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"When Things Go Wrong" (28 August 2002) (28.08.2002)

Address by Michael Brophy (Senior Investigator) at 10th European Conference on Health Records

Introduction

This conference comes at a very appropriate time in the history of the involvement of the Ombudsman in the health services in this administration. It is a time of great change. The focus on quality in the health services is increasing and the public, generally, is becoming more demanding in all areas of the health services. A new level of awareness has developed among the users of health services e.g. in 2001 complaints to the Ombudsman in relation to the health services were almost double those of the previous year. A momentum towards clarity of objectives, effective communications and 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. In addition the demographics of this country mean that a large chunk of the population is moving into middle and later life stages normally associated with hospitals/ nursing homes etc.

The new national health strategy Quality and Fairness - A Health System For You has considerable implications for the Ombudsman. The strategy confirms the Government's belief that his Office is the appropriate mechanism for dealing with complaints relating to the health system as a whole. 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 of 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.

Kevin Murphy holds the Office of Ombudsman in Ireland. In 1999 he was also appointed to the Office of Information Commissioner and, in that capacity, he examines appeals by requesters who have been refused access to information under the Freedom of Information Act, 1997. He is, ex officio, a member of the Referendum Commission which in the past has had responsibility for public information campaigns in relation to constitutional referendums. Finally, he is a member of the Standards in Public Offices Commission, which aims to ensure integrity in public life by requiring greater transparency in the area of interests, gifts and donations and, among other things, the relationship between Government and business. The common thread running through all of these functions are the concepts of openness, transparency and accountability.

May I explain the choice of title "When Things Go Wrong" for a paper relating to the management of health information. I have spent many years dealing with complaints and complainants. One strong element which appears in the majority of complaints made against health service providers is the question of information, the absence of, the lack of, inadequate, incomprehensible etc. I think it is true to say that most people instinctively regard complaints as unpleasant and not something to be welcomed because they are a very personal comment on performance. When the word complaint is used in a healthcare context there is always the danger of a personal, and usually negative, reaction. However, things can and do go wrong in every organisation. There is nobody at this conference (including myself) who can put their hand on their heart and say that nothing ever went wrong in their office, clinic, surgery or operating theatre in the management of information. The crucial question is how we react when we make such mistakes and things go wrong.

In this paper I would like to present some thoughts to you on this aspect of the management of health information. I will do this by way of setting out some relevant background to the concept of the Office of the Ombudsman in this area, and then some contrasting examples of issues relating to health information which demonstrate the impact of both the Ombudsman and Information Commissioner when things go wrong. It is at this stage that I very much hope to engage in a two way process with you to learn and benefit from your own experience in this area.

Ombudsman

Underlying all societies, even primitive ones or autocratic ones, is the concept of equity of fairness and the necessity for some mechanism to allow citizens to petition for redress of grievances arising from the abuse of power. We are all aware of the problems created for any society or democracy if any significant section of the population feels it is being treated unjustly or unfairly.

Up to the 1960's, citizens seeking redress generally went to their public representatives, or to the Courts. The complexities of the modern State, the domination of Parliament by Government, the delays and expense involved in going to Court and the growing alienation of citizens from all these institutions, led to the emergence in the 1960's and 1970's of the latter day Ombudsman, a variation on an office which had existed for many years previously in Sweden and Finland. Denmark was first, followed by New Zealand and Britain and Northern Ireland. The Irish model as set out in the Ombudsman Act, 1980 was greatly influenced by these countries.

It is interesting that the model which emerged in the 1960's and 1970's has continued to develop. In the newer democracies and particularly in Africa, Latin America and Eastern and Central Europe, the Office of Public Protector or Defensor del Pueblo has emerged with a remit which often extends to public corruption and infringements of fundamental human rights. Growing concern at the rift between citizens of the European Union and Union's institutions had also led to the setting up of a European Ombudsman.

