Issue 21 - February 2010
Welcome to the February 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 we regulate. We now have more than 6000 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 information about our new Chair, General Directions for the post mortem sector and our next public Authority meeting. You can also find out more about a new online portal that allows you to submit changes to your licence and Independent Assessor / Accredited Assessor reports.
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: enquiries@hta.gov.uk
The HTA e-newsletter is usually distributed every two months, but given that we expect there to be an election period over the next few months, we may not be able to distribute the e-newsletter in April.
New HTA Chair arrives
We are very pleased to welcome Baroness Diana Warwick as the new Chair of the HTA. Baroness Warwick took up her position on 1 January, having recently retired from her role as CEO of Universities UK.
Baroness Warwick said of her appointment: “I am tremendously excited to have been appointed to this role. I supported the introduction of the Human Tissue Act and the HTA has done well to set standards that are clear and reasonable in response to it. I look forward to leading the HTA and ensuring it continues to thrive and adapt to future change.”
You can read Baroness Warwick’s biography on our website.
HTA website updates
In June 2009 we relaunched the HTA website with a new design and structure. Since then we have been reviewing the content of all of the pages on the site to reflect our latest advice and guidance. The pages that we have updated now include the date on which they were reviewed at the bottom, so that you can be sure you are aware of any recent changes.
The review of web pages will continue through to the end of March. If you have any ideas about what you would like to see on our website, please contact us via email: enquiries@hta.gov.uk
Clarification on the disposal of identifiable but unclaimed material
In response to requests from licensed establishments, we have provided further clarification on the disposal of material which is identifiable but which is unclaimed by relatives. We have amended paragraph 73 of the code of practice on disposal of human tissue to reflect this change.
IT system improvements
In the December e-newsletter we explained that we will be making changes to some of our IT processes and systems. As part of this we will be introducing a new online portal which will mean changes to the way in which you:
- apply for licences and keep the HTA up-to-date with any changes to your licence
- submit serious adverse events and serious adverse reactions
- submit Independent Assessors and Accredited Assessors assessments and view progress on your submissions
- Access to the new portal will be provided through the HTA website with links on the appropriate web pages.
You will need to register before you can access the portal for the first time. This registration process will ensure that we have up-to-date contact information for you. If you will need to access the portal we will contact you directly in due course to provide more information about how to register.
If you have any questions during the IT system improvements, please contact us at enquiries@hta.gov.uk or phone 020 7211 3400.
Events
Public Authority meeting, 23 March 2010
The HTA holds two Authority meetings in public every year, one of which takes place outside London. The next public meeting will be held on Tuesday 23 March at the Royal York Hotel, York. We will be starting at 10.30 and the final agenda is to be confirmed.
This event provides an opportunity to observe the Authority as it discusses its business. There will also be an opportunity to ask questions once the formal agenda items have been discussed.
If you would like to attend, please register on our website by Friday 12 March.
Once you have registered, we will send you the full agenda and details of the venue a week before the meeting. You will be able to download the papers for the meeting from the HTA website one week in advance.
Review of the year, 15 June 2010
The HTA’s annual review of the year event will take place on Tuesday 15 June 2010. The event will take place all day in London. This is our main event of the year, during which we launch our Annual Review, and report back to stakeholders on the HTA’s key activities during 2009/10.
Invitations for this event will be issued in due course. You will also be able to register for this event from the events section of our website.
Licensing and inspections
Licence fees
We have started work to develop the licence fee structure for 2011/12, taking into account the comments we received from stakeholders at the workshops held last summer, and to analyse the cost of the activities that support licensing. PA Consulting are helping the HTA with this work. We hope to present proposals to the Authority meeting on 23 March, and to start a public consultation shortly afterwards.
Inspections update
Since the HTA began licensing in 2006, we have completed 717 phase one (desk-based) inspections and 392 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.
Information for the post mortem sector
General Directions
On 8 December 2009, we issued a regulatory alert to Designated Individuals (DIs) in the post mortem sector on compliance reporting and the retention of tissue and organs following post-mortem examination. The alert gave DIs advance notice that we will issue General Directions in April requiring them to audit relevant material from the deceased and submit results to the HTA in September.
The aim of the General Directions is to ensure that licensed establishments in the post mortem sector have robust and reliable systems of traceability and records management, and that there is knowledge about the nature and quantity of relevant material stored on the premises. We have consulted with representatives of the Royal College of Pathologists to determine the specification of the audit to ensure it provides the information we need, whilst placing the minimum possible burden on licensed establishments.
Additional General Directions will be issued in April requiring DIs to complete a compliance assessment report against core HTA standards for submission in June. We will publish details of our requirements at the same time.
HTA site-visit inspections in 2010/11 will focus on consent, traceability and records management. In addition, DIs will be expected to demonstrate that stored material is subject to audit and review, to ensure that material is not being stored without appropriate consent.
If you have any queries about the General Directions, please email enquiries@hta.gov.uk or phone 020 7211 3400.
