Category Archives: Clinical governance

Martha’s Law

Clinical governance, Communication, Emergency medicine, Ethics, General paediatrics, Generic

13yr old Martha Mills died in 2021 at King’s College Hospital, London, of sepsis after pancreatic trauma (fell off bike in Snowdonia). The family went to the local minor injuries unit, where they were reassured. She continued to have severe pain however, then vomiting – so they went to the nearest hospital. She was admitted to the ward, then ICU, before being transferred by helicopter to King’s College London (1 of 3 specialist centres for pancreatic injury in the UK).

“We are so lucky to be here”, writes the mum.

She was NG fed, a peritoneal drain inserted. She started mobilising after 2 weeks. Then she developed fever and diarrhoea – started antibiotics. “The consultants swooped in, and were ostentatiously deferred to by the junior doctors.

“They were chatty, assertive, grand.”

Martha then started oozing from drip sites and peritoneal drain site. A scan showed small pericardial effusion. She had a persistent fever – and it was the start of a bank holiday weekend.

Consultant went home after morning round. Martha’s mum raised her concern about septic shock but was told “it’s just a normal infection”. She was told not to look up things on the internet – “you’ll only worry yourself”.

When she developed low BP and tachycardia, then widespread rash, it was diagnosed as a drug reaction.

““Trust the doctors – they know what they’re doing,” said the nurses.

The consultant was contacted to discuss worsening PEWS – did not come in – no change in management was made. The consultant phoned PICU (routine) but gave limited info – advised against review “to avoid parental anxiety”. The night shift junior did not review. Martha was drinking copiously.

At 0545 she had a seizure, at which point people started arriving and things seemed to happen – she was moved to PICU, intubated and then moved to Great Ormond Street hospital for ECMO. She died 4 days before her birthday.

Issues

  • Mum is editor at Guardian newspaper
  • Nothing to do with insufficient resources, overstretched doctors/nurses, or cuts, or a health service under strain
  • Consultants dismissive and arrogant
  • Juniors “performing” competence
  • No one expressed concern, even if they had it
  • Lack of note keeping
  • Lack of consultant presence at weekend
  • All doctors mentioned at inquest were men

Mum’s advice to parents

  1. Our trust in doctors should have limits. Plenty of clinicians prone to arrogance and complacency.
  2. However indebted you feel to the NHS, don’t be afraid to challenge decisions if you have good reason to.
  3. Remember most of the doctors in hospitals are just [sic] training. Don’t be afraid to ask how long a clinician has been qualified. Junior doctors are often green and trying to stay composed to impress their superiors.
  4. Make sure, if you can, that a single consultant has overall responsibility: we all know that if you’re answerable for something, you try harder.
  5. Google like crazy.

Aftermath

September 2023 Riya Harani dies from invasive Group A streptococcus and influenza B. Seen in hospital the day before. Junior doctor diagnosed a virus and discharged her with advice to take over the counter painkillers and info re: management of sore throat. Consultant not involved. At inquest, coroner says ““I think it highly likely that if it had been open to Riya’s family to seek a second opinion at that point, they would have done so without hesitation.”

UK Minister for health has said they will progress with the right to urgent second opinions across the health service.

Second Opinions

Right to second opinion already in Good Medical Practice: “In providing clinical care, you must respect the patient’s right to seek a second opinion”. But not traditionally associated with acute care and no detail otherwise.

Seeking a second opinion is more common in:

  • women, middle-age patients,
  • more educated patients, higher income or socioeconomic status,
  • chronic conditions,
  • living in central urban areas.

Motivation is to seek to gain more information, or reassurance. Potential major impact on patient outcomes in up to 58% of cases. 

Solution

Condition Help (Pittsburgh, 2000s), Call 4 concern (Royal Berkshire) – hospital hotline to call rapid response team to bedside. Ryan’s rule (Queensland) is state-wide number for review of medical care.

But evidence of benefit sparse. Tends to be pain management and communication breakdown rather than acute deterioration. 18% of patients generated nearly half of all calls to Condition Help (in 41.4% of cases, a change in care was made).

International Society for Rapid Response systems includes family trigger system as one measure of effectiveness. 

