Issue 26 December 2010

Welcome to the December 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 an update on the arm's-length bodies review, our office move, and information about our independent evaluation to determine public and professional views on the regulation of human tissue. For the tissue and cells for treatment (human application) sector we provide an update on our recent conference. For the anatomy sector we provide clarification about consent requirements for anatomical examination. For the post mortem sector we provide an update on how we are working to support public and professional confidence.

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

Corporate news

Arm’s-length bodies review

In light of the Government’s arm's-length bodies (ALB) review and alongside operational work, the HTA is continuing to liaise with a range of stakeholders to inform the Department of Health about the options for transferring our functions by 2013. We held a stakeholder workshop on 27 October to canvass opinions and we thank all those who gave us their views. On 10 November, HTA Chief Executive Craig Muir met CEOs from all Department of Health ALBs to discuss the issue of ALB business services, common themes and how ALBs engage as organisations with the ALB review.

On 29 October, the government announced that it is intending to use a Public Bodies Bill to put in place the legal framework to reform public bodies. The Bill had its second reading in the House of Lords on 9 November and our Chair Baroness Diana Warwick participated in the debate. Baroness Smith of Basildon cited the Public Bodies Bill and its proposed impact on the HTA in a House of Lords debate on the Redfern Inquiry on16 November. The Bill entered Committee stage on 23 November, and it is not expected to conclude until early 2011.

As the Bill continues through Parliament, the HTA will monitor amendments. We will keep stakeholders regularly updated in our e-newsletter. You can read our special edition e-newsletter  online. For more information, visit our new ALB webpage.

HTA office relocation

The HTA will move from our current location to 151 Buckingham Palace Road on 13 December. Our main telephone number will change to 020 7269 1900. Our fax number will change to 020 7269 1999. Please note that once we move, any telephone extensions beginning with 34xx will not be available and calls will not be redirected. If you have any difficulty contacting a member of HTA staff, please call 020 7269 1900. The HTA will be located with the Medicines and Healthcare products Regulatory Agency, the Health Protection Agency and the NHS Litigation Authority. More information is available on our website.

Public and professional confidence increases

Public confidence in human tissue regulation has increased after three years, according to an Ipsos MORI poll which the HTA commissioned earlier this year.

The research, which aimed to determine public and professional views on the regulation of human tissue, shows a five percentage point increase in the proportion of British adults who have confidence in human tissue regulation – from 52% to 57%.  Nearly nine in ten (86%) professional stakeholders have confidence in the HTA as a regulator, with two in five saying their confidence has increased since 2007.

More information about the evaluation, including the public and professional reports, can be found on our website.

Advanced notice of Directions to be issued to the anatomy, public display and research sectors

In April 2011, the HTA will issue Directions to all HTA-licensed establishments in the following sectors: anatomy, public display and research. The Directions will inform establishments of the need to verify their registered details and require Designated Individuals (DIs) to review their licences to ensure the HTA has the most current information. We will also be seeking an update from establishments on the activities they undertake and how they meet our standards.

We will issue Directions by email to DIs and Licence Holders (or their representatives). Further information, including sector-specific exceptions, will be available on our website in April 2011.

The HTA moved to a system of continuous licensing in 2009 and it is essential that establishments update us with changes to licences to allow for appropriate regulatory oversight and accurate fee charges.

The HTA must be advised of changes to Designated Individuals and Licence Holder representatives, licensable activity or to contact details, before they occur. You can notify us through our website; by email licensing.enquiries@hta.gov.uk or by call 020 7269 1900.

Licensing and inspections update

Since the HTA began licensing in 2006, we have completed 734 desk-based inspections and 543 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. More information about the HTA inspection process can be found on our website.

Your feedback on site-visit inspections

Since 2006 we have sought feedback on our phase two site-visit inspection process from licensed establishments. The latest responses continue to demonstrate confidence in our inspection process. Upwards of 90% of professionals over the last two quarters responded ‘good’ or ‘excellent’ for all categories.

In April we launched a reformatted feedback form with a new scoring system, more space for text and an additional question focusing on the approach our inspection team uses.

We have trialled various methods of collecting feedback including email but we now provided establishments with a hardcopy form at the end of an inspection.

Response rates have increased: in 2007 – 2008 we received 42% of forms; in 2008 – 2009 we received 50%. We are grateful for all your comments and encourage staff at establishments to complete the forms as your views help us to continually improve our regulatory functions, and in particular, the way we conduct inspections. More information about our inspection process is available on our website.

New transparency webpage

In response to the requirements for public bodies to publish information as a result of the Coalition Government’s transparency agenda, we have created a new page to summarise the requirements and how the HTA is responding. The information is now available on our website.

