Pathology in a system : Wound swabs as an example of how pathology can spot system failures

Pathology in a system: The identification of system failures by Darunee Whiting

Systems theories have been used to describe and help predict how systems behave. It has been used for space projects, financial systems and can also be applied to the healthcare system. Key system concepts are that actors within systems are interdependent but may be disparate. There may be a time lag between actions and effects within systems, so that the effect of an action is not immediately felt and thus the root cause of a problem often goes unrecognised. This can be especially so when actors, actions and effects are in different parts of the system. Systems have feedback processes that can be accelerate growth/decline or rebalance. We see pathology tests as key decision points in a networked system of decision making with the aim of supporting patients, and those helping patients, to make good and timely decisions about their care.

Key decision points trigger actions within the system which can help patients on a path to better health, or in some cases lead them off this path! Tests are placed at key decision points. In primary care, within a clinical consultation there are four key decision points/ actions: these are whether or not to

1. Support the patient
2. Test
3. Prescribe or
4. Refer.

Systems can have patterns of behaviour. To help identify root causes of problems- these patterns of behaviour- system archetypes- have been identified. Our work on wound swabs in lower leg wound care demonstrates one of these archetypes and shows how primary care pathology can identify the root causes of health system failures, as pathology tests/ actions are placed at key decision points in care. Pathology can deliver value here and better health for patients by reducing system failures, through testing decision support and the optimisation of testing.

Lower leg wounds are common. They can become chronic in patients with underlying diseases such as venous or arterial insufficiency, diabetes and anaemia. The majority, approximately 80%, are due to venous insufficiency and require compression dressings to heal in optimal time. The remainder are made up of arterial and mixed arterial/ venous ulcers. It is important to perform a doppler ABPI (ankle brachial pressure index) test on all leg wounds to help decide the likely aetiology of an ulcer and subsequent dressing/ treatment. This is a key decision point. A venous ulcer treated with compression dressings should heal within 3 months. An arterial ulcer would deteriorate with compression dressings which constrict the circulation further. A doppler test can help differentiate between venous and arterial ulcers- and places a patient on the right path to quick healing.

What we did:

1) Identification of high volume/ low value test requesting= Lower leg wound swabs from primary care to the lab. Why was this? A clinical conversation between microbiology and tissue viability suggested that wound care in primary care was not optimal- as suggested by inappropriate tissue viability referrals for patients who hadn't received good primary treatment.

2) Go See: What was happening in primary care: The lab led a collaborative multidisciplinary meeting with microbiology/ vascular surgeon/ tissue viability/ practice nurse/ podiatrist/ GP. It was important to look jointly at the problems with the views of all healthcare professionals involved in the system.

3) Audit of patients with wound swabs/ lower leg wounds in primary care

4) Mapping of key decision points

5) Audit of patients vs mapped decision points

Findings:

Doppler tests not being done routinely or in a timely fashion- due to the lengthy time taken to do the test (30-40 minutes, not enough time was given in nurse timetables for this) This led to patients with venous ulcers not being put into compression dressings for a long time and consequently very very long heal times, and patients with arterial ulcers being referred very late to vascular surgeons for healing interventions This led to more nurse appointments for lower leg wounds that were not healing....which in turn made it more difficult to offer extended nurse appointments for doppler tests... (the system here was accelerating decline) When wounds were not healing, clinicians would often take a wound swab to look for infection. They would find bacteria colonising the wound, not causing infection, and often give unnecessary antibiotics. This demonstrates the 'Quick fix' systems archetype and often led to 'repeated quick fixes- fixes that fail to treat the underlying cause' It is much easier to take a swab, which takes seconds, and believe that this is the right decision, than to take the time to do a doppler (which the system also makes difficult to do in practice)

Here is a systems diagram showing this 'quick fix'

So, the root cause of the problem is in primary care: Wrong action: Doppler tests not being done Consequences of this action are felt throughout the system. Consequences for primary care: more nurse appointments. Consequences for pathology lab: More wounds swabs of low value Consequences for secondary care: Late vascular referrals- how much of this is contributing to high SARS rate for amputations? Consequences for patients: Unnecessary antibiotics, very long heal times/ morbidity Consequences for the health economy: cost

Pathology identified the route cause: a test which was a quick fix (wound swab) used instead of another test (doppler) at a key decision point- the root cause that would fix the whole system failures. The next step was to support primary care decision making and the optimisation of testing. Less wounds swabs- more doppler tests. We showed the key decision points and audit data. It was important to tell the story of how the system was not working and how this impacted on patients. The story for GP practices was that if they prioritised time for a lengthly doppler test, they would actually free up more time later through reduced nurse appointments and quicker heal rates. Addressing the root cause here would also reduce whole system failures- which is the patients story.... which was also important to tell. And the story for pathology? How many other times are tests used as quick fixes that lead to systems failures? Lets Go See!

