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The latest news from the Human Tissue Authority
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Issue 75: July 2019

HTA news

Anatomy

Organ donation and transplantation

Post mortem

Research

HTA News

HTA consultation on Code of Practice F in light of deemed consent 

The HTA has launched a consultation on changes to its Code of Practice F: Donation of solid organs and tissue for transplantation.

We have amended our Code of Practice to reflect changes to the Human Tissue Act 2004 as a result of the Organ Donation (Deemed Consent) Act 2019.

The revised code will provide advice and guidance to organ and tissue donation and transplant professionals in England on how the new law will affect their practice from spring 2020. It also provides guidance in situations where someone’s consent to donate their organs is not clear, or when clinical decisions are complex.

The HTA is asking professionals, stakeholders, partner organisations, and anyone else interested in organ and tissue donation and transplantation, to respond to the consultation, and to tell others about the consultation.

You can find out more about what the consultation will cover and how to respond to the consultation by visiting our website.

The consultation is open until 5pm on Thursday 26 September 2019, and it is looking for feedback on the proposed changes to our Code of Practice F, to ensure it provides organ and transplant professionals with clear and helpful information.

        
Find out more


HTA conference update

This year, our conference will take place on Wednesday 6 November in Euston, London. The programme will be aimed at professionals who work at HTA-licensed establishments, in particular, Designated Individuals, Corporate Licence Holders and Persons Designated. 

Thank you to everyone who has signed up to attend our conference already. The first release of tickets has now sold out. If you have registered, you should have received an email confirming your place. Please let us know if you have not received an email with your ticket.

If you haven't registered but would like to attend, you can still join our waiting list. We will be releasing more tickets to those on our waiting list soon.

Even if you are unable to attend, you can still take part by following the event live via the hashtag #HTAConf19 on Twitter, or via a live stream of the speeches and presentations on the day through our YouTube channel. Further details on how to access the live stream will be shared closer to the day through our Twitter account and via our website.
Find out more

Compliance updates 2019

All establishments licensed under the Human Tissue Act 2004 and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 are required to review their licensing records and complete a compliance update every two years.

The information we collect will be used to: 

•    maintain our regulatory oversight;
•    guide our regulatory approach; and
•    inform our risk profiling and the scheduling of site visits. 

In August, we plan to issue Directions and full instructions on how to complete and submit the compliance updates. These will be emailed to the Designated Individual or Named Contact and Licence Holder at each licensed establishment.
 
We are currently compiling the questions and anticipate that you will be able to submit your compliance updates via the HTA portal in September/October. We will confirm exact dates in August. 

To help you prepare your submission, we will also publish the questions on our website in advance of the portal being open for submissions.

If you have any questions about the compliance updates, please contact licensing.enquiries@hta.gov.uk

Changes to HTA inspection reports

From September, the HTA inspection report format will change.

We have been looking at the information we include in our inspection reports to ensure that they continue to be a consistent and transparent way of reporting our inspection findings. 

These changes will ensure that our reports are more accessible and user-friendly.

What will change?

  • The new reports will be shorter.
  • Inspection findings will be set out in a clearer way.
  • We have reduced the establishment background information section.
  • We have removed Appendix 1, which is the section that details the licensing standards in full.
You can still find all HTA licensing standards on our website. We have created downloadable versions that you can print off for each of our regulated sectors. We will begin rolling out the new reports for all inspections starting from 1 September. If you have any questions regarding the new report format, please let us know.

Read the latest HTA blogs!

Since our last newsletter, we have posted two new blogs:

Keep up to date with the blog

If you want to keep up to date with our latest blogs you can sign up to follow the blog and receive a notification when there are new blogs, or you can follow a specific blogpost to receive updates when new comments are added.

As always, we are keen to hear ideas from you as to which areas we might feature in upcoming posts. Please let us know of any suggestions for blog topics that would interest you.

See our blogs

Have you taken our online tests?

If you haven’t tried the tests yet, their purpose are to provide you with a useful resource to test your knowledge of the key requirements of HTA legislation.

The tests are open to all, taken anonymously, and will not count as an indicator of compliance against our standards.

Take the tests

Upcoming events


Monday 2 – Sunday 8 September: Organ Donation Week
NHS Blood and Transplant’s (NHSBT) annual Organ Donation Week promotes public awareness about organ donation and transplantation. It seeks to inspire people to join the NHS Organ Donor Register and encourages people to share their donation decision with their family and friends. The HTA will support the week by raising awareness of the important need for families to talk about organ donation and explain how consent for organ donation works in the UK.

