Issue 20 - December 2009
Welcome to the December issue of the Human Tissue Authority's e-newsletter.
The e-newsletter is the main way that we communicate changes to our regulatory policy and so is essential reading if you work in one of the sectors that we regulate, or if your work is linked to our regulation. We also use the e-newsletter to let you know about new advice and guidance and important updates to our website. We now have over 6,000 subscribers. This issue reports on a regulatory alert that we have issued to the post mortem sector. For the human application sector, there is news about our annual activity data collection and an update on the licensing of acellular products. This issue also includes information about the departure of the HTA Chair.
If you have any comments or queries about the issues raised in this e-newsletter, or any ideas for items you would like to see in future, please contact us at enquiries@hta.gov.uk.
The HTA office will be closed on 25 and 28 December 2009 and on 1 January 2010. The office will be open on 21–24 and 29–31 December 2009. We wish all our readers a happy festive season.
HTA Chair steps down
The HTA Chair, Shirley Harrison, will be stepping down from her role on 31 December. Shirley was appointed as Chair on 1 January 2007 and was previously a lay Member of the Authority. We would like to thank Shirley for her significant contribution to the HTA over the last four years.
The Appointments Commission advertised the post of Chair in the press and on its website at the end of August. They shortlisted in mid October and interviews were held in November. An announcement will be made about the new Chair shortly.
The Appointments Commission will be advertising for new Authority Members to take up position in April next year. Application details will be available on their website.
Summary compliance reports 2008/09
In October we launched our summary compliance reports which cover the 2008/09 business year. There are five reports – one for each of the sectors we license and inspect. Each report provides a clear summary and update of the extent of regulatory compliance and activity in each sector. The two largest reports are dedicated to the human application and post mortem sectors – the sectors that are at highest risk of non-compliance with HTA standards. In addition, this year we have also published an overview report covering all the sectors.
The summary compliance reports are available to download from this website. We contacted all DIs and Licence Holders directly in October to inform them about the publication of the reports.
Impact of legislation and HTA regulation on research
In 2008, the HTA worked with Opinion Leader, a research-based consultancy, to undertake an evaluation of perceptions of the impact of human tissue legislation and HTA regulation on research. The report from the evaluation was published on our website in September 2009.
To establish the next steps for this project we held a meeting with representatives from the research community who had contributed to the development of the evaluation. The meeting, which took place on 27 October, was attended by organisations including the Department of Health, Royal College of Pathologists, Wellcome Trust, Cancer Research UK, OnCore and the National Research Ethics Service. The minutes and presentations from this meeting can be downloaded from our website.
We received valuable input from all who attended on the findings of the report and how we can work together to help the research community understand the regulatory and governance requirements. We are currently reviewing how we can contribute to the next steps.
IT system improvements
We are committed to improving our processes and systems to make us more efficient and provide improved value for money. Over this business year, we have been working with an external contractor to develop our Information Technology (IT) systems to ensure that we capture and make best use of information. Licence Holders may notice some changes once the new IT system becomes operational in April 2010.These will include:
- changes to our licence application and licence variation forms as we will be reviewing and standardising them. We will also begin to pilot web-based submissions for all licence variations
- a small number of establishments will be assigned new licensing numbers in the New Year so that we are better able to store information relating to particular establishments – we will send further details to the establishments affected
- as we prepare to transfer data to the new system we may also be asking stakeholders to confirm some details so that our data is of the highest quality
- during the transfer of data to our new system it may take slightly longer than usual to respond to enquiries
If you have any questions during the IT system improvements, please contact us: enquiries@hta.gov.uk or 020 7211 3400.
New DNA website page
In response to an increasing number of enquiries about DNA, we have published a new website page that gives guidance about consent and the use of DNA. The guidance includes a series of FAQs, two flowcharts and a glossary.
Access this DNA page.
Events
Review of the year footage
For the first time the HTA is broadcasting video footage from our review of the year – held on 14 July, on our website. If you missed the event, or if you would just like a reminder of the day, you can view Adrian McNeil, Chief Executive, giving an overview of the HTA, our approach to regulation and achievements of the year. You can also watch Tim Courtney from the Better Regulation Executive presenting on the Hampton Implementation Review, alongside Dr Sandy Mather, Director of Regulation.
Post mortem sector conference
The HTA’s first post mortem sector conference brought together a full house of professionals, including pathologists, anatomical pathology technologists (APTs) and coroners.
‘Working together, building confidence’, held at the Royal College of Obstetricians and Gynaecologists, Regent’s Park, on 21 October, provided opportunities for lively discussion and questions, and for delegates to network with each other and HTA staff, discussing common issues.
Dr Sandy Mather, Director of Regulation, began the morning with a summary of the regulatory compliance report for the last year. She was followed by Dr Emyr Benbow from the Royal College of Pathologists, who spoke about the ‘barriers to excellence’ in the delivery of post mortem services.
