> ### CIVIL PROCEDURE PRE-ACTION PROTOCOLS

> ### CLINICAL NEGLIGENCE PROTOCOL

> ### THE PROTOCOL

> 3.1 | This protocol is not a comprehensive code governing all the steps in clinical disputes. Rather it attempts to set out a code of good practice which parties should follow when litigation might be a possibility.
> 3.2 | The commitments section of the protocol summarises the guiding principles which healthcare providers and patients and their advisers are invited to endorse when dealing with patient dissatisfaction with treatment and its outcome, and with potential complaints and claims.
> 3.3 | The steps section sets out in a more prescriptive form, a recommended sequence of actions to be followed if litigation is a prospect.

> ### GOOD PRACTICE COMMITMENTS

> 3.4 | Healthcare providers should:- ensure that key staff, including claims and litigation managers, are appropriately trained and have some knowledge of healthcare law, and of complaints procedures and civil litigation practice and procedure; develop an approach to clinical governance that ensures that clinical practice is delivered to commonly accepted standards and that this is routinely monitored through a system of clinical audit and clinical risk management (particularly adverse outcome investigation); set up adverse outcome reporting systems in all specialties to record and investigate unexpected serious adverse outcomes as soon as possible. Such systems can enable evidence to be gathered quickly, which makes it easier to provide an accurate explanation of what happened and to defend or settle any subsequent claims; use the results of adverse incidents and complaints positively as a guide to how to improve services to patients in the future; ensure that patients receive clear and comprehensible information in an accessible form about how to raise their concerns or complaints; establish efficient and effective systems of recording and storing patient records, notes, diagnostic reports and X-rays, and to retain these in accordance with Department of Health guidance (currently for a minimum of eight years in the case of adults, and all obstetric and paediatric notes for children until they reach the age of 25); advise patients of a serious adverse outcome and provide on request to the patient or the patient’s representative an oral or written explanation of what happened, information on further steps open to the patient, including where appropriate an offer of future treatment to rectify the problem, an apology, changes in procedure which will benefit patients and/or compensation.
> 3.5 | Patients and their advisers should - report any concerns and dissatisfaction to the healthcare provider as soon as is reasonable to enable that provider to offer clinical advice where possible, to advise the patient if anything has gone wrong and take appropriate action; consider the full range of options available following an adverse outcome with which a patient is dissatisfied, including a request for an explanation, a meeting, a complaint, and other appropriate dispute resolution methods (including mediation) and negotiation, not only litigation; inform the healthcare provider when the patient is satisfied that the matter has been concluded: legal advisers should notify the provider when they are no longer acting for the patient, particularly if proceedings have not started.

> ### PROTOCOL STEPS

> 3.6 | The steps of this protocol which follow have been kept deliberately simple. An illustration of the likely sequence of events in a number of healthcare situations is at Annex A.

> ### OBTAINING THE HEALTH RECORDS

> 3.7 | Any request for records by the patient or their adviser should – provide sufficient information to alert the healthcare provider where an adverse outcome has been serious or had serious consequences; be as specific as possible about the records which are required.
> 3.8 | Requests for copies of the patient's clinical records should be made using the Law Society and Department of Health approved standard forms (enclosed at Annex B), adapted as necessary.
> 3.9 | The copy records should be provided within 40 days of the request and for a cost not exceeding the charges permissible under the Access to Health Records Act 1990 (currently a maximum of £10 plus photocopying and postage).
> 3.10 | In the rare circumstances that the healthcare provider is in difficulty in complying with the request within 40 days, the problem should be explained quickly and what is being done to resolve it.
> 3.11 | It will not be practicable for healthcare providers to investigate in detail each case when records are requested. But healthcare providers should adopt a policy on which cases will be investigated (see paragraph 3.5 on clinical governance and adverse outcome reporting).
> 3.12 | If the healthcare provider fails to provide the health records within 40 days, the patient or their adviser can then apply to the court for an order for pre-action disclosure. The new Civil Procedure Rules should make pre-action applications to the court easier. The Court will also have the power to impose costs sanctions for unreasonable delay in providing records.
> 3.13 | If either the patient or the healthcare provider considers additional health records are required from a third party, in the first instance these should be requested by or through the patient. Third party healthcare providers are expected to co-operate. The Civil Procedure Rules will enable patients and healthcare providers to apply to the court for pre-action disclosure by third parties.

