HL Deb 03 June 1991 vol 529 cc523-34

9.10 p m.

Lord Hunter of Newington rose to ask Her Majesty's Government whether, in the light of the recommendations of the Audit Commission concerning the pathological services, they are in favour of the transfer of pathological testing from hospital laboratories to general practice.

The noble Lord said: My Lords, I rise to put the Question standing in my name on the Order Paper. I think that everyone would accept this philosophy as their objective in relation to the National Health Service, that working for patients and minimising costs while maintaining standards is a key to this situation. It is also true that more testing and diagnosing accurately near the patient is a major objective rather than just sending them to hospital. One s perhaps disturbed somewhat by the Government's plan, whereby the basic assumption seems to be that for many things patients will continue to go to the hospital and doctors will make financial arrangements with these hospitals.

However, there are a number of revolutions going on which are of the greatest importance. The most import ant factor, as I have said, is the trend towards more testing and investigation near the patients. This, and population screening, is likely to revolutionise the whole situation within a decade. I believe that a paper about this is being published tomorrow.

Of the many factors, dry chemistry is undoubtedly the leading change and the one with the greatest potential. Under many conditions it can provide all that is required quickly, conveniently, inexpensively and accurately. There are sometimes problems with pathological investigations which are carried on outside hospitals. There is a worry that clinicians and nurses taking over near-patient testing have insufficient knowledge, and local testing is carried out without a proper strategy or policy. The hospital laboratory must surely assume an important advisory and supervisory role in this situation, and the National Health Service organisation must facilitate this.

The technological key to stick testing is dry chemistry. This typically comprises thin pads or films containing all the reagents required for performing an assay. The number of substances of clinical importance that can be measured by dry chemistry technology, in blood as well as in urine, has grown enormously and continues to do so. Tests available in stick format are biochemical, microbiological and hematological. Even allergy testing is possible with a sensitivity and specificity comparable to that of traditional methods.

The greatest fillip to the expansion of stick tests for use with blood outside the laboratory was the introduction of the Reflotron blood analysis system. This enables a variety of the most commonly requested tests, such as urea, creatinine, uric acid and cholesterol to be measured on a whole blood sample collected from a single finger prick. The tests can be performed within three minutes by a person with minimal training, yet provide an accuracy and precision comparable with that obtainable in a quality controlled laboratory. More recently, multiple tests for blood analogues have become capable of giving liver, cardiac or kidney profiles. There is no limit to the number of conditions for which stick tests can be developed. They are already used for detecting toxins in foods and water and they have important applications in veterinary medicine.

We come now to the question of cost and patient convenience. Many of the single stick tests are competitive with similar tests performed in a central laboratory and have the added advantage of timeliness and convenience. Vitally important, however, is the maintenance of analytical standards, because despite their apparent simplicity stick tests are sophisticated systems and need efficient quality control.

Is it not urgent that studies be done to find out the most convenient way of providing these facilities in large group practices and to determine their relationship with central pathology laboratories? Many can be carried out by trained practice nurses. If this proves to be true then an enormous step forward has been taken in the diagnosis of diseases and the results of an accuracy which is undoubtedly greater than that of clinical judgment.

However, do these proposals clash in any way with the basic assumption in the Government's new plan recently introduced that patients should be referred to hospital and doctors will make financial arrangements with these hospitals? The audit report suggests something else; a further development —the introduction of consortia where existing laboratories pool their resources and effectively operate as one inter-hospital service. Staff could work for the consortium and not for individual hospitals. The Audit Commission draws an interesting parallel between the growth of patient testing and the introduction of desk-top computers. In many organisations central computer departments try to limit and control the use of micro-computers in order to maintain their position. As a result, many are reduced to running the payroll while the computing services in their organisations evolve in a haphazard and uncoordinated way. Others have taken a more positive line, maintaining an advisory service helping with the purchase of equipment and software. It would seem that pathologists too should carefully note this experience and be actively discussing user needs directly with the users and advising them on cheaper and better methods.

In December 1990 the Secretary of State announced the first 56 trusts. He said: 1 believe that the scale of the response to the trust initiative shows the very real enthusiasm from those working in the National Health Service to take advantage of the benefits of trust status".

He went on to say: Over time I expect to see trust status becoming the natural model for all units providing patient care".

Will the Minister please explain what has been achieved so far and whether the Government's view remains that all units involved in patient care in the future should have trust status?

9.18 p.m.

