• Tá Tú Anseo:
• Baile /
• Óráidí

Óráidí

"Above All Do No Harm" (22.04.2004)

Address by Ms Emily O'Reilly (Ombudsman) at ISQSH/IAMRA International Conference, "Collaborating for Patient and Professional Safety"

Introduction

At the outset I would like to say how pleased I am to be speaking to you today. I applaud this joint initiative by the Irish Society for Quality and Safety in Healthcare and the Irish Medical Council, particularly the emphasis which has been placed on listening to, and learning, from patients and their families. I know that many of you have traveled great distances to be here and your very presence is indicative of your commitment to the concept of patient safety. Whilst my observations in this presentation are rooted in the Irish health system I know that they also have an international dimension with which you will be familiar and interested in. This conference comes at a very appropriate time in the history of the Irish health services. It is a time of great change, both structurally and in a qualitative sense. The public, generally, is becoming more demanding in all areas of the public health services. A focus on safety in the health services is beginning to develop. A momentum towards individual accountability is being fostered by Government and this is being driven by ever increasing media attention on the inter-action between the health services and individuals or classes of individuals. The national health strategy Quality and Fairness - A Health System For You has considerable implications for my Office. The strategy confirms the Government's belief that my Office is the appropriate mechanism for dealing with complaints relating to the public health system as a whole, and also confirms the Government's intention to extend my remit to the public voluntary hospitals and other voluntary agencies in the health area. The strategy also provides for the development of a statutory framework for complaints to achieve greater clarity and uniformity of approach in dealing with complaints, structured local resolution processes as well as an opportunity for independent review. The strategy has also identified, as meriting particular attention, the perceived inability to question the actions or decisions taken by individual practitioners in regard to clinical matters, Whilst acknowledging the need for freedom in exercising clinical judgement, the Government has equally accepted the need for a stronger framework for questioning and investigating clinical decisions in particular circumstances. The strategy envisages, for example, that proposed legislation on the statutory registration of health professionals will contain adequate machinery for the investigation of complaints against individual professionals.

Above All Do No Harm

You might find it somewhat pretentious for a nonmedical person to quote the Oath of Hippocrates " Above All Do No Harm " to you. However, I have come to my role as Ombudsman with views derived from my previous work and personal experiences, as to what the Irish people want from their health services. I believe that they want a service which is accessible, and in which they have confidence, because they know that, by and large, it is responsive to them and inclusive of them. Above all, however, they expect it to be safe, and that no harm will come to them when they are a patient within the system. Despite the ongoing commitment to improve the level of positive outcomes for patients in the Irish health system, there is a developing awareness that patients can incur injuries and adverse outcomes as a consequence of medical and clinical management. Recent developments in Galway and Drogheda, which resulted in the closure of hospice services and the treatment of women after giving birth, are examples of this growing awareness.

The occurrence of adverse events in health care, and the need to develop strategies to improve safety, has been identified for some time now. Two landmark studies in recent years have highlighted, in a dramatic fashion, the critical need to establish a culture of patient safety within health care organisations. In 1999, the Institute of Medicine in the United States published "To Err is Human: Building a Safer Health System" which outlined the dramatic human cost of medical errors. It was estimated that 4% of hospital patients had complications resulting from their hospital stay, of which two thirds were due to errors in care, and that some 44,000 patients died in a year, at least partly as a result of that care. This is a figure in excess of the number of traffic fatalities in the same period. In 2000, the Department of Health in the United Kingdom published "An Organisation with a Memory", which examined the key factors at work in organisational failure and learning, in relation to reporting and analysing adverse health care events. This report revealed that adverse events in which harm is caused to patients occur in around 10% of admissions, costing the service an estimated ?2 billion a year in additional hospital stays alone, without taking account of human or wider economic costs. Within this overall figure; some 400 people die or are seriously injured each year arising from adverse events involving medical devices, some 10,000 people are reported to have had serious adverse reaction to drugs, with 28,000 written complaints made about aspects of clinical treatment in hospitals.

