To ask the Scottish Executive what is the membership of the reference laboratories working group.
The membership of the Reference Laboratories Working Group is as follows:
Chairman:
Dr B Watt Director
Scottish Mycobacteria Reference Laboratory
City Hospital, Edinburgh
Members:
Dr S Ahmed Consulant in Public Health Medicine
Greater Glasgow Health Board
Dr P Christie Consultant in Public Health Medicine
Scottish Centre for Infection and Environmental Health,
Glasgow
Dr A S Hutchison Clinical Director for Laboratory Medicine
Department of Biochemistry
Southern General Hospital, Glasgow
Dr D C Old Reader in Medical Microbiology
Ninewells Hospital, Dundee
Professor W J Reilly Deputy Director
Scottish Centre for Infection and Environmental Health
Glasgow
There are currently 2 vacancies on the Working Group, one for a histopathologist, the other for a Health Board General Manager. The Working Group is presently considering whether, with the abolition of the internal market in health care, it continues to need General Manager input.
The Working Group supplements its expertise as necessary with the support and advice of outside assessors from the Public Health Laboratory Service, Colindale, and others.
E.coli O157 service
The earliest occasion it has proved possible to document so far on which concerns about quality in the E.coli O157 reference laboratory were formally drawn to the attention of the reference laboratory at Grampian University Hospitals NHS Trust (then known as Aberdeen Royal Hospitals NHS Trust) was in September 1994.
Concerns about delays in response times first emerged in August 1993. Since then, repeated attempts have been made by National Services Division, the Reference Laboratories Working Group and the Department to resolve this and other concerns. This process culminated in an extraordinary meeting of the Working Group on 22 October 1998, after which it wrote to specify the areas in which improvements were seen to be imperative. These related to management issues, scientific concerns about the methodology used and the communication of results, as well as response times. The Chief Medical Officer decided that the gravity of the public health interest required that these concerns be aired at a formal meeting with the Head of the Reference Laboratories. That took place on 9 December 1998 and once again the concerns were spelled out, as was the urgent need for improvement.
The current specification for the E.coli O157 service provided by the Aberdeen Reference Laboratory is contained in the Service Level Agreement, which was most recently reviewed in 1998 by the National Services Division of the Common Services Agency on the advice of the Reference Laboratories Working Group.
A meeting took place on 26 February between National Services Division and the Aberdeen Royal Hospitals NHS Trust at which progress in responding to the concerns raised at the 9 December 1998 meeting was discussed. NSD also issued reminders during the year about the outstanding annual report. When it eventually saw the annual report, the Working Group took the view that its long-standing concerns had not been addressed, and recommended to the Scottish Executive that the service had to be put out to tender in order to safeguard this important area of public health in Scotland. The formal letter setting out the Scottish Executive's decision on the future of the E.coli O157 service, based on the Working Group's recommendation, was sent to the Trust on 1 September. There have also been exchanges of correspondence between the Trust and National Services Division since then about different aspects of the service.
Given this chronology of concern, it was not considered necessary to seek specific clarification of the 7 reasons given in the 1998-99 annual report for E.coli O157 response times. Previous annual reports from the reference laboratory have cited the same 7 reasons for exceeding response times.
The annual report was due by 31 May of this year, but was submitted 2 months late and the meeting of the Reference Laboratory Working Group on 12 August 1999 was the first opportunity for detailed consideration of its contents. As the problems which led to the Group's recommendation not to renew the Aberdeen agreement were of long standing and had been discussed and explored previously, the Group considered that a further delay to seek clarification would achieve little. If 6 months' notice had not been given, the Agreement with Aberdeen would have continued for another year, as would the potential risk to Public Health.
The target turnaround time in 1999-2000 is 95% of results reported within 8 working days, based on an anticipated annual activity level of 1250 isolates. According to information supplied by Grampian University Hospitals NHS Trust on 15 September 1999, 98% of the 210 samples processed between 1 April 1999 and 14 September 1999 were turned around within the required time. The period in question, however, falls after the period covered in the most recent annual report from the laboratory, on which the Reference Laboratory Working Group based its recommendation.
Invitations to express formal interest in providing an E.coli O157 reference laboratory service were sent to all microbiology laboratories in Scotland on 3 September. The letter set out 3 points to be addressed, along with information on the required entry criteria and a clear statement of the procedure for handling the tendering exercise.
Expressions of interest in the form requested have been received from:
- Grampian University Hospitals NHS Trust;
- Stobhill Hospital, North Glasgow University Hospitals NHS Trust;
- Western General Hospital, Lothian University Hospitals NHS Trust ; and
- Royal Alexandra Hospital, Argyll & Clyde Acute Hospitals NHS Trust
The Reference Laboratories Working Group decided that each of these organisations had addressed the points in the letter of 3 September sufficiently satisfactorily and that they should therefore be sent a copy of the Specification for the service and invited to tender for it.
In view of the importance of this service, the Working Group is determined to ensure that all applicants are treated identically.
In assessing tenders, the Scottish Executive is satisfied that it can rely on the advice of the Reference Laboratories Working Group, as an independent, expert multidisciplinary Group comprising professional and scientific staff. That advice will be peer-reviewed by External Assessors from outwith Scotland, in accordance with the Working Group's own standard procedures.
Campylobacter
There is general agreement amongst the Public Health Community on both sides of the border that the data generated by current campylobacter typing methods are of little clinical or public health value. The Working Group is also aware that that view is endorsed by the the recent evaluation of typing of campylobacter led by the Public Health Laboratory Service Wales.
It had already been endorsed by the Public Health community in Scotland, whose views were sought as part of the Reference Laboratories Working Group's 1998 user survey.
Given the overwhelming professional consensus in this area, the Working Group took the view that nothing would have been gained by consulting the Advisory Committee on the Microbiological Safety of Food.
The report of the UK collaborative group on campylobacter sub-typing has not been published.
As is common practice, responses to the 1998 user survey were invited on a confidential basis, and in order to preserve anonymity the results of the user survey have not placed in the public domain. Were the report to be published, it would be necessary to seek permission from all those who replied.
If a more discriminatory typing scheme for campylobacter can be devised, that is one which yields information of value in public health terms, the Reference Laboratories Working Group would of course consider drawing up a specification for a campylobacter reference service and inviting tenders.
The Aberdeen reference laboratory was asked to use 2 techniques for campylobacter serotyping in parallel: the Penner technique and the modified Penner technique. The aim was to try to determine if one was more effective than the other. The laboratory has so far produced parallel results but has made no comparisons between them in terms of effectiveness. There is therefore still insufficient evidence to reach a determination on the relative usefulness of the modified Penner technique.
GeneralThe representations so far received about the decisions on both services have come from MSPs, MPs, the MSF union and Grampian University Hospitals NHS Trust. To date, 2 other expressions of support for the E.coli O157 reference service have been sent to the Scottish Executive.