Over a 10-year period, the Medical Defence Union (MDU) settled more than 1600 claims on behalf of GPs in the UK.1 Just over half the cases reflected failure or delay in the diagnosis of well known conditions, with potentially far-reaching consequences, including appendicitis, testicular torsion, meningitis, diabetes, pneumonia, myocardial infarction and bowel carcinoma.
Of these cases, 26% arose from avoidable medication errors, such as incorrect drug, incorrect dosage or site, and drug interaction.
Thirteen per cent of the cases were associated with pregnancy, predominantly ectopic pregnancy, eclampsia, and/or failure to diagnose pregnancy. The last category of claims often arose because of mistakes about the efficacy of contraception and past terminations or sterilisations, and mistakes about maternal age – the claimant being considered 'too young' or 'too old' to be pregnant.
Complaints form a largely separate group, as relatively few go on to become claims. For the year ending 31 March 1999, the DoH reported 38 857 complaints about general practice medical and dental services in England and Wales,2 although less than 1% of these proceeded to independent review or beyond.
All of the MDU's studies of complaints in general medical practice show that the most common elements in complaints, as in claims, remain allegations about failure or delay in diagnosis.
In a separate MDU study carried out in 1999, 24% of medical complaints were made after bereavement.3 This is not surprising as the grief felt by relatives can make them more critical of a deceased patient's care.
Of these complaints, 34% were about non-clinical matters, with 10% being related to the 'manner or attitude' of the doctor or practice staff.
The fact that some patients perceive a GP to have an uncaring attitude is one of the major factors in precipitating complaints about other aspects of care.
The term 'risk management' entered the insurance world in the US in the 1960s, to describe the financing and control of insurance claim losses:
'The identification, analysis and treatment of those risks which threaten the viability and profit of professional practice'4
The concept spread to American medicine in response to the medical malpractice crisis of the early 70s, in an effort to reduce or at least limit the incidence of adverse events potentially attributable to medical negligence and allied 'system failures'.
Hospital indemnity in the UK became the responsibility of the NHS at the beginning of 1990,5 and many hospitals have followed their American counterparts by appointing risk managers to minimise risks and prevent avoidable harm to patients.
Although the MDU produced a risk assessment pack for GPs as long ago as 1995, the need for risk management in British general practice appears not to have been recognised by many commentators until clinical governance arrived in 1998 as a major initiative from the DoH.
Every health organisation in the NHS now has a statutory duty to monitor standards and to improve them. This applies as much to general practice as it does to the hospital service.
PCGs and trusts have set up the leadership, accountability and development arrangements required by the Chief Medical Officer.6 They need to consider a number of significant areas:
- Clinical audit
- Evidence-based practice
- Significant event reporting and risk assessment
- Complaints procedures
- Performance review by revalidation and appraisal
- Protecting patients by raising proper concerns about colleagues with the proper authorities.
Most of these issues are self-explanatory, and can be grouped together under the broad heading 'clinical risk management'. However, there is more to it than that, as reporting of adverse healthcare events will be mandatory in the near future (see below).
This clearly goes hand in hand with the assessment and reduction of potential and already realised risks at all levels within the organisation – in this case the individual general practice or primary care team.
Risk assessment may be defined as a careful and proactive examination of: any clinical procedure or event that could cause harm: its significance in terms of frequency and severity; and the precautions necessary to eliminate the risk or at least reduce it to an acceptable level.
Risks are often recognised only when an adverse incident or 'near miss' has occurred. The Government proposes to draw on a database of such risks by introducing 'a mandatory reporting system a full single database for analysing and sharing the lessons from incidents and near misses'.7
The precise framework has not yet been set out, but it is clear that the database will include material derived from the NHS complaints procedure and from data collected by the NHS litigation authority which provides indemnity for NHS hospitals and trusts. GPs will be expected to contribute to the database, and the onus of collating the data will probably fall at PCG level.
While the additional importance of 'learning free lessons from near misses8 must not be undervalued, there are more proactive ways of recognising risk. Practices may elect to self-assess using a detailed questionnaire, or may choose to address the issues through risk management workshops.
Both of these areas have been pioneered by the MDU in recent years. The MDU's risk management pack has now been used by more than 5000 practices in the UK.
A third of the settlements referred to above happened because 'system failures' had occurred – problems that were not attributable to the negligence of any one individual, but which resulted from a combination of deficient methods or inadequate forward planning, administration, monitoring or communication.
System failures are almost certainly the areas of clinical practice most susceptible to risk management initiatives – particularly through the development of protocols and guidelines.
These may be purely local, or be adopted and adapted from those put out by national organisations. The National Institute for Clinical Excellence has already started to put together clinical guidelines based on best available evidence and expert professional advice.
A successful risk management system will be based on a combination of self-assessment and critical event analysis. The careful and conscientious completion of a self-assessment questionnaire can open the eyes of practitioners and their staff to the potential for system failures, and help them to make any necessary changes.
The further stage of successfully implementing a significant or critical event analysis and response system that is both dynamic and self-perpetuating will require a more sustained effort from all members of the practice team.
Sharing problems and good practice at PCG level may help to create a blame-free learning culture and to improve the care given to patients, with the potential for enhanced patient safety and an increased confidence in the service overall.
For GPs and allied healthcare professionals, the adoption of quality procedures with full staff participation at all levels will undoubtedly engender satisfaction and confidence for the individuals concerned. Furthermore, they can help to protect the practice's reputation and reduce the possibility of future claims and complaints, with a consequent decrease in the very real stress and distress (for all parties) that may be associated with such events.
A few clinicians may be less than happy about risk management activities, seeing them as a possible slur on their competence, a threat to clinical independence and autonomy, or even a pathway towards the institution of some form of disciplinary proceedings. However, risk management should never become a witch hunt.
Health authorities, PCGs and PCTs have instead a definite obligation to demonstrate that risk management programmes can help to bring about improvements in the overall standard of practice. The real objective has to be to prevent avoidable harm to patients, and all health professionals must surely have a strong moral and ethical obligation to do just that – by promoting an active risk management culture.
- Internal MDU study 2000.
- DoH Press release 23 March 2000.
- Internal MDU study 1999.
- Hay S. Are You Negligent? London: Economist Publications Ltd, 1987.
- Department of Health. Claims of Medical Negligence against NHS Hospital and Community Doctors and Dentists. HC(89)34. DoH, 1989.
- Donaldson L. Clinical governance – medical practice in a new era. J Med Def Union 1999; 15(2): 7-9.
- The NHS Plan – a plan for investment, a plan for reform. National Health Service, 2000 (www.nhs.uk/nhsplan.htm).
- Barach P, Small SD. How the NHS can improve safety and learning.Editorial. Br Med J 2000; 320: 1683-4.
© Medical Defence Union 2000