94. Twelve items of advice were given against standard GQ7.
95. Establishments need to have systems to record and manage adverse events. When an incident occurs, the HTA advises that establishments carry out a thorough investigation to establish the root causes and put in place CAPAs to prevent recurrences. We expect all HTA-licensed establishments to have a procedure in place for dealing with incidents involving human tissue samples.
96. Advice was given to establishments to carry out analyses of their adverse event data in order to better understand any trends and identify areas requiring improvement.
97. Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007, serious adverse events and reactions must be reported to the HTA. On occasions, establishments have documented this reporting requirement in their SOPs, even though is not relevant to research establishments licensed under the HT Act. Although there is no mandatory reporting system for notifying the HTA about adverse incidents in the research sector, establishments are encouraged to discuss their concerns with us, especially if they require further advice.