Information for the tissue and cells for treatment (human application) sector

Human application conference

The HTA tissue and cells for treatment (human application) conference was held in Nottingham on 21 October and was a great success. Information and presentations from the day can be found on our website.

Information about the reporting of SAEs or SARs

Due to the HTA relocation, the online reporting system for serious adverse events or reactions (SAEs or SARs) will not be accessible from midday on Friday 10 December until Monday 13 December. If your establishment is affected by a SAE or SAR that has implications for other establishments and / or you need help from the HTA in managing the incident during this time, please contact a member of the serious adverse events and reactions (SAEARs) team on one of the numbers below:

Christiane Niederlaender on 07917 895552 or Emyr Harries on 07790 348010 / 07825 552761. For all other SAEs and SARs please submit your report at a later date. Please monitor our website for updates.

New General Directions 003/2010 implementing consolidated requirements

The HTA has published new guidance for the human application sector. The ‘Guide to Quality and Safety Assurance for Tissues and Cells used for Patient Treatment’ forms the annex to Directions 003/2010. The content of the guide consolidates the requirements of Directions 001/2006, 002/2007 and 003/2007 and aims to explain the licensing requirements for the sector. The draft guide was subject to external review, which provided valuable feedback. 

We hope that the new guide makes adherence to the standards for the sector easier. For more information about the guidance is available on our website.

Annual activity data and licence fees

We will shortly be contacting all establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S regulations) to request your annual activity data. These data cover the period January to December 2010. As we did last year, we are asking establishments to submit the data via our website. The data requested this year will be virtually unchanged from last year.

This year the annual activity data collection exercise will also be used to gather information required to calculate the licence fees for the sector. You will need to indicate which licensable activities (procurement, testing, processing, storage, distribution or import and export) you are planning to carry out at your establishment, or via an unlicensed third party acting on your behalf under a third party agreement, in the next business year (from April onwards). It is important that staff collating the data and / or reporting to us familiarise themselves with the definitions of the different licensable activities. See our website for more information.

The data submission form will be available online from 4 January 2011 and an email will be sent out to DIs with a link to the relevant webpage. The completed annual activity data must be submitted to us by 25 January 2011. Please note that it is a standard condition on your licence to supply us with these data.

For further information please email enquiries@hta.gov.uk  or call 020 7269 1900.

Umbilical cord blood guidance

The HTA has published guidance for establishments undertaking activities involving umbilical cord blood cells. In September, we invited representatives of the licensed establishments and other organisations to a workshop, when the contents of the document were discussed. We circulated a draft document to workshop participants for review before it was finalised for publication.

The information it contains aims to raise awareness of the HTA’s regulatory requirements and clarify the HTA’s position in relation to licensable activities involving umbilical cord blood. This will support establishments working with cord blood and related tissues to meet our licensing standards. The guidance is available on our website.

Communication about cord blood collection (procurement)

The HTA has issued a letter to stakeholders in the stem cells and cord blood sector about procurement, which was prompted by feedback. We have become aware that some NHS Trusts and private hospitals have changed their policies and no longer allow cord blood collection, stating that it is unlawful.

Our letter provides clarification about the circumstances in which cord blood collection is lawful under the Human Tissue (Quality & Safety for Human Application) Regulations 2007. If you need more information you can read the letter on our website.

Information for the research sector

Research relating to transplantation

 The HTA presented at the UK Donation Ethics Committee (UKDEC) and the National Research Ethics Service (NRES) ‘Ethics in Transplantation Research’ workshop held on Wednesday 10 November in London. Subjects covered included consent, licensing and the amount of information given to donor families regarding research. The UKDEC plans to publish the outcomes of the meeting and the HTA will continue to work with them and support the research community more widely.

Information for the anatomy sector

Consent for anatomical examination

Following feedback from recent meetings, we would like to remind our stakeholders of wording that represents valid consent to body donation for anatomical examination. For consent obtained after the Human Tissue Act 2004 (HT Act) came into force, it is essential that the consent is valid and declares that the deceased wished to donate their body for ‘anatomical examination.’ The HT Act makes a distinction between the scheduled purpose for research and that of ‘anatomical examination.’

For consent obtained before the implementation of the HT Act, DIs should continue to judge any ambiguous donation on a case-by-case basis, considering the consent framework in place at the time of donation. For more information please visit our website.

Information for the post mortem sector

Post mortem sector update

Following the significant regulatory action which we took in relation to University Hospital Wales, Cardiff, late last year and the operational difficulties this caused in the area, we have been communicating changes in our procedures resulting from the lessons which all those involved  learned. The experience reinforced work we had underway to review our decision-making processes.