At that time the NHS paid out around ?400 Million a year in settlement of clinical negligence claims, and had a potential liability of around ?2.4 Billion for existing and expected claims. Hospital acquired infections, around 15% of which may be avoidable, are estimated to cost the NHS nearly ?1billion In addition the report indicated that there is evidence that specific types of very serious adverse events happen time and time again, suggesting that the system as a whole is not good at learning from experience.

We do not have any comparable statistics for Ireland but is there any reason to think that we are any better or worse than either the US or the UK? Is it likely, therefore, that there may well be a serious problem in the Irish healthcare system which is not directly evident? In a paper presented in 2002 by Hilary Coates, Department of Health Science Management in the Royal College of Surgeons, at the IHCA Conference, she extrapolated the American experience into the Irish acute hospital setting. Her extrapolation indicated that some 937 deaths could occur annually as a result of preventable clinical error, and that death due to preventable clinical errors could exceed the number attributable to breast cancer then the sixth leading cause of death in Ireland at that time. This implied that, in 2002, more people would die as a result of preventable clinical error (937) than from Breast Cancer (602). If this extrapolation was proven then this is a truly an appalling vista.

You might well respond by asserting that such extrapolation is unfair, and presented by a non clinician who does not fully understand the practice of medicine. Could I refer you, therefore, to the observations of one of your colleagues, Atul Gawande, a surgeon in the United States. The thrust of his writing is that it is the individual decisions which are really critical in healthcare, and they are inherently imperfect because both doctor and patient are fallible, because there are still mysteries in medicine, things we do not understand, and because there is always going to be uncertainty. He believes that medicine is predicated on physical action, which implies risk, confusion, complexity and sometime mistakes. In relation to the issue of patient safety, it is refreshing to find a practitioner so forthcoming about his day to day experience of medical practice, affording credence to the conclusion that most of the real disasters in medicines are the result of a single human mistake, compounded by series of other mishaps, an evolving process rather than a single adverse event, the misfiring of systems allied to a breakdown of fail-safe mechanisms. Gawande is no innocent abroad. He was fearful in his writing that the response from his colleagues could be very negative. Surprisingly, he found the opposite. The struggles about uncertainty, the ways mistakes occur and the methods of trying to avoid them are the daily struggle of every physician. He considers that no matter what measures are taken, doctors will sometime falter and it isn't reasonable to ask that you achieve perfection, what is reasonable is to ask that you never cease to aim for it. Without setting out to, I found his writing, " Complications: A Surgeons Notes on an Imperfect Science " to be a superb introduction to the concepts underpinning patient safety in a personalised context, and should be compulsory reading for every medical student.

When Things Go Wrong

Things can and do go wrong in every organisation. There is nobody at this conference, including myself, who can say that nothing ever went wrong in their, office, surgery, clinic, ward or operating theatre. We all make mistakes. The critical question is how do we react when we make such mistakes and things go wrong. In my opinion the crucial element in this equation is culture. I would like to explore this element further within my own sphere of influence in the health system, that point where patients complaints and issues of patient safety meet.

Culture

Culture manifests what is important, valued and accepted in an organisation. It is not easily changed when it is deeply held, and not susceptible to change by a pronouncement, command or an emotionally laden description of a new vision. Most of us instinctively regard complaints as unpleasant and not something to be welcomed, because they are a very personal comment on performance. In the hospital context once the word complaint is used there is always the danger of a personal and usually negative reaction. In a study of consultants' responses to complaints in the UK, they talked about their sense of fear and hurt, concern about their reputation, distress at the lack of understanding of their action and motives, and their vulnerability. Worry, surprise, annoyance, anger, disappointment, anxiety and distress were amongst the most common reactions cited. Clearly, there may be a fear that complaints will have a significant and lasting impact on those to whom blame is attributed. The challenge to the practitioner's expertise is likely to be construed as greater than the content of the particular complaint, resulting in an almost symbolic resistance to such challenge. Responses can, and do, exacerbate a complainant's sense of grievance by appearing defensive, using technical language, commenting on the failure of complainants' attempts to manage illness, casting doubt on the complainants' account by labeling them a 'bad patient' and arguing that dissatisfaction is a symptom of the illness being treated. We do not have the benefit so far as I am aware of similar studies in this administration but my experience would not tend to indicate that things would be very different. Complaint handling is very much dependent on the goodwill and co-operation of medical staff in the heath sector. With certain exceptions I have rarely found that health professionals, particularly doctors and consultants, engage wholeheartedly with patients' complaints. In some cases complaints are seen as a consequence of irresponsible dissemination of information by the media. This, when allied to a reluctance by patients to complain, usually because they are very dependent on the system, makes for a very unsatisfactory situation. Complaint handling is invariably seen by medical staff as very much a matter for the administrators, even though the kernel of the complaint might well involve particular doctors or consultants. In addition, in the absence of the proposed statutory complaints framework, there are no procedures which oblige them to engage fully in the process. The other end of the cultural spectrum is one where the satisfactory resolution of complaints is seen as a very important objective and information generated by the complete process is valued. In this culture staff are adequately trained, and supported, with complaints investigated promptly and with authority.

