Clean In, Clean Through, Clean Out - A Methodology for Delivering Purposeful Pathology

This post summarises the work that has been happening in North Devon over the last few years to deliver more effective pathology. We will show that a focus on purpose, and attention to key points of leverage, has led to substantial improvements in the quality of care whilst making make cost savings. Our methodology has achieved this at pace and scale, and in a manner that is sustainable. We suggest that the problems facing pathology are not ones of efficiency, but rather of effectiveness.

What is the purpose of pathology? 

Our work started by talking to patients about what matters to them about their diagnostic tests. We heard

• that they want to trust those that are providing their care 
• they want to feel cared for 
• they want to know if they are normal 
• they generally want to be involved in their care. 

In essence, what this means for pathology is that our purpose is :

 "To enable citizens, and their carers, to make informed decisions about their care" 

What is the cost of sub-optimal pathology?

Diagnostic testing has been growing at about 5% per annum. There is a frequent assumption that this is linked to value, but this is not proved. As we will discuss in subsequent posts, there is considerable evidence that over-testing is now endemic in modern healthcare. There is an obvious link here to increased testing costs, which are not insubstantial. However, the greatest costs lie outside pathology. We will discuss how overtesting adds to an already stretched workload, and adds further costs from follow-on investigation. Most insidiously though, sub-optimal testing leads to considerable patient anxiety. Fran's story tells what it is like to be told as a patient you have an incidental finding of an abnormal result.

Deriving points of leverage from what matters - Clean In, Clean Through, Clean Out

Our work led us to the hypothesis that we will be delivering purpose if the following conditions of "Clean In, Clean Through, Clean Out" are met. In subsequent posts we will describe case examples (urinary tract infection, leg ulcer management, chronic disease monitoring) that provide illustration of these points of leverage. We will also consider the difference between 'inside out thinking' (in our case seeing the world from the perspective of the pathology service and the problems we have) and ’outside in’ thinking (seeing the world from the perspective of the citizen and the problems they have).

Clean In. 

Our standard definition requires tests to be 

1. Necessary

Our work showed numerous examples of tests that were not necessary to answer the clinical question being asked. As we will show this is expensive in and of itself, but that the true cost of inappropriate testing is under-recognised and lies outside the laboratory.

2. Maximally appropriate 

We also saw examples of where tests were not being done at a time when they would have most effectively answered the clinical question, leading to delayed and sub optimal decision making 

3. Informed 

Citizens often have little idea why things are being done to them in healthcare. Our work forced us to confront the implications of this, and it goes both ways. People are often surprised by the result of a test they were not expecting, and were not psychologically prepared for the implications. This goes someway to explaining why results are then not acted upon in the most rational manner. We also saw citizens who thought tests were doing something that they weren't, gaining false reassurance about their health.

4. Sufficient. 

When the above conditions are met, specimens should arrive at the point of analysis in a state and with sufficient information to allow the clinical question to be answered.

Clean through. 

Our standard definition requires specimens to be analysed :

1. Without error. 

In this context, we define error as variation that the system is attempting to avoid - or special cause variation. This should be viewed through the prism of citizen understanding, and this really means error that has a material effect on care.

2. With known variation 

This is similar in scope to “without error”, but looking at predictable variation which the system may accept (but needs to describe) - or common cause variation.

3. On time 

The results should be available within the clinically appropriate timeframe, ready to help informed decision making when it needs to happen.

Clean out. 

Our standard definition requires test results to be reported in a way that is:

1. Understood

Patients and their carers should know what the result means

2. Helpful 

The result should facilitate good decision making

3. Reflective of what is “normal for me “ 

For example, using reference ranges that reflect populations of people like me, and distinguish pathological values from outlying values.

Applying Clean In, Clean Through, Clean Out in Clinical Practice

In subsequent posts, we show that by applying these definitions to typical and predictable scenarios by looking at what happens to real citizens and why, then we are able to take simple, focussed and practical action based on what we learn. The results of doing this are predictably:

• more purpose
• more capacity
• less cost
• less harm

Antibiotics and behaviour change at the Health Foundation with BSAC

I had the pleasure of attending a meeting at the Health Foundation last week, courtesy of the BSAC. It was a great multidisciplinary event with microbiologists, junior doctors, intensivists and, perhaps most importantly, social scientists - of many different ilks. Here are some slightly unstructured thoughts (NB these are not verbatim notes and may not reflect what was actually said!)