What matters to patients about diagnostics?

What matters to patients about pathology results? Two talks over recent days have brought this question into sharp focus. First Joan Saddler talked from the perspective of a patient representative. Patients need to know

• why is a test being done (or not done)
• when will the result be available?
• what does the result mean?

So for me we have to think about the consent process (do patients /their carers understand the point of a test? Have they thought about what they will do with a result? Were other actions at this requesting decision point considered/correct?)

In terms of result availability, we need to think about whether necessary information available at time of key decisions. Was this information error free? Was there a predictable flow?

In terms of results there is a lot to do! We need to think about how we convey information in a way that informs decisions. (Was an appropriate action taken as a consequence of receiving the result?) This will include much more thought as to how we define and then convey inherent uncertainties in test results - if these are important when assessing options for action. If there is a 10% variability in creatinine measurement, how do we relay this? How do we deal with variation between laboratories? We cannot transfer uncertainty without considering how patients want this to be done. It will almost certainly be different for different patients.

And today listened to Bertie Squire talk about management of TB in Tanzania. A diagnosis of TB can account for 90% of a person's annual income - and this is with free access to medicine. It is important to get this right. Diagnostics may be expensive - but they are a tiny party of the system cost. This is why this work on delivering value is important. It is actually a matter of life and death.

Scripted consultation

Scripted consultations are being seen as a good way of delivering information to patients by non-experts. I suspect they are also a very good way of teaching the non-expert. They have the benefit of defining 'norms' for the non-expert, making them more confident in imparting information. Here's a draft scripted consultation draft for 'no antibiotic' consultation. Probably too long... Elicit information • What do you think is going on? (e.g. afraid it is pneumonia) • What did you want to have happen at this visit? Provide information • Your illness has the characteristics of a viral infection, so antibiotics will do nothing to help you recover, and they do not prevent complications. • We worry about using antibiotics when they are not definitely needed because : • Antibiotic use can result in the bacteria you always have in your body becoming resistant to antibiotics. Bacteria that cause disease can pick up this resistance, and this may make more serious infections (when antibiotics can be life saving) harder to treat • Resistant bacteria can spread in the community and this may put other people with life-threatening conditions at risk. • Antibiotics often cause unpleasant side effects, like diarrhoea and rashes • Some times these side effects can be very serious, like some allergic reactions. • The latest research suggests that antibiotics will kill off a lot of your friendly bugs that live in your guts, and some of these may never come back • We don’t really know what this means, but these bugs may keep us healthy in lots of ways so we need to try to look after them o They produce vitamins o They may prevent allergies o They may stop other intestinal disease, like coeliac disease o They may reduce the risk of some cancers o They may produce substances that keep our brains healthy o They may even help stop us getting fat • There is also new research that suggests antibiotics may affect the bits of our cells that produce energy. Again, we don’t know what this means to our patients, but it is another good reason to try to avoid antibiotics unless we are sure you really need them. Safety net • I have a handout here to help you manage your symptoms, and we can discuss warning signs that you might need to be reassessed. Summarise So, you understand that we won’t give you an antibiotic today? I don’t think it will help, but if you develop any of the concerning symptoms on the list we will have to reassess you. Do you have any questions?

Presenting pathology data to patients - a graphical representation of a haemoglobin result

Traditional pathology results, based on numerical values and strict reference ranges, maybe hard for both patients and doctors to understand. A lot of activity and worry is generated by tests that fall outside reference ranges. We need better ways of representing the 'normality' or otherwise of a result, so that we can have more honest dialogues with patients about meaning.

We recently saw a patient with an incidental finding of a haemoglobin of 108, with the lower end of the reference at 115. This 'low' result has caused anxiety to the GP, who must decide whether to follow guidelines for investigation of anaemia; but prinicipally to the patient, who now worries they may have cancer. 

