Issue 30 August 2011
Welcome to the August 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 a report on our Annual Review, Review of the Year event, our public Authority meeting, and an announcement about our new Chief Executive. For the post mortem sector we provide an update on the results of the audit, which the sector conducted last year.
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: email@example.com.
On 26 July the HTA launched our 2010/11 Annual Review Exercising Efficiency at our Review of the Year event. This year it has been published online only. The Annual Review describes our achievements and activities over the last year.
We hope the Review and the case studies included give you an overview of our efficiency, effectiveness and the value for money we provide to ensure public and professional confidence.
We are keen to hear your views on our Annual Review so please get in touch via: firstname.lastname@example.org
Review of the year, 26 July
On 26 July we held our Review of the Year event. The event was introduced by Baroness Warwick, HTA Chair. HTA Chief Executive Craig Muir gave an overview of the HTA’s work over the last year and Director of Regulation Alan Clamp took this opportunity to examine the HTA’s approach to regulation. Following him, Craig and Diana spoke about the arm’s-length bodies review. This was followed by a Q&A session with the audience.
Following these presentations, Sir Peter Simpson, Chair of the UK Donation Ethics Committee, chaired our debate titled Modern relationships in living organ donation: opportunity or risk? It focused on how, as relationships between potential donors and recipients become increasingly varied, the HTA can continue to ensure that living organ donation is something people enter into freely and without financial reward.
The HTA’s role in transplantation is to ensure that there is no reward involved and that the donor is not being pressured to donate. With this in mind, we felt the time was right to hold this debate. Sixty-two delegates had an appetite for a lively discussion. Sir Peter Simpson provided an anecdote about the public benefit of organ donation recalling a renal patient who has celebrated 42 years since her transplant.
The debate raised some interesting questions about whether people are developing more 'connections' remotely – for example though social media or distant cousins – as opposed to developing deep 'relationships'. It also raised questions about the role of third parties in transplant processes and whether organ donation could be altruistic if facilitation of the transplant was rewarded. For example, questions were asked about the role of publicity.
The debate will form part of our engagement on the assessment of living organ donations. We will also use the information to aid the development of a risk-based system for approval, which we will continue to ensure is a robust, proportionate and transparent system.
Public Authority meeting, 26 July
The HTA held our annual public Authority meeting on 26 July in London. This event provided an opportunity for 41 members of the public to observe the Authority as it discussed business and to ask Members and senior management questions.
Issues discussed included updates on plans to implement the EU Organ Donation Directive, on the proposed framework for living organ donation assessment, and a summary of the position to date on the arm’s-length bodies review. You can download the papers for the meeting from our website.
Arm’s-length bodies review
It has been over a year since the Government published the arm’s-length bodies (ALB) review which acknowledged that the HTA’s functions are essential but proposed they transfer to other bodies including the Care Quality Commission (CQC). In that time the Public Bodies Bill (PBB) – the legislative vehicle the Government is using to reform public bodies – has been debated in Parliament before passing to the House of Commons.
On 12 July, the PBB had its second reading in the Commons. This was the opportunity for the Commons to debate the principles of the Bill.
There was no mention of the HTA or our partner organisations. There was a theme throughout the debate about the cost of these reforms and the people affected by them. The Bill will continue to its detailed review in Committee on 8 September. It is expected to complete all its stages by the end of October.
The Government’s consultation on the HTA and Human Fertilisation and Embryology Authority’s (HFEA) functions is expected to start in October or November. In the meantime we are working increasingly closely with the CQC and the HFEA and on the shared services agenda.
To support this approach we have agreed with the CQC and the HFEA that we will adopt a strategic partnership agreement which will set out the principles of working together on a tripartite basis, to ensure the most efficient use of our combined resources, to ensure a joined up approach with the other bodies, and to reduce the burden on those we regulate.
The Authority’s ambition of keeping all our functions (including research) together appears to have general support. This is good news for public confidence in the safe and ethical use of human tissues and organs, and should give greater reassurance regarding the retention of expertise and for the future of the HTA. In the meantime we are making further efficiencies for the 2012/13 financial year which will be reported to the Authority in September.
As the PBB continues through Parliament, the HTA will monitor amendments. We will keep stakeholders regularly updated in our e-newsletter. For more information, visit our ALB webpage or read the paper from our last Authority meeting.
Post mortem sector audit report
The HTA published our special post mortem sector report in June. The report contains a summary of the outcomes of the self-assessment exercise and audit of retained material that establishments were required to complete last summer, to check their systems of consent, traceability and disposal.