Lord Rea

My Lords, I apologise for not having my name on the list of speakers and for intervening briefly in this manner. I am a practitioner of medicine in general practice within the National Health Service and I thought it appropriate that I should say a few words. I did not realise at first that it would be possible for me to be here tonight. I thought I would be away.

I have read the Audit Commission's report and it is quite properly very much based on the advice of the Royal College of Pathologists. The report and the college are concerned to preserve and extend quality as well as to provide good value for money. Very useful suggestions are made towards that end and some examples are given where good practice already occurs. This is particularly so when near patient testing is discussed. I should have liked the report to have discussed that a little more. I entirely agree with the line of thinking of the noble Lord, Lord Hunter of Newington, who has taken this a little further than the report. I also share his concern now that budget holding practices may be encouraged to do their own testing and so save the cost to them of purchasing the pathology service provided by the district or trust pathology laboratory.

I am particularly fortunate in that my non-budget holding group practice is able to obtain a very efficient and helpful service from the pathology department of UCH Middlesex. We have the added convenience of a twice daily pick-up service to transport samples to the laboratory and a computer link with the laboratory so that we get results as soon as they are ready. We have very few complaints, although there are occasional hiccups. I can see, however, that there are many advantages to be gained from the new methods which the noble Lord described—the stick or dry chemistry results. This will be particularly so for smaller GP units or those which are some distance away from a laboratory.

I agree with the noble Lord that if there is to be more on-site or near-patient testing it should be monitored and carefully supervised, with a continued link with the local pathology laboratory. This is particularly so as a result of the development to which the noble Lord referred of the increasingly reliable screening tests and analyses which are available on these simple dry chemistry strips.

Therefore I fully support the noble Lord's call for an organisational framework which will allow the continued link of practices with laboratories to be maintained so that standards can be kept up and the service to patients improved.

9.21 p.m.

Baroness Robson of Kiddington

My Lords, I do not know how many times in the past 18 months we have debated the National Health Service—I have lost count—but on no occasion can I remember us discussing the pathology services in the health service. We are therefore grateful to the noble Lord, Lord Hunter, for bringing to our notice the review by the Audit Commission of the pathology services.

The Audit Commission's report on pathology services makes interesting reading. It is a clear analysis of the problems facing the service, but in many ways it raises more questions than it answers. I am particularly interested in the financial aspects of the pathology services. I was therefore more than interested in reading the comments in the report. On the question of costs, the report points out that for years pathology has relied on incremental budgeting, with very small adjustments for additional activities or improved efficiency. That was also true for years for a large part of the National Health Service, but it has obviously carried on in the pathology services. As a result, any increase in efficiency leads to resources being taken away from that department.

There has also been poor financial control of budgets. Present accounting procedures are designed to control the cost of inputs such as staff, reagents, telephone calls—all the costs that go with running a pathology laboratory—but not to control the cost of activities. The problem is not improved by the allocation of resources to at least three separate budget holders: to capital, to medical pay, to non-medical pay, consumables and overheads. There may also be additional funding from universities for teaching and research and some capital equipment may be funded from research grants. This can on occasion—it says so in the report—result in staff salaried by the pathology laboratory service working in a university building on NHS work using equipment funded by research grants. That does not make for good accountancy and good control.

Secondly, pathology, in common with other branches of medicine, has also become divided into a large number of specialties, all of which, on the whole, are covered in most hospital laboratories. Moreover, productivity varies considerably between sections. Therefore, I should like to ask whether it would be possible for laboratories to become specialist laboratories, providing services for a number of hospitals on a cross-boundary basis. That should be more than possible at present as we have created within the health service the principle of provider and purchaser.

If such a system were to be introduced, it would necessitate the complete mobility of students between various units for the purpose of adequate teaching. It seems to me that there is merit in concentrating some services in certain laboratories. I say that because in many laboratories some tests are carried out so rarely that the. of expertise does not remain as high as it would be if the throughput were higher.

The noble Lords, Lord Hunter of Newington and Lord Rea, dealt at length with developments in what I am told is called—although I may be using the wrong term, as I am not a pathologist—"dry-stick testing". They mentioned the problems that this may create for the pathological services. There is no doubt in my mind that, from the patient's point of view, to be able to have a test carried out in the doctor's surgery and receive the answer in minutes—or at the most, perhaps, within an hour—is preferable to having to wait for three to five days for the results to be received from the hospital laboratory.

