The dangers of health care in Britain have been long understood. Systematic data collection of the hazards of health care can be traced back at least to the time of Florence Nightingale's publications in the 1860s.(1) In this short paper, we outline the evolution of patient safety and trace its development and progress over the last 10 years in Britain, where a nationalized health service and sustained commitment from Chief Medical Officer Sir Liam Donaldson and other senior figures have brought patient safety to considerable prominence.
The Evolution of Patient Safety
The United Kingdom, like the United States, has seen some remarkable safety initiatives over the past century. For instance, to examine maternal morbidity and mortality, in 1928 the British Ministry of Health set up a committee that initiated confidential investigations of 5800 cases.(2) National reports on maternal mortality were produced intermittently until 1952, when the "Confidential Enquiry into Maternal Deaths" was formally established. Since then, it has produced regular reports on all maternal deaths.(3) "Confidential Enquiries" have since been set up into peri-operative deaths and suicides and homicides under mental health services. Other reporting systems have also been set up to improve patient safety, such as the reporting system for serious hazards of transfusion.
Litigation has been an important driver of safety in the UK, but in a different way than in the United States. Although the threat of litigation certainly has hindered some safety initiatives by limiting open dialogue and reducing reporting, it has also raised public and professional awareness of adverse outcomes. Whereas, in the United States, risk management has had a primarily legal and financial orientation (with limited communication between risk managers and clinicians), in the United Kingdom and other countries, risk management had a clinical orientation ("clinical risk management") from its inception. Clinical risk management in this wider sense was really the precursor to patient safety; the terminology varies from country to country, but the aims of clinical risk management and patient safety are the sameto reduce or eliminate harm to patients.(4)
Patient safety initiatives in the UK emerged from a wide set of influences and events. These include the growth of audit and other quality activities in the 1970s and 1980s, the realization that clinical problems underlie much litigation, certain high-profile cases such as the Bristol pediatric cardiac surgery inquiry (5), the example of other industries that have focused on safety, psychological research on human error (6), and the major adverse events review studies.(7,8) Nevertheless, the history of quality and safety in the National Health Service (NHS) until recently has been a "rather fragmented affair" (9), with little overall coherence. However, in 1999, chief executives of all health care organizations were given a statutory duty and framework, known as clinical governance, to manage and actively promote risk management, quality, and safety.
This, together with the other initiatives described, played a part in the development of patient safety in the UK and formed the background to a highly influential report, which paved the way for a national program of action.
"An Organisation with a Memory"
In 2000, the Chief Medical Officer, Sir Liam Donaldson, published An Organisation with a Memory.(10) This report set the scene for improving patient safety in the NHS, giving the annual figures for known reported harm at that time: 400 people known to have died or been seriously injured from events involving medical devices, nearly 10,000 people known to have experienced adverse reactions to drugs, and hospital-acquired infections costing the NHS nearly £1 billion per annum. It described the NHS as having an old-fashioned approach to learning lessons when things go wrong and set out a way forward designed to enable the NHS to successfully "modernize its approach to learning from failure." Four key areas were identified as "must do's" to improve patient safety:
- Unified mechanisms for reporting and analysis when things go wrong.
- A more open culture, in which errors or service failures can be reported and discussed.
- Mechanisms for ensuring that, where lessons are identified, the necessary changes are put into practice.
- A much wider appreciation of the value of the system approach in preventing, analyzing, and learning from errors.
Many of the government initiatives at that time were designed to modernize the NHS, seen then as a monolith with intractably long waiting lists and death rates for key conditions higher than those in comparable countries. The drive to modernize has catalyzed a raft of new policy initiatives, with new hospitals built with private finance, new independent providers of state-funded care brought into the market, more medical and nursing staff (many from overseas), new commissioning and funding arrangements based on payment by results, national service frameworks setting out how care should be delivered, new organizational structures with Foundation Trusts, a new way of regulating health care organizations, and increased patient choice.
The drive to improve patient safety in the NHS has been ongoing throughout this time, and some, but not all, of these initiatives have been aligned with the goal of improving safety. The work of the National Patient Safety Agency (NPSA) (www.npsa.nhs.uk) has been important in focusing attention on the subject and increasing the international profile of patient safety. A number of other organizations have also influenced progress, such as the regulatory body for drugs and medical devices, the Medicines and Healthcare Products Regulatory Agency (MHRA). Hospitals have also been pushed to improve standards by the NHS Litigation Authority (www.nhsla.com), which indemnifies hospitals against litigation. This organization inspects hospitals against risk management standards and optimal clinical practice, and there are financial incentives to score highly. However, these inspections primarily focus on management processes, and it is not clear how effective this program has been in driving patient safety at the clinical level.
When the government changed the way that health care organizations were regulated and issued national standards in July 2004, patient safety featured as the first domain. NHS organizations are required to conduct a self-assessment against these standards with all members of each organization's Board signing a statement to confirm this assessment. This helped to bring patient safety onto the agenda of the Chairman and Chief Executive of all health care organizations. The Healthcare Commission, the UK regulatory authority, has also driven this agenda by highlighting safety standards in its regular inspections of health care organizations.
