Human Tissue Authority

The regulator for human tissue and organs

Part 4 – Themes

An analysis of shortfalls and HTARIs in the PM sector for the year to 31 March 2018 has highlighted some key themes.

As noted previously, there are four overarching standards against which establishments are assessed at inspection: Consent, Governance and Quality systems, Traceability, and Premises, Facilities and Equipment. All of these have been linked to incidents.

Consent (C) 

The consent standards relate to the process, documentation and training for those staff seeking consent for PM examination. 74 shortfalls were identified out of 59 inspections.

Key Findings: 

  • References to next of kin (NOK) as well as the hierarchy of qualifying relationships, which could lead to confusion about who is the appropriate person to give consent under the HT Act;
  • a lack of documented Standard Operating Procedures (SOPs) for the process and/or staff awareness of the SOP;
  • options for the fate of blocks and slides not clearly defined;
  • lack of training and refresher training on the requirements of the HT Act;
  • staff records not demonstrating up-to-date training; and,
  • lack of competency assessments for consent seekers.
Given this analysis, the HTA has the following good practice advice for establishments:
  1. Mortuaries/histopathology departments should be clear about exactly what services they can offer. For example, if there is no research activity undertaken, this should not be listed as an option for retained organs/tissue. 

  2. Those giving consent should be made aware of how long any tissue will be stored and what is expected to be the fate of tissue in differing circumstances, for example:

    • if it is not used for a scheduled purpose for which they have given consent, it will be disposed of after a specified time period; 

    • after it has been used for the intended purpose; and,

    • if it has been stored, what will happen to it after the end of the expected storage period. 

  3. Different options for the use of tissue should not be combined as a single choice, for example, use in research and storage for future use should be listed separately to give relatives the opportunity to make individual choices.

  4. PM consent training and competency assessments for consent seekers can take place face-to-face, using written material or online, providing it meets the requirements of the HT Act. An individual with understanding of what is involved in a PM examination and the options concerning the fate of any tissue should be present when consent for PM examination is sought.

Last updated on: 23 May 2019