Human Application (HA)
Alongside our core delivery, the focus in the HA sector this year will be further development to improve and streamline our internal procedures and support those actively working in this sector. This will include issuing guidance on a range of emerging policy areas and licence variation procedures. In parallel we will examine our licensing model as it applies to satellite sites and how we superintend activity carried out under the terms of third party agreements.
We will continue to review and adjust our inspection processes to ensure they are aligned with risks in the sector; a likely focus of the coming inspection cycle will be processing of tissues and cells. This year, greater emphasis will be placed on sharing learning from inspections to enable establishments to review, and if necessary amend, their working practices to ensure compliance with the legislative requirements.
Organ Donation and Transplantation (ODT)
Living donation: The focus this year will be on the delivery and implementation of the remaining work to improve the sustainability of the Independent Assessor framework. The aim of this work is to ensure the independent assessment process is future-proofed as far as possible, maintaining a system that remains robust, effective and able to respond to sector demands. This includes streamlining processes and reviewing training to support Independent Assessors across the country.
Deceased donation: As outlined above, we will be drafting, consulting on, and publishing updates to HTA Codes of Practice A and F to reflect the introduction of deemed consent legislation in England.
We have committed to reviewing the assessment criteria used during on-site audits to ensure they remain robust and fit for purpose in an area of medicine that is rapidly evolving. This will include a review of our Quality and Safety of Organs Intended for transplantation: A documentary framework. We continue to work closely with the sector, particularly NHS Blood and Transplant (NHSBT), in the oversight of Serious Adverse Events and Reactions, ensuring that learning from these incidents is shared appropriately.
Our partnership with the Health Research Authority (HRA) will continue throughout the 2019/20 business year, supported by our long-term secondment arrangement involving one of our Regulation Managers. Following the publication of the HRA/HTA public dialogue on ‘Consent to use human tissue and linked health data in health research’, we will further build on this work with HRA to improve our existing guidance and produce new guidance where it is needed.
We remain committed to working closely with the sector, providing guidance and support based on learning from inspections and incident investigations.
We continue to maintain strong links with professional stakeholders within the sector and other groups, including the Association of Anatomical Pathology Technology, Royal College of Pathologists, Coroner’s Society for England and Wales and the Home Office Forensic Science Regulation Unit. The HTA’s Histopathology Working Group provides a platform for us to engage with these bodies and we will also continue to contribute to external training and engagement events where possible.
Providing advice and guidance about body donation remains an important and valued service to the public and will continue during the 2019/20 business year.
We continue to attend, and present at, sector-related events, maintaining strong links with professional bodies and the Anatomy Associations Advisory Committee (AAAC). We will also liaise with Coroners about the death certification requirements for body donation.
The sector continues to be the smallest but with a diverse range of collections with varying degrees of risk and public interest. Within the last year, there have been two additional licence approvals, which have generated significant interest in the sector.
Engagement continues with sector establishments through our licensed establishment engagement programme and Stakeholder and Fees Group to ensure that regulation in this sector remains proportionate.