Tag Archives: regulation

English: Broken glass

Sometimes, the system is the problem. Broken glass (Photo credit: Wikipedia)

This report on the regulation of private hospitals in England from the Centre for Health and the Public Interest is important, but 15 years too late.

The UK has had and continues to have a love/hate relationship with the private (or independent as it is termed) healthcare sector. This has created a significant fault line across all reform and policy making on the NHS for at least 15 years. Reluctance to create a level regulatory playing field has been evident for years, despite the obvious need for one. I think part of the reason is that creating a level regulatory playing field so that the NHS and private hospitals had to meet common standards would legitimate the private sector itself.

However, when I first worked with a colleague to suggest, around the early 1990s, that the NHS hospitals should undergo some sort of accreditation, resistance was clear. At the time, I noted to others that there were more deaths in NHS hospitals arising from substandard care than from road traffic accidents.

But the view at the time was to ring-fence the NHS from that sort of performance and quality scrutiny at an institutional level. Based on some of the work I was doing at the time, and my own experience with accreditation systems, I felt that the negative reaction reflected a fear that NHS hospitals would fail; using pretty standard accreditation standards from the US, Canada and Australia at the time, I perceived that many NHS trusts would indeed fail. Mainly on safety and quality control grounds (I was teaching NHS managers about quality and quantitative methods in healthcare at the time). Many hospitals lacked any quantitative analytical or operations management capabilities within their organisation and had rather weak data for quality control and performance management purposes. The Department of Health, it must be said, had such expertise on contract but that was to inform their own policy making, not to improve operational performance. I would suggest that such quantitative expertise for quality is still missing at the hospital level.

The consequence has been years of fiddling with quality assurance and inspection regimes. Government has been advised, I think badly, by people who also shared the operative underlying assumption that a single regulatory and inspection system for both the NHS and private hospitals would be politically a step too far. Consequently, the private sector and the NHS have moved in different directions. The private sector has been both an opt-out for patients through private insurance arrangements, and an overflow supplier to the NHS when it ran into capacity constraints. Only more recently, has it been a direct and core supplier of services.

The UK situation constrasts wildly with practices in other countries where ownership of the hospital does not exempt the organisation from regulatory oversight. Indeed, many European hospitals seek out US-based Joint Commission International accreditation, a very high standard. Interestingly, there are no private providers in the UK that have achieved this standard, while (with any type of accreditation) there are 26 in Ireland, 3 in Belgium, 2 in Netherlands, 4 in Germany, 26 in Italy, 15 in Portugal, 23 in Spain, 13 in Malaysia and so on. Perhaps they know something?

I agree with the report’s sentiments, though perhaps not so much how it characterises the private sector as exceptionally risky. Indeed, the past years have demonstrated that NHS hospitals can be exceedingly risky. For instance, the report notes the 6000 admissions per year to the NHS from independent hospitals, while also noting that such hospitals do not have emergency facilities. One might ask whether a common regulatory environment would have led some independent hospitals to invest in such facilities? But such a figure should not be a surprise any more than transfer between NHS secondary hospitals of patients who need more complex tertiary and quaternary care; not every organisation can do everything. In respect of equipment, NHS equipment, too, has failed, gone missing or not worked properly (I have had personal experience of a nurse using equipment that lacked recent calibation); so before we cast the net, let’s make sure we know what we’re fishing for.

The report notes that the private hospitals do not directly employ their doctors, as though this were a problem. Many countries do not directly employ doctors, using fee-for-service type arrangements for compensation. What the report failed to note is that the private hospitals in the UK employ a system called “privileges”, which requires doctors to prove competency in areas for which the hospital in turn grants them privileges to offer that service in the hospital; NHS hospitals do not use a comparable system. I have argued that the NHS should introduce a privileges system, which would bring a more rigourous standard of clinical performance management than the NHS consultant employment contract does and would have the additional benefit of increasing flexibility in the supply of doctors, and perhaps importantly, keep doctors within their scope of primary competency.

