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Patient Diagnostic Services

Volume 570: debated on Monday 4 November 2013

Motion made, and Question proposed, That this House do now adjourn.—(Anne Milton.)

As it is the first time I have had the pleasure of speaking in the House since your election to the Chair, Madam Deputy Speaker, may I congratulate you and say how pleased I am to be speaking this evening under your guidance?

The doctors and consultants in Brent, like those in the rest of the country, are highly respected members of our community. Their work is part of the glue that keeps our society together and enables people to function and get on with their daily lives. Doctors, though, would be the first to admit that they are not omniscient—well, some of them would. Their work depends upon the work of many others in the health care sector—in particular, the work of laboratory and radiography technicians who provide the evidential base for diagnosis and treatment. The quality of patient outcomes will always depend on the quality of diagnostic services because a diagnosis delayed is a treatment delayed, and an incorrect diagnosis is potentially fatal.

This evening, I wish to detain the House and suggest to the Minister that the structural changes that his Government have introduced in the national health service have had a seriously adverse and dangerous impact on patient care.

In May 2012, the decision was made to outsource pathology services in Brent and Harrow. Previously, it had been provided by the NHS at a facility at Northwick Park hospital. The decision was taken because the hospital wanted to invest in improvements to the system. Rather than incur those financial costs, it was considered more efficient to outsource the contract to TDL Ltd—otherwise known as The Doctors Laboratory. That was a mistake.

The first indication that there was a problem came when a GP identified a serious technical flaw in the way patient test results were presented through the computerised system. The GP had received a list of multiple test results in respect of a patient. When looking at one set of results on the list and closing it or archiving it to the patient file, the GP realised that it was possible inadvertently to apply that same action to all the other test results returned on that list. Pathology results that required urgent action could be accidentally archived owing to an error in the TDL reporting system. Critical patient test results could be missed altogether or inappropriately actioned.

The GP reported that as a serious incident and immediately flagged up the issue to the North West London Hospitals NHS Trust, on the assumption that pathology services were still being carried out there. In fact, the service has been provided by TDL since May 2012. The hospital trust passed the concerns on to the Brent and Harrow clinical commissioning group, which was now responsible for managing the contract with TDL. At that time, the matter was not thoroughly investigated and was deemed to be a single incident and not a cause for concern.

However, GPs began to talk to each other about their concerns and realised very quickly that they were not alone in seeing a sudden change in the quality of results they were receiving from the service that had, up until 2012, been carried out adequately at Northwick Park hospital. At an emergency meeting with representatives of NHS Brent and Brent CCG, the GPs were led to believe that steps were being taken to resolve the matter.

The problem got worse. GPs across the borough were receiving many more abnormal results than they would ordinarily expect: test requests were ignored or the results were never reported back to them; other tests were being returned incomplete with only partial results and data omitted; and some samples were being incorrectly marked as complete and being discarded without being tested.

This alarming downward trend in the quality of the results finally prompted NHS Brent and NHS Harrow to launch a proper investigation, which commenced on 20 December 2012. Let me quote this root cause analysis investigation report, which finally reported in March of this year and found

“spurious results, missing results and samples not processed...reference ranges had changed and...the presentation of the results into groupings that did not make sense”.

One GP wrote to me to say:

“In the new year the scale of serious anomalies and problems had become so great that individual practices started to send out e-mails to each other to see if the problems were as isolated as we were being led to believe…The response was shocking. Our patients are at serious risk. Unless we have these basic services reliably we cannot diagnose and treat our patients.”

The situation in north London is clearly shocking. Does my hon. Friend know whether any of the tests that were outsourced relate specifically to diabetes, which is a huge problem for people who live in Brent? About 10% of the population is thought to suffer from diabetes.

I am grateful to my right hon. Friend for his intervention, and he is absolutely right that diabetes is a major problem in the Brent area. Given that many of the tests related to phlebotomy, I would assume that some of them might have related to diabetes, but I do not have that specific information to hand.

I was explaining that GPs across the borough were receiving many more abnormal results than they would ordinarily expect, that the downward trend in the quality of the results had prompted an investigation and that the GPs had expressed their own concerns by exchanging information among themselves to ascertain the extent of the problem.

