Clinical Negligence Protocol


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Unfortunately the volume of complaints and claims made against health sector professionals, medical practitioners and clinical care establishments here in the UK is on the rise, yet for many victims of cases of medical negligence (including surgical errors of various descriptions) the process of pursuing a claim has been found to be a needlessly laborious one.

Research conducted discovered that the primary reason for significant delays and increased costs incurred in clinical negligence-claiming circumstances revolved around what’s known as the pre-action phase. This fact-finding ultimately led to an industry-wide drawing up of a pre-action protocol, which was swiftly legislated on and put into practice in recent years as a more workable revision of the existing one.

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In a sentence, this updated version of clinical negligence events is fundamentally designed to streamline the claims process surrounding this particular area and to effectively help parties to settle claims by avoiding the need to go as far as court with an individual case.

This is achieved courtesy of seeking to resolve any outstanding concerns, complaints and claims with the minimum of fuss and time spent, and it’s envisaged that eventually all clinical negligence claims will adhere to this revised protocol sooner rather than later.

What are the objectives of the clinical negligence protocol?

From the perspective of all parties involved the general aims of this particular protocol are to:

  • MAINTAIN/RESTORE the relationship between patients and the healthcare provider
  • RESOLVE as many disputes as possible without litigation

Does that cover ALL the bases?

No, as there are also a range of more focused targets such as those outlined beneath:


  • To foster a line of communication between patients and healthcare providers from the very outset if and when an issue/problem first arises
  • To actively encourage patients to voice any concerns they may have as early as possible
  • To motivate healthcare providers to develop systems for early reporting of treatment outcomes, together with the provision of patient explanations in full
  • To ensure that sufficient information is disclosed to each party, so that they both have a full understanding of the others’ perspective


  • To promote and provide the earliest opportunity for healthcare providers to carry out investigations on cases where required
  • To ensure that all relevant medical records are disclosed to patients on request and in the allowed time
  • To ensure that all relevant medical records are made available to healthcare professionals (if they are in possession of patients or a third party)
  • For legal proceedings to commence (and kept within timely parameters) should an agreement not be reached from the outset
  • To actively dissuade claims which are not considered to be valid, in addition to discouraging the prolonged defence of valid claims


  • To ensure that all patients (and healthcare providers) are aware of all the options available when making and resolving disputes

What are the requirements of this new pre-action protocol in terms of clinical negligence cases?

This is essentially a two-fold mechanism which needs to be in place from day one and constitutes a code of good practice; which in itself should be adhered to if/when legal proceedings become a real possibility.

The re-configured protocol’s code of practice takes the form and function of the following two principles, and addressed the needs/requirements expected of, both the patient/claimant AND healthcare provider:

It’s in the patient/claimant’s best interests if they:

  • Report ANY concerns they may have to healthcare professionals at the earliest opportunity, which allows professionals to offer advice for patients in readiness to potentially take appropriate action
  • Consider the FULL options available where dissatisfaction was present
  • INFORM healthcare providers when the matter has been resolved and when the patient is satisfied

Conversely it’s in the healthcare provider’s best interests if they:

  • ENSURE that they have key staff who are appropriately trained for the event of a complaint/claim
  • ENSURE that clinical practice is delivered to an acceptable standard (and that this is routinely monitored)
  • INSTIGATE reporting systems to record and investigate unexpected outcomes as soon as possible
  • USE the results of incidents (and complaints) in a positive way, so as to improve services and prevent the same situation occurring in the future
  • ENSURE that patients are able to raise their concerns by providing them with relevant information
  • ENSURE that there are efficient systems in place to record and store patients records
  • ENSURE that adverse outcome reporting systems are set up
  • ENSURE that the abovementioned adverse incidents and complaints are treated positively in order to improve services to patients in the future
  • ENSURE that disputes are handled consistently
  • ADVISE patients of all possible outcomes (and provide written accounts on request of what happened)

What are the next steps of the clinical negligence protocol?

