Discretion

The Department of Health and Social Care has published a report entitled:

"Appropriate clinical negligence cover - a consultation on appropriate clinical negligence cover for regulated healthcare professionals and strengthening patient recourse".

You can find it at: https://www.gov.uk/government/consultations/appropriate-clinical-negligence-cover. The consultation closed on 28 February 2019 and focused on indemnity cover for healthcare professionals (including surgeons and doctors) who have to purchase their own medical indemnity cover because they are not covered by state-backed schemes.

At present those healthcare professionals are obliged by their regulator to hold a 'suitable' indemnity arrangement, and have the choice to obtain that indemnity from one of the traditional Medical Defence Organisations (MDOs) or from a Medical Indemnity insurer regulated by the Financial Conduct Authority (FCA).

The consultation’s introduction states that:

"There are concerns that the current arrangements held by healthcare professionals who are not covered by state-backed schemes could prevent patients getting appropriate compensation and put healthcare professionals at risk of being personally liable for the costs of claims. This is because these arrangements [through the MDOs] are mostly discretionary, where the providers are not contractually obliged to meet the costs of any claim and are not subject to prudential or financial conduct regulation."

The consultation seeks views as to whether this arrangement should be allowed to continue, or alternatively whether a change in legislation is required to require healthcare professionals who are not covered by any state-backed scheme to hold cover that is regulated – in other words, insurance cover from an FCA-regulated insurance company.

The consultation seems likely to generate a large number of responses reflecting widely different views – not only from the MDOs and insurers themselves, but from healthcare professionals who rely on their indemnity arrangements, or insurance cover, if they are unfortunate enough to have a negligence claim made against them. However, some commentators, such as the Independent Healthcare Providers Network have already been reported as saying that discretionary cover is "simply not tenable".

So what if those commentators are right, and the upshot of the consultation is that the government introduces legislation requiring healthcare professionals to purchase insurance rather than membership of an MDO that comes with discretionary indemnity cover? What are the implications for healthcare professionals who currently have their indemnity arrangements with an MDO?

Joanne Staphnill, Partner at DWF LLP commented:

"In my view one of the main implications for healthcare professionals would be the need for education on quite a large scale. In my work as a clinical negligence defence lawyer, and provider of medico-legal and insurance notification services, I very regularly work with healthcare professionals who have been indemnified through an MDO membership for their whole career, and have recently moved to insurance cover with a regulated insurance company. Those healthcare professionals very often need extra help and guidance in understanding the differences between their obligations under their previous MDO membership, compared with the obligations that arise under their new insurance policy. There is a whole new terminology to get to grips with – particularly the technicalities of ‘Claim’ and ‘Circumstance’. And there may also be something of a 'culture shock' when it comes to understanding why it is so important to insurers that potential problems get 'notified' to the correct policy year. On an individual basis it is very easy to provide that help and guidance, but the challenge for the insurance industry would be to be sufficiently prepared for a potentially large and sudden influx of new customers that would all need that sort of assistance."

Ian Redbourn, Head of Healthcare and Life Science at Incision Indemnity, said:

“Since we began providing insurance schemes in 2010, through various conversations with our Incision members, it has become apparent that surgeons in the UK are unaware of the unregulated and discretionary elements of the MDO membership and we are amazed that, to this day, we’re still having these discussions. Most are shocked when they understand how vulnerable discretionary cover leaves them with absolutely no recourse. “We support and welcome this consultation and we are available to assist with anyone moving from long-term MDO membership to insurance. At Incision Indemnity, our insurance policy is written in plain English, there is a well-established medico-legal and notification helpline service on call to answer individual questions, and a suite of guidance notes to help with the adjustment from a 'discretionary cover' mindset to an 'insurance policy' mindset. “Incision members have very broad coverage and the highest limits available in the current market, with each individual having the option to be insured for up to £40m aggregate limit.“

The world of healthcare professionals' indemnity arrangements might be about to have a major sea change that will have direct implications for thousands of self-employed surgeons. This consultation highlights the shortcomings of unregulated and discretionary coverage and it would be prudent to explore the advantages of an insurance contract sooner rather than later.

Using procedure-specific consent forms for total hip replacement, patients improved their recall of benefits associated with the surgery, according to a study in the Journal of Patient Safety.

Of patients surveyed four weeks after surgery, nearly 50% recalled the potential benefits of surgery better than they recalled the risks, and 90% reported being happy with the information they had received, the study noted.

Informed consent is an important step in the operative process, and surgeons have an obligation to provide information to patients that fosters shared decision-making. 

https://journals.lww.com/journalpatientsafety/Abstract/2021/09000/Patient_Recall_of_Informed_Consent_at_4_Weeks.25.aspx

Examination of patients is essential to a clinician's role, including intimate examinations, and examinations of vulnerable patients. Examinations are routine for clinicians, but many patients are unfamiliar with the process, and can find them distressing. The GMC's Good Medical Practice states at 47 "You must treat patients as individuals and respect their dignity and privacy", and appropriate use of chaperones can help achieve that.

Chaperones are also an aspect of risk management. While sadly there are clinicians who violate a patient's trust during an examination, there are also patients who will make unmeritorious allegations against an innocent clinician. Regardless of whether the patient has genuinely misinterpreted an innocent action, or is maliciously making a false allegation for gain, the presence of a reliable witness can be valuable protection for clinicians.

Incision members have access to detailed written guidance materials on this important topic, and this article contains extracts. Incision members also have access to a 24/7 medico-legal/notifications helpline so that they always have access to guidance on individual incidents, or tailored guidance for their specific practice.

What is the key guidance?

The key guidance is in the GMC's 2013 guidance note "Intimate examinations and chaperones" Intimate examinations and chaperones (gmc-uk.org). But what about video or other remote consultations, given the significant increase in remote consultations in recent years? NHS England published, "Key principles for intimate clinical assessments undertaken remotely in response to COVID-19" key_principles_for_intimate_clinical_assessments_undertaken_remotely_in_response_to_covid19_v1-(1).pdf (gmc-uk.org)  It recommends that you should update your chaperone and safeguarding policies to include remote consultations, and confirms that the GMC guidance applies to video consultations. It also addresses some practicalities by commenting, "a chaperone could be present with the practitioner (either virtually or in the same room) [to] witness the nature and extent of the video examination that was undertaken. The chaperone should be visible to the patient."  Also, "if a chaperone is not available (for example because you are remote working) or declined by the patient, use your professional judgement and carefully consider whether a remote examination method should proceed."

The CQC's guidance is within their guidance on GPs, but much it would apply equally to clinicians - GP mythbuster 15: Chaperones | Care Quality Commission (cqc.org.uk). This highlights the importance of chaperones receiving the right training, and that non-clinical staff who carry out chaperone duties, "may need a DBS [Disclosure and Barring Service] check".

Clinicians who only examine patients in private clinics or hospitals managed by others (independent clinicians with practising privileges) should familiarise themselves with the chaperone policy in each hospital or clinic they work at, and know which staff can be available to fulfil that role. Clinicians who examine patients in their own clinics, and Clinic managers, will be responsible for ensuring that their clinic has a robust chaperone policy, including clear and timely communication to patients that they are entitled to one.  The clinician or Clinic manager will also need to ensure that there are suitable people in the clinic with the training to be able to carry out the role, and for making sure that the chaperone is ‘impartial’ and empowered to speak up on the patient’s behalf."  In the very last paragraph of the article amend the penultimate sentence to read, "Such an allegation can lead to police investigations or GMC investigations (for GMC-regulated clinicians), and potentially CQC investigations into Clinics.

Plain English?

Is the word "chaperone" in the healthcare context is overdue for a 21st century plain English overhaul? Is this somewhat antiquated word always understood by patients? Would "Dignity and Safeguarding Attendant" better describe this vital role? Let us know about any alternative phrases coming into use, or your own suggestions!

What about insurance?

The presence of a chaperone cannot necessarily prevent an allegation of inappropriate behaviour or assault, but their witness evidence should make it much easier for the clinician to prove their version of events. Such an allegation can lead to police investigations or GMC investigations. The Incision policies contain cover for the cost of legal advice and representation in police or GMC investigations, and all clinicians should check that they have this vital type of cover.

Nobody likes to contemplate the possibility of being subject to a police investigation. The thought of an arrest or police involvement might be particularly worrying for surgeons or doctors, because they have their personal and professional reputation and their GMC registration to protect. An alleged criminal act can potentially result in multiple jeopardy for a surgeon or a doctor. The criminal allegation could lead to a GMC investigation, regardless of whether the alleged incident was in the surgeon/doctor's private life, NHS practice or private practice.  If the alleged criminal incident involves a patient's death, then there would likely be an Inquest. The alleged criminal incident can also give rise to a civil claim for compensation, as most criminal acts are also a breach of the civil law. If a police investigation proceeds to a full criminal trial, then the worst-case scenario is imprisonment for the surgeon, which would in turn very likely result in their removal from the GMC Medical Register and the effective end of the surgeon's career.

Few police investigations get as far as a full trial, but even at the earliest stages, surgeons/doctors can find police investigations incredibly stressful.  Therefore, Incision has produced this guide to give Incision members an overview of the earliest stage of the police investigation process, to demystify it and also to highlight how the Incision insurance policies and the Incision medico-legal helpline can assist you.

Overview of the initial stages of a Police investigation

What can lead to a Police investigation?

Anyone can report a potentially criminal act to the Police, on an urgent (999) or non-urgent (101 and various other routes) basis. Therefore, a Police investigation could be triggered by a report from a private individual, or a colleague or other individual health professional or sometimes the management of a clinic or hospital after investigating an incident themselves.

It is not possible to list out every potential criminal allegation that could be made against a surgeon/doctor, arising out of their private and professional lives, especially if you include road traffic offences. But in our experience the types of criminal investigation that a surgeon might be subject to include the following:

• Gross negligent manslaughter – where the patient died and it is alleged that this was due to extremely gross negligence on the part of the surgeon/doctor;
• Sexual assault – this category could encompass alleged rape (e.g., where a doctor thought he was having a consensual sexual relationship with a patient) through to alleged sexual touching during a clinical examination;
• Theft – for example of clinical equipment, restricted drugs or even patients' belongings;
• Possession and/or consumption and/or supply of illegal/recreational drugs;
• Road traffic offences involving dangerous driving or driving under the influence of drugs or alcohol.
• Actual Bodily Harm or Grievous Bodily Harm, assault or being drunk and disorderly – for example at or after a social event.

How will you know that an investigation has started?

You may first learn of the investigation when the police contact you on a non-urgent basis to ask you to attend an interview at a Police station. They should identify themselves as the police and explain to you what alleged incident they are investigating. 

Alternatively, you could be arrested immediately by a police officer. You will know if you are being arrested because the Police are under an obligation to give you key information – they must identify themselves as the police, tell you that you’re being arrested, tell you what crime they think you’ve committed, explain why it’s necessary to arrest you and explain to you that you’re not free to leave. There are more details at Police powers of arrest: your rights - GOV.UK (www.gov.uk).

Can I get legal advice?

If you are arrested by the Police, then one of your legal rights is free legal advice (there are other rights you should be aware of, summarised in the link below). You can get free independent advice from the duty solicitor at the station, who is available 24 hours a day, or the police can contact the Defence Solicitor Call Centre (DSCC), or you can ask the Police to call your own solicitor. There are more details at Being arrested: your rights: Legal advice at the police station - GOV.UK (www.gov.uk)

If you ask for legal advice, the police can’t usually question you until you’ve got it (although there are some exceptions).  However, sometimes the police will commence a formal interview, and ask you at the beginning whether you would like a legal representative.

We provide more detail on how best to protect your interests by obtaining the right sort of legal advice below.

How long can I be held and what are my rights at the station?

You can be held for up to 24 hours before the Police have to charge you with a crime or release you (although there are various exceptions to this rule). You have rights that must be strictly observed, including the right to tell someone where you are, to have medical help if you’re feeling ill and to see the rules the police must follow (‘Codes of Practice’).  There are more details at Being arrested: your rights - GOV.UK (www.gov.uk).

Do I need legal advice?

Yes – getting proper legal advice before you are questioned by the police is absolutely crucial. This applies both to situations where the Police invite you to the station on a non-urgent basis for questioning, or where you are suddenly arrested.

Surgeons and doctors are often by nature very public-spirited people, and many might feel that the morally right thing to do is to cooperate fully with the Police and answer all questions put to them straight away even without the benefit of legal advice. Many might assume that the best way to protect their own interests is to answer all questions put to them without legal advice, to show transparency.  Some might also feel impatient to be released from custody and want to waive their right to legal advice just to try to hurry things up and be released.

All these approaches might be understandable because being involved in a criminal investigation is inherently stressful.  But if you are ever unlucky enough to be arrested or invited for questioning by the Police it is of paramount importance to put any such feelings aside and obtain legal advice before you are questioned by Police.  Even if you consider the alleged criminal act to be relatively trivial, the reality is that it is not always in your best interests to rush to cooperate with Police questioning, and there could be major ramifications for your professional life and your GMC registration. You need legal advice, every time.

Guidance if you are arrested without prior warning

Being arrested without prior warning is potentially the most difficult situation you can face.  We hope this never happens to you, but if you do this guidance might help:

• Exercise your right to tell someone where you are straight away – a spouse, close family member, close friend or colleague might be best. You will need to let them know that it is possible that you could be held for up to 24 hours, and therefore they need to inform anyone who needs to know. They will need to help ensure that any caring responsibilities you may have for children or other dependents (including pets) are managed another way. Equally, they may need to inform any hospital or clinic where you work so that any clinical care to patients that you should have been providing over that time can be rearranged or managed another way. There is not always a strict limit to the number of calls you can make – there is no rule saying that you are limited to literally just one phone call. So, if you need to make more than one call to make sure that both the necessary people are informed in both your personal and professional life, then you should insist on making more than one call.
• Exercise your right to get legal advice straight away – Your Incision policy does not cover the cost of legal advice at the Police station if you are suddenly arrested. Therefore, you will either need to i) rely on the duty solicitor or the DSCC, or ii) call a law firm with expertise in both criminal and healthcare regulatory law.  If you need to rely on the duty solicitor or DSCC, be sure to inform them that you are a GMC-regulated surgeon or doctor, and therefore the criminal investigation could in due course be followed by a GMC fitness to practice investigation.  Ask your solicitor for advice as to whether it is possible to delay the Police questioning until you can be represented by lawyers with a dual specialism in criminal law and healthcare regulatory law.  If that is not possible, ask for advice about whether it would be better to go ahead with an interview under caution without the benefit of specialist healthcare regulatory advice, or alternatively to give a purely 'no comment' interview (where you answer all questions with the words "no comment" so that any future interview can be carried out with the benefit of specialist legal advice. Despite the wording of the police caution, ("You do not have to say anything. But it may harm your defence if you do not mention when questioned something which you later rely on in court. Anything you do say may be given in evidence."), it won't necessarily count against you if you give a no comment interview, because a solicitor can submit a statement on your behalf at a later date.
• If possible, call the Incision medico-legal helpline for guidance – The difficulty here is that someone being held in custody is not allowed to discuss the full facts of the case over the phone with a third party (even a medico-legal adviser). However, if you can call them, then you can simply inform them of the fact that you have been arrested and on suspicion of what offense, and the team will be able to start the process of informing your insurers, and they could put you in touch with specialist lawyers who may be able to advise and represent you.

Guidance if you are contacted on a non-urgent basis and invited for questioning

This is a much easier situation to manage.  Simply take down as many details as possible from the Police, do not make any comments or start giving your side of the story to the officer.  Then call the Incision medico-legal helpline immediately.  Your Incision policy does include cover for the cost of legal representation at a police interview that you are invited to in advice, so your insurers will be able to appoint lawyers to advise and represent you.

When to notify your Incision insurers?

The terms and conditions of your Incision insurances includes a requirement to inform ("notify" is the insurance jargon) your insurers about problems promptly.  Notifying at the right time is in your interests because it avoids potential problems with cover, but also gets you access to the right medico-legal (and full legal) advice and assistance when you need it.  There is never any benefit to waiting to see whether the matter develops into anything serious.

You need to notify your Incision insurers as soon as you know or suspect that a criminal allegation may be made against you.  You should do that regardless of whether you think the allegation will have any merit, and regardless of whether the alleged incident was in your NHS or private practice, or indeed in your personal life. 

For example, it may be that your hospital is investigating an alleged criminal incident, or a patient or family member makes an allegation or threatens to report you to the Police.  Even if you think they have no good reason to refer you, and even if it seems like an empty or 'heat of the moment' threat, you should contact Incision straight away to protect your insurance position.  If you anticipate or suspect that the Police could get involved, you should contact Incision as soon as possible. 

Contacting Incision as soon as you can foresee that a Police investigation could start is doubly important, because of the 'multiple jeopardy' aspect. The Incision medico-legal team will assess whether the incident may also result in any other proceedings involving you, such as a GMC investigation, a claim for compensation or Inquest proceedings, and will protect your position by also notifying the parts of your Incision policies that deal with those other sorts of proceedings.

Perhaps more importantly, contacting the Incision medico-legal team as soon as you can foresee a problem means that you will get medico-legal support (and formal legal advice and representation, within the terms of your Incision insurances) at the time you need it, if and when matters progress.  This will give you the best possible prospect of getting through any such Police investigation with your professional reputation (and sanity) intact, and with expert and sympathetic advice and support every step of the way.

As a surgeon or doctor, you will certainly be handling sensitive health data about your patients. Unfortunately, if you handle patient data, there is always a risk that you will inadvertently commit a data breach.  These risks could range from 'old school' errors such as leaving paper patient records on a train, through to more technical breaches such as not having the correct patient permissions to use their data for certain purposes.

Also, surgeons and doctors are using computers, smart phones and electronic communication in their practises more than ever before. Some will also have set up small computer networks at home or in their clinics to help manage their practice alongside their practice manager and medical secretary. Again, there are inherent risks.  These could range from inadvertent errors such as accidentally sending sensitive patient information to the wrong email address, through to having patient data stolen by malicious third parties. Hackers have been known to gain control of a surgeon's computer network or email account and to demand a payment to release the system – this is known as a network extortion threat.  In the past it was mostly surgeons with celebrity clients who were targeted, but now absolutely anyone could be targeted, especially as 'ransomware' can be deployed to attack large numbers of victims.  Unfortunately, there is no security in obscurity, and all surgeons are potentially vulnerable.

Patients have rights in relation to their personal data and its safety, so any of these incidents could be a data protection breach even if the surgeon or doctor is as much a victim as the patient is. Under the Data Protection Act 2018, data subjects are able to claim compensation for data protection breaches, both for emotional distress and financial loss. The Information Commissioners Office has the power to fine an organisation over £20 million or 4% of the company's global annual turnover of the previous financial year, whichever is higher. On top of that, the surgeon may have to incur costs remedying the breach, or regaining access to a system that has been hacked.  Therefore, while such cases would be rare, in principle it is possible for a pure data breach to result in bigger liability for the surgeon than a clinical negligence claim, and has the potential for reputational damage for the surgeon too.

So, what should surgeons and doctors look out for and how can they protect themselves? This is a big topic! Incision has produced a more detailed guidance note for its members with tips on how surgeons can help prevent cyber-attacks and data breaches. 

But perhaps the most important way for surgeons and doctors to protect themselves is to make sure that they have a specific policy to cover Cyber risks (including data protection breach risks). A specially-designed policy is important because pure medical indemnity policies typically have express exclusions for cyber risks and data breaches. 

Incision's policy has insuring clauses to cover Security and Privacy Liability, Network Interruption Expenses, Event Support Expenses, Private Regulatory Defence and Penalties, Network Extortion, Liability arising from website media and even payment card industry fines or penalties.

