In this issue ...

· Changes in Chairmanship of Advisory 
   Committees
· CPA Annual Conference 2002
· Job advertisement

As of 1 April 2002 the following changes apply:

Clinical Biochemistry SAC 
Chairman: Mr Martin Nicholson

Immunology SAC 
Chairman: Dr Gavin Spickett

We wish to thank the outgoing Chairmen, Dr Ceridwen Dawkins and Dr Tim Wallington, for all their support over their term of office.

Tim Wallington has been Chairman of the Immunology Specialist Advisory Committee for six years and we shall miss him. However, he has agreed to continue to support CPA via on-going assistance with standards revision and inspector training.

The news on arrival at the railway station was that “the train was in reverse formation”!  Hoping that this did not mean I would end up even further away from London I boarded with some trepidation.  The gamble having paid off, we were later comfortably ensconced for the morning session entitled “The Politics of Pathology”.  Professor Sir Duncan Nichol was unavoidably absent so Mansel Haeney rose to the occasion and admirably chaired the morning speakers.  Sir Liam Donaldson, Chief Medical Officer, began by saying that he was not a specialist but very interested in our work.  He gave an overview of the NHS and clinical risk management.  He delineated some of the pressures on the health service. Finances and emergency care are overstretched at a time whenever higher quality is expected and there is a huge change in demographics with more people living longer.  There has to be a balance between centralization of the health service and views of consumers, who want immediate local access.  He talked through the media portrayal of health services – the media tend to concentrate on the lower quality providers, failures being portrayed as a tip of an iceberg with a lot of poor quality below.  This image is wrong - the variation of quality follows a gaussian curve from lower quality through to exemplas.

 When things do go wrong, research shows that it is rarely an individual solely at fault.  Many of the problems are in the culture and organisation. Weak leadership, little collaboration, poor communication within the organisation, the absence of coherent strategy and lack of involvement with education and research are some of the relevant issues.  He stated an example of an accident when IV drugs were given intrathecally – one of the recent cases was looked into by an accident investigator without a health service background.  About 40 system failures were identified.  If any of the failures had not happened there was the possibility that death would have been averted.  Humans make mistakes because the systems, tasks and processes they work in are poorly designed.  In the UK it is thought that about 10% of inpatient episodes lead

to unintended harm.  Sometimes these events can be devastating.  The health service needs successive layers of defences, barriers and safeguards to avoid failures.  We therefore need information on near misses and no-injury accidents.  This information must be shared within the wider organisation so that lessons are learned and future potentially adverse events prevented.  He finished up by saying that “to be human is to err, to cover-up is wrong, but to fail to learn is unforgivable”. 

 In the following question and answer session, confidentiality in EQA schemes was raised – would the question of confidentiality become extinct?  He thought we should not view it in this way.  Patients’ safety reports would be anonymous.  Confidentiality was still an important overriding principle to which to adhere.

 Dr David Colin-Thomé, National Clinical Director of Primary Care, then spoke about Primary Care – the future.  He thought that in the future the NHS would offer more choice to patients.  This might involve patients dealing with general practitioners, dentists, pharmacists, community nurses, optometrists, etc.  All of these health service staff may wish to access pathology services directly.  The stated aim of Primary Care Trusts is to improve the health of the nation and decrease inequalities.  They will also be involved in commissioning, i.e. re-designing hospital services.  By 2004 they will hold 75% of the NHS budget, (100% of the local budget).  They are therefore very important players in the future planning of health services.  Their relationship with the Strategic Regional Health Authorities will also be influential.  The new contract for GPs, PMS (personal medical services), has strong focus with regard to quality. 

 Dr Colin-Thomé thought that interactive television with people at home may well impact on pathology services in the future.  Patients may even wish to have their pathology results downloaded directly to them.  They would be able to book appointments, nurse consultations,

etc. directly.  He felt that traditional general practice will continue but that there will be an increasing need for investigation of patients and that long-term chronic disease management will happen much more in primary care that it now does. 