“The recurring problems of hierarchy, arrogance and poor culture have not been tackled despite decades of effort… It is not the job of patients and families to wait around for healthcare providers to sort out their culture.” [(Helen Haskell, BMJ 2023)]

Such systems do not address problems of overcrowded wards, lack of beds, delayed assessments, poor nurse:patient ratios etc… Perhaps don’t appreciate informal senior discussions that happen all the time. Potential for delays in appropriate treatment if process of getting second opinion interferes with management?


“I’d like to imagine a world in which Martha was transferred to intensive care in time and her life was saved.

In this parallel universe, I talk endlessly about the doctors and nurses who helped her. I go on a fundraising walk for the hospital.

Bright and determined girl as she was, Martha aces all her exams, goes to university, has a career and children.

She visits us at weekends and we recall those distant weeks when she was in hospital.”

Mrs Mills

Faye Hawkins case

Clinical governance, Ethics, General paediatrics, Generic

A consultant paediatrician who received a formal warning from the GMC for missing a case of fatal appendicitis.

Found that she failed to consider possible underlying serious cause for fever, and that lethargy and mildly elevated heart rate are “red flags”. But actually, they are not – common and poorly predictive, and not in NICE Fever in under 5s table. Patient was 5 already, anyway. Did not flag on Sepsis tool.

Also found that she failed to examine again or look for other possible red flags when she discharged Elspeth from hospital; failed to adequately advise parents on how frequently they should monitor her temperature and pain symptoms; and failed to record the advice given in the notes.

British association for general paediatricians complained that the pressure of the acute unit were not taken into account, but GMC response was that tribunal (which is independent from GMC) took this into account, although they could not agree on what standards for a “reasonably competent clinician” could be applied!

Remote consultations

Clinical governance, Communication, Generic

Schedule time, rather than fit in between jobs.

Confidentiality: where you are, where they are! “Are you somewhere private?”

Consent before you proceed. “Are you happy for us to talk just now?” “Can you hear me clearly?”

Contemporaneous notes.  Explain why there may be typing noises during conversation.

Beware if not your usual patient, and long term medication/condition.  Consult with GP or other appropriate professionals.

Prob not appropriate where Safeguarding issues or doubt about mental capacity of adults.

“You may need to justify a decision to consult remotely” – not for your convenience!!!

If speaking with a child, use speaker so parents can hear.

Since you can’t see cues and can’t nod in agreement, good to check understanding and summarise what has been said to you.

Say when you will phone back if you need to discuss with someone else.

Easy to become over focussed on one particular issue and forget to assess more fully.

If becomes emotional, respond by showing you have noticed “It sounds as though you are worried/angry/frustrated about…”.  Apologise if becomes hostile.  Focus on what you can do rather than what you can’t do.  Avoid pre-empting what someone is going to say.

If parents not reassured, or your assessment of the seriousness of the condition differs from theirs, err on the side of caution and arrange a face to face consultation.

For long term conditions, it may be helpful for family to have a list of concerns before hand.

When ordering tests, discuss how these will be fed back – consider whether likely to need face to face follow up to discuss results and treatment options.

Wait until the other party has hung up.

See also Remote consultations – use of images.

Audit

Clinical governance, Generic

Process of collecting data against a set of standards, in an attempt to improve compliance with those standards. But often ineffective – especially when no changes made (“closing audit loop”) to improve performance. And slow – by the time you’ve collected the data and summarized it, you’ve wasted time that could be been used to improve things you’ve already seen going wrong.

Often just turns into criticism, with intervention being no more than “perform better”. And then just induces resistance.

Cochrane review of audits in general found median 4.3% improvement with compliance, which isn’t much, but potentially more with incremental gains and repeated audit. And potentially scalable. And about a quarter achieve nothing.

Audit chain only as strong as weakest link – awareness of standards, reliability of processes, feedback.  All aspects of programmed should be designed with a focus on desired change in behaviour, and barriers should be anticipated.