We assumed that most haemoglobins measured in primary care are in patients with no underlying pathology. We plotted sequential results from women aged 65-75 (the demographic of our patient), to show the context of results we would be expecting. We then plotted the patients result, and used a large data point to represent the uncertainty that is inherent in any result. We added a line showing 2 standard deviations from the mean.

We think that this shows a result in a way that is instantly understandable in context. By showing the population variation as data points rather than in relation to a static mean, or between confidence limits, may give a feel for the dynamic nature of a test which is perhaps lost in traditional reports. Other background 'normal' data sets might be used if available - and this would be essential if there was a high proportion of data from patients with significant pathology.

An alternative way of presenting the data. My feeling is that this does not display the uncertainty of a test in a way that is as meaningful - it still emphasises the abnormality of the result. This may also be beacuse it uses set 'normal' ranges that may not be entirely appropriate for the popultation

Disease registers

James FalconerSmith also talked at today's RCPath day on systems, about disease registers for thyroid disease and health registers to coordinate care of those with mental illness. The general health needs of these patients may be poorly looked after, as they fall between the stools of general medicine and psychiatry. Pathology services maybe in a good place to coordinate this.

Pathology could coordinate care of many similar issues, from high risk conditions (eg lithium, DMARD monitoring, post radio iodine) to the complex (eg albuminurua in patients with diabetes, haematuria, MGUS, recurrent UTI).

These things work best when there is willingness from all stakeholders to work together. The thyroid register in Leicester was set up at the request of the endocrinologists. Labs need to be more confident in giving clinical advice.

We still need to grapple with how we commission this 'value add'. A service which is compared on test cost alone will be tempted to strip away expensive 'luxuries'  that are bundled into test contracts. One option might be for commissioners to require services to act on a certain number of system wide problems, with 'bonus' payment linked to delivery of some meaningful purpose focused measurement. For this to work well there needs to be a large degree of trust between commissioner and provider that the latter will act in the best interest of the patient. Otherwise there is a danger that the whole thing descends into management led performance monitoring of proxy measures, with perpetuation of the gaming that goes with this.

Plate sets for standardised microbiology working

I had a good discussion with Gifford Batstone today about how microbiology will fit into the NLMC. It is very hard to standardise microbiology working and this leads to difficulty in setting standards and comparing labs. I suspect this is mainly because of a lack of clarity of clinical pathways that lead to testing, and uncertainty about the action that should follow a test. I'm not sure if these are possible to reconcile at anything other than a local level. This may be due to local differences in priorities (eg. Detecting multi resistant pathogens, or reducing drivers for antibiotic prescribing) and it may also reflect significant differences in interpretation of a very confused literature. We also give out mixed messages about the role of testing, with, for instance, the national SMI for wound swabs targeting a huge range of organisms, when clinical algorithms refer only to staphs and streps.

One way out of this mess maybe to build up order sets according to the target pathogens only and whether or not sensitivity results would be made available. This would leave labs free to decide exactly which pathogens they would look for, how they would do this in a way that supports the clinical pathway, and what they would do with the results. This would have to be linked to a clinical algorithm which would stipulate the entry into the testing pathway along with scripted actions that would happen with each result.

This is really no different to what we should be doing already. But because the entry into testing is so dirty we have lost sight of the purpose of the microbiology lab in supporting care. There is little point in sorting out testing if we can't take on the mess of the pre analytical pathway and take more responsibility for what happens on the other side of the lab.

Lithium registers

James Falconer-Smith gave an impressive talk on pathology held disease registers in Leicestershire, at today's RCPath day on systems thinking with Muir Gray.

10000pts on lithium register since 1991. Li is high risk for patients and rapidly increasing cause of litigation. Average GP will only have 2 patients on Li and unlikely to have skills to manage. GPs can now refer to pathology held register which will manage everything from coordinating testing to dose management. Since starting service%of patients with TSH>10 has fallen from 9% to 2% and %with no bloods in last year fallen from 19% to 4%. Importantly the pathology service knows who has not been tested and can act accordingly rather than ignore. Also lab can set personalised therapeutic ranges in liaison with psychiatrist. All patients have designated lead clinician who is ultimately responsible for li management. Example shows how pathology can integrate care that currently falls between GP, psychiatry, medicine and pharmacy.

Service relies on good clerical staff. Hard to see how formally commissioned but this is clearly a great example of the value add from pathology.

Previous poor performance often blamed on patient. This may illustrate the point in the last post where the commonest response to being an outlier is to find something else to blame. But the insight from James is that this is a highly motivated group of patients with a lot to lose if things go wrong. To me it shows how the medical profession is quick to stigmatise patients when things don't go right.