 Education will be very important to ensure an appropriate use of pathology services.  In the future the health and assessment of an individual will be much more focused around that person, even where there are multiple pathologies.  There are dangers with medical interventions and so they should only be used when really necessary.  There must be equity of access to health systems.  There will gradually be more merging of secondary care into primary care with consultants working out in the community.  Outpatient departments will be used more selectively and the use of diagnostic and treatment centres increased.  The health service will develop more of a team approach. The four National Service Frameworks that have already been published are good examples of how multi professional staff are involved in patient care.  In the future there will be an increasing emphasis on challenging all the money spent on health care.  Direct hospital care will have to compete with improvements to social support, diet, transport, reducing addiction, reducing social exclusion and  other wider issues.

 One questioner asked, “Was there a risk that Primary Care Trusts could go off at individual tangents?”  The answer to this was “Yes”.  Strategic Health Authorities will be very important in making sure Primary Care Trusts stay “on track” and there may well be a lead Primary Care Trust within a locality with primary care networks.  He thought there should be maximum use of all health care providers, whether they are in the public sector, private or voluntary, but quality must be managed across the network.  The main message I derived from this talk was the need to cultivate contacts with local Primary Care Trusts.

The third and final talk of the morning was from Ms Ann Stephenson, Branch Head, Policy-Hospital, Department of Health, who gave a talk entitled “Universal Accreditation”.

However, the content was Pathology Modernisation.  She emphasised that the government’s vision of the NHS was a service designed around and for the patient.  The wish was for radical reform, not just change in the structure but also change in behaviour with genuine shifts in ways of working.  She felt the diagnostic services were a key area within modernisation, an accurate diagnosis being vital if patients are to receive high quality effective treatment and care.  Regarding pathology, she particularly mentioned the challenge of new technologies, working closely with clinical colleagues, the ongoing increase in workload, and reiterated the point made by the previous speaker regarding the drive towards primary care.  She also mentioned staff shortages and pointed out that pathology has an ageing workforce itself (reflecting the increase in average age of the general population).  The average increase in workload is about 8% per year, increasing GP usage a major percentage. 

 The first 3 years of Pathology Modernisation had concentrated on capital investments, £28 million being spent on 39 projects, mostly large scale reconfiguration, new management systems using IT and/or automation, or rationalising specialist services.  She thought that the initiative had ensured that local managers realised the importance in investing in pathology services. 

 The Department of Health is developing Pathology Modernisation Guidance.  The aim is to give practical advice, not dictate models of service delivery.  It will address such issues as meeting clinical needs of users, creating an evidence-based service, equitable and timely access, contribution to improving patient health outcomes, research and development, managed pathology networks, commissioning arrangements, system re-design, demand management, informatics, standardisation, specialist services and workforce issues.  The pathology workforce is a major resource.  It is going to be increasingly important in the future that we work in teams, have good career pathways, are committed to education, continue professional development and have family friendly, flexible ways of working. 

 CPA is valued by the Department of Health and she supported the concept of having quality managers in laboratories.

circumspect way, saying that the possibility cannot be excluded and that there will be formalisation of QA processes with clearer expectations.  She would not be further drawn.

After an excellent lunch we convened in discipline specific groups to hear reports from pilot inspection visits using the new CPA standards.  This report is from the Clinical Biochemistry /Immunology group.  There were also groups for Microbiology/Virology, Haematology/Blood Transfusion, and Histopathology/Cytology. 

Dr Tim Wallington chaired the Clinical Biochemistry/Immunology session.  John Wood from Southampton gave his perspective from the CPA standards revision group.  He emphasised that the changes made were not just for the sake of change.  Changes were only being made that would be beneficial to CPA applicants. The partnership with UKAS is strengthening.  Six pilot sites had been visited at Dundee, Preston PHLS, Wrexham, Walsall Manor, Quest Diagnostics and Sheffield.  These covered a range of sizes and configuration of laboratories including the private sector.  Results were confidential but the visits would be discussed in broad terms.  One of the main differences with the new inspection against the old is that the inspectors report any non-conformances as they go along.  Several new reporting formats have been designed that cover vertical audit, horizontal audit, examination audit and non-conformance reports.  The vertical audit retrospectively follows a specimen through the laboratory from request through analysis to report and has been well received by the pilot sites.  However, it was now suggested that the vertical audit was done on day one and that day two of the visit should concentrate on horizontal audit and witness audit.  Horizontal audit looks at documentation and practice across an organisation, e.g. appraisal for staff.  Witness or examination audit watches a member of staff performing an analysis. 

