Patient safety in general practice
General Practitioner/Director of Primary Care, National Patient Safety Agency
E-mail: mbaker{at}rcgp.org.uk
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Abstract |
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‘First do no harm’ is a basic principle of the medical profession, believed to be handed down to us by Hippocrates. Yet, every doctor has personal experience of patients who have come to harm while receiving care. We are all familiar with stories of hospital-acquired infection, such as MRSA or Clostridium difficile and with horror stories like those about patients who have had the wrong kidney removed. But do we, as doctors, really have any idea of the extent to which things go wrong in health care and the numbers of patients who come to harm?
Patient safety is a specific curriculum statement (3.2) within the section relating to personal and professional responsibilities. The rationale for this statement points to the need for GPs to understand their personal responsibility for safety as a core part of medical professionalism. General practices, as the sites where most GPs work, can also have a major impact on safety in the design and implementation of systems of care. The statement describes the learning outcomes for safety in general practice training and these include basic tools and techniques for patient safety that should be applied in the context of general practice. Within the statement are references to key texts, tools and techniques that will equip GPs with the knowledge, skills and attitudes to practice safely and protect their patients from avoidable harm.
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The patient safety movement is relatively new in health care, having developed through the 1990s and noughties. The pioneers of patient safety have highlighted the extent of the problem and also drawn attention to other safety critical industries, such as aviation or the engineering sector, with the aim of applying the same principles of safety and risk that these industries have used to great effect. Although health care is a complex field relating to people rather than to machines or physical structures, many of the principles used in other safety related industries, for example incident reporting, risk assessment and incident analysis, can legitimately be applied to our ways of working.
To date, the main focus of patient safety initiatives has largely been in the acute sector where errors and incidents can be more high profile. However, we are sadly not immune to things going wrong in primary care and general practice. These incidents may be less likely to hit the headlines, but they can be just as devastating to the people themselves—primarily patients and their families, but also to those staff involved in an incident. Fortunately, general practice is well placed to implement patient safety techniques as practices are generally smaller and more autonomous than hospitals and practice teams have considerable freedom in agreeing and implementing improvements.
The aim of this article is to introduce the basic concepts of patient safety and then describe a framework for applying these principles to general practice. Safer care is better care and, to refer again to Hippocrates, avoiding harm to our patients must be our first and foremost consideration.
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Background to the patient safety movement |
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Lucien Leape, a physician and Professor of Health Policy at Harvard School of Public Health, is generally regarded as the ‘grandfather’ of the patient safety movement. His 1991 retrospective study of hospital medial records indicated an adverse event rate of 3.7%, of which two-thirds were ‘errors’ and he published his seminal article, ‘Error in medicine’ in 1994. These articles clearly demonstrated that sometimes things can go wrong in medical care and that many of these adverse events resulting in patient morbidity and mortality are, in fact, avoidable. A subsequent Australian study in 1995 gave an error rate of 16.6% and the first British study, by Charles Vincent, using a similar methodology showed an error rate of 10.8% in the hospital records of subjects selected for the study. The combined effect of these papers indicated that, in the developed world, avoidable adverse incidents occurred in a significant proportion of patients admitted to hospitals.
But although these academics, and others, were building a case for medicine to answer, the extent of medical (or clinical) error was not generally known to patients and the public. The publication of the report, ‘To err is human’ from the US Institute of Medicine was to change that at least within the USA. This report stated that as many as 98 000 people die each year in the USA from medical errors that occur in hospitals. That means more deaths than from road traffic accidents, breast cancer or AIDS. At the time of the report, medical error was the fifth leading cause of death in the USA. With the publication of this report, professionals, policy makers and the media started to register that health care was not as safe as it could, or should, be and that as other industries had benefited greatly from the application of safety science, it might be possible to take this approach in health care.
Meanwhile, the emerging patient safety movement had been noted with interest in the UK. The Chief Medical Officer in England, Sir Liam Donaldson, published his own report, ‘An organization with a memory’. This report looked at the ability of NHS systems to detect, report, analyze and learn from adverse events in the NHS. It also considered the ability of other sectors to learn from when things had gone wrong and to improve practices and move on. One way in which this had happened was by taking a systems approach in analyzing errors (see Box 1). Sir Liam concluded in his report that the NHS was doomed to make the same mistakes again and again as there was no systemic way in which it could identify, and learn from, failure.