> ### LETTER OF CLAIM

> 3.14 | Annex C1 to this protocol provides a template for the recommended contents of a letter of claim: the level of detail will need to be varied to suit the particular circumstances.
> 3.15 | If, following the receipt and analysis of the records, and the receipt of any further advice (including from experts if necessary - see Section 4), the patient/adviser decides that there are grounds for a claim, they should then send, as soon as practicable, to the healthcare provider/potential defendant, a letter of claim.
> 3.16 | This letter should contain a clear summary of the facts on which the claim is based, including the alleged adverse outcome, and the main allegations of negligence. It should also describe the patient's injuries, and present condition and prognosis. The financial loss incurred by the plaintiff should be outlined with an indication of the heads of damage to be claimed and the scale of the loss, unless this is impracticable.
> 3.17 | In more complex cases a chronology of the relevant events should be provided, particularly if the patient has been treated by a number of different healthcare providers.
> 3.18 | The letter of claim should refer to any relevant documents, including health records, and if possible enclose copies of any of those which will not already be in the potential defendant's possession, e.g. any relevant general practitioner records if the plaintiff 's claim is against a hospital.
> 3.19 | Sufficient information must be given to enable the healthcare provider defendant to commence investigations and to put an initial valuation on the claim.
> 3.20 | Letters of claim are not intended to have the same formal status as a pleading, nor should any sanctions necessarily apply if the letter of claim and any subsequent statement of claim in the proceedings differ.
> 3.21 | Proceedings should not be issued until after three months from the letter of claim, unless there is a limitation problem and/or the patient's position needs to be protected by early issue.
> 3.22 | The patient or their adviser may want to make an offer to settle the claim at this early stage by putting forward an amount of compensation which would be satisfactory (possibly including any costs incurred to date). If an offer to settle is made, generally this should be supported by a medical report which deals with the injuries, condition and prognosis, and by a schedule of loss and supporting documentation. The level of detail necessary will depend on the value of the claim. Medical reports may not be necessary where there is no significant continuing injury, and a detailed schedule may not be necessary in a low value case. The Civil Procedure Rules are expected to set out the legal and procedural requirements for making offers to settle.

> ### THE RESPONSE

> 3.23 | Attached at Annex C2 is a template for the suggested contents of the letter of response.
> 3.24 | The healthcare provider should acknowledge the letter of claim within 14 days of receipt and should identify who will be dealing with the matter.
> 3.25 | The healthcare provider should, within three months of the letter of claim, provide a reasoned answer - if the claim is admitted the healthcare provider should say so in clear terms; if only part of the claim is admitted the healthcare provider should make clear which issues of breach of duty and/or causation are admitted and which are denied and why; it is intended that any admissions will be binding; if the claim is denied, this should include specific comments on the allegations of negligence, and if a synopsis or chronology of relevant events has been provided and is disputed, the healthcare provider's version of those events; where additional documents are relied upon, e.g. an internal protocol, copies should be provided.
> 3.26 | If the patient has made an offer to settle, the healthcare provider should respond to that offer in the response letter, preferably with reasons. The provider may make its own offer to settle at this stage, either as a counter-offer to the patient's, or of its own accord, but should accompany any offer by any supporting medical evidence, and/or by any other evidence in relation to the value of the claim which is in the healthcare provider's possession.
> 3.27 | If the parties reach agreement on liability, but time is needed to resolve the value of the claim, they should aim to agree a reasonable period.

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