Issue 28 April 2011
Welcome to the April 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 updates on the arm's-length bodies review and a reminder of our 2011/12 fee structure which launched on 1 April.
It also includes news about our latest summary inspection reports and details about our new role as Competent Authority for the Organ Donation Directive (ODD). The ODD will improve the quality and safety of organs for patients across Europe.
In addition to all the usual features, for the tissue and cells for treatment (human application) sector we provide an update on requirements for any material stored for human application including bone and tendon. For the anatomy, public display and research sectors we provide important information about new Directions which we will be issuing. For the post mortem sector we provide an update on the Serious Untoward Incident reporting system and instructions on completing self-assessment forms for licensed activities.
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 update
As you may be aware, the arm’s-length bodies (ALB) review published in July 2010 recognised the essential nature of the HTA’s functions and the importance of our work continuing.
The review proposes that our functions should transfer to three or possibly four organisations, whilst our main licensing functions should transfer to the Care Quality Commission (CQC). The HTA will continue in its regulatory role until any transfer takes place.
In efforts to meet our strategic aim to build and develop effective relationships with stakeholders and the public our Chair Baroness Diana Warwick wrote to a number of public group stakeholders, seeking their opinions on our functions and how our work and the ALB review might affect what they do.
The Public Bodies Bill (PBB) continues its passage through Parliament. On 28 February Lord Taylor of Holbeach (Government spokesperson) announced a number of significant developments. Amendment 175 called for safeguards over ministerial powers to be introduced. Lord Taylor said he intended to reach a solution, with peers that would offer further protection.
The Government also announced that it would withdraw schedule seven of the Bill – which would have allowed the government to modify the functions of, or abolish, any of the list of bodies in that schedule.
The HTA remains in schedule five, which allows our functions to be transferred, abolished or modified in some other way. The Lords reached schedule five on 8 March when we were debated. During the ninth and final Committee stage of Public Bodies Bill on 9 March, there was a consensus across all benches that both the HTA and the Human Fertilisation & Embryology Authority do sterling work. Lord Howe said:“The HFEA and the HTA are models of regulatory authority that were right for the times in which they were created and which have done an admirable job in meeting the demands placed on them.” The Bill went to report stage in the House of Lords on 23 March.
On 28 March it went to the second sitting at report stage. It was an interesting debate which our Chair spoke at, but our status was not pushed to the vote. In response to our Chair’s comments Lord Howe said: “The noble Baroness, Lady Warwick, asked a number of detailed questions about the effect of our proposals on bodies regulated by the HTA and the way that its functions are performed. The case that she put eloquently was an argument in favour of keeping the HTA's functions together. I understand her point of view; however, I reassure her that we will consult on the option of keeping the HTA's functions together.” The Third Reading – the final stage in the Lords – will probably be after Easter; date to be confirmed.
With regard to timescales, Lord Howe said the consultation on where the HTA’s functions will be transferred would take place in late summer. He added that the Government intends to develop plans for the transfer of functions in consultation with the CQC over the next few years and that no transfer would take place before then. He has promised to set out timescales in a letter to peers. The Government now appears to be working to a timescale for implementation of 2014 at the earliest.
As the Bill 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.
HTA to set EU transplant standards
The Human Tissue Authority (the Authority) has been selected as the body that will set standards for the quality and safety of transplant organs across the EU, the Department of Health has announced.
The Authority has been named as the Competent Authority for England and Wales for the EU Organ Donor Directive (ODD) and we will take the lead on developing the first formal regulatory framework for the donation and transplant of organs and its implementation into legislation by August 2012. The Scottish and Irish Assemblies have also asked us to be their Competent Authority for the ODD and we have accepted these roles.
The ODD is a European requirement that aims to bring all EU countries up to the same high quality and safety standards. With better organs available in the EU, more UK citizens may benefit from the availability of suitable organs transferred from across Europe.
Public Health Minister Anne Milton said: “I am pleased the HTA has agreed to carry out this important role. Organ transplantation in this country has an excellent safety record and can transform a patient's life. The HTA are extremely well placed to build on the successful system we have already to make sure the standards for quality and safety are upheld.”
On Thursday 19 May we will be running a joint workshop with NHS Blood and Transplant in London where transplant unit representatives can inform the drafting of the Regulations and supporting documents, and gain an understanding of how the ODD will affect governance and clinical practice in organ donation and transplantation.
We have invited representatives from hospitals involved in organ procurement/transplant to send delegates to the meeting. We also welcome delegates from the private sector. If you are concerned that your organisation has not received an invitation please contact email@example.com.
For further information please contact firstname.lastname@example.org.
Reduced licence fees for 2011 /12 now in place
New licence fee rates came into force on 1 April. We know how important it is that we keep licence fees as low as possible and that we provide you with value for money. We have, therefore, challenged ourselves to manage with reduced fee income for 2011/12 and the savings are reflected in the new licence fees.
We are delighted that we have been able to pass these savings on to our licensed establishments as part of our strategic aim to continuously improve the way the HTA is governed and managed. If further savings arise, we will pass these on to establishments too.
