We’re conscious that medical professionals won’t have much spare time for reading in the coming months, so we’ve designed this newsletter to be short and useful.

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Discover more below. 

Consent in healthcare has had its fair share of the legal spotlight in recent years, but the subject matter is not new; informed consent has been the subject of GMC guidance for some time and is seen to reflect good practice.

Then why do we still see so many claims from patients alleging a lack of informed consent? The answer, we suspect, is in the details. Specifically, the details given to the patient.

In order for a patient to provide informed consent, they must have the mental capacity to do so (which is decision-specific), be able to give it freely without pressure and have sufficient information to make an informed decision. 

The key issue, which has been the subject of fairly recent judicial commentary, is the question of whether a patient has sufficient information to make a decision. The case of Montgomery v Lanarkshire Health Board [2015] SC 11 [2015] 1 AC 1430 specifically establishes a duty of care on a clinician to warn of ‘material risks’. 

In this case, the claimant, Nadine Montgomery, was diabetic and claimed that she was not advised of the risk of shoulder dystocia in pregnancy, which resulted in severe difficulties at birth. The doctor did not routinely advise of this risk in diabetic patients, as she was concerned that all mothers would then opt for a Caesarean section. 

It was found that the doctor ought to have advised the mother of the risk of shoulder dystocia and the option of a Caesarean section, on the basis that the mother should have been made aware of a material risk that she would have personally placed significance on.

So, what is ‘material’? 

The decision indicated that this is based on a reasonable person in the patient’s position and if they would be likely to attach significance to a risk, or that a doctor is or should be aware that the particular patient would be likely to attach significance to it. It is therefore not a one-size-fits-all approach and must be tailored to the individual patient in their circumstances. 

This does not mean that you must explain every single potential risk to a patient. In Mrs A v East Kent Hospitals NHS Foundation Trust (a Clyde & Co case) the failure to advise the risk of a chromosomal abnormality was not negligent, as that patient would not have attached significance to it. The Judge was clear that risks that were negligible or fanciful did not need to be explained.

Lessons learnt

  • In considering whether a risk is material, this should not only depend on how frequently it occurs. Bear in mind what would be significant to that particular patient.

  • It is not enough to only have a patient sign a consent form – it will help, but you must also satisfy yourself that you have communicated the material risks (and benefits) and alternative treatments (or the option of no treatment) and that the patient has understood it.

  • Bear in mind the GMC guidance about sharing information with patients

     

Claire Petts
Partner, Clyde & Co LLP
Claire.Petts@clydeco.com

Clyde & Co LLP and Premium Medical Protection Ltd accept no responsibility for loss occasioned to any person acting or refraining from acting as a result of material contained in this summary. No part of this summary may be used, reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, reading or otherwise without the prior permission of Clyde & Co LLP. © Clyde & Co LLP 2020

PMP appoints Rachel Stanley as Managing Director

PMP are delighted to announce that from 1st March 2020, Rachel Stanley has assumed the role of Managing Director. Rachel joined Premium Medical Protection in 2012 and has played a key part in the growth of the business, helping to ensure that the customer is always at the heart of PMP. Rachel has a wealth of experience in project management and operations and has successfully managed PMP’s head office and operations for several years.

Preventing and Managing Complaints

We all have to deal with complaints from time to time, no matter what our profession. It is an unfortunate occupational hazard, but there are steps we can take to minimise the risk of complaints being made, and in the unfortunate event of a patient having cause to make a complaint, there are ways in which it can be treated as a positive intervention.

Prevention is of course better than cure, so we have recommended some simple steps below to help reduce the risk of complaints being made in the first place:

  • Build a good relationship with your patient so that they feel comfortable asking any questions they may have about the proposed treatment or procedure.

  • Ensure you allow sufficient time to explain the proposed treatment or procedure and allow time for the patient to ask you questions. Patients who feel rushed, harried and as though they haven’t been listened to are the ones most likely to complain.

  • Give your patient clear and detailed information about the treatment or procedure, its risks, any potential complications and the alternative treatment options that are available to them.

  • Set realistic outcomes, goals and timeframes.

  • Provide your patient with information leaflets to take away with them so they can consider their options outside the setting of a doctor’s office, where they can sometimes feel rushed into agreeing to treatment without having had sufficient time to consider their options.

  • Document the advice that you give, including a record of what advice, information and leaflets you have given to the patient.

If a patient does have cause to complain, it is important to respond to it promptly, honestly and openly. If things have gone wrong, do not be afraid to apologise. In the event of a complaint:

  • Notify your Professional Indemnity Insurers as soon as a complaint is received so that they can provide you with assistance in preparing an appropriate response.

