Select Committee on Health Minutes of Evidence



II.  FACTORS LEADING TO ADVERSE CLINICAL INCIDENTS

  The factors that can lead to adverse clinical incidents causing harm to patients include:

    —  Failures in the doctor's clinical judgement.

    —  Faulty technique/procedure.

    —  Communication failures.

    —  Inadequate medical records.

    —  Systems/administration/organisational failures.

    —  Lack of training.

    —  Others—including problems with staffing, continuity of care and equipment.

  An analysis of settled claims against UK GPs contained on The MDU's database fall into the following clinical categories 6:

    —  Medication errors—26 per cent.

    —  Failure to diagnose a surgical condition—21 per cent (eg appendicitis, testicular torsion, fracture).

    —  Failure to diagnose a medical condition—13 per cent (eg Meningitis, diabetes, pneumonia).

    —  Management of pregnancy and labour—13 per cent.

    —  Failure to diagnose malignancy—11 per cent.

    —  Minor surgical procedures—7 per cent.

    —  Failure to diagnose cardiac/vascular conditions, predominantly myocardial infarction—6 per cent.

    —  Other—3 per cent.

III.  AVAILABILITY AND ACCESSIBILITY OF INFORMATION, SUPPORT AND ADVICE TO PATIENTS, RELATIVES AND CARERS

  If a patient has been harmed, or if a patient or his/her relatives are unhappy with the treatment he/she has received, there are many ways in which they can obtain information and there are several avenues of redress open to them. Doctors may also have to account for their actions to their registration body, the General Medical Council (GMC), and for their contractural responsibilities, to their employer.

A.  Doctors' Ethical Obligations

Patients are entitled to expect confidentiality

  Communication with patients is the cornerstone of the doctor patient relationship. Patients have the right to have their autonomy respected and to consent, or otherwise, to treatment on the basis of correct and adequate information on the nature, purpose and material risks of the treatment. Equally, with certain specific exceptions, patients are entitled to expect their confidentiality will be respected 7, 8.

Explanation and apology
The GMC requires registered medical practitioners to explain fully to a patient what has happened and the likely long and short-term effects and, where appropriate, to offer an apology, if a patient under that practitioner's care has suffered serious harm. If the patient is under 16 and lacks the maturity to consent to treatment, the GMC makes it clear that practitioners should explain the situation honestly to those with parental responsibility for the child. If a patient under 16 has died, the practitioner must explain to the best of his knowledge the reason for and the circumstances of the death to those with parental responsibility. Similarly, if an adult patient has died the GMC requires the practitioner to provide information to the patient's partner or next of kin unless the practitioner knows the patient would have objected 9.

Court of Appeal ruling

  We are aware that concerns have been raised by MPs, and by patients and by parents of child patients, who have been dissatisfied with the way that information is made available, for example, to bereaved relatives. These concerns are sometimes expressed in the context of the 1997 Court of Appeal ruling where the court struck out a claim by the parents of a child who died. They claimed compensation for damages and psychological trauma caused by the discovery of an alleged cover up by the doctors after the death. The effect of this ruling was not to suggest that doctors have no duty to provide parents and/or their relatives with information. It dealt solely with the question of whether or not doctors owe a duty of care, compensatable in damages, to the relatives of patients.

  The court ruled that explaining about a death did not put the doctor into a doctor/patient relationship with the relatives. There was no duty of care of the kind a doctor owes to a patient, and it followed that there was no breach of the duty of care which might result in recovery of damages. However, it does not follow, and has never been suggested, that because there is no duty of care which if breached may result in compensation, there is no ethical duty to provide information in these circumstances. Indeed quite the opposite is true, as the GMC's requirement, published in 1998, clarified.

MDU advises "Say sorry"

  The MDU has, for over 40 years, advised members that a patient who is dissatisfied or has suffered harm is always entitled to a prompt, sympathetic and accurate account of the facts and an appropriate apology 10. We sometimes hear it said that the MDU tells doctors not to say anything when something has gone wrong. This is not so and would be contrary to the interests of patient and doctor.

Consent to disclose information

  The patient's consent must be obtained before disclosing information to third parties, including relatives and friends. If the patient does not have the mental capacity to understand, the doctor must make a decision, based on the patient's best interests, as to who can and should be offered information about the patient.

Conclusion

  In circumstances where a patient is dissatisfied or has suffered harm as a result of medical treatment, it is clear that it is the practitioner's professional ethical duty to provide an explanation to the patient or, if appropriate, the relatives.