Checklist for doing audit well –

  • Can you recommend actions consistent with established goals and priorities
  • Actions that are under audience’s control?
  • Actions that are specific
  • Can you provide multiple data points as feedback ASAP – and as often as frequency allows
  • Individual as well as general feedback if possible
  • Can you provide comparators that reinforce desired behaviour change
  • Format of feedback – link visuals with summary message, multiple methods, minimize distractions.
  • Actionable plan along with feedback
  • Address barriers
  • Short, actionable message with optional detail
  • Realistic goals.
  • Address credibility. 
  • Anticipate defensive reactions
  • Construct feedback through social interaction

Feedback to clinicians, who all think they’re great, requires careful thought.  Trying to improve already high performance may be a waste of effort, there is a ceiling for most things where organisation close to max capacity.

Patients and the public often surprised by the extent of variation.  They express frustration at difficulties in routinely measuring less technical aspects of care, such as consultation skills and patient centredness.  Patients are an untapped force for change which audit could learn to harness.

[ Revitalising audit, BMJ 2020;368:m213]

Medical Error

Clinical governance, Generic

See Bawa-Garba case.

In a complex system, some errors are unavoidable. Their incidence can be reduced by better system design but they cannot be eliminated.

An error may have been the result of a decision, that could have been made differently, but when people are trying to work in an under-resourced and overstretched system, errors may be difficult to avoid.

Deterrence should therefore not involve criminalisation, but those who can influence the system eg managers and service directors.

Many errors are minor and inconsequential, but James Reason’s Swiss Cheese model highlights how a number of errors can align to enable more serious harm to occur.

In cases of “gross negligence”, the prosecution must establish beyond reasonable doubt that the failures caused the death. Unfortunately, a not guilty verdict may suggest that care was adequate. Prosecutions focus on the individual, not on the wider team or the healthcare system.

Good Practice

  • Families should receive open disclosure and an apology
  • If possible, the harm should be treated as a priority
  • When relevant, compensation should be paid
  • Appropriate mechanisms should be in place to hold to account those responsible for delivery of care
  • Punishment may be appropriate but should be proportionate to the moral culpability of the behaviour, not the outcome of complex clinical problems
  • Responses to problems should be timely – complex systems need repeated and rapid adjustment. Not served well by lengthy investigations.
  • Motivated staff should be afforded the safety of a “just culture”, rather than “no blame” or “who’s the one to blame”.
  • Culture of safety from health minister to most junior

Legal basis

According to the Bolam judgement, if a doctor has acted according to proper and accepted practice (standards of one’s peers), s/he is not guilty of medical negligence (even if some disagree with that practice); whereas the Bolitho judgement adds that practice must however be logically defensible – it’s not enough just that others do it!

Montgomery vs NHS Lanarkshire –

Bellshill shoulder dystopia and CP – Supreme Court overruled previous judgment. “Whether a risk is material should not be reduced to percentages”, nor should it be simply for the doctor to decide. “Would a reasonable person in the patient’s position be likely to attach significance to a risk?” Or does the doctor have reason to think the particular patient might feel it was significant?  That is the test of “materiality”. 

Patient does not have to ask specific question. Indeed, responsibility for concerns to be explored. 

Does not mean patients must be bombarded with information, must be comprehensible. 

Official verdict is as follows:

  • Doctor is under a duty to take reasonable care to ensure that her patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.
  • The test of materiality is whether, in the circumstances of the particular case, 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.
  • The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact sensitive, and sensitive also to the characteristics of the patient.
  • What amounts to a material risk and the skill and judgement required in explaining risks to the patient is for the Court, and not the medical profession, to judge.
  • To prove a breach of duty to advise and warn, a pursuer does not require to prove that no doctor of ordinary skill would have failed to have given her advice, if acting with ordinary care, as supported by medical opinion.
  • A patient may decide that she does not wish to know what her risks and options are.
  • The “therapeutic exception”, which allows a doctor to withhold information from a patient only applies if its disclosure would be seriously detrimental to the patient’s health, or in circumstances of necessity, such as where the patient is unconscious or unable to decide.
  • Causation continues to be based on a subjective test: what the pursuer was likely to have done, had she been warned and advised properly. To prevent hindsight bias, this will require to be tested by other evidence.

Interesting that language of consumers and choice was used in judgement, as if these decisions are simply a matter of providing information and allowing rational judgement – when lots of evidence to say that isn’t how people behave in practice!

