A new body to investigate clinical failure and incidents of patient harm in the NHS will “operate without fear or favour”, the government has said.

  • IPSIS will use expert led investigations to identify learning from clinical incidents
  • New body will seek to promote high quality local investigations
  • Government to consult on new notification requirements for NHS providers
  • HSJ Live: more on NHS Improvement

The new Independent Patient Safety Investigation Service will be led by national patient safety director Mike Durkin and hosted by the new regulator called NHS Improvement, which is being created by merging Monitor and the NHS Trust Development Authority.

The investigation body is being created following criticism of the NHS system in both the Morecambe Bay and Mid Staffordshire inquiries which found widespread failures to investigate and learn from clinical incidents.

Mike Durkin image

Mike Durkin will lead the new Independent Patient Safety Investigation Service

Patient safety incidents are currently reported to the National Reporting and Learning System but the new service will build on this by selecting incidents to investigate and ensuring lessons from serious failures are learned and acted on across the NHS.

Current patient safety functions, such as the NRLS, which reside with NHS England will be transferred to NHS Improvement and will require legislation to amend the Health and Social Care Act 2012.

The government believes the new model of investigation, similar to that used to investigate incidents in the airline industry, will be a force for improvement and promote learning from incidents as well as setting an example of how to do investigations well on a local level.

It remains unclear exactly how this body will be established and whether its independence will be guaranteed in legislation. It is also unclear what, if any, powers it will have to forcibly investigate NHS providers, or impose its recommendations upon them.

The Department of Health said details would be worked out over the coming months.

In its response to the Morecambe Bay inquiry, published today, the government said: “An important principle of this new service will be its ability to exercise independence and operate without fear or favour irrespective of its location in order to get to the bottom of any patient safety incident that it examines.”

The document says IPSIS “will be selective about the incidents it investigates to ensure optimum effectiveness, and it will focus on incident types that signal systemic or apparently intractable risks within the local healthcare system”

However, officials accept IPSIS will only have sufficient capacity to investigate “a small proportion” of incidents and its wider role “will be to champion the need for good quality local investigations and lead on approaches that will enhance the capabilities of providers to conduct their own investigations”.

Events it will investigate include those involving high cost litigation, never events, and incidents such as medication errors and wider systemic failings. IPSIS will use expert led investigations and disseminate learning to other parts of the NHS.

It will not seek to apportion blame and will not handle patient complaints.

Currently, NHS trusts and foundation trusts are required to notify the Care Quality Commission and Monitor when serious incidents occur but the government says it is now planning to launch a consultation on forcing providers to notify regulators when they commission external investigations or reviews.

This follows a decade at University Hospitals of Morecambe Bay Foundation Trust where external reports were carried out into poor care but were not shared with regulators leading to opportunities to take action being missed.

IPSIS will be able to respond to concerns from patients and families and ensure their views are incorporated into terms of reference of any inquiries it carries out, the document says.

It added: “We agree that independent non-statutory investigations provide a useful, more rapid and potentially more efficient alternative to statutory public inquiries as a last resort for investigating failings in care.”

John Illingworth, policy manager at the Health Foundation, welcomed the creation of the investigation service but said there were concerns over how it might operate in practice.

He said: “If we want to try and understand some of the system-wide issues and genuinely learn and improve the service then a function like this is absolutely critical.

“Our concern would be is the independence and the issue of hosting the branch within a body that has a regulatory function. Will the new branch, depending on its relationship with the new regulator, be able to make recommendations to the host organisation?”

An expert group will advise on the exact purpose and function of the new body over the coming months.

IPSIS is expected to be formally up and running from 1 April next year.