Strengthening regulatory oversight: Evidential Compliance Assessments in mortuary regulation

In the last year we have continued our programme of innovation in our approach to regulation. This has built on the activity we have delivered over the last few years to strengthen our approach to the post-mortem sector. I want to outline the actions we have taken and share some reflections on our recent use of Evidential Compliance Assessments (ECAs) in the post-mortem sector - a valuable exercise in our evolving approach to regulatory oversight, particularly regarding security, governance and quality standards.

The drive to trial this approach came from persistent risk factors in the sector, including security vulnerabilities, capacity challenges, misidentification/traceability issues and the risk of disconnect between documented processes and operational reality, all of which can lead to a significant negative impact on the dignity of the deceased. Recent criminal offending in a mortuary setting and the subsequent recommendations from the Fuller Independent Inquiry Phase 1 report have further highlighted security as an area requiring enhanced vigilance.

In response, we have taken action focused on clarifying expectations through enhanced guidance, increasing assessments to reinforce licencing standards, and using data for targeted risk-based upskilling and assessment. This has included the publication of updated guidance for both post-mortem and anatomy sectors covering auditing CCTV, enhanced security measures, and stricter access controls. Moreover, we worked with NHS England to improve building and security standards, including CCTV use.

The HTA has worked across the system to raise standards and has collaborated with partners like AAPT, SAIF, and NAFD. We supported training delivered by AAPT as part of their level 3 and 4 diploma and have undertaken advisory inspections of unlicensed body stores in Wales.

Building on these foundations, we developed a comprehensive approach that began with mandatory webinar presentations  for Designated Individuals (DIs), delivered in March and April 2024. These sessions focused on HTA standards relevant to mortuary security, drawing on themes identified through reported incidents and inspection findings. Following this educational phase, we required all licensed establishments to submit evidence focusing specifically on mortuary security and access control.

The assessment process evaluated evidence against critical standards including GQ1(a), GQ2(a), GQ6(c), PFE1(d), and PFE1(e), which collectively cover documented policies and procedures, audit schedules, risk management, and security arrangements. Our review categorised establishments as 'compliant', 'compliant with advice and guidance', or 'non-compliant', with appropriate follow-up actions for each category.

The findings provided insights into sector-wide compliance. Of the 158 assessments reviewed, around of fifth of establishments were found to be fully compliant. The majority were compliant but needed some form of advice and guidance, and nearly a third were identified as non-compliant. For those requiring improvement, we implemented targeted follow-ups through existing Corrective and Preventative Action plans, scheduled inspections, or fast-tracked focused assessments.

A particularly encouraging outcome has been the positive reception from establishments, with many DIs reporting that the assessment findings helped secure funding for security system upgrades. This demonstrates how regulatory oversight can drive tangible improvements in practice when approached collaboratively.

This intensive regulatory exercise required significant internal resources. While the value of these assessments is clear, we are mindful of the resource implications for future initiatives.

We went on to introduce unannounced inspections for the post-mortem sector in September 2024, with a comprehensive evaluation planned shortly. This represents another step in our commitment to maintaining consistent compliance across all standards.

The ECA programme has proven effective in raising awareness, improving compliance, and strengthening our regulatory oversight. However, future iterations would benefit from a more focused approach, targeting specific standards to optimise resources while maintaining regulatory effectiveness. By continually refining our methods, we can ensure that our regulatory framework remains responsive to emerging risks while supporting establishments in upholding the dignity of the deceased and public confidence in the system.

The post-mortem sector remains a sector of concern for the HTA, and we know mortuaries remain under pressure. We will continue our targeted programme of activity and review and assess the impact of our interventions to ensure they are raising compliance with our standards to  reinforce that the dignity of the deceased is essential and maintained.

Mark Wrigley, Head of Regulation