Charis Marwick - Scottish Infection Intelligence Platform (IIP) : an attempt to get innovative ways to integrate data to support clinicians. Some interesting data that changes to surgical prophylaxis in orthopaedic surgery towards aminoglycosides led to more AKI (which was published here). New data shows that this trend has been reversed with a change in guidelines. We haven't seen this in SW England when we looked, but not sure our data is as robust.

Charles Vincent - On safer healthcare. His new book is freely available here thanks to the Health Foundation. We need to move from assurance to inquiry. Are boards and regulatory bodies up for this challenge? It's a profoundly different form of governance. But one that is more honest (what target is not gamed) and the basis of improvement. We need to think about how we build resilience. Patients themselves may be a key resource in monitoring safety and we need to think about how we do this. Is this what the CQC were getting at with their proposal to use social media as the canary in the coalmine?

Esmita Charani  - The importance of understanding culture and team dynamics. There is too much focus on guideline adherence. There is not enough focus on decision making, team working etc. For example, what do you find when you study why prescribers make the decisions they do? You see a prescribing etiquette. There is a reluctance to interfere with the decisions of others; an accepted non-compliance, with emulation of peers a far stronger determinant of behaviour than guidelines; and a clear hierarchy (juniors will defer to consultants). Any attempt to think about stewardship as a set of guidelines and audits is clearly magical thinking. It's hardwork engaging with this sort of deeply engrained behaviour, but we've got to do it.

There is also just too much intervention, and generally too much of everything. There is no time or space for thinking about what is right, or considering unintended consequences.

She finished with a lovely metaphor - all our systems are trying to build bridges across canyons of sub-optimal practice

. 

But this doesn't reflect the reality of chaotic, complex, adaptive systems that will never respond in predictable ways to simplistic interventions. We're dealing in a crowded market place, and we need to get in there and get our hands dirty.

Peter Davey suggested that perhaps we have too much focus on antibiotics...maybe we need to be focussing on higher level principles. In some situations antibiotics are just not the big medication problem. It might be warfarin, It might be insulin. By forcing people to focus on an issue that has little salience to them, maybe we reduce our credibility. Perhaps we need to be wiser in how we pick our battles.

Building on work I've been doing on primary school governance, perhaps there is a parallel in the way I have seen headteachers set a number of 'non-negotiables'. For instance, everyone must follow the marking policy. But within this framework, teachers have complete freedom to deliver purpose. By trusting and supporting people you can profoundly improve performance. There are echoes of Laloux's Reinventing Organisations here. One of the most profound books I've read in recent times.

Nick Sevdalis. Why has the WHO surgical checklist failed to live up to its promise as originally reported? After all, what other intervention has been discovered that could have the profound effects that were reported? He quoted Lucian Leape :

"The likely reason for failure is that it was not actually used"

So they studied the reasons. This was not a compliance audit - it was a proper sociological study of what actually happens at the interface of guideline and practice. A quick nod here to the concept of mindlines that I came across just after this. 

What they found, essentially, was that the checklist may have been implemented in body, but not in spirit. eg. in only a third of cases did the team actually pause. In other words, implementation was not as intended. The consequence of this is vividly portrayed in "Wrongfooted" in which a failure to follow the checklist led to the wrong foot being operated upon.

In general, what we see when these guidelines come out is a complete lack of strategy for how to implement. If you were going to be sensible, you'd focus on the bright spots and use concepts such as dissonance to promote behaviour change. Instead we drop the guideline from a great height and are surprised with the complete lack of engagement on the ground. We perhaps need to differentiate the strategic from the operational. I'm not completely sure about this - I think we need a common purpose at all levels of the organisation - perhaps the difference is how we talk about this depending on context.

So what we see with poor implementation of research or other good practice is :

• lack of fidelity (implementation was not done as described; inconvenient corners were cut)
• lack of understanding of causality. When things don't happen as we would expect we usually lack the data to know whether this is because the intervention is actually ineffective, whether is it effective but poorly applied, or whether it was effective in another setting, but not in this one.
• lack of engagement :  a vicious circle
• poor precedent : spill over effect of negativity towards other interventions

Also, people remember when you get risk mamagement wrong. 

