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This publication has reviewed and analysed data collected from licensed establishments through the biennial compliance submissions, incident reports and inspections during the year to 31 March 2018, the first year following the introduction of the new HTA standards for the PM sector.
The Premises, Facilities and Equipment standards include storage arrangements for bodies and maintenance of the premises and equipment to ensure dignity of the deceased is maintained. 164 shortfalls out of 59 inspections were identified.
Key findings:
The Traceability standards cover the systems and records for the traceability of bodies and tissue and disposal. Out of 59 inspections 66 shortfalls were identified under this standard, 28 of these were under standard T1(c) in relation to the requirement for three identifiers to be used.
...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:
An analysis of shortfalls and HTARIs in the PM sector for the year to 31 March 2018 has highlighted some key themes.
The analysis of inspection findings under the revised standards is based on the 59 site visit inspections in the PM sector in the year to 31 March 2018. Each of these inspections were undertaken at different establishments.
The HTA’s revised Codes of Practice and licensing Standards for sectors regulated under the Human Tissue Act 2004 (HT Act) came into force on 3 April 2017.
The revised standards are grouped under four headings:
Every two years establishments licensed by the HTA in certain sectors are required to submit compliance data. Collection of this information contributes to our oversight of a sector, guides our regulatory approach, informs the scheduling of site visit inspections and supports our system of...
Analysis of the data we have collected has identified key themes and areas for improvement that the HTA will use to inform the sector through additional advice and guidance, some of which has been included in this document.
The Human Tissue Authority (HTA) regulates and licenses establishments in England, Wales, and Northern Ireland where post-mortem (PM) examinations take place and tissue may be removed and stored for a number of scheduled purposes as set out in the Human Tissue Act 2004.