Post-mortem examination facilities at University Hospital of Wales, Cardiff
In August 2009, the HTA suspended two licences authorising University Hospital of Wales, Cardiff, to carry out post-mortem examinations. This followed our inspection of the post-mortem facilities on 30 July 2009. The inspection raised serious concerns about practices, procedures and the suitability of premises, which did not comply with HTA standards. On inspection, records could not be provided for some of the tissue that was being stored. In August 2009, we referred our findings to South Wales Police.
South Wales Police have confirmed that, upon taking the advice of the Crown Prosecution Service (CPS), the circumstances do not raise a reasonable suspicion of criminality justifying further police involvement. The CPS and police agreed that the HTA referral was necessary to ensure public confidence. The priority now is for the hospital to dispose of tissue where appropriate according to the HTA’s code of practice.
Since July we have worked closely with the hospital to help get the facilities up to standard. The hospital has invested significant time and resources and made great improvements. We are working with Cardiff and Vale University Health Board (the NHS organisation which manages University Hospital of Wales) to build on the significant improvements that have already been made. The suspension of the licences was lifted on 18 September 2009.
Before the Human Tissue Act, post-mortem examinations were not regulated in law and this case demonstrates the importance of regulation. The public need to feel reassured that we monitor compliance with our standards and will take the appropriate regulatory action where necessary.
Cardiff and Vale University Health Board has set up an information line for any families that think they may be affected. The number is 0800 952 0244. The information line number is freephone and is open 9am – 6pm Monday to Friday.
Information for the human application sector
Third party agreements
We have recently updated the frequently asked questions (FAQs) on our website about third party agreements.
DIs and Licence Holders (LHs) in the human application sector are reminded that under HTA Directions we require information about the third party agreements they have in place for procurement, processing, testing, distribution and import / export carried out by third parties on their behalf.
DIs will be in breach of the standard condition on human application licences if they fail to report third party agreements to the HTA. This may result in regulatory action.
DIs and LHs can report third party agreements to us by using the submission form on our website.
HTLV 1 and 11 testing for tissue donors
On 11 November 2009, the American Association of Tissue Banking (AATB) issued a news release detailing changes to standards for Human T-lymphotropic virus (HTLV) testing.
The news release said “The Board of Governors has approved changes to AATB's standards for tissue banking to remove the requirement to test tissue donors for antibodies to human T-lymphotropic virus type I and type II (anti-HTLV-I and anti-HTLV-II).”
This change has potential implications for establishments importing human tissue from America.
The testing requirement stated in point 1.2 of Annex B of HTA Directions 001/2006 is: “That HTLV-I antibody testing must be performed for donors living in, or originating from, high incidence areas, or with sexual partners originating from those areas, or where the donor’s parents originate from those areas.”
America is considered to be an area with an increased prevalence of HTLV-I and therefore, according to the legislation, testing for the presence of this antibody is required for material imported into the UK from American suppliers.
More information is available on the AATB website.
DIs importing tissues and cells from America intended for human application should ensure the testing requirements set out in the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Directions 001/2006 continue to be met.
If you have any questions about this please email enquiries@hta.gov.uk or call 020 7211 3400.
HTA submission to the Science and Technology Committee’s inquiry into Bioengineering
In December the HTA made a written submission to the Science and Technology Committee’s inquiry into Bioengineering.
The Committee launched the inquiry to examine how the UK can maintain a globally competitive position in emerging and existing bioengineering research fields. The inquiry focuses on three areas: research, translation and regulation. The inquiry will take synthetic biology, stem cells and genetic modification (GM) as areas within which to explore the issues of research, translation and regulation.
You can read our submission on the Science and Technology committee website.
More information about the inquiry is available on the Science and Technology Committee website.
Information for the organ and bone marrow transplant sector
Organ donations from living people
From 1 April 2009 to 26 January 2010, 938 reports from Independent Assessors were submitted to the HTA, 935 of which were approved. One case is awaiting further information before a decision can be made. Since 1 April 2009, 43 cases have been referred to a panel of HTA members for a decision.
Bone marrow donations from children and adults who lack competence to consent
From 1 April 2009 to 26 January 2010, 62 reports from Accredited Assessors were submitted to the HTA, all which were approved.
Recent media stories about human tissue
The HTA issued a media release to announce the approval of 3,000 living donors and received media coverage on the BBC as well as being covered by Press Association, The Daily Mirror, The Liverpool Daily Post and The Belfast Telegraph. We also contributed to two radio features on altruistic donation that were broadcast during the Christmas period – one was on BBC Radio 4 and the other on BBC World Service.
To increase public awareness of the options to donate tissue and organs after death and the role of the HTA, our outgoing Chair Shirley Harrison provided a comment piece for the BBC’s Scrubbing Up Column.
We issued a statement in relation to a news story about a serious incident at a hospital mortuary.
We also issued a statement on respectful interment of retained organs, fetuses and tissue samples.
South Wales Police issued a media release on 4 February about post mortem facilities at University Hospital of Wales, Cardiff. The HTA issued a media statement in reaction that was quoted in The Telegraph, The Western Daily Press, The Western Daily Mail and on Wales Online and the BBC.
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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