In addition to the legislation, codes of practice and licensing standards, Royal Brompton & Harefield NHS Foundation Trust must also comply with the following.
Licensing conditions
The Human Tissue Authority (HTA) has set out conditions attached to each licence. Conditions can be:
- statutory – set down in the Human Tissue Act 2004 or other legislation
- standard – applies to every establishment licensed in a particular sector
- additional – unique to an individual licence
Please contact the tissue governance manager for more advice on the details of HTA licensing conditions.
HTA directions
The HTA has statutory authority to direct people who are working under a licence. Directions can be issued:
- generally, e.g. to all establishments within a sector
- specifically, e.g. in respect of an individual licence
View the HTA’s list of general directions.
Regulatory alerts
The Trust must respond to any regulatory alerts issued by the HTA. Most regulatory alerts relate to incidents that may affect the quality and safety of tissues and cells for patient treatment (e.g. recall of consumables used to store tissues or increased prevalence of an infectious disease).
View the HTA’s list of regulatory alerts.