HTA newsletter

Issue 79: August 2020

HTA COVID-19 guidance for establishments 

As part of our response to the coronavirus outbreak, we have produced guidance and key information on our website to support professionals working at HTA licensed establishments.

Our guidance covers:

• Key information for Designated Individuals
• New inspection arrangements and our regulatory oversight
• Anatomy sector guidance
• Human Application sector guidance
• Post Mortem sector guidance
• Organ Donation and Transplantation sector guidance
• Research sector guidance

Our aim as always, and particularly during the current situation, is to act proportionately and take a right-touch approach to regulation.

We will be updating our website guidance on a regular basis as circumstances change and following government advice.

We recommend that you keep checking these pages for up to date information.

Update on HTA inspections 

In mid-March, the HTA suspended all scheduled inspections due to the outbreak of COVID-19 in the UK.

While we are carefully monitoring the situation and government advice as lockdown measures ease, we have taken the decision not to conduct any routine site-visit inspections in Quarter 3 2020/21. This ensures that we can prioritise the health and wellbeing of our staff, those working at licensed establishments, and reduce pressure on the system at this time.
 
We will continue to maintain regulatory oversight by providing advice and guidance to establishments, and using our full suite of regulatory tools, such as the monitoring and investigation of reported incidents, and desk-based assessments. We will, of course, continue to act on any serious matters that require our attention.

We will contact you again when we have an update on our plans to restart routine site visits. It may be that inspections resume in some sectors before others, and we will notify any establishments affected well in advance to help you prepare. If you have any questions about this, please contact us.

Disclosing information on incidents (HTARIs and HA SAEARs) 

In line with the HTA’s commitment to transparency, we publish details about the volume and nature of incidents that are reported to us. This includes HTA Reportable Incidents (HTARIs) in the Post Mortem sector and Serious Adverse Events and Reactions (SAEARs) in the Human Application and Organ Donation and Transplantation sectors.

Previously, we published descriptions of incidents following freedom of information requests and as part of standard reporting to our Authority (the HTA’s Board) on regulatory activity. 

From 1 July 2020, the way in which we publish this information has changed.
We will now produce a quarterly report detailing the volume and nature of incidents, which will be published on our website. This report will include the following information for all incidents that have been investigated and closed in the quarter:

• Case number
• Type of incident
• Establishment name
• Licence number
• Brief description of the incident

We will no longer routinely contact establishments before publishing this information. Instead, the HTA Regulation Manager responsible for managing the incident will confirm the details we intend to publish for each incident at the point of case closure. Establishments will then have five working days to provide any comments or concerns about the information we intend to publish, with the incidents being published towards the end of each quarter.
 
This change in our approach is aimed at providing greater consistency to the information that we publish and should reduce the number of occasions on which we ask establishments to review incident summaries retrospectively.

The report for incidents closed in quarter two will be published towards the end of October.

You can find more information about disclosing information about HTARIs and SAEARs on our website.

HTA stakeholder evaluation 

Every two or three years we commission an evaluation of key stakeholders, to better understand what they know, think, and have experienced in relation to the HTA’s work.

This year, between January and March, Savanta ComRes – who we commissioned to conduct the research – contacted professionals working at HTA-licensed establishments, inviting them to complete an online survey. A further 30 individuals across all our regulated sectors were also kind enough to volunteer for an in-depth telephone conversation to delve into more detail. Thank you to everyone who responded to this invitation and for your feedback.

The results from the evaluation will help us to ensure our regulatory approach is fit for purpose, and enable us to continue to evolve and improve our approach.

On the key metrics, the response was very positive, with positivity scores of:

• 96% - knowledge of what the HTA does
• 94% - confidence in HTA regulation
• 87% - favourability towards the HTA

Read the latest HTA blog 

Our latest blog comes from Catherine Hennessy, an Anatomy Teaching Fellow at Brighton and Sussex Medical School. In her fascinating blog, Catherine reflects on the impact and use of social media in anatomy education, and recent work to develop some proposed guidelines for anatomists.

Social media guidelines for anatomists – how they came about and how they link to the HTA
 

Resuming body and brain donation  

From the discussions we have had with our colleagues in the Anatomy sector, we are aware that establishments are planning to resume their body donation services as we emerge from the peak of the COVID-19 outbreak. A similar situation applies for brain donation services.
 
It would be very helpful if you could let the HTA know when your body or brain donation services resume.
 
We will track this information and it will help us to answer the many questions we get from the general public. As you know, we receive many enquiries from people interested in donating their body or brain, and having up-to-date information would really help us pass on correct information to them.
 
If you have any questions, comments or suggestions, please get in touch with us.

Anatomy compliance update report 2019  

In October 2019, we completed the collection of compliance updates for the Anatomy sector. We have now published an overview of the data we received, which gives a snapshot of the key findings and themes.
 
We hope that this report will be useful to people working in the sector, as well as to members of the public who have an interest in body donation. You can view the publication by following the link below.

COVID-19 questionnaire for the HA sector 

Last month, we sent out a questionnaire to HA sector establishments regarding the current level and nature of activities being carried out. Many thanks to all who responded to us.
 
We are working through your submissions to better understand risks in the sector as a result of the COVID-19 pandemic and to inform our approach to regulatory oversight over the coming months.

Revised Code of Practice F: Donation of solid organs and tissue for transplantation

Updated HTA Quality and Safety of Organs Intended for Transplantation: A documentary framework 

Guidance for transplant centres considering using different premises 

COVID-19 living organ donation guidance 

Guidance on the Post Mortem sector licensing standards

Procedures to identify bodies and tissue

It is important that procedures to identify bodies and tissue are robust. Licensing standard T1(c) requires that a minimum of three identifiers of the deceased are used to identify bodies and tissue. We provide detailed advice on this in our guidance on the Post Mortem sector licensing standards.

All establishments licensed in the Post Mortem sector should review their identification procedures to ensure that they are robust and that staff have been trained and competency assessed in the procedures.

Please contact us if you require further information on this licensing standard.

Updated HTARI guidance

We have updated our guidance document on HTARIs. This includes updated information on the categories of HTARIs and near-miss incidents that must be reported to the HTA.

Please note that establishments must notify the HTA of incidents or near-miss incidents within five working days of the incident occurring or being discovered. Do not wait until your internal review or investigation is complete before notifying the HTA of a HTARI or near-miss incident. If you have any questions, please get in touch with us.

DIs who are working remotely

We are aware that HTA licence contacts in the Public Display sector may be working remotely or away from the establishment site for an extended period. If this applies to your establishment, please refer to our website for key information for Designated Individuals.

If you have any questions, please get in touch with us.

Research compliance update report 2019

In October 2019, we completed the collection of compliance updates for the Research sector.

We have now published an overview of the data we received, which gives a snapshot of the key findings and themes.

We hope that this report will be useful to people working in the sector, as well as to members of the public who have an interest in medical research. You can view the publication by following the link below.