All these things have significant implications for the way we 'do' antibiotic stewardship. We need to be rigorous, we need to get the evidence, we need to understand why things happen and we need to help people feel that they are part of the solution and have a stake in getting it right.

Implementation is a process. Attention to implementation is triggered by problems - timing is everything perhaps. We need to look for the moments of cognitive dissonance and strike when the iron's hot. Banging away at a psychological brick wall is depressing for everyone.

Finally, we need to find ways for senior management and service led teams to share a common language and purpose. Every board meeting I've been to will pay lip service to quality, but in the end only end up talking about money. Most board members do not understand value as they do not spend enough time building understanding in the workplace. We must move away from assurance by spreadsheet towards a deep understanding of the nature of demand on our services.

Detection and management of sepsis - Fabiana Lorencatte and Neil Roberts. There is too much ISLAGIATT (It seemed like a good idea at the time) in service redesign. There is no learning from success or failure. Meaningful change requires understanding of the determinants of human behaviour. This is a complex field and can seem bewildering to the non-specialist. But there are common themes underlying most behaviour change theories. They talked about TDF. Personally, I like the Switch framework. There was a lot of discussion about how we do this sort of work at pace. Quick and dirty...and wrong? This then feeds into the difficulty in knowing (at all levels of an organisation) how to to make sense of competing imperatives. How do we decide whether antiiotic stewardship is most important? Or Sepsis 6? Are these the same thing...they don't feel it. 

Carolyn Tarrant - line infections in ICU. What predicted good uptake of Matching Michigan?. 

• Passionate clinical lead who sets expecations.
• Peer education and persuasion
• Role modelling
• Active use of data
• Embedding and normalising
• Any opportunity to remind people "This is what we do"

We must avoid the temptation to focus on technical aspects of intervention. 

"Improvement and implementation is inherently social."

Discussion.

We need to move away from seeing Sepsis 6 and antibiotic stewardship as competing goals. Stewardship is too negative. Why as, as informed citizens, would we not have amoxicillin for a cold? Or meropenem for cellulitis? We need to find the salient motivators for patients and clinicians, and not see stewardship as a worthy compromise that is good for the public but bad for the patient. 

There was a lot of agreement that our common and unifying goal is optimisation of infection management.

Should we be spending so much time as clinicians worrying about intervening in individual cases? Management may often not be as we would do it, but are the marginal gains always worth the pain? Again, we come back to dissonance- is insisting on a 48 hour IV to oral switch actually always a good use of time. Perhaps better to spend the time discussing 'grey cases' with prescribers. Exploring real life problems and talking about pros and cons of different management approaches. Being seen to be working with people towards a common purpose, rather than against them in a somewhat abstracted form, must surely be a better way forward?

Mike Cooper talked about 'higher order goals'. These are things that are more likely to motivate people to change,and if we can measure them in ways that have credibility, these are powerful ways to create dissonance and promote change.

Another way to talk to prescribers is to ask them "What made you uncomfortable in the last 24 hours?" This is the basis of the 'heads up' campaign, I can't find a link for this, but it sounds a great way of engaging with what really matters to people. And this is really the essence of all behaviour change. Finding that feeling that shows people you get what matters to them, and will be there for them. They are not interested in your problems. So there it is. Easy really. 

Points of leverage in infection management optimisation?

Some work we have been doing in pathology recently shows how profoundly misguided we are to be focussing so heavily on clinical outputs over which we have no real control. These include things like cost. Or mortality rates. These aggregated measures tell us nothing about what happens to individuals, And it is these individual encounters that build up into the aggregate picture.  The other type of measure we often use to describe our services are process measures, such as turn around times. Most of us know these are pretty meaningless to patient care, but because we haven't been able to think of any good alternatives we have increasingly badged the quality of our services according to these variables,

So our only mechanism to improve (our points of leverage) are at the level of input into the care of the individual. In diagnostics, this has led us to the concept of clean in, clean through and clean out. By following this methodology we have seen dramatic improvements in care, mainly by reducing the potential for iatrogenic harm by overtesting. So we've reduced MSU submission rates by 50%, and have now done the same for liver function tests. We have started to develop new ways of thinking about laboratory error that have clinical meaning. And we are beginning to use new ways of displaying results that help patients and clincians understand what they actually mean and promote the correct actions.