A few other points that struck me:

1. Clinical risk does not transfer to the private provider when treating an NHS-funded patient. I’m not sure how this is a useful restriction, especially if the patient chose the private hospital. It seems to me that part of a level playing field would ensure that clinical risk transferred, too. The report addresses this obliquely in terms of whether the NHS is the provider of last resort.

2. The observation that clinical workflow is different is interesting, but it does appear somewhat anecdotal. The private sector is excluded from the requirement to take trainees, and that may contribute to the lack of depth, but I doubt the public would feel reassured that the clinical depth the authors referred to was reliance on trainees! We know what that looked like with registrars. The solution is to ensure the private hospitals are included in the system for training the health professions as a consequence of a common regulatory regime. By the way, I’ve looked at the supervision and training of junior doctors and other health professions and one should not be complacent that it is done well. However, I share the authors’ concerns over the organisation of clinical work, but would not single out the private sector on this point.

3. The volume of work in specific areas is a point well taken. However, I would again suggest that is an artefact of the regulatory system, and lack of effective use of the clinical resources themselves. Proper contracts for suitable volume, rather than handling overflow, would shift workload closer to levels where higher quality standards apply. It might also enable the consultant, for instance, to integrate their clinical workloads, rather than adding the private patients on at the end of an already busy day. Again, organisation of work arises from the current rules and may perhaps be causative of may of the identified problems.

4. I note that only one of the two authors is a specialist in healthcare or health policy, particularly patient safety with grounded expertise.

Many of the report’s comments, with which I broadly agree can seem quite disturbing, really arise from the regulatory box that the private sector has been put in. Given that private hospitals use the same doctors in the main as practise in the NHS, do these doctors lose their minds when they practice privately, or something else is certainly wrong at a system level. My guess is that the box is the problem, and the private hospitals are quite capable of meeting care standards, given a level playing field.

My remarks are meant to focus attention on the important distinction between the NHS as an organising principle for ensuring (and assuring) healthcare to people and the mechanisms used to identify and engage providers who meet the requisite standards. Focusing on the latter, would necessite doing what the report recommends, but ’tis a shame it has taken this long, to say once again, what has been said for years.

Is now any different?

Further reading: Vito Tanzi’s excellent book, Government versus Markets The Changing Economic Role of the State. Then think again about this



1. I don’t have private health insurance.

2. I have received NHS-funded care in a private hospital.

3. My NHS trust has recently been reviewed as overall inadequate by CQC.

4. I know something about the issues I am writing about.

The UK government is releasing, over time, its review of the balance of competencies of EU legislation. Within the first 6 papers released is the one on Health, Review of the Balance of Competencies between the United Kingdom and the European Union: Health.

At minimum, these reviews provide a timely perspective on this balance of competencies, and provides a focus for further commentary. Other EU members states may find it useful to be reminded what this balance is. It is not always in the interests of the European project to look at all things taken together as it shows whether overall the claimed benefits are in fact there. But such policy review, if that is another way of talking about them, does draw a line in the sand against which to measure and assess changes in the future, and avoids the problem of the boiled frog syndrome, where small incremental changes are not noticed until it is too late.

Health is a funny subject for the EU as it is both inside and outside the European competency box, depending on how you define things. Countries can run their healthcare systems broadly as they wish, and maintain control of financing, but the European Court of Justice, in a variety of decisions, has defined the contours of that national control, as seen through the lens of the single market, and freedom of movement of goods and services in particular — both of which are agnostic with respect to health. It all depends whether you think of healthcare systems commercially or socially. That hospitals are socially beneficial but also commercial entities does not help, any more than drugs as goods flowing across EU borders, and so on.

The report concludes in the main that the balance is about right. There is little argument with the benefits of European action in medicines regulation, public health, tobacco, etc. Where the UK has a problem is with employment policy as it impacts the UK more generally and the National Health Service specifically. Different logic of the relationship between the employee and the workplace applies in the UK and this throws up a wide range of relevant issues.