Due to the efficiency savings which we made in 2010/11, we will be crediting surplus licence fee income to establishments, in proportion to the fees they have paid in 2010/11. We are providing details of the individual amounts to establishments early in April. This credit will be offset against 2011/12 fees. We will arrange refunds for establishments who no longer have a licence.
We will send establishments invoices for 2011/12 annual fees, with credit notes for the adjustment described above, showing the net amount to be paid. Invoices will be issued at the same time as in previous years (in July for ‘procurement’ establishments in the human application sector, in April for all other human application establishments, and in September for other sectors).
New establishments will be invoiced for their annual fees at these times or if that month has passed, when the licence is formally granted after acceptance by the establishment. From 2011/12 we charge an application fee to assess new licence applications and this will be invoiced on receipt of the application.
For further information please contact email@example.com.
Summary report of performance against HTA standards for all sectors
On 7 April the HTA published its 2009/10 Summary report of performance against HTA standards for all sectors. This report provides information about our regulatory activity and inspection findings for the 2009/10 business year. Where relevant, we have drawn conclusions and highlighted good practice. In doing so, we aim to create opportunities for learning that will support those we regulate and help to further improve standards. The report is accessible via our website.
In 2010, as a result of General Directions which we issued, the post mortem sector undertook an audit of tissue and a self assessment against HTA quality standards. The findings of these will be shared with the sector shortly.
General Directions for Anatomy, Public Display and Research sectors
In our December 2010 e-newsletter, we notified establishments of our intention to issue Directions in April 2011. We will be contacting Designated Individuals and Licence Holders by email before Easter with instructions and documentation. There will be an online form to complete and submit to us no later than Thursday 30 June. The Directions and supporting documentation will also be made available on our website.
The Directions will require establishments to check and confirm their licensing information; to undertake a self assessment against our standards; and provide general information about activities.
Following assessment of the information provided, we will update establishments’ licensing records. The information from this exercise will inform our inspection programme and regulatory approaches to each sector.
Authority meeting, 22 March
The last HTA Authority meeting took place at The Westminster Conference centre in London on Tuesday 22 March. The items discussed included an update on the arm’s-length bodies review, the HTA’s strategic plan 2011 to 2014, the corporate business plan and budget and the communications strategy.
All meeting papers presented are available to download from the HTA meeting papers webpage. The next Authority meeting will be on Tuesday 24 May. The subsequent one on Tuesday 26 July, will be the first public meeting of 2011. It will be combined with our annual review of the year event and will take place in London.
More information will be made available on our website.
Licensing and inspections update
Since the HTA began licensing in 2006, through to the end of the 2008/09 business year, we completed 646 desk-based assessments and 232 site-visit inspections across our five licensed sectors.
During the 2009 /10 business year we completed 42 desk-based assessments (26 human application, seven research, six anatomy, two post mortem and one public display) while to date in 2010/11, we have completed 54 desk-based assessments (24 human application, 15 research, one anatomy, 11 post mortem and two public display).
During the 2009 /10 business year we completed 189 site-visit inspections (99 human application, 15 research, two anatomy, 72 post mortem and one public display). You can read more about these inspections in our 2009/10 Summary report of performance against HTA standards for all sectors. To date in 2010/11, we have completed 184 site-visit inspections (79 human application, 21 research, four anatomy, 75 post mortem and four public display).
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.
More information about our inspection process can be found on our website.
Information for the tissue and cells for treatment (human application) sector
Annual activity data 2010 update
We would like to thank all medical treatment (human application) establishments that provided their annual activity data for the period January to December 2010.
We are currently analysing the information submitted and will be making a portion of the information available, in an anonymised format, via the EUROCET website. In addition to this, we will make some of the high level data available at events including Designated Individual training events and publications including the summary report of performance against HTA standards for all sectors.
Our inspectors review this information before inspections and it will be used as a tool for updating our licence management systems. To find out more about annual activity data requirements, please visit our website.
Please contact the HTA at firstname.lastname@example.org if you have any questions.
Publication of updated guidance on the microbiological safety of human organs, tissues and cells used in transplantation
In February the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) published guidance on the microbiological safety of human tissues and cells used in transplantation. The guidance is aimed at everyone working in transplantation.
The HTA was pleased to have the opportunity to consult with the steering group in the development of these guidelines to ensure that where possible, a cohesive and consistent approach to ensuring patient safety is adopted.
Storage of any material for human application including bone and tendon for over 48 hours
The HTA has recently become aware that some establishments which do not have a storage licence receive bone, including femoral heads and tendons, from suppliers and store the material in freezers for more than 48 hours before they are implanted into patients.
We would like to remind the sector that any establishment which stores tissues and cells intended for patient treatment for more than 48 hours requires a storage licence. Tissues and cells must be stored under the appropriate conditions in order to minimise risks to patients.
Please inform us if your establishment stores bone or tendons for more than 48 hours so that your licence can be updated. Please note that this storage licensing requirement does not apply to end-users who store acellular material.
For more information about licensing requirements under the quality and safety regulations see our frequently asked questions webpage.