The noble Lord, Lord Rea, pointed out that he has a wonderful back-and-forth service with University College Hospital, Middlesex. However, that does not apply to all practices, and certainly it does not apply if you ate living in a slightly rural area. Incidentally, in such cases, near patient testing in the doctor's surgery would Jso save a lot of money in transport costs. Above all, I believe that it is in the interests of the patient to be able to obtain the result quickly.

However, the overriding problem which has to be addressed is the question of quality control and the training of staff in near patient testing. I believe that the noble Lords, Lord Rea and Lord Hunter, said that such control would have to be exercised by pathology consultants working in the community. They would also have to be consulted on the purchase of equipment and be required to give advice on its use and its maintenance.

It seems to me that the report opens the way for us to think seriously whether we should move towards an increase in the use of stick testing in the doctor's surgery and concentrate the expertise in specialist laboratories. By doing so, I believe that we would probably save money, make the patient happier and, perhaps, in the end create greater expertise.

9.28 p.m.

Lord Ennals

My Lords, I should like to thank the noble Lord, Lord Hunter of Newington, not only for introducing us to the subject but also for persuading us to read the report. Indeed, it is perfectly possible that I would not have read it if he had not tabled this Question. It is a fascinating document. It shows the changes which are taking place in modern pathology.

The report states that the pathologists and pathology laboratory services carry out a wide range of investigations. They include: the examination of cervical smears; biopsies for cancer; blood group tests and cross-matching for transfusions; the investigation of patients infected with bacteria such as listeria and salmonella; the identification of viruses such as HIV; and biochemical tests for the diagnosis of a host of different conditions.

As the report says: The service is at the heart of the development of modern scientific medicine". It also points out that the practice of pathology has become steadily more diverse and complex over the years. The range of investigations available and the number of requests for them have grown steadily. The technology available has been increasing in sophistication and cost, with significant advantages in automation, mainly in clinical chemistry and hematology, with the introduction of test kits for many investigations.

There has been a report of the steady increase in the requests for laboratory investigations. Page 16 states: The number of requests from doctors has been growing in all branches of pathology in recent years". Exhibit 6 shows that in 1987–88 and 1988–89 there was a modest fall down to the levels of 1982 and 1983. I could not understand from the report why that was so and why there had been a fall. It was not clear whether there was a different method of accounting. As I understand it, changes in the method of calculation in histopathology do not explain the fall.

There are many other interesting aspects in connection with the report that one could raise, but I must turn to the essentials of the Question asked by the noble Lord, Lord Hunter. The noble Baroness, Lady Robson, referred to the attractions of on-site or near patient testing. I understand the attraction. My reading of the report is that the arguments against GPs taking on the responsibility from the laboratories is overwhelming. In paragraph 43 on page 31 we see some of the arguments set out against the process. On quality, it says: There is a growing worry, both in the laboratory and among users, that clinicians and nurses are taking over near-patient testing with insufficient knowledge about the equipment to buy, its use and maintenance, the provision of adequate quality control, and how to interpret results". The commission considered safety, and it states: There is concern about the safety of staff working without correct training with samples which could be potentially hazardous". On economics, it says: There is concern that near-patient testing is more expensive and duplicates work being done in the laboratory". On strategy: Local testing is carried out on a piecemeal basis with no coherent strategy or policy to minimise costs and ensure quality". It continues: Near-patient testing could affect the pattern of work requested from laboratories…Near-patient testing could equally lead to increases in workload, with abnormal results being referred to the laboratory". I could not match the arguments against with the arguments in favour. I shall look with great interest at what the Minister says. As I understood it, the report did not argue the case for such a significant change, attractive though the prospect may be.

I shall now mention an anxiety about an issue raised in paragraph 7 on page 13; The NHS and Community Care Act (1990) will alter the environment within which pathology services operate in a number of important respects, making it even more necessary to ensure that the service is effectively managed. In future there will be a range of purchasers of services who will contract with providers". The district health authorities will contract for patient services for their resident populations from directly managed units and/or NHS trusts. There will also be references from GP fund holders and other agencies; for example, the private sector. But what about the GPs who are not budget holders? That was an issue that I thought my noble friend Lord Rea might have raised.

Paragraph 8 is a little confusing in that respect. It states: The Department of Health has advised that DHA contracts are not likely to specify levels for laboratory services, except in relation to direct access for GPs who are not fund holders". In practice, in recent weeks we have seen many examples of the development of a two-tier NHS as a result of the Act. I should like an assurance that this part of the report will not be another example of a two-tier service because of preference being given to the budget holders as opposed to the non-budget holders.