The interim deputy director of quality and safety for Brent, Ealing, Harrow and Hillingdon CCGs reported

“many incidents of patients attending for repeat blood tests at both the practice and within the hospital and some patients…referred to A&E Department because of high potassium levels.”

Many consultants began to experience similar problems with the service and were also having to carry out further unnecessary tests. One consultant, when pressed, scribbled a note setting out a variety of issues:

“Immunology—assay results; Calcium results—change in calculations; Change in reference ranges; Potassium—delays in transfer and refrigeration”.

I am sure the Minister will agree that such failings in service are wholly unacceptable.

The question then arises how any competent company of qualified health professionals could come to make such errors. After all, its website states that it is

“providing quality accredited pathology services to the UK and worldwide”.

I trust the Minister will be as surprised and as disappointed as I was to learn that, at the time the service was outsourced, TDL was

“not currently registered with Clinical Pathology Accreditation (UK) but is working towards this”.

The words “working towards this” should be accompanied by some degree of scepticism, given that the final report on the root causes of the problem identified that TDL was so incompetent that

“There was an operational issue with the new robotic sorter which resulted in a number of samples being filed incorrectly as ‘analysis complete’ and subsequently discarded. There was also a problem with one of the lines in the calcium analyser as a result of which samples were transferred to another laboratory, and a number of issues were attributed to human error.”

Compounding the confusion, when the service was transferred, TDL used different reference value ranges to assess and analyse results in order to fit in with its own IT systems. Unfortunately, it failed to communicate this change to the GPs or consultants who were now expected to interpret results that they did not understand, based on reference ranges with which they were not familiar. TDL was found to have not followed its own procedures, which required it to flag up to its service users when systems were changing. Owing to this transition, GPs and consultants were effectively left blind about the difficulties they might experience with pathology reports.

Of course, the quality of any test results will always depend on the quality of the samples received. Just as in the world of computing, “garbage in leads to garbage out”. One would imagine that when the decision was taken to outsource the pathology courier service that delivers samples to the pathology laboratory, clear and appropriate clinical advice was sought about precisely how this contract should be specified—and it was. In fact, GPs suggested that a courier service carrying samples for potassium tests must be refrigerated in order to avoid the impact of temperature change on the quality of the sample. However, the terms of the contract failed to specify that, and the eventual service that was commissioned did not provide for temperature control.

I have also received complaints about delays in delivery, as well as allegations that damage to samples in transit has made it difficult to record and analyse them properly. Indeed, the NHS Brent CCG noted in a report to the Brent health overview and scrutiny committee that issues of transportation quality and service delays on the part of the courier service, Revisecatch Ltd —trading as Courier Systems—

“appear to play a seasonal role in the variation of potassium levels; in that they add to the instability of the samples due to fluctuation in temperature during storage at the GP practice and/or during transportation to the laboratory in both summer and winter”.

Another privatised diagnostic service, the London NHS Diagnostic Service, is provided by InHealth. It is designed to enable London GPs to make direct referrals for their patients so that they have already had tests before being referred to specialist consultants. The tests might include ultrasound, echocardiography, audiology, cardiac physiology, magnetic resonance imaging, X-ray, endoscopy or phlebotomy scans. The intention was to reduce the CCG’s consultant costs by referring only patients who really needed their attention. In other words, GPs would filter patients to avoid unnecessary and costly referrals.

GPs have objected that that practice has simply introduced a middleman to the process, and that delaying a diagnosis from a specialist consultant may put patients in danger. I am told that the problem is compounded because the scans received from InHealth are often themselves delayed, and are frequently found to be of such poor quality that the patient must be referred to a specialist consultant in any event. My office has also been given anecdotal evidence that staff at diagnostic centres do not possess the necessary skills or understanding to handle complex diagnostic services.

General practitioners are not specialists. They are not consultants, and they are seeing scans which they cannot decipher or which are in a format that they cannot use. The patients are sent for another scan, or often are simply referred to the consultant whom they would have seen under the old system, who then usually orders a further scan at his or her own site. What started off as a way of saving money and freeing consultants to focus on clear cases of need becomes a bureaucratic process that puts patient outcomes at risk and costs more money as a result of duplication and delay. I should like to know from the Minister whether it is still the case that a patient has a statutory right to see a consultant, and whether a patient can insist on a direct referral from his or her GP without the interposition of additional diagnostic tests.