The National Patient Safety Agency was set up in 2001, charged with establishing a national reporting and learning system for adverse events, taking lessons from these reports, and developing solutions to prevent, or considerably reduce, the risk of recurrence. The national reporting system is now up and running with all NHS organizations connected. It is receiving several thousand reports per month, and the cumulative database now contains more than a million reports. This has served to highlight the importance of incident reporting as part of the drive to improve patient safety. Safety alerts have been issued on a wide range of topics from correct site surgery to standardizing the crash call number in all hospitals.
To drive up reporting rates, the NPSA also began to work on ways to change the culture from one of blame to one that is open and fair. This included a program of training groups of staff in every NHS organization in the techniques of root cause analysis. Tools, techniques, and training packages have also been developed and rolled out in safety culture assessment, being open with patients after an incident, and how to assess and manage the staff involved. One area likely to have a long-term effect is working with the providers of medical education to put patient safety firmly on the medical curriculum.
The "Safer Patients Initiative" has gone further than those described already in finding ways to directly improve the safety across an entire organization. This is a £4.3 million initiative funded by the Health Foundation (www.health.org.uk), an independent charitable foundation working to improve the quality of health care across the UK. Working with experts from the Institute for Healthcare Improvement (IHI), the 4-year "Safer Patients Initiative" is providing the resources and technical expertise needed to drive system-wide changes in four hospital sites. The program involves a range of initiatives targeted at critical safety issues such as medication error and surgical site infection, drawing on IHI's extensive experience of work in specific clinical areas but bringing it together in a cohesive program. An additional 16 sites have recently been recruited to extend the initiative. This second wave will again work with IHI but also learn from the experience of the first wave. While evaluations have been commissioned, no findings are yet available; however, those involved have been very enthusiastic and positive, and the program has without doubt been a very important development in Britain.
Although much has been done to bring improvements to patient safety in England, there remains a frustration that, to quote Sir Liam Donaldson, "the pace of change has been too slow."(11) Following a review of progress during 2006, the Department of Health issued a document last December entitled "Safety First."(11) The key message is summarized in a quote by the chair of the regulatory body, the Healthcare Commission, Sir Ian Kennedy: "Safety cannot be allowed to play second fiddle to other objectives that may emerge from time to time. It is the first objective." The document's proposals to increase the pace of change include:
- Building patient safety into the next set of national goals, priorities, and targets for the NHS.
- Better coordination of the effort to improve patient safety at a national level through the establishment of a National Patient Safety Forum chaired jointly by the Chief Executive of the NHS and the Chief Medical Officer.
- A new national campaign to engage, inform, and motivate clinical staff and health care providers to address patient safety.
- A refocusing of the work of the NPSA, including redesigning the national reporting system to take more account of analyzing risk-prone situations and anticipating adverse events.
- Patient Safety Action Teams to be set up in each Strategic Health Authority area, with access to specialist investigators.
- Clearer accountability for patient safety at Board level.
- A more high-profile program of monitoring organizations' progress by the Healthcare Commission.
- A national network of patient champions working in partnership with local NHS organizations to promote the active involvement of patients and their families.
Considerable progress has been made in some respects in the last 5 years. There are much greater awareness of the problem, a more reflective approach to instances of error and harm, policy initiatives to address safety, a dedicated research program, and the beginnings of a more humane approach to injured patients and their families. Progress is also being made on developing solutions for safety problems.
The changes proposed in "Safety First" are now in the planning stages, and it will take time to see how these new initiatives work, and whether, as intended, the changes really do create a safer NHS for all. The gestation period is over; the delivery is being speeded up. It took the airline industry 30 years to mature its safety systems; the NHS, and its patients, cannot wait that long.
Susan BurnettDirector, Safe Quality Care
Charles Vincent, PhDProfessor of Clinical Safety Research, Imperial College London
Back to Top
1. Vincent C. Patient Safety. Edinburgh, Scotland: Churchill Livingstone; 2006.
2. Kerr JM. Maternal Mortality and Morbidity. Edinburgh, Scotland: E & S Livingstone; 1932.
3. Sharpe VA, Faden AI. Medical Harm: Historical, Conceptual and Ethical Dimensions of Iatrogenic Illness. Cambridge, England: Cambridge University Press; 1998.
4. Vincent CA. Clinical Risk Management. London, England: BMJ Publications; 1995.
5. Department of Health. The Report of the Public Inquiry into Children's Heart Surgery at the Bristol Royal Infirmary 19841995: Learning from Bristol. London, England: The Stationery Office; 2001.
6. Reason JT. Human Error. New York, NY: Cambridge University Press; 1990.
7. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results from the Harvard Medical Practice Study I. N Engl J Med. 1991;324:370-376. [go to PubMed]
8. Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Newby L, Hamilton JD. The Quality in Australian Health Care Study. Med J Aust. 1995;163:458-471. [go to PubMed]
9. Donaldson LJ, Gray JA. Clinical governance: a quality duty for health organisations. Qual Health Care. 1998;7(suppl):S37-S44. [go to PubMed]
10. Department of Health. An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS Chaired by the Chief Medical Officer. London, England: The Stationery Office; 2000.
11. Department of Health. Safety First: A Report for Patients, Clinicians and Healthcare Managers. London, England: The Stationery Office; 2006.