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EEA: The European Economic Area (EEA) consists of the 28 Member States of the European Union in addition to Iceland, Norway and Liechtenstein.
45. Overall, establishments demonstrated good practice in relation to the consent standards.
46. Some establishments had given particular consideration to the development of age-appropriate information sheets to ensure that donors of all ages were able to provide informed consent for...
157. Overall, establishments had well-developed disposal SOPs and systems to capture traceability, from the point of human tissue sample receipt to disposal.
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...
143. Good practice was noted at one establishment which regularly and manually challenged the alarm system by creating out-of-limits temperature events, to ensure it was functioning as expected. Other establishments demonstrated robust temperature monitoring and trend analysis of data.
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:
The majority of licensed establishments in the Anatomy sector reported that they have good quality management and governance systems in place. 36 establishments reported that they regularly undertake traceability audits.
The majority of licensed establishments have quality management and governance systems in place, with reassuring data being reported in relation to audits and risk assessments. Figure 3 illustrates the type of internal audits carried out by research establishments.
The majority of licensed establishments have good quality management and governance systems in place, with 34 out of 36 establishments undertaking regular traceability audits. We will follow-up with the remaining two establishments through inspections this business year.