There are a number of essential elements which must exist before the title Ombudsman can be legitimately used;

The first of these is complete independence, which requires in turn; statutory underpinning, security against arbitrary removal, the power to issue and publish reports with the protection of legal privilege and, of course, adequate resources. In this context a recent Review Group on the Irish Constitution recommended that the statutory independence of the Ombudsman should be further copper-fastened by its becoming a constitutional office.

The second essential is that the Office must be accessible to citizens in the sense that they can come direct with their complaints in the knowledge that there are no costs involved for them.

The third essential is that powers of investigation must be adequate. Access to information is central to an Ombudsman's capacity to investigate. The Ombudsman Act, 1980, for example, provides the Office with unrestricted access to information. We may require any person who has relevant information, records or documents to furnish that information or those records and documents to the Ombudsman or to attend before him. The only exception is documents relating to decisions and proceedings of the Government or of any committee of the Government. Furthermore, a person may not obstruct or hinder the Ombudsman in the performance of his functions and such obstruction is punishable by law. Without access to files, records and documents an Ombudsman's effectiveness would be severely limited. Access places us on equal terms with the decision makers; allow us to question, and requires them to justify, each stage in the decision making process.

The fourth essential is that the Ombudsman should have power to propose adequate remedies and to secure compliance with his findings. The Ombudsman Act 1980 permits us, inter alia, to recommend "that measures or specified measures be taken to remedy, mitigate or alter the adverse effect of the action". There are, therefore, no financial or other limits on what the Ombudsman may recommend and no restriction on our dealing with complaints which could involve large sums of damages. It is sometimes argued that, because he only has the power to make recommendations rather than binding decisions, his power to secure compliance is weak. This apparent weakness is, in fact, a great strength. It allows the Ombudsman to operate pragmatically and flexibly avoiding the legalistic and adversarial approach of the courts and of many administrative tribunals. He is able to recommend remedies which, in some cases, would not have been given by a court and to hold bodies administratively liable even where there is no legal duty of care or statutory liability. The provision for special reports to the Oireachtas in cases where recommendations are rejected has proved to be a very effective sanction and no recommendation has ever been rejected.

Let me turn now to some practical examples of the involvement of the Ombudsman and Information Commissioner in issues relating to the management of information in the health services.

Patients Charts/Records

A person's medical records are amongst the most sensitive of personal records and great care should be taken to ensure the safe holding of such records. Apart from their sensitive nature, there is also the very practical consideration that they can be of considerable clinical value in relation to the ongoing care of a patient. In this respect the continuity of a patient's care may be adversely affected, through an increased risk of medication or other treatment being duplicated or omitted, the introduction into a patient's medical and nursing care programme of communication problems between staff, both nursing and medical, the failure to focus attention on early signs of deviation in a patient's condition and the failure to place on record significant observations and conclusions. They can also be of great importance in relation to any case of medical negligence, or other such litigation, and they may be of value to the family of a patient after he or she has died.

Our experience, however, is that when we have had occasion to examine patient files we have often found them to be unsatisfactory as a record of the various elements of a period of hospitalisation. Such records are immensely important working documents during a person's stay in hospital, and they are also vital in the event of any query or complaint subsequently, not least as a tangible basis for clarification for the person on duty at the material time. One purpose of records is to ensure that a patient's history can be accurately identified later on. The retention and efficient management of patient's records should be a key responsibility. In this context the Ombudsman would expect that such records would be legible, intelligible, complete, specific, contemporaneous and not filled in much later from memory, signed and dated. That makes life easier for all hospital personnel using the records, for the hospital administration in dealing with any complaint and, ultimately, for the Ombudsman if he has reason to include such records in the examination of a complaint.

