A Solution to the Alder Hey Problem?

MD was recently invited to a high-level meeting at the Department of Health to discuss, amongst other things, what to do about the Alder Hey problem. The charge sheet against Alder Hey is long and complicated (Eyes passim ad nauseam). While no hospital is able to provide the highest standards of care for all its patients at all times, the main concern is that the culture of secrecy, bullying and poor practice that allowed the organ retention scandal (1988-1995), persists today.

The culture of fear, secrecy and the silencing of whistleblowers is not unique to Alder Hey, but as the Bristol whistleblower Prof Stephen Bolsin commented, the best way to resolve bitter NHS disputes is simply to focus on patients. The key questions for anyone charged with investigating Alder Hey is whether children have been harmed by poor care, or whether proper informed consent has been denied for acid reflux operations that are not approved by NICE.

Holding surgeons to account has never been easy. When MD trained, a surgeon could invent an operation of dubious rationale and no evidence base, and carry on for years unchallenged. Another might do an established operation very poorly for a lifetime safe in the knowledge that his or her colleagues wouldn’t speak up and often needed a reference. This club culture was supposed to have changed after the Bristol heart scandal. In 1998, one surgeon was struck off by the GMC and another was suspended from operating on children, not just because their results were demonstrably much worse than elsewhere in the country but because they didn’t tell parents the truth about their results and other centres or options where they might get better, safer care.

After Bristol, the National Institute of Clinical Excellence was established to tell the NHS not just what drugs and operations were effective, but what the NHS could reasonably afford. Patients are entitled to NICE approved treatments, and the NHS should only offer NICE approved treatments unless there is very good reason not to, such as being part of a proper clinical trial to test an unproven procedure. This important principle went horribly wrong recently in the ASR prosthetic hip scandal. 10,000 new hips that were not NICE-approved, were put into UK patients and now failing in disastrous numbers, a huge human and medico-legal catastrophe (Eyes passim). Worse still, this choice of prosthesis was usually completely inappropriate, given very good tried and tested alternatives were available. And many patients simply weren’t told the truth or offered better alternatives when they were ‘consented’.

The same pattern of lack of accountability and action in the NHS and private sector was exposed this year in the scandal of surgeon Ian Patterson, who performed unnecessary, un-evidence based and incomplete surgery for breast cancer for many years unchallenged. The nub of the Alder Hey problem is that senior surgeon Matthew Jones has for many years been performing an operation on children with acid reflux that is not recognised nor recommended by NICE. NICE recommends a fundoplication that wraps part of the stomach around the lower oesophagus to restrain reflux. Jones – in some patients only – adds vagotomy (cutting the vagus nerve), semi-paralyzing the stomach and necessitating that the pylorus get opened and reconstructed (pyloroplasty). This adds risks of leaks and needlessly exposes the operation to contamination by gut microbes. NICE can find no evidence to support this approach, but the potential long term side effects are significant. Neither Jones nor Alder Hey have provided the Eye with evidence of whether children have been harmed in the longer term or whether their parents were given proper consent and realised the procedure was not recommended by NICE and other proven alternatives are available.

The next step would seem obvious. Alder Hey must suspend the procedure whilst a no-blame investigation is carried out as to its appropriateness, to check facts and that proper consent was obtained and see whether children have been harmed in the longer term. In the meantime, no child will be denied treatment, but will get the NICE approved, evidence-based, highest quality treatment that other specialist units in the NHS are currently providing. MD has suggested this course of action to Bruce Keogh, medical director of NHS England and to Mike Richards, Chief Inspector of Hospitals at the CQC. Thus far he has had no response. MD raised it again in the meeting at the Department of Health. If no action is taken now, the NHS has learned nothing from the Bristol and Alder Hey scandals.

The Black Hole

The NHS in England alone is facing a £30 billion deficit over the next five years, as demand in just about every area outstrips both the supply of services and the funding for them. Ed Miliband’s extra £2.5 billion a year would plug the debt for 2015-2016 but not cover it subsequently, leaving nothing to pay for 36,000 more staff he has also promised. He is right that the NHS is hitting the wall now, with over two-thirds of acute hospitals in England failing to balance their books this summer and five of the key waiting times standards missed, including the maximum of two-month waits of urgent GP referrals for treatments. David Cameron’s promise of a marginal year on year increase does nothing to address this. The bottom line is that if no party is prepared to fund care for a population living longer, patients will have to wait longer for care, accept brief, poor quality care or not get it at all.