Presentations were delivered on consent, by Ruth Musson a pathology nurse in the Department of Histopathology, Queen’s Medical Centre, Nottingham NHS Trust and an HTA Authority Member; the Coroners’ Bill, by Judith Bernstein from the Ministry of Justice; and the changing role of the Anatomical Pathology Technologist, by James Lowell, Chair of the Association of Anatomical Pathology Technology.
In the afternoon, there was a choice of workshop sessions on a variety of topics, including forensic post-mortem examination, the role of the Designated Individual (DI), and the complex relationships and communication channels between those working in the post mortem sector, the Coroner Service and bereaved families. The HTA presented new guidance on this last issue in the form of a communication flowchart. There were opportunities to speak with members of HTA staff throughout the day and also during a lunchtime ‘surgery’.
Of the 87 evaluation questionnaires returned, nearly all (98%) of respondents felt the content of the day was useful and relevant to them and that the presentations were interesting and thought-provoking. A common theme in the feedback was that people wanted to be able to attend all of the seminars and many would have liked the conference to have been extended over two days.
The event coincided with the launch of the HTA’s 2009 report of compliance in the post mortem sector (see section for the post mortem sector below).
Download the presentations from the conference here.
Licensing and inspections update
Since the HTA began licensing in 2006, we have completed 714 phase one (desk-based) inspections and 349 phase two (site-visit) inspections across our five licensed 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.
Licence fees
We are pleased to confirm that licence fees for 2010/11 will remain at the 2009/10 rates. The fee “holiday” for licensed establishments in respect of activities carried out under Third Party Agreements (which only occur in the human application sector) will continue for 2010/11.
Holding licence fees at 2009/10 levels will provide a period of stability while we develop the 2011/12 fee structure. We will review the points many of you made earlier this year about the present fee structure and consult you in 2010 about the proposals for 2011/12. Further details about the plans and progress will be included in future issues of the e-newsletter.
Sue Martin, who joined the HTA as Director of Resources in October 2009, will be leading this work.
Move to continuous licences
As explained in previous e-newsletters, following feedback from the licensed sectors we decided to change from a fixed-term licensing system to a continuous licensing system. Earlier in the year we issued proposals to all licensed establishments to transfer to continuous licences and make some changes to the standard licence conditions. Each establishment that received a proposal has now been transferred to a continuous licence.
We are issuing the new licence certificates on a rolling basis and will ensure that each establishment receives a new continuous licence certificate before their current licence certificate expires.
As part of the move to continuous licensing, we will also be asking for updates on compliance with our standards. The first sector required to provide compliance information will be the post mortem sector, followed by the anatomy, research and public display sectors. This will help to inform our knowledge of individual establishments and the sectors as a whole, and ensure we continue to take a risk-based approach to our regulatory licensing and inspection functions. We have a statutory remit to inspect establishments in the human application sector every two years so at present, we are not asking for compliance updates to be submitted from this sector.
If you have any queries or concerns about your licence, please contact the regulation directorate at: licensing.enquiries@hta.gov.uk or 020 7211 3400.
Information for the human application sector
Licensing of acellular products
In the UK, suppliers of acellular bone or skin products for patient treatment must hold an HTA licence. The rules ensure that material which comes from human donors is tested for diseases such as HIV, Hepatitis B and Hepatitis C before use and that any products derived from human tissues or cells that may pose a potential health risk, can easily be recalled. The rules apply to all acellular products used for patient treatment, including products derived from human skin used to promote wound healing after injury, or products derived from human bone which may be used in dental or orthopaedic surgery.
On 27 November 2009, the HTA issued a press release which called on dentists and oral surgeons in particular, as they may not have high awareness of our regulation, to ensure they only obtain supplies of acellular products from HTA-licensed establishments.
You can read the media release and find a list of HTA-licensed establishments on this website.
Annual activity data
We will shortly be contacting all establishments in the human application sector to request your annual activity data. This data covers the period January to December 2009. We are asking establishments to submit the data online via our website. We will email DIs in early January to provide a link to the website page for data submission.
The completed annual activity data must be submitted to us by 11 February 2010. Please be aware that it is a standard condition of your licence to supply us with this data.
For more information please contact Lucy Atwal, Regulation Officer: lucy.atwal@hta.gov.uk or 020 7211 3448.
Reporting of serious adverse events (SAEs) and serious adverse reactions (SARs)
We have noticed that staff in human application establishments often delay the reporting of SAEs and SARs to us by weeks or even months. SAEs or SARs need to be reported via the HTA online system as soon as possible after they are identified. Reporting to the HTA should not be delayed until an investigation is complete. Staff at establishments have the opportunity to submit follow-up reports after the initial notification when an investigation is complete. Timely reporting is important so that we can assess the need to issue regulatory alerts to the sector or take any other action.
Each establishment must have a standard operating procedure covering the reporting of SAEs and SARs, including procedures for reporting in the absence of the DI. We are currently considering the implementation of mandatory timelines for SAEs and SARs.
More information about the reporting of SAEs and SARs can be found on our website.
