Issue 17 - June 2009
Welcome to the June 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 more than 4,800 subscribers. We also use the e-newsletter to let you know about new advice and guidance and important updates to this website.
This issue sees the launch of this new and improved website - thank you to everyone who contributed to its development by taking part in the website survey or user testing. In this issue you can also find out about our upcoming events - our review of the year event on 14 July, where we launch our Annual Review and discuss the future of cord blood banking; and our conference for the post mortem sector on 21 October. You can also read about how we are updating our Guidance for transplant teams and Independent Assessors.
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.
Launch of new HTA website
At the end of 2008 we carried out a survey to find out your views about the HTA website. The aim of the survey was to form a greater understanding of the visitors to our site, to find out how well they thought the site represented the HTA, and how easy they found it to use.
The survey provided us with some extremely valuable feedback on the content, layout and structure of the website. We have incorporated this feedback into the development of this website and are very pleased to announce that we have now launched this new site.
You will see that the website has a number of new features including a more user-friendly structure and design, an improved search facility and links to the most popular pages, HTA news feeds, and more photos.
You may notice that the links for the website have changed. However, if you bookmarked any of the pages from the old site these should redirect automatically.
At this stage, we have not updated the full content of the website, but we plan to do this in the coming year.
Please have a look at our new website and let us know what you think: fiona.mckinson@hta.gov.uk
Consultations
Codes of practice consultation
Following the consultation on our revised codes of practice, seven of the codes have now been laid before Parliament:
- Code 1: Consent
- Code 2: Donation of solid organs for transplantation
- Code 3: Post-mortem examination
- Code 4: Anatomical examination
- Code 6: Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation
- Code 7: Public display
- Code 9: Research
We also consulted on code of practice 5 - Disposal of human tissue - but the Human Tissue Act does not require this code to be approved by the Secretary of State or laid before Parliament.
The draft versions of the codes that have been laid before Parliament are available on our website. Code 5 is also available on the website. Providing there are no comments from Parliament, the final versions will be published on our website in September, and brought into force through Directions.
Licence fees consultation
Our consultation on licence fees ended in March and the licence fee model for 2009/10 only was agreed at our public Authority meeting later in the same month. We applied three main criteria in determining the fee model:
- to take a ‘light touch' approach to regulation, that is efficient, fully meets our statutory remit and maintains the confidence of professionals and the public
- to keep operating costs as low as possible
- to comply with HM Treasury's requirement that the full cost of licensing is met by licence fee income
An overview of the responses to the consultation is available on this website.
Some of the consultation responses suggested we should assess the scope for setting fees within each of the sectors on the basis of activity, size, risk and perhaps other variables. The Authority decided that we should consider the alternatives to the current fee model and make the changes we think are practicable and appropriate. As a result, we held three workshops with stakeholders at the beginning of June to discuss what the alternatives may be. These workshops provided us with some extremely useful feedback, which will be used to develop a new fee structure for discussion at our next Authority meeting in July. Following this discussion, we will then hold a full public consultation. We are aiming to confirm in October the fee structure that will be operative from 1 April 2010.
Upcoming events
Review of the year event, 14 July
The HTA's review of the year will take place on Tuesday 14 July at BMA House in London.
This is the HTA's main stakeholder engagement event of the year, during which we launch our Annual Review and report on our key activities during 2008/09. The event will also include a discussion on the subject ‘Cord blood: benefits, risks and options for the next 10 years'. Speakers at the event will present their perspective on this issue, followed by a discussion with the audience. Speakers will include Donna Dickenson - author of ‘Body Shopping' - and representatives from the Department of Health, the National Childbirth Trust, NHS Blood and Transplant, and a commercial cord blood bank.
Places at the event are limited and will be allocated on a first-come, first-served basis. If you would like to attend, please register on our website by Friday 26 June.
Post mortem sector conference, 21 October
On Wednesday 21 October we will be holding a conference in London for establishments in the post mortem sector. The theme of the conference is ‘working together, building confidence'.
This conference will provide a valuable opportunity to discuss issues of relevance to the sector, and will include keynote speakers from the Royal College of Pathologists, the Association of Anatomical Pathology Technology and the Ministry of Justice. Topics will include: consent, the changing role of the Anatomical Pathology Technologist, and the pathologist's perspective on how professional bodies in the post mortem sector can work together to improve standards. In addition, the conference will provide an excellent opportunity to network with colleagues from the sector, and will see the launch of the 2009 summary report of compliance in the post mortem sector.