The Working Time Directive is the elephant in the room here. The concerns are how the NHS structures clinical work, trains junior doctors, and generally organises itself to provide for continuity of care. Other countries, not just the European ones, have the same concerns about over-worked doctors. The heroic fictional doctors on television, who nap on couches and awake fully prepped to save patients is fantasy. Next time you’re in mid-Atlantic, be grateful your pilots got a good night’s sleep. The criticism of the WTD is more an indictment of the inability of the NHS and its massive provider infrastructure to put in place appropriate patient management systems that ensure a sensible balance of workload and rest. But the Health Paper makes the point that the European Court’s judgements have actually further constrained operational flexibily within the NHS. While the paper notes that the NHS operates on a 24 hour system, it actually doesn’t as it isn’t fully staffed on weekends, and many services operate within a traditional working hour day (e.g. laboratories, imaging). Much of this arises from the politically influenced structure of the NHS which has made it very difficult for alternative providers to enter the healthcare market in the UK, and thus offer relevant services, whether day-case surgery, or imaging, at times more convenient to patients. However, other countries in Europe appear able to manage demand and service provision more easily, so one much wonder why the NHS problems of their own doing.

The other area that exercises the NHS is free movement of patients. Medical tourism is a big issue in the UK, as its health system is based on residency. Social insurance systems have built often formidable barriers to gaining healthcare cover because they generally link the insurability with the workplace. Self-employed individuals are frequently disenfranchised from full benefits, and often pay disproportionately. Retired people continue to need insurance. But an insurance system does make cross-border transactions much easier. The UK has not really understand the operational dimension of the differences for UK taxpayers moving within Europe. The Limosa Convention is not mentioned in the briefing, while the European Health Insurance Card is. The EHIC is only really for tourists and retired people and the paper promotes the benefits of them. However, the EHIC is not for people temporarily located in another country for employment or work purposes.  They do not refer to the bureaucratic overhang of the A1 and S1 forms needed for people working in other EU countries and the forum-shopping associated with it as countries seek to get ‘the other country’ to pay the bills. I wonder how many people realise they need an S1 to run a seminar in another country as this is defined as work, or that working from home and living in country A while your office is in country B could be a bureaucratic nightmare. The report is silent here.

We are awash with regulation. Healthcare and medicines are particularly affected.

For instance, in their wisdom, European lawmakers have deemed it inappropriate for medicines to be advertised. And this in the 21st century, with open information access, calls for transparency and the empowered and informed patient. Of course, the logic of such restrictions reflect real-world anxieties, but they also reflect the anxieties of another age. If we examine regulatory practices, we’ll find that in the main they use instruments that would have been popular in the 1950s and 1960s. Today, more subtle and information rich tools are available.

We regulate to coerce people and organisations to behave in certain ways that they would not, of their own volition, otherwise do. This coercion is legitimate if it arises through due process and democratic accountability, and not just the whim of the regulator or government. Sometimes this coercion has perverse consequences, such as with medicines where the legitimate manufacturer of a product is prohibited from publicising a product, but all manner of snake-oil salesman can make all manner of inappropriate claims for medicines, each pits or peanut butter as a sunscreen! The truth lies somewhere but regulations make truth-telling more difficult and not always in the public interest.

What I want to propose draws its inspiration from the US, with Don Berwick and colleagues suggested Triple Aim tool for determining high-value intervention targets (the three are: quality of care, patient satisfaction, and cost).

The Regulatory Triple Aim would comprise three tests, the simultaneous failure of which would indicate that the proposed regulation should not be considered further.

