Human Tissue Authority

The regulator for human tissue and organs

Governance & Quality (GQ)

The Governance and Quality standards cover a number of key areas concerning the effective management of a licence and the activities covered by the licence. 206 shortfalls were identified in this category out of 59 inspections. These were predominantly under:

GQ1 – ‘All aspects of the establishment’s work are governed by documented policies/SOPs’

GQ2 - ‘There is a documented system of audit’

GQ6 - ‘Risk assessments of the establishment’s practices and processes are completed regularly, recorded and monitored’

Key findings – GQ1:

  • SOPs did not accurately reflect actual practice;
  • SOPs had insufficient detail to ensure that all essential steps in the process would be undertaken;
  • a lack of methodology to record that staff had read and understood SOPs;
  • SOPs on PM examinations not being clear that a pathologist must see the body before evisceration;
  • a lack of DI oversight in areas where licensable activity takes place; and,
  • no minuted meetings of staff working under the licence.

Based on these findings, the HTA’s advice for good practice are given below:

  1. An SOP should contain sufficient detail to enable a suitably competent person new to the establishment to undertake the task.
  2. Persons Designated (PDs) play an important role overseeing activities in areas where the DI does not have regular involvement, such as in maternity units or ED.
  3. All areas outside the mortuary where licensable activity takes place should have a PD, as should any premises remote from the hub site, such as a satellite site. The DI should have regular contact and hold regular meetings with PDs.
  4. If the Mortuary Manager is not the DI, it is good practice for them to be a PD to ensure that any HTARIs can be reported within the required time scale, even if the DI is not available.

 

Key findings - GQ2:

  • establishments not having an audit schedule;
  • audits being undertaken but not recorded;
  • audits were incomplete in that there was no follow up investigation process to identify the root causes when anomalies were found; and,
  • failure to make full use of the value potentially to be derived from audits as there was no mechanism to share audit investigation findings.

The HTA’s good practice advice based on these findings is as follows: 

  1. Process audits are a good way to assess practice against SOPs. These types of audit can help identify whether staff need additional training (helping to identify competency issues) or whether an SOP needs to be updated.
  2. In addition to process audits, audit calendars should include audits of traceability of bodies from the point of arriving at the mortuary, through to PM examination and release. Tissue audits should include checks against the consent given by the highest-ranking individual in the hierarchy of qualifying relationships. Audits should also be conducted for pregnancy remains from point of collection through to disposal. 
  3. Traceability audits should look at a representative number of samples, not just one or two cases. 
  4. Establishments storing tissue under the control of the police for criminal justice purposes should include these in their tissue audits and regularly follow-up these cases with the police or Coroner to establish whether the tissue still needs to be retained or if it can be disposed of or returned to the family, in accordance with their wishes.

 

Key Findings – GQ6:

  • only health and safety risk assessments were carried out;
  • risks to bodies or tissue were not considered, for example accidental damage, release of the wrong body or security breaches;
  • control factors referenced SOPs but the SOPs had insufficient detail to prevent the incident, for example, a SOP for viewings describing how to prepare the body, with no detail of the number of identifiers required to be checked or how to obtain this information from whoever has arrived for a viewing; and,
  • significant risks were not escalated within the establishment (such as to the Health Trust, Health Board or Local Authority risk register).

The HTA’s good practice advice arising from these findings are given below:

  1. Risk assessments need to include licensable activities and to the same standard and detail as health and safety risk assessments. The HTARI categories can be used as a guide to develop these to ensure all areas are assessed.
  2. It is important to have clear documentation and training for all staff, including porters and those undertaking out-of-hours activity, such as site managers, to ensure they are aware of the risks associated with the activities they are undertaking and are aware of which incidents need to be reported to the HTA.
Last updated on: 29 May 2019