However, it is not just those diagnostic support services that are being privatised; front-line diagnostic services are being outsourced as well. I am, of course, referring to the NHS 111 service. The service was designed to ease pressures on accident and emergency departments by providing telephone-based triage, but many criticisms have already been made of it. Reference has been made to patients’ calls being answered by medically illiterate staff and to failure to meet targets to transfer calls to a clinician or nurse within 60 seconds or return them within 10 minutes, and there have been stories of patients simply being referred to A and E departments because call centre staff do not know what alternative facilities are available.

I do not wish simply to add to that catalogue of failings. My concern is more specific. In Brent and Harrow, we have an NHS 111 service that was awarded to Harmoni. That in itself was cause for some concern, as the company’s shareholders included the majority of the Harrow clinical commissioning group board that had decided to award it the contract. However, that is not the potential conflict of interest on which I wish to focus.

The urgent care centre at Central Middlesex hospital happens to be owned by Care UK, the company that also now owns Harmoni. Let me make clear that I am not accusing Care UK of encouraging its NHS 111 staff to make referrals to Central Middlesex in the knowledge that they will benefit from the treatment of any patients at the urgent treatment centre there, because I have no information to suggest that that is the case. Nevertheless, it is clear that there is a serious conflict of interest that any contract must monitor and guard against.

The interests of Care UK are clear, but its performance is not. I wrote to the Secretary of State for Health asking how the service in Brent had performed relative to the service specification. I asked,

“how many calls have not been (a) answered, (b) referred to a clinician or trained nurse within the appropriate timescale or (c) in receipt of a call-back from an appropriate clinician within 10 minutes”.

I received the following response:

“Local commissioners are responsible for performance management of NHS 111 services, and set their own performance targets for services…Data…is not available in the format requested.”—[Official Report, 23 October 2013; Vol. 569, c. 213-4W.]

In other words, the only people responsible for policing such conflicts of interest are the very people who have stood to gain from them.

The final issue I wish to raise with the Minister is that of the National Clinical Assessment Service. In many respects, this could merit an Adjournment debate all of its own. NCAS was established to undertake performance assessments of GPs and clinicians when primary care or hospital trusts had expressed concern that their clinical results or statistics appeared to have been outside normal parameters. There are more than 1,000 referrals a year, and in the vast majority of cases NCAS will assist simply by advising the trust in order to return the clinicians to safe and effective practice. However, in 50 or 60 cases each year an extraordinarily detailed and intensive process of assessment and remediation is required. Only about 60% of those who undergo that process make it back into safe and effective practice, while 40% never return to work in the NHS. NCAS is therefore one of the key guardians of patient safety.

In 2010, it became clear that NCAS would be restructured as part of the reconfiguration of the NHS. Its budget was cut by 20%, and it was told that it would have to become self-funding by 2013. In 2012, Deloitte was asked to conduct a review of the service, but it is due to publish its report only on 14 November, 10 days from now. In April this year, NCAS was joined to the NHS Litigation Authority, which has since consulted on a new structure prior to publication of the Deloitte report.

I understand that senior clinicians in NCAS are deeply worried that the head of the NHSLA has simply dismissed the very serious concerns that senior and experienced practitioners fed into the consultation about the proposals and the impact they might have on patient safety. NCAS is now haemorrhaging junior staff, whom it is allowed to replace only with agency people. The advertisement for a replacement for the senior assessment adviser specifies that the person concerned must be someone on secondment, and for one year only. The restructuring proposals dispense with the post of the director responsible for the “back on track” service, but no one else in the service has the clinical capacity to perform the role.

For some 50% of those who come for assessment, previously unidentified patient safety issues are revealed, often involving the cognitive impairment of the clinician himself or herself. I believe that before the proposed changes are allowed to proceed, the Minister must provide satisfactory answers to two questions. First, how will those patient safety concerns be discovered under the new model? Secondly, how will doctors who present a risk to the public be remediated and returned to safe and effective practice, given that the proposal specifically does not replace the key post with the clinical capacity to carry that out?