Box 1. Systems approach in health care
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Patient safety in the United Kingdom |
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TOPAbstractThe GP curriculum and...Background to the patient...Patient safety in the...Evidence from general practiceThe systems approach to...The seven steps to...Step 1: build a...Step 2: lead and...Step 3: integrate your...Step 4: promote reportingStep 5: involve and...Step 6: learn and...Step 7: implement solutions...ConclusionReferences |
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As a result of developing concerns on patient safety, the National Patient Safety Agency (NPSA) was established in 2002, with a remit to set up an incident reporting system for England and Wales and to support patient safety in the NHS. The National Reporting and Learning System (NRLS) now has received in excess of two million reports and is the world's largest database of patient safety incidents (see Box 2). As well as the establishment of the NRLS, the NPSA has also developed a number of patient safety solutions: the ‘Being Open’ programme to support better communication with patients when things go wrong and an educational programme ‘Safe Foundations’ to facilitate teaching of patient safety to doctors in the foundation years. (The programme, consisting of four modules, can be accessed on www.saferhealthcare.org.uk). NPSA has also published ‘Seven steps to patient safety’, a framework for building patient safety in the NHS. A companion document, ‘Seven steps to patient safety in primary care’ has also been published, and each of the seven steps is considered in detail below.
Despite the efforts of NPSA and others working for patient safety in the UK, most observers still feel that safety, as an issue, still languishes low down on the agenda of health-care managers—and indeed NHS professionals and staff. Therefore, Sir Liam Donaldson together with David Nicholson, Chief Executive of the NHS in England worked together to produce ‘Safety First’, intended to make patient safety the number one priority in the NHS. Much work and commitment has to take place to make this happen. We in general practice have our own responsibility for safety in our consultations and in our practices. Safe industries and organizations are those where it is recognized that everyone has responsibility for safety—it is time to make this happen in general practice.
Box 2. Some definitions
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Evidence from general practice |
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Much of the literature on patient safety relates to the acute sector, and most acute trusts have well-established risk management systems and controls in place. There has traditionally been less emphasis on those things that go wrong in general practice, possibly because such events are less likely to hit the headlines than problems in large hospitals. However, as we all know, things do go wrong in primary care and general practice, and we too need to rise to the challenges of providing safer care.
There have in fact been a number of primary care-based studies in different countries. A helpful review of the English language literature in patient safety in primary care by researchers at the University of Manchester in 2002 indicated that error rates found in the studies varied widely, between 5 and 80 per 100 000 consultations (at the upper end of the range, a rate of 0.08%). This work suggested the most common error to be delayed or incorrect diagnosis. The very small error rates indicated in this work are more likely to reflect the relative lack of data than to be a true reflection. A further study, also from Manchester in 2004, analyzed databases from clinical negligence litigation (in these cases, patients had been harmed or had died) and again found diagnostic errors to be the most common problem. Other common problems were medication errors, failure or delay in referral and failure to recognize or warn of, side effects of medication. Another interesting study, although conducted over a short time and in a small number of practices was conducted by researchers in the north-east of England in 2003. This study, using methodology similar to that used by Vincent in 2000, showed an error rate of 7.5%.
The studies discussed above have provided a useful insight into the nature of patient safety incidents occurring in general practice, but much research could usefully be conducted in this area.
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The systems approach to patient safety |
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TOPAbstractThe GP curriculum and...Background to the patient...Patient safety in the...Evidence from general practiceThe systems approach to...The seven steps to...Step 1: build a...Step 2: lead and...Step 3: integrate your...Step 4: promote reportingStep 5: involve and...Step 6: learn and...Step 7: implement solutions...ConclusionReferences |
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When things go wrong, in any field of human endeavour, it is very rarely because of a single isolated event. Fortunately, aeroplanes do not tend to fall from the sky as a result of a single error—nor do ships sink when one accident happens. In other safety critical industries, there is a recognition that errors and incidents occur within a ‘system’ and that there is generally a sequence of events that occur before resulting in an incident or accident. The systems approach in patient safety starts from the premise that human performance and human error are two sides of the same coin—humans are fallible, will make mistakes and patients can be harmed as a result, even in the best-run organizations. Ultimately, we cannot change human nature, but we can change the systems in which we work so that errors are less likely to happen.
