA to explain how it will ensure that licensed establishments are, and continue to be, compliant with the new regulatory requirements. It is likely that the workshops will be delivered between April and May 2012 and that we will be inviting applications for licences from early June 2012.
The HTA needs to recover the costs of licensing by charging licensing fees. During October, we will be developing a fee structure and determining fee levels for establishments that will be licensed under the new legislation. The fee strategy will be presented to our Authority for approval in November and we are aiming to publish information on the fees in December 2011.
The EUODD will bring some changes to current practice, which will inevitably cause some concern. By working closely with the sector, building on the relationships we already have and maintaining good communications, we are confident that we can implement the Directive in a proportionate manner whilst ensuring that the quality and safety objectives underpinning the EUODD are met. To find out more visit our website.
Serious adverse events and reactions workshop
As part of the implementation of the EUODD the HTA will set up a system for the reporting of serious adverse events and reactions (SAEARs). NHS Blood and Transplant (NHSBT) are supporting the development of this system. We will also be issuing guidance on the type of events and reactions that are reportable, as part of the Framework, on our website.
On 11 October the HTA and NHSBT held a workshop with 38 clinicians and transplant coordinators on EUODD SAEARs. Delegates discussed scenarios in areas where the reporting requirement may be unclear and gave their opinions on which categories of event and reactions should be reportable.
Of the 26 delegates who responded with feedback, 25 said the event provided an opportunity to input into the HTA's and NHSBT's planning for an SAE and SAR reporting system, all respondents said they thought events like this were a good way of engaging with stakeholders, and 25 delegates said they enjoyed attending the event.
This input from the workshop will inform the development of our guidance in this area. If you are concerned that your organisation was not represented, you can view presentations from the event on our website.
Organ donations from living people
Between 1 April and 20 September, the HTA approved 512 reports from Independent Assessors (IAs). Between 1 April and 20 September, the HTA referred 50 reports to a panel of HTA Members for decision because they involved altruistic, paired or pooled cases.
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 and 20 September, the HTA approved 32 reports from Accredited Assessors (AAs). You can read more about bone marrow donation on our website.
Recent media stories about human tissue
The HTA was mentioned in the media in coverage of directed donation between people who do not have a genetic or established emotional relationship in the Sunday Times, as well as on BBC Radio Five Live and The Daily Telegraph. This story was also covered on ITV regional news, the Today programme, BBC online, BBC London, News Point (SA), and the Deccan Chronicle.
The HTA was cited in a feature on BBC Radio Wales about Presumed consent, and our Director of Communications and Public Affairs Dr Shaun Griffin was interviewed for the programme.
Previous copies of the HTA's e-newsletter are available in the news and events section of our website.
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