The following stage tends to be divided into the three main components which are documented beneath to afford you a better understanding of the continuation of the process:

Requesting of Medical Records

  • At a time when a patient/claimant (or their advisor/claims representative) lodges a formal request for the surrender of medical records, it’s their prerogative to convey sufficient information to alert the healthcare provider where an adverse outcome has been serious (or had serious consequences). Furthermore they are required to be as specific as possible about the records which are required at this juncture. The request should always be facilitated by using the prescribed form which is annexed to the protocol
  • The co-operation of third party healthcare providers regarding the disclosure of any health record requests kept by them when approached by the aforementioned parties is a prerequisite.
  • A maximum of 40 days is the time frame in which copy records should be released for a patient/claimant to be privy to once initially requested, whilst there’s restrictions in place in relation to a healthcare provider can charge for providing copy records. Should a healthcare provider fail to surrender copies of medical records within the 40 day period, then patient/claimants are entitled to apply to the court for an order for pre-action disclosure

Letter of Claim

  • It’s the responsibility of the patient/claimant to notify the healthcare provider that they intend to pursue a claim by way of forwarding what’s referred to as a ‘letter of claim’, prior to the commencement of court proceedings
  • The protocol clearly specifies what information should be enclosed within a letter of claim, including a detailed summarising of the key facts surrounding the main allegations of negligence which form the backbone of the pursuit of compensation

The Response

  • It’s decreed in the new protocol that the healthcare provider should take no more than 14 days (from the date in which they received the ‘letter of claim’) to officially acknowledge that said correspondence in in their possession. In adhering to this, the healthcare provider should also use this juncture to identify who will be dealing with the matter from their perspective
  • The healthcare provider has a maximum of 4 months from the date of the letter of claim in which to provide a reasoned answer and thereby either accept or deny the claim made against them
  • Should the claim be admitted to by the healthcare provider cited by the patient, then they are required to ascertain why using clear terminology. In the event where only a percentage of the claim is admitted, the healthcare provider is required to make it clear which issues are admitted and which are denied, along with an explanation of why this is the case. Any admissions will be binding on the healthcare provider
  • If the claim is denied the healthcare provider should explain why and, where appropriate, put forward its own version of events
  • If the healthcare provider relies on additional documentation it is required to provide copies of such documents
  • Should the patient/claimant made an offer to settle, then it’s the healthcare providers’ responsibility to acknowledge/respond to said offer within the same returned letter; preferably outlining reasons
  • The healthcare provider is entitled to submit its own offer to settle the claim at this point, however any such offer should be accompanied by any supporting medical evidence and/ or any other evidence relating to the value of the claim which the healthcare provider may be in possession of
  • Where the healthcare provider admits liability the parties should aim to agree a reasonable period of time to resolve the value of the claim

Is there anything else I should be made aware of with regards this next phase?

It’s worth noting that expert opinions may well be sought in some cases which are at the centre of ongoing and unresolved disputes concerning the two parties, with a view to assisting in any decisions being made on either side.

It may well be in the interests of both fractions/deemed more appropriate to employ a single party in this instance, but beware that by jointly instructing an expert it needs to be ironed out whether reports are disclosed sequentially or by exchange.

Is that everything?

Not quite. There’s also the ‘alternative dispute resolution’ to think of too, which – in a nut-shell – requires both parties to consider alternative approaches to the stand-off, prior to litigation proceedings being ushered in.

Typically these may comprise of additional discussion, negotiation and mediations for parties to agree on an outcome and settle the claim then and there. The protocol sets out some of the forms of alternative dispute resolution which the parties might decide to adopt, which includes making a complaint under the NHS Complaints Procedure.

It’s likely that the court may then stipulate that the parties provide evidence that alternative means of resolving the dispute were considered. The courts take the view that court proceedings should be a last resort, yet at the same time recognise that parties cannot (and should not) be forced to enter into any form of alternative dispute resolution.

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