UK stem cell Tool Kit
On 14 December the Department of Health will be launching the UK Stem Cell Tool Kit – a single resource for those who wish to develop a programme of stem cell research and manufacture, ultimately leading to clinical application. The Tool Kit consolidates existing regulatory resources and helps to clarify where the remit of individual regulators begin and end.
The Tool Kit has been developed with the support of the Gene Therapy Advisory Committee, and regulators including the HTA and MHRA. It demonstrates the commitment of regulators, government and funders to work together to help stem cell scientists in the UK translate basic stem cell research into clinical outcomes and commercial benefits.
Once the toolkit has been launched a link will be available on the stem cells page of our website.
Information for the post mortem sector
Post mortem regulatory alert
On 8 December 2009, the HTA issued a regulatory alert to all licensed establishments in the post mortem sector.
The purpose of the alert was to inform licensed establishments and other key stakeholders in the post mortem sector of five serious adverse events involving the storage of a brain and to share lessons learnt. As a result of these adverse events the HTA will issue General Directions in April 2010 requiring DIs to undertake an audit of all material from the deceased stored on the premises. The results of the audit must be submitted to us in writing by September 2010.
The regulatory alert also gives DIs advance notification of the first annual compliance update for the post mortem sector which needs to be submitted in 2010 following the HTA’s decision to convert all licences to continuous licences. The HTA will issue General Directions in April 2010 requiring DIs to complete the compliance assessment report against core HTA standards for submission by June 2010.
You can read the full text of the alert on this website.
Communication flowchart for coroners’ post-mortem examinations
In consultation with coroners, pathologists, mortuary managers and the Ministry of Justice, the HTA has developed a model communication flowchart. Based on the revised codes of practice, the flowchart gives guidance on steps to ensure that tissue taken at a coroner’s post mortem is stored only with appropriate consent or is disposed of in line with the wishes of the family.
You can download the model communication flowchart.
Daniel Gey Van Pittius, Consultant Histopathologist and DI at the University Hospital of North Staffordshire, has welcomed the flowchart as a means of improving communication with coroners and has already put it into practice. He has met the coroner, agreed training for pathologists and the coroner’s officers and identified a nominated person, whose name has been inserted into the flowchart. We would be interested to hear from any other establishment that has implemented a new system of communication based on the flowchart.
Model consent form
In November we published an updated post mortem model consent form on our website. The form provides a suggested format for NHS Trusts obtaining consent for post-mortem examination of adults, in line with the requirements of the HT Act. The form may be adapted, providing it complies with the HT Act and follows the HTA codes of practice on Consent, Post-mortem examination and Disposal of human tissue. It could be used for older paediatric cases, but is not recommended for stillbirths, neonatal deaths, fetal tissue or non-fetal products of conception.
The HTA’s model consent form is not prescriptive due to local variations in practice and may be adapted as necessary for local needs. Model consent forms are part of the consent process and should be supplemented with further discussion and more detailed explanation where necessary. More information about model consent forms is available on this website.
All sudden deaths should be DNA tested – HTA response
In response to a Royal Society of Medicine press release issued on 6 November, the HTA issued a statement on DNA testing following sudden death. Under the HT Act a new offence of DNA ‘theft’ came into force making DNA testing without consent illegal. The HTA has guidance on this matter on our website. Further guidance is provided in our code of practice on Consent which was referenced in the Royal Society of Medicine's press release.
Coroners and Justice Bill
The Coroners and Justice Bill received Royal Assent on 12 November. The Bill is now an Act of Parliament (law). The Act has been eagerly awaited, which is why we invited Judith Bernstein, Head of Current Coroner Policy from the Ministry of Justice, to provide a presentation on this issue at our post mortem sector conference. You can download Judith’s presentation.
Information for the organ and bone marrow transplant sector
Organ donations from living people
From 1 April to 13 November 2009, 662 reports from Independent Assessors (IAs) were submitted to the HTA, 659 of which were approved. One case is due to be referred to a HTA panel for decision. One case is awaiting further information before a decision can be made. Since 1 April 2009, 28 cases have been referred to a panel of HTA members for a decision.
Bone marrow donations from children and incapacitated adults
From 1 April to 23 November 2009, 52 reports from Accredited Assessors (AAs) were submitted to the HTA, all of which were approved.
Transplant approvals over Christmas
Our transplant approvals team will be considering submissions from IAs during the Christmas period, but we recommend that only urgent cases are submitted at this time.
The out-of-hours service for emergency organ transplants (usually liver failure) will operate over the whole Christmas period. Details of this process will be included in the December issue of the IA bulletin which will shortly be available from our IA Bulletin page.
Recent media stories about human tissue
In November we received media coverage in The Times about our role in approving living donations. The HTA also received media coverage in relation to a story about a family becoming the first to store umbilical cord tissue as well as umbilical cord blood.
Previous e-newsletters
Previous copies of the HTA's e-newsletter are available in the news and events section of our website.
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