I thank the noble Lord for raising the issue and look forward with interest to the reply from the Minister.

9.35 p.m.

Lord Cavendish of Furness

My Lords, I too wish to thank the noble Lord, Lord Hunter of Newington, for introducing the debate and other noble Lords for taking part and for reading the document which has well informed the discussion.

I wish to begin my response by looking back at the Question of the noble Lord, Lord Hunter. He asks whether, in the light of the recommendations of the Audit Commission, we are in favour of the transfer of pathological testing from hospital laboratories to general practice. This is not, as will be appreciated, a reference to any lock, stock and barrel shift in the way pathology services are provided. But it is a recognition that there have been, and continue to be, technological developments in testing. Those developments enable some tests in some pathology specialties to be done outside the laboratory—for example, at the patient's bedside or in the general practitioner's surgery. Differing terms are used to describe this activity; for example, near patient testing or extra laboratory testing, in the sense of "outside the lab". Stick testing is one form of near patient testing. It was well described by the noble Lord, Lord Hunter, sometimes at a technical level slightly beyond my comprehension.

The noble Lord's Question refers to the Audit Commission's recommendations. We welcome the commission's report entitled The Pathology Services —A Management Review. We are in broad agreement with it, as the noble Lord has already been told by my noble friend Lady Hooper. Noble Lords will recall that the Government widened the remit of the Audit Commission to cover the NHS. It is charged with reviewing value for money provided by the health service.

Pathology was one of the first NHS areas to be studied by the commission, which took the starting point that the significant resources available to pathology—over £460 million in 1989–90—should be used to best effect. The report made constructive suggestions on the organisation, staffing and management of pathology services and on quality of service. It looked at the demand for services, and it considered the question of near patient testing. But it did not recommend a lessening of pathology workload by a shift towards testing outside the laboratory. In fact, it pointed to potential problems with near patient testing. I shall focus on three particularly: quality, safety and economics.

First of all quality: I mentioned that near patient testing was a developing area. The Audit Commission report points to the fact that at this stage users may not have enough knowledge about what equipment to buy, how to use and maintain it, how to ensure adequate quality control and how to interpret results.

Secondly, safety: some patient samples could pose a risk to those carrying out the tests, and others handling specimens. Adequate training is needed in aspects of health and safety of all staff involved in those activities.

Thirdly, economics: near patient testing may in fact be more expensive than tests carried out in the laboratory, when the total costs are considered. It may be cheaper to perform tests in large numbers, as is done in laboratories at present. Often the test needs to be repeated later in a laboratory.

Having identified problems, the report suggests ways of addressing them. It envisages that pathology departments could, by virtue of their expertise, provide centralised oversight and advice. In this way, pathology departments would be supporting near patient testing by ensuring that it was used to provide accurate and correctly interpreted results. But a key factor for our debate is that the Audit Commission acknowledges that such support for near patient testing in general practice would present considerably more problems. For near patient tests within the hospital the pathology department could identify the extent of activity, register equipment, advise on purchase and maintenance of equipment, advise on staff training in safety and interpretation of results, monitor the quality of results and identify costs to ensure that the near patient testing that is carried out is cost-effective.

To sum up so far, therefore, the Audit Commission report highlights problems relating to near patient testing and acknowledges that its recommendations for addressing those problems are difficult to apply to general practice. All those points were raised by noble Lords and especially by the noble Lord, Lord Ennals.

Noble Lords may be glad to know that this is not the end of the story however. Near patient testing in general practice is not being neglected. The Royal College of General Practitioners set up a working party last autumn. It will oversee the growing use of near patient tests and it plans to issue a series of papers advising GPs on the appropriateness of various types of tests, how quality of results can be ensured and how to act on those results. The Department of Health is also funding several projects on near patient testing, including a study by St. George's Hospital and Warwick University on the impact of new technology on investigations in general practice.

My broad statement in response to the noble Lord's question about increasing levels of testing in general practice has to be that at this stage we must sound a note of caution. Some forms of near patient testing could be candidates for providing fast results cheaply. If that were so, it could be beneficial to patients. Patients and GPs are sometimes critical of the delay between sending a sample on a patient and receiving a report. Near patient testing means that a result may be available almost immediately and this is one of the major advantages promoted by supporters of near patient testing. That was mentioned by the noble Baroness. It is hoped that with the introduction of medical audit and laboratory accreditation this problem will be addressed and it may well be that with the advent of near patient testing there will be additional encouragement to laboratories to produce results more swiftly. However, if we are thinking in terms of diagnosing a patient's illness, then the terms "fast results" and "cheaply" need closer attention.

