Introduction of the Patient Safety Incident Response Framework

However, this approach is due a significant shake-up, with the new Patient Safety Incident Response Framework (PSIRF) expected to be introduced any day now. PSIRF was first announced two years ago, in March 2020, with Early Adopters currently testing the new procedures. The NHS had four key aims in setting out this new framework:

1. To allow a more proportionate response to safety incidents;
2. To allow a greater range of responses to incidents, as opposed to reliance on formal investigations;
3. To improve support to, and the involvement of, affected patients, staff and families; and,
4. To improve the existing governance and oversight procedures.

To achieve those aims, there are a number of key differences between the old framework, and the new PSIRF.

A much broader investigatory approach is to be taken toward incidents which fall within the framework. Whilst previously under SIF a distinction was made between serious incidents and all other incidents, PSIRF seeks to cover all incidents which caused, or had the potential to cause, harm. Organisations will be expected to produce a response plan every two years, setting out how they will identify relevant incidents and how they are to be addressed.

Despite the increased range in scope, there is also a newly-imposed limitation on when formal Patient Safety Investigations are deemed appropriate. Under PSIRF only incidents posing the most significant of risks, incidents arising in particular defined areas, or exceptional cases with the most significant opportunity for learning, will be expected to have a formal investigation. All other incidents can instead be addressed with a range of different tools, such as informal reviews, debriefs and training.

The heavily-relied upon Root Cause Analysis (RCA) methodology is also set to be scrapped, along with the 60-day time limit for investigations. Instead a broader approach will be expected to be undertaken, with all contributory factors considered as well as the strengths of the adopted systems, rather than merely the root cause of the incident. The time limits under such an approach are to be agreed directly with the patient and/or their family.

Investigations under the new framework will now be signed off by the Board responsible for the investigation. The hope is that such a body will have greater oversight over the entire investigation, to ensure appropriate processes and standards are being applied, unlike the current sign-off procedure whereby an investigation is only reviewed upon its conclusion.

The NHS have suggested that this new framework is to be introduced in Spring 2022, but have also clarified that they do not expect organisations to be amending their current practice in respect of investigations and incidents yet, until the final version of the framework has been made available. It is not yet clear when this will occur, but, when it does, the NHS has expressed an intention to provide organisations with a 12-month window to implement the new framework, to ensure an effective and meaningful transition. We will seek to update you as developments arise.

The full draft framework and NHS Guidance can be found here. If you have any further queries with regards to this framework, or with regards to Health and Regulatory law in general, please feel free to contact Lisa Evans at Lisa.Evans@wardhadaway.com who will be more than happy to help.