Writing a statement

Clinical governance, Communication, Generic

  • Include full name, qualifications, job title and how long you have been doing it.
  • Don’t assume reader knows anything about the case
  • Use first person
  • Who did what, why, when
  • Concentrate on your observations and your understanding (no need for long quotes of what was said to you, which is what a clinical report would require)
  • Say what you found, but also what you looked for and didn’t find
  • If you’re not exactly sure what you did, and nothing documented, acceptable to say “My normal practice would be…”
  • When you have referred to or discussed with someone else, give their name and who they are, describe what they did on the basis of the notes and your understanding, but don’t comment on the adequacy or otherwise of their performance.
[https://www.themdu.com/guidance-and-advice/guides/writing-a-report-for-the-coroner]

Bawa Garba case

Clinical governance, Ethics, Generic

High Court ruling regarding Dr Hadiza Bawa-Garba following the tragic death of a 6-year-old boy in 2011. Subsequently convicted of manslaughter. Removed from the GMC register, although Medical Practitioners Tribunal Service (MPTS) decision was to suspend for a year.  GMC appealed, saying it had not taken into account the manslaughter conviction.

High Court then overturned erasure, saying that tribunal did not commit any errors in its procedures, and therefore its conclusions were valid.

The trust acknowledged systemic failures, so why the vindictiveness? Its report into the death (“no single error responsible for death”) was not brought before jury, as being beyond scope of the trial! Not lazy or under influence, rather, took on extra duties in overstretched hospital with very little supervision.

And since when was gross negligence manslaughter law the right way to deal with errors made by doctors in training?

Why not corporate manslaughter case against trust?

Concern about reflective notes being used in court – despite being confidential? Used in support of Dr Bawa-Garba to show remediation efforts.

Twitter response from consultants was to emphasise “WE are responsible – so long as you tell us what’s going on”.

Subsequently 2 reviews –

  • Marx review by GMC
  • Williams review by government into medical gross negligence.
    • Suggested that GMC lose right to appeal Tribunal decisions.  Most of these appeals have been regarding sexual misconduct cases.  Professional standards Authority would still be able to appeal.
    • Suggested that GMC not be allowed to access reflective notes eg portfolio.  Could still be used as evidence in prosecution, however, not clear whether would help defence or prosecution more
    • Touched on high rate of cases involving black or minority ethnic doctors, but did nothing other than suggest BAME representation in investigations
    • Recommends explanatory note for gross negligence law, to improve consistency.  Law remains the same, however

Significant Event Analysis

Clinical governance, Generic, Patients

Traditional M&M (mortality and morbidity) meetings – Many errors are not reviewed, and the key protagonists often not present when a case is being discussed; fail to engage affected families. This lack of transparency in the context of the Francis report is at odds with our duty of candour to patients when things go wrong.

Much energy is spent in the NHS concluding whether errors, adverse incidents and deaths are ‘avoidable’ or ‘preventable’.

‘Avoidability’ is an arbitrary conclusion – what matters, surely, is the care that the child received. Professional analysis of the care given reassures parents that their child’s life is of primary importance, and may provide some comfort that their experience will benefit other children.

Root cause analysis (RCA) tracks the origins of an adverse event back to find causes – too simplistic?

cf ‘Safety-II’ approach – focuses on understanding how things usually go right, and only then exploring why things occasionally go wrong.  Rare serious events, although easy to identify, often have complex aetiology, and factors may be difficult to modify. In contrast, “normal” behaviour may be easier to understand and to influence.

Parents’ own questions should inform professional discussion.  Analysis should go beyond identifying what the child died from, to considering why a child died of that condition, in that place,  at that time.

“The investigation of medical error, adverse events and child mortality each requires a distinct approach that revolves around a continuous cycle of reporting, professional scrutiny and follow-through of SMART actions. These processes should separately feed into a properly formatted clinical governance meeting, the purpose of which is to provide assurance to hospital boards and other regulatory bodies that there exists coordinated oversight of risk management, clinical effectiveness, audit and patient experience.”

[James Fraser, Bristol – Arch Dis Child doi:10.1136/archdischild-2015-309536 ]