Organizations with strong safety cultures proactively look for those things that could go wrong within systems—’hazards’—and attempt to build in barriers—’defences’—to minimize the likelihood that these things will happen. This is well illustrated by the ‘Swiss cheese model’ developed by Reason in his seminal book, ‘Human error’. A representation of this model is shown as Figure 1.
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In contrast to the systems approach is the person-centred approach, whereby the accidents of an individual are identified as the cause of an incident and that individual takes the blame for the harm that occurs. Such an approach invariably damages the lives and careers of those, generally well-intentioned, staff who find themselves performing the act—at the end of a long chain of errors—that results in harm to a patient. The really sad aspect of this approach is that, without changes to the system in which the error occurs, the same event can potentially happen again and again.
Taking a systems approach in looking at errors does not mean that malicious, criminal or frankly negligent individuals should escape the consequences of their actions. Rather, there is a recognition that sometimes individuals find themselves operating in poor systems where there are ‘accidents waiting to happen’ and that in those circumstances, it is more appropriate to redesign the system than to inappropriately discipline the professional.
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The seven steps to patient safety |
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TOPAbstractThe GP curriculum and...Background to the patient...Patient safety in the...Evidence from general practiceThe systems approach to...The seven steps to...Step 1: build a...Step 2: lead and...Step 3: integrate your...Step 4: promote reportingStep 5: involve and...Step 6: learn and...Step 7: implement solutions...ConclusionReferences |
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The ‘Seven steps’ (see Box 3) are intended as guidance to NHS organizations to ensure that care provided is as safe as possible and that, should things go wrong, appropriate action is taken. Following the seven steps should also assist organizations in complying with their clinical governance, risk management and controls assurance targets.
Box 3. 
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In response to feedback from primary care organizations (PCOs) and professionals, NPSA subsequently produced Seven steps to patient safety in primary care as best practice guidance describing the key areas of activity that primary care teams can work through to safeguard the patients they care for.
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Step 1: build a safety culture |
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The definition of ‘safety culture’ as suggested by the Health and Safety Commission is shown in Box 4, together with the definition from NPSA, but a more pithy definition has been suggested by the Confederation of British Industry as ‘the way we do things round here’. The NPSA regard a true safety culture as one in which every person in the organization recognizes their responsibility for patient safety and works to improve the care that they deliver—there is also a recognition that health care is not without risks and that errors and incidents will occur. The emphasis in general practice should be on minimizing these and on ensuring that when things do go wrong, the practice can identify this and take appropriate action.
Building a safety culture for a practice will need clinical and managerial leadership. This is further discussed in Step 2.
| Box 4. Definitions of safety culture Health and Safety Commission—The safety culture of an organization is the product of individual and group values, attitudes, competencies and patterns of behaviour that the commitment to, and the style and proficiency of, an organization's health and safety programmes. Organizations with a positive safety culture are characterized by communications founded on mutual trust, by shared perceptions of the importance of safety, and by confidence in the efficacy of preventive measures. NPSA—A safety culture is where organizations, practices, teams and individuals have a constant and active awareness of the potential for things to go wrong. Both the individuals and the organization are able to acknowledge mistakes, learn from them and take action to put things right.
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Step 2: lead and support your staff |
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GPs have a special role in leadership within practices. Often, they are independent contractors and employ other staff. Whatever the employment model, they are senior professionals in primary care and always have a central role in delivery of care. So, if GPs care about patient safety, and demonstrate that safety is always a prime consideration for them, they will effectively be taking a leadership role in patient safety for their practice or health community. Above all, GPs need to demonstrate their understanding of safety principles and lead by example. In other safety critical industries, the safety culture is generally set by the senior people in the organization. This has to be much more than just rhetoric—’patient safety is important to us’. If leaders say one thing and do another (such as talk about patient safety, but always put financial considerations first), then this inconsistency is obvious to staff and they will not believe their organization truly values safety.