Handling data is unavoidable!

After GDPR was introduced in 2016, and the Data Protection Act 2018 (DPA2018) passed in the UK, the security of personal data has had a higher profile than it had for many years. But managing data appropriately (and its close relation, patient confidentiality) has always been an important part of clinical practice for surgeons and doctors.

As a surgeon or doctor, you will certainly be handling sensitive health data about your patients. But you will also handle other categories of data about your patients. Personal data is any type of data which can be used to directly or indirectly identify an individual. This can include names, health related data, date of birth and postal addresses. Usually, the data will only be used for the purposes of providing clinical care to your patients and billing them (in private practice), but sometimes surgeons may also wish to use the data for training purposes, and some even as part of their publicity and marketing efforts.  Great care is needed to avoid inadvertent breaches of the data protection laws, and especially where the data is used for something other than clinical purposes.

Use of computers and electronic communication almost unavoidable!

The pace of developments in computing and electronic communication over the past decades has been remarkable. While most surgeons and doctors will still use paper-based records and notes for some purposes, there are now some treatments where the whole process, including obtaining the patient's consent signature, is done electronically.  Virtually all surgeons and doctors will use email for communication as a bare minimum, and many have more than one email account.  Virtually all surgeons and doctors now use smart phones for messaging, photo sharing, mobile email and even taking clinical photos. Many others have embraced digital storage of patient records.  Some will also have set up small computer networks at home or in their clinics to help manage their practice alongside their practice manager and medical secretary.  Almost all surgeons and doctors will now need to use computers and computer networks to be able to practice, both their own and those provided by the hospitals they work in.  Today, the use of computing and electronic communication is now almost unavoidable in clinical practice.

What are the risks?

Unfortunately, if you handle patient data, there is always a risk that you will inadvertently commit a data breach.  These risks could range from 'old school' errors such as leaving paper patient records on a train, through to more technical breaches such as not having the correct patient permissions to use their data for certain purposes.

Similarly, if you use computers or electronic communication, there are inherent risks.  These could range from inadvertent errors such as accidentally sending sensitive patient information to the wrong email address, through to having patient data stolen by malicious third parties. Hackers have been known to gain control of a surgeon or doctor's computer network or email account and to demand a payment to release the system – this is known as a network extortion threat.  In the past it was mostly surgeons or doctors with celebrity clients who were targeted, but now absolutely anyone could be targeted, especially as 'ransomware' can be deployed to attack large numbers of victims.  Unfortunately, there is no security in obscurity, and all surgeons and doctora are potentially vulnerable.

Patients have rights in relation to their personal data and its safety, so any of these incidents could be a data protection breach even if the surgeon/doctor is as much a victim as the patient is.  Under the DPA2018, data subjects are able to claim compensation for data protection breaches, both for emotional distress and financial loss. The Information Commissioners Office has the power to fine an organisation over £20 million or 4% of the company's global annual turnover of the previous financial year, whichever is higher. On top of that, the surgeon/doctor may have to incur costs remedying the breach, or regaining access to a system that has been hacked.

While such cases would be rare, in principle it is possible for a pure data breach to result in bigger liability for the surgeon/doctor than a clinical negligence claim, and has the potential for reputational damage for the surgeon/doctor too.

What should I look out for and how can I protect myself?

There are many forms of cybercrime including phishing, social engineering, system hacks, ransomware and network extortion threats.  Hackers are sophisticated and manipulative, so you must be on your guard.  If you find that you suddenly cannot access your usual computer system, computer or email account, consider whether you are at the start of a network extortion incident or other type of cyber-attack and seek help immediately.

To manage your risks, make sure you are using a professional email and computer system with a good level of encryption, and that you have set strong passwords.  It is unlikely that free consumer email services such as Gmail and yahoo will be able to provide the level of security you need to protect patient data and avoid cyber-attacks.  Also, be alert to emails, computer alerts and even phone calls that don't seem right.  Watch out for emails from addresses you don't recognise inviting you to click on links or open attachments.  Even if an email looks like it comes from someone you know, look out for things that don't 'fit', like a colleague whose spelling is usually perfect suddenly emailing you with a poorly written invitation to follow a link or open an attachment.

If you need to use portable devices to transport data, make absolutely sure they are properly encrypted.  Many Cyber policies (including the Incision one) contain important exclusions where an un-encrypted device is lost or stolen, so this is both a risk management issue and something that has a bearing on the availability of cover.  Think carefully about all the portable devices you use in your practice.  It may seem obvious to you that an external hard drive should be encrypted, but the same applies to any smart phone that you may have patient data on, and even the memory cards for your digital cameras.  Clinical photos are 'data' for the purposes of the DPA2018 too, so if your camera or camera memory cards are not capable of being encrypted, you would need to download them to an encrypted device and delete the images from the camera memory straight away.

Does my Incision policy cover these risks?

Your Incision suite of policies includes a specific policy to cover a range of Cyber risks (including data protection breach risks).  At the end of this article is a table providing an 'at a glance' summary of what is covered under that specific policy.

But a data protection breach or cyber incident can give rise to other problems for surgeons/doctors too.  For example, if a patient was so upset by an alleged data breach that they referred the surgeon/doctor to the GMC, then a GMC investigation could follow too.  Or if a malicious attack on a surgeon or doctor's computers somehow interfered with a patient's clinical care (perhaps deleting records such that an important follow-up was missed and a problem went undiagnosed), then a clinical negligence claim could follow too.

Therefore, if you have any concerns at all about a potential data breach or cyber incident, or if anyone alleges that their data has been lost or misused, the best thing to do is to contact the Incision medico-legal helpline for guidance immediately.  They will be able to assess what notifications are needed to protect your insurance position, and they or your specialist insurers and the insurers' specialist professionals can also provide you with urgent guidance on managing the situation.

Contacting the Incision helpline promptly is particularly important because the terms of your Cyber policy require you to notify as soon as you become aware of any claim (within 14 days) or any circumstance which may lead to a claim (within 30 days).

Incision Cyber Cover at a Glance

Bodily injury caused by a Cyber Event

As the market leader, we strongly believe in looking for improvements to the scope of our Members' cover and we are proud to announce another enhancement to the scope of Incision cover.  Existing Members will have the benefit of this enhanced cover straight away, and new Members will have the benefit of this enhanced cover when they join.

There are numerous ways for a Cyber Event to happen, but among the most potentially dangerous include network extortion threats, incidents where a malicious third party locks you out of your own computer system or email account, or a computer virus that locks you out or deletes data.

The risk for you and your patients is that this will adversely affect patients' care.  Patient records could be lost or deleted and would take a long time to recreate. Inviting and arranging follow-up appointments could be severely disrupted. Delays in follow up could result in diseases including cancer going undiagnosed and untreated, or serious post-op complications not being managed.  There are so many situations where a delayed follow up could result in very severe clinical consequences for the patient.

In short, there are situations where a Cyber event could lead to bodily injury to your patients, not just financial loss and inconvenience to you.

Many other policies have a lacuna in cover here.  Most medical indemnity policies contain exclusions to ensure that the medical indemnity insurer does not inadvertently become liable to pay the financial cost of a Cyber incident.  And similarly most Cyber policies contain exclusions to ensure that the cyber insurer does not inadvertently become liable to pay clinical negligence compensation claims. The combined effect could be that a clinical negligence claim where the 'negligence' was clearly caused by a Cyber incident, might not be eligible for cover under either policy.

The enhancement to the Incision medical indemnity policy is designed to solve this problem.  The wording has now been amended to make it clear that even where the patient's claim for bodily injury arises from a Cyber event over which the surgeon had no control, the patient's claim for compensation for those injuries is still covered.

While cover will always be subject to the overall terms and conditions of the policy, we hope it reassures to know that we are always working hard to identify ways to protect our Members, and their patients, in the best way.

Incision Members can contact the 24/7 Incision Medico-Legal helpline if they ever need to discuss or notify these or any other incidents arising from their practice.

Do you know how to get it right from the start and what to do if it goes wrong?

Your doctor/patient relationships are sacrosanct. They require mutual trust and respect, communication, and empathy. In the majority of cases you will establish and successfully complete treatment relationships with your patients but, like all relationships, some should not have started in the first place, others start well but face difficulties, and occasionally the relationship entirely breaks down and has to be terminated. 

Incision knows that as a private surgeon, doctor or Clinic providing non-urgent care, you need to know how to select the right patients for your practice from the beginning – and how to avoid taking on patients that you can never satisfy.  If challenges unexpectedly emerge later, you also need to know how to manage the patient relationship.  If matters reach the stage where termination of that relationship is permissible or even mandatory to comply with your professional conduct obligations, you need to know how to terminate that relationship with the minimum possible consequences for you and your patients.

Difficulties in the patient relationship can sometimes lead to compensation claims, GMC referrals or even police investigations.  Therefore you also need to be able to identify when you need medico-legal guidance on a particular patient, and also when to notify your insurers to protect your insurance position. 

Incision members have access to detailed written guidance materials (a toolkit) on these important topics, and this article contains extracts from that guidance.  Incision members also have access to a 24/7 medico-legal/notifications helpline so that their members always have access to guidance on individual cases.

The art of patient selection

To help protect yourself and be able to offer the best service to your private patients, you need to evaluate:

• What is this patient looking for?
• Am I the right surgeon, doctor or Clinic to provide what they need?
• Would it be in the patient's interests to politely decline and refer elsewhere?

The question of how you effectively (yet efficiently) carry out this evaluation will depend on the features of your particular practice.  A robust process will likely include good pre-consultation paperwork (patient questionnaires and information leaflets), asking key questions at each initial consultation, and including certain information as standard in your follow up clinic letters.

These considerations have an overlap with obtaining Montgomery compliant informed consent.  The factors that help you evaluate whether you will be able to satisfy this particular patient's expectations are often similar to the factors that help you understand what risks are 'material' to them.  The factors will depend on your medical specialism and practice, but to take just one example, a patient who wants to be fully recovered by the time of their wedding could have higher expectations of the outcome of the surgery or treatment and more likely to complain about non-negligent complications. If you always check in advance whether the patient has any special events coming up (or other time pressures) then you can make an informed decision about whether you want to take on a patient in the first place, and if so make expressly clear that they are accepting a risk of not being fully recovered in time for the wedding.

The art of patient selection is to develop and refine ways to identify the patients who are most likely to complain even if the treatment has gone objectively well.  Given your professional conduct obligations, it is considerably easier to politely decline to treat a patient and refer them elsewhere, compared with the difficulties of terminating a patient relationship once you have commenced treatment.

How to conclude the doctor/patient relationship after treatment has started

If you are considering discharging them from your care before their treatment is concluded, you will need to establish that termination of the professional relationship is justified.  This will need to be evaluated on a case by case basis, and ideally with medico-legal guidance on the GMC's rules and guidance in these situations.

Most medical professionals will be involved in an Inquest at some point in their careers, whether this involves attending purely to give witness evidence, or as an Interested Person ("IP") in their own right.

Even where the surgeon/doctor's only role is to give evidence, it can still be a daunting experience.  Especially as an unexpected patient death is usually distressing for the surgeon/doctor as well as for the family of the deceased.  But where the surgeon or doctor was directly involved in the circumstances of the death, the Coroner's findings can have consequences.  The family of the deceased may use the findings to help progress a compensation claim against the surgeon/doctor, the Coroner might refer the surgeon/doctor to the GMC to investigate their fitness to practise, or (rarely) the police might need to investigate whether the death was the result of a crime.

An Inquest is very much a fact-finding inquiry, as opposed to a fault-finding trial.  The Coroner has no power to levy fines or order compensation. But there are still situations where a surgeon/doctor needs their own individual legal representation.  A surgeon or doctor who is given IP status by the Coroner has the right to actively participate in the Inquest proceedings, including all the preliminary hearings dealing with questions of evidence and procedure.  It is unlikely that a surgeon or doctor could effectively represent themselves as an IP, and it is not always appropriate for the surgeon/doctor to rely on the lawyers for the hospital or Trust, so formal legal representation for the surgeon/doctor can be vital. 

There are other practical difficulties for surgeons and doctors, because the Coroner may require a written report/statement from the surgeon/doctor before the Coroner has decided who will have IP status.  That statement will become an important part of the evidence, so if there is any prospect that the surgeon/doctor might become an IP they should seek assistance from their indemnifiers and medico-legal advisers straight away.

With this in mind, surgeons and doctors need to check that their indemnity arrangements include cover for the cost of legal advice and representation if they are made an IP.  Surgeons and doctors also need to understand any notification requirements of their indemnity arrangements and notify promptly if a patient death could lead to the surgeon/doctor being an IP at the Inquest, or to a GMC referral, a clinical negligence claim or even a police investigation.  Notifying at the right time is in your interests because it avoids potential problems with cover, but also gets you access to the right medico-legal (and full legal) advice and assistance when you need it.

The details of Inquest procedure is unfamiliar to most surgeons and doctors, so Incision has produced a detailed guide to give Incision members an overview of the Inquest process, to demystify it and provide some key guidance.  Incision members have the benefit of insurance policies that pay for legal representation in Inquests where the surgeon/doctor is an IP, as well as GMC investigations and police investigations, and of course cover for compensation claims.  Incision members also have access to a specialist medico-legal helpline team staffed by dual qualified doctors and lawyers who are on hand to assist and support members if they are unlucky enough to be involved in an Inquest.

A single clinical incident in private practice can potentially result in multiple jeopardy for any GMC-regulated surgeon or doctor. It can potentially give rise to a clinical negligence claim, a criminal investigation, an Inquest or even a GMC investigation.  If a GMC investigation proceeds to a full Fitness to Practise ('FTP') hearing, then the worst case scenario is removal from the Medical Register and the effective end of the surgeon/doctor's career.

Few GMC investigations get as far as a full FTP hearing, but even at the earliest stages, surgeons/doctors can find GMC investigations incredibly stressful. 

A referral can arise out of anything that could impact on a surgeon/doctor's fitness to practise. This can include matters relating to clinical competence, the surgeon/doctor's own physical or mental health, or the surgeon/doctor's behaviour towards others.  A referral to the GMC can come from a range of individuals and organisations. 

Sometimes a surgeon/doctor is informed that a referral is being made, but often their first knowledge of the investigation is when the GMC sends its Rule 4 letter and a Work Details form.  The GMC allows an opportunity to provide comments at the Rule 4 stage, and surgeons/doctors are often very keen to do so.  But a careful judgment has to be made about whether to comment at all at this stage - it is not mandatory and it is not always in the surgeon/doctor's interests.  Medico-legal (and sometimes full legal) advice is often necessary to assess what is best in that individual case. 

Regardless of whether comments are made to the GMC at the Rule 4 stage, a surgeon/doctor should give very careful consideration to whether there is any 'remediation' that they should do to protect and mitigate their position (even if they do not consider that they did anything wrong).  The surgeon/doctor may well benefit from medico-legal (and sometimes full legal) advice about remediation. 

At any time in the process, a surgeon/doctor can be referred for a hearing before the Interim Orders Tribunal ('IOT') to decide if a surgeon/doctor's practice should be restricted while an investigation takes place.  Given the potentially very significant impact on a surgeon/doctor's practice, surgeons/doctors should usually have full legal representation at an IOT.

If the Registrar has decided that the concerns need to be investigated by Case Examiners, the GMC will write to the surgeon/doctor with specific allegations, providing them with full documentation supporting those allegations. This is known as the Rule 7 stage. The surgeon/doctor has 28 days to respond. 

After that the outcome can range from no further action to warnings to undertakings or referring the matter for a full FTP Hearing before the MPTS.  If an FTP hearing takes place then findings of fact will be made and findings about whether there is any impairment in the surgeon/doctor's fitness to practice.  The consequences of a finding of impairment can include removal from the register, so full legal representation is essential for the surgeon/doctor.

With all this in mind, surgeons/doctors need to check that their indemnity arrangements include cover for the cost of legal advice and representation if the GMC investigates them, and particularly from the Rule 7 stage onward.  Surgeons/doctors also need to understand any notification requirements of their indemnity arrangements and notify promptly once they learn of a GMC referral, or of circumstances that could lead to a GMC referral (such as a threat of referral or some hospital investigations).  Notification is even more vital if the issue or incident could also lead to the surgeon/doctor being an Interested Person at an Inquest, or to a clinical negligence claim or even a police investigation.  Notifying at the right time is in your interests because it avoids potential problems with cover, but also gets you access to the right medico-legal (and full legal) advice and assistance when you need it.

The details of GMC procedure are unfamiliar to most surgeons/doctors, so Incision has produced a detailed guide to give Incision members an overview of the GMC process, to demystify it and provide some key guidance particularly on remediation.  Incision members have the benefit of insurance policies that pay for legal representation in GMC investigations, Inquests and police investigations, and of course cover for compensation claims.  Incision members also have access to a specialist medico-legal helpline team staffed by dual qualified doctors and lawyers who are on hand to assist and support members if they are unlucky enough to be involved in a GMC invesitgation.

Many surgeons and doctors prepare expert reports for use in civil or even criminal litigation, or even in GMC proceedings against another surgeon or doctor.  But is insurance necessary for expert witnesses? 

A 2011 court case, Jones v Kaney [2011], overturned the historical partial immunity of expert witnesses from being sued.  An expert witness can be sued in negligence just like any other professional whose role involves giving an opinion about a technical subject.  The phenomena of expert witnesses getting things wrong is so common that a legal journal called Lexology carried an article in 2018 commentating on recent cases where there had been "deficiencies".  The author reviewed a number of published cases and summarised typical mistakes including "Lack of Realism", "Applying the Wrong Test", "Attempt to Mislead", "Unreasonableness", "Lack of Independence."

While mistakes and misunderstandings might be more likely at the early stages of an expert witness's career while they are still gaining experience, even the best experts can inadvertently fall into error because the most respected and experienced expert witnesses will tend to get instructed in the more difficult types of cases.

Also, experts can inadvertently lose confidential information or data, or be the victim of a hacking attack or other cyber event, which can lead to both claims for compensation and possibly also fines from the ICO.

Even more concerning, surgeons and doctors can and do get referred to the GMC for reasons arising from their expert witness work alone.  Referrals can be made by the instructing party, the other side or even the Judge if he or she considers that the expert has significantly failed in their duty to the court.

Is insurance necessary for expert work?

If you do the sort of expert witness work that requires you to hold a licence to practise (for example because a clinical examination is part of your instruction) then you need to hold medical indemnity insurance to comply with GMC requirements and avoid a professional conduct breach.

Even if medical indemnity insurance is not technically obligatory (perhaps purely 'desk-top' reports with no clinical examination), it would be very risky indeed to undertake medico-legal/expert witness work without insurance to protect you from third party claims, GMC referrals or cyber events arising from it, and to pay for the necessary specialist legal advice and representation.  Insurance is a practical necessity to protect against the inherent risks of expert witness work.  Given the highly specialised nature of medico-legal expert witness work, it is necessary to obtain your insurance through a specialist such as Incision, which can understand and meet your needs.

What about jurisdiction and territorial limits?

Have your instructions come from outside of the UK for use in proceedings outside of the UK?

If so, it is vital to check your insurance cover for your expert witness work, to make sure that you are covered to carry out work in that jurisdiction, and that you are covered if a claim against you is started in the courts of that jurisdiction.

When should I notify my indemnifiers? 

Even unmeritorious or misconceived allegations against you should be notified to your indemnifiers as soon as you know about them, to protect your insurance position.

If your indemnifier provides a medico-legal helpline service you should contact them for guidance straight away.  Dealing with a complaint arising from your expert witness work can be complicated because of the impact of the relevant procedural rules and your duties to the Court, so it is best to get specialist assistance to avoid exacerbating a problem. 

