Select Committee on Health Minutes of Evidence



Memorandum by the Medical Defence Union


PROCEDURES RELATED TO ADVERSE CLINICAL INCIDENTS AND OUTCOMES IN MEDICAL CARE (ACI 94)

INDEX
INTRODUCTION
EXECUTIVE SUMMARY
    Conclusion
    The MDU's recommendations
I.  Adverse Clinical Incidents and Outcomes
    What is an adverse clinical incident?
    Adverse clinical outcomes
    Clinical audit
    Adverse clinical incident reporting systems
      Definitions
    Procedure after reporting
    Problems with adverse clinical incident reporting systems
    Risk management
    Patient information
      Conclusion
      Recommendations
II. Factors Leading to Adverse Clinical Incidents
III.  Availability and Accessibility of Information, Support and Advice to Patients, Relatives and Carers
  Doctors' ethical obligations
    Patients are entitled to expect confidentiality
    Explanation and apology
    Court of Appeal ruling
    MDU advises `Say sorry'
    Consent to disclose information
    Conclusion
    Recommendations
B.  Statutory provisions
1.  Access to Health Records Act 1990 and the Data Protection Act 1998
    Therapeutic privilege
    Records of deceased patients
2.  Access to Medical Reports Act 1988
3.  Common law right of access
      Conclusion
IV.  Procedures Undertaken Following Adverse Clinical Incidents and Outcomes in Medical Care
A.  Coroner's Inquest
B.  Complaints Procedure
    Local resolution
    Independent review
    The Ombudsman's inquiries
    Private sector
    Conclusions
    Recommendation
C.  The General Medical Council
    Conclusion
    Recommendation
D.  Disciplinary Procedures
    General practice
    Hospital practice
    Conclusions
    Recommendations
E.  Inquiries
    1.  Public inquiries
    2.  Private inquiries
    3.  Psychiatric inquiries
    Conclusions
    Recommendation
F.  Claims for Medical Negligence
    Civil claim
    Civil justice reforms
    Pre-action protocol
    Alternative dispute resolution
    Funding
    Community legal services fund
    Conclusions
    Recommendations
G.  Criminal Investigations
    Conclusion
H.  The Media
    Conclusions
V.  Summary
VI.  References

INTRODUCTION

  The Medical Defence Union (The MDU) is the UK's leading medical defence organisation. We were established in 1885 and are the oldest organisation of our kind in the UK. We provide indemnity and 24-hour advice and assistance with medico-legal and ethical problems to our members who include doctors, dentists and nurses. In the UK our members work in the NHS, community and private practice. They are held accountable for their conduct in a number of ways including: patients' complaints procedures, disciplinary proceedings by their employers and their registration body, and the courts.

  The following statistics should help the committee to form an idea of the scale of our involvement in assisting members of the medical profession. In 1997 we took over 22,000 calls on our 24-hour advice line and opened 14,000 new files assisting members with complaints and claims on behalf of patients. We also opened 224 files replying to members' enquiries about the General Medical Council.

  Our comments relate to our experience of assisting members with medico-legal problems in NHS and community, and private medical practice in the UK.

  Since 1990 The MDU has had extensive experience in advising trust hospitals on risk management issues including the introduction of adverse clinical incident reporting systems. We have undertaken risk assessments of high risk clinical areas such as obstetric and A&E departments, operating theatres and intensive care units in approximately 30 NHS trusts throughout England and Wales. We have a dedicated risk management department that carries out regular reviews of our database of complaints and claims against our GP and private practice members and we share this information with them in articles, booklets and risk assessment checklists, highlighting the areas of high risk. This information can be used to avoid similar incidents in their own practice in the interests of patient safety.

EXECUTIVE SUMMARY

  The document that follows is a lengthy one because if covers much of the work we do at The MDU in terms of assisting our UK doctor members with a wide variety of medico-legal problems. We have set out our conclusions and recommendations at the end of each section of the document, but it is important in this summary to highlight the key points.

Conclusions

  Some of the concerns which have given rise to this inquiry predate changes in professional accountability such as the GMC's advice on saying sorry and the introduction of clinical governance. These changes should help to address many of the problems being investigated by this inquiry. In our evidence we also refer to problems some of our members have experienced with the independent review stage of the NHS complaints procedure. We suggest that patients may have experienced similar problems and frustrations with the procedure and believe that these may be addressed by the NHS Executive's review of the complaints procedure which is currently under way.

