Human Tissue Authority

The regulator for human tissue and organs

Conclusion

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. 

As discussed in this document, the first year since the introduction of the new standards has seen a rise in the number and severity of shortfalls identified during site visit inspections. This rise may only be partly attributable to the change in standards, which are greater in number and more specific, suggesting that this may be coupled with an underlying rise in non-compliance with HTA standards.

Inspection data indicates that establishments have not necessarily updated their practices and procedures to ensure they are sufficient to meet the revised standards. Our review of inspection shortfalls identified recurrent themes, for which we have issued further advice and guidance to support and help establishments achieve the required standards. In addition, the HTA are in the process of reviewing and updating the guidance that supports each individual standard to improve the information about what is required to meet each standard.

In addition to the issues identified from compliance submissions and inspections of premises, the number of HTARIs has also increased, with accidental damage to and incorrect identification of bodies still being the most common. We will continue to monitor all incidents reported to us, to share learning and provide advice and guidance to the sector. It is hoped that the information and advice contained in this document will assist DIs and establishment staff, helping to inform procedures and enable them to improve their practices. 

Establishments are encouraged to actively review the HTA’s codes of practice, Code A: Guiding and fundamental principles of consent and Code B: Post-mortem and the updated Standards, to help ensure their practices and procedures are sufficient to meet the HTA’s requirements. 
 

Last updated on: 29 May 2019