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Towards proactive medical regulation – preventing fires as well as putting them out

Marie McInerney writes:

Earlier this year the United Kingdom’s medical regulator took the “nuclear threat option” and threatened to remove junior doctors – who make up one-third of staff – from a leading London hospital if it did not address concerns about under-staffing and risks to patient safety.

pichosapitalThe move forced the North Middlesex University Hospital Trust in London to inject a “huge input of resources, borrowing staff from other hospitals, to try to deal with the crisis that could have caused harm to patients”, Professor Terence Stephenson, chair of the General Medical Council (GMC), told the 12th International Medical Regulation Conference in Melbourne last week.

The GMC has now put almost 80 sites under what it calls its “enhanced monitoring system”. This means “undertaking active monitoring of the trainee environment to ensure they and patients are being kept safe”, according to a spokesman. Here, for example, is its notification about concerns with the Emergency Department at the North Middlesex University Hospital Trust.

UK media have reported the move as part of efforts to prevent a repeat of the Mid Staffordshire scandal in which shocking standards of care in the early 2000s resulted in hundreds of patient deaths and “appalling and unnecessary suffering”.

Media reports said the GMC had put hospitals on notice this year after “finding alarming levels of bullying, handover systems so poor that desperately ill patients got ‘lost’ and left at risk of serious harm during weekends, unmanageable workloads and bed shortages in intensive care.”

They quoted GMC chief executive Niall Dickson as saying: “We are here to protect patients, not doctors… We are not part of the medical establishment, as we might have been seen in the past.”

Speaking about the action against the North Middlesex University Hospital Trust, which had argued that the GMC couldn’t “use the trainee tail to wag the system dog”, Stephenson told the conference: “We said we had ‘the nuclear threat option’.”

He was speaking during a plenary session on risk-based regulation, which discussed growing (but contested) moves by regulators to use research and data so they are not just responding to unsafe practice or casting their prevention work too widely, but can predict risk and prevent harm in the first place.

It’s also known, session chair Dr Anna van der Gaag quipped, as: “Find the doctor before the lawyer does”.

The session also heard from research being done by Dr Marie Bismark, as part of a risk-based regulation collaboration with the Australian Health Practitioners Regulation Agency (AHPRA), that identified past behaviour as a major predictor for future complaints, and tracked different impairments in doctors across their lives and careers.

Digging deeper into coronial data as part of the collaboration, Bismark also published research recently in the Medical Journal of Australia showing that the risk of dying by suicide for women working in medicine was more than twice that in other professions (more about her work follows below).

Stephenson explained that the GMC differs from many other national regulators – and therefore had greater fire power in its move against the the North Middlesex University Hospital Trust – after taking on responsibility for the quality of training of junior doctors in 2010 in the wake of the Mid Staffordshire scandal.

He outlined three examples where the GMC uses the “shed loads” of data gathered from its annual survey of around 55,000 postgraduate and undergraduate trainees, which attracts a response rate of around 95 per cent and is the biggest training survey in the world.

He said medical trainees are the “canaries in the coal mine” for health care – their experiences acting as red flags to system or team failures.

Stephenson said the GMC last year launched a “very targeted proportionate intervention” in 12 different hospitals – six departments of surgery and six of obstetrics and gynaecology – in response to “persistent, egregious” reporting by trainees of bullying and harassment.” See some case studies here about the action, and more about the way the GMC gathers risk information.

He said: “All the evidence shows us that departments where there is bullying and harassment are dangerous for patients and bad for doctors so we went into those, in partnership with hospitals, to try to prevent this deteriorating situation where either harm would come for patients and doctors and there would be ‘fitness to practice’ issues.”

A third example was where the GMC provides a ‘Welcome to the UK Practice‘ free half-day learning session to help doctors new to the UK to understand cultural and ethical issues in practice. It was, he said, preventive action that should be the responsibility of hospitals.

“But if they’re not doing it, we will,” he said. “A cent spent on prevention is worth a dollar spent on cure.”

Not a crystal ball

While some regulators like AHPRA have adopted risk-based regulation as a guiding strategy, concerns were expressed at the conference about it being a “probabilistic model” that risks antagonising huge numbers of medical practitioners with the “false positives”.

Responding to such concerns, Dr Marie Bismark, from the Centre for Health Policy at the School of Population and Global Health at Melbourne University, said she looks on data as “a red flag, not as a crystal ball”.

She said an understanding of risk factors can “help to triage notifications (and) identify practitioners and notifications that merit a closer look”.

She pointedly compared risk-based regulation with other screening programs “that doctors are very familiar with”, such as for cardiovascular conditions and bowel cancer. Equally, she said, there was “no point doing it unless we have an evidence-based intervention that will make a difference.”

Bismark outlined three case examples from her research work, which is being funded by AHPRA and the National Health and Medical Research Council, to illustrate the benefits of using data to “confirm intuitions, dispel myths, and reveal the unknown”.

She said analysis of 19,000 patient complaints in Australia shows that around three per cent of doctors account for 49 per cent of complaints.

“So Gerry Hickson [a US expert on poor physician practice] is right: there is a medico-legal cloud over all doctors, but it certainly rains more heavily on some than others,” she said.

The study is confirming the now accepted evidence that older male medical practitioners, and particularly surgeons, are most likely to attract complaints from patients or their peers.

But Bismark said that one other factor predicts complaints more than any other: past behaviour.

After two years of follow up , a doctor with one previous complaint has around a 20 percent chance of another complaint. By five years, it’s 40 percent.  After two years of follow-up, a doctor with five previous complaints has around an 80 percent chance of another complaint. By five years, it’s more than 90 percent.