Incision members have access to a medico-legal helpline staffed by dual-qualified doctors and lawyers, with experience in assisting members in problems arising from their expert witness work.

Unfortunately, complaints (whether reasonable or not) from patients are almost inevitable. Complaints could stem from the treatment itself, whether due to unfortunate complications or errors in the surgery, or clinical care. Some patients complain about the clinicians's behaviour.  Administration issues such as invoicing or scheduling of appointments is also a regular topic. Therefore, it is imperative that clinicians, and all members of practice staff, are able to deal with complaints effectively to minimise the time they take up, any damage to the doctor/patient relationship, as well as any subsequent reputational damage.

All surgeons and Clinics should have a written complaints policy for their private practice. It is CQC requirement.  A written complaints policy also benefits the clinician. They can give patients comfort that they can voice concerns and be taken seriously. They can also help to manage the expectations of patients – some demand an immediate response even on complex issues, but this is simply not feasible.

A written complaint policy does not have to be long or complex. The key is to set out the steps you will take, together with the timescales. For example, say when you will acknowledge the complaint (eg, within three days of receipt), and when the substantive response will arrive (eg, within 14 days).  Once you have created your written complaints procedure, make sure that all your patients and staff know where to find it.

When responding to a complaint you need to set out an honest and accurate response, expressed in a suitably courteous tone, even where your conclusion is that the complaint is baseless. Where the complaint actually has merit, it is important than you apologise and accept your mistake. Put simply, mistakes do occur and it is better that clinicians/the practice accept these mistakes rather than attempt to hide them, mislead the patient and breach the GMC Good Practice Guidelines.  Alternatively, if you find that the complaint has no merit, then you should of course state this and explain why, albeit without appearing dismissive.

The other key thing is to notify your insurers. Depending on your indemnity arrangements, you may be obliged to notify your insurer/indemnifier about the complaint to comply with the terms and conditions and protect your position in case the matter ever develops into a claim and you need indemnity. Contacting your insurers can also be helpful for you, because you can gain access to any medico-legal assistance provided by your indemnifier. Incision members have access to a medico-legal helpline service staffed by specialist dual-qualified doctors and lawyers, who will assist on responding to the complaint, and notifying your insurers if needed.

Do:

• Make your complaint policy easily accessible to your patients.
• Make your policy as clear and simple as possible.
• Maintain patient confidentiality even once a complaint is made.

Don't:

• Ignore a complaint in the hope that it will go away.
• Respond immediately or without getting guidance.
• Automatically cease treating the patient.

As the COVID-19 Vaccination program progresses with speed across the UK, our members will be aware that not all patients are accepting the offer of a jab; a decision for each individual patient to make for themselves.

Our members should, however, be aware that they themselves are in a special position when it comes to the COVID-19 vaccination. This is due to the fact that they treat vulnerable patients on a daily basis and risk passing on the coronavirus at each face-to-face consultation, even with the use of PPE equipment. As such, they should consider carefully their own decision on being vaccinated and as front-line staff, they will be high up on the list of priority patients and should be offered it early on.

The GMC has published advice on their website as below:

As a doctor, should I be vaccinated against COVID-19?

In Good medical practice we say at paragraph 29 that doctors should be immunised against common serious communicable diseases, unless this is contraindicated.

While there is no absolute duty to be vaccinated against any particular disease, there is a potential risk of inadvertently spreading coronavirus to vulnerable patients. This weighs in favour of doctors being vaccinated unless there are good reasons why it isn’t appropriate in your individual circumstances.

We recognise that you may need to take account of any underlying health conditions. In some cases, there may be other appropriate options for managing any risk to patients and colleagues. 

If you have good reason not to be vaccinated, you need to be confident that there are measures in place where you work to manage any risk of transmission to patients. You will need to take appropriate steps to reduce risks and prioritise patient safety.

In addition, The BMA, NHS England and the CMO, Professor Chris Whitty, have clearly stated that Doctors have a ‘professional duty’ to be vaccinated.

There may also be obligations in employment contracts to be vaccinated against communicable diseases and therefore a legal duty to accept the vaccine when it is offered.

We would therefore advise our members to consider their own position carefully in light of the above advice. If you have any further questions, please contact us.

Dr Anahita Kirkpatrick

24 February 2021

2020 was a challenging time for most, but especially hard for many of you on the front line.

As a token of heartfelt appreciation for those working hard to keep us safe, Incision is pleased to have donated to and support the Royal Medical Benevolent Fund (RMBF), the charity for doctors. 

The RMBF provides support for doctors and their families through all stages of their career and beyond. This support ranges from financial assistance in the form of grants to a telephone befriending scheme for those who may be isolated and in need of help. 

Whilst we sincerely hope you or your colleagues will never personally need such support, recent times have shown that unprecedented events can bring about changes that we are unprepared for. Depending on the event, indemnity insurance can be an important cushion. However, the RMBF can offer a lifeline in times of hardship for doctors, medical students and their families, a cause which Incision are very happy to contribute to going forward.

Creating suitably clear and detailed patient records is a professional conduct requirement and is vital to providing good care to your patients. Good records are also extremely important from a medico-legal perspective. In the event of a complaint, claim or regulatory action against you, these records are key to your defence.

But even after the records are created, there are more responsibilities, lasting for years. The records have to be stored safely for lengthy periods, in case they are needed for future clinical care or legal action. Therefore, storage, retention and access to confidential medical records is a daily and ongoing activity and concern for surgeons in private practice.

This guidance note aims to provide Incision members with an overview of their obligations and of good practice. It will also assist with some questions that Incision's medico-legal advisers are frequently asked. We hope it is helpful, but more specific advice is always available via the Incision medico-legal helpline service (medicolegal@incisionindemnity.com).

How long must I retain records?

For private practitioners, the relevant guidance is set out in The Private and Voluntary Health Care (England) Regulations 2001 (Schedule 3). This sets out minimum periods that private records should be kept, and includes the following:

• For patients who were under the age of 17 at the date on which the last treatment was concluded, keep the records until that patient’s 25th birthday
• For patients who were aged 17 at the date on which the last treatment was provided, keep the records until that patient’s 26th birthday
• For patients who died before the age of 18, keep the records for a period of eight years beginning from the date of the patient’s death
• For patients treated for a mental disorder, keep the records for 20 years beginning on the date of the last entry or eight years from the date of the patient's death
• All other cases - a period of eight years beginning on the date of the last entry in the patient records.

These are minimums – should I retain records for longer?

There may well be situations where it is sensible (albeit not obligatory) to store those records for longer than the prescribed minimums, depending on the particular features of your practice. It may help to think about the clinical and legal rationale for retaining records for many years.

From a clinical perspective, the records are retained for years in case they are needed for future clinical purposes – essentially they are being retained for the patient's benefit. You will know your own practice best, so consider whether you carry out procedures where your detailed medical records may still be needed for clinical reasons after eight years. In our experience this is fairly rare, especially if the key details are in correspondence to the patient's GP, as GP records are usually retained for longer than eight years.

From a legal perspective the records are retained for years in case they are needed for the purposes of a compensation claim by the patient – essentially they are being retained for your benefit and protection. Therefore, the question of how long to retain the records depends on when the patient's ability to bring a claim expires.

In most cases involving adults with full mental capacity, the patient has only three years to bring the claim starting from the date of injury or the date of knowledge, which can be later. The Court also has a discretion to extend the period further. However, in most cases the patient's right to bring a claim will have expired well within the statutory eight-year minimum record retention period, so there is no need to retain the records for longer. 

But there are some key exceptions. In law, if a person is “under a disability” (broadly, they lack mental capacity due to mental illness, other illness or injury) then the normal time limit for starting their claim does not start until they have capacity again or they die. To take an extreme example, if a patient was an in-patient at a mental health facility lacking capacity, or in a coma, for many years, on recovery the patient could still be within the time limit to bring a claim. If you had destroyed your records by then, it might prove difficult to set out any positive defence. In many specialisms’ patients with serious ongoing lack of capacity are rare. But, for those such as neurosurgery or some types of spinal surgery, errors or complications are more likely to result in the patient lacking capacity for a time. Therefore, it might be prudent for surgeons in these specialisms to consider retaining their records for longer than the statutory minimums, in cases where these types of complication occur.

Even where your patient is an adult with full mental capacity, there can be occasions where they are legally entitled to bring a claim very many years after the procedure in question. There are cases where neither the clinician nor the patient could have known about any negligence until many years after the event. To give an extreme example, a hip replacement may appear to have gone smoothly at the time. If the prosthetic joint fails earlier than expected, the joint would be replaced. It might become apparent at the revision surgery stage that the early failure was due to an error during its original implantation. Only at the time of the revision surgery does the patient know that there was an error and that it caused an injury sufficient to require revision, so in this scenario the three-year limitation period would only start then. The patient could start a claim after the minimum retention period had elapsed and the records destroyed. Therefore, consider whether your practice involves the risk of 'latent' errors or complications that may take many years to come to light. If so, it might be prudent to consider routinely retaining the records for longer than the statutory minimums.

What if I don't hold all the records?

The guidance above applies to the records that you personally hold. However, other records relating to the patient and the procedure you performed might be held by a third party, such as a private hospital. Nursing records are an obvious example and these types of records can be as important to your defence as your surgery notes on the day of the procedure.

For the records that are held by a third party such as a hospital, it will be the responsibility of that entity to retain the records for the minimum period. That entity will likely have its own policy as to whether and if so when records are retained for longer than the statutory minimums.

In practical terms, there may not be much you can do to persuade third parties to retain records for longer than the statutory minimum. The logistical challenge of managing such large volumes of records can make it difficult to accommodate exceptions and requests. Probably the best you can do is identify what procedures you carry out where a longer retention period would be sensible for the protection of you and the hospital, and contact the records management team to find out whether they can accommodate your request or make a longer retention period standard for certain procedures.

Can I just retain them forever to be on the safe side?

In short, no. One of the principles of GDPR, brought into UK law by the Data Protection Act 2018, is 'data minimisation'. In short, you should not create more data than is necessary, nor keep it for longer than is necessary. Therefore, you cannot retain medical records indefinitely. You should consider how long you need to retain the records using the guidance above and at the end of that period arrange for the records to be securely destroyed or deleted.

Thoughts on storage of medical records

Good practice in safely storing medical records for long periods is potentially a complicated question in itself. 

The type and volume of medical records that the individual consultant will need to retain and store very much depends on the features of their individual practice.  Some consultants will hold all of the medical records for a procedure.  Others will only hold a handful of clinic letters and some clinical photographs, with all the other records being held by a private hospital or clinic.  Some will hold only hard copy records, some only electronic, with most holding a combination.  The storage of hard copy records and electronic records each have their own logistical and technological challenges, as well as different costs.

For that reason, it is difficult to give general guidance about the 'best' way to store records for the minimum required periods, but these high-level principles may assist.

• Think about how and when you create documents or records. Also, what administrative processes you have in place to ensure that those documents are reliably transferred to the patient file and thereafter retained or saved for the relevant time. If you work with a medical secretary many of these processes may already be well established and robust, but do look for potential problems. One aspect that is often at risk of being overlooked is clinical photographs, especially if the images need to be transferred from the camera's memory to be filed or stored. It might be worth auditing your processes every few years or every time you change medical secretary to make sure that your records retention processes remain suitable.
• Security of the records is vital, especially given that you are inevitably dealing with sensitive health data. For electronic records password protection might not be enough, and encryption of the records may be necessary.
• Continued access to the records is also vital, as the records could be requested by a patient (or your defence lawyers) at any time. Consider what fail-safes you need in place to ensure that the records will always be accessible, even in the event of your own death or incapacity.
• Have a plan in place to securely destroy or delete records once the relevant retention period has expired.

What about my Incision insurance?

Your Incision policies include protection in relation to a number of scenarios relating to your duty to make and retain medical records. For example, there is cover available for certain consequences of medical records being inadvertently lost or destroyed (for example by fire). Similarly, there is cover for a number of consequences of data protection breaches, such as those that arise when hard copy records are lost or stolen, or when your electronic systems are maliciously 'hacked' for the information they contain.

Therefore, if you ever have any concerns that medical records you are responsible for have been lost or destroyed, or if you are concerned that patient data or records has fallen into the wrong hands, please contact the Incision medico-legal helpline team without delay (medicolegal@incisionindemnity.com) and they can assist you with any necessary notification to your insurers to protect your insurance position, as well as getting you access to any specialist assistance you may need.

Incision

January 2021

In our experience, the most difficult claims come from patients that the surgeon, doctor or Clinic could have avoided treating.  Surgeons, doctors or Clinics sometimes unconsciously assume that they should treat any patient who comes to them.  As long as you are not rejecting patients for discriminatory reasons (a professional conduct breach), in private practice there are times when this is the most robust risk management action a clinician can take.  When seeing a new prospective private patient, things the surgeon, doctor or Clinic should be considering include:

1.Is this a 'serially dissatisfied' patient? You will ask about previous procedures as part of the medical history. Consider asking whether the patient was happy with their care and the outcome.  Was the patient was unhappy with his or her care for reasons that you consider to be odd?  If so, consider whether this patient has unrealistic or unmanageable expectations, and whether you want to take the risk of treating them, especially given that revision procedures often carry greater risks than the initial procedure.

2.Does the patient suffer from a personality or mental health disorder? When taking the medical history, you should include questions to screen for them. If the patient does have a disorder, this may not be a reason to reject them in itself.  However, the results of the screening questions can be an indication that you need to know more about that aspect of the patient’s medical history, or even an independent psychological evaluation, before you can make an informed decision over whether you should accept them.  In a serious case the patient’s ability to give informed consent to a procedure might even be impaired.  Effective screening gives you the opportunity to avoid inadvertently treating patients with severe problems, and to help you give appropriate care to those patients that you do accept.

3.Is the patient trying to emotionally manipulate you?  Some surgeons, doctors or Clinics accept patients because the patient flatters or pressures them into providing care against their better judgment.  Unfortunately, compliments paid before the treatment don't stop the patients from making complaints afterwards.  Trust your gut.  If you decide that you cannot or should not treat any particular patient, don’t allow yourself to be persuaded by emotional appeals.

4.Is the patient non-compliant? Perhaps you suspect that the patient doesn't understand what you are offering them in terms of advice and treatments, or that they will not comply with your after-care instructions properly. Take extra care to make full clinical notes and notes of any advice or warnings you have given, and find ways to double-check that the patient is actually giving informed consent to any treatment you agree to give.

5.Is this a high net worth patient? Consider your risk appetite. In a worst case scenario there could an extremely large claim for the patient's loss of earnings.  For patients such as high profile sportspeople or musicians, or other high earners, even a relatively minor adverse outcome could be enough to prevent them returning to lucrative work.  You don't necessarily need to avoid treating all high net worth patients, but consider how many such patients you take on and for what treatment.  Work with Incision to ensure you have the right amount of insurance for your practice.

A safe and profitable private practice depends on having good patients, so be discerning when accepting new patients.

This article is an extract of a more detailed and extensive guidance note available only to Incision members. 

Complaints and claims against healthcare professionals – including surgeons/doctors in private practice – are an unfortunate fact of life these days.  That is why having excellent medical indemnity insurance is so important.  But are you getting the most out of your medical indemnity insurance?  Do you know:

• Why using your medical indemnity insurance pro-actively can save you time and money - and help protect your professional reputation?
• How to avoid breaching the terms of your medial indemnity insurance – and losing cover altogether?
• How to educate your medical secretary and other colleagues about getting the best out of your medical indemnity insurance?

Some surgeons/doctors seem to forget they have medical indemnity insurance, or treat it as a last resort.  We hear anecdotally that some surgeons/doctors deliberately avoid informing their insurers about potential problems, assuming that this will automatically result in higher premiums at renewal.  But this is not the case!  Medical Indemnity Insurance does not work in the same way as, say, car insurance.  Reporting a precautionary notification is not the equivalent of getting points on your driving licence.  Reporting a potential error, a complaint or a potential claim to a Medical Indemnity Insurer is a confidential process, and it does not carry any implication or inference that you accept you have done anything wrong.  Insurers are much happier for you to have a dozen very precautionary notifications on their books that never develop into anything, than be told about one full blown claim far too late.  

In reality, you should pro-actively involve your medical indemnity insurer as soon as you know about a potential error, complaint or claim.  And this is especially so where your insurance arrangements include access to a proper medico-legal advice line.  Medical indemnity insurers, and the medico-legal advisers who work alongside them, are very experienced in dealing with these issues, so they can help and guide you to resolve or mitigate the situation as quickly as possible.  Also, your medical indemnity insurers and medico-legal advisers have the expertise to know when specialist lawyers are needed, so you get legal help at exactly the right time.  Far too often, healthcare professionals delay in informing their medical indemnity insurers about a potential problem, thereby denying themselves access to specialist assistance that could save them time and money. 

Of course, you can only get the best out of your medical indemnity insurance if you comply with all its terms and conditions.  You need to know how to avoid inadvertently breaching the terms of your personal insurance policy, especially as some breaches can lead to you losing cover altogether.  Like all insurance policies, your medical indemnity insurance requires you to inform your insurers (“notify” them, in the jargon) of any allegation of negligence, or anything which could indicate that a claim might be made in due course.  The duty to notify without delay is sometimes so strict that if you fail to do so at the right time, your insurers can refuse to cover the claim at all.  This could leave you liable to pay your own defence costs and any compensation due to the claimant; potentially eye-watering sums if they had to come out of your pocket.

Most self-employed surgeons/doctors have to apply for and purchase their medical indemnity insurers themselves.  They will inevitably be asked whether they know of any errors, complaints, claims or issues that could give rise to a claim later on, and will no doubt answer honestly.  If errors, complaints or claims come to your attention during the policy, Insurers have to be told straight away, and all surgeons should make sure they understand what their policy requires of them in that regard. 

But are you always made aware of complaints or potential claims against you?  Do you ever find yourself asking a colleague, “why didn’t you tell me sooner?”  A really important way to get the most out of your medical indemnity insurance is to make sure your medical secretary also recognises when a problem might need to be referred to your medical indemnity insurers.  Similarly, if you work in a private hospital or clinic, you may need to be pro-active in getting the hospital's management or legal department to keep you properly up to date about patient complaints as they develop.  The patient may have indicated to the hospital that a claim against you is contemplated (for example in the course of requesting medical records), but time and time again nobody at the hospital actually informs the self-employed surgeon/doctor.   

So what do Insurers need to be told about?  Experienced practitioners will be used to dealing with patients who voice some dissatisfaction.  You need to recognise when things have gone further and become something that Insurers might need to know about.  Depending on the exact features of your practice and the exact wording of your policy, you will probably have to notify insurers as soon as you become aware of a claim or a ‘circumstance which could lead to a claim’.  A claim can include any allegation of negligence, or even just an assertion from a patient that they are entitled to compensation.  You (and your secretary or colleagues) need to be alert even to spurious allegations or assertions, whether made in writing, over the phone or in a consultation.  As for ‘circumstances that could lead to a claim’, examples could include a situation where you or a colleague notice that a mistake has been made in a procedure that could have consequences for the patient in due course.  Insurers may need to be informed even if the patient has not yet complained.  Most surgeons/doctors have the Duty of Candour at the forefront of their minds, but too many forget that their insurers also need to be informed of these incidents straight away. 

How can Incision help?

Incision insureds have access to a dedicated medico-legal/notifications service staffed by specialist dual-qualified doctors/lawyers.  For Incision members, help and guidance about any of these issues is only ever a call or email away.  Incision members also have access to detailed guidance and learning materials, and this article is a shortened version of more detailed materials available only to Incision members.

*Article originally published in February 2020

Despite the astounding pace of scientific research and development relating to Covid-19, there are still some crucial medical and scientific questions about immunity from coronavirus. How long does any immunity last after recovering from Covid-19? How effective will the vaccinations be in real life? We all hope to have answers soon.