Recommendations

  Patients who have suffered harm should be treated speedily, sympathetically, to their satisfaction and with an appropriate apology. The practitioner 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;

    —  equally important, it should be made clear that if a patient has died or does not have mental capacity, the doctor has an ethical duty to inform and apologise to the relatives in a similar way.

B.  Statutory Provisions
1.  Access to Health Records Act 1990 and the Data Protection Act 1998

  The Data Protection Act 1998, when it comes into force in July 1999, replaces the Access to Health Records Act 1990 which gives a patient the right to see and/or have copies of any records made after 1 November 1991, and to have these explained. The Data Protection Act will remove the date limit, but this will apply only to living patients. Access to records of patients who have died will continue to be governed by the Access to Health Records Act 1990 and the date limit of 1 November 1991 applies, unless it is necessary to see earlier records to understand what follows.

Therapeutic privilege

  A practitioner may deny access to part of the records if, in his opinion, it may cause serious harm to the patient's physical or mental health, or if it might break the confidentiality of another person (this does not include healthcare professionals). This is known as therapeutic privilege. The patient does not have to be told that information is being withheld. However, he or she is not prevented from asking the practitioner whether the full record has been made available, and may apply to the courts if dissatisfied with the answer.

Records of deceased patients

  Where the patient has died, an application for access to a health record may be made, by the patient's personal representative and any person who may have a claim arising out of the patient's death. Those who may have a claim arising out of the patient's death are the dependants and those entitled to claim bereavement damages which, in the case of a child, would usually include the parents.

2.  Access to Medical Reports Act 1988

  The Access to Medical Reports Act 1988 and the Access to Personal Files and Medical Reports (Northern Ireland) Order 1991 gives patients right of access to reports provided by a medical practitioner for employment or insurance purposes, to ensure accuracy and prevent the perpetuation of serious errors that may be prejudicial to an individuals interests.

  Only reports prepared by a doctor who is or has been responsible for the patient's medical treatment are covered by the Act.

3.  Common Law Right of Access

  Regardless of specific legislation, a patient may ask to see his complete medical or dental records, including those which existed before the Access to to Health Records Act 1990. In the test case of Martin, the Court of Appeal refused to decide whether the patient had a common law right of access 11. The court did, however, indicate that a health authority or practitioner was entitled to deny the patient access to records if it was not in the patient's best interests, for example, when disclosure would be detrimental to his health 12.

Conclusion

  The right to access to health records, including those under the various statutory provisions, does not appear to be unfairly restrictive on patients and/or their relatives.

IV.  PROCEDURES UNDERTAKEN FOLLOWING ADVERSE CLINICAL INCIDENTS AND OUTCOMES IN MEDICAL CARE

  A single adverse clinical incident resulting in harm to a patient may be investigated through one, several or, occasionally, all of the following:

    —  Inquest;

    —  Investigation under the complaints procedure;

    —  Investigation by the General Medical Council;

    —  Disciplinary action by a practitioner's employers;

    —  Public or private inquiry;

    —  Claim for medical negligence;

    —  Criminal investigation;

    —  Media enquiries.

  These mechanisms may also be used to investigate adverse clinical outcomes. If it is thought that an adverse outcome is due to an adverse clinical incident, an investigation may be needed to determine whether or not this is correct.

A.  Coroner's inquest

  The Coroner's Act 1988 sets out the circumstances in which a coroner should hold an inquest. These are where the coroner has reasonable cause to suspect a person has died a violent, unnatural or sudden death and the causes are unknown, or where a person has died in prison or in such circumstances as to require an inquest under any other act.

  We understand the Home Office issues guidelines about dealing with requests from relatives for access to documents in the possession of the coroner before the inquest. Documents mean records, statements, post mortem reports etc. We also understand one of the reommendations of the Stephen Lawrence inquiry is that advance disclosure of information such as records and witness statements may be made before an inquest takes place.

  The Select Committee on public administration, in 1998, stressed the need for clinicians to disclose all relevant information to the coroner to ensure a fully informed decision on cause of death. 13 Clinicians who have information which could help the coroner's inquiries should disclose it voluntarily and not only if requested. The GMC has made it clear 14 that, subject to his right not to produce evidence which may lead to criminal proceedings being taken against him, the practitioner must co-operate fully with any form of inquiry into the treatment of a patient. Doctors should not withhold relevant information and must assist the coroner (or procurator fiscal in Scotland) when an inquest or inquiry is held into a patient's death.