The problems and failings I have outlined this evening are not a series of unfortunate but unrelated events, but the logical consequence of a restructured NHS that has put competition and cost, rather than patient care and patient safety, at the heart of the health service. There has been a failure to ensure quality commissioning of the services being provided. In fact, one GP has written to me noting:

“It perhaps raises an interesting learning point for the future; that being if GPs are going to commission services and deal with private providers, what mechanisms are in place to stop patients being harmed by”


“negotiating a less than water tight contract? We are GPs not lawyers.”

Certainly with respect to the takeover of the pathology laboratory by TDL, no risk assessment was carried out to predict the potential problems that might arise from a change in both system and process, and no suitable performance measures were implemented, nor was a structure of monitoring put in place to ensure that a good quality of service was maintained. The Health Secretary has been keen to argue that privatising these services is on the basis of improvements to patient welfare and sound clinical evidence. It is not.

The awarding of the contract to Revisecatch Ltd shows that the clinical advice was ignored on the basis of cost, despite the clear implications for patient safety. The irony is that the subsequent change in contract specification almost always results in much higher costs, to the benefit of the private provider.

Patient care and patient safety can only be prioritised in a system where transparency thrives. Only in such a system can mistakes be learned from and become the basis of better future practice, but it is not in the interest of private companies to disclose any aspect of failing service. The root cause analysis report notes:

“The report provided by TDL on 08 March, was light on detail in parts and so it was difficult to identify lessons learned. TDL enjoy a good reputation and it is understandable that they would wish to protect this. However, in light of the requirements to put patients first and the duty of openness, transparency and candour, as recommended by Francis, it is felt that all involved could have been more open throughout the process.”

This issue of transparency and openness will remain a serious challenge for as long as private companies compete for contracts on the basis of cost.

Too many medical professionals are having to discover to the detriment of their patients that, for all their clinical expertise, they were never trained in the dark arts of commercial contract law, contract specification, negotiation and monitoring. It is the dogma of this Government that has put competition at the heart of our national health service, where patients should rightly be.

It is a great pleasure to be speaking in the Chamber under your chairmanship for the first time, Madam Deputy Speaker. I congratulate you on your success in being appointed.

I congratulate the hon. Member for Brent North (Barry Gardiner) on securing this debate. Before I correct some of the assertions he has made, I want to highlight the fact that the diagnostic services in England, and especially in Brent, are in rather robust health under this Government. Average waiting times for a diagnostic test remain low and stable, despite the NHS carrying out over 2 million more key tests a year since May 2010. The percentage of patients waiting six weeks or more at the end of June and July 2013 was 0.9% of the total number of waits. We can therefore see that the number of diagnostic tests is increasing, the availability of diagnostic services to patients has improved under this Government, and very few patients are waiting in excess of six weeks for the services provided.

Latest provisional data from the diagnostic imaging dataset show that almost 32 million imaging tests were reported in England in the 12 months from June 2012 to May 2013. Diagnostics have a key part to play in reducing premature mortality, particularly as NHS England estimates that over 1 billion diagnostics tests are carried out within the NHS every year. Access to safe and high-quality diagnostic services, such as endoscopy, genetics, and imaging, is critical to all clinical pathways. They underpin over 80% of clinical decisions and they contribute to the holistic care of patients, not just single episodes of care.

It is worth reminding the hon. Gentleman that the previous Government introduced, and championed the role of, the private sector. I believe we are all Blairites in this Chamber, in that we all believe in respect of publicly funded care that where the provider—be it the NHS, a private provider or a local charity or voluntary sector organisation—gives high-quality patient care, that has to be a good thing because it improves the quality of care. It is also important to highlight that the previous Government introduced private sector providers into the NHS to reduce waiting times for operations, which were unacceptably high at that time. I think we would all agree that it was a good thing that waiting times were reduced so patients no longer had to wait unacceptably long times for treatment they so desperately needed.

The first independent sector treatment centres were opened in October 2003, under the previous Government, and they gave £250 million to private providers of independent sector treatments. To their shame, they paid the independent sector on average 11% more than the NHS price for the same treatment.

Our intention in the reforms we introduced was to look at the mistakes the previous Government made in commissioning private sector services, to make sure there was a level playing field. There is no competition on price, as the hon. Gentleman asserted; there is only competition on quality in NHS services. It is important that any provider of NHS services and care to patients does so in an integrated way that delivers joined-up and integrated care based primarily in the community. Providing early diagnosis and early treatment and improving diagnostic services is a key part of that.