 

bismarkuseBismark said her second example busts the myths put forward by some that the introduction of mandatory reporting of concerns about doctors in Australia “would open the floodgates” to nurses, midwives and other practitioners unfairly levelling accusations of poor practice.

She quoted one doctor who wrote to a newspaper to express his indignation:

I liken a nurse reporting a physician to someone who plays a little chess deciding to report to authorities the likes of an international grand master for their choice of opening moves”.

Rather, she said, her analysis of more than 800 mandatory reports found that nurses are more likely to make reports about other nurses, doctors about other doctors and so on.

bismark2
Dr Marie Bismark

In fact, she said, inter-professional reports are so rare that there should be concern that “even though nurses are very well placed to be able to identify poorly performing doctors, there appear to be significant barriers to coming forward to regulators with those concerns”.

Her final case study was to illustrate the importance of digging deeper after preliminary analysis of AHPRA data found very little difference in the level of notifications of physical or mental impairment, including substance abuse or dependence, between older and younger doctors.

When researchers looked more closely, they found “strikingly different” patterns of health impairment concerns along the life course: with mental health issues dominating the picture among new graduates, moving to a pattern of alcohol and drug misuse in middle age, and then, finally, a “sharp increase” in cognitive decline and physical illness over the age of 65.

Focus on bullying and discrimination

In response to a question, Bismark said that potential links between patient complaints and concerns with bullying, harassment and discrimination in the health professions was “a really ripe area for exploration” by regulators in the context of patient safety.

In separate sessions, the conference delegates heard of work being done by the Royal Australasian College of Surgeons after an expert review found discrimination, bullying and sexual harassment were rife among surgeons in Australia and New Zealand, as well as a culture of fear and reprisal that made it “career suicide” to make a complaint.

RACS CEO David Hillis said the organisation was getting some “push back” from hospitals and its fellows against the Action Plan it has launched to drive cultural change in the profession, saying he still often hears comments that trainees in particular have to “toughen up”.

“I’d say it’s the consultants who need to learn how to cope with the stress and their workload,” he said, adding that major cultural deficits are a link between revelations about the profession in Australia and New Zealand and medical scandals like at MidStaff in the UK.

The RACS review was sparked by the revelations of Melbourne neurosurgeon Caroline Tan whose career was derailed after she spoke out about sexual assault. It revealed “a profound lack of leadership and ownership” of the problem and little confidence that medical colleges, universities, hospital human resources departments or medical regulators would address it, Hillis said.

“I get confronted by outright denial or grief reactions from members of the medical profession who say ‘it doesn’t happen in my patch’. But it does, and it particularly occurs in surgery,” he said.

He acknowledged that it’s very difficult for senior clinicians to learn how to take a stand: “You spend 30 years walking past it, how do you suddenly say to your colleague, ‘You can’t say that, that’s sexual harassment’.” But he said role modelling has a profound impact.

The RACS vision for change is not only a commitment to a safe workplace and learning environment for the profession, but that every patient has a right to expect their health care is not being compromised by discrimination, bullying and sexual harassment, he said.

The RACS announced last week that it had signed its first Action Plan agreement with a tertiary education partner – the University of Otago Medical School in New Zealand. Health organisations committed to the plan so far include Ramsay Health, Monash Health, St Vincent’s Health and Metro South Health in Queensland.

Prevention, partnership and problem solving

Chairing a session on risk-based regulation, Dr Anna van der Gaag, Chair of the UK’s Health and Care Professions Council, recalled a rallying cry from Harvard University’s Professor Malcolm Sparrow at the 2014 IAMRA conference, when he urged delegates to think beyond the “traditional style of enforcement” in regulation.

Instead of being reactive, adversarial and incident-driven, he urged prevention, partnership and problem-solving to find more innovative forms of risk reduction and harm prevention.

AHPRA CEO Martin Fletcher said Sparrow had been hugely influential for AHPRA’s work on becoming a risk-based regulator, trying to move from “just holding rich data” to actually learning from it, while respecting how sensitive it is. That has led APHRA to invest in staff skills not traditionally held by a regulator: in statistics, epidemiology, research and maths.

Van der Gaag said most regulators were more comfortable with traditional approaches: setting standards, keeping a medical register, and investigating complaints.

“But there is much less focus by us on the impact of complaints on those who are involved, why they arise in first place, what can be done to prevent then, and indeed why there are fewer complaints from certain groups…the young, old, and people with disabilities,” she said.

“Are we like firefighters in the station waiting for fires to break out, or working with our communities to reduce the risk of fire breaking out in first place?”

annadvg

See also Marie Bismark’s blog post from the 2014 IAMRA conference on the seven qualities of highly effective regulators.

These are: 1. Clarity about purpose; 2. Agility to use the right regulatory tool for the purpose; 3. Trustworthy; 4. A willingness to question, a desire to learn, and an openness to new evidence; 5. The humility to recognise that none of us operate alone, that there is much to be learnt from others, and that there are some problems that regulation alone cannot solve; 6. The ability to make fair, independent and unbiased decisions; 7. Proactive – they look upstream for opportunities to prevent harm before it occurs.

More reports from the Twittersphere

complaintspanel

surgeonscheck9check8check7

check4

check3check2check10

dartondatafaulkner

hardestthing

Focus on listening

stephensontraineesurveys

listen


• Journalist Marie McInerney is covering #IAMRA2016 for the Croakey Conference News Service.

Bookmark this link to follow the coverage.

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