Human Tissue Authority

The regulator for human tissue and organs

Advice and learning

128.  Fifty six items of advice were given against standard PFE3, which is the highest number of advice items compared to all other standards.

129.    Establishments need to have suitable and defined contingency arrangements in place. There were often additional fridges or freezers that could be used to store tissue in the event of a critical storage area failure. However, contingency arrangements had not always been formalised as a procedure or within an agreement.

130.    Critical storage conditions need to be monitored and alarmed. Temperature monitoring of critical storage areas is important as it provides on-going assurance that equipment is functioning optimally and may help to identify any problems before equipment failure occurs. Furthermore a schedule of alarm testing ensures that they are functioning correctly.

131.    Other items of advice related to ensuring that the premises and critical storage areas where relevant material is stored:

  • are appropriately secured;
  • have risk assessments for use of paper records in case of data loss;
  • have suitable containers to store relevant material, which are fully labelled and are clear about containing human tissue.
  • provide information about the alarm set points;
  • provide advice to personnel about what to do if an alarm sounds.