Examination of Witnesses (Questions 660
THURSDAY 22 NOVEMBER 2001
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
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 thesewhat can I call them?cowboys.
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
(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
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.
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
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
(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.
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
(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
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
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. CertainlyI do not know whether Dr Prudo
would agreewe 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.
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
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.