  It is our general view that there are a number of ways in which patients can gain access to the information they need about their own treatment. There are procedures which offer remedies and explanations when something goes wrong and the needs of each individual patient will determine which procedure is appropriate for that patient. For our part, when something has gone wrong with a patient's treatment and we are assisting a member, we believe it is important to do all we can to ensure that any problems are solved as speedily and as satisfactorily as possible, in the interests of doctor and patient alike.

  However, we believe that it is even more important to help doctors to avoid such incidents in the first place. Pooling of adverse clinical incident data is essential so that clinicians can learn from past mistakes to improve their own practice and to safeguard their patients. (See sections on adverse clinical incident reporting and criminal investigations.)

The MDU's recommendations

    —  Patients who have any queries or concerns regarding their treatment should receive information and answers to their queries when these are made. Relatives' questions should be answered in the same way, if appropriate consent has been given.

    —  Patients who have suffered harm should be treated speedily, sympathetically, to their satisfaction and with an appropriate apology. The doctor should take steps to rectify the problem, if possible and provide an explanation. This should be widely publicised and understood, not just by doctors, but by those who represent patients.

    —  Risk prevention systems should be developed through appropriate adverse clinical incident reporting systems in NHS hospitals, general practice and private healthcare.

    —  We believe that a collaborative data pooling exercise is essential across the UK if the Department of Health wishes to identify and to reduce the potential for incidents which give rise to complaints and claims. We are happy to offer our anonymised data for analysis together with NHS data and for dissemination to clinicians and managers.

I.  ADVERSE CLINICAL INCIDENTS AND OUTCOMES IN MEDICAL CARE

What is an adverse clinical incident?

  These are also known as untoward incidents and were defined by the Health and Safety Executive in 1985 as an event which gives rise to, or has the potential to produce, unexpected or unwanted effects involving the safety of patients, users or other persons. The definition includes "near misses" which are of particular value in prevention.

  Our experience relates to assisting our medical members and for the purpose of this evidence we shall confine our comments to adverse clinical incidents, ie occurrences which affect patients while they are undergoing treatment or are in a healthcare setting which could have, or actually have caused harm and could lead to a complaint or claim. We leave it to other organisations to provide evidence relating to adverse incidents occurring to others, such as members of staff or visitors.

  Many healthcare facilities have adverse clinical incident reporting systems. There are also other systems where adverse clinical incidents/outcomes are reported, some of which have statutory force such as:

    —  Confidential inquiries, for example, into peri-operative deaths and maternal deaths;

    —  Yellow Card reporting scheme for adverse drug reactions reported to the Committee on Safety of Medicines;

    —  Medical Devices Agency—all adverse clinical incidents involving medical devices should be reported, varying from serious, ie death/injury to the less serious such as minor faults which may indicate inadequate quality assurance on the part of the manufacturer or supplier.

Adverse clinical outcomes

  An adverse clinical outcome may be a result of an adverse clinical incident. Alternatively, it may be a consequence of the disease process and/or treatment for the disease even when the treatment has been given in a manner consistent with the normal care of a patient and in accordance with the normal operation of protocols and systems. For example, an adverse outcome, such as impotence after prostatectomy, may be the result of treatment for a condition which carries a material and recognised risk and this risk will have been explained to the patient before the procedure began as part of the process of gaining consent. It should not be assumed, if an outcome is adverse, that something must have gone wrong.

Clinical audit

  Clinical audit is the process of monitoring outcomes in clinical practice. Clinical staff should be auditing their outcomes on a regular basis as part of a quality approach to practice. In addition, data gathered as a result of adverse incident reporting systems can be used to highlight areas of practice that may need clinical audit. A recent NHS Confederation study of clinical risk management in NHS trusts showed that a variety of incidents, including some of the following, led to clinical audit: medication errors in prescription or administration, availability and quality of clinical records, consent to procedures and wrong labelling of specimens.

  We would expect as a matter of routine that surgical outcomes, such as infection rates, and other complications, would be audited.

Adverse clinical incident reporting systems

  The purpose of such a system is to detect deficiences in practice so that standards may be improved. The aim is to record adverse clinical incidents affecting patients, staff or visitors, to analyse these events so as to introduce systems to prevent further incidents, and to minimise harm and improve the quality of healthcare.

