HTA newsletter

Issue 80: November 2020

HTA Business Plan 2020/21 and HTA Strategy 2020/23 

The HTA has published its three-year Strategy 2020/23 and annual Business Plan for 2020/21. The Strategy sets out our vision and longer-term view of organisational priorities and activities that will support the ongoing delivery and development of effective regulation.  Our business plan sets out our priorities and objectives for the 2020/21 business year and the steps we will take to successfully achieving and delivering the Strategy.

Changes to the way we operate

Our vision and strategy over the last two years has been centred on achieving greater sustainability, agility, and resilience across our activities.  This continues to be a focus for the HTA and acts as strong drivers in how we strengthen the use of data in our regulatory approach and further develop and seek opportunities for partnership working with the sectors, other regulators and also stakeholders.

As with many organisations in the healthcare sector, the pandemic has meant that we have had to look at how we need to adapt our approach to ensure that we continue to deliver our services in the changing environment.  A number of sectors and establishments will have already experienced some changes such as to licensing and the piloting of virtual regulatory assessments.  Over the next six months, the HTA will be exploring, testing and seeking your engagement on planned developments to ensure that we effectively respond to the pressures placed on regulated sectors and support the ongoing delivery of operational activity and develops a sustainable regulatory model that broadens our regulatory offer. 

The findings of the stakeholder evaluation identified a number of opportunities that would be positively received by establishments, such as the introduction of a more streamlined regulatory model incorporating relationship management, and shorter, more focused inspections.

As the thinking and development evolves, we are keen to engage with our stakeholders to inform this process, assist in piloting different tools and approaches, and share any changes in how we work together. 

You can read more about these upcoming changes in our Business Plan 2020/21 and our Strategy 2020/23 on our website.
 

Update on our regulatory oversight 

We recently announced that there will be no scheduled site visit inspections this business year and shared some of our plans that will enable us to provide regulatory oversight and ensure compliance with HTA Standards.

Onsite inspections are only one of our regulatory tools, and as we continue to develop our data and intelligence model - making better use of the information we already hold and how we work with establishments to improve that – we will be looking to incorporate Virtual Regulatory Assessments (VRAs) into our model.

In 2021, we will also be looking at how we can return to some form of site visits in the Human Application sector. There will be a further announcement on that later this year. 

UK Transition guidance  

The UK is leaving the EU (European Union) single market and customs union at the end of the transition period on 31 December 2020. At the end of the transition period, there will be regulatory changes within the UK.
 
We have updated our website guidance which sets out what HTA-licensed establishments must do to prepare for the end of the transition period.
 
Establishments should also refer to the Government’s guidance on the Quality and safety of human organs, tissues and cells from 1 January 2021 for further advice.

You can also contact us directly if you need further guidance on what the end of the transition period means for your establishment.

Licence variation requests 

We have seen a substantial increase in licence variation requests sent by those not authorised to do so under HTA legislation. Please note, all variation requests (including changes to premises, Persons Designated, Licence Holder, Designated Individual and licensable activities) must be sent by the Designated Individual or Licence Holder / Licence Holder contact only.

In the specific cases of variations to a Designated Individual or a Licence Holder, the request must be sent by the other party (for example, any change of Designated Individual must be given by the existing Licence Holder or any change of Licence Holder must be given by the existing Designated Individual). 

Variation requests received from anyone other than the Designated Individual or Licence Holder will not be accepted. It may also lead to approval delays as we would need to seek clarification from the Designated Individual or Licence Holder before an assessment can start.

Find out more about HTA licence variations on our website.

Incidents reported by establishments in Q2 

We have published a report detailing incidents in the Post Mortem, Organ Donation and Transplantation, and Human Application sectors that were investigated and closed during quarter two of the business year.

You can find the report on our website. The next report will be published towards the end of January 2021.

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

Body and brain donation activity 

Since the first peak of the pandemic, we have been tracking body and brain donation activity at medical schools to help us answer the many questions we get from members of the public who are interested in donating.
 
If donation activity changes at your establishment, it would be very helpful if you could let the HTA know so we can pass on the correct and the most up to date information to our enquirers.

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

Virtual Regulatory Assessments (VRAs) 

As mentioned above, we have begun to contact establishments in the Human Application sector to schedule a Virtual Regulatory Assessment (VRA). Don’t worry if you don’t hear from us at this stage though.

These VRAs will develop as we work with you and will form part of our regulatory toolkit, as one of a number of ways we check compliance and provide support to drive up standards.

We will share more information on this process and its development in the coming months.

Guidance and feedback from the COVID-19 HTA questionnaire 

We sent out a questionnaire to Human Application (HA) sector establishments in July about the level and nature of activities being carried out during the pandemic.

The exercise was extremely valuable in helping us to keep our oversight of the sector during a period when site visit inspections have not been possible. The information we have received from you shows that most HA establishments have found and implemented various control measures to mitigate the risks posed by the pandemic.

We have issued more guidance, taking into account the information you shared with us. The guidance sets out further considerations and control measures you should take at this time.

2020 annual activity data collection 

We will be collecting 2020 annual activity data from establishments in the Human Application sector in the coming months.

We will email you with further information and with detailed guidance on what will be covered in the next data collection.

Updated ODT (Organ Donation and Transplantation) SAEARs FAQs

COVID-19 living organ donation guidance 

Mortuary guidance on traceability procedures of the deceased 

Guidance on contingency storage arrangements for the deceased

We know that winter adds more pressures on mortuary capacity, and this can pose problems if adequate numbers of refrigerated storage spaces are unavailable. 

HTA licensed establishments in the Post Mortem sector should have documented contingency plans in place to prepare for winter pressures. Your plans should clearly define the actions to take if your mortuary body store is nearing capacity or unexpected major equipment failure occurs.

To help you prepare for potential winter pressures, please see our Guidance on contingency storage arrangements for the deceased.

Removal of samples from the deceased to test for COVID-19

Obtaining a swab sample (or any other sample containing cells) from the body of a deceased person to test for COVID-19 can only take place with appropriate consent (or coronial or police authority) and on HTA licensed premises.

Consent – The HT Act sets out who may give consent for this activity – our guidance document  provides information about this. Where consent or authority from an appropriate person has not been given, the activities cannot go ahead.

Licensing – HTA licences are premises specific. The relevant licence must be in place before the activity is undertaken.

We will not be charging licensing fees for temporary licences that are needed as part of the national response to COVID-19.

Our website provides further information about the consent and licensing requirements and how to apply to an HTA licence.
 
Please contact us for advice if you are uncertain about the licensing and consent requirements for removing samples from the deceased to test for coronavirus (COVID-19).

Consent records held by licensed research establishments

We have had several enquiries about the records that licensed research establishments should hold to show that consent has been obtained in line with the Human Tissue Act and the HTA Codes of Practice.

We have supplied advice on this specifically in our Research tissue bank FAQs, although this advice applies to licensed research establishments more generally.  advice applies to licensed research establishments more generally.

The consent records you should hold are:

• Documents used within the research consent process (for example, participant information sheets or consent forms); and/or
   
• A legal agreement with another party which confirms that appropriate consent is in place (a copy of a blank participant information sheet and/or consent form could also be provided with the agreement). Signed consent forms should remain with the other party and be kept in line with its local policies.