Li testing is a significant commitment from patient (weekly bloods until stable then quarterly). We need to be imaginative in supporting this. Is there, for example, a possibility of self phlebotomy where the path lab could mail out test kits, a bit like the bowel cancer screening programme for FOB?

Disease register is a great possibility for research. For example shows that drop in GFR is minimal for most patients. Can integrate with other data eg prescribing.

Commissioning pathology and data

Peter Huntley, now retired from Kent and Medway CCG, talked about the role of the commissioner in setting the direction for pathology. Some persuasive content on how we need to be better at presenting data to clinicians and how we need to start combining data sets eg with prescribing.  Users need to know where they stand in relation to peers.

First of 2 speakers to use lithium monitoring as an example of how pathology can change from test provider to system integrator.

Current lack of standardisation of testing approaches and costing between providers cannot be tolerated. Less than £10/test in one locality to more than £14/test in another. Lack of common currency means hard to know what this means, but commissioners can start to insist we adopt this.

Some personal thoughts
- is practice level data adequate for combining data sets? Do we need integration at patient level to allow data to be turned into coherent narratives, and explore the interaction of behaviours?
-how do we get users to engage with the data? Pathology advisors could have a role here in helping users 'find the feeling'. I doubt shame is enough - most will be motivated by the patient stories behind the data.
-users must be allowed to explore and challenge the data, perhaps with the help of an advisor. Peter gave an example of how more junior GPs request more. There is a danger that this becomes implicit criticism which may evoke a unnecessary defensive response. For example, it may be the higher requestor reflects best practice, or they may be the one  that nurses write down on nurse-driven requesting. Or not. But if we don't go to this level of detail we may not bring people with us.
-basically we need people who are skilled at using data as a tool for quality improvement, and not as a blunt stick for driving compliance against arbitrary standards

Supporting Critical Decision Points 1. - The Example Of Urinary Tract Infection and patient harm driven by testing

Tom Lewis and Darunee Whiting

In a previous post we talked about how pathology, or diagnostic medicine, can add value to patient pathways. In this post we show how a lack of attention to the unintended consequences of routine screening leads to patient harm. In the next blog, we will talk about how we tackled this through collaborative working between clinicians and the laboratory.

The rate of submission of Mid Stream Urine samples (MSUs) from primary care has showed an inexorable year on year increase (fig.1).

fig1. Number of urine samples received from primary care per 1000 population

Some of this increase may be accounted for by an ageing population, but much of the new demand appears related to the introduction of primary care quality targets for monitoring of chronic kidney disease. Assessment of kidney damage in these patients requires an assessment of the amount of protein excreted in the urine. A quick way of doing this is to use point of care urine dipsticks.  There are many urine dipsticks on the market, and some only detect protein and glucose. However, some of these dipsticks provide multiple additional tests - irrelevant in the management of chronic kidney disease, but of possible utility in other situations, such as determining likelihood of urinary tract infection in patients with vague symptoms of this condition (as an aside, clinical assessment performs better than dipstick assessment in the diagnosis of UTI in patients with clear cut symptoms such as dysuria and frequency).

And here we see the rub - the dangers of testing that is not aligned to a clinical question. These patients with chronic kidney disease who are presenting for routine 'check ups' (and so in whom we would not be worrying about infection) often give positive dipstick results for nitrites and leucocytes - classically described as the dipstick signs of infection. We see the same results in other people - in other words, dipsticks for infection have a high sensitivity but a poor specificity. We then bump into the psychological aspects of a 'positive' test on the clinician - it is very difficult to ignore this 'positive' dipstick. So to deal with this discomfort, the urine sample is sent to the laboratory to look for bacterial growth - traditionally seen as the gold standard arbiter of infection.