In one particular case the Ombudsman had to take issue with a Health Board in relation to the maintenance of its record system. It was clear that the medical records in relation to the individual complainant could not be traced. Arising from an inspection of the relevant Medical Records Section it was evident that there was no central record of files which had been removed from the section, their present location or the amount of time they have been outstanding from the Section. In addition, there was no register of missing files maintained and, as a consequence, when a file which had been temporarily mislaid was returned, there was nothing to alert the seeker of that file to its return, nor was there scope for an audit of other sections of the Hospital for missing files. There was no written code of practice covering the health records function. I am very much in your hands in this regard but I would consider that any such code would include policies covering security, privacy and confidentiality of patient information (regardless of the medium on which it is stored), filing and retrieval of records, retention of records, principles of record organisation and management, patient access to records etc. In addition the indications were that the staff responsible for the health records system at the hospital did not receive any formal training in this capacity. There was no written job description for the function of the manager with professional responsibility for hospital records, or any co-ordination of the medical records service function between the Board's hospitals to exploit best practice.

Medical and Nursing Notes

The purpose of medical nursing records is; to provide accurate, current, comprehensive and concise information concerning the condition and care of a patient; to record associated observations by nursing and medical staff; to provide a record of any problems that may arise and take the appropriate action in response to them; to provide evidence of the medical and nursing care required including intervention by nursing or medical staff; to record the chronology of events and the reasons for decisions made; to support standard setting, quality assessment and audit trail of the care and treatment administered; and to provide a baseline record against which improvement or deterioration may be judged.

To fulfil these purposes, properly made and maintained records should; be made as soon as possible after the events to which they relate; identify factors which jeopardise standards or place the patient at risk; provide evidence of the need for further intervention by other specialist or more senior medical or nursing staff; and be written in terms which other nursing or medical personnel will clearly understand.

I understand that it is an accepted principle of good medical practice that entries should be made after every patient contact, with each entry clearly signed and timed by the examining doctor. The latest edition of the Medical Council's A Guide to Ethical Conduct and Behaviour, under the heading Medical Records in the section dealing with "Professional Responsibilities", states: "It is in the interest of both doctors and patients that accurate records are always kept."

Deficiencies in Medical Records

Deficiencies in the foregoing standards were given concrete reality in a particular case dealt with by the Ombudsman in the past year, in which the care and treatment afforded to a patient in the days prior to his unexpected death was under consideration. In that investigation the Ombudsman found; a paucity of records covering critical treatment junctures, a stark failure to meet the standards of medical record keeping expected of medical staff following their contact with patients and an absence of relevant entries on the nursing notes during a period of significant nursing intervention. The paucity of the records made it difficult to establish precisely what happened during the period in question. The absence of medical note entries following examinations raised the question of how any doctor, who was subsequently called to examine the patient, could quickly apprise himself or herself of the patients' condition, in particular where a previous, but unrecorded, medical examination was significant in terms of diagnosis or treatment. The Ombudsman recommended that the hospital review its procedures to ensure (i) that entries on the nursing records created by nursing staff accurately reflect the contacts made with medical staff for the purposes of patient review and the reason that the contact was made; (ii) that all significant observations on a patient's condition that are made to members of the medical team by the nursing staff are recorded on the nursing notes. Furthermore, he recommended that the responsible health board take action to ensure that all the hospitals under its control meet the standards outlined in the recommendation. The outcome of the response by the Board to these recommendations was:

1. The development of a programme of nurse education relating to best practice in the maintenance of nursing notes, followed by a chart review and audit of nursing documentation to determine the effect of the programme, and generally to monitor documentation.
2. The development of a new module in the induction programme for non consultant (Junior) doctors, concentrating on best practice for medical notes.

Mistakes with Hospital Records

Perhaps nowhere are mistakes in record management potentially more damaging that in the case of hospital patient charts. A particular example is outlined below.

A man complained that, on admission to a hospital, his late mother had been treated for a period of time on the basis of another patient's hospital records. As a result, and despite the fact that she was not a diabetic, he claimed that insulin and morphine had been administered to his mother. In support of his case, he claimed that his late mothers' temperature chart indicated that insulin and morphine had been administered, but, despite requests, the hospital had failed to provide him with a copy of that chart. He also claimed that medical staff only became aware of the mistake when he drew their attention to it.