  Some medical staff may be reluctant to be involved in adverse clinical incident reporting and be concerned that information collected could be used for disciplinary purposes. For an adverse clinical incident reporting scheme to be successful it requires:

    —  An open, honest and blame-free culture.

    —  Staff participation and training in identifying incidents which need reporting.

    —  Feedback of results to staff and managers.

    —  Reported incidents to be acted upon as soon as possible.

  Staff training is essential and it is important that the reporting system should be as simple as possible. It must be made clear that the clinical incident reporting system will not be used for disciplinary purposes, save when a malicious or reckless act is identifed. It is important to decide which issues are to be recorded, and it is often helpful that staff are involved in compiling the reporting criteria, eg:

    —An incorrectly completed consent form.

    —A fault detected in a piece of equipment.

  The incident report form should be concise and simple to complete. Any member of staff may record an adverse clinical incident. The facts should be stated in as much detail as necessary to give an objective, clear account of the events. The names of members of staff who were involved in the patient's care at the relevant time should be included. Adverse clinical incident reporting forms are disclosable in the event of litigation, and it is important that staff are trained not to provide value judgments or apportion blame. Completed forms should be assessed by the consultant in charge of the patient or by the head of department and immediate action taken if appropriate.

  It is common to classify adverse clinical incidents into:

  1.  Minor.

  2.  Medium.

  3.  Serious.

  4.  Dangerous.

Definitions

Dangerous

  Actual or potential permanent incapacity or death. Urgent action may be necessary to prevent recurrence. For example, cardiorespiratory arrest, major nerve lesion, amputation of a limb.

Serious

  Actual or potential severe harm causing or likely to cause disability or impairment of health. For example, fracture, pneumothorax, peripheral nerve lesion.

Medium

  Patient suffered inconvenience or minor harm requiring remedial action, but no permanent sequelae. For example, minor cut, soft tissue infection.

Minor

  Patient suffered no actual harm or potential for only slight discomfort or inquiry. For example, delayed appointment, bruise.

Procedure after reporting

  The effect of an adverse clinical incident, whether or not it results in a complaint or claim, can be devastating for both patient and doctor. The patient may find he not only suffers the damage resulting from the adverse clinical incident, but must also cope with feelings of anger, bewilderment, betrayal of trust and helplessness 2. The physician too, faced with adverse clinical incident despite his best efforts, may suffer the emotional impact of a complaint or claim, including loss of self confidence, remorse and anxiety 3.

  It is essential that adverse clinical incidents are investigated quickly and recorded in a database. Appropriate action must be taken to limit damage and prevent recurrence. This is achieved by reviewing practices and protocols, and providing feedback to staff.

  Analysis of an adverse clinical incident often reveals a series of errors combined with a set of unusual circumstances which together led to the adverse outcome. Analysis can reveal latent unsafe features within the structure and functioning of an organisation, eg, an incorrectly dispensed drug may be discovered before it is given to a patient, but the circumstances that led to the incorrect dispensing can still exist, with the inevitable risk that a patient may be harmed.

  Collection of adverse clinical incident data is useless unless it is properly analysed and used for positive benefit to the organisation and its patients. Reports are usually undertaken by the risk manager and fed back to the appropriate department through the relevant consultant. It is essential that the results of the analysis are disseminated to the appropriate groups of staff. The risk management recommendations that arise from this analysis should be used to change policies and procedures. The process must be continuous and become part of the organisation's approach to quality.

Problems with adverse clinical incident reporting systems

  1.  The "blame" culture. This is deeply rooted in the healthcare system and it is clear that staff are unlikely to report adverse clinical incidents or near misses if automatic disciplinary investigation follows. A very clear statement about the system and its purpose is needed at the outset.

  2.  Signing adverse clinical incident report forms. There is a natural reluctant—in some instances—to be identified as the member of staff reporting an incident. Some organisations allow anonymous reporting, and our anecdotal experience is that larger volumes of adverse clinical incidents are then reported.

  3.  Lack of ownership of the systems. It is often seen as an imposition by management, and failure to involve, in particular the clinicians, in the establishment of the system can impede its effectiveness.

  4.  Inadequate training of all staff.

  5.  Difficulties in deciding exactly what to report. Some staff, particularly doctors, see adverse clinical incidents merely as a complication of a disease process and not to be reported.

  6.  Initial enthusiasm which soon wanes. Anecdotally we know of large variations in the number of reports.

  7.  Lack of feedback. If staff fail to receive information about adverse clinical incident reports and the action taken as a result, there is a natural tendency to lack confidence in the system.