  The evidence given at an inquest is intended to answer questions put by the coroner. Doctors who are called have been in charge of the care of the patient; they are not there in an expert capacity. Doctors are often asked to read out their statements, or the coroner may ask them questions based upon it. After the coroner has examined the witnesses they may also be questioned by representatives of the other parties, including if necessary the witness' own representatives, with the coroner's permission. Relatives, who can be legally represented, may, with the coroner's consent, ask the witnesses about their involvement in the patient's care. 15

B.  Complaints Procedure

  There is no formalised patients' complaints procedure affecting all doctors inside and outside the NHS. However, the GMC requires all doctors to respond to patients' concerns and complaints quickly and sympathetically.

  The NHS complaints procedure was introduced in April 1996. It is intended to address any complaint the patient might have in relation to the clinical and general provision of care under the NHS in general practice or hospital care. It is intended to be run entirely independent of any disciplinary investigation, which is a confidential matter between the employee and the employer. There are three steps in the complaints procedure:

    —  Local resolution;

    —  Independent review;

    —  Appeal to the Ombudsman.

S Cross

Local resolution

  Local resolution was introduced to encourage a dialogue between a dissatisfied patient and the healthcare provider. It is aimed at providing a complete, prompt and satisfactory response to a patient's complaint. If a patient has died and a complaint is not made by a parent or next of kin, confidentiality must be respected and the doctor will need to seek appropriate consent. The complainant should receive a full and positive response aimed at satisfying him that his concerns have been taken seriously and, where appropriate, an apology and an explanation of what will be done to avoid future problems. Written complaints should receive a written response.

  In our experience local resolution works well due to its informality. Patients may be supported by a friend or, for example, a representative from the community health council. In general practice the health authority (HA) is also required to provide conciliation services. Patients or anyone making a complaint on their behalf can find out more from the GP or the health authority.

  A survey of complaints made against general practitioners notified to The MDU during 1998 showed that 93 per cent of complaints were resolved at practice level, suggesting patients are receiving the support and explanation they need.

Independent review

  Complainants dissatisfied with local resolution may request an independent review. A convenor (a non-executive and non-clinical member of the HA or trust) will determine whether or not the matter will proceed to independent review. The convenor will not recommend an independent review if legal proceedings are intimated. If a complaint does proceed, it is heard by a lay panel advised by two professional advisers. The panel receives reports from both doctor and patient. It interviews and questions those involved. At the inquiry the doctor and the complainant may be accompanied by silent friends. A report containing the facts and recommendations is sent to both parties.

  We have encountered some difficulties with the independent professional review procedure from the doctor's point of view. For example:

    1.  On occasions the convenor has ignored the time limit for investigation of the complaint and some complaints have been investigated beyond the time limit.

    2.  A few independent review panels did not set out their terms of reference for the investigation, and did not state clearly the matters they would look into, so the investigations went outside the terms of reference and raised new matters.

    3.  Occasionally practitioners have been subject to a degree of hostility during the course of questioning.

    4.  There has been inaccurate reporting of the hearing in quite a few instances. In our experience only about half the cases are tape-recorded, in others there is reliance upon secretarial support of varying quality.

    5.  Reports of the independent review should be sent to the respondent doctor to check for factual accuracy. This does not always occur.

    6.  Some panels have disregarded the opinion of the medical assessors on clinical matters.

  Given that we have identified a number of problems from the doctors' perspective, it is likely that patients and their representatives will have similar concerns.

The Ombudsman's inquiries

  The Health Service Commissioner (the Ombudsman) is the final arbiter in the NHS complaints procedure. He receives complaints arising from the outcome of the first and second stage of the complaints procedure and at his discretion may instruct his officials to carry out an inquiry. These inquiries are thorough. The officials will interview the complainant and the doctor and each party may be accompanied by a silent friend. The officials may also seek independent expert advice. The inquiry culminates in a report of facts and recommendations and the timescale for implementation. The Ombudsman can re-visit the trust or GP to ensure that his recommendations are being complied with.

Private sector

  There is no formalised patients' complaints procedure affecting all doctors outside the NHS. The complaints are usually dealt with along similar lines to the local resolution procedure within the NHS. This is a recent development prompted by the GMC's requirements. There is no equivalent in the private sector to the independent review procedure nor does the Ombudsman have jurisdiction outside the NHS.

