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The latest news from the Human Tissue Authority
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Issue 76: September 2019

HTA news

Human Application

Post mortem

HTA News

Brexit: preparing for ‘no deal’ 

The Government is committed to the UK leaving the EU on 31 October 2019, whatever the circumstances.

Our Brexit guidance page sets out guidance to help you prepare. We will update this page regularly with any new information that you will need to know.

You should also be referring to the Department of Health and Social Care information on planning to leave the EU.

If the UK leaves the EU without a deal, it will become a third country for the purposes of the EU Tissues and Cells Directive and the EU Organ Donation Directives. The UK will also consider EU Member States to be third countries.

We will be writing to establishments in the Human Application and ODT sectors with further guidance. If you have any other questions about how to prepare you should contact us.

See our Brexit guidance page

HTA consultation on Code of Practice F: thank you for your response

Thank you to everyone who submitted a response to our consultation on our revised Code of Practice F.

We will publish our consultation response and the revised Code of Practice in advance of the law coming into force in Spring 2020 on our website and share via our usual channels.

If you have any questions in the meantime, please email us at code@hta.gov.uk

        
Respond to our consultation

Compliance updates 2019

A reminder that 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 by Friday 18 October.

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.
     

More information on this year’s questions and how to complete your submission is available on our website.

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

See our compliance updates guidance page

Changes to HTA inspection reports

We will roll out a new inspection report format for all HTA inspections starting from 1 October.

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.

HTA welcomes two new Authority members

We are very pleased to introduce two new Authority Members to the HTA.

Professor Gary Crowe and Dr Charmaine Griffiths have joined us for a period of three years from September 2019. Each Member will bring valuable skills and expertise to the Authority, from biomedical science and research to organisational development and transformation.

Members’ responsibilities include helping to shape the organisation’s strategy and regulatory activity, as well as holding the HTA’s executive to account.

Their appointments follow the end of the term for HTA Authority Member Professor Dame Sally Macintyre. We want to extend our greatest thanks to Sally for her hard work and commitment over the years.

Read more about our Authority Members

HTA conference: join us online


Thank you to everyone who has signed up to attend our conference in November. There are no more tickets available.

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 presentations on the day through our YouTube channel.

Further details on how to access the live stream will be shared closer to the day on our Twitter page and on our website.

Read the latest HTA blogs

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

See our blogs

Upcoming events

Friday 27 September: Home Office Mass Fatalities guidance workshop
The HTA will be attending two workshop events with the Home Office regarding their work to update and revise their Mass Fatalities Guidance. This connects to the HTA through our role in licensing of emergency mortuaries.
 
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.
 
Saturday 12 October: European Day for Organ Donation and Transplantation
The European Directorate for the Quality of Medicines & Healthcare (EDQM)/Council of Europe organises the European Day for Organ Donation and Transplantation (EODD) every year in a different country to raise awareness on the importance of organ donation, as a way of saving and improving lives. This year, it will be hosted in the UK and the HTA will be supporting the series of events.
 
Monday 4 – Sunday 10 November: National Pathology Week
National Pathology Week (NPW) is Royal College of Pathologist’s annual celebration of pathology when they highlight the important contribution pathologists make to healthcare. Working in partnership with pathologists and laboratory scientists across the UK, our programme of events and activities aims to engage people of all ages, and improve public awareness and understanding of how pathologists and scientists diagnose disease.
 

Human Application

Common shortfalls in the Human Application sector 

Over the comings months, we intend to issue guidance in relation to shortfalls that are frequently identified during site visit inspections in the Human Application (HA) sector.

In this September issue of the newsletter, we provide guidance relating to the requirement to carry out independent audits.

Independent audits

The HTA’s HA licensing standard GQ2c requires an audit to be conducted in an independent manner at least every two years. This is to verify compliance with protocols and HTA standards and to ensure that any findings and corrective actions are documented.

We are often asked whether HTA site visit inspections satisfy this requirement - they do not.

Establishments carrying out licensable activities in the HA sector are expected to have a system for auditing their activities in an independent manner that is separate from any inspections carried out by the HTA. 

Read our guidance on independent audits

Regulatory Alert 001/2019: West Nile Virus  

We have issued a regulatory alert that covers important information relevant to establishments in the Human Application and Organ Donation and Transplantation sectors.

The alert highlights information about recent cases of West Nile Virus (WNV) in individuals in France, Austria and Romania.
 
Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

You can find more information on our website.

Read Regulatory Alert 001/2019

Post Mortem

HTA licensing of emergency mortuary facilities


The HTA can issue a licence for an emergency mortuary in the event of an incident.

We have developed a system for doing this, working with the Home Office and other relevant bodies.

Emergency planning teams should refer to the HTA guidance for further information about HTA licensing of emergency mortuary facilities and how to apply for an HTA licence on our website.
 

 
Read our emergency mortuary guidance
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