Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 660 - 679)




  660. Presumably you would be concerned about that gap in legislation.
  (Professor Lilleyman) Yes, we are. The irony is that there is regulation in veterinary laboratories but not in human laboratories.

Dr Naysmith

  661. Is that what you meant by legitimate, presumably versus illegitimate, services?
  (Professor Lilleyman) I was using the term loosely.

  662. Would that be the rogues or something else which was not legitimate?
  (Professor Lilleyman) I do not want to over-emphasise this. Most independent pathology services are perfectly legitimate in all senses of the word. I am just mentioning the fact that there have been one or two experiences where patients have been put at risk by these—what can I call them?—cowboys.

Andy Burnham

  663. Do you have concerns about private sector companies increasingly being involved in what is effectively an unregulated area? Is that a potential area of concern for the Committee?
  (Professor Lilleyman) No, it is just a loophole. I am concerned that there is still this loophole, that independent entrepreneurs without any appropriate training or qualifications can set up laboratories and there is nothing to stop them doing so.

  664. There is no concern in the specific context of the private sector in the NHS.
  (Professor Lilleyman) I do not think they would actually be bidding seriously for NHS contracts. I would hope not.


  665. Are there some requirements which would prevent the NHS dealing with a less desirable independent provider?
  (Professor Lilleyman) Not that I am aware of.

Sandra Gidley

  666. May I put the same question to Mr Spiller?
  (Mr Spiller) I would not disagree with what has been said. Our experience with Omni Labs, with Quest, with TDL is that the quality is to a high standard. The quality in NHS pathology laboratories varies from the best in the world to one which is clearly inadequate. That is much more reflected in the investment which has been put in in the past than almost any other single factor. The comment was made earlier about West Middlesex where pathologists were having to organise transport. That seemed to me to be an indication of one of the problems we have: if pathologists are organising the transport, who is doing the real work? This demonstrates the lack of management control on occasions and if many of these issues were resolved then the quality issue in some of the NHS laboratories would rapidly start to improve. It is something which needs attention, but there is no difference between the two.

  667. May I move on to a slightly different angle? You have talked about being able to streamline, you have bought the most modern equipment and one measure of the quality of pathology services is the turnaround time for tests. When you have been bidding for contracts, have you been able to give evidence that you can offer improved turnaround of tests? As the situation becomes more regionalised, which seems to be the way everybody is suggesting it might go, is there a downside to that because travel times are involved?
  (Ms Ward) From our experience, when we began the partnership with the West Middlesex Hospital, cervical cytology was an area which is a very good example. There was a very small number of staff, the turnaround time for routine cervical smears was about 16 weeks. We invested heavily in that and we now have increased the staff fourfold. We have them all trained in liquid based cytology and turnaround time has come down to about seven working days. That is one area where I would say we have had an impact on turnaround times for routine tests. I would say that turnaround time is only one measure of quality. Because everywhere has to be conscious of resources, it is wasteful to be striving to do tests ever faster if there is no real clinical need.

  668. I would agree.
  (Ms Ward) That is not a sensible use of resources. Our perspective on this is that the service has to be focused on clinical need and if a test is required within ten minutes it should be provided within ten minutes if that is going to help a doctor deal with that patient better. If it is not required for another two weeks because that is when the next appointment is, then it really is not appropriate to spend additional resources getting that through the same day.

Dr Taylor

  669. A few years ago there was a concern among laboratory staff about GPs doing more and more tests on equipment they were getting. Does that still exist? I presume GPs are doing more and more in their surgeries. Is there a method of checking the reliability of their equipment and the accuracy of results?
  (Ms Ward) There are still some GPs who would like to have more near-patient testing, but there is perhaps a bit more realism now about what it can do. Certainly for any near-patient testing we are involved in, we have to be sure there is an adequate quality control system in place, that the staff who are using the equipment are properly trained, that it is maintained properly. The cost of near-patient testing equipment is inevitably going to be higher and the testing cost is going to be higher than if it is done in a routine laboratory. That needs to be borne in mind. There is no reason why that should stop it going forward if it provides the clinical benefit. The most important thing people are beginning to realise is that near patient testing is only worth doing if it is going to change how you interact with that patient. If it makes a difference to how that patient is treated for the better, then that is a good thing. If it is just a question of saying "I'd like to have that test in front of me but I am probably going to repeat it", then there is really no valid reason.

  670. I am not arguing about the pros and cons for it, just about the reliability when it exists. How do pathologists greet this going on in general practitioners' surgeries?
  (Professor Lilleyman) We see it as an evolutionary trend which is inevitable and there are many good aspects to it. We are very close to the point now where nearly all diabetic control and all anti-coagulant control will be based in the home. The quality of inbuilt quality assurance in these kits is now approaching that sort of level of confidence. It would be important that the regional pathology service still retain ownership of the supply and scrutiny of such materials through the primary care trusts. We would not like to let go completely of the clinical responsibility for it, but we do recognise and welcome it. That is one end of something which is pulling pathology in two opposite directions, because you have near patient testing, which is increasingly sophisticated and useful, then you have these huge multiple channel analysers which can cross the traditional boundaries between haematology, chemistry, immunology. These big beige boxes have to be humming along 24 hours a day to be really cost effective. They are pulling towards centralisation and the near-patient testing is pulling towards the patient. The tension line, I am afraid to tell you this again, is right over the District Hospital.