All non-conformances should be signed-off at the end of the inspection by both the inspectors and a laboratory representative. A non-conformance needs to clearly identify the standard that is breached.  When the laboratory corrects the non-conformance they will let CPA know.  If the situation has become satisfactory, the condition will then be removed. 

So far, users had been positive about the process with the new standards.  Inspectors had found it rather difficult.  The role of the supernumerary team leader needed further clarification. 

There also needs to be further discussion about the potential of visiting single disciplines.  CPA would welcome feedback on their suggested timetable for inspections. 

Future training for inspectors was being planned in October – December 2002.  Initially this would be one-day training in addition to the inspector updates already held.  Eight venues would be involved and there would be discussion on interpretation of standards, evidence of compliance with standards and quality management systems.  In February 2003 there would be further training of one-and-a half days for 25 inspector groups with intensive skills training.  He finished his talk by pointing out that the inspectors at one pilot site were housed in the psychiatric unit.  Comment was unnecessary!

Mr B Perry from Liverpool, Mr H Ferguson and Dr P Dore from Hull, put forward their views as inspectors.  They agreed that the inspectors found the process harder than did the laboratory being inspected.  There were 44 old standards.  There are now 48, with 117 clauses, 339 sub-clauses.  If you spend one minute per clause, this equates to 5 hours 39 minutes.  Prior to the visit, inspecting the laboratory application form and quality manual is vital.  A description of the document control system is helpful and a catalogue of the laboratory policies and procedures useful.  Once the new standards had been in use for a number of years, previous annual reports from the laboratory would be read prior to the visit.  A mechanism of assessing user opinions prior to the visit would also help the preparations. 

The time involved for an inspection should be independent of size but the number of sites does have a significant impact.  The audits are random using the tools provided by CPA.  A horizontal audit would take about four hours, vertical audit about three, and examination audit about one hour each.  From talking to other people at the meeting it would seem the time involved in these audits will vary between the disciplines.  The first vertical audit would be very intensive but the second and third, if there was time, would be quicker.  The audit would pick up individual non-conformances and these would need further investigation to assess the degree of penetrance within the department.  The examination audit was effective but could be viewed as being intrusive and threatening for the individual involved, who could sometimes be fairly junior.  The SOPs in practice were often not sufficiently detailed to be followed by the assessor. 

The closing meeting should be common across the disciplines for

general thanks and farewells.  The discussion of the non-conformance reports should be discipline specific.

 Assessor re-training for the standards would have to facilitate familiarity with standards, how to use the tools provided, understanding assessor responsibilities, perhaps provide examples for completed audits and theoretical scenarios.  They also raised the issue of inspector competency assessment.  This is going to be important, but how?  The new standards were significantly less subjective than the old and there was a much clearer understanding of the outcome. 

 Dr Callum Fraser and Professor Mike Kerr from Dundee then spoke from the perspective of an inspected laboratory.  Dundee had applied as pilot laboratory, they have four sites, three laboratories at different points in the accreditation cycle.  The management had felt that this would be an excellent opportunity for improving quality within the laboratories with wide staff involvement.  They had “eaten, slept and drunk” the new standards for six months prior to their inspection so they were very well prepared.  In summing up the laboratory preparation they emphasised the importance of all staff keeping strictly to the timescales laid down by a group such as the Laboratory Quality Steering Group.  In Dundee they have based their quality manual on the CPA template and found it extremely useful.  Quality managers shared many ideas, approaches and documentation across the disciplines.  They described all laboratory processes as SOPs.  They had found a laptop useful to keep an electronic record of policies and procedures, this facilitated updating.  It was not as easy to lay out the paperwork according to the new standards as the old.  Having a room very close to the laboratory was important and it might

have been useful to have someone there from personnel, IT or other interactive department.  Documentation was categorised as policymaking, policy, procedure, or audit, i.e.  how we improve it, what we do, how we do it, does it work?  They found the use of the non-conformance forms easy and agreement was straightforward in their particular situation.  Having copies left behind was helpful.  One problem highlighted was the lack of universal knowledge about the new standards and the philosophy of the new approach.  Within a pathology department all staff need to be aware of quality and how policies and procedures apply in practice to aspects of their work.  He also brought up a query about standard E6 - referral laboratories.  Should they have to provide information repeatedly for each referring laboratory as they are inspected or could CPA keep a central record? 