NHS England has allowed the £400m normally used for ‘winter’ planning to deal with this backlog, and is doubtless praying for a warm January. But NHS England has very little control over what devolved Foundation Trust hospitals do to balance the books. On August 26^th, Andrew McKirgan, Executive Chief Operating Officer of University Hospitals Birmingham NHS Foundation Trust sent a blunt letter to the chiefs of Clinical Commissioning Groups (CCGs) who are just outside their area.

‘I am writing to inform you of a change to how the Trust manages GP referrals from your Clinical Commissioning Group. Unfortunately due to an unprecedented year on year growth in GP referrals to our local district specialties we are no longer in a position to combine patient choice with a guaranteed maximum 18 week waiting time. Following discussion with our local Clinical Commissioning Group we have taken the reluctant decision to no longer accept referrals into a number of our clinical specialties from GPs that reside outside our local catchment population.  

Those specialties initially affected are Pain, Dermatology and General Surgery. As a result these specialties will be removed from Choose & Book and any written referrals received by the Trust will be returned to the GP immediately for referral to an alternative hospital. In addition a letter will also be sent to the patient explaining that we are sadly unable to accept their GP referral with a request to them to contact their GP regarding a referral to another hospital.   We are unable to confirm at this stage how long these measures will remain in place however we will continue to monitor our waiting’

The freedom of Foundation Trusts to fiercely protect their own finances was pushed through by Tony Blair against the wishes of English MPs but passed with the backing of careerist Scottish Labour MPs who’s own country and constituents do not have a corporatized NHS. The result is that NHS England the Department of Health and CCGs have much less power to deal with NHS debt, leaving the market and the media to decide which services continue to be funded. Mental illness has never attracted the same kudos or funding as cancer and heart disease, even though it costs the economy £70 billion a year and those with mental illnesses have much worse physical health. Mental illness also tends to start in adolescence, and yet Child and Adolescent Mental Health Services (CAMHS) across the NHS are in crisis (Eyes passim), as this consultant told the Eye:

‘We get on average 17 new referrals a day of young people with serious mental health issues. We are so overloaded and the staff are so stressed that many of them have gone off sick, making it even harder for those of us who remain. We simply have to refuse many referrals even though I know young people need us and they will get worse without us. I may have to choose between seeing a young person who has self-harmed for a year, and a young person who has done it for a week. The person who has self-harmed for a year will be absolutely desperate, but I will be more likely to achieve a positive outcome for the person who has only harmed for a week. Who should I see? How do I allocate these precious NHS resources? Do we have to wait until a young person we’ve turned away commits suicide before somebody sits up and notices how we are struggling to cope? And we’re struggling to cope because the communities our young people live in are struggling to cope. There is a very, very big mental illness iceberg out there and it’s showing no signs of melting.’

The NHS in Scotland and England

Oh the irony. Labour’s killer argument to win the next election –that the Tories are destroying the NHS – has become Alex Salmond’s killer argument to win independence and lose Labour some safe seats. Salmond argues that the privatization of the NHS in England will shrink the health budget and have a knock-on effect in Scotland, and that independence will protect the budget and also allow protection from future privatization to be (hastily) written into the Scottish constitution.

Yet the NHS in Scotland is already devolved and has the power to resist private providers. In Scotland, personal care, prescriptions, dental check-ups and eye-tests are all free. Scotland has more GPs, medical hospital staff, nursing, midwifery and health visiting staff per person. It has no ‘market’ in healthcare; there are no Foundation Trusts, just a few PFI hospitals and none of the extra bureaucracy and regulation needed to manage the market. It has comparatively little private provision either outside or within its NHS. Scotland’s spend on public health is highly focused and it was first to introduce the public smoking ban. And yet despite this publically funded, controlled and provided NHS, life expectancies in Scotland are 2.7 years lower for men and 2.2 for women. If Scotland votes for independence, the life expectancy in what’s left of the UK will increase.

Life expectancy – and the number of years lived in good health – are far more strongly determined by poverty than how much money goes into the NHS. By far biggest risk for Scotland’s NHS is if independence makes the country poorer, which would cause a double whammy of greater demand on the NHS and less tax to fund it. There’s already nothing to stop the Scottish parliament increasing NHS spending, but it has to be paid for. Meanwhile, the flat-line funding of the English NHS makes it harder for NHS trusts to balance their books, private companies to make money and for patients to get care. Both the Nuffield Trust and NHS England calculate that by 2021, the shortfall in NHS funding will be £28-30 billion.

