Human Tissue Authority

The regulator for human tissue and organs


GQ8 Risk assessments of the establishment’s practices and processes are completed regularly and are recorded and monitored appropriately

98.  This standard received the highest number of shortfalls, with twenty minor shortfalls and one major shortfall being identified.

99.  The vast majority of minor shortfalls were due to a limited scope of risk assessments. Frequently, only risk assessments relating to health and safety risks were in place and there were no documented risk assessments associated with human tissue and licensed activities.

100.  Risk assessments are a useful tool for establishments to assess which activities or areas pose the most risk. They also enable establishments to assess whether the control measures that have been implemented are adequate to reduce the likelihood of a problem occurring. Risk assessments should be regularly reviewed, especially when procedures or practices are subject to change. 

101.  One establishment was storing human tissue in multiple locations on its premises, some of which were un-catalogued tissue collections. A major shortfall was identified because tissue traceability systems were found to be unsatisfactory and there were no risk assessments covering tissue traceability. 

Last updated on: 3 Aug 2016