But surgeons, doctors and other healthcare professionals are also concerned about a different type of immunity – immunity from being sued or prosecuted in respect of their crucial work in these extremely difficult circumstances. Early in the pandemic it was reported that some bodies (including the MDU) were calling for emergency legislation to provide some form of legal immunity, particularly for the NHS and NHS staff. Lobbying has continued since then in the UK.  Some US states such as New York, New Jersey and Michigan did introduce some immunity from civil liability.

But what does this mean for healthcare professionals treating patients right now? And is this relevant to private practice?

So far the UK government has not made any such law. If any new protection was introduced, nobody knows whether it would only apply to NHS work, or provide some protection to those in private practice too. Until a new UK statue is actually passed, there is no immunity for healthcare professionals from claims, even those arising out of care and treatment provided at the various peaks of infections and hospitalisations.

At the moment, we have to assume that the normal legal tests for clinical negligence apply. Fortunately the legal test already builds in some flexibility to account for the circumstances in which the healthcare professional is working. As long as a reasonable group of healthcare professionals in the same circumstances would have done the same thing, then it is unlikely that the actions were negligent.

However, this may not be much reassurance to those healthcare professionals and commentators who fear that large numbers of claims and allegations will be made, despite the Herculean efforts being made across the country. We all hope that this fear is not justified, but cost of medical negligence in the NHS has climbed steeply in recent years, so it must remain a realistic possibility.

In these difficult and uncertain times, our advice would be:

• Don't be misled by opinion, speculation and lobbying – there is no guarantee that any new legal 'protection' will arrive, nor how it will work.
• As disheartening as it may be to be thinking about dealing with claims or allegations after all the sacrifices that are being made, it remains as important as ever to deal with complaints, claims and other investigations as you usually would. Those working in the NHS should follow the usual guidance from their Trust's legal and complaints teams. For those with their own personal Medical Indemnity insurance, it is more important as ever to comply with the requirements of that policy.
• For example, Incision members have cover for the cost of legal representation in GMC regulatory, criminal or certain inquest proceedings, regardless of whether the incident happened in the NHS or in private practice. Therefore, as long as they inform their insurers straight away about anything that could lead to GMC, criminal or certain inquest proceedings, then they have peace of mind and expert assistance at hand. Incision members have access to its dedicated 24-hour medico-legal helpline service, to make that process as quick and convenient as possible. Examples of situations the medico-legal helpline has assisted with include a threat to report a doctor to the GMC from a distraught family member. It initially appeared that the threat was in the 'heat of the moment', but the family of the patient who sadly died did then go ahead with a complaint to the GMC. Other examples in the current crisis could include allegations (even those based on an honest misunderstanding) over misuse of limited PPE supplies, or bullying allegations as tired and distressed colleagues misinterpret innocent interactions.
• Incision members also have cover in respect of complaints and claims arising from their private practice. To gain peace of mind, the key thing is to inform insurers straight away of anything that could lead to a claim. Even if a patient is making apparently absurd complaints such as not being able to see you in person during lockdown, the relatively small time needed to get the incident recorded with the insurers could save you from facing considerably bigger problems down the line.
• The other key thing will be to keep continuity of cover. Claims can be made for at least three years after the treatment in question (and very often longer), so healthcare professionals will need the best possible cover available to them in the years following this coronavirus pandemic. Many healthcare professionals' private income will have been reduced because of the lockdown, so there will no doubt be a temptation to economise on cover at next renewal. But we would recommend that it would be better to budget and plan ahead to get or maintain the best possible cover. It doesn't make sense to economise on your Medical Indemnity cover when some commentators predict a new wave of claims and allegations arising out of these unprecedented times.  For the same reason, if you happen to retire in the next few years, make sure you purchase excellent run-off cover to protect yourself against claims that may only arrive years after you stopped practising.

*Article originally published in May 2020

Even before the pandemic of 2020, technology developments had made remote consulting by telephone, message and video conference much more realistic than before, and various companies were already investing in this area as an attractive option for some patients. But there was an immediate increase in the use of tele-medicine because of the Covid-19 pandemic, and the U.K. government's various lockdowns, Tier restrictions and self-isolation rules aimed at slowing its spread. At the time of writing the mass vaccination program has started, although there has also been a worrying increased in cases. Therefore it seems clear that remote clinical consultations will continue to be necessary at least for the short-medium term.

But what are the insurance and risk management considerations for specialist surgeons and doctors who may be offering remote consultations in their private practice?

A vital consideration is whether the surgeon/doctor's medical indemnity insurance for their private practice covers them for remote consultations.  Any surgeon or doctor who is unsure should seek immediate advice from their broker.  Incision members are indemnified for remote consultations. 

Even where there is cover in principle, there can still be insurance technicalities.  In particular, the physical location of the patient can make a difference to whether there is cover for a particular remote consultation, because many policies have "Territorial Limits".  If the patient is outside of the UK, surgeons and doctors should get advice about whether their policy would respond. 

Patient confidentiality can also be tricky in remote consultations.  Surgeons and doctors need to think about the security/encryption of the device or telephone/video conferencing service they use for remote consultations.  If a third party could eavesdrop on an unsecured communication channel, that has very serious ramifications for the surgeon or doctor.  We cannot recommend any particular service, but www.nye.health is an example of a telephone/video conference service especially designed for doctors, that might be more appropriate than generic services that are not designed with patient confidentiality in mind.

Similarly, surgeons and doctors need to advise patients to take responsibility for their confidentiality wherever they are, for example by making sure that they cannot be overheard while having the remote consultation.

The GMC already has guidance on remote consultations - https://www.gmc-uk.org/ethical-guidance/ethical-hub/remote-consultations.  Patients need to understand the limitations inherent in a remote consultation, and make sure that they give informed consent to any agreed treatment plan, bearing in mind any risks arising from the surgeon/doctor's inability to carry out a physical examination.

A successful remote consultation will depend on the surgeon/doctor's ability to communicate clearly with the patient.  Therefore patients should be warned in advance to be prepared to spend time describing their physical condition in detail. The surgeon or doctor should consider where there are any language barriers or disabilities that might need to be taken into account.  Even the patient's broadband speed or mobile phone signal strength can have a bearing on whether a consultation can go ahead safely and without disruption.

With Covid-19 precautions causing very significant disruption to many surgeon/doctor's practices, remote consultations could be a good way of providing care.  Being alert to the risks can avoid surgeons and doctors facing liability problems down the line.

*Article originally published in April 2020

Most doctors get enormous satisfaction from working with patients, and the positive difference they make to so many lives. After the pandemic of 2020, the NHS is probably now more venerated by healthcare professionals and the general public than it has ever been, and rightly so. However, anyone with experience of the early years of training and practice knows how exceptionally tough that period can be, even without the additional pressures of tackling a novel coronavirus. There has been slew of medical memoirs over recent years, as well as high-profile disputes such as the government’s changes to the NHS junior doctors’ contract in 2019. These have made it more obvious than ever what a significant toll those years can have on doctors, both personally and financially.

So, anyone who becomes a consultant is to be highly praised not just for their medical skills, but also for their resilience. Many consultants (no reliable figures are available to say exactly how many) will at some point do private work. This is entirely understandable. The opportunity to earn additional income, and the hope of escaping at least some of the bureaucracy, must be extremely welcome after the challenges of a working life entirely within the NHS.

However, consultants starting out in private practice after years in the NHS are not necessarily equipped with all the additional knowledge and skills to run what is, in reality, a small business. Some of them face a rude awakening after tripping up over the many hazards that private practice can present. For those who turned to private practice as a way to increase income and reduce stress, imagine the sheer disappointment of having to deal with things like allegations of clinical negligence, breach of data protection laws, or even tax disputes. The pressure can be even more intense for those who are juggling private practice with ongoing NHS commitments, as well as family life.

The first key to success in private practice is to be realistic about what it will involve. There will inevitably be a learning curve on the 'business management' side of things. You personally will have to deal with issues that would be the responsibility of others as an NHS employee. Yes, some of it may be stressful, frustrating, time-consuming and expensive at first. If you acknowledge those realities in advance and take action (for example temporarily scaling back other responsibilities, or seeking additional help with childcare) then the transition to part or full-time private practice should feel a lot smoother.

The second key to success is having a support structure in place for your private practice. Think about whether you have any trusted friends or colleagues who also do private work, who might be willing to act as a 'mentor' for a while. Even more importantly, make sure that you have access to the right sort of professional advice. For example, you should choose an insurance broker who will work with you to make sure that you definitely have all the types of insurances you need (which will likely range from Medical Indemnity insurance through to Cyber insurance and possibly Employers' and Public Liability depending on your circumstances). Similarly, make sure that you have access to confidential medico-legal advice. Many of the hazards of private practice are related to the tangle of laws and regulations you will have to navigate, and there is no substitute for being able to speak to someone qualified to give reliable help.

Just to give you an insight into the sort of issues you will need to manage in private practice, here are some comments on topics that can often cause problems. Please bear in mind that this is a far from a comprehensive list.

Data protection

Patient confidentiality has always been paramount, but the financial consequences of failing to protect patients' data (including sensitive health data) are more severe than ever under the Data Protection Act 2018. The publicity around GDPR has also raised awareness with patients about their rights relating to their data. Don't treat data protection as an afterthought – patient confidentiality and data protection need proper planning and care to get right. You will need to be registered with the Information Commissioner's Office, and the ICO website has some helpful resources about your responsibilities as a doctor in private practice. Other practicalities will include making sure that all your electronic communications are definitely encrypted (please don't assume that consumer email services such as Hotmail and Gmail are sufficient), and training any admin staff you employ on how to keep data secure.

Marketing and PR

Some doctors need to publicise their practice, but care is needed to avoid problems. The data protection laws restrict what you can do in terms of sending out mass emails, for example. The GMC Code of Conduct contains guidance on what publicity activities are appropriate, and the rules about conflicts of interest can also be relevant where mutual referrals or financial incentives are involved. Vitally, don't assume that you can safely emulate the publicity you see from other doctors. For example, it has become very common for aesthetic doctors to post patient photos online, including on services such as Instagram. However, few of those are doing so in a way that complies with professional obligations, and huge numbers of doctors could well face regulatory action and claims as a result.

Dealing with complaints and claims

This is a huge topic in itself. There is a real skill in managing patient complaints and claims appropriately, including knowing how to phrase things in written correspondence. It takes time and professional guidance to acquire those skills. Even if you are used to helping to manage dissatisfied patients in the NHS, in private practice there are many other factors to manage. These include your wish to preserve the reputation of your private practice, your contractual obligations to your insurers and the possibility of fee refunds. On top of that you may well feel that the complaint is more 'personal' and upsetting than a similar complaint in an NHS setting. It is crucial not to feel pressured into responding to patients immediately and to seek medico-legal guidance, as well as guidance from your insurers, before you do anything substantive in response to a patient complaint.

Choosing patients

You need to think differently about patient selection in private practice. Don't have an 'NHS mind-set’ that you are obliged to treat everyone who comes your way. And don't assume that 'beggars can't be choosers' and take on any private patients available to build a practice. As long as you are not engaging in discriminatory behaviour, you can refuse to accept private patients in many circumstances. It is important to remember that this is good risk management and is also best for the patient. If you are unsure whether you can fulfil the patient's needs (including managing their expectations where relevant), then it might be best to refer them to someone else rather than risk disappointing them and inviting a complaint or claim.

Contracts with private hospitals, or private health insurers

Unless you are setting up your own clinic, you may well need to gain practising privileges at one or more private hospitals. Many surgeons will also need to get on to the approved surgeon lists of key private health insurers. Most hospitals and health insurers have their standard contracts that they will oblige self-employed private consultants to sign. However, it is important to properly understand the terms of those contracts, as well as any additional policies that the hospitals will require you to follow. Some consultants have signed hospital contracts, only to realise years down the line that various onerous terms apply if they want to cease practice at that hospital. Similarly, some doctors have got drawn into disputes with health insurers about the correct categorisation of particular procedures, and accordingly the correct fee. While individual doctors may not have much negotiating power with large private hospital groups or health insurers, they should at least have their eyes open to what they are signing up to. This should minimise the risk of inadvertent breaches, and of wasting significant time dealing with disputes with hospitals and health insurers.

*Article originally published in December 2019

The internet makes it simple to instantly tell the world precisely what you think. Anyone with an internet connection can post comments about anyone or anything on social media platforms such as Facebook, Instagram and Twitter. It now seems to be the norm for consumers to publicly rate and review every product and service. Websites are dedicated to the publication of consumer reviews, from Google Reviews to specialist sites such as Realself.com for cosmetic surgery.

Therefore specialist self-employed surgeons and doctors are increasingly likely to be commented about on social media, or be the subject of an online review by a patient. Which? it isn't, with the majority of reviews being self-published by the patients, with little oversight by host site’s moderators, nor much pro-active work by host sites to ensure that reviews are accurate, objective or balanced.

The Incision medico-legal helpline service has had numerous requests for help from surgeons and doctors arising out of negative online posts or reviews. The patients' motivation varies. Some deliberately use the threat of negative reviews to try to bully 'freebies' out of surgeons and doctors. Others are genuinely upset at the outcome of their treatment and are seeking catharsis.

So what, if anything, can surgeons and doctors do? Incision members have access to a detailed guidance note on this topic, but we highlight a few key aspects here.  

Even if a surgeon or doctor is outraged by an online post, it is important to nevertheless think first about their professional/clinical duties. It would be asking for trouble to respond in kind in the heat of the moment!  The professional conduct and clinical aspects can include; i) does the post indicate that the patient needs clinical follow-up, including mental health intervention? ii) does it indicate that the doctor/patient relationship has irretrievably broken down? iii) would responding on-line inadvertently breach patient confidentiality?

As a result, very great care is needed when considering what, if anything, can be done about negative posts or reviews.

For some surgeons and doctors, it might not be worth investing time and effort in trying to 'clean up' their own online profile. Not all surgeons and doctors get any significant proportion of their private work as a result of their online profile. However, for those whose practices do depend on online publicity, there are a few potential avenues.

It might be worth considering whether the post is defamatory, although since the Defamation Act 2013 came into force, it is now difficult to bring actions unless the surgeon or doctor can prove a financial loss.

Even if a defamation action is not realistic, the surgeon/doctor might be able to ask the website owner to remove it (albeit that great care would be needed to avoid breaching patient confidentiality in doing so). The website itself will have terms of use (or 'community guidelines') so if the post breaches rules such as no foul or threatening language, then the surgeon/doctors could simply inform the website owner of the violation of their own rules and ask them to remove the post.

Alternatively, surgeons and doctors could try gently and sympathetically asking their patients to remove the post, so that the patient him or herself does not come to regret publicising the fact of their procedure and their unhappiness with it.

That won't work for some patients, but negotiating the removal of the post for a full or partial refund or discount might be appropriate in some cases.

Leaving aside the question of what can be done about negative posts, there is an important Medical Indemnity insurance aspect to consider. Many surgeons and doctors overlook the fact that a negative online post or review might indicate that the patient intends to bring a clinical negligence claim, and fail to notify their insurers. Not only do they miss out on support and assistance, they could even store up problems in having the eventual claim covered by those insurers.

*Article originally published in July 2019

It is very rare for medical secretaries, medical administrators or practice managers to be qualified healthcare professionals in their own right. Nevertheless, their roles are vital to ensuring that you as a surgeon or doctor can fulfil all your duties and obligations to your patients. Similarly, if they make an error in their work, it is possible for one of your patients to be harmed and for a negligence claim to result.

Arguably, the greatest risk arises from their role in managing patient appointments and your diary. When a patient is still in the process of being diagnosed multiple appointments might be needed over a period of time for examinations, or to discuss test results. If, by secretarial error, the right appointments are not made at the right time then this could cause a delay in diagnosis, and in turn treatment, leaving the patient with a worse overall outcome. Similarly, where treatment or surgery has already been provided, making follow up consultation appointments for the right intervals is vital to ensure that complications are identified and addressed promptly, to avoid harm being caused or exacerbated.

Other situations where an error in the medical secretarial role could lead to harm and a claim include where clinic letters or referral letters are necessary to ensure the patient receives the right treatment. Failures to send the letters at all, or failure to send letters to the correct address, or recipient, could also lead to delays that would ultimately damage the patient's health.

Also, a medical secretary's pivotal role in managing patient records makes them vulnerable to errors that give rise to significant problems and financial losses to you. You have a professional obligation to maintain medical records in any case, but for patients still in the course of diagnosis or treatment, those records can be vital to ensuring that they receive the right care. Surgeons and doctors often rely heavily on medical secretarial staff in relation to those records and they sometimes are accidentally damaged, destroyed or lost due to a secretarial error rather than the surgeon/doctor's. Similarly, the patient's confidentiality can be compromised when records are lost.

Why don't medical secretaries get sued more often?

Even though medical secretaries have a vital role that can and does impact on patient safety, it is rare for them to be sued in their own names.

The reason for this is that medical secretaries are usually employed by a hospital or clinic, or directly by a particular surgeon or doctors. In those situations, the employer hospital, clinic or surgeon/doctor is "vicariously liable" for any negligent error by the secretary. The legal doctrine of vicarious liability means that the employer is held to be responsible for the employee's negligent error in the course of the employee's work, even if the employer did not know about, or cause, the error and would otherwise be innocent of any negligence.

As a result, most properly represented claimant patients who have been harmed by a medical secretarial error know that the correct defendant in that situation is really the employer hospital, clinic or surgeon/doctor. The hospital, clinic or surgeon/doctor then gets sued, rather than the medical secretary personally. For this reason, claims against medical secretaries personally are relatively rare.

When might a medical secretary get sued?

Despite this, it is absolutely possible for medical secretaries to be sued in their own name. There could be situations where a claimant patient is simply not sure who the employer of the medical secretary is and so decides to sue the secretary personally, as a tactic to obtain information to identify the 'right' defendant. Similarly, if the medical secretary is freelance or self-employed, it might not be clear to the claimant patient whether anyone is vicariously liable for their work, so the secretary will be sued personally.

Also, because of the very significant changes in litigation funding since 2013, it is now much more common for claimant patient to not have formal legal representation at all. Litigants in person usually lack a proper understanding of the relevant law and procedural rules, so it is common for them to sue the wrong party. A medical secretary could be personally sued by a claimant patient over alleged delayed appointments leading to a delayed diagnosis, simply because they do not know about the doctrine of vicarious liability and take a much more literal approach to their claim.

What if there is no Medical Indemnity insurance cover for the medical secretary?

For many Medical Indemnity insurance policies available to surgeons/doctors - although not the Incision policy - the only claims that are covered by the insurance are those where the surgeon or doctor personally is named as a defendant. Therefore, for surgeons and doctors holding those policies, their medical secretary will not be insured if they are sued in their own name. Even, where it should be clear that the surgeon or doctor will be vicariously liable for the secretary's error, the claim will not be eligible for cover under the policy, because in literal terms the claim is not against the named "Insured" ie the surgeon/doctor.

The surgeon or doctor might be able to persuade the insurer to cover the claim anyway despite the medical secretary technically not being eligible for cover. But this outcome is far from guaranteed because it depends entirely on the goodwill of the insurer.

The more likely outcome would be that the surgeon or doctor would pay the secretary's defence costs. This obligation might be a strict legal obligation arising from the terms of the employment, or other contract, between the surgeon/dcotor and secretary. Or, it could be done for 'moral' or practical reasons in order to maintain a good working relationship with the secretary. After all, making the secretary pay for their own legal defence would likely cause significant bad feeling. Also, if they have only limited funds to pay for legal representation then the claim might not be defended effectively, or defended without thought to the interests of the surgeon/doctor. Inappropriate admissions or statements might be made, which could lead to adverse consequences down the line for the secretary and the surgeon or doctor, including in terms of professional reputation.