  1. Will the regulation produce poor quality or substandard outcomes? This is likely to be measured through evidence or insight into perverse consequences, weak enforcement, lack of suitable performance data, etc.
  2. Will the regulation produce dissatisfaction amongst the regulated? This is comparable to the patient satisfaction and goes to whether the regulation is appropriate and proportionately coercive and will it enjoy high degrees of compliance.
  3. Are there avoidable costs associated with the regulation? This is an interesting test as it actually asks two things: [1] is there an incremental burden of costs associated with regulation and [2] is the cost proportionate to the benefits.

As a formula, we have Quality (#1) + Satisfaction (#2)  divided by Costs (#3) = Value for Money.

We need ways to sharpen our focus on regulation, and we need to ensure that there is not too much of it for the value we seek to achieve.

Let’s test it with the regulation that was intended to control refillable olive oil containers or pots in restaurants, something that more insightul minds eventually decided was a silly thing to do (I’ll wager though that has just gone into hibernation while a study is commissioned to find evidence that such refillable containers are full of fake olive oil or somesuch and then it will re-emerge), but it did get a long way along the regulatory process without anyone (group think?) challenging it — are people really that dumb? I wonder how that happened — did no one apply a Wilson matrix to this to see if the distribution of costs and benefits was properly understood? Anyway, back to Triple Aim.

Olive Oil in Refillable Pots or Containers

Would regulating olive oil in refillable pots or containers …

1. … produce poor quality or substandard outcomes?

2. … produce dissatisfaction?

3. … create avoidable costs?

Triple failure, meaning answering YES to each question, would suggest this would not be a good idea.

Post your assessments and comments. Obviously, if you’ve got better examples, (such as regulation of clinical trials or whatever) please feel free to expand the scope.



Régulation de la machine à vapeur Merlin

If only it were that easy. (Photo credit: zigazou76)

There have been quite a few cases of late of regulatory failure by the Care Quality Commission [CQC] in the UK.  How can regulatory performance be monitored and improved?

The first thing to realise is that regulators are monopoly suppliers of regulation; that means, that if they don’t do a good job, the regulated don’t have a choice.

Regulators often find reasons to expand their remit (regulatory creep) and because they are prima facie trusted to do their work, regulatory overseers’ consent. Tight performance expectations coupled with effective oversight helps, as does conducting regulatory benchmarking exercises to assess comparative performance with other regulators. This helps keep regulators focused and not get drawn into expanding, like a gas, from what they need to do essentially.

The people who work as regulators invariably derived there expertise from the industry area being regulated. In the case of the CQC, people who had worked in hospitals. This creates an obvious risk in terms of ‘regulatory capture’ by the regulated. The NHS used to speak of being a ‘family’, all cosy, and as we all know, in families it is important to support each other and suppress dissent — paternal/maternal models of behaviour dominate.

But, regulators need to learn how to adopt new behaviours from what got them the job in the first place; much organisational failure arises from failure of people alter their behaviour as roles change. The relationship between regulatory and regulated cannot be chummy; it must be built on evidence that the regulator knows what they are doing and are not going to be compromised by past relationships or a need to be ‘liked’ by the regulated. The selection of the ‘great and the good’ to act as chairpersons and chief executives risks individuals putting their own reputation ahead of the need to regulate with vigour. Sometimes, as the NHS is learning, regulators have to have the teeth to do what needs to be done.

Perhaps more relevant is how regulatory inspectors use their knowledge when inspecting a hospital. While one hopes they use their knowledge well, they are not immune from making assumptions that something is happening (because in their experience seeing ‘A’ means ‘B’ is happening, when in fact it may not). I recall doing some performance work in a UK NHS hospital, and as I was walking through A and E and noticed that guideline posters were both out of date and not dated.  I was told they would change that immediately. Well, mundane stuff making sure guidelines are current, and dated as such, but pretty sloppy. Perhaps a regulator might assume that staff would know what to do. A risky assumption.