The big challenge that faces the whole of the NHS and the health and care sector is the fact that many people are living longer, and often with multiple medical conditions like diabetes, dementia and heart disease. The challenge is to make sure that we treat them with dignity and respect. We must also make sure that when we can diagnose a problem or illness early, we do so. That is why we are very proud to have increased the amount of early diagnosis and the number of diagnostic tests available in our NHS. The remaining challenge is to make sure we continue improving early diagnosis in Brent, London and throughout the country.

We know that when disease is diagnosed early, patients have a better chance of a good outcome. One-year survival for kidney and bladder cancers is as high as between 92% and 97%. At a late stage, however, it drops to between just 25% and 34%. The clinical case for early diagnosis and the investment we are making in diagnostic services is very clear, therefore.

Of course, apart from the clinical benefits of early diagnosis, there are other benefits. When people are ill, they want to know as soon as possible what might, or might not, be the cause of their illness. Having to wait a long time for diagnostic tests can be hugely stressful for patients.

Let me deal with the issues the hon. Gentleman raised about the commissioning of services. Since the beginning of April 2013, clinical commissioning groups have been responsible for commissioning many health care services to meet the requirements of their population. In doing so, CCGs need to ensure that diagnostic services are considered fit for purpose and reflect the needs of the local people as part of their process for commissioning clinical pathways. Local clinicians are best placed to understand the needs of their local population and commission the diagnostic services they need.

Local clinicians are commissioning in a way that is increasingly effective in diagnostics and elsewhere, so more choice in diagnostic services is essential. Many patients who require diagnosis—perhaps an ultrasound scan—will be working, and traditionally some of the NHS diagnostic models have not embraced seven-day working. We know that it is much easier for working people to access NHS services in the evening or at weekends. Therefore, bringing providers that supply greater choice for patients into the NHS makes it much more likely that patients will receive appropriate services at the right time and in a convenient way. It also increases patient compliance, not only with treatments, but with making sure they have their scans and diagnostics in a timely manner.

The Minister rightly says that clinicians are best placed to make clinical judgments about their patients’ needs, and there is no dispute between us on that. My concern is that in a case such as that of TDL the clinicians understood the clinical need but clearly did not have the expertise to ensure that the contract was properly engaged in; that it was risk-assessed in the first place; that it was properly monitored; and that it was executed in a manner that was going to ensure the proper relationship between the practitioner and the tests that were being done. Similarly, on the courier service, they had the clinical evidence right, saying that refrigeration was needed, but when it came to putting the contract in place there was no such refrigeration.

I hope that the hon. Gentleman will forgive me for saying that many of the contracts to which he is alluding were put in place under the old arrangements, before this Government’s reforms, which have delivered clinical leadership. Many of these contracts were negotiated under the powers put in place under the previous Government, whereby people without clinical experience often negotiated the contracts and so did not always understand what the important clinical factors were. He rightly raised the point about potassium and the refrigeration of biochemical samples. It is important that we preserve the integrity of all samples collected. Of course, a clinician, a biochemist or someone with clinical experience would understand that, whereas someone who is commissioning services without that background might not. We saw that happen far too often with primary care trusts. The clinical input under the new arrangements will put us in a much better place to commission services in the future. Many clinical commissioning groups have been saddled with those old arrangements and so are having to enforce arrangements and contracts that they did not directly negotiate. We hope that when the contracts come up for renegotiation that problem will be put right, thanks to the reforms that we have introduced. They will lead to clinical leadership at CCGs, so that doctors and nurses are in charge of negotiations, rather than people who have not necessarily had the relevant clinical experience and do not have the knowledge to understand what the contract they are commissioning is about. National frameworks are being developed for some commissioning contracts by NHS England. So if concerns arise locally on the part of a CCG about the commissioning of contracts, NHS England is always available to provide advice.

I wish to reassure the hon. Gentleman that not just any old health care provider can deliver diagnostic services. By law, health care providers must register with the Care Quality Commission to carry out diagnostic services. That helps to ensure that patients receive only high-quality care, because the CQC, to which the Government are granting greater independence and strengthened powers to intervene where there are quality of care concerns, is the organisation that will be able to intercede if there are concerns about the quality of any health care service which may affect patient care. Service providers must be registered with the CQC and they must prove that they can meet strict quality criteria. That regulated activity includes a wide range of procedures related to diagnostics, screening and physiological measurement, including all diagnostic procedures involving the use of any form of radiation, including X-ray, ultrasound or magnetic resonance imaging. Regulated activities are listed in schedule 1 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010.