There is now a second misunderstanding related to the gold standard nature of urine culture (interestingly perpetuated in much of the literature on urine infection). Clinicians are often taught that a growth of 10^8 organisms per litre is diagnostic of infection. The original work by Kass on this subject did not claim this - rather it showed that a pure growth of this magnitude was predictive of reproducibility of this growth in a research setting. It is important to understand that this is most definitely not the same as a diagnosis of infection in a routine clinic setting. The incidence of asymptomatic colonisation of the urinary tract is high - and there is good evidence that this should not be treated with antibiotics, except in well defined populations (eg. pregnant women). In addition, the quality of urine specimens is often poor from routine settings, with samples frequently contaminated with perineal flora. There then may be substantial delay getting these specimens to the laboratory, and specimen stabilisation is never absolute.  The consequence of all this is that the performance of urine culture in routine practice is significantly divorced from that seen in the research setting. To give some idea of the magnitude of this problem, all newly pregnant women are asked to send a urine specimen for culture (as this is a group in whom asymptomatic bacteriuria is a very high risk for causing pyelonephritis). Our laboratory requests repeat samples from all pregnant women if they have no symptoms but a pure growth of organisms. We find that this pure growth can only be reproduced in one third of patients. In other words, the specificity of a pure growth of bacteria for diagnosing UTI is very poor. As with all tests, the prior probability of the condition being present is key when trying to interpret a test result, be it the result of a point of care test (eg. dipstick) or a laboratory test (eg. culture).

So what happens to a patient in whom a pure growth of an organism has been reported, but who has no symptoms of infection. Some time ago I looked at 40 patients from primary care with a pure growth of E. coli. 30 of these patients had symptoms of infection (interestingly the culture result had no impact on their management, apart from in 2 patients who had got better on empirical treatment, but had evidence of in vitro resistance to the chosen antibiotic. Both these patients were given a repeat antibiotic script - an incorrect decision and harmful exposure of the patient to further unnecessary antibiotics). 10 patients had no symptoms of infection, but had had samples sent for just the reasons described above (ie. positive dipsticks on routine screening for other conditions). All these patients were prescribed antibiotics. This is clear harm to the patient driven by inappropriate testing. It is also worth considering the effect of abnormal results on the GP. The abnormal result will need to be considered when it arrives back. The choices are to ignore it or to act. Ignoring a test is not trivial, and comes with an opportunity cost - there has to be a conscious decision not to act, or there is a danger that abnormal results performed for good reasons may be erroneously ignored. This is an ever increasing problem with the inexorable rise of testing. And as we have seen the decision to act can be even more problematic - not only does it take time to 'do something', there is a very real risk that this action will lead either to direct harm to the patient (eg. antibiotic prescribing), or more insidiously perpetuate further work in the system ('failure demand') - bad for the patient and bad for the sustainability of healthcare.

In the next post we will consider how tackling this problem collaboratively as a system has improved outcomes, reduced cost and reconnected healthcare professionals with the purpose of their work.

Pathology Reporting- Enabling patients to self-manage their health

The NHS IT strategy focuses on the power of information to deliver the ambition for patient-centred healthcare.

“ Pathology is an information business.
   Pathologists provide useful answers to good questions.”

Evidence, safety and quality – an information strategy for NHS Pathology (Royal College of Pathologists, 2008)

If pathology is an information business, how can pathology deliver the ambition for patient centered care?

By 2015 pathology reports are to be made available directly to patients. For pathology, reporting is a principal means of conveying information.

‘The move to patient online access to GP records – including test results – by 2015, and eventually to fully integrated electronic health and social care records, will be transformative in the relationship between health professionals and patients, and between patients and their health and wellbeing’ (National Pathology Programme: Digital First: Clinical Transformation through Pathology Innovation)

Currently, pathology reports are sent back to the requesting clinician, who acts as an intermediary between the patient and the information that they would like to know about their  health.  

Here is an example of a typical lab report:

This  pathology report is written in bio-medical code. They are abstract- if taken out of context. They need interpretation- expert clinical or expert patient interpretation. They answer a question posed by a clinician, not a patient or at least mediated by a clinician. Do they deliver information in a format that is patient friendly? Do they answer the questions that the patients really need answering? Do they transform the relationship that the patient has with their own health and wellbeing? Do they enable more active self-management?

NHS England and the RCGP are looking towards self-management to transform the outcomes for patients with long-term conditions and meet the challenge of an aging population.

NHS England and the RCGP support a new model of care for long-term conditions , ‘The house of care’, that also aims to be ‘transformative in the relationship between health professionals and patients, and between patients and their health and wellbeing’

Pathology plays a large part in long-term chronic disease management. Chronic disease monitoring bloods make up more than 50% of all bloods requested in primary care. These blood tests are central to monitoring disease progression and therapies and thus enabling the NHS outcomes framework domains:

Domain 1: Preventing people from dying prematurely
Domain 2: Enhancing quality of life for people with long-term conditions

These blood tests have become systematic care processes in primary following the introduction of blood monitoring processes and targets in the GP quality and outcomes framework (QOF) contract. However, outcomes from QOF have been disappointing, one of the reasons being that it is not enough to just perform a process, such as a blood test,  processes need to be acted on- and ultimately by patients.