This month, our Chair Baroness Diana Warwick has written to Designated Individuals and Corporate Licence Holders in the sector, as well as key opinion leaders, to provide an update on other issues relevant to the sector. The letter gives details of some specific pieces of work that we are taking forward and their status.

Directions 001/2010 – advanced notification of 2011 submission requirements

We would like to remind all HTA-licensed establishments in the post mortem sector about the Directions which we issued this year requiring establishments to provide us with an annual update on activities undertaken and how our standards are met. In April 2011 we will issue new guidance to Designated Individuals and Licence Holders (or their representatives) on what information will be required in the 2011 submission and the deadline for receipt.

Update on PM audit of retained relevant material

Since the HTA issued Directions to the post mortem sector in April requiring an audit of retained post mortem tissue by the end of September, all establishments have submitted their summary reports.

Our decision to instigate the audit was informed by evidence gathered during inspections that gave rise to concerns about unnecessary tissue retention. The objective of the audit was to understand more fully the nature and quantity of relevant material stored on licensed premises and the reasons for its retention so that we can provide appropriate advice.

The HTA consulted the Royal College of Pathologists to define the specification of the audit, to help ensure that it was proportionate whilst giving us the necessary assurances of observing the consent requirements of the Human Tissue Act. We acknowledge that the audit has been difficult for some organisations to undertake. However, feedback from many Designated Individuals on inspection has been that it was a useful exercise, which has resulted in significant improvements in practice, a tightening up of procedures and increased confidence that material is only kept with appropriate consent.

The information is now being reviewed to determine the extent to which:

• there is retention of tissue without appropriate consent
• systems to dispose of tissue in a timely manner need improvement
• establishments are experiencing communication challenges with coroners or police forces which impact on their licensing requirements

We will provide advice and guidance to individual establishments as required. Where the audit shows common difficulties across the sector, for example in relation to the traceability of microscope slides, this information will inform our regulatory policy to ensure that we take a proportionate, risk-based and fair approach and that the sector is clear about what is expected.

The HTA recognises that this exercise represented additional work for establishments and would like to extend a sincere thank you for submission of this valuable information.

We will publish a report in March 2011 containing a summary of the self-assessment information submitted in June 2010 and the results of the tissue audit. This will provide information about how licensed establishments are performing against HTA standards for protecting the public and ensuring public and professional confidence in the regulation of the retention, storage, use and disposal of human bodies, body parts, tissues and cells.

Information for the organ and bone marrow transplant sector

Organ donations from living people

Between 6 April 2010 and 1 November 2010, the HTA approved 652 reports from Independent Assessors (IAs).

Between 6 April 2010 and 1 November 2010, the HTA referred 56 reports to a panel of HTA Members for decision. For more information about organ donations visit our website.

Bone marrow donations from children and adults who lack capacity to consent

Between 6 April 2010 and 1 November 2010, the HTA approved 35 reports from Accredited Assessors (AAs). For more information about bone marrow donation visit our website.

Online Submission System (OSS) unavailable 9-13 December

Due to the HTA’s office relocation, the online submission system for Independent Assessors (IAs) and Accredited Assessors (AAs) will not be available between 5.00pm on Thursday 9 December and midday on Monday 13 December. Please do not attempt to submit any reports during this period.

Christmas and New Year office opening hours for transplant assessments

Should you or your associated transplant unit have an emergency case during normal office hours – Monday to Friday 9.00am to 5.00pm – then please contact the HTA transplants approval team on 020 7269 1900/1960. The office will be open as normal on 29, 30, 31 December 2010 and 4 January 2011. If you call and continue to reach the answer phone, please use the emergency out-of-hours system.

Where emergency cases occur out of office hours*, please contact the duty officer at NHSBT on 0117 975 7575. The duty officer will then contact a representative at the HTA, who will be able to assess the case and provide a decision.

* Over Christmas / New Year this also includes 25–28 December 2010, as well as 1–3 January 2011.

Recent media stories about human tissue

October

We published a statement on Professor Sir Gordon Duff’s independent review of the NHS Organ Donor Register. A range of national and regional media outlets including the Liverpool Echo and Nature mentioned the HTA in coverage of the ALB review. In October we also issued a media release about our independent evaluation of public and professional views on the regulation of human tissue, which was covered by the Bristol Evening Post, BMA news and others. We also issued a media release on our reduced fees for 2011/12.

November

The BBC referenced the HTA in coverage of the police audit into existing holdings of human tissue. Additionally, the BBC highlighted the Human Tissue Act in coverage of the Redfern Inquiry into human tissue analysis in UK nuclear facilities. The HTA provided evidence to the Inquiry and issued a statement in response to its publication. The Telegraph also cited the HTA in a feature article on altruistic organ donation.

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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