The hospital accepted that an incorrect patient chart had been provided by the medical records staff. However, when the mistake was realised, it asserted that, the new records which had been applied to the incorrect chart were removed and transferred to the correct chart. Our enquiries did not support the assertion that insulin and morphine had been administered incorrectly as a result of the error. Given that the incorrect hospital record had been extracted, I had one of my staff visit the hospital to examine the record retrieval system in place at that time. It was apparent that the mistake arose as a result of a failure to have appropriate verifications carried out properly. The Board subsequently introduced a new computerised system part of which was designed to eliminate the possibility of similar errors occurring in the future.

Information Commissioner

In relation to medical records the Commissioner has quite often found that a request for records is refused because the records in question cannot be found. There also seems to be a particular problem in the case of medical records which go missing or get mislaid. Despite their undoubted importance, the Commissioner has found that the incidence of lost medical records seems to be greater than for other categories of records held by public bodies.

A number of review cases raised the issue of what happens to hospital records after the closure of a hospital. In one case the requester sought his hospital records for the period 1966 - 1983. The hospital was unable to deal with the request as the records had been micro-filmed and the relevant index to the micro-filmed records had either been destroyed or lost. Pending the re-construction of this index, the request could not be met. In relation to other requests the patient records had been placed in storage. However, the storage facility was burned down and roughly 150,000 patient charts were lost. Clearly, this highlighted the importance of storing such sensitive records in a secure location and in fire-proof conditions.

Problems arose also in relation to relatively recent hospital records. In one case records created in 1997/1998, in respect of a particular patient, could not be found. In another case records relating to a patient who died in 1994 could not be found. In another case records relating to a mother, and to the birth and early death of her infant in 1981, could not be found. While these latter records were more than twenty years old, given the sensitive nature one would expect them to be available. In another case sensitive medical records of a patient who was convicted before the Courts in 1985 , and whose medical records were taken to Court by a medical witness, cannot since be found.

In a number of other cases the issue concerned record retention by General Practitioners. For FOI purposes, GPs are covered only were they provide a service for health boards, under a contract for services, to medical card (GMS) patients. Given that health boards are responsible for meeting FOI requests for GP records in the case of GMS patients, it would seem very desirable that the health boards would agree standard record management and record retention practices with those doctors. Unfortunately, it appears neither the boards nor the Department of Health and Children have sought to establish any specific arrangements with the GPs in relation to record keeping. As a consequence, there appears to be no requirement regarding the nature of records to be maintained (other than that GPs keep "adequate clinical records"), no requirement as to the period for which records should be retained, and no requirement in relation to the records of deceased patients. Clearly, this is not satisfactory.

The Commissioner has highlighted the foregoing deficiencies in his most recent Annual Report. However, he has also acknowledged that several of the health boards are developing detailed record management guidelines in relation to hospital records and such guidelines will be of significant benefit for the future. He has suggested that a similar exercise might be undertaken in the health boards in relation to the records of GPs treating GMS patients. Finally, in the course of an investigation into the practices and procedures adopted by public bodies generally for the purpose of compliance with FOI the Commissioner recommended that each public body should;

• devise and publish a records management policy covering the creation maintenance and destruction of records
• devise detailed guidelines based on these policies and provide staff training in these guidelines
• re-evaluate their record management systems to ensure that they are adequate to meet their business needs, including the need to deal with requests under FOI
• allocate responsibility at senior management level for ensuring that development and improvement of records management is accorded the appropriate priority.

Conclusion

I think the foregoing examples give flesh to the concept that I outlined earlier that things will go wrong in every organisation. I hope that I have given you some flavour of the importance of the role of the Ombudsman and the Information Commissioner in the resolution of such difficulties. As I said earlier, the crucial element is how your react when things go wrong. In my experience that is a question of culture in any organisation and could well form the basis of a separate paper in its own right. In this context, I hope to use our exchanges as a two way process as I consider that I have a great deal to derive from this conference, particularly in the area of standards, guidelines and principles which can provide some direction to my work in this area. I look forward to discussing these issues further with you over the period of the Conference.

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