So is there something here for antibiotics? If we are not going to look at resistance rates or mortality (aggregated outcome) or time to antibiotics, or guidelines adherence (process and compliance measures), what can we measure? This needs some work, but it might look something like :

Clean in to prescription

• Antibiotics are necessary (or justifiable - this will be a continuum)
• Antibiotics will cover likely (including previously and subsequently isolated) pathogens (sufficient)
• Antibiotics are maximally appropriate (without unnecessary side effects, including overly broad spectrum)
• Appropriate diagnostic tests have been taken before antibiotics (eg Urine culture- UTI; Wound swab - cellulitis with open wound; blood cultures - severe sepsis)

Clean continuation

• Antibiotics are given in a clinically appropriate time frame
• Antibiotics are given by a clinically appropriate route
• Antibiotics are reviewed as soon as results and clinical progress dictates

Clean discontinuation

• Antibiotics are stopped when clinical improvement unless clear need to continue
• Source control is achieved were necessary
• Patient understands the diagnosis and what they need to do to prevent recurrence if appropriate

I think the big difference here with things like Start Smart is the shift away from compliance based approaches to a more forgiving and learning collaborative approach. I think to do this will require infection specialists to act in a coaching role and encourage clinicians to explore their practice in a much more open manner. This will be much more fun. I'm going to start tomorrow with my very nice respiratory consultants, I'll let you know how we get on.

Why I love Antimicrobial Stewardship in Primary Care

Nest week, on the 18th November, it's European Antibiotic Awareness Day. As part of our activities for this event, we've been supporting the Listen To Your Gut campaign (www.listentoyourgut.org.uk). This is aimed primarily at parents, helping them understand the role bacteria have in keeping us healthy, and understanding why we want to try to look after our 'healthy bugs' by only giving antibiotics when they're really necessary. The 'Treating Your Infection' self-help guide that goes along with this teaches people what to expect from self-limiting infection, and symptoms to look out for that suggest they need to see a doctor. Yesterday I launched this programme to GPs in North Devon at their prescribing day, and today I went to a practice to talk in more detail about antibiotic stewardship. This is by far the most enjoyable bit of my my job, and here are some thoughts as to why that's the case.

1. Data. It's so easy to get data on things in primary care, in ways that are completely impossible often in secondary care. Prescriber, time of prescription, nature of consultation (face to face vs telephone), basic patient demographics, co-morbidities. The one thing that's a bit hard is indication for antibiotics, but that's often not that important if you approach the data in the right way - this is just a starting point for conversation. So we see some interesting things coming out that are the starting points for challenging (and often supporting) practice. So for instance,

- 20% of young people (aged 20-39) get an antibiotic each year. This is mainly amoxicillin. And it's mainly for coughs and colds.

- 10% of antibiotic prescriptions occur within 2 weeks of a previous prescription. Why is this? Is it treatment failure? Intolerance to first choice? Never infection in the first place? If someone is not better in 3 days in primary care, how often is there an indication for a second course? I don't know the answer to this - but I'd quite like to think about it a bit more. Do any microbiologists understand this group of patients?

- If you get given fluclox, then the follow on antibiotics are doxycycline, co-amoxiclav and clarithromycin. What could these antibiotics be doing that fluclox wasn't doing? Is it a dosing issue? Is it non-infective? Is it pilonidal sinuses involving gram negatives? And how actually do you manage these nowadays in primary care, especially now that access to surgical specialities is apparently more difficult?

Nursing prescribers are the biggest prescribers by far. They see all the minor ailments. Are we giving them the support they need?

2. Trusted relationships and continuity of care. GPs really know their patients and their lives. They work in close knit teams and have a shared purpose. And, having worked closely with them for a number of years, it feels that I have developed a culture of trust with them. We can talk about anything without fear of judgement. They can talk with me about specific issues in context, not abstract 'guideline' derived approaches which often fail to address the difficult situations which do not 'fit' our medical archetypes. It's no good saying "Don't ever give prophylaxis for urinary tract infections" if you haven't sat with them and talked in a specific way about just what you would do, and show that you understand the problem from the perspective of the patient. I gained 'validity' here by doing joint clinics with GPs talking to patients with recurrent infection.

