Issue 12 August 2008
Welcome to the August 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. We now have 4000 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 licensing of procurement organisations and licensing guidance on the procurement of blood vessels during organ retrieval. You can also find out how to respond to the consultation on our revised codes of practice and read our 2007/08 Annual Review.
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.
Codes of practice consultation update
On 1 August 2008, we launched a public consultation on our revised codes of practice. The consultation will run until 14 November 2008.
Seven of our codes of practice are being revised to reflect our experience of regulation and we have also produced an entirely new code on research.
This is your opportunity to have your say on the advice and guidance that the HTA provides to professionals.
Read the codes and find out how to respond to the consultation.
In October, we will be holding consultation workshops in London and Newcastle for people from the regulated sectors. We plan to issue invitations for these workshops in August.
If you have any questions about the consultation process, please contact Rosanna Bate, Policy Officer: rosanna.bate@hta.gov.uk or 020 7211 3414.
Information for the human application sector
Licence applications for procurement
As of 5 July 2008, the procurement of tissues and cells for human application must be carried out on licensed premises or under the authority of a third party agreement with a licensed establishment.
We received 46 applications for procurement licences and we are now completing a desk-based inspection of the applications. During this process, we normally need to contact prospective Designated Individuals (DIs) and Licence Holders by email or telephone to request more information.
Where this information is required, we ask for this to be provided as soon as possible and within 10 working days of our request. With this in mind, prospective DIs and Licence Holders should ensure they are available to answer any questions we may need to ask over the coming weeks.
Procurement of blood vessels during organ retrieval
Additional blood vessels or ‘accessory vessels’ may be procured at the time of organ retrieval, usually during liver retrieval. In some cases, these vessels are stored for longer than 48 hours and may be used in patients other than the recipient of the organ.
If vessels are procured at the time of organ retrieval and are intended for sole use during organ transplant, the HTA considers the removal of the vessels to be part of the organ retrieval procedure. Under these circumstances the retrieval does not need to be licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations). The vessels must not be stored for more than 48 hours after retrieval, and any residual tissue following the organ transplant must be disposed of.
If vessels are procured at the time of organ retrieval, but there is a potential for the vessels to be stored for longer than 48 hours, or to be used in procedures other than the organ transplant, removal of the vessels must be licensed under the Q&S Regulations. Lawful procurement can only take place on licensed premises or under the authority of a third party agreement; and storage of any vessels for more than 48 hours must take place on licensed premises.
If your organisation carries out vessel procurement when retrieving organs, you should contact Christiane Niederlaender, Regulation Manager: christiane.niederlaender@hta.gov.uk or 020 7211 3446, to discuss the licensing requirements.
Theft of liquid nitrogen tanks
In recent weeks, there have been a number of organised thefts of liquid nitrogen storage tanks from hospitals in London. We believe that this is due to the perceived scrap metal value of the tanks.
If you keep nitrogen tanks in an external location, we would advise you to check your security arrangements.
Quality management systems
One of the areas assessed by the HTA is governance and quality, and there are many software systems available that can be purchased to support quality management. We advise that establishments keep their quality management systems proportionate to the size and activity of the establishment and the number of staff, and that they concentrate on making the system manageable, functional and useful.
Licensed establishments should be aware that the HTA cannot endorse any products that are purchased to support their quality management systems (e.g. to track samples).
Information for the research sector
Evaluating the views of the research community
At the HTA, we pride ourselves on working closely with the professionals we regulate. The experience we have gained from licensing and inspection has helped us to implement the legislation effectively, and the process of feedback and review is integral to the way we work.
Last year we commissioned an independent report, conducted by Ipsos MORI, to ask professionals and the public about the regulation of human tissue. The main conclusion was that our professional stakeholders are very positive about the HTA, though as a ‘young regulator’, there was a feeling that the HTA was ‘still work in progress’.
We have two projects planned for this year to obtain the views of the research community.