Invitations for the conference will be issued at the beginning of July, along with details of the agenda and speakers. You will also be able to register on our website. Please save the date in your diary if you are interested in attending the conference. You can find out more about the conference on this website.
Licensing and inspections
Licensing and inspections update
Since the HTA began licensing in 2006, we have completed 666 phase one (desk-based) inspections and 262 phase two (site-visit) inspections across our five licensed sectors. Inspections are usually scheduled according to assessed risk; however they may also be scheduled to validate our risk methodology, or on a reactive basis following receipt of information.
Summary inspection reports
In September 2008 we launched five reports summarising our key findings from inspections across the five licensed sectors. The human application and post mortem sectors demonstrated the lowest level of compliance with HTA standards, and so this year we have decided to focus on publishing summary inspection reports for these sectors.
This year's reports will not only summarise inspection findings, but will also provide a summary of the overall level of regulatory compliance in the human application and post mortem sectors, and include information collected through means other than inspection, such as investigations, complaints and annual activity data.
In addition to the two summary inspection reports, we will be producing two other sets of information. The first is an overview of HTA licence applications and compliance across all the sectors. This will be particularly useful for those people working in establishments that are carrying out licensable activities across more than one sector. The second is a short summary of compliance in the research, anatomy and public display sectors.
All of the reports will be available on this website in October. If you have any questions please contact Kristi Adams, Head of Regulation: kristi.adams@hta.gov.uk or 020 7211 3413.
Contact details for licensed establishments
We recently wrote to all licensed establishments to inform them about the move to a continuous licensing system. As part of this change we have issued a Notice of Proposal to all establishments which will implement a new set of standard licence conditions. One of the new conditions is that establishments are required to inform us about any change of contact details for the Designated Individual or Licence Holder.
Please ensure that you meet this licence condition by emailing licensing.enquiries@hta.gov.uk if there are any changes to your contact details. More information about changes to your licence is available on our website.
Information for the human application sector
Frequently asked questions on cord blood and third party agreements
To provide additional guidance for the human application sector, we have recently published frequently asked questions (FAQs) on our website about the procurement of cord blood and about third party agreements under the Human Tissue (Quality & Safety for Human Application) Regulations 2007.
Information for the anatomy sector
Disposal of relevant material (including that which has been imported)
We provide general guidance on disposal of relevant material in our codes of practice and encourage establishments to make decisions about the most suitable method of disposal in each case.
In response to requests for specific guidance about the types of relevant material which can be incinerated or cremated, we have produced a position statement on the disposal of anatomical specimens, former anatomical specimens and body parts (including those which have been imported) and a series of FAQs on this issue.
Import of fresh frozen bodies and body parts
The import of fresh frozen bodies and body parts is emerging as a potentially common practice for some HTA-licensed establishments. In recognition of this, we have produced a position statement on the import of fresh frozen bodies and body parts, which is derived from our policy on the import of fresh frozen bodies and body parts.
The policy includes the HTA's expectations of the responsibilities of establishments that import or export fresh frozen cadaveric material.
Information for the organ and bone marrow transplant sector
Organ donations from living people
From 1 April 2009 to 22 May 2009, 144 reports from Independent Assessors (IAs) were submitted to the HTA, 142 of which were approved. One case is currently awaiting more information before it can be adequately assessed and one is awaiting referral to panel for decision. Since 1 April 2009, three cases have been referred to a panel of HTA members for a decision.
Bone marrow donations from children and incapacitated adults
From 1 April 2009 to 22 May 2009, eight reports from Accredited Assessors were submitted to the HTA, seven of which were approved. One case is currently awaiting more information before it can be adequately assessed.
Revised guidance for transplant teams and Independent Assessors
The HTA Guidance for transplant teams and IAs was published in 2007. We are currently updating the guidance to reflect the changes in the revised code of practice on the donation of solid organs for transplantation, as well as to expand our guidance on the areas which we most frequently receive enquiries about. The updated guidance will be published on our website in the summer.
Recent media stories about human tissue
An article appeared in the Daily Telegraph on Tuesday 26 May about body donation. The article focused on a special thanksgiving service which was held at Southwark Cathedral on Friday 29 May in memory of those from London and the South East who have, over the past year, given their bodies to science. The HTA worked with the journalist who wrote the story to give background and found people to interview.
The Independent ran a feature on Tuesday 7 April about altruistic kidney donation. The article highlighted Barbara Ryder, an altruistic kidney donor, and discussed her motivation and the process that she went through to become a donor.
Previous e-newsletters
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