A primary aim of the exercise was to assess the effectiveness of the HTA’s regulation of the post mortem sector and, in particular, to ensure that establishments’ operational procedures and practices are successful in ensuring that retention of post mortem tissue is properly authorised to ensure the public have confidence.
The information we have gathered shows that the sector continues to have a strong focus on implementing systems that meet regulatory requirements and ensure tissue is kept only with the appropriate consent. This has resulted in a high incidence of HTA standards being met and a very low incidence of unauthorised tissue retention.
There are still improvements to be made in some of the underlying systems supporting the delivery of post mortem services, and we hope the information contained in the report, and further guidance that the HTA will issue in the forthcoming months will be helpful to all those working in the sector.
For more information read our press release.
The HTA will start work in late August to review the level of licence fees to be charged for 2012/13. New fee rates will be announced in December 2011 and we expect these to be no 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.
Update on publishing corrective and preventative action plans
In our February e-newsletter, we informed you that corrective and preventative action (CAPA) plans would be published on our website. The HTA has now decided not to publish CAPA plans for site-visit inspections because we judge there would be insufficient value added to justify the costs. A number of factors influenced our new position.
Many of the plans are quite complex, would require additional formatting and would have to be edited in accordance with our responsibilities under the Freedom of Information Act 2000 and the Data Protection Act 1998. We decided instead to publish a statement on the online inspection report which informs readers that establishments have taken the required steps to address all shortfalls identified during site-visit inspections.
Staff at establishments not yet inspected may not be familiar with the CAPA process. Our Regulation Managers review and agree CAPA plans to ensure that the steps taken are appropriate and address the shortfalls which were identified. We monitor the plans to ensure that the agreed actions are completed on time.
Once Regulation Managers are satisfied that the establishment has completed all agreed actions, we will update published inspection reports by adding a statement to reflect this. You can read more about CAPA plans on our website.
In January we started to publish inspection reports on our website for all site-visit inspections since November 2010. The publication of inspection reports increases transparency about the regulatory actions we take following an inspection.
For more information about our inspection process, visit our website.
Annual Report and Accounts 2010/11
The HTA published our fifth Annual Report and Accounts on 30 June. This publication covers our work from 1 April 2010 to 31 March 2011, and is available to download from our website.
New HTA Chief Executive announced
Alan Clamp has been appointed as the HTA’s Chief Executive with effect from 1 October. Alan joined the HTA in January this year, as Director of Regulation. Craig Muir will step down from his role at the end of September. We wish him well in his new role as Chief Executive of the charity Age Exchange.
For more information read our press release.
Licensing and inspections update
To date in 2011/12, we have completed 58 site-visit inspections (31 tissue and cells for treatment, 18 research, four anatomy, four post mortem and one public display). There have been five desk-based assessments completed this business year – three tissue and cells for treatment and two research.
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 via: email@example.com.
Further information about our inspection process including inspection reports can be found on our website.
Information for the organ and bone marrow transplant sector
EU Organ Donation Directive
Between September and December the Department of Health will be consulting on the draft Statutory Instrument which transposes the EU Organ Donation Directive (EUODD) Regulations into UK law. At the same time, we will be consulting on the draft regulatory framework. We are expecting to hold a programme of workshops for Designated Individuals in early 2012.
We will be sending our consultation to all relevant stakeholders and will provide further information in the next edition of this newsletter.
The presentations from the successful workshop which we jointly hosted with NHSBT in May will shortly be available on our website. To find out more about EUODD read our Director of Regulation’s update to the Authority.
Organ donations from living people
Between 1 April and 29 June, the HTA approved 257 reports from Independent Assessors.
Between 1 April and 29 June, the HTA referred 22 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 29 June, the HTA approved 12 reports from Accredited Assessors. You can read more about bone marrow donation on our website.
Information for the research sector
Factsheet on research within the scope of the Human Tissue Act
Following useful discussions with transplantation researchers, in June the HTA published a factsheet on our website which summarises the key requirements for human tissue research under the Act. It is not intended to replace or supersede the detailed information that we already provide on our website. Researchers are also encouraged to read the HTA’s codes of practice and frequently asked questions (FAQs).
Recent media stories about human tissue
The HTA was referenced in a post mortem story on BBC London, in The Evening Standard, The Daily Mail and The Metro. The HTA was also referenced by the BBC, The Independent, The Daily Mail and The Metro in coverage of a police audit. The Guardian highlighted the HTA in a feature on body donation. Wired cited the HTA in a public display feature. In July we issued a media release announcing our new CEO. We also published a media release about the ten year anniversary of retained organs, foetuses and tissue samples. In addition to this, we issued a media release about our post mortem sector audit report.
Previous copies of the HTA's e-newsletter are available in the news and events section of our website.
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