Both the speakers emphasised that with wide staff involvement they had discovered some hidden talents within their workforce and they were very positive about the process.

We then had a panel discussion.  Several points were raised, many as yet without answers.  It was agreed that there must be more clarity or unification about titles, for example, do we refer to people as inspectors, assessors or auditors and do we use the term non-compliance or non-conformance?  If departmental audit is of a high standard, inspection could be much easier in the future.  How do we assess assessor/inspector competency?  In the future there will almost certainly be clearer, timetabled inspections so facilitating planning.  There was some discussion about the post of quality manager –this will vary depending on the size of the laboratory but it was felt that the person must be sufficiently senior that they can independently report to

higher management levels within the organisation.  Trusts are also setting up their own quality systems into which Pathology will need to feed.  The whole process needs resource and enthusiasm.  Teamwork is very important.  Documents may be produced at a high level but their content must be delivered by everyone –“One must buy into it because you want it”.  There was some discussion of a professional CPA inspector or team leader role.  A lead assessor is important as a point of reference.  It is always going to be important that inspectors have a firm basis in the laboratory so that they can link into laboratory ethos.  It was pointed out that the number of non-conformances is irrelevant – it is the degree of non-conformance that is important.  In the future, CPA or a similar form of accreditation could well become mandatory. This may facilitate the process and enhance the satisfaction to be gained within the organisation.  The training process will be open to applicant laboratories’ staff as well as potential inspectors.

At the end of the afternoon the Chairman summed up that we had all been given much food for thought in a very interesting afternoon.  The new standards are seen as a significant improvement although their detail, application and assessment will evolve.

 This was a good day.  CPA meetings always have a certain buzz about them and the 2002 annual conference was no exception. 

 As a point of interest, the meeting was held in the Commonwealth Institute at the same time as the Company Clothing Conference.  One wonders whether CPA will move into this area.  Will there be a Company tie or headscarf?!

Ceridwen Dawkins
Consultant Chemical Pathologist
North Bristol Trust

CPA (UK) Ltd
Administrative Assistant
Salary £23010 - £26918 (Grade 7)

This is the first time we have been able to advertise nationally within our own newsletter for a new member of staff. We currently have a vacancy in Central Office for a senior administrative assistant. This is an excellent opportunity for an individual working within laboratory medicine interested in a change of career. 

If this post interests you please contact Cheryl Blair at CPA Central Office for further information.

Pilot Scheme Funding
The Board has accepted the EQA Committee’s recommendations that the following Pilot Schemes should be supported in the fifth year of pilot funding (2002/3).

· UKNEQAS for Quantitative Toxicology in Blood
(Dr J Wilson, Cardiff)

· UKNEQAS for Interpretative Comments in Clinical Biochemistry
(Dr G Challand, Reading)

· Cl Esterase Inhibitor and Functional Complement Assays
(Dr A Milford Ward, Sheffield)

· Serum Thyroglobulin/Thyroid Cancer
(Dr P Perros, Newcastle and Mr F Mackenzie, Birmingham)

Three other applications were received which the CPA(EQA) Committee were unable to support.

The Accreditation Process
Concern has been expressed by some EQA providers and EQA Committee members about certain aspects of the accreditation process particularly the time the whole process takes, the size

of the inspection teams and the time spent on site. The EQA Committee has considered these problems and has agreed to changes in two areas.

A flow diagram has been prepared to clarify who is responsible for what parts of the whole process and timescales have been incorporated into this document both to speed up the process and to provide a basis for audit.