Most likely, the surgeon/doctor would be or at least feel obliged to retain and pay for lawyers to represent the medical secretary. The legal work needed would depend on the precise situation.

However, it could include the costs of:

• Checking/investigating the secretary's precise employment status to ascertain whether vicarious liability should apply and who exactly should be vicariously liable for the secretary's actions;
• Complying with the procedural obligation to acknowledge service of the claim;
• Applying for summary judgment of the claim on the grounds that the relevant employer is the correct Defendant;
• Representing the secretary at the hearing of that application;
• If necessary applying for, or negotiating, formal directions to require the claimant patient to redirect the claim to the relevant employer, who will then be covered by the employer's usual Medical Indemnity policy.

If the claimant patient is legally represented then this could all be a reasonably straightforward process that would only cost a few thousand pounds in legal fees. However, if the claimant patient is a litigant in person then the whole process might be much more time consuming and difficult, and the legal costs for the surgeon or doctor to fund could easily reach five figures.

Risk management and medical secretaries

Because of the vital role that medical secretaries perform in the care of patients and the discharge of a surgeon/doctor's professional obligations it is worthwhile investing in their training and professional development in the same way as you do your own. Especially, if they are new to the role or returning to work after a career break.

You need to ensure that they have the necessary access to training and information about a variety of topics.

These could include:

• Why maintaining proper medical records is so important from a patient safety and regulatory point of view;
• How the data protection laws (particularly around health data) affect the practicalities of how they carry out their role;
• Medical developments that will affect how you want the patient pathway to operate;
• iv) The potential clinical consequences of errors in making appointments.

Ideally, you should be working with your secretary to develop robust policies and procedures for your practice that will help ensure that your patients are kept safe. Having those policies and procedures properly documented could also help avoid the sort of errors that arise when a medical secretary leaves, or has a lengthy absence, and you have to recruit a temp or a replacement.

Similarly, it is worthwhile giving your secretary access to training and information (for example Incision's publications) about the requirements of your Medical Indemnity insurance, and particularly what sort of things have to be notified to insurers. Your secretary may well be the first one to know of a situation that will develop into a complaint or claim, particularly if they are the first to read your correspondence/emails, take calls from patients or deal with fee queries or non-payments by patients. If your secretary is trained to recognise what sort of situations have to be notified to insurers, then you will have assistance (and hopefully also a safety net) in complying with your insurance obligations.

Joanne Staphnill, Director, DW Law LLP

Benefits of your Incision medical indemnity insurance?

Your Incision Medical Indemnity insurance expressly provides cover for your medical secretary, medical administrator or practice manager, even where they are sued in their own name.

Ian Redbourn, Partner, Incision

*Article originally published in January 2019

While some surgeons and doctors work as truly self-employed individuals, many surgeons and doctors set up corporate entities for their private practice. Some set up a small limited liability company of which they are the sole director and sole employee (except perhaps for a medical secretary), to assist with matters such as tax-efficiency. There are also surgeons and doctors who have organised themselves into small groups and formed limited liability partnerships (LLPs) or limited liability companies. The set-up of such companies varies greatly, with some having no employees, and others having a variety of administrative and clinical employees in addition to the surgeons and doctors. The exact purpose of, and services provided by, those companies or partnerships also varies greatly.

Can such companies protect the individual surgeons and doctors from clinical negligence claims? The short answer is "not really". It is difficult to influence in advance a patient's decision about who precisely they sue. Also, even where a company is involved, the individual surgeon or doctor might still be the legally correct person to sue for compensation arising out of that advice or treatment, depending on the exact circumstances.

So, why can there be variation in whether the patients should sue the company or the individual surgeon/doctor or both? Incision members have access to a detailed guidance note which explains why the question of the 'correct' person or entity for the patient to sue is not legally straightforward. Because of this complexity, patients (whether legally represented or not) might make their decision based on a reasonable legal analysis, or alternatively based on a pure misunderstanding about who they should be suing in any given situation.

Regardless of whether the patient is represented or not, if the company or surgeon/doctor thinks that the patient has started a claim against the wrong party, it still costs some money to bring those incorrect proceedings to an end. This is because the defendant(s) might have to apply to the court for a summary judgment or strike-out and have a hearing in front of a judge before the incorrect claim can be ended and the patient required to re-start the claim against the correct defendant.

So, how does any of this affect the Medical Indemnity (and other) insurance you need for your private practice as a surgeon or doctor? The first key point is that even if you do all your private work via a company, you almost certainly still require Medical Indemnity insurance in your own name. It is almost impossible to avoid the risk of having at least some clinical negligence claims brought against you in your own name. Perhaps more importantly, your cover for regulatory proceedings by the General Medical Council will need to be in your name because such proceedings will always be against you personally. The second key point is that if you use a company to facilitate any part of your private work, you need to have a discussion with your insurers or indemnity providers about whether that company needs to be added to your insurance cover as an "Insured" in its own right, alongside you as a natural person. Otherwise you could find yourself with a 'gap' in your cover. If a patient sued your service company (rightly or wrongly) and the service company technically did not have Medical Indemnity insurance, then the company (and you as its director) might end up footing the bill for that claim despite the fact that you would have been covered by your insurance if sued in your own name.

Incision members have the benefit of assistance from both the Medico-Legal Advice line and the Membership Information line for guidance at any time about their particular situation.

*Article originally published in July 2019

What constitutes a notifiable claim or circumstance under the policy?

This would be an indication that a claim for compensation may be intimated on behalf of the patient, or anything that makes it possible that a claim or regulatory proceedings could result.  You should look out for formal requests for medical records for the purposes of investigating a claim, or any other letter from solicitors acting on behalf of a patient. Be alert to threats from patients to report you to the GMC, especially as it is difficult to know which patients will carry out such threats. There are some incidents that will almost inevitably trigger an external investigation (eg GMC or Inquest) or an internal investigation. Therefore you should think of serious patient safety incidents (regardless of whether harm to a patient resulted), unexpected patient deaths or internal disciplinary issues arising out of care provided to a patient as having the potential to become a claim or formal regulatory proceedings.

When should I notify underwriters of a notifiable claim or circumstance under the policy?

Underwriters should be informed at the earliest possible opportunity. This is because late notification could prejudice the Defence of the claim and may result in cover being withdrawn. As soon as you believe there may be the possibility of a claim it is safer to inform your insurers (via the medico-legal helpline provided by Incision). It is very risky to 'wait and see', because any delay on your part could prejudice your position in relation to your insurers. You should notify via the medico-legal helpline irrespective of your own assessment of the relative merit of the claim, complaint or allegation.

Why is early notification necessary?

Early notification of any potential claim or incident which could result in a legal claim will mean that it can be properly investigated at the outset and we and your insurers can provide you with advice and support to ensure that your position is protected from the outset.

Can I correspond with the patient’s solicitors myself?

Any correspondence from a patient’s solicitors should be passed to Incision (using the medico-legal helpline service), whereupon your insurers may appoint solicitors to act on your behalf and protect your interests.  You should not liaise with representatives for any patients without prior discussion with Incision, because your insurers might need to give their express approval to your proposed response to the patient's solicitors. Under no circumstances should you make any admission of liability without your insurers' express permission.  This could prejudice the Defence of any claim.

Do I have input into the Defence of the claim?

As soon as solicitors are appointed to act on your behalf they will be in contact with you to update you on the position and discuss a strategy for how to proceed.  These panel solicitors will report to your insurers and will keep you informed and seek your assistance and instructions where necessary to ensure that the claim is defended appropriately.

What will I have to pay if a claim is made?

You will only be responsible for a sum up to the value of your policy excess (if one applies). This could be used to pay for defence solicitor costs and / or damages and claimants solicitors costs if the case is settled. Once your policy excess has been exhausted you will not be responsible for any further payments as these will be met (up to the applicable Limit of Indemnity) by underwriters

How do I notify a claim or circumstance?

In the first instance, all claims, incidents or circumstances should be notified via the dedicated Incision notification and medico-legal hotline on 0333 010 2826. It would be helpful to have your policy number and any relevant details to hand

*Article originally published in May 2018

We are often asked what our golden rules are for surgeons and doctors faced with patient complaints. Here they are!

Do inform your medical indemnity insurers immediately, even if you think the complaint is unmeritorious or trivial. Our members have access to a 24/7 notification and medico-legal helpline, so there is always someone to assist with getting the necessary information to insurers straight away. Then keep insurers updated on any developments and seek guidance on any proposed responses to the patient, especially written ones.

Don't get ambushed. If a patient on the telephone or in person demands your response immediately, try not to get drawn into making comments on the complaint straight away. Take as many details of the grievance as you can and then confirm that you understand their concerns and will investigate and respond urgently. The key thing is to give yourself the breathing space to gather the facts and your thoughts, and to contact your medical indemnity insurers.

Do be open to the option of paying a small sum of money or refunding fees to your patient, with your medical indemnity insurers’ agreement. Paying a relatively modest settlement payment at the outset can save you a large amount of time and money further down the line. These settlement agreements don’t necessarily require you to admit you were in the wrong. There can be other benefits too, such as giving you the opportunity to bind the claimant to confidentiality and non-publicity clauses so that they cannot harm your reputation.

Do act quickly. A speedy response may mollify your patient and reassure him or her that you are taking the complaint seriously.

Do keep the lines of communication open. Just because a claim is made does not mean you should refuse to speak to the patient. If you can maintain a civil relationship this can help to encourage early amicable resolution.

Do consider if an apology is appropriate. If worded appropriately (and authorised by your medical indemnity insurers), this could be very helpful in reaching a resolution.

Don’t put the complaint in a drawer and ignore it. It will not go away, and will come back bigger and more difficult to resolve.

Don’t get cross! You may want to tell your patient what you think of them, but this may simply provoke them into escalating the complaint towards a formal claim or court proceedings.

This article is an extract of a more detailed and extensive guidance note available only to Incision members.

*Article originally published in May 2018

If you have bought an insurance policy to cover you against claims for medical malpractice, then you have bought that policy for one thing: Protection. Protection from not only the fees and costs that come with the defence and settlement of a clinical negligence claim, but also to provide you with an appropriate defence against the allegations that have been made against you.

It is important to remember, however, that your insurance policy is also a contract that comes with terms and conditions, which your insurers expect you to abide by. Although you will have an understanding of what your policy provides cover for, some of these terms and conditions may not be as obvious. In our experience, the most common example is the question of what our clients should "notify" to their policy (that is, what problems they should inform their insurers about) and when they should make a "notification" (that is, provide information about a problem).

Indeed, it is possible for insurers to completely decline to cover a claim simply due to late notification. So, what should you look out for? What should you notify?

There is a wide range of things that could be notifiable. Some are quite obvious such as a formal written complaint from a patient you have treated, or a letter from the GMC in relation to an investigation they are commencing. However, there are other situations where you might feel quite unsure about whether the matter should be notified, such as when a patient seeks a copy of his or her medical records, or where the patient has only expressed dissatisfaction verbally.

To notify, or not to notify? If you are asking yourself that question, then you need advice straight away. Incision members have access to a 24/7 notification and medico-legal helpline to assist with exactly these sorts of questions.

This article is an extract of a more detailed and extensive guidance note available only to Incision members.

*Article originally published in May 2018

In your private practice, has a patient ever asked you whether you have insurance, or for your insurance details? Did the question put you on edge?

There are situations where the question may be innocent. It could demonstrate that the patient is appropriately cautious in selecting a surgeon. A patient sensible enough to ‘do their homework’ might be more likely to consider your clinical advice and warnings carefully.

By contrast, for patients to whom you have already provided advice or carried out a procedure the “do you have insurance?” question might carry worrying overtones, regardless of whether the patient has otherwise expressed any dissatisfaction with your advice or the procedure. Unless your patient happens to work in the insurance industry and is asking out of mere professional interest, it is difficult to avoid drawing the inference that the patient is, at some level, thinking about making a complaint or claim.

So how do you answer the question?

Having an indemnity arrangement is compulsory for surgeons in private practice. Therefore there is no downside to confirming to your patient that you have appropriate indemnity arrangements in place. There is no obligation to provide any more details, and it is best not to. Revealing those details without your insurers' express authority might be a breach of the terms of your policy with them. Also, giving details of your policy might influence your patient (or his or her lawyers) when deciding whether to bring a claim or not, or for how much.

Is there anything else you need to think about? Absolutely! If the context of the insurance question, the patient’s demeanour or other comments gives you any concern that he or she is thinking about making a complaint or claim, then you need advice about whether to make a precautionary notification to your insurers. Incision members have access to a 24/7 notification and medico-legal helpline to provide that exact sort of assistance.

What if the request for your insurance policy details comes from solicitors appointed by your former patient? Some patients’ solicitors do state in correspondence that the surgeon "should" or "must" provide his or her insurance details within a short time. However, surgeons should not respond to any such request until they have had proper advice, because in most situations the patient's solicitors are simply not entitled to know the details of the surgeon's policy.

This article is an extract of a more detailed and extensive guidance note available only to Incision members

*Article originally published in May 2018

While the year has been dominated by the Covid 19 pandemic it should not be forgotten that two major reports into medical governance were published this year.  To quote the authors of those reports:

‘This report is not simply a story about a rogue surgeon…it is far worse. It is the story of a healthcare system which proved itself dysfunctional at almost every level when it came to keeping patients safe…’ The Rt Revd Graham James, Chair of the Paterson Inquiry.

‘Systemic failures, spanning the breadth of the healthcare system and ‘institutional resistance to patient safety.’ Baroness Julia Cumberledge, Chair of the Independent Medicines and Medical Devices Safety Review (‘IMMDSR’).

While there were two reports, one about a rogue surgeon, the other about safety issues arising from Primodos, Sodium Valproate and vaginal mesh, there was one common theme: more work needs to be done to learn from harm to prevent recurrence and improve patient safety.

The reports identify similar issues as requiring action for improvement.

Informed consent

To facilitate clearer understanding of treatment options risks and benefits, the Paterson Inquiry Report recommended that consultation letters are sent to patients, copied to the referring GP, rather than the other way round as at present.   It also recommended a mandatory period of reflection for surgical procedures, a recommendation echoed in the wider context in the IMMDSR report First Do No Harm (‘FDNH’).

Comment:

Although consent should be dealt with in a face-to-face discussion, the consultation letter is important as it provides the patient (and GP) with an information source about the discussion and an opportunity to reflect and ask questions.  It is integral to the medical notes and a crucial record of the consent process for patient and doctor. Following the Supreme Court decision in Montgomery (2015) it is essential that patients are provided with all treatment options (including conservative treatment or doing nothing) and details of the risks material to the patient. 

Complaints

Both Reports recommend clearer signposting of how to complain. The Paterson report considered that the means to escalate a complaint to an independent body should be communicated more effectively and that all private patients should have the right to ‘mandatory independent resolution’ of their complaint. FDNH recommends that patterns and trends should be identified and shared.

Comment:

Complaints are one of the earliest warning signs that care is unsafe and they should be analysed regularly to spot trends to prevent future harm.  It is essential that complaints are triangulated against claims as well as incident reporting to extract the maximum learning.

Duty of candour

FDNH noted that a culture of denial, fear of blame and absence of accountability still exists. The Paterson Inquiry found that apologising was conflated with admitting legal liability despite the duty of candour and guidance on saying sorry.

Comment:

An apology is not an admission of liability and should be given at an early stage if things go wrong. You should also discuss this with your insurer ideally before any formal written apology is given so as not to prejudice your position in any way.

Performance and regulation

A common theme can be identified around sharing concerns. Specifics include a recommendation that suspension should follow a hospital investigation into a healthcare professional’s behaviour, if there is a perceived risk to patient safety. Concerns should be communicated to any other provider where he / she works. Failure to follow guidance which adversely impacts on patient safety should be reported by colleagues and the GMC alerted.

Comment:

In the post – Paterson era it is likely that there will be a greater level of communication and inquiry between health providers as well as between providers and the surgeons they have operating at their hospital to ensure all relevant information regarding patient safety is known and shared.

Quality and assurance

FDNH considered that systems for clinical audit and quality assurance should be strengthened. Better governance arrangements around conflicts of interest (individuals and organisations) were needed as well.

The Paterson Inquiry Report recommended a central register of the location of consultant practising privileges and other data such as how frequently and recently a procedure has been carried out. Its use by NHS and independent sector managers and healthcare professionals should be mandatory.

Comment:

All healthcare organisations should ensure that their systems for clinical audit, quality assurance and managing conflicts of interest are robust. Work on bringing consultants’ performance data across the two sectors into line has started with a consultation on the Acute Data Alignment Programme.

Conclusions

Culture in the health sector has changed in recent years, but it appears that there is still some way to go. Healthcare practitioners and their organisations need to ensure that they comply with the duty of candour, obtain fully informed consent and have robust governance processes in place.  Instilling a learning culture in all healthcare organisations is key to preventing future harm. The government’s response to both reports is awaited but it is likely that in 2021 they will address this further.

On the 25^th May 2018 the General Data Protection Regulation (“GDPR”) came into force.  This was a significant development for the way that we all process and deal with data in our professional lives.  The provision of new stricter requirements required many surgeons or doctors to review their data handling procedures and implementing changes, and hopefully most surgeons and doctors are now familiar with the requirements on them. 

However, even now, over two years later, it is not uncommon for surgeons or doctors to inadvertently have a data protection problem, or at least find themselves unsure about whether a data protection question has arisen.  Therefore it is worthwhile for all surgeons or doctor to refresh their memory of the requirements, and reconsider whether there is anything more to be done to ensure data compliance.  The ICO has published information for healthcare professionals at https://ico.org.uk/for-organisations/in-your-sector/health/, including further guidance and resources for use in healthcare practice.

Here is a summary of some particular issues that have affected some Incision members recently, by way of food for thought about situations where surgeons and doctors need to be alert to potential data problems.

How long to store patient records

The Incision helpline commonly receives questions from Members about the correct length of retention of patient records and how these records are stored.

The publicity around GDPR and the Data Protection Act 2018 seems to have contributed to some uncertainty amongst surgeons and doctors.  One of the GDPR principles is data minimisation, including that data should be stored for no longer than is necessary.  This means that it is not acceptable to keep all records indefinitely, even if the cost of doing so was manageable. 

However, this GDPR principle does not affect the long-standing requirement on medical professionals to retain medical records for a specified period – a minimum of eight years, and often longer for particular groups of patients such as children.  All surgeons and doctors need to retain their records for at least that period.

Also, patient records often prove crucial in the defending of any claims for negligence with many being a starting point for recollections or treatment and/or as evidence that the treatment provided was not negligent.  The destruction of records prematurely could potentially limit the effective of any defence to future claims.

We don't know of any official guidance about whether the Coronavirus Lockdown means that medical records should be stored for longer.  However, it is clear that there has been extensive disruption to medical care across most specialties, with swathes of surgery being postponed for long periods.  Also, it is clear that many claimant solicitors were significantly affected by Lockdown and had difficulty progressing claims that were already in the pipeline, or were about to start.  Therefore it is possible that records may be needed for somewhat longer than they would be in normal times.  We would suggest that it would be prudent to pause any data destruction activities, for a few months at the very least.  For example, if you have records that are now eight years old that you would usually have securely destroyed, it would probably be prudent to keep those records for a further six months at least, and then review matters again at that stage.