And yet the demands on the NHS are rising year on year as we live longer. The majority of patients using GP and other community services are already over 75. The average age of hospital patients is over 80, and 10 per cent of the patients over 90. The average age of patients admitted with hip fracture is 84, of whom one in three has dementia, one in three suffer delirium and one in three never return to their former residence. Most patients over 85 go to hospital because of an emergency, and stay on average for about 12 days. The majority of people nursed at home and who get help with activities of daily living such as washing, dressing and eating are 75 or older. Older patients account for more than half the caseload of district nurses, half a million people receive home care from social services and 84 per cent of them are over 75. Around 2.5 million people over 75 also have some kind of informal care at home from close family members, neighbours and friends. A quarter of carers are themselves 65 or older. Andy Burnham has warned that five more years of austerity will “push the NHS off the cliff-edge” but will Labour and the SNP commit to raising taxes to prevent its decline?

The Tory solution is to hope that enough people who can afford to get fed up with the waiting and pay to go private, particularly in NHS hospitals. The number of patients in England waiting for routine hospital treatment on the NHS has reached a six-year high with 3.2 million awaiting surgery, scans or other treatments, a rise of 700,000 from April 2010. By lifting the cap on the amount of private work NHS hospitals are allowed to do, the coalition has encouraged NHS hospitals to tout for private business and many are undercutting private hospitals. Meanwhile private hospitals are having to take on state-funded patients from the NHS to balance the books. Care is not driven by need, but by a business plan that searches for customers. The profit motive has gone viral in the English NHS

The argument for NHS expansion of private work is that some of the profits get ploughed back into the NHS, the argument for allowing private companies to take on NHS services is that they deserve a chance to do better. The Circle takeover of Hinchingbrook hospital has not yet made a penny in profit, and its support payments from the NHS to stay afloat are nearly £5 million. Circle won the 10 year contract based on the assumption that it could deliver £300 million savings, but without being able to cherry pick, it simply can’t. It’s ‘friends and family’ scores are high but the true test of a well performing trust is the staff survey. Out of 28 Key Findings, it came out worse than the NHS average on two thirds (19), and is in the lowest 20% in half. Like many trusts, Hinchingbrook can only balance its books by expanding its private business, an option the Scots are avoiding. For now.

Gordon Brown may promise Scotland that its NHS it will never be privatised but in England he endorsed market competition and the handover of large chunks of public money – and the power and control that brings – to private corporations and their shareholders, to run NHS services. When they can’t make a profit, they will up sticks and leave – or have to be bailed out by the NHS. The Scots should be very wary of Brown’s bluster, but all four home nations will struggle to deliver high quality healthcare for an ageing population, whatever the outcome of tomorrow’s vote.

PRIVATES ON PARADE

Last month’s report by the Centre for Health and the Public Interest on patient safety risks in private hospitals made depressingly familiar reading. Over 802 people died ‘unexpectedly’ in private hospitals in the last 4 years and there were 921 serious injuries, but it’s very hard for patients or polticians to meaningfully compare this with safety in the NHS because private hospitals are still not required to make data on hospital deaths and safety incidents publicly available (Eyes passim).

Coding in private hospitals is often poor too but even without accurate data, the risks are obvious in an emergency. The majority have no intensive care beds, some have no dedicated resuscitation teams, and surgeons and anaesthetists usually work in isolation – without assistant surgeons and anaesthetists in training present. There is often very little experienced cover at night, with typically one very junior doctor covering and entire hospital, and there are gaps in after-care too if things go wrong.

The private hospital sector now gets over a quarter of its income from treating NHS-funded patients, so there is no excuse for not having comparable data available to patients about hospital performance and safety. The NHS still serves as a ‘safety net’ for the private sector. Thousands of people are regularly transferred to NHS hospitals following treatment in private hospitals, with over 2,600 emergency NHS admissions from the private sector in 2012-13. The NHS is not reimbursed for this, even if the emergency care follows a failure by a private hospital.

Regulation of private healthcare in England is the responsibility of the Care Quality Commission (CQC), but the CQC can only make judgements on the data available (or lack of it). Records of clinical negligence claims against private providers are not publicly available, as they are in the NHS. And the Care Act somehow exempts private providers from the new criminal offence for providing false or misleading information to the regulators.

Patients using the private sector have no statutory rights to support complaints or to receive independent advice and support, nor recourse to the Health Service Ombudsman. And taking legal action for clinical negligence against a private provider is even tougher than in the NHS, where everything is overseen by the NHS Litigation Authority. A claimant against a private provider may have to try to prove whether it is the hospital or the individual surgeon or sub-contractor who is liable.