  671. Ms Ward, you said you had got the turnaround time on cervical cytology to seven days. Professor Lilleyman, do you know what the average would be in the NHS for the turnaround time? Looking across the NHS, do you have a rough idea what it might be?
  (Professor Lilleyman) This focus on turnaround time is understandable but probably not all that useful for the debate.

  672. I understand that, I recognise that and I appreciate that, but do you know the answer to the question I asked you? If you do not, it does not matter.
  (Professor Lilleyman) It would vary from hospital to hospital.

  673. I wondered what the average might be, in order to understand what seven days means. Is that a much shorter time than what you would understand to be the average across the NHS? If you do not know, we can find out from other sources.
  (Professor Lilleyman) I want to be quite clear what you are asking me. The average turnaround time —

  674. —on cervical cytology. According to Ms Ward it is down to seven days from 16 weeks. That is quite a significant reduction.
  (Professor Lilleyman) No, sorry, I do not know the answer to your question, not without reference.

  Dr Taylor: Seven days sounds absolutely remarkably excellent to me.

  Chairman: I was very interested because it is an area which has concerned me over many years.

  Sandra Gidley: The Chairman has probably never had to wait for a cervical cytology result, but that does seem very quick to me.

  Chairman: I do have female members of my family

Sandra Gidley

  675. There are several things which are coming together today and giving me a certain concern. On the one hand we have a recognition that perhaps we are going to have to move to bigger and better mass testing areas with small labs in the hospitals to deliver what is necessary there. Completely news to me is the fact that it is an unregulated profession, which I must admit I was unaware of. The mention of cervical cytology has prompted the next link with this. In the past hospitals have been identified which have been very bad, lots of women have been recalled, there have been big problems. What does concern me is if you have an unregulated body in bigger areas. Are we likely to see a huge problem in the future? What are the mechanisms for ensuring public safety here?
  (Ms Ward) I would say that clinical pathology accreditation in the UK has been a significant step forward for laboratories both in the public and the private sector. Any reputable laboratory would sign up to that process. There are difficulties with the current accreditation expectation and that is that people are less inclined to be open about their performance than they are in maybe an organisation such as ourselves. That was for very good reasons. The original external quality assurance schemes were set up and they were there to help people to improve their performance, and there was a need for it to be kept confidential to encourage people to take part. Things have moved on since then and there needs to be greater public confidence that laboratories are performing. Certainly—I do not know whether Dr Prudo would agree—we are quite happy for our QA performance to be scrutinised because we expect people who use the service to want to be confident that they are using a service which is of very high quality. There are still pockets of resistance to that kind of performance being openly available within the Health Service and probably with good reason. In terms of public confidence, there needs to be something which is more transparent about individual laboratories' performance. That is not to say that the scheme has to be punitive or anything like that. We certainly operate a QA process in our organisation which is global, it is across the company in every country where we operate and that is there really to help; it is a developmental, a learning and an educational tool. Everyone participates in that respect.

  676. You are a reputable company and you just stressed that and the lack of regulation does concern me.
  (Ms Ward) CPA is one of the organisations which is there to ensure that laboratories operate to the right standard. It may be that needs to be applied a bit more rigorously than it is at the moment.
  (Professor Lilleyman) I do not want to give you the misunderstanding that many laboratories are unregulated. It is the laboratories which are unregulated not the individuals who work in them. The professions we have discussed today are all regulated very closely by the CPSM, or soon to be the Health Professions Council, or the General Medical Council. What I am talking about is individuals who are not professionals who set up a service for patients; that is not regulated and there is nothing to stop them doing it. That is what I was trying to say and one or two people have done this. It is not a huge problem, so I do not want to distort the discussions we are having today.

Dr Naysmith

  677. Are you saying that you have to seek accreditation as a laboratory? Are you saying that it is not a requirement?
  (Professor Lilleyman) It is not mandatory at the present time for pathology services contracted to the NHS either private or public to be accredited, although I believe that at the present time there is with Ministers a recommendation that this should be so. The profession generally would support this. There are logistic concerns about scaling up the activity, but something like 25 per cent of NHS laboratories are not in the accreditation scheme anywhere at all; they have not begun to think about it yet.

  678. As part of the accreditation do you have to have appropriate staff?
  (Professor Lilleyman) Yes.

  679. And that is part of the accreditation procedure.
  (Professor Lilleyman) Yes.
  (Dr Prudo-Chlebosz) May I bring to your attention a publication of the Department of Health in July last year called Independent Health Care National Minimum Standard Regulations and the Care Standards Act, which suggest three pillars of quality, CPA accreditation, which is under the auspices of the Royal College of Pathologists, the state registration of laboratory staff and the support of training schemes for laboratory personnel. Those are the guidelines that we should be following. Those guidelines are not met by all laboratories. There is a significant minority who do not meet those.

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