Patient Safety - Health Committee Contents


Every 36 hours, NHS services are used by around a million people; the vast majority receive care which is safe and effective. However, as in every other healthcare system, not all care is as safe as it could be and some patients are harmed, sometimes seriously, even fatally. Reviews of patients' case notes indicates that in the NHS and in other healthcare systems as many as 10% of patients admitted to hospital suffer some form of harm, much of which is avoidable. Tens of thousands of patients suffer unnecessary harm each year and there is a huge cost to the NHS in consequence.

Nearly a decade ago, the Government became one of the first in the world to make it a priority to address patient safety across a whole healthcare system. This put the NHS in England in the vanguard of the emerging international movement to make healthcare safer. Patient safety policy has focused on the creation of a unified national mechanism for reporting and analysing incidents, underpinned by a new culture of openness in the NHS. As a result, staff would feel able to report and discuss incidents without fearing unfair blame. Systems for reporting, and learning from, incidents, were established, centred on the National Reporting and Learning System (NRLS) and the National Patient Safety Agency (NPSA).

Although reporting is useful for learning from incidents, it is not a reliable way of measuring the extent of harm. Judging the overall effectiveness of patient safety policy is made difficult because of the failure by the Department of Health (DH) to collect adequate data. Nevertheless, it is apparent that, for all the policy innovations of the past decade, there has been insufficient progress in making services safer. Underlying Lord Darzi's emphasis in the Next Stage Review on safety, there appears to be a tacit admission that not all services are safe enough yet. The perception that this is so is strengthened by the recent cases of disastrously unsafe care that have come to light in a small number of Trusts, such as Mid-Staffordshire NHS Foundation Trust.

Patient safety is a multifaceted issue that touches on many aspects of the NHS and we have examined in some detail what we regard as the most important of these. We have concluded that there are significant deficiencies in current policy. We recommend several changes that need to be made in order for there to be further progress in tackling unsafe care.

Measurement and evaluation

In order to monitor whether or not services are being made safer, data on the incidence of harm must be systematically collected. The best available means of doing this is by reviewing samples of patients' case notes at periodic intervals, in order to calculate a rate of harm. This should be undertaken by all hospitals and data produced in this way should be gathered together by the NPSA.

Harmed patients and their families or carers

Harmed patients and their families or carers are entitled to receive information, an explanation, an apology and an undertaking that the harm will not be repeated. Too often, however, this does not occur.

Recent changes to the complaints system are unlikely to improve how the NHS treats complainants. Patient Advice and Liaison Services should be provided independently of the NHS organisations to which they relate; and the Independent Review stage of the complaints process should be reinstated.

Harmed patients are currently forced to endure often lengthy and distressing litigation to obtain justice and compensation. At the same time, NHS organisations are obliged to spend considerable sums on legal costs and are encouraged to be defensive when harm occurs. Three years ago, Parliament passed the legislation which enabled the DH to introduce an NHS Redress Scheme, which would change this situation, removing the need for litigation in many cases. However, the DH still has not implemented the Redress Scheme and has no timetable for doing so, which we find appalling.

An open, reporting and learning NHS

The NRLS is now collecting significant amounts of data, which are being used to help make services safer, but there remains significant under-reporting, particularly in respect of incidents in primary care; medication incidents; serious incidents; and reporting by doctors.

A major reason for under-reporting is the persistent failure to eliminate the "blame culture". Another important factor is fear of litigation or prosecution, underlining the need for the Government to address the medico-legal aspects of patient safety; we particularly recommend the decriminalisation of dispensing errors on the part of pharmacists. The "one size fits all" nature of reporting systems is also a significant cause of under-reporting, for example by GPs.

As much as possible of the data collected by the NRLS should be published. We welcome the decision to start publishing reporting data broken down by individual NHS organisation.

However, there has been too much emphasis on gathering summary data on common types of incident and on less serious incidents. The NRLS should gather more in-depth information on serious and sentinel events (those needing immediate investigation and response, since they involve death or other serious injury, or the risk of those), particularly less common types. There must be much wider, and better, use of root-cause analysis, which is an investigative method that seeks to identify the underlying causes of an incident, with a view to preventing its repetition.

While the Patient Safety Observatory is already collating data from a variety of sources other than reporting data, this must now become a key priority for the NPSA.

Patient safety at the front line

Known patient-safety solutions too often fail to be adopted at the front line in the NHS. Solutions are handed down from on high as diktats (if they are passed on at all) without clinicians being convinced of their effectiveness. Moreover, a culture persists in which various types of easily avoidable harm are seen as inevitable risks of treatment. However, improvements in safety can be fully integrated into frontline services by engaging and involving clinicians, and other healthcare workers. This has been shown in schemes such as the Safer Patients Initiative and the Productive Ward programme which have been successfully adopted in a number of hospitals.

