Surgeons - Medical Professionals - Private Clinics -
10th May 2019
3 mins read
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.
by Incision Indemnity - 6 mins read
On 16 April 2020 the UK Government announced that coronavirus lockdown will continue for at least three more weeks, but ...
On 16 April 2020 the UK Government announced that coronavirus lockdown will continue for at least three more weeks, but could not set out a plan for easing it. The Government briefed that there will be five conditions for lockdown to be eased, including reliable data showing the rate of infection decreasing to manageable levels, and ensuring that the supply of tests could meet future demand.
Coronavirus testing has been a key issue throughout this crisis, with the Government announcing a desire to carry out 100,000 tests a day by the end of April, but only 16,000 a day actually happening by the middle of the month. To add complexity, there are two key types of test – diagnostic to ascertain if a patient is currently suffering from Covid-19, and the anti-bodies test to ascertain if a patient has already recovered from Covid-19 (and therefore hopefully immune from re-infection).
Many doctors in private practice have had to pause their usual work, and are no doubt keen to assist in the national response. But should they be offering coronavirus testing (diagnostic or anti-bodies) privately, as opposed to in a purely NHS setting?
Our in-house specialists have been giving careful thought to this issue, and we have collaborated with our trusted external legal experts too. Right now, providing private testing does not seem prudent, and we outline the potential pitfalls below. However, the picture is likely to change rapidly over the coming days, weeks and months. There could come a time when the private sector is permitted or even encouraged to provide testing services. Here are our preliminary thoughts on what doctors should have in mind before providing any sort of coronavirus testing service.
Insurance – doctors in private practice are obliged by the GMC to hold suitable indemnity arrangements for all their private activities. So, the first question is whether your personal medical indemnity arrangements would actually cover you for claims arising out of coronavirus testing. This is a complex issue. It depends on things like the exact terms of your policy, and how you described your usual practice and income when you applied for it. Before doing any private testing or supplying kits, you need to speak with your broker or insurer to find out whether you are covered for those activities. Failing to ensure you have suitable indemnity arrangements in place, even for short-term changes to your practice in the context of a national crisis, could potentially have serious ramifications. They could range from having to pay claims yourself, to investigations by the GMC for failing to hold the necessary indemnity.
Any test better than no test? The Government does not think so. The Department of Health & Social Care published a strategy document on 4 April 2020, and in its discussion of mass anti-body testing emphasised that an unreliable test is worse than no test. The Chief Medical Officer has strongly discouraged organisations from buying their own unvalidated anti-body tests. Therefore a doctor that offered unvalidated tests could be vulnerable to investigation by the GMC. Doctors should only go ahead if they can properly obtain tests that are validated by MHRA and meet the Government’s standards for reliability.
Other professional conduct/ethical concerns – The GMC has published a joint statement with other regulators (https://www.gmc-uk.org/news/news-archive/how-we-will-continue-to-regulate-in-light-of-novel-coronavirus) which includes the comment:“We recognise that the individuals on our registers may feel anxious about how context is taken into account when concerns are raised about their decisions and actions in very challenging circumstances. Where a concern is raised about a registered professional, it will always be considered on the specific facts of the case, taking into account the factors relevant to the environment in which the professional is working. We would also take account of any relevant information about resource, guidelines or protocols in place at the time.”
Clearly tests validated for use in a clinical setting exist, and are being used on a large scale within the NHS. However, as at 16 April 2020 there does not appear to be any guidance on the specific question of when and how doctors can offer coronavirus testing on a private basis. It is not clear whether and if so when the GMC will publish any such guidance. Public Health England has issued guidance for “Rapid tests for use in community pharmacies or at home”, advising against their use because of a lack of published evidence about their suitability for diagnosing Covid-19 infection in a community setting. But we have not found anything to guide doctors who wish to provide private testing services in a clinical setting.
Until there is formal guidance it would be difficult for a doctor to be sure that they were complying with their professional conduct obligations. This is especially so in the context of an unprecedented national health emergency, where the Government is heavily reliant on scientific evidence to guide its policy decisions, and where at present it seems that there are insufficient tests available to meet the Government’s own targets and (presumably) test all NHS staff, key workers and vulnerable groups within a reasonable time.
In this situation, a doctor considering providing private testing would face various difficult ethical and legal questions. When (if at all) is it ethical to test individuals who are not NHS workers, key workers or in a vulnerable group? Does the Government need private doctors to report test outcomes, and if so how can the data protection implications be managed? What level of profit (if any) is it reasonable to make?
Given the crucial importance of managing this coronavirus outbreak for everyone in the country, any doctor who made the wrong judgment call could fall foul of Good Medical Practice para 65, among others: “You must make sure that your conduct justifies your patients’ trust in you and the public’s trust in the profession.”
Looking ahead – Doctors who would be willing and competent to offer private coronavirus testing, need to watch and wait. Formal guidance about how doctors in the private sector can contribute to a safe and coordinated national testing strategy will be vital to understanding what activities are acceptable and what obligations (such as reporting) are involved. Once suitable validated tests are available for use in private practice then it could well become possible, even desirable, for doctors to get involved – but only if they can obtain the necessary indemnity arrangements to protect themselves from claims and regulatory investigations arising out of that work. Even once formal guidance has arrived, doctors may well need medico-legal guidance before going ahead, and Incision members can access that through our medico-legal helpline service.
In light of the current Covid-19 pandemic, Incision is continually working hard behind the scenes, finding solutions to ...
In light of the current Covid-19 pandemic, Incision is continually working hard behind the scenes, finding solutions to all of the issues (popping up daily!) facing surgeons in private practice.
So far, we are very proud of what we have achieved for our members, which has included the enhancement of various coverages as well as taking into account any reduced private practice income resulting from the Covid-19 pandemic.
We also want to assure you that it is business as usual at Incision and all our areas are fully operational to handle any situation. Whether this is to provide you with assistance with the completion of application forms, coverage queries or claims, we are available by telephone, email, WebEx, Zoom; you name it – and we will make it happen.
Our team is busy working hard remotely and we will continue to deliver the very high levels of service that all of our members expect from us.
If you would like to know more or have any questions about how Incision Indemnity can help with your Medical Indemnity insurance situation, please contact us at email@example.com
Incision is a trading name of Paragon International Insurance Brokers Limited (Paragon) which is authorised and Regulated by the Financial Conduct Authority and is an Accredited Lloyd’s Broker. Registered in England. Company no. 03215272. Paragon International Insurance Brokers Limited, 140 Leadenhall Street, London, EC3V 4QT