We had a great discussion today about different techniques GPs use to talk to patients. Again, this sort of peer led discussion is a key part of any 'norming' part of a behaviour change methodology, and can only be done within a culture of trust. We talked about how it's really helpful to draw a graph of 'symptoms' vs 'time' and show patients where they are on the line. We then thought about how the 'Listen To Your Gut' message could fit in after this. Then talk about red flag symptoms and whether the patient has any. And then really allow the decision to prescribe antibiotics to sit with the informed patient. It's no longer a battle, but a conversation.

3. The detail is important. So developing this concept of validity, you have to be able to talk in detail about things in a way that connects with those asking the question. If you can't have a trusted opinion on how to manage a patient who's had a cough for 3 weeks (even if it's "I don't know - there is no evidence; my feeling is that this is appropriate") then there is not a huge point in having a meeting.

4. It's a two way thing. These meetings in primary care are not about me ("the expert") giving information. It's partly about this ("frankly I only really worry when they're rigoring and dropping their blood pressure...you can probably watch and wait in most other situation"; "co-amoxiclav adds no significant additional cover to fluclox for skin infection and has worse pharmacokinetics and more side effects" "I know we use multiple antibiotics to treat TB to stop emergence of resistance. But it doesn't seem to work that way in most infection, and you just increase side effects.")

But for me, it's more about giving me a sense of the demand as it present to primary care, and thinking about how we help.  Just what do you do in a confused old person? In hospital they get chest X-rays, blood tests by the gallon and we then sort of have a plan. This is just so much harder in primary care. How can we support people to do this better. Urgent bloods? In someone with otitis media not responding to amoxicillin, is it reasonable to give co-amox? I have to confess I don't have a strong opinion on this - I can explain the bacteriology of why this might be appropriate because of resistant Haemophilus - but actually, do I know what the natural history of this disease is, and what investigations are appropriate, if any? If we don't hear these stories as they present, how can we have an opinion?

Three next steps for primary care infection optimisation

1. Is stewardship a bit too negative? Our common purpose is to optimise the care of the patient in front of us with possible infection. I would suggest that we should talk more in this positive manner. Again, I would note how the Listen To Your Gut message fits well with this approach.

2. We need to develop antimicrobial stewardship teams that work across health communities. It is important I know about how infection is managed in both primary and secondary care. We need to develop teams that can work in this way.

3. We need to work with all stakeholders - and we clearly need much more focus on non-medical prescribers; but also HCAs and nursing homes. They may not be able to prescribe, but they can strongly influence prescriber behaviour by the way they relate the patient story or request investigations.

Antibiotic sensitivity testing - are current methods leading to bad stewardship?

We did an interesting exercise in the lab today trying to quantify the degree of 'uncertainty' in a lab report. We did what many people already do for internal quality assurance and just put 20 urine specimens through the lab independently. We looked at culture report, sensitivity report, pyuria report, and whether 'extra' tests were done. It was good to see surprisingly high levels of certainty, even in things I thougeh might be a bit subjective, such as assessment of level of pyuria.

The uncertainty around sensitivity testing however made me revisit some basic assumptions. We are looking for a zone of inhibition around an antibiotic impregnated disc. If that zone falls below a certain size we say the organism is resistant to that antibiotic. This cut off, or breakpoint, is defined by committee and is based on a combination of pharmacokinetic and epidemiological criteria. When you consider the science behind the technique, we are making big calls based on small interpretative differences. And this matters - clinicians will, quite rightly, not use an antibiotic that has been called resistant by the lab. So if we call an antibiotic resistant we are denying it to the patient. For urinary tract infections we only have about five oral antibiotics we can routinely use. If we lose some of these we cut down our options - we see increasing number of patients with no oral options left - these patients are often admitted to hospital for intra venous therapy. Perhaps worse still, we push clinicians towards using 'last resort' antibiotics, such as meropenem. Each meropenem prescription brings the day of antibiotic Armageddon ever closer, when we have no good options left.

So what happened when we looked at uncertainty of antibiotic resistance testing? Small numbers, but we saw 3 out of about 48 zones were reported discrepantly. ie. One lab scientist called resistant, the other called sensitive. When we looked at why this was, all the zones were on the breakpoint - it would have been easy to read either way. So there are some people who will respond to this by saying things like "standardise better, and get some calibrated measuring calipers, or an ISO accredited ruler, and beat your scientists harder."

