Evidential Compliance Assessment (ECA): Retrospective review of HTA Reportable Incidents (HTARIs)

All HTA-licensed establishments in the Post Mortem sector are required to complete a mandatory Declaration as part of this ECA. The Declaration must be completed by the Designated Individual (DI) for the licence. 

Step 1: Review incident records

DIs must undertake a retrospective review of incident records covering the period 1 April 2015 to 30 June 2026. 

The review should include:

• Local incident records and logs for all licensed areas, including maternity and histopathology where applicable.
• Near-miss incidents meeting HTARI reporting criteria have been submitted to the HTA.
• Unreported incidents identified during an HTA inspection that were not submitted through the portal as they were managed via the CAPA process.

Submit Your Declaration

Following completion of the review, the DI must declare, by the 18 September, either:

Option A – Full Compliance

The review confirms that all incidents, including near misses, meeting HTARI reporting criteria have already been reported to the HTA. 

Option B – Unreported Incidents Identified

The review identifies incidents, including near misses, that should have been reported but were not submitted to the HTA. The DI will be required to declare the number of unreported incidents identified. 

Step 2: Submit Retrospective HTARI Reports

Where unreported incidents are identified, DIs must submit retrospective HTARI reports through the HTA Portal by 30 September 2026. 

DIs are encouraged to begin reporting as soon as their Declaration has been submitted.

Incomplete or missing records:

For gaps in incident records, incomplete incident logs, or records that are unavailable or inaccessible for part or all of the review period, establishments are still required to report where they are aware that an incident occurred. This will help reduce the risk of under-reporting and support a more complete assessment of retrospective HTARI reporting.

• Where an establishment is aware that an incident occurred, but only limited information is available, the incident should still be reported to the HTA.
• Where records are no longer available due to records retention policies, establishments should expect to be asked to provide details of the applicable retention policy and confirmation that records were retained and disposed of in accordance with that policy.
• Where records are unavailable for part of the review period and an establishment is unable to provide assurance that all reportable incidents would have been identified and reported, an incident report should still be submitted to the HTA. In these circumstances, establishments may consider reporting under the HTARI classification 'Any incident not listed here that could result in adverse publicity that may lead to damage in public confidence', as the absence of records means that reportable incidents cannot be ruled out.
• If in doubt, establishments should contact the HTA at ECADeclaration@hta.gov.uk as soon as possible. 

Helpful Resources

Important Information

When submitting HTARI reports, do not include any identifiable information relating to patients, families, staff members or other individuals. This includes names, photographs or other personal identifiers. 

The retrospective review covers the period 2015 to 2026. Relevant HTARI guidance published between 2013 and March 2024 has been included, as the March 2013 guidance remained in effect until it was superseded by the June 2015 update.

Key points to consider when reviewing archived guidance are: 

• The HTARI framework evolved from a relatively narrow focus on defined incident types in 2013 to a broader, systems-based approach to incident reporting and governance by 2024. 
• The 2015 update introduced significant clarification of existing classifications and reporting expectations, while the 2024 guidance provided the most substantial expansion of interpretation, examples, near-miss reporting and regulatory expectations. 
• The overall classification framework has remained largely stable throughout the period. Only one new HTARI classification was introduced: Post-mortem cross-sectional imaging of the body of a deceased person included an invasive procedure for which consent had not been given, added in 2016. 
• Later versions of the guidance place greater emphasis on consent, traceability, organisational governance, public confidence and learning from incidents. 
• As a result, some events that may not have been considered reportable under earlier versions of the guidance may fall within existing HTARI classifications under the current guidance.

To assist with the review, archived versions of the guidance are listed below alongside a link to the current guidance. A summary table is also provided, highlighting the HTARI classifications and the key changes made throughout the evolution of the guidance.

To support establishments throughout the ECA reporting period, the HTA has put the following arrangements in place:

• Dedicated support mailbox: if you have questions about the process please contact ECADeclaration@hta.gov.uk
• Webinar: An ECA webinar was held on the 31 July. A recording of that session is now available (link)
• Drop-in sessions: Weekly drop-in sessions will run from the 31 July to the 25 September, between 11.00am and 12.00pm. These sessions provide an opportunity to ask questions on the reporting requirements. Register here.