Ensuring patient Safety

What regulation can do

Safety is at the heart of the quality healthcare services. Any regulator of healthcare quality would not be able to do its job without assessing safety. Being able to tell the consumers / patients that a healthcare provider delivers clinically effective care is only half the picture. Even organisations providing excellent clinical care and those who are very responsive to patients’ needs make mistakes. So, the other half of the picture is what the organisation does to build a culture and resilience to prevent things from going wrong, and what it does when things inevitably go wrong: how it encourages staff to report incidents and how it learns from them.

A regulator has to respond to serious safety concerns by investigating incidents and reporting on them independently. This reassures the public that root cases have been identified and action will be taken, thus ensuring wider learning across organisations.

In England, healthcare providers themselves are responsible for reporting, analysing and experiencing from incidents and conducting investigations of serious incidents. Other local players have an important role in improving safety, such as Patient Safety Action Teams based within strategic health authorities that are among others responsible for improving the standard of local investigation of serious incidents. A range of national organisations have a role in improving safety, for example, the National Patient Safety Agency encourages learning and improvement based on incidents reported to the National Reporting and Learning System (NRLS). And, the NHS Institute has a role in encouraging improvement in safety within trusts that sign up to its programmes such as ‘Leading Improvement in Patient Safety’.

As the regulator of healthcare quality for England, we are a fundamental part of the picture because we conduct independent assessment of all organisations and report publicly. This means that there is a robust and comparative picture of performance reflected back to trust executives and boards, and patients know how well their local providers address safety issues. As such regulation is one of the drivers for improvement in the system; it throws a spotlight on poor performance and stimulates action. For example, the Healthcare Commission’s ‘Annual Healthcheck’ of NHS trusts is now in its third year. Last year’s results show that only 58 per cent of trusts are compliant with all the Department of Health’s core standards for safety. Non-compliance with the core standards is unacceptable, particularly when the safety of patients is concerned.

It is sometimes argued that a regulatory focus on where things are going wrong could decrease the likelihood of people being open and honest about incidents. Thus, in turn, decreasing safety. However, whether regulation disincentivises openness and learning depends entirely on how the regulator operates: the assessments it makes and what information it uses to make those assessments. If the regulators were to use a national reporting system such as the NRLS to identify those organisations who report high numbers of incidents, and penalise them on the basis of those reports, it could have a detrimental effect on reporting and learning. However there are a range of things the regulator can and should do.

The approach that the Healthcare Commission has taken is to:

(a) Provide independent assurance that organisations are following safe practice

• In a number of areas the key risks to patient safety are well known. Risks can be reduced or avoided by following existing national guidance or requirements every time for every patient. The regulator can check whether organisations follow safer practice—we don’t have to wait until things go wrong. We ensure that our programme of work covers a range of the key risks to patient safety. We do this throughour focus on certain key risks within the assessment of the Government’s core standards in the annual health check. These look at infection control, medicines and medical device management, decontamination, waste management, safe environments, nutrition and the implementation of safety alerts.
• Our in-depth assessments of compliance with the Government’s hygiene code (to be carried out at all acute trusts in 2008/9, and also at a proportion of non-acute trusts this year). The 95 specific inspections, which we have so far carried out in 2007/8 against the hygiene code, have resulted in3 improvement notices being issued and we have made a number of recommendations to other trusts.
• Our in-depth reviews of particular services, for example our recent review of maternity services and our planned review of medicines management across acute and primary care boundaries this year
  Our surveys of patients, which probe aspects of safe practice such as whether patients were given information on the potential side effects of medicines

(b) Assess performance on some outcomes
We do this in situations where reporting of incidents is well developed or mandatory and the likelihood of disincentivising reporting is lower. For example, we assess performance on infection control targets annually.

(c) Assess safety culture
We look at whether organisations encourage reporting and learning from incidents. We do this through our assessment of certain core standards and in the survey of NHS staff. The results of which continue to raise questions about the extent to which staff are encouraged and supported to report incidents locally.

(d) Conduct independent investigations where serious concerns are raised, if necessary
The assessment of safety is a continuous thread throughout the Healthcare Commission’s work, and we address it in a number of ways in order to promote improvement. The openness of our reporting is the key to this. More information on our reports and assessments can be found at www.healthcarecommission.org.uk