  Many NHS trusts now have a risk management department and employees are expected to notify it of incidents that might have or did cause harm to patients. However, we know of no arrangements for aggregating information collected by NHS trust risk management departments or for dissemination of this information. We know of no consistent arrangements across general practice or private healthcare.

Risk management

  The MDU believes that risk management techniques are a practical way of improving the quality of healthcare. Risk management is a systematic approach involving:

    —  Identification of risks.

    —  Analysis of of adverse clinical incidents, claims and complaints.

    —  Control of risk by use of systems and checking procedures.

    —  Reduction of risk of harm to patients and staff.

  The MDU has an extensive database of cases involving adverse clinical incidents, claims and complaints. This provides us with a broad view of the issues underlying adverse clinical incidents. Analyses of our database form the basis of our risk management advice to members in various clinical specialties. Data is aggregated and anonymised to protect patient and doctor confidentiality. Understanding common issues leading to adverse events, and introducing measures to prevent a recurrence is a positive contribution to patient safety. The MDU has developed risk management tools for our GP members to use to assess the clinical risks in their own practice. We encourage our members to inform patients that they have such a system in place, as it is a clear indication of their concern for the quality of health care they provide.

Patient information

  A successful adverse clinical incident reporting system can provide medical and nursing staff with accurate, factual information to discuss with patients and relatives when an adverse clinical incident has occurred. There is no reason why these reports could not form the basis of the explanation provided to patients about the incident and the measures being taken to prevent its recurrence.

  Although patients and their relatives want to feel they have unrestricted access to all information, they do not necessarily want all the information at any particular time, so the clinician will need to judge when and how to offer access to information 4. Adverse clinical incidents range from lethal to trivial and there is also the question of what information should be passed to a patient about an adverse clinical incident which does not result in harm 5.

  All questions by patients, and their relatives if the patient has given consent, should be answered honestly and openly. Where no harm has occurred, for example when a patient was nearly given an incorrect injection, it may not be in the patient's best interest to give this information as it may cause unnecessary anxiety. The correct procedure is to identify the factors that led to the "near miss", and put in place procedures to control the risk and prevent a similar occurrence.

Conclusion

  The introduction of clinical governance, covering a wide range of quality issues, makes it a requirement for clinicians to participate in activities such as audit, adverse clinical incident reporting, effective monitoring of clinical care and clinical risk assessment programmes. It is intended that information from these programmes will lead to identification and analysis of causative factors in adverse clinical incidents and outcomes. When this information is shared with clinicians and managers it should enable them to take preventative and remedial action to improve the quality of healthcare and ensure patient safety.

Recommendations

  Patients who have any queries or concerns regarding their treatment should receive information and answers to their queries when these are made. Relatives questions should be answered in the same way, if appropriate consent has been given.

  Risk prevention systems should be developed through appropriate adverse clinical incident reporting systems in NHS hospitals, general practice and private healthcare.

  Adverse clinical incidents and outcomes should be investigated through systematic audit and adverse clinical incident reporting systems, not dependent upon complaints or claims from patients and others.

  Quite clearly for these systems to work well, they need to be adequately resourced. If the support, in terms of funding, staffing and information technology is not adequate, the additional workload for our members and may well detract from their clinical work and have an impact on patient safety. We believe it is important that adequate funding and additional time is made available.

  Standardisation of audit and adverse incident reporting systems should allow comparisons to be made of their effectiveness on an NHS-wide basis. We recommend that clinical staff and managers regularly receive feedback of the effectiveness of such systems so that they can evaluate their own performance.

  In the MDU's experience many adverse clinical incidents arise because of systems and equipment failures which are not the responsibility of the individual member of the healthcare team, but rather the result of managerial decisions taken, sometimes years earlier. It is essential that senior managers, and not just those with clinical responsibilities, are fully involved in receiving and acting upon information received from audit and adverse clinical incident reports. The data should be used to identify high risk areas of practice and will help to avoid harm to patients, and to learn from errors so that avoidable mishaps can be avoided.

  In addition we believe that a collaborative data pooling exercise is essential across the UK if the Department of Health wishes to identify and to reduce the potential for incidents which give rise to complaints and claims. We are happy to offer our anonymised data for analysis together with NHS data and for dissemination to clinicians and managers.


 
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Prepared 29 July 1999