Mass Emails and other Mass Mailings

Surgeons and doctors sometimes do send out mass emails or other mass mailings.  Sometimes this could be essentially marketing – perhaps raising awareness of an offer or opportunity.  Other examples could include information such as changes of clinic address or contact details.  It may be that Coronavirus has prompted more mass mailing than usual.  Many surgeons and doctors will have had to send out mass emails or other mailings to patients to provide essential information about changes to their practice – everything from remote treatment options, changes to whether and if so how in-person consultations can happen, and Coronavirus safety measures for when they do happen.  Even once the emergency is over, some surgeons or doctors may find that they need to engage in more marketing to re-build their practises after the interruption of Coronavirus.

Under the GDPR, in order to process a person's personal data, a controller of personal data must have a "lawful basis" on which to do so.  Therefore in order to avoid inadvertent data breaches, the surgeon or doctor must carefully consider the basis on which they are sending the mass communication, including whether they have each patient's consent for their data to be used for that purpose. 

To take marketing communications as an example, under GDPR it is acceptable to send marketing emails on the basis of "consent" or "legitimate interests".  If you have a record of the patient's agreement that you could contact them for marketing purposes, then that is sufficient.  But if you do not the position is more complicated.  For example, if you were contacting a former patient from a long time ago, it is unlikely that the patient (the data subject) would reasonably expect to receive marketing material after a lengthy period.  The sending of the marketing email could, therefore, be a violation of the GDPR.  As a controller of personal data, this could expose you to the risk of receiving a financial penalty imposed by the ICO.

By contrast, if you are sending a mass mailer that does not contain any personally identifiable details of any patient, strictly to a group of existing patients who are still under your care, to inform them about something relevant to their care with you (such as updated Covid-19 safety measures), then this would likely be acceptable under GDPR.  Having said that, it is still important to be vigilant, because if any of those patients responded to the mass mailer with a request relating to your communications with them, particularly if they ask that you cease contacting them or change them, then you and your administrators need to make sure that all those requests are complied with.

What about my medical indemnity insurance?

If you find that some patient records or data have been lost, damaged or even stolen, or if anyone alleges that you have breached your obligations to retain patient records or your data protection obligations in relation to mass mailings or anything else, you should contact the medico-legal helpline straight away.  Incision’s expert medico-legal advisers will give you guidance on what to do next, including assisting you with notifying your insurers to protect your interests.  If it transpires that you need specialist or detailed advice on data protection as it applies to your practice, Incision works closely with specialist lawyers who advise on data protection matters who can assist (although it may be necessary for them to charge fees for that advice).

September 2020

Incision

World-wide Recall of Biocell Textured Breast Implants and Tissue Expanders due to link with Breast Implant associated Anaplastic large-cell Lymphoma (BIA-ALCL)

What is BIA-ALCL?

BIA-ALCL is a rare and highly treatable type of T-cell non-Hodgkin lymphoma that can develop around breast implants. BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. This is a cancer of the immune system, not a type of breast cancer. The current lifetime risk of BIA-ALCL is estimated to be 1:2,207 - 1:86,029 for women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades.

Typically, the cancer cells are found near the scar tissue and fluid near the implant but in rare cases they can spread.

More than 50 people have been diagnosed with the condition in the UK and hundreds more worldwide. Cases have occurred between 3-14 years after surgery. BIA-ALCL can be cured successfully if treated early with surgery, most often without the need for radiotherapy and chemotherapy. Following a request from the US Food and Drug Administration (FDA), Allergan issued a global recall of Biocell textured breast implants and Tissue Expanders on July 24 2019. 38 countries have now recalled this implant and it would not be surprising if a number of clinical negligence claims follow. Although this could easily be categorised as solely a product or manufacturing issue, the surgeon or the clinic could also be criticised for using a product that is now considered unsafe in the UK, the Medicines and Heathcare Products Regulatory Agency (MHRA) is currently collecting data on women affected. They issued a joint statement with several of the UK’s leading surgical bodies in July 2019 advising that it is “essential” that surgeons make all patients considering a breast implant for reconstructive or cosmetic purposes fully aware of the potential risks.

What could this mean for claims against surgeons?

There may well be some litigation on the horizon involving patients affected by BIA-ALCL due to these types of implant.  We anticipate that the majority of such claims would be "product liability" claims directed against the manufacturers only.

However, this issue could give rise to claims against surgeons too, so Incision members who have ever used these types of implants, or are still using them, will need to be alerted.

Since the MHRA is still collecting data, it is too early to say whether patients will ever be able to argue that no reasonable surgeon would have recommended or used these implants.  However, surgeons should keep abreast of news, because if and when a recommendation is made that (say) their use should be discontinued, a surgeon who continued to use these implants subsequently would have great difficulty defending a resulting claim.

The more immediate issue for surgeons is probably obtaining informed consent from their patients.  As all surgeons should know, following the Montgomery decision 2015, obtaining informed consent based on what is "material" to that individual patient is key to avoiding claims arising from even non-negligent complications.  Following the MHRA statement of July 2019, advice on these potential risks probably should have been part of a breast surgeon’s fully-informed consent procedure from that date onwards, and possibly even earlier as concerns about these implants started to be reported although to our knowledge, at least at the time of writing, there has not been a decided court case on this specific point).  Surgeons should make sure that their current consenting process includes a discussion of the risk of BIA-ALCL with textured implants, and that the discussion is well documented in the notes.  It would also be prudent to check back to around July 2019 to see whether there are any patients who received a textured implant without first having been warned of these potential risks.

What does this mean for your insurance?

As always, informing ("notifying") your insurers about either "Claims" or "Circumstances" that could lead to Claims is key to making sure you are covered for these issues, and also that you have prompt medico-legal guidance and legal advice at the point where it will have most impact in protecting your position.

Therefore if you notice that you have patients who received a textured implant after the MHRA statement of July 2019, without express warning of and consent to those potential risks, then it would be prudent to call the medico-legal helpline so that we can help you make a precautionary notification to your insurers if necessary.

Similarly, if any patients contact you about their textured implants and allege or imply that they blame you for recommending them (regardless of whether their complaint has any merit), then you should call the medico-legal helpline so that we can provide guidance on how to manage that patient’s complaint, and help you make a precautionary notification to your insurers if necessary.

We will be on hand to help you if any of your patients are unlucky enough to be diagnosed with BIA-ALCL, or if any patient requests their records in relation to these types of breast implants.

With effect from the 1st April 2020, Incision are pleased to announce the launch of Incision Support.

We are delighted to confirm that Dr Michael Kyriagis, who has been providing support to our members since 2015, will now be providing an ‘in-house’ service and will continue to lead our medico-legal helpline alongside the latest addition to our team, Dr Anahita Kirkpatrick. 

Qualified in medicine from Guy’s and St Thomas Hospital, having also obtained an intercalated BSc in Psychology, Dr Anahita trained in Psychiatry up to Registrar level before moving into medico-legal work, holding positions at the MDU and MDDUS. Together, Dr Michael and Dr Anahita have over 40 years’ combined experience in advising and assisting doctors with legal aspects of their clinical practice.

They will continue to be supported by specialist lawyers Joanne Staphnill and Tracy Sell-Peters, and their team.

In addition to the medico-legal helpline, Incision Support Plus will provide discretionary cover for professional matters and claims arising from risks connected to your practice which are not otherwise covered by your medical indemnity.

Incision Support will also provide a risk management service, helping to educate you on best practice and mitigating risk within your private practice.

If you have any queries or would like more information regarding Incision Support, or your policy, please do not hesitate to contact a member of our dedicated team on 0333 444 1515 or email info@incisionindemnity.com.

Obtaining valid patient consent is one of the most fundamental pre-operative responsibilities of surgeons. In 2015 there was an important development in the UK case law – the now well-known Montgomery decision - which resulted in a sharp increase in claims against healthcare professionals generally arising from the consenting process.

Understanding the current legal landscape and the practical challenges will help surgeons keep their processes updated to promote good practice in obtaining consent. In turn, this should help prevent unnecessary claims or regulatory proceedings from arising in the first place and, provided it is properly documented, will make it easier to defend any claims that do arise.

This guide has been broken down into 4 parts and is intended to help busy surgeons deal with issues arising from Montgomery and informed consent:

• Providing a recap and refresher on 'where we have got to' in legal terms over the past few years;
• Providing an in-depth reminder of the practical challenges that the legal developments have thrown up, with suggestions of how those challenges can be addressed;
• Providing 'food for thought' suggestions to help surgeons optimise any standard or template forms they may already use to support the process of good consent-taking;
• Providing information about real-life situations faced by specialist surgeons to illustrate the potential pitfalls and how to avoid them.

We think that this information is worthwhile even now, nearly four years after Montgomery was decided. We still regularly come across current examples of surgeons misunderstanding their obligations. We have assisted in cases where the surgeon simply omitted to warn of or consent for certain risks because they 'didn’t want to worry the patient', or thought that a risk was 'pretty unlikely' to manifest. All these matters required notification to insurers, and some required fee refunds or compensation payments to resolve them, because the surgeons mistakenly used an approach to consent that is no longer legally acceptable.

Letter of the Law

What is the current UK law?

In 2015 the UK Supreme Court decided that 'informed consent' is now the correct approach. There is no higher court in the UK than the Supreme Court, so there is no prospect of any big departure from this key principle for the foreseeable future.Montgomery v Lanarkshire Health Board [2015] UKSC 11 ("Montgomery") clarifies that healthcare professionals have a duty to discuss with the patient the "material risks" involved in the proposed treatment and any alternative treatment options.

'Materiality' is to be judged by reference to the individual circumstances of the patient. A risk of the procedure is 'material' if a reasonable person in the patient's position would be likely to attach significance to the risk, or if the doctor is or should be aware that the particular patient would be likely to attach significance to it. This requires consideration of the patient as an individual – a holistic approach.

There will be situations where it is not possible to obtain informed consent before treatment, for example where the patient lacks the capacity to provide consent, where emergency treatment is to be provided or where disclosure of risks would be seriously detrimental to the patient's health. However, those situations will be rare.

There has been a small amount of case-law to help understand what 'materiality' means. For example, in A v East Kent Hospitals University NHS Foundation Trust (2015) the judge found that a risk that was “theoretical, negligible or background” did not have to be communicated to a patient. In that case expert evidence in that case had estimated the particular risk under consideration at 1:1000. In another reported case that same year, Tasmin v Barts Health NHS Trust (2015), the judge made a similar point that a 1:1000 risk is 'too low to be material'.

These cases give some comfort to surgeons that they will not always be obliged to waste valuable consulting time providing reams of information about every 'theoretical, negligible or background' risk that might exist. However, we would strongly caution against taking these two cases literally. Surgeons should not assume that they never need to mention risks that are below a notional 1:1000 threshold.

This is because the test will always be as stated in Montgomery - “…a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it”. This means that there will be patients whose particular individual position means that they would be unwilling to take even a 1:1,000,000 chance of a particular adverse outcome.

The practical challenge that this throws up for busy surgeons is how to remain alert to 'outlier' patients who will need to be counselled in relation to very marginal risks as well as all the more likely ones. In the part of this guide we suggest some approaches to help surgeons identify the instances where they do need to go into more detail with a patient on remote risks.

What does this mean for surgeons?

A risk that is material for one patient may not be so for another. Therefore a 'one size fits all' approach to advising patients is no longer safe or appropriate. Surgeons will need to update their practice to ensure they obtain informed consent from every patient for every intervention or procedure.

In our view, following Montgomery, it is vital to think of consent as a process rather than a single event. The process of consent will often be best approached in these broad stages and further commentary on each is provided in the next section:

• Obtaining the patient's medical and social history;
• Obtaining consent for ancillary matters, such as clinical photographs;
• Consulting with the patient, including providing patient information leaflets;
• Final consent to go ahead with the intervention/treatment.

Ideally, and particularly for elective surgery, there should be sufficient time between each stage for the patient to think about the risks and a realistic opportunity for them to pull out of surgery entirely at each stage. The potential risks of patients who feel 'committed' to a procedure before they have had a chance to evaluate the full implications are analysed later in this guide.

We appreciate that, in some situations, all stages of the consent process will have to take place within one meeting between the patient and the healthcare professional. If the procedure is quite urgent, or the clinic very busy, there may not be much time for the discussion. Nevertheless, if surgeons keep these stages in mind they are more likely to obtain valid informed consent from their patient, even when they are working under significant time pressures. It is essential that each stage of the process is carefully documented in the patient's notes, as this will be vital evidence in defending any subsequent claim.

Does it have to be in writing?

Consent that is obtained orally and not recorded in writing is technically valid, so carrying out investigations or treatment based on oral consent only is not going to be a criminal assault.

However, from the legal perspective of defending compensation claims, there is simply no substitute for written records. We have assisted surgeons who believed that it was sufficient to have a clinic letter that stated, "all the potential complications were discussed", and their recollection of what their practice was at the time in terms of explaining potential complications to patients. It is not.

If there is no written record that a particular risk was warned of, then in a hypothetical trial the judge would be faced with a surgeon whose evidence is, 'I don't have a specific record, but I believe I must have warned of this' and a patient whose evidence is 'no he didn't'. The judge will virtually always prefer the evidence of the patient in that situation. The received wisdom is that the consultation will have been an unusual or significant event for the patient such that their recollection of the particulars is likely to be better than that of the surgeon, for whom this will have been a routine meeting very similar to dozens of others. Also, the judge will be unwilling to give a surgeon the benefit of the doubt when documentation of the meeting is always the surgeon's responsibility, rather than the patient's.

Well-designed template forms can help with the consent process and thereby reduce the risk of expensive complaints and claims arising in the first place.

For example, while a 'checklist mentality' is not necessarily helpful, a standard document can be a helpful aide memoire for a busy surgeon to help ensure that all the necessary material is covered with every patient. They can be particularly helpful as a prompt to mention newly-discovered or unusual risks of a procedure. They also help ensure that complete records are kept by providing a convenient and consistent way to make the necessary notes, which is vital in defending any claims which arise.

Effective forms are those that have been designed or adapted for the surgeon's particular practice. They should be regularly reviewed and updated to make sure they capture all the necessary information and to reflect any changes in the known risks for the procedure. They should be written in clear and straightforward language.

When designing or adapting forms, surgeons need to consider not just the content of the form but also the layout and format. For example, in my experience too few surgeons give sufficient thought in advance to whether their standard forms include sufficient space to record all the necessary details. Poorly designed forms often leave so little room for answers that important information is either not recorded or becomes illegible.

What if surgery would have been deferred, not rejected?

We have spoken to some surgeons who have gained the impression that if the surgery is essential and will certainly go ahead, then the consent process is less important because the patient is going to have to take the surgical risk. In our view, that is a potentially risky mischaracterisation of the legal position.

Even where a surgery is essential and will certainly go ahead, then there could still be a consenting issue over when exactly it goes ahead (except for emergency surgery, of course).

The difficulty arises because of a somewhat controversial case called Chester v Afshar. That case decided that in a situation where a patient was not adequately consented, the patient only has to prove that they would have delayed the surgery. If they do that they have demonstrated the legal causation between the inadequate consent and the injury suffered and are entitled to compensation. In other words, even if the patient would only have taken an extra day to think about the risks, the court has to 'deem' the causation of injury to be proven. This is a legal fiction of course, there is no reason why the adverse outcome would have been avoided if the surgery was delayed by a day but still went ahead. Unfortunately, that is the legal reality we are all stuck with. The patient does not have to prove that the surgery would never have gone ahead to be entitled to compensation.

While some patients would allege that if they had been warned about the risks more fully they would have taken an extra day or so to think about them, other patients might have actual practical reasons for delaying or deferring surgery. For example, a parent of small children might want to delay surgery until all the children are at school to better manage the recovery process and any risk of delayed healing. A patient facing surgery with a significant mortality risk might want to wait a few days to make a will. A patient facing surgery that could prevent them from driving afterwards might want to wait until they have changed jobs to one that does not rely on them driving.

The practical upshot of the legal landscape for surgeons is that in the consent process they need to get the patient to think about not just whether they will ever have surgery, but if so when. There could be lots of practical reasons why a patient might want to delay or defer the surgery – whether for a short time or many years – until a point where they are better able to accept or cope with the risks that are material to them.

Final thoughts on the legal landscape

Surgeons care deeply about their patients. While most agree that driving up standards is essential, some feel frustrated that this has caused the growth in process-driven care that risks depersonalising patients. In this context, Montgomery should be considered a cause for optimism because it requires healthcare professionals to consider each patient from a holistic point of view and to understand how a proposed procedure will affect them personally.

Nevertheless, this case has created an increased risk for surgeons because it is now rare for a claimant’s pleaded case to not contain allegations about a failure to obtain informed consent. Documentation is key and following the above processes will help protect you. If the documentation is lacking or does not exist at all, it will be impossible for your lawyer to defend you against such allegations.

Taking the medical and social history

A recap on the current UK law was provided in Part 1 of this guide. The upshot of the legal changes is that the process of consent will often be best approached in these broad stages:

• Obtaining the patient's medical and social history;
• Obtaining consent for ancillary matters, such as clinical photographs;
• Consulting with the patient, including providing patient information leaflets;
• Final consent to go ahead with the intervention/treatment.

In this section we focus on the practicalities of obtaining the patient's medical and social history.

Obtaining the patient's medical and social history

Montgomery makes it clear that surgeons need to give advice about the risks material to that individual patient. It will be almost impossible to do that without a detailed medical and social history that allows the surgeon to gauge what is material to the particular patient.

For example, if the surgeon does not know that the patient is a professional singer, they would not advise of any potential risk (however rare) of permanent damage to the vocal cords during surgery (perhaps due to the need to ventilate under general anaesthetic). In turn, they could be sued in negligence if the patient's voice is permanently damaged during the procedure and the patient contends that they would not have consented to the procedure had they known of that risk.

Each healthcare professional needs to give careful thought to which medical or social factors could potentially make a difference to the advice about the consequences and risks of a procedure for that particular patient.

While this is necessary for all types of surgery, even those where the only alternatives would inevitably lead to death or serious disability, the process is perhaps particularly important for the following types of surgery:

• Medically necessary, but not urgent and can be deferred for some time. In these cases the issue for the patient might not be so much whether to accept the risks of surgery, but when to go ahead so as to manage the potential complications best. For example, if a risk of surgery is slow healing leading to a long recovery period, a patient who is a parent of small children might find that risk easier to accept if the surgery is delayed until the children are all in school. Similarly, if a risk of the surgery is that the patient might not be able to drive for a time after surgery, and the patient's job is dependent on them being able to drive, the patient may wish to defer the surgery until after retirement.
• Not strictly medically necessary, purely elective. The classic examples include aesthetic surgery and some types of eye surgery, but examples exist in most surgical specialisms. In these cases the consenting process can be especially difficult because the very factors that give the patient the desire for the surgery might make the inherent risks more 'material' for that patient. For example, a patient who is so concerned about his aesthetic appearance that he is willing to pay privately for aesthetic surgery is inherently less likely to be able to accept the risk that the surgery might in rare cases leave him with a worse aesthetic appearance. Similarly a patient whose job or hobbies mean that they would like to be able to dispense with spectacles might be least able to cope if rare complications manifest that adversely affect their vision.

After Montgomery surgeons simply must ensure that sufficient information is obtained from each patient to allow them and the patient to assess what risks are most 'material' to them in the particular context.

Surgeons must also document that information as part of the evidence on which their clinical judgement and advice was based. The medical and social history process is a key part of this process.

How to obtain and document the medical and social history

Often, the most convenient method for taking a patient's medical and social history is to have a standard written questionnaire for the patient to fill in before or at the consultation. While a 'checklist mentality' is not necessarily helpful, well-designed forms can be a helpful aide memoire for a busy surgeon to help ensure that all the necessary material is covered with every patient, to give the best possible chance that the surgeon identifies what risks will be particularly 'material' to that patient.