The NHS lags unacceptably behind other safety-critical industries, such as aviation, in recognising the importance of effective teamworking and other non-technical skills.

Inadequate staffing levels have been major factors in undermining patient safety in a number of notorious cases. This is unacceptable, particularly given the recent huge increases in funding and staffing levels overall.

Technology and patient safety

Several technologies could make significant improvements to care but are being implemented far too slowly. Examples include:

  • Automated decision support systems, including electronic prescribing-support systems;
  • Automatic Identification and Data Capture technology, such as barcoding; and
  • the Electronic Patient Record.

We are alarmed at the lengthy delay in developing spinal needles that cannot be connected to a Luer syringe, which is a simple technical solution to a known, and potentially lethal, problem. It is unacceptable that the NHS does not have a mechanism to ensure that changes such as this, which impact seriously on patient safety, occur in a timely fashion.

Education and training curricula

There are serious deficiencies in the undergraduate medical curriculum, Tomorrow's Doctors, which are detrimental to patient safety, in respect of training in:

  • clinical pharmacology and therapeutics;
  • diagnostic skills;
  • non-technical skills; and
  • root-cause analysis.

These must be addressed in the next edition of Tomorrow's Doctors.

Patient safety must be fully and explicitly integrated into the education and training curricula of all healthcare workers. In addition, there must be more interdisciplinary training: those who work together should train together.

Commissioning, performance management and regulation

A key role for Primary Care Trusts (PCTs) in commissioning services is to ensure the quality and safety of those services. We have grave doubts as to whether all PCTs are actually doing so. We welcome the principle of linking payment by PCTs to the quality of care, but recommend that it be piloted first. We support the use of "Never Events" by PCTs, but have doubts about whether they should involve a financial penalty; we recommend this be piloted too.

The performance-management role of Strategic Health Authorities (SHAs) appears to be ill-defined and to vary between SHAs. We recommend that the DH produce a formal definition of this role.

Regulation has been costly and burdensome. It has been too rule-based, looking at processes and procedures rather than actual outcomes and consequences and professional competence. Consequently, the Annual Health Check has failed to pick up major failings in some cases. The Care Quality Commission's registration system must focus on the outcomes being achieved by NHS organisations rather than formal governance processes.

The relationship between bodies responsible for commissioning from, performance-managing and regulating NHS service providers is not defined clearly enough. In particular, there is a lack of clarity about the role of Monitor. The DH should produce a succinct statement regarding how commissioning, performance management and regulation are defined, and how they (and the organisations responsible for them) relate to each other.

The role of managers and Boards

There is disturbing evidence of catastrophic failure on the part of some senior managers and Boards in cases such as Mid-Staffordshire NHS Foundation Trust. While other Boards are not failing as comprehensively, there is substantial room for improvement. Boards too often believe that they are discharging their responsibilities in respect of patient safety by addressing governance and regulatory processes, when they should actually be promoting tangible improvements in services. There is a case for providing specialist training in patient safety issues, particularly to non-executive directors, to help them scrutinise and hold to account their executive colleagues. Patient safety must be the top priority of Boards and, to show this, it should without exception be the first item on every agenda of every Board.

We commend to NHS organisations the measures piloted as part of the Safer Patients Initiative, namely:

  • implementing tried and tested changes in clinical practice to ensure safe care;
  • banishing the blame culture;
  • providing the leadership to harness the enthusiasm of staff to improve safety;
  • changing the way they identify risks and measure performance, by using information about actual harm done to patients, such as data from sample case note reviews.

We strongly endorse the DH's view that no Board in the NHS should always be meeting behind closed doors and we urge the Government to legislate as necessary to ensure that Foundation Trust Boards meet regularly in public.

The NHS remains largely unsupportive of whistleblowing, with many staff fearful about the consequences of going outside official channels to bring unsafe care to light. We recommend that the DH bring forward proposals on how to improve this situation.

The role of the DH and Government

The Government is to be praised for being the first in the world to adopt a policy which makes patient safety a priority. However, Government policy has too often given the impression that there are priorities, notably hitting targets (particularly for waiting lists, and Accident and Emergency waiting), achieving financial balance and attaining Foundation Trust status, which are more important than patient safety. This has undoubtedly, in a number of well documented cases, been a contributory factor in making services unsafe.

All Government policy in respect of the NHS must be predicated on the principle that the first priority, always and without exception, is to ensure that patients do not suffer avoidable harm. The key tasks of the Government are to ensure that the NHS:

  • develops a culture of openness and "fair blame";
  • strengthens, clarifies and promulgates its whistleblowing policy;
  • provides leadership which listens to and acts upon staff suggestions for service changes to improve efficiency and quality and, by the provision of examples and incentives, encourages and enables staff to implement practical and proven improvements in patient safety.

In addition, the Government should examine the contribution of deficiencies in regulation to failures in patient safety.

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Prepared 3 July 2009