  • Respond as quickly as possible. When things go wrong, it can have a devastating impact on a patient, and they often want answers as to what went wrong and why. The longer you leave it to respond, the more difficult it will be for you to remember precisely what happened; ignoring the complaint won’t make it go away, and dragging it out will only make the patient more upset.

  • Give an honest response. Patients are better informed than ever, so they will not accept a response which attempts to brush off their concerns. If you must use technical language to explain what went wrong, break this down into language which will be more accessible and easier for the patient to understand.

  • Apologise where things have gone wrong. The vast majority of complaints arise because patients simply want you to say you’re sorry for what went wrong. Apologising for what happened can therefore help to resolve the complaint before it escalates into litigation. An apology will not always prevent litigation, but it can often go a long way towards resolving the complaint at the outset.

  • Explain what you have learned from the experience, and where appropriate, set out the steps that you will take to ensure that the same problem does not arise again in the future.

  • Offer the patient a resolution. This may be in the form of remedial surgery, further treatment, onward referral or perhaps a refund on part or all of the costs of the original treatment. However, it is vital that you speak to your insurers before offering any such refunds to ensure that you fully understand the legal implications of your offer.

In summary, you can reduce the number of complaints you receive by building a good patient-doctor relationship. By allowing a sufficient amount of time to explain all the possible outcomes, and by giving the patient the opportunity to ask questions, they will feel valued and part of the process, and this will minimise the chances of them making a complaint in the unfortunate event of something going wrong.

If a patient does have cause to complain, it does not have to be a negative experience. You can use the complaint as an opportunity to learn from what went wrong and improve your own practice to ensure the mistake is not repeated. If handled promptly and properly, with apologies where appropriate, a complaint can usually be resolved at the outset before it escalates into litigation.

Claire Petts 
Partner, Clyde & Co LLP
Claire.Petts@clydeco.com

Clyde & Co LLP and Premium Medical Protection Ltd accept no responsibility for loss occasioned to any person acting or refraining from acting as a result of material contained in this summary. No part of this summary may be used, reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, reading or otherwise without the prior permission of Clyde & Co LLP. © Clyde & Co LLP 2020

15 Essential Risk Management Strategies for Surgeons

Surgeons face various risks in day-to-day practice. Adverse outcomes related to surgical treatment, diagnosis, and medical treatment can result from a variety of factors, including issues with technical competency, clinical judgment, communication, documentation, and more. The following list offers 15 essential strategies to help surgeons mitigate risks and enhance patient safety.

  1. Participate in ongoing performance improvement opportunities to enhance technical surgical skills and ensure competency (e.g., mentoring, continuing education, and ongoing practice performance evaluation/appraisals).

  2. Use evidence-based guidelines (e.g. NICE, Royal College of Surgeon Guidelines) and clinical pathways to standardise processes, improve efficiency, and support quality care.

  3. Consider using decision support systems, consultations, and multidisciplinary team decision-making to support clinical reasoning and avoid errors in clinical judgment.

  4. Implement protocols for team-based communication, including protocols for care transitions, telephone triage, and communication with radiology regarding incidental findings on diagnostic studies.

  5. Communicate adequate, clear, and appropriate information to patients. Conduct thorough informed consent discussions, provide patient education in a format that is clear and unambiguous (1), and encourage patients to participate in their care.

  6. Use a technique — such as teach-back (also called ‘show-me’)— to gauge patient understanding by confirming whether the patient understands what is being explained to them, which reduces the risk of miscommunication, and supports patient adherence to care plans.

  7. Perform complete patient assessments and ensure timely ordering of tests and consults to prevent problems associated with ruling out or documenting abnormal findings.

  8. Review patient selection criteria for each procedure, reconcile patient medications, and ensure that all appropriate health information is available in patients’ health records (if a private patient, include a copy of your personal notes in the patient’s hospital records.)

  9. Verify that all necessary equipment and supplies are available prior to the start of each procedure.

  10. Participate in surgical team timeouts prior to commencement of surgical procedures. Participate in the completion of the WHO Surgical Checklist. Encourage “speaking up” behaviours to address potential safety issues in accordance with principles set out in the National Safety Standards for Invasive Procedures 2015 revised in 2019 (2).

  11. Use safety precautions throughout each procedure, such as proper patient positioning, infection control best practices, and surgical item counts.

  12. Following surgical procedures, hold team debriefing/huddle sessions to identify opportunities for improvement at the end of the case/theatre list.

  13. Document a complete, concise, and accurate operative report the same day of each procedure. Ensure the entry is dated, timed and signed.

  14. Maintain a consistent assessment process following procedures, and evaluate patients against established discharge criteria prior to releasing them.