Conclusions

  It is our experience that the NHS complaints procedure functions well at local resolution level in general practice. Our hospital doctor members consult us less about hospital or trust complaints at this level, and this may well be because there are complaints managers available to act as facilitators.

  Independent review is less satisfactory in both hospital and general practice. We are actively trying to resolve the issues we have identified and will give information on our experience to the NHS Executive in its review of the complaints procedure.

  The Ombudsman's role as final arbiter is effective. At present he is the only person who has an overview of complaints within hospital and general practice. He is in a position to draw conclusions about the main factors leading to complaints and to make recommendations for their avoidance in future.

Recommendations

  That chair-persons of independent review panels should be legally qualified and the two medical assessors should be full voting members of the panel rather than merely advisers to the panel.

  That the role of the Ombudsman be extended so that he becomes a national and independent assessor of patient's complaints across both the NHS and the private sector. This should allow pooling of information regarding adverse clinical incidents and patient dissatisfaction. This information could then be used to manage risks more effectively and will help to improve patient safety.

C.  General Medical Council

  The GMC provides a 24-hour service offering registration checks.

  The GMC takes complaints against doctors seriously and every complaint it receives is considered by a preliminary screener. While the GMC offers advice and guidance to anyone wishing to complain, a complainant may be discouraged because the process can appear legalistic. Unless the complainant is a public body, he/she must offer an affidavit of the allegations and charges are formulated and evidence is given under oath.

  However, we believe that such safeguards are essential because of the severity of the sanctions available to the GMC if it decides to pursue a complaint and finds a doctor guilty of serious professional misconduct.

  When a patient makes a complaint to the GMC much of the investigatory work lies with the GMC and, unlike the NHS complaints procedure, there is no specific mechanism to enable a flow of information back to the complainant. If the GMC believes there are grounds to pursue the complaint, there are three ways in which it can investigate the matter: through conduct, performance or health procedures. It is up to the GMC to decide whether it pursues a complaint and, if so, which procedures it invokes.

  If the GMC does not pursue the complaint, for example if it does not raise a matter which is serious enough for the GMC to review the doctor's registration, the complainant will be informed. He may choose to pursue the complaint through another avenue.

  If the GMC decides to pursue the complaint, it is referred for consideration by the preliminary proceedings committee. The complainant will be informed of the action the committee decides to take. It can take no further action; send the doctor a letter of warning or advice; refer the matter to the health or professional performance procedures or; hold a public hearing before the professional conduct committee.

  If the GMC decides to invoke the professional performance or health procedures, this takes place in private. The complainant is unlikely to have to appear as a witness. The complainant will only be informed if the doctor needs medical supervision or retraining.

  If the matter is referred to the professional conduct committee, at the professional conduct hearing, the patient may become a witness. He or she may be called upon to give evidence and once this has been given, the patient may listen to the rest of the evidence to learn more about the case. The committee's decision is made public.

  We believe this system is correct. In a case in which serious professional misconduct is alleged, it is important to protect the integrity of any witness, including the complainant, so that no suggestion can be made of contamination of the witness through feedback of information by the GMC before the matter arrives at the conduct committee.

  This protects the integrity of the complaint and the complainant and allows a fair system for analysis of the allegations made against the defendant doctor.

Conclusion

  The GMC regulates the medical profession through formal procedures designed to protect patient safety and ensure practitioners adhere to proper standards of good medical practice. The GMC provides clear advice to doctors about the standards expected of them in its booklet, "A Problem with your Doctor?" 16. It also provides pateients with information about how it deals with complaints and what patients can do if they want the GMC to investigate a problem with a doctor. The booklet tells the patient where they can get help in making a complaint and what to expect once a complaint has been made.

  We believe it is important that the procedure retains its legalistic safeguards because a doctor's reputation and future career are at stake. However, we do realise that this may sometimes make the process daunting for the patient.

Recommendation

  Patients and complainants can be assured that their concerns are always taken seriously by the GMC. Its primary purpose is to safeguard patients, but it does not always provide them with a detailed explanation of the events which have caused them concern. To safeguard doctors, we think this should not change. We believe that patients and complainants should be able to use other avenues to get an immediate answer to their questions. If patients or their representaives are not getting the answers they need, it is the other complaints procedures which should be reviewed, not the GMC's.


 
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Prepared 29 July 1999