Guidance on implementing the never events framework

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Operating on the wrong part, or leaving an instrument inside a patient, should not happen. Martin Fletcher and Tanya Huehns look at attempts to make such ‘never events’ history

While patient safety is a relatively new area of focus for healthcare systems around the world, there is nonetheless a growing expectation that certain types of patient harm should no longer occur.

This is what lies behind the concept of “never events” - a set of patient safety events that may or do result in serious patient harm or death and that are largely preventable based on current knowledge.

In short, they should never happen.

The term never event was introduced by the National Quality Forum in the US in 2001 to refer to medical errors (such as wrong-site surgery) that should never occur.

The National Quality Forum initially defined 27 such events in 2002 and revised the list in 2006. More recently, the Centers for Medicare and Medicaid in the US have begun to develop policies that link reduced payment to such events, a number of which overlap with the National Quality Forum Never events.

From October 2008, Medicare, the federally funded health plan for older Americans, is excluding payment for what it terms ‘hospital acquired conditions’ and ‘never events’, when these occur during an inpatient stay. Some private insurance carriers in the US have adopted similar policies and state run Medicaid programmes for low-income people are also beginning to follow suit.

Over here, never events were highlighted by health minister Lord Darzi in his report High Quality Care for All. Lord Darzi proposed that there should be a way of locally identifying and monitoring never events as part of the commissioning process by primary care trusts as a lever for safer care.

As a result, the National Patient Safety Agency has worked closely with the NHS to produce a framework for action on never events across the NHS in England. The never events framework 2009-10 was launched in March 2009.

Its action framework contains details of eight core never events, selected to fit the criteria developed, together with guidance for PCTs and providers around the process.

The guidance includes advice on how never events should be monitored and reported by commissioning PCTs and how measures are put in place to prevent them.

The first years of using the framework will test the process and provide learning about its potential further use as a tool for commissioners to improve patient safety.

Never events for the NHS

The eight core never events for 2009-10 in England are:

wrong site surgery;
retained instrument post-operation;
wrong route administration of chemotherapy;
misplaced naso or orogastric tube not detected prior to use;
inpatient suicide using non-collapsible rails;
escape from within the secure perimeter of medium or high security mental health services by patients who are transferred prisoners;
in-hospital maternal death from post-partum haemorrhage after elective caesarean section;
IV administration of mis-selected concentrated potassium chloride.

The core list in England is different from the US list, in that it is smaller, more focused, and clearly relates to existing national advice on prevention. It has achieved wide general acceptance to date.

The following criteria were used for defining a never event in England:

the never event may or does result in severe harm or death to patients or the public;
there is evidence that the never event has occurred in the past, that is it is a known source of risk (data sources: NPSA reporting and learning system and other serious and untoward incident reporting systems);
there is existing national guidance and/or national safety recommendations on how the never event can be prevented, along with support for implementation;
the never event is preventable if the national guidance and/or national safety recommendations are implemented;
occurrence of the never event can be easily identified, defined and measured on an ongoing basis.

PCTs can use these criteria to add other events they consider are important locally.

What steps should PCTs take to implement the policy?

Five key steps are proposed:

Clear leadership to implement Never events PCTs should have identified an individual to lead on this policy within the commissioning team.

Open discussion with providers PCTs should discuss the core set of Never events with their providers, together with any other events that the PCT proposes to include in local commissioning arrangements.

Build shared commitment Never events should be part of building a shared commitment to improve patient safety on the part of both commissioners and providers. Both parties will be interested in assurance that appropriate systems are in place to prevent the occurrence of never events.

Informing boards There should be procedures in place whereby the boards of both the provider organisations and the PCT are informed of any never events occurring, the lessons learned from any investigations carried out, and preventive measures that need to be strengthened or put in place.

Report annually PCTs and providers should decide how they are going to publicly report on never events at least on an annual basis. Quality accounts may be a vehicle for reporting.

Case study: NHS Manchester

Rajan Madhok, medical director, and colleagues in Manchester PCT have been working closely with local providers, including acute and mental health services, to develop their programme of work on patient safety. This has included encouraging identification and reporting of patient safety incidents and training for key staff.

In addition to consolidating progress so far, Manchester PCT is planning to extend its work in two ways. First, it is exploring the idea of balancing rewards with penalties - the key issues being: should there be penalties? Would these be financial penalties? How much? And when to invoke them?

Second, although most of the attention in patient safety has focused on acute hospital services, it is clear that there are major risks in other healthcare sectors, in particular in primary care and for services commissioned jointly with

the local authorities such as nursing homes, drugs and for substance misuse, for example. The systems for clinical governance of these sectors are poorly developed and pose additional challenges.

Manchester PCT strongly supports the never events policy, which will strengthen its role as commissioner and continue to drive improvements in patient safety locally.

The organisation is keen to learn from others and to work with the National Patient Safety Agency to further develop its patient safety programme and reduce the level of avoidable harm to patients in healthcare.

What next?

The first years are about testing the policy - seeing how these events are reported, investigating how discussion around them between commissioners and providers has been established, and how such discussion has been conveyed to board level in NHS organisations. Evaluation will tell us if some of this is being achieved.

Nationally, a revised core list in later years will help PCTs to direct their discussions and locally, commissioners will be expected to use their own local learning and experience to take this policy forward as needed.

The National Patient Safety Agency will continue to support development and provide learning via its website and supporting regional and national events in the future.