Testing Times

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.

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Incision Indemnity

Incision Indemnity