  15. Document all instances of patient non-adherence as they occur using objective information, and document any follow-up education provided to the patient or caregiver to address non-adherence.

  1. https://www.england.nhs.uk/ourwork/patient-participation/health-decisions/

  2. https://improvement.nhs.uk/resources/national-safety-standards-invasive-procedures/

Laura M Cascella
MA, CPHRM

Anne E Jenkins
MSc, RGN, CIRM

Premium Medical Protection Ltd accept no responsibility for loss occasioned to any person acting or refraining from acting as a result of material contained in this summary. No part of this summary may be used, reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, reading or otherwise without the prior permission of Premium Medical Protection Ltd.

Maintaining your health and wellbeing during COVID-19

Responsibilities and GMC guidance

The GMC’s Good Medical Practice guidance underlines that doctors are responsible for protecting patients against risks posed by their own health or their colleagues’ fitness to practice. 

Long hours and difficult working conditions can cause both physical and mental stress that can ultimately impact patient safety. GMC guidance is to seek advice from a suitably qualified colleague or other medical professional, and not to self-prescribe. 

Support resources

NHS Practitioner Health Free, confidential service for help with mental health and addiction problems.

NHS COVID-19 Workforce Wellbeing support Additional NHS resources for healthcare professionals.

BMA Wellbeing Support Services Comprehensive range of support services for doctors, including counselling and peer support.

Health for Health Professionals Wales Self-help, guided self-help, peer support and virtual face to face therapies with accredited specialists.

PMP’s medico-legal helpline is available 24/7 if you need advice in relation to a clinical incident or complaint.

Advice for doctors during the COVID-19 pandemic

Advice for doctors during the COVID-19 pandemic

As a result of the rapid spread of COVID-19, the UK’s healthcare system is currently under significant strain. The pressure caused by this burden has led to thousands of elective procedures being cancelled, healthcare professionals being redeployed away from their normal work, and retired doctors and nurses being contacted by their regulator asking them to return to the front line.

In this unprecedented situation, it is inevitable that healthcare and facilities will not meet the usual standards, and the normal way of delivering healthcare will dramatically change. To date there has been tremendous public goodwill and support shown to NHS staff, who will continue to work tirelessly in the weeks and likely months ahead. However, human nature dictates that in some cases there will inevitably be issue taken with some of the care provided and doctors, many of whom will work round the clock, will be called to account for their actions, potentially by the GMC. Keeping a few key principles in mind will help protect you in the weeks and months ahead.

In a statement (issued jointly with other professional healthcare regulators across the UK) the GMC has already acknowledged that doctors may have concerns about decisions they need to make in order to provide the best care in challenging circumstances. There is a recognition that “in highly challenging circumstances, professionals may need to depart from established procedures in order to care for patients and people using health and social care services,” and that healthcare professionals “may feel anxious about how context is taken into account when concerns are raised about their decisions and actions in very challenging circumstances.” In terms of guidance and reassurance the GMC’s position (absent any specific further specific guidance at this stage), is that any concern “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.” The joint statement adds, “…We would also take account of any relevant information about resource, guidelines or protocols in place at the time.

Whilst the GMC (and other healthcare regulators) have committed to take into account factors relevant to the environment in which a doctor is working, inevitably this guidance is very general. In practical terms you should bear in mind the following:

  • If you have concerns about system failures and risk of harm to patients it remains important that you escalate those concerns with colleagues/management, and in writing where possible;

  • In addition to the GMC’s own guidance as set out in Good Medical Practice, ensure you are aware of the guidelines and protocols issued by your NHS Trust/organisation;

  • Make sure you understand your own level of clinical competence – this is particularly true for those professionals returning to practice following retirement;

  • Be clear with your colleagues, patients and others about your level of competence and expertise;

  • Discuss patient’s expectations with them, and be clear about what can and cannot be achieved. Ensure all options discussed with the patient and/or their family are clearly recorded;

  • As always, make sure all the relevant information, your decision making and discussions with patient are noted clearly in the patient records;

  • Be aware of your own health – make sure you self-isolate if required.

If you have any queries regarding this advice, please contact the PMP medico-legal helpline to ensure you receive the right support and advice when you are trying to do your best in less than ideal circumstances.

Claire Petts
Partner, Clyde & Co LLP
Claire.Petts@clydeco.com

Judith Duffin
Consultant, Clyde & Co LLP
Judith.Duffin@clydeco.com

Clyde & Co LLP and Premium Medical Protection Ltd accept no responsibility for loss occasioned to any person acting or refraining from acting as a result of material contained in this summary. No part of this summary may be used, reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, reading or otherwise without the prior permission of Clyde & Co LLP. © Clyde & Co LLP 2020