The following is certainly not a prescriptive statement of what a surgeon's questionnaire should contain. Instead it is intended as guidance and 'food for thought' to help you review your current documentation and assess whether improvements can be made to help protect you from complaints and claims.

In addition to thinking about the content of your template documents for use in the medical and social history-taking process, you should also think about the layout and format. Even a form with a perfectly optimised set of questions could be rendered useless if there is so little space left for the answers that incomplete information is actually obtained or recorded.

Example outline medical and social history form

• Explanation that giving a complete and accurate medical and social history is necessary to enable the surgeon to provide the appropriate advice and care.
• Warning that inaccurate or incomplete answers to the questions could put their health at risk or lead to other unwanted consequences.
• Patient identification details: full name, title, any aliases.
• Patient's address: consider how far the patient has to travel, especially for any follow-up or to treat urgent complications post-discharge.
• Date of birth and age at date of consultation.
• Sex/gender description – having just two options 'male' and 'female' is not enough. If the patient has an inter-sex condition or is gender-fluid for any other reason, it is important to take this into account when considering any risks of the procedure that may be particularly significant for this individual patient.
• Social history:
  • Patient's present or immediate past job/work/career details – any change in job or career contemplated?
  • Any hobbies/interests that are very important to them?
  • Is the patient married/in a civil partnership/in a relationship?
  • Does the patient have children? Number and age? Any further children contemplated?
  • Does the patient have any other caring responsibilities – eg parents, friends, neighbours even animals who rely on them?
  • Language/reading ability considerations – how fluent is the patient in the language the surgeon will be using in the consultation and the language any patient information leaflets are written in? Do they have any difficulties in reading written material (eg poor eyesight, dyslexia, low literacy)? This is crucial, because if the patient can't understand the information provided, they arguably cannot give informed consent. Needless to say, surgeons need to find a way to ensure that the patient is asked about this orally – to have only a written question on a form would defeat its purpose.
  • Any future social factors to consider? Does the patient have any forthcoming events that are important to them that could potentially be affected by the proposed procedure, either inevitably or if complications arise? eg is the patient getting married, attending a special social event, or do they have a holiday booked/paid for? You would be surprised how many complaints and claims arise because the patient 'really wanted to be better in time for my wedding' – the imminent wedding they hadn't thought to mention to their surgeon…
• Past medical and social history.
• Does the patient have children? Number and age? Any further children contemplated?
  • Set out questions to gain sufficient information about the patient's medical and social history including medication being taken, past procedures, past health problems – anything and everything that, to your clinical knowledge, could possibly have a bearing on the risks of the particular procedure in question.
  • Include specific questions about the patient's past mental health. If there is a mental health history, confirm that the patient has the requisite capacity to provide informed consent for the treatment.
  • Consider including questions about the patient's personality type – eg how optimistic are they generally, how resilient when things go wrong.
• Any future medical and social history to consider? Is the patient planning or anticipating other medical procedures, whether in the short or long term? Are those other procedures booked/paid for yet?

Other steps in optimizing your template or standard forms

We hope that this guide contains helpful guidance about designing or optimising your template forms or documents for use in the process of taking a patient's medical and social history.

If you would like additional assistance in updating your documents, you have various options. We understand that various companies offer consenting ‘systems’ that aim to ensure that healthcare professionals use compliant consenting documents and processes. By way of an example only (we do not endorse this or any other provider), here is the website of one such provider https://www.eidohealthcare.com/.

Consultations and Information Leaflets

In this section we focus on the practicalities of consultations with patients, providing patient information leaflets to support that process, and obtaining the final consent to go ahead.

Consulting with the patient and providing patient information leaflets

In this stage, the patient is given information about the nature and purpose of the proposed intervention or procedure and the potential risks. Depending on the exact procedure, this could be a lengthy and complex discussion and it is important that wherever possible the discussion is led, and documented, by the surgeon who will actually performing the procedure. The risks of 'delegating' parts of that process are reviewed in part 4 of this guide.

It is very important indeed that the process includes a detailed discussion about any potential alternative treatment options, and the relative merits of such options. This includes alternatives that the surgeon may not consider to be the most appropriate, as well as the option of not proceeding with any form of treatment at all.

Failure to advise of alternatives is a particularly common allegation in consent claims. For example, where a patient who was consented for surgery alleges that he or she was not appropriately informed of the option of conservative treatment.

Obtaining effective consent depends on ensuring that the patient receives all of this information in a format and manner that makes it comprehensible to them. Each surgeon needs to give careful thought to what information the patient needs about each procedure they offer. They also need to design an effective process for ensuring that all of the information is provided to the patient and that records are kept.

Therefore, any template forms used for consultations should be individually drafted to deal with each type of procedure offered. The template forms should also have enough flexibility to be adapted to the particular situation of each individual patient.

While conveying all the potential 'material' risks and the pros and cons of all the alternatives is necessary for all types of surgery, even those where the only alternatives would inevitably lead to death or serious disability, the process is perhaps particularly important for the following types of surgery:

• Medically necessary, but not urgent and can be deferred for some time. In these cases the issue for the patient might not be so much whether to accept the risks of surgery, but when to go ahead so as to manage the potential complications best. For example, if a risk of surgery is slow healing leading to a long recovery period, a patient who is a parent of small children might find that risk easier to accept if the surgery is delayed until the children are all in school. Similarly, if a risk of the surgery is that the patient might not be able to drive for a time after surgery, and the patient's job is dependent on them being able to drive, the patient may wish to defer the surgery until after retirement.
• Not strictly medically necessary, purely elective. The classic examples include aesthetic surgery and some types of eye surgery, but examples exist in most surgical specialisms. In these cases the consenting process can be especially difficult because the very factors that give the patient the desire for the surgery might make the inherent risks more 'material' for that patient. For example, a patient who is so concerned about his aesthetic appearance that he is willing to pay privately for aesthetic surgery is inherently less likely to be able to easily accept the risk that the surgery might in rare cases leave him with a worse aesthetic appearance. Similarly, a patient whose job or hobbies mean that they would like to be able to dispense with spectacles, might be least able to cope if rare complications manifest that adversely affect their vision.

After Montgomery, surgeons simply must ensure that sufficient information is provided to each patient to allow the patient to make a fully informed decision about whether to go ahead. Particularly, bearing in mind any risks that are particularly 'material' to them personally.

I have heard surgeons quibble with that on the basis that too many patients will be put off from going ahead with surgery that might benefit them. It is fair to say that if a surgeon does the consenting process properly, some patients will certainly be put off from the procedure entirely, or will elect to defer it for a long time. The surgeon might not agree with or understand the patient's rationale – they may even find the patient's decision irrational - but that is the upshot of Montgomery. The 'paternalistic' model no longer holds good and the patient must be given all the necessary information about the risks they will be running, so that they can make their own subjective decision about what risks are acceptable to them.

Surgeons must also document the advice and information they provided. This is partly to help ensure that a surgeon has a record to use in follow up or future treatment. It is also necessary in order to be able to defend the surgeon in the event of a complaint or claim.

Are patient information leaflets helpful?

Depending on the type of procedure, and particularly whether it is an elective procedure, it may be appropriate to provide the patient with information leaflets about the proposed procedure.

Good information sheets help the surgeon to present generic information about the procedure to the patient in a clear way. They are an important support and complement to the advice the surgeon gives the patient in consultation, especially as written information can allow space for the patient to reflect, often after the consultation, in a way that the face-to-face consultation may not.

By the time a claim is made, it can be difficult to prove whether an information sheet was provided to the patient at all, and if so which information sheet was provided. Therefore it is vital to find a robust way to record which information sheet each individual patient received.

Also, almost needless to say, information leaflets are only as helpful as the information they contain. If a leaflet contains incomplete or outdated information then it could arguably do more harm than good. If a surgeon decides to use information leaflets as part of the standard consenting process, then the surgeon must accept that this will entail investing time every so often in reviewing and updating those documents.

Some surgeons who have ceased using physical leaflets and instead direct their patients to their websites, which contain regularly updated information about the procedures they offer. The benefit of using a website rather than physical leaflets is that the cost of printing physical leaflets is saved. Also, a website can be quickly and regularly updated for all the patients (indeed often the whole world) to see. The potential downsides are that even today not all patients can get online or are comfortable doing so. Also, it can be somewhat more difficult to ensure that the patient has actually gone to the website and read the right parts of it. In some cases the surgeon might need to print off the relevant pages for a patient who would not otherwise be willing or able to access them.

In this stage, the patient, having been provided with all the necessary information, records his or her final consent to go ahead with the procedure, usually by signing a form to that effect. Such a form is often referred to as 'the consent form'. Such terminology is unhelpful because it suggests that consent is an event that simply involves the signature of a form, when in reality obtaining consent is a process culminating in the signature of a form.

Templates and documents for the consultation stage

Often, a very convenient method for structuring a patient consultation and obtaining final consent is to use standard written documents. While a 'checklist mentality' is not necessarily helpful, well-designed forms can be a helpful aide memoire for a busy surgeon to help ensure that all the necessary material is covered with every patient, to give the best possible chance that the surgeon does give advice about everything that is 'material' to that patient.

The guides in the two appendices to this section are certainly not a prescriptive statement of what that documentation should contain. Instead it is intended as guidance and 'food for thought' to help you review your current documentation and assess whether improvements can be made to help protect you from complaints and claims.

In addition to thinking about the content of your template documents for use in the consultation process, you should also think about the layout and format. Even a form with a perfectly optimised set of questions could be rendered useless if there is so little space left for the answers that incomplete information is actually obtained or recorded.

Outline consultation guide and records

• Patient identification details
• Proposed procedures.
• Space on form to record any updated medical/social history that the patient did not mention on their medical and social history questionnaire.
• Ask the patient why they want the procedure and record their answer in detail.
• Explanation of what the proposed procedure involves. This should be a step-by-step summary of:
  • What tests/investigations need to take place first (eg x-rays, blood tests).
  • Whether the patient will need to do any preparation (eg losing weight, stopping smoking/drinking, nil by mouth before surgery etc.).
  • Whether anaesthetic needed and if so what type (local/general).
  • What happens during the procedure
  • What happens after procedure and before discharge.
  • Any tests/checks that need to take place afterwards (eg blood pressure).
  • What happens after discharge, what the follow up will be, why attending follow up is necessary.
• Explanation of what the intended/hoped for benefits of the procedure are (eg reduction in pain).
• Explanation of the inevitable consequences or side-effects of the procedure. Explain that these are inevitable and will occur even if the treatment is carried out optimally, eg for an open surgery, there will almost inevitably be scarring from the surgical incision, pain to manage, a minimum recovery time before normal activities can resume. Ask the patient to think about how these will affect them and to plan how their other responsibilities (eg childcare) will be managed over that time.
• Explanation of the recognised potential risks or side effects of the procedure. Explain that these unwanted outcomes can occur even if the treatment is carried out optimally. Explain all the potential risks, from the common to the rare, eg for an open surgery, there is a risk of infection and around x% of cases will develop a post-surgery infection, and there is also a small risk of death which occurs in around every y% of cases. Also, explain that a potential risk is that the intended/hoped for benefit will not happen, such that the patient could experience disappointment with the outcome.
• Explain the potential alternatives to the proposed procedure, including having no treatment at all. Explain the pros and cons of the available alternatives. Ask the patient for their thoughts on those potential alternatives and record the response, especially if the patient gives reasons for not wanting to explore those alternatives further. The healthcare professional also needs to explain and record the potential risks of any procedures associated with the 'main' procedure, particularly of any anaesthetic that may be required.
• Ask the patient expressly whether they have any questions. Record their questions and the healthcare professional's answers.
• Explain that the patient needs to read any patient information leaflets provided, and/or any other resource (such as a website) that is appropriate. If the patient intends to do his or her own further research, do not dissuade them, but caution the patient against using potentially unreliable sources, such as Wikipedia or public discussion forums. Record the exact information sheets/leaflets provided, including what date or version they are.
• - Explain that the patient needs to consider the information sheets/leaflets, reflect on the discussion, and consider whether they have any more questions, before deciding whether to go ahead. Give guidance on how much time they have to reflect – in cases where the patient is deteriorating quickly find a way to give them time to reflect without inadvertently putting pressure on them to rush a decision.
• If going ahead is not recommended, but the patient is insistent that they nevertheless want to go ahead, the healthcare professional should expressly record their advice and the reasons for it in narrative on the document. Also, record the patient's reasons for nevertheless wanting to go ahead.
• For surgery under general anaesthetic the healthcare professional will need to discuss with the patient what should happen if during surgery it is found that further or alternative operative measures are found to be necessary or advisable. Does the patient want to consent to the surgeon using discretion to carry out those additional procedures to save them the need for a separate further surgery? Or would they prefer to wait until they have had the opportunity to consider whether to go ahead with any such other procedure?

Outline final consent form

• Patient identification details, space on form to record any updated medical/social history and further questions asked by the patient and the practitioner's response.
• I provided a medical and social history on [date]. I have seen my signed record of that medical and social history dated [date]. It is and remains complete and accurate. I understand that giving a complete and accurate medical and social history is necessary to enable those treating me to give me the appropriate advice and care.
• I have attended consultation(s) with [name(s)] on the following date(s) [dates]. I have seen the consultation records dated and signed on [date]. I agree that the document(s) contain a complete record of advice I received about the nature of the procedure, its intended benefits, its inevitable consequences and sideeffects, and its potential risks and sideeffects. I agree that the document(s) contain a complete record of the advice I received about the potential alternatives open to me.
• I confirm that I received the patient information leaflets recorded in those document(s). I confirm that I have read those leaflets. I have also read the following additional information [list any websites/other resources considered].
• I agree that I have been given sufficient time to consider the advice and information received. I understand that I am not obliged to have this, or any, treatment or procedure. I have decided to go ahead with this procedure knowing of the alternatives explained to me.
• I understand that there can be no guarantee that the procedure will bring about the intended benefits. I consent to go ahead with this treatment/procedure in the knowledge that the intended benefits may not come about. I understand that inevitable consequences and sideeffects will occur, and that the potential risks and side effects could occur, even if the treatment is carried out perfectly and with no errors on the part of the medical staff. I consent to this treatment/procedure knowing the consequences, sideeffects and risks explained to me.
• [If applicable] [I acknowledge and accept that I have been advised against going ahead with this treatment and I have nevertheless decided to proceed and consent to this procedure knowing that it is not recommended for me.]
• Healthcare professional's statement – I have fully explained the proposed procedure. I have provided the information recorded in the consultation records and on this consent form. I have taken the medical and social history provided by the patient into account and their explanation of what they want to achieve [space for the healthcare professional to sign].

Particular challenges in obtaining consent

In this final section of our guide to informed consent, we look at some particular practical situations where obtaining valid consent can present a challenge.

Consent for ancillary matters such as photographs

Clinical photographs of the patient may need to be taken. At an appropriate point in the consent process, the surgeon should explain the purpose of taking photographs and the fact that they will form part of the patient's medical records. The patient's consent to the photographs being taken should be recorded in writing, ideally by the patient signing a suitable form, before any photographs are taken.

In the vast majority of cases, getting consent to take clinical photographs of the patient is extremely straightforward as the vast majority of patients understand that they are a necessary part of clinical recordkeeping and will consent straight away.

Nevertheless, we know of surgeons who have been faced with practical difficulties even in this aspect of the process. For example, one surgeon had a patient who simply refused to allow clinical photographs to be taken of her lower body (where the surgery was to take place), on the basis that she found the idea of the photographs "intrusive" and was worried it would exacerbate her clinically diagnosed PTSD.

We gave guidance that without consent to the photographs they could simply not be taken. Without clinical photographs the surgery could not properly go ahead, given the importance of those records in complying with the duty to make and keep proper records. We recommended that the patient be referred to her existing mental health team to assist with ascertaining whether she could or would consent to the photographs with the necessary support and if not then it would be much safer for the surgeon to not go ahead with surgery for that patient.

While examples such as this are rare, they do highlight how important it is to avoid treating consent as a 'rubber stamping' exercise and be alert for patients that have unusual needs that give them problems with even routine aspects of their care.

Can the 'patient pathway' affect the validity of the consent?

In our view, yes it can.

We have dealt with a number of cases where a patient paid for the procedure upfront on a non-refundable basis after only a preliminary consultation (a cynic would say 'sales pitch') from an employee of a private healthcare provider company. Only then was the patient allocated to a self-employed surgeon to actually carry out the surgery. While more detailed consultations with the surgeon did follow before the actual surgery, the purported consent for surgery was very questionable because by then the patient had made a financial commitment. The particular examples we have seen have arisen in the context of elective eye surgery or aesthetic surgery, in relation to companies that specialise in marketing certain procedures to the general public, and contract with self-employed surgeons to carry out the actual surgery. In principle the problem could arise in any situation where the surgeon does not have control over the whole consenting process.

The General Medical Council and the law are clear that it is the surgeon who ultimately has the responsibility for obtaining valid consent. This is the case even if in practice the majority of the informing and consenting process is purportedly taken care of by other healthcare professionals. This is also the case even if the self-employed surgeon does not have any real control over when he or she sees the patient for the first time or how long he or she has with the patient to deal with consent before surgery. If a patient brings a claim for compensation alleging a lack of consent, the surgeon's defence team will of course endeavour to 'pass on' some of the legal liability to the company that actually took conduct of the initial stages of the consenting process. Ultimately, the best outcome in that situation is sharing liability with another defendant, rather than being able to completely defend the claim.

While it is possible to 'delegate' the consent process, this should only be done if the treating surgeon is confident that i) the person obtaining consent is suitably trained and qualified, ii) the person obtaining consent has sufficient knowledge of the proposed investigation or treatment and understands the risks involved.

Therefore we would recommend that all self-employed surgeons should endeavour to find out exactly what the 'patient pathway' is for private patients in the organisations they work within, and particularly what information patients are provided with (if any) by others before they reach the surgeon. The surgeons should ideally review that material (which could include 'sales scripts', patient information leaflets or even patient information videos) and decide what else the patients need to be able to give valid consent. This is particularly important if the other healthcare provider makes it a contractual obligation to use patient information materials or consent forms produced by them.

The surgeon should also consider whether the financial arrangements between the patient and the other healthcare provider will make it difficult to ensure that valid consent is actually being obtained in each case. Based on that, the surgeon can make a better informed decision about whether it will be safe to provide self-employed surgical services through that organisation, or whether they will be at risk of taking the consequences of another organisation's inadequate patient consenting process.

Consenting for anaesthetic risks

Other examples of how the 'patient pathway' can affect the quality of the consent process and the vulnerability of the surgeon comes from observations that surgeons have made about certain differences between the NHS consenting process and that in many private hospitals.

In the NHS the patients are often sent for an assessment appointment led by nurses and anaesthetists who will specifically assess the anaesthetic risks for the patient and advise them in preparation to be consented for surgery later on. By contrast, it is often the case in private hospitals that there is no equivalent process to deal with anaesthetic risks specifically. The surgeon has to take charge of consenting the patient for the anaesthetic risks and the patient may not even meet the anaesthetist until the day of surgery itself.

The upshot for surgeons in these situations is that they need to be sufficiently well informed to be able to ensure that the patient is warned of any material anaesthetic risks, as well as surgical ones, or risk being liable for a consent failure if an anaesthetic risk manifests.

Final thoughts

Surgeons care deeply about their patients. While most agree that driving up standards is essential, some feel frustrated that this has caused the growth in process-driven care that risks depersonalising patients. In this context, Montgomery should be considered a cause for optimism because it requires healthcare professionals to consider each patient from a holistic point of view and to understand how a proposed procedure will affect them personally. Nevertheless, this has created an increased risk for surgeons because it is now rare for a claimant’s pleaded case to not contain allegations about a failure to obtain informed consent. Documentation is key and following the above processes will help protect you. If the documentation is lacking or does not exist at all, it will be impossible for your lawyer to defend you against such allegations.