The culture of healthcare organisations is set by the chief executive together with senior clinical and professional staff. It is essential that they view the handling of complaints and patient safety as an integral part of clinical governance and risk management. My understanding of clinical governance, and I am, of course, a layperson in this context, is that it is about using information so as to manage processes in a way which will ensure the effectiveness and safety of clinical outcomes. Information may come from clinical audit, untoward incident reporting, risk management and complaints procedures. This can lead to the systemic identification, treatment and evaluation of risks, incidents and near misses with consequent learning from the lessons observed.

The culture must reflect the fact that they are accountable for their performance and that their management processes are increasingly open to scrutiny by the Government, the general public and, indeed, the media. This accountability and openness extends to how it handles complaints, and this, in turn, requires that staff are adequately trained to deal with complaints and supported in the event of a complaint being made against them. Ideally training in handling complaints should be a compulsory part of induction and continuing education. The acceptance of regular reporting on the complaint handling process would also feature prominently in this culture, not merely as a record of the number of complaints received without any adequate analysis or comment, but rather with a view to monitoring arrangements for complaint handling, considering trends in complaints and lessons which can be learned particularly for safety improvement.

Complaints and Safety

A good internal complaints system provides essential feedback from the public on the services provided by indicating where problems may exist in the provision and safety of services. It can also act as a means through which the public can tell the health service provider how well it is, or is not, succeeding in its efforts to provide a safe service. Satisfaction with grievance procedures is closely related to the quality of apologies, levels of defensiveness and the perceived accuracy of explanations given. There is also a strong positive correlation between satisfaction and the complainants' belief that providers intend to improve things for the future. You often only get one chance to satisfy complainants. Dissatisfied patients who do not perceive that improvements will be implemented tend to suffer a loss of confidence in the system's ability to deal safely with them. Patients and their carers experience a number of difficulties in complaining. I think that it is commonly accepted that the majority of grievances about medical services go unvoiced. Service users may prefer to put negative experiences behind them or avoid confrontation, but for others it is structural inequalities in the user-provider relationship which discourages them from pursuing a grievance. Patients tend not to make formal complaints, particularly when they have a long-term relationship with a service provider. Reluctance to complain may be seen as a good thing to providers but problems may remain concealed and overall dissatisfaction with service may intensify as a result.

It has been my experience that complainants have a variety of expectations in making their grievances known. It is rare for a complainant to be motivated by prejudice or malice. Some complainants may be very difficult, sometimes because their complaints are made out of feelings of grief or guilt. This does not mean that their complaints are not justified, but it can mean that it may be very difficult to satisfy their expectations. However, they all want to be taken seriously, to have their views - and the fact that they had reason to complain - to be acknowledged and they want remedial action. A major component of such action is the prevention of similar harm to other patients. It has been my experience that complainants rarely seek financial compensation in the first instance, nor do they seek disciplinary action against staff. In their calls for redress they place emphasis on 'soft' remedies such as apologies and explanations rather than 'hard' remedies like compensation, I have never had a complaint presented to me which escalated into a legal claim or a request for disciplinary action. I understand that it is the experience of the Medical Council confirm that the majority of their complainants also place great emphasis, without malice, on explanations, prevention, learning lessons and apologies.