As well as picking up the tab for complications of private healthcare, the NHS can also be left with the legal bill for negligence claims. Vanguard Healthcare was approached by Musgrove Park Hospital in Taunton in February 2014 to help clear a backlog of cataract patients. The initial contract was to do 600 cataract operations but the contract was pulled after four days when 62 operations had been done. Of those that received the treatment, 31 subsequently reported complications including an 84-year-old man who has been left blind. If negligence is proven, it is the NHS as commissioners of the care, rather than the private providers of the surgery, who foot the bill.

Doctors, however, can be held to account wherever they operate. Surgeon David Sellu is currently in prison for unlawful killing of Jim Hughes at the Clementine Churchill Hospital in Harrow. Mr Hughes suffered a perforated bowel following a knee operation, and Sellu was judged not to have acted swiftly enough to save him. Mr Hughes deteriorated on a Friday afternoon, when there was no staffed operating theatre ready and no anaesthetist on hand. Sellu could have called 999 and put Hughes in an ambulance, but decided to observe him at the Clementine. There was only one junior doctor on after hours in the 141-bedded hospital. Vital does of antibiotics were missed and Sellu got further delayed in theatre. Like all doctors sometimes do, he took on too much (Hughes was not his patient originally) and made errors under pressure, for which he and the Hughes family are paying heavily.

The Sellu case, and others like it, will probably make surgeons more defensive and risk averse, but it should also make them responsible for telling patients the truth about the extra risks of having surgery in a private hospital when an emergency happens. These risks need to be measured, published and – if significant – included on the consent forms.

My Background

I am an NHS doctor, investigative journalist, broadcaster, campaigner and comedian. I was previously a lecturer in medical communication at the Universities of Birmingham and Bristol, training medical students and doctors to cope with difficult consultations. As a doctor, I worked part time in general practice for over 20 years, and has also worked in sexual health. I currently works in a specialist NHS team for young people with chronic fatigue syndrome/ME.

I have been Private Eye’s medical correspondent since 1992, broke the story of the Bristol heart scandal that year after being given evidence of poor care by Dr (now Professor) Stephen Bolsin. I gave evidence to the subsequent Public Inquiry and have been an advocate for NHS whistle-blowers for 22 years, covering many of their stories. In 2012, I was shortlisted with Andrew Bousfield for the Martha Gellhorn Prize for Investigative Journalism for ‘Shoot the Messenger,’ a Private Eye investigation into the shocking treatment of NHS whistle-blowers (attached)

I am also a Vice President of the Patients’ Association and a patron of Meningitis UK, the Doctors’ Support Network, the Herpes Viruses Association, Patients First, PoTS, the NET Patient Foundation and Kissing It Better. I am also a fundraiser and advisor for the Association of Young People with ME.

My Thoughts

Speaking up and raising concerns is, or should be, a routine and daily part of patient safety procedures. The aim is to protect patients from avoidable harm. It should not be seen as anything unusual, rather the reverse. We should all be doing it every day. It should be in our DNA.

The priorities whenever you speak up are always

Protect Patients from Avoidable Harm. Speaking up needs to happen in real time, with a real time response. A public inquiry years after repeated avoidable harm is a sign of massive systemic failure.

Protect the Evidence. Routine real time safety monitoring should include recording, dating and keeping all serious concerns securely. Staff should be trained to follow a process of speaking up in four stages. 1. State the concerns (actual or unacceptable risk of avoidable harm). 2. State and supply the evidence in real time (even if it is incomplete). 3. State who you raised the concerns with and when, what you think needs to happen now and what the possible solutions are as you see it. 4. State what actions are taken and whether they address your concerns satisfactorily. If not, complete the cycle until they do.The above would capture the problem-solving suggestions of the member of staff as well as documenting all the evidence in real time should future inspection and improvement bodies need to see it. A key problem when staff raise concerns is that evidence can be tampered with and go missing, and information can be erroneously recalled after the event. So real time monitoring and secure documentation of serious concerns is needed. And everyone in the NHS needs to know how to do this and that it is their duty and legal obligation to do this.

Promote Transparency and Accountability. Patients and carers must be told about any avoidable harm that may have occurred, be fully involved and informed in any investigation and have clear instructions as to the chain of accountability should they wish to pursue it further.