The house of care model aims for a transformation of the relationship between health professionals and patients. Information is to be owned by patients, clinicians facilitate a personalised action plan.

Pathology reports can facilitate the house of care model and this transformation of care, by providing reports for long term conditions for patients, not clinicians, and thus enabling patients to self-manage.
Can pathology infographics do this? Can this format deliver information in a way that is useful to patients in managing their own health?

(test report by Dr John O’Connor, consultant biochemist RDE Hospital)

Order comms and chronic disease order sets could facilitate these reports by automatically coding the request as a chronic disease review. Reporting algorthims could be agreed with all stakeholders and the reports could become more personalised as IT becomes more integrated and other measures such a weight and BP are available to the lab to incorporate into the reports.

The reporting IT platform could also be linked to more innovative  patient information, tele-health monitoring or social media self care communities that support each other.
The lab could also agree referral criteria and make onward e-referrals to specialists ie: renal physicians and diabetes specialists (innovative direct referral pathways)

Enabling further innovation:  for cardiovascular disease, diabetes and renal disease, the pathology lab could co-ordinate all care processes into a personalised care report for patients. You could see, for these longterm conditions, at least, the lab taking on the co-ordination of all monitoring processes. For chronic disease, where complexity is low, the lab could   provide better  standardisation of care through agreed reporting algorithms?

This can free up clinical time in primary care to focus on relationships/ action planning and holistic care/ discussion of personalised reports……which may improve outcomes in a way that QOF has not delivered.

What will we need to do to make this happen?

• Good pathology and GP collaboration- in the use of order comms and chronic disease order sets and reporting
• Working on an IT solution to deliver reports that work for patients, primary care and secondary care and enable lean patient pathways and facilitate further patient self-care
• Primary care, pathology and specialist algorithms/ pathways
• Working with patients to find out what they really want to know
• Working with public health and behaviour change specialists, medicines optimisation teams- how should we be presenting information and what information is useful to patients?

Atlas are not Roadmaps - why big data does not lead to change

The recent edition of the Bulletin of the Royal College of Pathologists contains an article by Bernie Croal that discusses the NHS Atlas of Variation. The Atlas of Variation is an interesting project that takes health data from across the country and displays variation graphically. As discussed in a previous blog, pathology requesting patterns can be a rich source of data for analysis of variation. The NHS Atlas looks at a number of examples at a national level, including TFTs, BNP and Ca 125. The article discusses the large variation seen in these requests across the country, and highlights the role that inappropriate requesting, variation in local clincal pathways, and variation in laboratory practices have to play in this. It is probably hard to justify variation, although sometimes this may reflect differences in local availability of other services (eg. access to echocardiography and BNP). But variation is always interesting and should never be ignored. Variation leads to health inequality, and drives the failure demand that may account for up to 75% of health expenditure. The problem with big data approaches like the Atlas are that they are easy to ignore. There are at least 2 reasons why this occurs. It is hard to know what the root cause of variation is (many reasons for variation). The problems are often at a system level that most people feel disempowered to change - and getting to the root causes requires a level of immersion in the problem that few people with the 'power' to make the change are able to achieve. The second related problem is that it is hard to engage those who are nearest to the root cause with aggregate data - it lacks the personal touch and context that is so important. Not only does the data feel irrelevant to an individual, it is easy to dismiss as someone else's problem. And so we return to the concept of the general pathologist. What we need are people who are skilled at analysing data and expressing it in ways that are meaningful to those that are nearest to the roots of an issue. We need people who are skilled at working with these people to understand this variation, and this probably requires a considerable amount of time reviewing case histories, talking about alternative management options, and ultimately discussing with patients what their experiences are. This granularity and personalisation of data is where pathologists can add real value. Working in this knowledge economy is the way that pathologists will help to turn the atlas into a roadmap.

A need for diagnostic medicine specialists in primary care

Pathology laboratories across the UK are in a state of upheaval. Ever since the publication of the Carter report there has been pressure to remove costs from laboratory medicine. The debate is polarised – on one side a group of ‘modernisers’ who look at the unit cost of pathology, note the disparity with benchmark costs on a range of national or international comparisons, and project savings from reorganising and consolidating existing services. On the other side is a group who emphasise the hidden costs of pathology that are often not taken into account in unit cost analyses, point to low total pathology costs in the UK, and strive to protect the status quo of local laboratories linked to local hospitals.