Communications and Safety

It is very important for you to remember that patients, in general, are vulnerable while in hospital. They may be disoriented, they may be frightened, they may be dependent on others to assist with basic functions for the first time in their adult lives. In other words they have had to surrender control to the medical system whose language they may not understand and that makes them impatient and perhaps a little less receptive than normal. Their relatives will also be on edge and will be resisting their loss of control over the welfare of their loved one. At the same time I fully appreciate that health professionals are working with many constraints on their priorities and energy; they are also operating in an environment which is familiar to them in terms of its procedures and language. Medical and nursing staff may have their sensibilities blunted to some extent by having to deal with thousands of patients. However, what is humdrum and shorthand to them is unique to the patient.

In such conditions it is very important for all health professionals to appreciate the patient's perspective, to make all exchanges as sensitive, meaningful and humane as possible and to understand that effective communication means more than simply saying something to somebody. Failure or inability to communicate (and allowance must be made for the capacity of the patient to hear) or the method by which something is communicated ( and there are non-verbal dimensions) can lead to upset, misunderstanding, medical error and can often be the reason why a complaint is made. It can also be some time before the consequences of some action or inaction in this delicate area become apparent. If you listen to patients and their cares, communicate closely with them and with each other, noting what has been said, then the scope for later misunderstanding and dispute would be greatly reduced.

Freedom of Information

I would now like to turn briefly to the matter of access to information concerning issues of patient safety. You may be aware that I hold the office of Information Commissioner in addition to my office as Ombudsman. In my opinion there are several barriers to effective participation in the management of risks and patient safety. One key barrier, found in most industries, is fear. Such fear can result in an environment which is characterised by, blame, guilt and a lack of trust in colleagues regarding clinical errors, allied with a misguided loyalty because of the fear of colleague alienation. There may well also be a reluctance to report incidents because it is feared that the completion of an incident form will be construed as an admission of negligence that could give exposure to legal liability. It is well acknowledged that such fear creates a disincentive to medical participation in patient safety initiatives I am told that freedom of information legislation compounds this fear. In Ireland the Freedom of Information Act permits access by the public to information about the functions of publicly funded hospitals. I am further given to understand that many doctors are worried that information supplied in incident forms, that is audited and converted to data, may be accessible under the Act. The argument is made that release of audited incident or quality data could be inappropriately utilised and act as a barrier to learning from the data. Comparable FOI legislation in Australia contains a specific exemption for risk and quality audit data. This was introduced to facilitate frank and open discussion by healthcare providers about clinical errors. In the United States all incident reports are privileged and not available to the public. You might well ask why such records are not, as a class, exempt under the Irish FOI Act. Perhaps I should explain that an FOI request for such data would not automatically succeed in this administration; rather it would be considered, on its merits, by reference to the existing exemptions in the Act e.g. functions of public bodies, information given in confidence etc. There is sometimes a common misunderstanding in relation to how some of the exemptions in the FOI Act - particularly the exemption in respect of information given in confidence - should be interpreted. Information, which by any reasonable measure, could not be considered confidential is sometimes refused because the public body or a third party which supplied the information fears that any disclosure will set a precedent which will apply in the future regardless of the nature of the information. In fact, this is not true because the exemptions in the Act must be applied on a case by case basis. Once such fears are allayed, it may become possible to obtain agreement to the release of such information. As the exemptions must be applied on a case by case basis it not possible to say in advance whether access to records would be granted in any particular case. In this context you will be interested in an observation by the Australian Council for Safety and Quality in Health Care, in an issues paper published in 2001, that FOI exemptions have been effective, in certain circumstances, in preventing the release of information on the basis that such disclosure would impede the future flow of information and, therefore, would be against the public interest.

