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6. Patient safety organisations and structures

The National Patient Safety Agency
The National Patient Safety Agency (NPSA) was set up in July 2001 in response to recommendations in the report An organisation with a memory. It is a special health authority responsible for co-ordinating the efforts of healthcare professionals, in order to learn from adverse events and near misses at a local level.

It is also responsible for launching and managing a new national reporting and learning system for errors, called the National Reporting and Learning System (NRLS).

An open and fair cultureAs well as making sure that events are reported in the first place, the NPSA promotes an open and fair culture across the health service. Doctors and other staff are encouraged to report incidents and near misses without fear of personal reprimand and to understand that by sharing experiences, others will learn lessons, and patient safety will improve.

The NPSA has worked with the NHS Confederation and with input from the National Clinical Assessment Authority (NCAA), royal colleges, trade unions and others, has developed the  Incident Decision Tree. This is a tool to help NHS managers determine the best course of action for dealing with staff following a patient safety incident.

The NPSA will improve patient safety by:

  • Collecting and analysing information on adverse events and near misses from local NHS staff, patients and carers
  • Taking into account relevant safety information and experience from other industries and countries
  • Learning lessons and ensuring that, with NHS staff support and involvement, these lessons are used in practice, service organisation and delivery
  • Ensuring that where risks are identified, action is taken to prevent harm, specify national goals and establish mechanisms to track progress
  • Involving and listening to patients, users and the public

Testing and rolling out the reporting systems
The reporting system was piloted in 28 hospitals and primary care units in 2001. This demonstrated that it was technically possible to link many existing data collection systems across the NHS and that staff were willing to report to the NPSA. A full audit was undertaken to determine any gaps in the data and a report on this published on  May 8, 2003 as part of the NPSA's Business Plan for 2003/04. A phased roll-out of the reporting system across the NHS in England and Wales began in 2004 and will be supported by training programmes and 32 patient safety managers.

Patient safety alerts
NPSA safety alerts are issued when specific risks to patients are identified. The NPSA works with the Department of Health and inspection bodies to make sure the guidance is adopted. The alert system was set up in response to the recommendations of An organisation with a memory, which targeted a reduction in the number of serious errors in the use of prescribed drugs.

On 23 July, 2002, the NPSA launched its first patient safety alert on prevention of accidental injection with intravenous potassium, which can cause death. Potassium chloride ampoules can look very similar to those containing saline solution.

The alert explained how to address and overcome the risks of accidental overdose, while ensuring that seriously ill patients who urgently require intravenous potassium could continue to receive it promptly. It recommended the introduction of new control arrangements in critical care areas and said that concentrated potassium should be replaced by a diluted product on wards.

The NPSA itself will work with the NHS, Medicines and Healthcare Products Regulatory Agency (MHRA) and manufacturers to ensure the availability of a broader range of diluted products and to develop distinctive packaging that will help reduce the risk to patients.

The NPSA has already begun to have an impact on patient safety and has issued practical solutions in a range of areas, including:

  • Deaths linked to methotrexate
  • Infusion device safety
  • Use of alcohol-based hand-rubs to reduce hospital infections

The National Clinical Assessment Authority
While poor performance by individual doctors remains uncommon, if left unchecked the results can be catastrophic for the patient and families concerned.

In 1999, the CMO published the report Supporting doctors, protecting patients. This contained a wide range of measures to ensure that poor clinical performance was recognised early on and resolved effectively. This has led to the establishment of the National Clinical Assessment Authority (NCAA).

The National Clinical Assessment Authority aims to improve public confidence in doctors' performances by:

  • Helping local organisations manage performance problems swiftly, effectively and sensitively
  • Promoting the development of local and national procedures for preventing, identifying and resolving performance problems
  • Assessing individual doctors and dentists, and recommending practical ways in which their performance can be improved

When a problem arises that cannot be evaluated or resolved locally, the NCAA will make a thorough and objective assessment and provide advice to the NHS trust or health authority concerned. Serious problems are referred to the General Medical Council (GMC) for assessment.