This debate somewhat misses the point – both sides are effectively arguing over the same data - how to minimise unit costs. Although quality is often thrown into the mix, it is at a rather low level of laboratory accreditation, or via the rather poorly defined concept of patient safety. There is, however, a clear opportunity to use this crisis in pathology to reinvent the specialty as one that is fit for the 21st century.
What are the challenges facing modern healthcare? Management of a rapidly growing population living with long term conditions and support of the frail elderly are the two issues that feature at the top of most commissioners lists. How does diagnostic medicine currently support these? For LTC, we tend to provide a reactive service. Order sets from different practices may be wildly different. Every unnecessary test adds to workload and generates the risk of iatrogenic harm. This leads to an additional workload that sits on top of a system that is already under strain. The problem is even worse when one considers how the laboratory supports the frail elderly in the community. There is enormous variation in how clinicians use tests to support their management – this must go beyond the personal preference of individual clinicians, and represents a real quality issue that must be addressed. It is no longer sufficient for laboratories to blindly accept these requests without understanding the behaviours and beliefs that sit behind requesting patterns.

Over the last couple of decades pharmacy has seen similar upheavals, with the role of the traditional pharmacist disappearing in the community. A few far sighted pharmacists realised that they sat in a privileged position to provide a degree of governance to prescribers. They could monitor prescribing patterns, challenge variance, introduce best practice, and control costs. These small teams have now grown substantially as their worth is recognised. GPs highly value this specialist input embedded into their practice, and this is now an accepted part of all practice governance. The parallels with diagnostic medicine are obvious. We can see variation in requesting patterns, and knowledge of diagnostic best practice is a highly valued skill. The increasing recognition that testing adds to workload is now a major driver for most practices to get on top of their laboratory usage. It is not clear whether current laboratory staff have the skills to provide this service, but there is almost certainly something to be learned from talking with pharmacists about their experiences.

Putting pathology at key clinical decision points – the importance of clinical value and developing strong user-laboratory relationships.

By Tom Lewis (Lead Clinician for Pathology, North Devon) and Darunee Whiting (GP and Lead Commissioner for Diagnostics, NEW Devon CCG)

The concept of ‘value’ is increasingly being used in healthcare. Essentially, ‘value’ describes a willingness to pay for a service. In pathology, one can consider value to reflect the utility of a test (ie. its ability to inform patient management), offset against costs of the test (both financial, but also in terms of patient and user acceptability).

While diagnostic tests can enhance patient management, it is clear that diagnostic tests are often used in a way that fails to deliver value to the patient (ie. inform good, timely management). There are a number of ways in which diagnostics may fail, despite high quality internal laboratory performance, for example:

Pre-analytical

• Test that could inform management not used at correct time
• Inappropriate test for condition, leading to wrong management choice
• Test not carried out appropriately, leading to erroneous result
• ‘Shifting the burden’. Performing a simple, but inappropriate action as a way of delaying a harder, more appropriate action. This is seen in pathology as :
  • Inappropriate action in place of testing (eg: prescription/ referral/ admission). Maybe due, for example, to difficulty in accessing test, or time delay from test to result.
  • Inappropriate testing due to difficulty accessing other more appropriate action (eg. other test/ prescription/ referral/ specialist review/ intervention).

Analytical

• Time frame of testing does not match time frame of clinical decision

Post-analytical

• Test not acted upon appropriately

For a pathology service to deliver true value, it is important to recognise that tests cannot exist outside of the system in which they are performed. Thus, an accurate test that is either inappropriately requested, or inappropriately acted upon, has little or no value, and may indeed result in harm (negative value). A high value test is affordable, acceptable, and supports key clinical decisions.
The logical conclusion of these issues is that pathology tests cannot sit outside a diagnostic framework that places the test firmly within its clinical context.  To determine this context, pathologists must work closely with all users who have an interest in the area under discussion, to understand how pathology services can best support key decision steps (deliver value).
Failures of the healthcare system can be thought of as occurring whenever there is a failure to deliver maximum value to patients, on a consistent basis. System failures may result in direct harm to patients, but also lead to problems with sustainability.  Importantly, pathologists may be well placed to see these system failures.  System failures may manifest to pathology services in a number of ways:

• Variability in test requesting between users
• Unexpected changes in demand
• Clinically inappropriate test requesting
• Data from other areas (eg. referrals / admissions / prescribing) where inappropriate testing has ‘shifted the burden’

In future blogs, we will discuss a number of examples in which pathology services have identified system failures, and then worked with primary care practitioners, and other health professionals, to develop diagnostic frameworks that support key decision steps and deliver high levels of value to the patient.