Leadership for safety in general practice means taking a systemic approach and ensuring that all practice activities are regularly ‘safety checked’ to minimize the opportunities for things to go wrong. Patient safety tools and techniques, such as structured risk assessment and significant event audit (SEA)—see Step 6—should be explicitly introduced and patient safety should be part of formal induction for every new member of staff. Above all, staff need to be valued by the GPs for speaking up for safety and for taking seriously their own role in building a safe practice.
Practices and other organizations should consider whether they might have a ‘patient safety champion’, in the same way that they have clinical governance leads or information guardians. Champions might have extended skills and knowledge that they share with their colleagues and could also act as the organization's ‘conscience’ for safety. They might also be part of a local or regional network for safety, to maximize the opportunities for learning from others. The patient safety champion could be a GP, or another member of staff, but support in this role from the GPs will be critical to success.
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Step 3: integrate your risk management activity |
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Risk management can be defined as the process of identifying, quantifying and managing risk. There are a great variety of tools and techniques that can be applied and are used extensively in safety critical industries. Medicine, and general practice, can also use these techniques with benefit. However, at the most basic level, risk management falls into the following categories:
- What can go wrong?
- How often can it go wrong?
- How bad can it be?
- What are we going to do about it?
Organizations known to be operating within a culture of safety are sometimes termed ‘highly resilient organizations’—they have systems in place such that safety is embedded and not dependent on an individual or a specific initiative. Within practices, it should be possible to take a systemic approach to risk. Information from areas of activity such as incident reporting, complaints and SEAs should be fed into ongoing reviews of practice business. Practices have systems for all sorts of things—such as appointments, repeat prescribing, referrals, results management, etc. It should be possible for practice teams to meet and formally consider what systems they have, whether their systems could be safer and whether there is any safety information that needs to be fed into the review. Ideally, reviews should be conducted on a regular basis, with the opportunity for more frequent review, if there are indications from any of the above areas that a particular system needs to be strengthened from a safety perspective.
By taking an integrated risk management approach, practices should not only be able to assure themselves that they are as safe as they can reasonably be, but will also be likely to benefit from more efficient, patient-centred and cost-effective systems for patient care. Ultimately, this approach could see the development of the ‘highly resilient practice’.
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Step 4: promote reporting |
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A safety principle that is generally applied in safety critical industries is that of ‘incident reporting’. If we are to be able to learn from when things go wrong, we need to be able to look at an incident or a number of incidents; identify that there is a problem; seek the underlying cause, or causes, of the problem and design solutions to address those. Industries such as aviation, shipping, rail and nuclear power all have well-established (usually confidential) reporting systems and these are generally considered to have driven safety improvements in those industries.
The NHS in England and Wales has its own reporting system, the NRLS which has been designed to accept incident reports from every NHS sector. Implemented in 2004, there are now in excess of two million incident reports, making the NRLS the largest repository of patient safety incidents in the world. This is an anonymous reporting system and any identifiable information regarding patients, staff, locations or reporters is removed.
However, only a tiny proportion of these reports originate from general practice. There are a number of reasons why this is the case. General practice, indeed primary care, has not really had a culture of incident reporting, whereas this has been a normal procedure in the acute sector for many years. Additionally, incidents are generally reported into the relevant PCO (information from the Trust's systems is automatically sent to the NRLS) but practices often have fairly arm-length relations with their PCO and may be reluctant to report incidents to them. This state of affairs does mean that it is much more difficult to obtain a true picture of the number and nature of patient safety incidents arising within general practice. GPs and practices who take safety seriously should be looking at their own culture of reporting and whether this might be improved. It is also possible to report incidents directly to NRLS, using a web-based portal and that might be a more appropriate way for some doctors and practices to report incident from general practice.
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Step 5: involve and communicate with patients and the public |
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Those with the most to gain from a safety culture and safer care are, of course, our patients. Increasingly, greater emphasis is being placed on supporting patients to help keep themselves safe. Including patients in discussions relating to investigations, diagnosis and management plans can act as a powerful safeguard in that patients then know what they should expect to happen and may be able to question or to act if things do not appear to be progressing as planned or expected. Many practices have patient partnership groups and could consider involving these groups in some of their safety activities. For instance, if practices have structured safety reviews, as outlined in Step 3, it could be very valuable to have patients’ input to those reviews.