It has also been agreed that the requirement for an inspection visit every two years will be discussed at the time of submission of an application to the CPA(EQA) Committee. Where the paperwork is satisfactory and the panel and participants are still satisfied with the quality of the EQA provision then a full inspection on the two year cycle may not be necessary. However, all EQA Schemes will have a full inspection visit every four years.

EQA Standard Revision
Following the development of the new Standards for Laboratory accreditation the CPA Board agreed that a revision of the Standards for EQA Scheme accreditation would be 

appropriate.  A CPA(EQA) Standards Revision Group has been established, led by Dr Stephen Jeffcoate and including Dr David Burnett and several members of the CPA(EQA) Committee.  At the time of writing a second draft of the new Standards is under consideration by the group members.  It is planned to circulate a draft of the new Standards for consultation with CPA Shareholding bodies, EQA providers and the Department of Health in the near future with a view to taking an updated version of the new Standards to the CPA Board at its next meeting in June.

EQA Providers/Participants Meeting The next meeting will be held in the afternoon of 30 October at the Royal College of Pathologists in London and the main item will be an introduction to the new Standards although other items it is hoped to cover include reports on Pilot schemes and the developing partnership between CPA and UKAS.  Further details will be announced in the near future.

Problems encountered
· The preparation and dispatch of slides took at least three hours
· Data entry and analysis also took at least three hours
· It was difficult to obtain sufficient slides and of a wide range of cases. No bone marrow aspirates had been obtained for distribution.
· E-mailed digital images and CD-Rom distribution had limited success. Most participants preferred to have glass slides.
· Return of responses was a problem with an increasing number of late replies during the course of the scheme.

Complaints
These were generally few and minor.

Developments
· There is sufficient confidence in the Panel scoring scheme to drop the Furness system.
· Some bone marrow aspirates have now been obtained and will be distributed.
· Patient consent will be formalised.
· The possibility of providing material on CDRoms is still being explored.
· Using the EQA data for educational purposes through the web is being developed.
· Scoring could also be achieved using a web site and is being explored.
· So far the material has been confined to blood morphology but extending it to other areas of data interpretation and clinical advice is also being examined.

For more information about this scheme contact Dr J A Copplestone, DCL-Haematology, Derriford Hospital, Level 7, Plymouth, PL6 8DH to whom we are very grateful for the report.

Mike Wheeler
CPA(EQA) Committee

Hopefully today, those who run External Quality Assessment Schemes (EQAS) have persuaded both their heads of departments or pathology directors and their hospital managers the important role EQA plays in Clinical Governance and therefore the importance of their activities.  Most Schemes arose out of the enthusiasm of a single individual.  This activity was not formally part of their job description and it is unlikely that hospital managers were aware that such an activity was occurring in their organisation.  No formal arrangements for financial support, protection of income, adequate accommodation or additional staff existed, as required by standards EQA 1C, GL1, GL2A AND GL2C.  The first inspections of EQAS centres found that none had any written contract set up with their Trust or host organisation although there was verbal support from both Chief Executives and Heads of Department.   

So that appropriate documentation could be put in place, this standard was initially treated flexibly, but no longer.  This standard provides some security to the scheme organiser, the staff and the continued operation of the scheme.
The areas of staffing and accommodation included in standard EQA 1C are adequately covered within standards GL1 and GL2 but no other standard covers the financial security of the scheme.  It has taken some skilled negotiation by some organisers to arrange for the income from the scheme to be carried over into the next financial year; a procedure alien to most finance managers.  As managers have become aware of the importance of EQAS formal contracts are more easily arranged. 

 Is standard EQA1C now redundant?  I would argue that it is not.  CPA is not only concerned about the quality of EQAS operation but also the continued existence of EQAS.  

DIARY DATES


CPA(EQA) Providers/Participants Meeting 
Wednesday 30 October 2002 – Royal College of Pathologists, London

Inspector Re-training
We are organising the first courses for inspector re-training against the new standards. These are scheduled for October to December 2002. Once we have accommodated all our inspectors, the remaining available dates will then be advertised for other interested parties.