But in response to that, is worth viewing the EUCAST website. They've got loads of data on zone sizes.  We can see a few things :

1. If we look at the distribution of zone sizes in bacteria we often see a normal distribution, with a separate population of resistant organisms with very small zone sizes. But the (somewhat arbitrary) breakpoint often sits at one end of the normal distribution, so including many sensitive organisms.
2. If we look at the distribution of zone sizes in organisms that are known to be resistant, they generally have very small zone sizes (with some notable exceptions)
3. If we look at the inherent variability of zone sizes measurement, by putting the same organism though the same process every day (what we do for internal quality control) we see generally about a 5-10mm variation. That's about 20% expected variation in zone sizes. And we make calls based on less than 5% differences - is this really a good idea, or even scientifically correct?

So this is my current thinking. Breakpoints are useful for epidemiological information and studying trends over time. But they are perhaps massively unhelpful in clinical practice in many situations. I wonder whether we should report 'sensitive' if a big zone, 'resistant' if no/very small zone, and call everything else intermediate/uncertain. But looking at the data, chances are most people will respond just fine in these situations. Saving them, and us, from yet more unnecessary broad spectrum antibiotic use.

Targets, KPIs and why we should be wary

In a 2006 paper, Bevan discusses the problems with targets. In summary these are twofold. One is synedoche - the assumption that the part represents the whole. The other is gaming. Gaming leads to 3 phenomena.

The first is the ratchet effect where things get 'better' year on year, often as a result of setting future targets against benchmarks of previous performance. We see this a lot in healthcare. It is rife in infection control - 95% hand hygiene compliance rates (when the best studies achieve only about 60%) is one example. No hospital wants to look like its hand hygiene is worse than that of the next door hospital.

The second is the threshold effect, where managers alter the system to deliver to the target...and no more. There is no reward for doing better. In the paper, Bevan sites the evidence that ambulance trusts redistributed response centres to urban areas. This had little effect on urban response times, beyond bringing them below an 8 minute threshold, but had a profound effect on rural response times. But as these were relatively small numbers, the effect on the target could be ignored. 

The third type of gaming is manipulation of the output data. There are many ways to do this. Clinical coding is a minefield of variability to be exploited here. And we are all familiar with the stories of A+E trolleys becoming beds. I recently heard about an out of hours GP service that performance manages against time to triage. Very worthy. But clinicians quickly learn they can stop the clock by entering a single full stop into the clinical record, getting the managers off their backs, while they get on with doing the work they were trained to do.

But more worrying is actual distortion of clinical practice. So, for example, surgeons refusing high risk cases. And I know of one laboratory that doesn't load blood cultures if clinical details are vague in order to hit MRSA targets. There is a valid clinical argument here, but it's quite weak, and surely this decision is now open to considerable criticism in the face of the target culture.

Bevan discusses how the target culture in the USSR led initially to large productivity gains over the first couple of decades. But this was followed by stagnation and ultimate failure. Perhaps we see the same in health. Targets initially are well meaning and often focus activity on issues of concern. But quickly, the target becomes the point, and the purpose of the target as an agent of change becomes traduced.

Bevan argues that we can improve things. More random checks perhaps, using more random measures. But ultimately we probably just need more face to face peer led assessment. And for me, this probably leads us away from the comfort of the target, to a more nuanced narrative assessment written in collaboration between assessors and those doing the work.

Why clinicians shouldn't think about test costs

There is evidence that making clinicians aware of test costs reduces requesting, and this has been used as justification for including costs at the requesting stage as a means of reducing unnecessary testing. This would go into the typical arsenal of 'demand management'.

Clinicians are already under pressure to make complex management decisions that are in the best interest of the patient. How does adding more information into this equation at this stage help?

The way costs are interpreted will be dependent on how they are framed. So I could say that it costs £50 to manage a possible infection.  Adding a CRP into the mix, at about £5, is relatively trivial. Or I could say that a CRP is about 50 times more expensive than a standard biochemical test, and that this is now a considerable burden on lab expenditure.

The clinician will either then choose to do the test (it's not that expensive, it doesn't really matter) or choose not to do the test (I need to do my bit to save the health economy money). There are at least two problems with this approach.

1. It leads the clinician away from their primary purpose, which is to optimise care for the patient in front of them. They cannot be expected to make an accurate economic assessment on the basis of one piece of information.

2. True costs of testing will be hidden. So there is less pressure to reduce high volume but low cost testing. This adds up, but an individual clinician working in isolation cannot be expected to understand or evaluate this.