Diagnostic Builders - Chaos in the Brickyard

By Tom Lewis after Bernard Forscher for original concept and with thanks to Brian Nosek for posting this.

Once upon a time, amongst the activities and occupations of medicine, there was an activity called Laboratory Medicine, and the performers of this activity were called clinical pathologists. In reality, however, these men were builders who constructed edifices, called diagnoses, by assembling bricks, called test results. The work of builders was much valued by the architects, or doctors, who planned great cities but lacked experience in the detailed work of assembling edifices that were safe and that were useful.

Now, when the bricks were sound and were assembled properly, and the ground upon which they were placed was chosen with care, the edifice was sound and brought pleasure, as this work was seen as useful. If the bricks were faulty, or the edifice constructed badly, or the ground was poor, the edifice would crumble, and this kind of disaster could be very dangerous to innocent citizen users of the edifice, as well as to the builder and architect who could be destroyed by the collapse. Because the quality of bricks was so important to the success of the edifice, and because bricks were so scarce, in those days the builders made their own bricks. The making of bricks was an expensive and painstaking undertaking and the wise builder avoided waste by making only bricks of the shape and size necessary for the enterprise at hand. The builder was guided in this manufacture by a blueprint, called a diagnostic question. This blueprint arose from long and detailed conversations with the architect, and required a deep understanding of the purpose of the edifice.

It came to pass that the builders were sorely hampered in their tasks by difficulty in obtaining bricks. Thus there arose a new skilled trade known as brickmaking, carried out by laboratory technicians, to give the artisan proper pride in his work. This new arrangement was very efficient and the construction of edifices proceeded with great vigour. In spite of the separation of roles, bricks were still made with care. In general, brickmaking was done on a custom basis because it was a difficult and expensive process.

And then it came to pass that a misunderstanding spread among the architects (there were some who said that this resulted from careless training of a new generation of architects.) The architects became obsessed with the making of bricks. When reminded that the ultimate goal was the edifices, not bricks, they replied that, if enough bricks were available, the builders would still be able to select what was needed and continue to build edifices. The flaws in the argument were not readily apparent, and so, with the help of the brickmakers, amazing things happened. The expense of brickmaking became a minor factor because large sums of money were made available and the time and effort involved in brickmaking were reduced by ingenious automatic machinery.

And so it happened that the land became flooded with bricks. It became necessary to organise more and more elaborate systems of storage for all these bricks. And then some people noticed that structures could now be produced very cheaply if builders were no longer needed. Without builders, there was no need to consider blueprints, and architects could assemble their own edifices. Sometimes these edifices were good, but often the architects lacked the skill in selecting the right bricks, and did not choose the right ground on which to assemble their edifices. Sometimes citizens, who had been previously happy without the need for an edifice, were tempted by the architects to use these new cheap and readily available structures. The architects thought that they were doing these citizens a great service, but in fact these piles of bricks that resembled edifices could then do great harm to the citizens that came to use them.

Throughout this, the brickmakers retained their pride and skill and the bricks were of the very best quality. The brickmakers found that they became poor if they discouraged the architects from building edifices without a blueprint, and so they continued to produce the high quality bricks that the architects were demanding. In order to compete successfully with other brickmakers, production emphasised those sort of bricks that were easy to make and only rarely did an adventuresome brickmaker attempt a difficult or unusual design. As it was sometimes difficult to tell the difference between a pile of bricks and a useful edifice, the influence of cost in brick production methods and in types of product became a dominating factor.

Unfortunately the builders were almost destroyed and the blueprints were lost. It became difficult to find the proper bricks for a task because everyone had to search through so many. It became difficult to find a suitable plot for construction of an edifice because the ground was covered with loose bricks. It became difficult to complete an edifice because as soon as the foundations were discernible they were buried under an avalanche of random bricks. The architects found they were spending a lot of their time trying to correct problems with the structures they were creating, and this made them unhappy. And saddest of all, sometimes no effort was made even to maintain the distinction between a pile of bricks and a true edifice.