The first is our consultation on the new code of practice for research (see earlier in this e-newsletter); we are looking forward to receiving stakeholders’ views on this. We also plan to undertake an independent, external survey of the impact of the Human Tissue Act on the research community in the current business year. More information about this will be provided in a future issue of the e-newsletter.
National Cancer Research Institute consultation
The National Cancer Research Institute (NCRI), in collaboration with the National Cancer Intelligence Network and onCore UK, is seeking views on access to samples and data for cancer research. More information about the consultation is available on the NCRI website. The HTA will be submitting a response to the consultation and we encourage other organisations to respond as well. The closing date for consultation responses is 19 September 2008.
Information for the organ and bone marrow transplant sector
Organ donations
From 1 April to 28 July 2008, 326 reports from Independent Assessors (IAs) were submitted to the HTA, and 323 were approved. We are currently awaiting more information on three cases before they can be adequately assessed. Since 1 April 2008, eight cases have been referred to a panel of HTA members for a decision. More information can be found in our Independent Assessors bulletin.
On 5 November 2008, we will be holding our second annual Independent Assessor conference at the Wellcome Collection Conference Centre. IAs and members of transplant units have been invited to the event and more information can be found in our Independent Assessors bulletin.
Bone marrow donations
From 1 April to 28 July 2008, 20 reports from Accredited Assessors (AAs) were submitted to the HTA, all of which have been approved. More information can be found in our Accredited Assessors bulletin.
Inspections update
Since the HTA began licensing in 2006, we have completed 590 phase one (desk-based) inspections and 173 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.
We have analysed the reports from the inspections we have undertaken and have produced a summary inspection report for each sector, so that learning may be shared and standards improved. These will be launched at our report-back event on 18 September (details below). If you have been inspected in the last year, please note that your establishment will be listed as an annex to these reports.
Public Authority and report-back meetings, 18 September
Our next public Authority meeting will be held on the morning of Thursday 18 September 2008 at the Wellcome Collection Conference Centre in London. This is an opportunity to observe the Authority discussing its business.
We are also holding our report-back event in the afternoon at the same venue. This is the HTA’s key annual meeting when we officially launch our Annual Review and report on our work over the last year. There is also an opportunity to hear the experiences of people from some of the sectors that we regulate. Attendees at this year’s event will be the first to see the results of our inspections of licensed establishments over the last 12 months, and will also be the first to receive a copy of the new key messages guide which explains our work for patients and the public.
Places at the meetings are limited and will be allocated on a first-come, first-served basis. If you would like to attend, please register by 25 August 2008.
Once your place at the meetings has been reserved, you will be sent a confirmation letter and agenda at the beginning of September. The papers for the Authority meeting will be available to download from the publications section of our website in September.
Recent media stories about human tissue
Organ trafficking and transplant tourism
In July, the HTA issued a press release announcing the publication of the Istanbul Declaration to tackle transplant tourism and organ trafficking. Adrian McNeil, HTA Chief Executive, appeared on Radio 4’s Today Programme and New Scientist published a news article.
Quality and Safety Regulations
On 5 July, the HTA began licensing organisations which carry out procurement of human tissue. We issued a press release to announce the start of licensing. A commentary was published in the BioNews e-newsletter on the lessons that the HTA has learnt from implementing the Q&S Regulations.
Annual Review
We have recently published our 2007/08 Annual Review ‘Building confidence’.
This has been a busy year for the HTA in which we approved almost 1000 living-donor transplants and licensed nearly 750 establishments (including satellite sites). In the Annual Review, professionals and members of the public share their experiences of working with the HTA. This demonstrates not only the diverse range of work that we are responsible for, but also the positive effect our regulatory activity has had.
Read the Annual Review and our full Annual Report and Accounts.
If you would like to order a printed copy of the Annual Review, please email Serena Box, Communications Assistant: serena.box@hta.gov.uk or 020 7211 3403.