Significant Adverse Event Reviews

NHS Lothian is committed to delivering safe, effective and person centred care. Significant Adverse Event Reviews are carried out following events that have resulted in unexpected harm or death.

NHS Lothian has developed and implemented improvements to it’s policy and procedure for managing and learning from adverse events over a number of years now, both prior to and following the initial Healthcare Improvement Scotland (HIS) review programme in 2013.  This work has been informed by and responded to the publication of National Framework for Learning from Adverse Events in 2014 and the refresh in April 2015.  NHS Lothian’s progress has been reviewed by HIS in October 2014 and 2015.

Management of adverse events 

All significant adverse events (SAEs) have full reviews in accordance with the review protocol to identify learning, and an improvement plan put in place and implemented if relevant.  An improvement plan is not always required as the findings of the review do not always identify any care or service delivery problems. Conversely, an improvement plan may include actions to address issues which are not directly related to the event, but have been identified during the course of the review as opportunities for service improvement.

In Lothian, we have adopted a low tolerance for harm, therefore all adverse events with major harm (including fractures) or death are classed as SAEs, reviewed as such and a report produced using the SAE template. This approach takes cognisance of the definition of harm in the HIS framework which states that:

‘All harm is not avoidable, for example, the worsening of a medical condition or the inherent risk of treatment.  However, it is often not possible to determine if the harm caused was avoidable until a review is carried out."​

5320 Adverse event policy FINAL 1 2.pdf5320 Adverse event policy FINAL 1 2.pdf

5320 Adverse event operational procedure FINAL 1 6.pdf5320 Adverse event operational procedure FINAL 1 6.pdf


NHS Lothian has taken the decision to publish approved SAE reports and improvement plans from 1 February 2016.  The reports have been fully anonymised to protect personal data to comply with the Data protection Act 1998 (DPA).

The evidence provided for all recommendations in the attached action plans has been analysed and approved.  Therefore all recommendations have been assessed as fully implemented.


August 2016


Last Reviewed: 06/04/2016