Tuesday 17 September: Wales Transplantation Advisory Group (WTAG)
The HTA will be attending the June WTAG meeting. WTAG is a group that meets quarterly to discuss organ donation and transplantation in Wales, and includes representatives from the Welsh Government, NHSBT, as well as those who work in the sector in Wales.

Saturday 28 September:  Association of Anatomical Pathology Technology (AAPT) Annual Educational Event
The AAPT Annual Educational Event is an opportunity for delegates to update their knowledge of scientific, technological, legal and social issues. The 2019 event will be held in Edinburgh at the Royal College of Surgeons & Ten Hill Place Hotel. Confirmed lecture topics include: Sepsis, Unconscious Bias, Forensic Paediatrics and an update from the HTA. Find out more on the AAPT website.

Anatomy


Model body donation cards

In the last newsletter, we let you know about a survey we shared with members of the public on our body donor cards. Many fed back that they would carry a card indicating that they are a body donor, but were unaware that they existed.

In an effort to generate awareness, we have developed a template body donor card that medical schools can amend to include their own logo and offer to donors after they have a consented to donate their body. This is along similar lines as the model anatomy consent forms that we provide.

You can edit and tailor the card in any way you like. A downloadable PDF version of the model body donor card is now available on our website.

If you require the template in an alternative format, please email us to request it.

Organ Donation and Transplantation

Launch of new HTA licensing arrangement to support research in organ donation and transplantation 

NHS Blood and Transplant (NHSBT) are committed to saving and improving lives. A primary objective of the strategy in Organ Donation and Transplantation is to increase the number of organs available for transplantation. To help meet this important objective, NHSBT ODT has been working with stakeholders in transplantation and research to consider how to increase the number of organs available for use in pioneering research and innovation.

At present, the NHSBT ODT Directorate provides approved research studies with access to donated organs, when organs are retrieved for transplantation but then found not suitable for this purpose. This use in research is subject to the appropriate consent or authorisation by the donor’s family. In a small number of hospitals, consent or authorisation is gained for the removal of specific organs for research purposes – this activity takes place under the HTA licence of the donor hospital (outside of Scotland). 

Until now, the removal of organs for the primary purpose of research has not been an activity that has been available under NHSBT’s research licence. 

In autumn this year, NHSBT will be supporting research in organ donation and transplantation by taking responsibility under the NHSBT HTA research licence for the removal of certain organs. Families of organ donors will be provided with the opportunity to agree to the removal of the Heart, Lung and Diabetic Pancreas for research (or other scheduled purposes), if these organs are not suitable for transplantation as whole organs or tissues (heart valves).  NHSBT have introduced a robust governance process to support this process in accordance with the requirements of the Human Tissue Act (2004) and the Human Tissue (Scotland) Act 2006

Post Mortem

Regulation of the Post Mortem sector 2017/2018: shared learning


In the last newsletter, we let you know about a report we have published analysing information on our regulation of the Post Mortem sector since 2017. The report captures the themes and trends we have seen in compliance submissions, HTA Reportable Incidents (HTARIs), and inspection findings. It also gives advice on our key findings and shares examples of good practice and learning from the sector.

We have received positive feedback on the report following its publication. We now have a downloadable PDF version of the report available. It can be accessed alongside our website version by following the link below:
 

 
Find out more

Webinar on our regulation of the Post Mortem sector 

Our Regulation Managers recently hosted a webinar explaining our role in the Post Mortem sector to the public. The session explained how we license establishments in the Post Mortem sector and provide advice and guidance to help share learning across the sector. It also provided information on how we regulate body, organ and tissue donation.
 
If you have not had an opportunity to watch it yet, you can watch it on our YouTube channel.

Our regulation of the Post Mortem sector: 16 May 2019

Research

HTA/HRA Public dialogue project one year on

Following the publication of the report Consent to use human tissue and linked health data in health research last year, the HTA and Health Research Authority (HRA) have carried out an extensive review to identify those areas not already covered by their existing guidance.

We found that the majority of the recommendations are either addressed by existing HTA and HRA guidance or can be addressed with minor modifications that will be made as part of both organisation’s routine review procedures.

The HRA, in collaboration with the HTA, will be leading on three important projects over the rest of this year and beyond.


 
Find out more

New FAQs on research tissue banks (RTBs)

In collaboration with the HRA, the HTA has published a new set of FAQs on research tissue banks, or ‘biobanks’ as they are also referred to. These FAQs cover both the ethical and regulatory aspects of research tissue banks, and cover consent, licensing and ethical review. 

You can find the FAQs on our website.

Find out more
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