Obtaining valid patient consent is one of the most fundamental pre-operative responsibilities of surgeons. In 2015 there was an important development in the UK case law – the now well-known Montgomery decision - which resulted in a sharp increase in claims against healthcare professionals generally arising from the consenting process.

Since then we have been carefully monitoring legal and practical developments and gathering real-life case studies from Incision members and other specialist surgeons. Understanding the current legal landscape and the practical challenges will help surgeons keep their processes updated to promote good practice in obtaining consent. In turn, this should help prevent unnecessary claims or regulatory proceedings from arising in the first place and, provided it is properly documented, will make it easier to defend any claims that do arise. 

As part of our commitment to protecting Incision members in a holistic way, together with DWF we have produced a short series of four guidance notes. They are intended to help busy Incision members by:

• Providing a recap and refresher on 'where we have got to' in legal terms over the past few years;
• Providing an in-depth reminder of the practical challenges that the legal developments have thrown up, with suggestions of how those challenges can be met;
• Providing 'food for thought' suggestions to help surgeons optimise any standard or template forms they may already use to support the process of good consent-taking, in the form of example outline documents;
• Providing information about real-life situations faced by Incision members and other specialist surgeons to illustrate the potential pitfalls and how to avoid them.

We think that this series is worthwhile even now, nearly four years after Montgomery was decided.  We still regularly come across current examples of surgeons misunderstanding their obligations. We and DWF have assisted in recent cases where the surgeon simply omitted to warn of or consent for certain risks because they 'didn’t want to worry the patient', or thought that a risk was 'pretty unlikely' to manifest. All these matters required notification to the insurers, and some required fee refunds or compensation payments to resolve them, because the surgeons mistakenly used an approach to consent that is no longer legally acceptable.

After reading these guidance notes, Incision members should have a better understanding of:

• Why a 'one size fits all' approach to consent is now risky;
  Why, in terms of valid consent, the patient must be able to decide when the surgery takes place as well as simply whether it goes ahead;
• Why consent has to be a process rather than an event;
  Why the consenting process has to be recorded in writing;
• How the 'patient pathway' and the amount of control the surgeon has over the early stages of the patient consent process can affect the validity of the purported consent;
• How to design an optimal medical and social history questionnaire;
• How to design optimal documents for use in patient consultations.

Gillick Competence - What do you need to know?

An adult of ‘sound mind’ can provide valid consent to medical treatment, including a refusal of treatment that would lead to deterioration in their health, or even death. For under-18s, the starting point is that consent to medical treatment for a child is required from a person with parental responsibility (PR), but there are a number of exceptions.

Who has parental responsibility?

• The child’s mother
• The child’s father if married at child’s birth or registered as child’s father and (only after 1 December 2003) has PR under a PR agreement or court order.
• The child’s guardian, if parents are dead
• A local authority with a Care Order
• A person with a Residence Order
• The local authority, or authorised person, with an Emergency Protection Order

Informed consent for 16 and 17 year olds

Under s.8 Family Law Reform Act 1969 a minor with capacity can consent to medical treatment and it is unnecessary to obtain parental consent as the child is deemed ‘Gillick competent’.

Gillick competence for children (under 16s)

A child with sufficient maturity and understanding to comprehend the nature and implications of treatment, may be considered ‘Gillick competent’ and able to consent to treatment. When considering competence clinicians need to consider the child’s:

• Understanding of relevant information
• Ability to hold information in their mind long enough
• Ability to weigh up and use the information to decide
• Ability to communicate their decision

In the case of contraceptive advice, clinicians should refer to the Fraser Guidelines in the House of Lords’ 1985 decision in the case of Gillick.

If a child is not Gillick competent, consent is required from a person with PR.

Refusal of treatment

Someone with PR can consent to treatment which is refused by a patient under the age of 18. However, the position is not always clear cut as parental rights under family law may clash with provisions in the Mental Capacity Act 2005 (MCA), Human Rights Act 1998 (HRA), Mental Health Act 1983 (MHA) and the MHA Code may need to be factored in. If the dispute remains unresolved an application to court may be needed.

Practical tips for dealing with Gillick competence and Fraser guidelines

• Proof of status should be requested if there is any doubt about who has parental responsibility.
• Even if a child under 16 appears mature and capable of understanding, ensure that they pass the four-point test and that the basis of the assessment has been fully documented.
• Following the Supreme Court decision in Montgomery (2015), the patient should be warned of any material risks and any reasonable alternatives to the proposed treatment.
• If there is an unresolved dispute between either a 16 or 17 year-old, or a Gillick competent under-16, refusing treatment and someone with PR, legal advice should be sought as a court order may be necessary.
• Care should be taken not to unlawfully breach the young person’s right to confidentiality.

Discretionary and contractual medical indemnity are the two types of protection available to doctors. What exactly is the difference between these forms of cover―and why is it critical to get the contractual indemnity?

Medical indemnity is a complex matter, but the difference between discretionary and contractual indemnity is simple:

• Discretionary indemnity means just that, discretionary―there is no guarantee that it will pay out;
• Contractual medical indemnity is guaranteed cover within the terms of the policy, and surgeons involved in private work are among the medical professionals who need this sort of protection;
• Contractual cover shows the specifics and the details; discretionary does not;
• Contractual medical indemnity is regulated.

With the right insurance policy in place, doctors can be certain about the level of protection provided under regulated contractual medical indemnity with rights of recourse.

But with unregulated discretionary indemnity from traditional medical defence organisations (MDOs), the risk to livelihood, reputation and finances is real.

Contractual indemnity: full cover in writing

Discretionary cover simply cannot compete, says Ian Redbourn, “and the facts speak for themselves”. As a partner at Incision Indemnity, he has an expert understanding of the benefits of contractual indemnity from specialised insurers.

“If you simply ask what’s covered by the policy wording in the member organisation’s indemnity, it’s not long before a doctor discovers there simply is no policy wording.”

Incision Indemnity believes the MDOs act like public bodies―after all, the only recourse you have if they do not pay out is Judicial Review. Incision wanted to know the full extent they have declined to cover doctors under the discretionary clause. Yet we can’t send Freedom of Information requests. The traditional mutuals are not answerable even to these, because “Freedom of Information” law does not see them as public bodies.

“These matters are too important not to have them down in black and white, but the reason the traditional mutuals don’t detail the levels of indemnity is that the cover is discretionary. There simply is no guarantee of full cover that could be put in writing.”

What is in writing, in the ‘articles of association’ of the MDOs, is a disclaimer about discretion.

Traditional cover: it is always just discretionary

The following parts of the MDOs’ articles of association are the clauses that turn their indemnity into just discretionary cover (we have used italics to highlight the disclaiming phrases)

MPS (Medical Protection Society), item 40(1):5

“The grant of an indemnity shall be entirely in the discretion of the council, who shall have the power to impose such terms and conditions on the grant of any indemnity as it thinks fit, and may in its absolute discretion limit or restrict such indemnity or decline altogether to grant the same” and: “A qualifying applicant shall, in relation to any qualifying claim in respect of which an indemnity has been requested and/or granted, comply absolutely with the directions of the society…”

MDU, object 3(iv):6

“To indemnify wholly or in part and on such terms and conditions as may from time to time seem expedient any member [against claims]…”

MDDUS (Medical and Dental Defence Union of Scotland), object 2.2(b):7

“…to defend members when they are attacked; provided always that any advice, assistance or defence provided by the union shall be provided solely at the discretion of the board” and, in 2.2(c): “The grant of any indemnity … shall be entirely in the discretion of the board who shall have power to impose such terms and conditions on the grant of any indemnity as the board thinks fit and may in the Board's absolute discretion limit or restrict any indemnity or decline altogether to grant any indemnity.” Finally, 2(c): “To grant indemnities…subject to such exclusions and limitations as the board from time to time determines…”

The stakes are high of course. contractual indemnity spells out the legal representation that will be provided against claims of clinical negligence.

But with discretionary indemnity, how do you know whether a case can be taken up in the first place? We spoke to a senior medical defence lawyer based in London, who fights claims of medical negligence lodged against doctors, sometimes all the way to court.

She outlined the case of an ophthalmologist left unprotected by their MDO. (We can’t name the lawyer because of the duty to client confidentiality.)

Specialist doctor funding six-figure sums because of discretionary indemnity

The ophthalmologist had received three “pretty large claims in quick succession”. The compensation levels being alleged were: one in the £50k bracket, a second approaching £200k and a third £300k.

“The total was over half a million.”

Yet the ophthalmologist received the MDO’s decision that it would not pay the compensation claims.

Nor would monthly legal fees be covered to deal with the claims. These fees, including input from medical experts, clock up into tens of thousands of pounds.

The MDO did not even give any detailed reason for deciding to use the discretionary clause.

The defence lawyer felt “awful” because their client was losing everything he had worked so hard for, and even then, the amounts he could afford to pay in compensation were not really going to be enough to pay the ongoing care costs that the claimant needed to cope with their ongoing disabilities.

Working “only to pay the claim” ― and potentially facing personal financial ruin―the ophthalmologist was being left high and dry by the discretionary indemnity.

The only small consolation, the lawyer said, was that there were no GMC proceedings for the specialist to also have to find the money to fight.

The key problem, as the specialist legal practitioner reminded us, is that with discretionary indemnity:

• You cannot rely on any guarantee of MDO support;
• They do not have to tell you any reasons for the decisions they make, or at least not in enough detail;
• There is no recourse if an MDO declines discretionary indemnity to a doctor in trouble (except the extremely arduous route of Judicial Review).

Contrast that with the guarantees under contractual indemnity:

• Insurers providing specialist contracts of insurance are regulated to detail the cover and make their pay-out decisions crystal clear;
• They are bound by a legal ombudsman service that is free, quick and set up to deal with insurance disputes properly;
• Contractual indemnity insurers are ultimately answerable to the High Court.

In short, providers of contractual medical indemnity cannot hide behind impenetrable cloaks of discretion. And they must be backed by large financial reserves.

Medical negligence cases and GMC hearings

Added to the expensive legal complexities and sheer personal risks faced by a doctor having to answer medical negligence claims, surgeons, physicians, general practitioners and others needing contractual indemnity can also find themselves in fitness-to-practise cases heard by General Medical Council (GMC).

Legal representation is strongly recommended―“in a doctor’s best interests” in fact. The service hearing fitness-to-practice cases reminds medical practitioners of the GMC requirement for “adequate indemnity and insurance cover”. You simply cannot risk being without it. And the law states that this cover must be appropriate to the particular risks and scope of a doctor’s practice.

Government action on discretionary indemnity

A number of very specific concerns about discretionary indemnity are laid out by the UK Government, in the December 2018 report Appropriate clinical negligence cover.

“At the heart of a contract of insurance,” the report says of commercial cover, “is a legally enforceable obligation”.

The report refers to contractual indemnity as regulated insurance. This is a key differentiator between contractual and discretionary, leading to the following clear benefits of a specific contract of cover:

• Commercial providers legally have to pay out, and the policy wording must make covered activities completely clear;
• Insurance companies must hold enough reserves for insurance claims, and enough capital for any unexpected losses.

“In contrast,” to legally enforceable duties, the report says, “MDOs offering discretionary indemnity do so on the basis that their discretion is absolute … they therefore are not obliged to pay out in any circumstances.”

Traditional cover might pay out, at whatever level the MDOs “see fit”. So are they really prepared for the rising indemnity risks in healthcare?

Contractual insurance is better. It spells out the high ceilings, and these regulated providers definitely are prepared with enough cover―simply because they are required to be.

Will discretionary indemnity survive?

The government consultation on discretionary indemnity was open until 28 February 2019. The four objectives of the government’s policy are clear:

• “Appropriate compensation” for patients;
• “Stable and sufficiently funded” clinical negligence cover;
• “Greater clarity and confidence about the security and terms” for healthcare professionals; and
• “Greater clarity and confidence” for patients of their “recourse to any compensation”

University research bodies and pharmaceutical companies that engage doctors in their work, fertility clinics, and groups of surgeons are all among many in the independent healthcare sector who need regulated contractual indemnity and may wish to respond online to the government consultation report.

All three of the mutuals entice medical students with free membership. But in the years after medical school, how many doctors pick up that the indemnity is overridden by these discretionary clauses? As soon as indemnity is really important for doctors―in their paid professional work―MDO membership falls very short.

As a response to the Francis Inquiry, a statutory duty of candour was introduced under Regulation 20 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This has applied to all Care Quality Commission (CQC) registered providers of health and social care services since 1 April 2015. Although the statutory duty only applies to organisations, it is expected that an organisation’s staff will co-operate to ensure the obligation is met.

Regulation 20(1) sets out a general duty to act in an open and transparent way and applies to all interactions with patients about care and treatment.

Regulation 20(2) sets out a specific duty that must be followed when things go wrong. The specific duty applies, as soon as reasonably practicable, after becoming aware there has been a notifiable safety incident (NSI).

In addition, the General Medical Council and Nursing & Midwifery Council give guidance on the professional duty of candour and the National Health Service (NHS) Standard contract requires all providers of services to NHS patients to comply with a contractual obligation of candour.

When does the specific duty of candour apply?

The definition of an NSI depends on whether an organisation is a NHS body or not.
For NHS bodies, an NSI is an unintended or unexpected incident that could result in, or appears to have resulted in:

• death
• severe harm
• moderate harm
• psychological harm

For non-NHS bodies (including independent healthcare providers), an NSI is an unintended or unexpected incident that appears to have resulted in :

• death
• impairment to sensory, motor or intellectual function for longer than 28 days
• changes to the structure of a person’s body
• prolonged pain or psychological harm
• shortening of life expectancy
• requires treatment to prevent any of these sequelae

Why are there two definitions for an NSI?

The intention for having two definitions was to reduce the administrative burden caused when the statutory duty of candour was introduced, given the different notification systems for NHS bodies and all other providers.

The threshold for when the statutory duty of candour applies is lower for NHS Trusts than it is for primary care and private providers. Although a primary care or private provider may choose to be open when there has been an incident which has the potential to cause harm, they are under no statutory obligation to do so.

Complying with the specific duty of candour – how to be open and honest

Providers can demonstrate this by having policies and procedures, to support and promote a culture of openness, providing staff training, treating untoward incidents seriously and immediately considering whether an NSI has occurred.

If an NSI has occurred, the patient (or any person entitled to act on their behalf) must be notified as soon as is reasonably practicable and reasonable and support must be provided. Where the degree of harm is not clear but could fall into one of the NSI categories, the patient must be informed.

The first notification must be given in person and :

• must provide an account of all the facts known about the incident at that time
• advise on what further enquiries into the incident are believed to be appropriate
• there must be an apology (an expression of sorrow or regret for the harm but which is not an admission of liability)
• must be recorded in a written record

This must be followed by a written notification covering all of the issues discussed in person. When deciding who should notify the patient, it is important to consider a range of factors including seniority, relationship to the patient and expertise.

Consequences of not complying

One purpose of having a statutory duty of candour is to move away from a defensive approach when things go wrong to a more open one which, promotes candour and honesty and supports learning. Failure to comply with the statutory duty can lead to regulatory action from CQC and, in the most serious and persistent cases, a criminal prosecution.

What is Run-off Cover? 

Run-off cover in healthcare, is insurance for any claims made against a medical professional or their practice, after the practice has closed or an individual has retired or stopped practicing. 

The typical reason for run off cover is to protect against future legal action being taken, against any work that was carried out whilst individuals were still practising. 

Who needs Run-off cover? 

Run-off cover is typically for those who purchase claims-based indemnity, as opposed to occurrence-based indemnity. Claims-based cover only provides coverage for any claims made whilst the policy period was active, and not after the policy is cancelled. 

Doctors who had purchased a claims-based indemnity cover, in the run-up to the introduction of Clinical Negligence Scheme for GPs (CNSGP) in 2019, were additionally advised that they would need run-off cover, as the CNSCP would not provide this. If you are a GP, it is important to check if this will affect you, to ensure you have sufficient cover in place. 

For medical professionals who have always held occurrence-based indemnity, there is no need for an additional run-off cover. Occurrence based indemnity provides cover for the time when the policy was active. If the claim was made after the policy was cancelled, but related to an incident during the time the policy was active, this will still be covered regardless of when the claim is made. 

Find out more on the differences between Occurrence and Claims Made coverage here, or watch the video below for more:

Take a look at the video below:

Claims Occurrence vs Claims-Made. 

There are two types of liability coverage which you need to be aware of: occurrence and claims-made insurance. Both types of insurance come with their own advantages and disadvantages, however it is vital to know what your coverage provides, to ensure you are protected. 

Occurrence-based indemnity offers coverage for incidents which occur during the policy’s period, meaning that if a claim is made in 2023 on an event which occurred in 2016, if your policy was active between 2015 and 2022, you will still be covered on claims made relating to 2016, despite your policy having ended. As long, as the incident occurred during the time that your policy period was active, you are provided with lifetime coverage for claims made during this timeframe. 

Claims-made policies cover against any claims which occur, and are reported, during the time that the policy is active. Once a policy is cancelled, any further claims that come through will not be covered. If a claim is made in the future, against an incident which occurred during the policy period, it will not be covered if the policy has ended. 

Run-off Coverage, is an additional coverage to protect against any claims made after the expiration date of a claims-made policy.

Read our article on run-off coverage for more information. 

Mental Health Awareness week starts every year on the second Monday in May - in 2018 from 14 - 20 May. The Mental Health Foundation has hosted this awareness week since 2000 and its aims, together with various helpful resources relating to mental health matters, can be found at https://www.mentalhealth.org.uk/.

In this article we highlight how your own mental health can affect your clinical practice. We also explain some of the resources available to Incision members to help manage these issues.

Sadly, many of the Incision members who call our dedicated 24/7 medico-legal helpline are facing enormous pressures. This is not surprising given the features of modern practice. It is important not to underestimate the intellectual, physical and emotional stresses that clinicians face every day. ‘Work’ stressors can and do coincide with personal life problems, and it is humbling to see how many doctors soldier on even when dealing with severe events such as bereavement.

If that wasn’t enough, clinicians are increasingly likely to face complaints and claims from patients. Patients and the Courts seem to hold clinicians to ever-higher standards, and litigation funding options such as ‘no win no fee’ encourages more patients to try to seek redress. Even though complaints and claims are almost inevitable, receiving one can still be difficult and stressful. Even when a claim lacks any merit, the clinician has to somehow find the time to deal with it. Also, it is never pleasant to face allegations about clinical work done with the patient’s best interests at heart.

Many clinicians are so accustomed to dealing with these various pressures that mental health problems can creep up unnoticed. Some clinicians don’t realize that they are showing symptoms of illnesses such as depression until their difficulties have become quite serious. Others may ‘self-medicate’ with excessive alcohol or drug use to the detriment of their physical health. In other cases, the clinician may be just about coping until a complaint or claim comes along and becomes ‘the straw that broke the camel’s back’. Either way, a clinician whose mental health is poor is more likely to make errors of judgment in practice, in turn causing more complaints. It is a cruel irony that the more stress a clinician is experiencing, the greater the risk of adverse incidents that pile on yet more stress.

Therefore this Mental Health Awareness week, please remember that looking after yourself and your mental health is important in itself, and also helps you fulfill your vocation of providing excellent care to patients.

Incision members have access to a dedicated 24/7 medico-legal helpline to help with a wide range of matters relating to their practice. The service is expressly intended to help you cope with the significant demands of modern clinical practice. In addition to practical guidance through the medico-legal helpline, Incision members also have access to a confidential telephone counselling service.

This article is an extract of a more detailed and extensive guidance note available only to Incision members.