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Laurence is a regular contributor to Medico-legal Magazine and is an active patient safety advocate, following his retirement from practice in January 2020. He has over 30 years’ experience of clinical negligence litigation, representing claimants and their families in many high-profile cases, including the families affected by the Bristol children’s heart surgery scandal of the 1990s.
The Healthcare Safety Investigation Branch (HSIB) published their final report on 17 December 2020 following their investigation into safety issues surrounding the placement of nasogastric feeding tubes raised. The report raised concerns on a number of levels, not least the reference to practitioners telling investigators that the relevant guidelines intended to address the avoidable problem of misplaced tubes – a Never Event - were “too long to read”.
https://www.hsib.org.uk/news/hsib-highlights-patient-safety-risks-nasogastric-tube-never-events/
The HSIB launched its national investigation into the problem of misplaced nasogastric (NG) tubes after reports of a 26-year-old man having 1,450ml of liquid, enteral feed mistakenly fed into his lungs in December 2018 following a motorcycle accident. He suffered a significant deterioration before the error was discovered, even after staff had performed an X-ray, but did recover and was discharged two weeks later.
Misplacement of an NG tube into a patient’s lungs rather than his or her stomach and the failure to identify this before the tube is used for feed, fluid or medications constitutes a Never Event: defined by NHS Improvement as a patient safety incident considered to be preventable because there is national guidance or safety recommendations that provide strong systemic protective barriers which should have been implemented by health care providers.
In spite of patient safety alerts and warnings and reports of clinical negligence claims and inquests over the last 15 years, the incidence ofNG related Never Events has continued to rise. Between September 2011 and March 2016, there were 95 incidents of a misplaced tube reported by NHS staff. The latest data shows there were 14 incidents between April and September 2020: alarming statistics given that incorrect placement has the potential to cause severe complications and avoidable harm.
In 2017 a Regulation 28 Prevention of Future Deaths report was issued by the Coroner for Cumbria to the North Cumbria University Hospitals NHS Trust following the deaths of Amanda Coulthard, 57, at Carlisle Cumberland Infirmary the previous year and Michael Parke, 40, at West Cumberland Hospital Whitehaven in 2012. Both had NG tubes inserted into their lungs – a “failing of the highest magnitude” according to the Coroner who concluded that both had died from neglect.
A number of NHS staff admitted to the HSIB investigators that they knew of the existence of the guidelines issued by the Society of Radiographers in 2012 intended to avoid this preventable error but had not read them as they were “too long to read.”
The HSIB said staff had suffered from “inattentional blindness”, missing what should have been visible because, the HSIB suggested, their attention had been diverted elsewhere out of concern to avoid a worsening in the condition of an often critically ill patient.
The HSIB investigation revealed systemic problems which left patients at increased risk of harm. As well as the failure of staff to read and heed the guidelines, there was no consistency in training staff in how to carry out testing or interpret results, and no adequate system to check their competence. Performing an X-ray or pH testing of acidity of fluids from the stomach as methods of checking correct NG tube placement were potentially unreliable. There was no standardised method of interpreting X-rays. It would be beneficial if chest X-rays for acutely ill patients were interpreted and reported by a radiologist, or a radiographer who has undertaken training. The report should include the position of an NG tube if one is present on a chest X-ray. Manufacturers of pH testing strips used different colour coding with no universal process for reading them.
The HSIB recommended a national programme of training and a formal NHS-wide system of accreditation for those qualified to clinically evaluate and record their findings.
The HSIB called for improvements in the design of devices as well as in the reporting of safety incidents.
The failure of individual Hospital Trusts to ensure awareness and implementation of the established guidelines by their staff through rigorous clinical governance came as a major surprise.
As a misplaced NG tube constitutes an avoidable Never Event, a negligence claim on behalf of an injured patient would be difficult to defend. Ignorance of a relevant, authoritative, well-known guideline would be unlikely to afford a defence. There are a number of arguments that could be raised to challenge the legitimacy and relevance of a guideline, but I doubt that a Court would be sympathetic to any suggestion that a guideline should not apply because it was too long for practitioners to read. There must be a presumption that doctors should be aware of current guidelines as part of the duty to reasonable skill and care, even in those specialties in which keeping up to date with journals and guidelines constitutes a significant burden.
In recent years there has been a significant increase in clinical guidelines and protocols issued at local, national and international level by professional bodies, regulators, Royal Colleges, NHS Trusts and other organisations. Their aim is to promote best practice in a standardised way, ensuring a consistent level of care, ultimately leading to improvements in patient safety, reducing avoidable harm and in turn driving down the cost of negligence claims against the NHS.
Medical practitioners have not always been receptive to guidelines. In general practice doctors complained of a “flood” of guidelines twenty years ago and the impression is that clinicians do indeed feel that they face a deluge of guidelines from multiple sources. GPs, after all, will often see patients with multi-morbidities, so compliance with a number of single disease guidelines is not without its difficulties.
In 2003 Professor of Cardiology, John Hampton, wrote “Guidelines—for the obedience of fools and the guidance of wise men”
https://pdfs.semanticscholar.org/88be/52abb7babfbecc4c72af540db838f15b1762. pdf Clin Med. 2003; 3:279–284
Guidelines are just that: guidance. “Guidelines, not tramlines,” said Professor David Haslam, then Chair of NICE in a lecture to the Royal College of Physicians in June 2016. They provide doctors with a guide to options and recommendations as to best practice, to be consulted as a support to clinical decision-making. Guidelines have the potential to improve the quality of clinical decision-making and ultimately change beliefs. Provided they are seen to be authoritative, reflecting evidence-based research, guidelines may play an important role in persuading doctors to abandon outdated practices. Life will hopefully become increasingly difficult for the maverick doctor or surgeon.
We don’t know yet if the existence of relevant guidelines has resulted in improved safety standards. The Sepsis 6 guidelines are perhaps the closest we get to Commandments: protocols that are clear and unambiguous, known and respected universally and which must be obeyed. Greater awareness of sepsis and the sepsis guidelines among medical professionals and the public will inevitably have resulted in earlier diagnosis and treatment, but it isn’t yet clear if this has resulted in a decrease in negligence cases coming forward. Sadly, we still see reports in the press of hospitals failing to comply with the guidelines.
Guidelines and protocols are likely to play an increasingly important part in clinical negligence litigation. The impact on the litigation process, though, is difficult to assess due to the lack of reported cases in which their relevance and validity and the weight to be afforded to a guideline and the implications of compliance or non-compliance have been fully argued and tested in Court. I will give my take on the medico-legal implications of clinical guidelines and the potential arguments that might be raised to challenge the validity of an apparently authoritative guideline in Part 2 of this article in the next issue of Medico-Legal Magazine.
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