Environmental air particle monitoring requirements for processing of tissues and cells
The HTA has received a number of enquiries regarding the requirements for ‘in operation’ and ‘at rest’ particle counts and we will be publishing some frequently asked questions on our website.
In the interim, Designated Individuals in the human application sector should familiarise themselves with our guide to quality and safety assurance for human tissues and cells for patient treatment and the requirements for meeting our premises, facilities and equipment standards.
Where tissues or cells, or any medium coming into direct contact with them, are exposed to the environment during processing, without a subsequent microbial inactivation process, then this must be in a working environment with air particle counts and microbial colony counts equivalent to those of Grade A as defined in the current European guide to good manufacturing practice (GMP), annex 1 of Directive 2003/94/EC. The background environment for processing must be at least equivalent to Grade D. Measurements must be taken at rest and in operation to show compliance.
Clean rooms and clean air devices should be routinely monitored in operation. For Grade A zones particle monitoring should be undertaken for the full duration of critical processing. Where this cannot be technically achieved due to the nature of the operations, reasons must be documented and simulated operations or media fills must be carried out.
Information for the research sector
Health Research Regulator
In his Budget ‘plan for growth’ announced on 23 March, the Chancellor George Osborne set out the latest position on the proposed Health Research Regulator.
Section 2.191 discusses regulation of research, and the Academy of Medical Sciences (AMS) Review of health research regulation and governance. There is a proposal in the AMS review to transfer the HTA’s research functions to the new regulator.
The Authority does not believe the proposal to transfer the HTA’s research functions to the new regulator would achieve simplification, reduce burdens or achieve savings.
We believe that keeping all functions together will maintain focus and ensure that the public continue to be confident that human tissues and organs are always used safely, ethically and with proper consent. Earl Howe made a commitment in a debate on the Public Bodies Bill that the Government would consult on overall proposals for the future of the functions of the HTA which would include an option which keeps all the HTA functions, including research, together.
National Institute for Health Research Support Services framework
Over the past year, the HTA has contributed to the development of National Institute for Health Research (NIHR)’s Research Support Services Framework, which aims to streamline the management and governance of research and development (R&D) studies in the NHS and is based on good practice.
The framework provides a national model for NHS research managers, which includes guidance, standard operating procedures, templates and tools for both risk management and planning.
With the aim of “improving the health and the wealth of the nation through research”, the National Institute for Health Research (NIHR) is responsible for delivering the NHS’s R&D strategy.
In line with our regulatory approach, the HTA supports any initiative intended to improve the UK’s health research environment. The framework, which will be launched in May, can be found on the NIHR’s website.
Information for the post mortem sector
Serious untoward incident reporting update
There have been a few minor alterations to the Serious Untoward Incident (SUI) notification form and guidance document. Please make sure you are using the correct version of the notification forms.
As of 6 April, establishments must submit an SUI notification within five working days of the incident occurring.
General Directions 001/2010
On 30 April 2010, we issued Directions 001/2010 requiring Designated Individuals in post mortem establishments to complete an annual self assessment against our standards. As detailed information was provided by the sector last year, we will only require establishments to check and confirm their licensing information and to provide some general information about activities.
We will be contacting Designated Individuals and Licence Holders by email before Easter with instructions and documentation. There will be an online form to complete and submit to us no later than Thursday 30 June 2011. The supporting documentation will also be made available on our website.
Following assessment of the information provided, we will review the risk ratings assigned to establishments last year to ensure they are appropriate. The information will also be used to inform our regulatory approach to the sector.
Information for the organ and bone marrow transplant sector
Organ donations from living people
Between 6 April 2010 and 28 February 2011, the HTA approved 988 reports from Independent Assessors (IAs).
Between 6 April 2010 and 28 February 2011, the HTA referred 87 reports to a panel of HTA Members for decision.
Bone marrow donations from children and adults who lack capacity to consent
Between 6 April 2010 and 28 February 2011, the HTA approved 63 reports from Accredited Assessors (AAs).
Recent media stories about human tissue
The HTA was cited in a range of media outlets including Sky in news about DNA testing. Bionews published a report on the debate about the arm’s-length bodies review in the House of Lords on 1 February.
In Wales, Dragon's Eye examined the presumed consent debate and the role of the HTA and the Human Tissue Act in this area.
The Guardian referenced the HTA in a feature about body donation and The Times highlighted the HTA’s role in research in a feature about Breast Cancer Tissue Banks. BBC slideshow, Thisisbristol.co.uk and Motherwell Times cited the HTA in coverage of an exhibition featuring a human brain. We published a media release about the re-appointment of six of our Authority Members. The Department of Health issued a press release about the HTA becoming the Competent Authority for the Organ Donation Directive. This was covered on govtoday.co.uk.
The Observer mentioned the HTA in a feature on altruistic donation. This story was also covered on BBC Breakfast where our Chair Baroness Diana Warwick was interviewed, on BBC Radio Sheffield, and on Premiere Christian Radio.
Previous copies of the HTA's e-newsletter are available in the news and events section of our website.
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