There must be an optimum level of testing. What we need are ways to understand the utility of diagnostics across whole pathways. We need to understand how these tests benefit (or harm) patients. We need ways of assessing the true costs of tests to the health service, with transparency of how labs price their tests, and with inclusion of downstream costs.  We then need to find ways to help clinicians order these tests accurately.

All this must include an assessment of cost effectiveness. But keep this out of the clinic and do it with proper informed debate.

I will add that this almost certainly needs new ways of working between labs and users, and needs approaches to contracting that break the insidious link between activity and income. But that's another blog.

The Kings Fund on Better Value and Pathology Optimisation

For a number of years here in North Devon we have been working towards creation of a pathology optimisation capability. This will have the remit of working across patient pathways to improve the way we use diagnostic tests, from the decision to do the test all the way through to the way that results inform management. We have borrowed heavily from the thinking and structure behind Devon's medicines optimisation team, in which pharmacists help ensure that medicines are used to maximum effect. They aim to balance costs and benefits at all levels across the health system - from individual patient prescribing situations, to prescribing policy and formulary support.

So it is exciting that tomorrow we will launch a new pathway for DVT management in primary care, which has been arrived at through close collaborative working between pathology, pharmacy, physicians and primary care. And even more excitingly, we will also introduce the new optimisation team, which consists of two of our North Devon biomedical scientists, a pathologist, a GP, a GP trainee, and a public health doctor. We have also secured funding for link GPs in all practices who will work with the optimising team to a) understand demand b) study the gaps between demand and delivery and c) work towards closing this gap.

It is sometimes a little disconcerting to be doing things that few others see as possible. Although we have heard many good things about the work we have been doing, few others seem to be trying to replicate it. So it is reassuring to read the recently released Kings Fund report "Better Value In the NHS." This document is a call to arms for clinicians to lead the way on improving value in the NHS, and sees this as the way to ensure the future sustainability of the service. Many of the things it calls for are in our Pathology Optimisation service.

1. We need to tackle overuse and underuse of services. This is optimisation. Overuse, in particular, is hugely expensive. We have seen that this is not just financial, but also through opportunity cost. And in services that are stretched, where demand exceeds capacity (and this is almost everywhere, but particularly in primary care) it is this opportunity cost that is slowly killing the sort of healthcare that people actually want. The use of diagnostics has skyrocketed over the last decade. This has been associated with negligible benefits (as we have posted previously) but considerable harms, some physical, some mental. 5% of test results lie outside reference ranges. We have seen how this leads to activity that is usually of no benefit to patients, but that sucks the lifeblood from the NHS.

2. Teams delivering better care. We cannot design services in isolation. This is a traditional problem for pathology, which produces highly accurate results, but often throws up its hands in despair when asked to consider whether the tests were actually appropriate or results acted on appropiately. "These are not things we can control." "The standard of education these days is just not what it was." But we have shown that we can act on the pre- and post - analytical pathways; and that the only way to do this is through close engagement with all stakeholders, with the purpose of the pathway, as defined by the citizen through their stories, as the compass which keeps us on track.

Our latest work, on the DVT pathway, was blocked by silo thinking. We could see no way to get an urgent D-dimer test performed in primary care. We could see no way of dealing with anticoagulation in low risk (below knee) potential DVTs if an ultrasound was not available immediately. And yet we heard the patient stories of care that did not seem to care - patients shunted around the system being treated in ways that were certainly sub-optimal at best (such as having to travel 40 miles to have a blood thinning injection that was not actually necessary).

These problems were unblocked when we got together as a team and understood the problems from others' perspectives, challenging the limits of what was possible. For our pathway, the key enablers came when the laboratory showed that a D-dimer was stable in a refrigerated citrated blood for 24 hours; and the physicians said it was safe to wait 24 hours before making a treatment decision on a low risk (below knee) DVT. We must not be complacent that we have 'got it right', and the optimisation team will be important players in embedding this pathway into practice, and monitoring its efficacy.

I will leave the last words to the Kings Fund, :

"The challenge facing the NHS over the coming years is fundamentally about improving value rather than reducing costs. Framing the debate in these terms emphasises the role of quality and outcomes in meeting the challenges facing the health system, as well as providing the right language to engage clinicians and frontline staff in making change happen."