The Minister will have been aware of the report on TDL in north-west London and in no sense could it have been said that a satisfactory service was being delivered. So why did the CQC not intervene in a timely fashion? Why, when the initial report by the GP was made about a serious incident, was it not taken seriously? Why did it take so long to make sure that these services were being provided properly and that my constituents were being kept safe?

Clearly, the events that the hon. Gentleman has raised were distressing and appear to have caused difficulties for patients, and I know that local commissioners found that regrettable. I do not know whether the case was reported to the CQC. He will also be aware that the CQC has come on a considerable journey, from being an organisation that was not fit for purpose a few years ago to being an organisation, with new chief inspectors in place, that is in a much more robust state of health now. The Secretary of State has put in place a number of measures to beef up and improve the inspection regimes in all care settings. We now have a chief inspector of care, a chief inspector of hospitals and a chief inspector of general practice. Following the Francis inquiry, there is now much more transparency, openness and passing of information between health care commissioners at a local level and the CQC. That did not happen as effectively as it should have done in the past, and that was to the detriment of those in Brent.

Indeed, and the Francis inquiry took place this year and a lot of action has been put in place by the Secretary of State to recognise where there have been failings in the health system in the past. We know that the majority of the health service, however it is commissioned, be it through a provider of NHS services, through the voluntary sector or through private providers, provides fantastic care on a day-to-day basis. We are proud that we have a publicly funded health service that has many fantastic front-line staff—I count myself still to be one—who do a very good job of looking after patients.

We know that things sometimes go wrong: the hon. Gentleman has highlighted what went wrong in his constituency and in the wider NHS things went wrong, very tragically, at Mid Staffordshire. We need to learn from those mistakes and ensure that they are put right in future, whether they are in the commissioning process—clinically led commissioning should put us in a much better place in that regard—or in the care that is provided to patients. We need to ensure that all hospitals, as well as other health care providers and care sector providers, step up to the plate, recognise that patient safety must always be paramount and ensure that the lessons that need to be learned from the Francis report are learned. My right hon. Friend the Secretary of State will report back to the House in due course—later this month, I believe—with further recommendations that will, I hope, reassure the hon. Gentleman.

In conclusion, let me turn specifically to diagnostic services in Brent. I am aware that the hon. Gentleman has recently asked questions about referral processes for diagnostic services provided in his constituency. As he knows, the contracts for those services were originally let by the then PCT under arrangements encouraged by the policies of the previous Government and are managed by the North and East London commissioning support unit on behalf of the CCGs. The London NHS Diagnostic Service, provided by InHealth, offers GPs and other health care professionals direct access to high-quality diagnostic and imaging scans and tests throughout London delivered from a range of sites, including mobile, fixed and community-based facilities.

I hope that it reassures the hon. Gentleman to hear that between September 2010 and August 2011, 2,397,018 diagnostic tests were carried out in London but more recently, between September 2012 and August 2013, there was an increase of about 300,000 to 2,651,560. That shows that the service in London is in robust health and is being used to facilitate scans and other procedures to diagnose many more patients today than two to three years ago.

I understand that the hon. Gentleman has been in communication with local commissioners and that the relevant NHS England area team has advised him that GP practices do not receive any referral payment when patients are referred to the London NHS Diagnostic Service provided by InHealth. I know that that is an area of concern to him and he was possibly suggesting that there might be some cosy internal relationship among local health care services to the detriment of patients. I can reassure him that that is certainly not the case. GPs make clinical decisions on the basis not of financial bribes, but of what is best for their patients. I hope that he will be reassured by the answer he has received from the commissioners and I do not think that it is in any way likely that GPs or other health care professionals will act in a way that is outside the best interests of their patients. It has always been my experience that front-line health care professionals, with very few exceptions, act with openness and integrity and always advocate for their patients’ needs. I hope he will be reassured by that.

I hope that the hon. Gentleman is reassured that diagnostic services are in robust health under this Government nationally, and in Brent.

Question put and agreed to.

House adjourned.