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Our strategic approach is based on right-touch regulation. This means being clear on the risks we are regulating, being proportionate and targeted in regulating those risks, taking into account the role of professional bodies and other regulators, and using the minimum necessary regulatory force...
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...
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:
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.
An analysis of shortfalls and HTARIs in the PM sector for the year to 31 March 2018 has highlighted some key themes.
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.
Seven of the 37 (14%) Anatomy establishments do not undertake any preservation on site. We found that a range of methods are undertaken at the remaining 30 establishments, with most establishments utilising several different methods for preserving bodies and tissue (Figure 4).
The majority of Anatomy establishments are licensed as a single facility; a small number have satellite sites (Figure 1).