This page provides information about the Human Tissue Authority (HTA) regulatory assessment process. The following individuals should read this guidance:
the designated individual (DI)
the licence holder / corporate licence holder contact
the person(s) designated
all interviewees as part of the regulatory assessment.
Under the Human Tissue Act 2004 the HTA has a statutory responsibility to assess whether the conditions of a licence and licensing standards are met, in relation to the suitability of the DI, licence holder, premises and practices. For example:
- the DI is a suitable person to supervise the activity authorised by the licence
- those who will be working under the licence are qualified and trained
- suitable practices are used in the course of carrying out the activity
- the conditions of the licence are complied with
- the licence holder is a suitable person
- any premises are suitable for the activity carried out under the licence
Suitability may be assessed through different means of regulatory assessment including desk-based assessment, virtual regulatory assessment (a remote form of assessment conducted using video technology e.g. Microsoft Teams), site visit or a combination of these in order to:
- review operational policies and procedures
- inspect premises and facilities
- scrutinise practices (e.g. through documentation review)
- interview staff
High-risk sectors, such as Post Mortem and Human Application (HA), undergo more frequent inspections. The HA sector's biennial inspections are legally mandated. In the Post Mortem sector, we introduced the mandatory HTA Reportable Incident (HTARI) process, mirroring the Serious Adverse Event and Adverse Reaction (SAEAR) reporting systems in the HA and Organ Donation and Transplantation (ODT) sectors, indicating legislative recognition of higher risks, particularly physical harm to patients.
We use various tools, from advisory support to licence revocation, to ensure compliance. Evaluations of risk consider factors like compliance history, incidents, and complaints. We also consider potential harms, such as distress to families, physical harm, and legal breaches, guiding operational planning and inspection priorities.
Regulatory assessments may be scheduled in advance or unannounced, and may cover all licensing standards or be themed (with a focus on a narrower set of standards).
Over one or more days, depending on the complexity of licensed activities, we will assess suitability, offer advice on areas for improvements and identify any shortfalls in relation to the standards and the conditions of a licence.
After every site visit inspection, we write a report documenting our findings which will be published under the relevant licence.
After every site inspection we write a report documenting our findings. The report is an exception-based report and highlights where standards have not been met. The reports are reviewed through internal processes, aiming for consistency in assessing shortfalls across all sectors despite varying standards and risk relevance. Each report is then shared in draft with the establishment to check for accuracy. Once reviewed, the report will be published under the relevant licence.
You can find copies of the reports on the Find an establishment section of this website.
Where we identify that a standard is not being met, this will be reported to an establishment either as a ‘critical’, ‘major’ or ‘minor’ shortfall.
If an establishment is unable to provide evidence that demonstrates compliance, it will be the DI’s responsibility to determine how the identified shortfalls will be addressed and to seek the HTA’s agreement on a timescale for completion of actions, through the submission of a Corrective and Preventative Action (CAPA) plan.
CAPA plans should be submitted to the HTA within 14 days of receipt of the final report, unless a shorter timeframe has been specified because of the seriousness of the shortfall(s) identified. Establishments are expected to implement actions to address the shortfalls within the timeframes agreed with the HTA.
The HTA assesses progress towards addressing any shortfalls. Further regulatory action may be considered if the HTA cannot confirm that appropriate corrective or preventative action has been taken. This could include issuing directions, adding conditions, suspension or revocation of a licence.
Once any shortfalls have been addressed, a statement to that effect is added to the published inspection report.
Find the most recent inspection reports on the latest inspection reports section of our website.