The NPSA suggests using the ‘speak up’ framework to help engage patients in protecting their safety. This is shown in Box 5.
Box 5. Speak up
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Source: National Patient Safety Agency
However, there is still the potential for things to go wrong even to the best doctors and even in the best practices. In those circumstances, it is important to be open and truthful with patients or their families and to give them all the information they need to understand what has gone wrong and why. Often, it is an overriding concern for people that the same thing should not happen again to someone else and a ‘Being open policy’ can help to demonstrate that the doctor, or the practice, is doing everything they can to address the situation and to minimize the chances of it happening again. In an attempt to support local Being Open policies, NPSA has developed a package of tools and resources including training material and an e-toolkit. Further information is available at www.npsa.nhs.uk.
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Step 6: learn and share safety lessons |
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When things go wrong with our care in general practice, what can we do to prevent the same thing from happening again? Probably, the most effective tool we have for learning from error and failure in general practice is SEA.
It appears to be part of received wisdom that patient safety developments have taken place largely in the acute sector and that some of these have filtered ‘down’ to primary care. However, the technique of SEA was developed by the RCGP in the mid-90s, preceding the publication of ‘To err is human’ and ‘Organisation with a memory’, so, this is one patient safety innovation that should rightly be claimed for general practice!
SEA is a technique that allows structured discussion of an incident by the clinical team (the primary care team in this context) in a non-judgemental, and hopefully non-threatening, manner. The details of the incident are presented and discussed by the team, focusing on what went well and what could have been better. Recommended actions, such as review and redesign of a practice system or initiation of conventional audit, are noted and a date for formal follow-up is agreed. The strengths of SEA are that it is
- Team based
- Practice based
- Structured
- Minuted
- A regular scheduled activity
- Possible to agree decisions and enact these
The biggest drawback of SEA is that although there may be very effective learning within the particular practice, generally there is no mechanism to share that learning more widely. One way to address this criticism is to explicitly link SEA to incident reporting, as above. Additionally, some practices regularly come together, often under the aegis of the PCO, to share the learning from SEA.
Root cause analysis (RCA) is another tool for retrospective review that is widely accepted and practised. In general, this is a more intense technique than SEA and normally occurs at Trust or PCO level. Given the greater time and resource required to properly run RCA, these are normally undertaken where there has been a very serious incident such as a death or an incident affecting large numbers of people. Practices may be invited to contribute to RCAs and practices could also formally consider whether any of their SEAs could be referred to the PCO as being suitable for RCA.
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Step 7: implement solutions to prevent harm |
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Patient safety solutions are often thought of in terms of designing equipment, for example anaesthetic machines or large media campaigns, for example cleanyourhands. However, it is possible to introduce solutions by such means as redesigning practice systems or developing ways to communicate more effectively with patients. In implementing solutions to a patient safety problem, it is essential that care is taken not to introduce new threats to safety that may even be worse than the original problem. The NPSA has suggested a staged approach to the development of patient safety solutions and this is demonstrated in Box 6.
Box 6. Staged approach to solution development
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Conclusion |
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TOPAbstractThe GP curriculum and...Background to the patient...Patient safety in the...Evidence from general practiceThe systems approach to...The seven steps to...Step 1: build a...Step 2: lead and...Step 3: integrate your...Step 4: promote reportingStep 5: involve and...Step 6: learn and...Step 7: implement solutions...ConclusionReferences |
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The extension of the patient safety movement to British general practice, and to general practice/family medicine worldwide, is still at a very early stage. There is considerable scope for practices, or groups of practices, to grasp this agenda and take a much more structured approach to safety in general practice. Doctors now training for general practice will be the first generation to enter practice with a good grounding in safety principles, tools and techniques. There is every reason to believe that they will work with colleagues and patients to build safer general practice for the future.
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References |
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TOPAbstractThe GP curriculum and...Background to the patient...Patient safety in the...Evidence from general practiceThe systems approach to...The seven steps to...Step 1: build a...Step 2: lead and...Step 3: integrate your...Step 4: promote reportingStep 5: involve and...Step 6: learn and...Step 7: implement solutions...ConclusionReferences |
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