Regulatory inspectors need to be able to test all the systems to ensure the are working together. This means, for instance, taking a patient chart at random from the records and tracking the patient care through to discharge, and perhaps follow up at home.  I did a review of discharge on an NHS hospital and was looking at the charts and asked the ward staff about discharge plans for various patients. I was told for some of them that they didn’t have target dates, but that they made up dates for patients to keep them quiet. I asked what the patients thought of this and they said they usually forgot anyway. Needless to say, this sort of dishonesty is easy to catch (the staff thought I was ‘like them’ and would understand the need; I wasn’t and I didn’t); doing good chart audits of this sort are part of a detailed hospital regulatory inspection. Are the staff still dishonest, though? Let’s just say they didn’t do very good care planning as they had no target dates for discharge against which to calibrate resource use and then review when things didn’t happen as planned. Easy to pick up. With better care planning, it is easier to be honest with the patients.

I take a leaf from the nuclear industry regulatory inspection process. A basic assumption is that the regulated have good reasons to conceal, mislead and hide relevant information.  Since the stakes are high that poor inspection leads to system problems (think Japanese report on Fukushima nuclear site), starting from a position of doubt about the veracity of information enables a more robust approach to regulation.

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There's a reason the French call a traffic jam, 'bouchon" or cork.

The English NHS is in such a confused process of change that its CEO, David Nicholson wrote a letter of clarification to ‘everyone’ on 17 February 2011.

In this letter he sets out key challenges and issues. My mind for a moment flashed to autocrats championing their own view of the world, as though one were speaking to children. I have said often enough that the NHS has to learn to be an adult organisation. It doesn’t help with letters from ‘daddy’.

But something in this letter caught my eye, on page 5: “Support consortia to achieve authorisation, and will operate a rules-based intervention
regime to ensure consortia remain fit for purpose”. This is very interesting considering the underlying complexity of healthcare and being ‘fit for purpose’ might work for a toaster, but organisations don’t work like this in quite the way this linear mode of thinking suggests. It is worth keeping in mind that the fit-for-purpose mantra has been around in the public sector in the UK for quite some time, and yet the taxpayer continues to fund many dysfunctional organisations. So it is hardly a decisive criterion that organisational survival might depend on.

There is an active debate between rules-based and principles-based regulatory processes, and for a good reason, one of which had to do with the recent crisis in financial markets. What are these two?

  • Principles-based regulation focuses on outcomes, rather than processes.
  • Rules-based regulation requires the regulator to foresee every possible area of activity. This is often characterised as ‘tick box’ regulation.

In comparison to principles, the rules-based approach removes considerable discretion in behaviour, and to some extent simplifies the oversight process as you pay less attention to outcomes.

Let’s consider an example from something I did once. In the regulation of nursing homes, a document of over 60 pages of detailed inspection standards was prepared by an academic group (no surprise there, I guess): this is a set of rules.  What was missing was any statement of what purpose these inspection standards served; this document was silent on outcomes nursing home care should achieve.  So we had lots of rules on inputs and processes and nothing on outcomes (Donabedian would hardly approve). With a group of people, I helped them replace this 60-odd-page document with a single sheet of paper with 5 outcome criteria against which nursing home care could be assessed. These are principles.

The difference between the two can be looked at from a human perspective. If I work in a nursing home, do I carry around in my head 60 pages of inspection standards? No. I am trying to manage care processes. Could, instead, I carry around in my head 5 quality outcome criteria? Most likely.

Since we are talking of processes managed by humans, human frailty needs to be taken into account, and outcomes are a better guide to personal conduct than 60 pages.

I am now worried that an intrusive, pedantic system of compliance management is being put in place which will frustrate clinical service staff, drive management  crazy, and in the end probably provide far too many sources of tension between the two, to say nothing of the regulatory and inspection overhang from the NHS executive suite which will simply get in the way. It is just a useful reminder that the greatest barrier to change lies at the top — that why we say that the bottleneck is at the top of the bottle.

Anyway, healthcare is sufficiently complex that we can’t really create sensible rules.  I wonder why people keep acting as though this weren’t true.

One step forward, at least two back.

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