I am advised that as current technology stands, it would not be reasonable to accept a diagnosis solely on the results of a near patient test such as a stick test. The results would need confirmation by conventional testing in the laboratory. That detracts both from speed and cost-effectiveness. I am strongly advised that there is some way to go before near patient testing equipment could be used as a reliable, safe and economical total substitute for full diagnostic testing. It is also likely to be the case, as noble Lords will appreciate, that even with advances in technology it is unlikely that near patient testing will ever be appropriate to some fields of pathology. I am thinking, for example, of histopathology, which involves the examination of tissue.

Near patient testing in general practice does, however, have a role in some circumstances. I understand that near patient testing can prove useful in monitoring the progress of disease in people whose disorder has already been diagnosed and is being treated.

The noble Lord, Lord Hunter, asked what has been achieved so far in this field under the new trusts. That is a little wide of the matter we are discussing, but I know of nothing that is inconsistent with the pathology services. I believe the noble Lord, Lord Rea, expressed anxiety about fund-holding GPs who might skimp on pathology tests. Like other GPs, fund-holding GPs are concerned to provide the best possible service for their patients. They have a responsibility to ensure that appropriate diagnostic testing is available for their patients. Regulations require that fund holders produce monthly reports on their activities which are monitored by the family health services authorities and regional health authorities. If the regional health authorities consider that activity patterns are changing without adequate clinical grounds, they are entitled to question the practice and, if necessary, remove fund-holding status.

Lord Rea

My Lords, I am sorry to intervene at this late hour and I thank the noble Lord for allowing me to make this intervention. What I said in relation to fund-holding practices was not that they would skimp on the total number of tests but that they would be likely to do more of them as a stick or near patient test and that that may have certain implications. It would be difficult for a laboratory to monitor what was going on if special arrangements were not made. That was the implication of my question and the question of the noble Lord, Lord Hunter. What arrangements would cover that point?

Lord Cavendish of Furness

My Lords, I am sorry if I misunderstood the emphasis of the question. At the moment there is no hard and fast arrangement. What I have said indicates that the situation is evolving. I am speaking against the background of a very strong note of caution on the whole subject of near patient testing.

The noble Baroness, Lady Robson, asked how testing which was done by GPs would be supervised. The Royal College of General Practitioners has set up a working party which will oversee the use of near patient tests and advise GPs on the appropriateness of various types of tests, how quality of results can be ensured and how to act on those results. Additionally, GPs could participate in quality assessment schemes and seek advice from local pathology laboratories. As in the case of all medical professionals of course, GPs are subject to the overall regulations of the General Medical Council.

The noble Baroness also asked whether it would be possible for some collaborators to become specialists and provide a service to several hospitals on a cross-boundary basis. I agree that the NHS reforms and the separation of purchaser and provider functions should make it easier for that very sensible suggestion from the Audit Commission to come about, but it may be necessary for some pathology functions to remain on each hospital site to deal with urgent "hot tests", as they are known.

The noble Lord, Lord Ennals, asked why there was an apparent fall in tests in 1987–88. As explained in the caption to the table, the measurement system for counting the number of tests changed at that time. Therefore, it is merely a technical movement.

The noble Lord asked how GPs will compare with fund holders and whether there will be a two-tier system. GPs will continue as they are at the moment and so far as I know that is proving satisfactory.

To conclude, let us now consider the current position. The Audit Commission made some constructive recommendations for the management of pathology services, but not because it saw pathology as a notable problem area. Although it acknowledged the heavy demands on pathology services, it did not point to fundamental inadequacies. Its tone was rather of strengthening what we already have.

General practitioners have direct access to pathology laboratories. Health authorities are asked to consider GPs' wishes when placing contracts for services. Technological developments in near patient testing have not yet come to full maturity. Checking those preliminary results with the pathology laboratory tends to duplicate effort and cost. Cost-effectiveness is in the interests of all patients, who are entitled to expect the highest quality of service. Near patient testing is a developing art and we should continue to be sensitive to its implications for the care of patients. Those are largely implications for the future. The noble Lord, Lord Hunter, has constructively instigated debate on the subject tonight, for which the House will be grateful.

House adjourned at eleven minutes before ten o'clock.