Human Tissue Authority

The regulator for human tissue and organs

Good practice: GQ1-GQ8

106.  Established governance meetings, where matters relating to HTA-licensed activities could be discussed, were noted as good practice throughout a range of inspections. These meetings were often used effectively to discuss audits findings, SOPs, incidents and any other matters relating to licensed activities. 

107.  A comprehensive approach to audits, including those focussed on record completion, traceability and consent checks, was observed throughout inspections, together with a robust follow-up of actions arising from audits. Some establishments also had routinely adopted audits undertaken by external reviewers, in addition to their own internal audits.   

108.  SOPs and quality documents had typically been written to a high standard, with documented procedures made available for all licensed activities. 

109.  Several establishments were using effective traceability systems that were tailor-made to meet their needs as complex research tissue banks managing varied tissue collections. During our inspections, we noted several establishments who had adopted a unified approach to managing human tissue stored under the governance of NHS ethical approvals and human tissue stored under the HTA licence.

110.  Although standard GQ8 was associated with the most advice, several establishments did have a good range of risk assessments identifying the key risks to human tissue.

Last updated on: 3 Aug 2016