By way of example, in a recent case before me on health and safety issues, I accepted that information was given and received in confidence and that its release would involve a breach of confidence. More significantly however, I accepted that its release could reasonably be expected to prejudice the effectiveness of the public body's investigations and I therefore decided that it should be withheld. Having satisfied myself on that aspect of the case, I was then obliged to consider whether the public interest would, on balance, be better served by granting than by refusing the particular request. There were a number of public interest factors in favour of release of the records. These included the public interest in requesters exercising their rights of access under the FOI Act and the public interest in public bodies being open and transparent in matters related to regulation and as to how they carry out their statutory functions. I was also conscious that the circumstances pertaining to that investigation meant that particular attention had to be paid to the understandable desire of the requester to have access to all records. However, against these arguments there was a strong, indeed an overriding public interest in ensuring that public bodies, that are charged, in that case, with enforcing standards of public safety and investigating breaches of those standards, are able to carry out effective investigations. In the case of the public body in question, the subject of its investigations could be of an extremely serious and tragic nature. Therefore, I was satisfied that the public interest in granting access to the records did not outweigh the public interest in ensuring that such investigations are not prejudiced and I upheld the decision of the body to withhold the information.

On the other hand there is the inevitable tension created between the public interest in access to information about the safety of the health care system. Patients are becoming equally filled with increasing scepticism and mistrust about error and perceived lack of accountability. The recent series of high profile reports have shaken the public faith in the system and raised questions about the safety of care. Patients are now demanding safeguards to protect them and ensure that they receive appropriate care. The culture of safety which I outlined earlier must reflect the fact that medical errors can, and must be prevented, and must be disclosed. One of the reasons that the public feels powerless to do any thing about these issues is the wall of silence that surrounds them. When mistakes come out from behind these walls there is a greater likelihood that public support for you in dealing with these issues will emerge. There are examples to support this contention , not least of them being the issues of breast cancer and AIDS. These are issues which are now being addressed openly and with considerable effect in western societies. However, where walls of silence still exist e.g. for breast cancer in eastern Europe and AIDS in Africa, the inaction is striking and the death toll is stunning. Rosemary Gibson, a leading writer in this area, has posited a new social norm " to err is human , to forgive is divine, but forgiveness isn't so divine if the same mistakes are made over and over again " Remember the issue of smoking in airplanes, cinemas, and indeed our recent experience of smoking in the workplace. Societal norms in relation into smoking have changed beyond recognition due to the availability of relevant information and rigorous public debate, and so they will in relation to medical error. I think that it is incumbent on you to realise that understanding for you in this area can only be improved when the public shares the knowledge of medical infallibility.

Conclusion

I hope to bring to my position as Ombudsman - and particularly in the area of healthcare - not just my own professional experience of reporting the social, cultural and political life of this country for almost twenty years, but also my own life experience as a woman, as a mother of five young children, as the daughter of two now elderly parents and therefore as someone with regular, personal contact with the health services right though from maternity provision, paediatric care, the dental services, cancer care, the care of the elderly and also, on rare occasions thankfully, acute emergency care. As such, I am acutely aware of the importance of involving patients and their families is all aspects of patient care and safety. I acknowledge that there are various ways in which such involvement can impact on the service providers, not all of them positive. One of my investigators recently had reason to query the abbreviation "B O M" in the medical records of a complainant. The young doctor, after some hesitation, advised that it meant "Beware of Mother". Whilst I appreciate the irony of such an abbreviation, the perspective of the patient and their family is important and cannot be ignored. Not only are they capable of participation in their own care, such participation is also a critical factor in helping to develop informed, empowered, working partnerships between patients and doctors. One way to achieve this is by educating the public on how to participate in, and safeguard, their own care. In this context I am particularly supportive of the initiative currently underway within the Irish Society for Quality and Safety in Heathcare, under the concept of Community of Practice, to develop such education. However, healthcare professionals and leaders must also be educated about the importance of such partnerships and the patient/family perspective, with safety and medical error prevention also built into healthcare professional education curricula.

Finally, could I put before you the Statement of Principle adopted by the National Patient Safety Foundation, a foundation established by doctors themselves via the American Medical Association.

" When a health care injury occurs, the patient and the family or representative are entitled to a prompt explanation of how the injury occurred and its short- and long- term effects. When an error contributed to the injury, the patient and the family or representative should receive a truthful and compassionate explanation about the error and the remedies available to the patient. They should be informed that the factors involved in the injury will be investigated so that steps can be taken to reduce the likelihood of similar injury to other patients. Healthcare professionals and institutions that accept this responsibility are acknowledging their ethical obligation to be forthcoming about health care injuries and errors "

I think that patients in the Irish Health system deserve no less.

Thank you very much for your attention

Back to contents