Following on from the 2004 review of the Department of Health's arm's-length bodies, the work of the NCAA is being brought together with the NPSA and established as a separate division within it.

Commission for Healthcare Audit and Inspection
From time to time, patients are harmed because of a major weakness in the operation of health services. Until recently, such incidents were investigated via internal inquiries, investigations and public inquiries. There was no clear guidance to determine what sort of investigation should be in initiated in each particular circumstance.

The Commission for Health Improvement (CHI) was set up in 1999. CHI's primary remit was to offer an independent review of clinical governance in NHS trusts, primary care trusts (PCTs) and health authorities but it also had an important role in investigating failing services. On 31 March, 2004 it ceased operating and was replaced by the Commission for Healthcare Audit and Inspection, known as the Healthcare Commission.

The Healthcare Commission encompasses the work of CHI, the national NHS value-for-money work of the Audit Commission and the independent healthcare work of the National Care Standards Commission. It inspects health services, reviews performance and publishes the results. It also works with other bodies to reduce the bureaucracy of regulation.

Public inquiries
From time to time, issues of serious public concern may still arise. In some cases, it may reflect the lack of systematic examination of a particular problem and the Secretary of State for Health may establish a public inquiry to investigate. Recent examples include inquiries into children's heart surgery in Bristol and Harold Shipman, the doctor convicted of murder.

Clinical governance
In 1999, the Government introduced legislation so that NHS organisations had a statutory duty to provide quality care. Each organisation was asked to implement a clinical governance programme to assure and improve the quality of their services. It aims to build effective teams within a changing culture and create a truly patient-centred approach to care. It also establishes the systems, methods and staff skills for assessing the quality of care as well as identifying ways of improving it. The implementation of clinical governance is being led and supported by a National Clinical Governance Support Team working as part of the Modernisation Agency.

Expert group on blocked tubing
Safety concerns arose about a tiny piece of equipment called an angle piece, used to connect anaesthetic tubing to the patient during surgery, after four cases where something blocked the oxygen flow during an operation.

Initially there was speculation that the tubes may have been sabotaged and Essex police investigated to see if the blockages were deliberate. They worked closely with the Department of Health, the Health and Safety Executive and the Medical Devices Agency and found that similar incidents had happened across the UK.

Research showed that angle pieces, which should be thrown away after a single use, were sometimes being washed and stored for further use. In some cases, they became accidentally blocked by another small device, which was difficult to spot.

In 2002 the Government set up an expert group to review the information gathered by police, establish causality and determine whether steps could be taken to reduce the risk of future blockages. The group's recommendations were published on May 10, 2004 while, this type of incident is very rare, the work of the expert group will help to minimise any further risk in the future.

International initiatives
In addition to the steps described here for England and Wales, The following initiatives are taking place around the world:

The World Health Organization (WHO) launched a World Alliance for Patient Safety on 27 October, 2004. The alliance,  led by Sir Liam Donaldson, will develop global standards and recognise excellence in international patient safety.

In the US, the Agency for Healthcare Research and Quality (AHRQ) is developing a broader understanding of patient safety problems.

The Institute for Healthcare Improvement (IHI), a US organisation, hosts seminars and promotes a collaborative approach to reduce errors. Its notable 'Breakthrough Series Collaborative' aims to reduce adverse drug events and medical errors.

The US-based Institute for Safe Medication Practices (ISMP) is dedicated to making safety the highest performing function in its member organisations. The institute produces the ISMP Medication Safety Alert.

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) is a nationally recognised accreditation agency for hospitals and other US healthcare facilities. JCAHO has established a reporting system for "sentinel events" - unexpected occurrences involving death or serious physical injury, including loss of limb or function or psychological injury. It looks at the causes and then makes improvements.

The Australian Patient Safety Foundation (APSF) provides leadership in reducing patient and consumer injury; follows a systems approach to patient safety improvement based on collaboration with clinicians and health staff; and provides funding for patient safety research.

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