Protect the Livelihood and Mental Health of NHS Staff. Raising serious concerns is very stressful for both those doing the raising and anyone who may be implicated in avoidable harm. Intelligent and kind inspection and improvement bodies are needed. A swift ‘no blame’ suspension of services may be needed if unacceptable risk to patients is deemed ongoing. A ‘fair blame’ culture in needed as the investigation unfolds. Rarely is a serious single error in a chaotic system the fault of an individual. However, failure to act on a clear concern to prevent a repeat is more likely to be.

Speaking Up Beyond Your Organisation but Within the NHS

This must happen when you do not believe the organisation has taken your safety concerns seriously, and patients are either being harmed or are at an acceptable risk of avoidable harm.

If your organisation does not agree with you, you have to have a secure way of protecting the evidence and protecting yourself and passing information securely to both inspection and improvement bodies for appropriate consideration and action. Everyone in the NHS must be clear what this process is, and it should happen as a matter of routine rather than under the label of whistleblowing. At this stage, the information is still remaining within the NHS, although patients and carers always have the right to make what they are told public. The NHS should therefore operate under the understanding that serious errors will always become public knowledge.

There is currently some debate about who the inspection and improvement bodies are. The CQC says itself as an inspection body only and not an improvement body. The current leadership at NHS England seems to be distancing itself as an inspection and improvement body. It is not clear, for instance, whether medical director said Bruce Keogh will continue to lead investigations into trusts with, for example, high mortality rates or concerns about heart surgery. There is an urgent need to clarify who the overarching inspection and improvement bodies are, and how members of staff, patients and carers with serious concerns should contact them. If the commissioners are to be responsible for improvement, there needs to be good evidence that they have the expertise and resources to do this.

A further complication is that the National Institute for Health and Care Excellence sets very high and admirable Quality Standards that the NHS aspires to reach. However, it does not at present set minimum standards that the NHS must reach at all times. The CQC may use such minimal standards but these need to be explicitly stated and circulated so those raising concerns can judge whether the service has fallen below an acceptable level, or whether it is ‘good enough’ without being excellent.

Some of the whistleblowing cases I have investigated have been disputes between those raising concerns with very high standards, and those defending services with ‘good enough but not great’ standards.

Speaking Up Outside the NHS

This is what most people would define as whistle-blowing, and in these days of social media and mobile phones in hospital it is just as likely that patients and carers will do this as staff. A photo of a pressure sore or of a cupboard with a bed in it is very emotive, particularly when it is posted on Twitter next to the hospital’s and chief executive’s Twitter name.

If members of staff do not believe the inspection and improvement bodies have acted appropriately to protect patients from avoidable harm, then they too should take the information outside of the NHS. How and when you do this depends on the urgency of the situation, whether patients are being harmed now or whether the risk is at some stage in the future. It also depends on what you perceive the threat to your own mental health and livelihood is. You also have a duty of confidentiality – public whistleblowing campaigns are far more successful when NHS staff and the patients/carers affected unite around common goals.

When whistle-blowers contact me, I tell them that I have never been sued in 22 years for getting a whistle-blowing story wrong, but I have never been able to get a whistle-blower his or her job back. From a personal livelihood and mental health perspective, it is a huge risk doing what you think is the right thing, and any public exposure also increases the stress levels of those who you are raising concerns about, perhaps even making the situation even riskier for patients, at least in the short term. It’s also important to get proper legal advice and advocacy, which your union and defence body may not always be willing to give – presumably because your concerns could upset many other paid up members.

For these reasons, I tell those who want to raise concerns via the media to think carefully, ensure they have considered all other angles and that they have enough evidence to support their claims, even if it is incomplete. I tell them to get legal advice, and that I will give the NHS organisation right of reply, which usually means very protracted correspondence with lawyers. I never print the identity of a whistle-blower if they do not wish it to be revealed, but organizations generally reach their own conclusions and this does not stop them trying to shoot the messenger rather than accepting they have a patient safety problem.

My firm belief is that we will always occasionally need whistle-blowing outside of the NHS, but with speaking up seen as a routine, every-day and vital part of patient safety monitoring, secure capture of concerns and evidence that can’t be tampered with or forgotten at a later date, and patients and carers told honestly and kindly whenever they have been harmed by care, the need for protracted media campaigns and hugely damaging and costly public or GMC/NMC inquiries well after the event could be reduced. But it needs strong leadership to cement this transparent, accountable, spin-free, politics-free culture in place.

Finally, people who have taken their concerns outside of their organisation with the noble intent of protecting patients may find it hard to return to that organisation but they should, if they want, be offered appropriate employment elsewhere in the NHS. In my experience, these are often the very people who could give the NHS the strong, transparent, accountable leadership it needs.