Human Tissue Authority

The regulator for human tissue and organs

Advice and learning

85. Forty eight items of advice were given against standard GQ6.

86.  A register of donated material should be maintained by the establishment for all human tissue stored under the licence. HTA-licensed establishments should be able to demonstrate their awareness of, and ability to track, ethical approval expiry dates. 

87.  Although human tissue samples were typically traceable during HTA audits, there were instances where it was difficult to obtain traceability information as it was not always readily available. Although samples could be located, the associated paper or electronic records were sometimes not easily accessible. Therefore, establishments should consider the methods used to store and retrieve records. 

88.  A few establishments were found to be storing ‘existing holdings’ of human tissue in the form of slides that had not been catalogued. Under the HT Act, existing holdings are exempted from the consent requirements; however, they must be stored under the governance of a HTA licence. All samples must be catalogued if they are to be stored on licensed premises for use in research. 

89.  Where discrepancies or transcription errors were identified during our traceability audits, advice was given to establishments about including a regular audit of records to ensure that errors are identified and corrected.

90.  It is important that traceability records are created and maintained consistently by staff. Establishments are expected to have procedures that describe how each key component of the database should be populated. For example, establishments may also choose to use laminated work instructions located near work stations to enable staff to access this information readily.

91.  Establishments may wish to set out agreements that make specific reference to all associated tissue samples received under the terms of the agreement along with their respective unique identifiers.  Establishments used this approach to further strengthen tissue traceability.   

Last updated on: 3 Aug 2016