Introduction In this issue ...

• An opportunity to deliver the future of medical laboratory accreditation
• CPA Annual Conference 2005
• CPA Trust Funding

An opportunity to deliver the future
of medical laboratory accreditation

Assessor interviews will be held on 13 and 14 October 2005 with a closing date of 26 August 2005

CPA is the organisation responsible for accreditation of medical laboratories in the United Kingdom .  The Central Administrative Office is based in Sheffield . 

The Company is currently re-structuring and in the future each of our assessment visits will be co-ordinated by a full-time paid assessor.  They will work with the professional peer assessors, forming the assessment team recommending the status of a medical laboratory to CPA.   

This is a new role and provides tremendous scope for individuals interested in quality management and medical laboratory standards.  The jobholders will work from home and therefore a significant amount of travel will be included on a regular basis.  A current driving licence is essential. 

 It is expected that the Assessment Managers will have experience of medical laboratories.  The posts of Assessor may suit someone who has a medical laboratory or quality management background.  

You will have good communication skills, a high degree of 
flexibility and excellent time-management skills. 

If you think that you could fit into our team the application pack is available from:

CPA ( UK ) Ltd, 45 Rutland Park,
Sheffield , S10 2PB
Telephone: 0114 251 5800
e-mail: office@cpa-uk.co.uk

If you would like to have an informal discussion about the 
posts contact:
Mrs Cheryl Blair, Executive Manager
telephone:   0114 2515800  
e-mail: office@cpa-uk.co.uk  

Dr Ken Scott, Chief Executive
telephone:  01902 695287
e-mail: Kenneth.Scott@rwh-tr.nhs.uk        

The CPA Conference is always a popular event and this year was no exception. On Tuesday 15^th March 2005 a capacity audience of 300 delegates attended the conference held in the excellent surroundings of the Royal College of Physicians in London . As in previous years, the morning was mainly devoted to a single theme, while the afternoon was concerned with a range of issues affecting the CPA Accreditation process. 

 The morning sessions, under the chairmanship of Professor Sir Duncan Nichol, Chairman of the CPA Board of Directors, dealt mostly with topics surrounding Point of Care Testing. In the first session Dr David Burnett, Chairman of the CPA Standards, Training and Education Group, and fresh from the Caribbean , dealt with some problems of the lack of regulation of accreditation.  CPA (UK) limited and its standards are now valued internationally and form the basis of accreditation systems in other countries such as Hungary and the Caribbean .  However at present in the UK there is no effective regulation of medical laboratories and POCT. While, in theory, registration/enrolment in an accreditation scheme is now compulsory, there is no mechanism in place for enforcing that enrolment and the subsequent actual accreditation.  Dr Burnett quoted his own experience of one of the many horror stories circulating regarding POCT, of a nurse neighbour who had her cholesterol measured at a local chemist.  The cholesterol level was elevated and she was offered statins.  She sensibly went to her GP who requested thyroid function tests and she was diagnosed as being hypothyroid.  As with other industries and situations it may be that effective regulation will not be introduced until (another) pathology disaster occurs. 

 Neil Porter and Dr John Wood, both members of the CPA Standards, Training and Education Group, did a dual presentation presenting a wide-ranging overview for anyone wanting to set up a properly managed POCT scheme.  Beginning with some near-patient testing figures taken from a survey in the Northern General Hospital at Sheffield, they went on to cover the standards, legislation, management, procedures, training, equipment and audit of a POCT scheme.  When done properly it is a large-scale project, but ensures that the patient receives a quality service while the laboratory is seen to be not just “defending its own patch”.  Questions at the end of this session covered such topics as the re-certification of staff using POCT equipment, what to do if your Trust decides (without laboratory help) to move tests out to their local pharmacies, and when does a piece of equipment cease to be a laboratory managed device.

Dr Jane Beaumont, Director of Accreditation at UKAS, spoke on the developing partnership between UKAS and CPA. Moves towards this partnership started as long ago as 1998, culminating so far in a joint agreement signed by both parties last year. CPA and UKAS are both active on the European cooperation for Accreditation (EA) Committee on Healthcare, and the CPA/UKAS partnership will be included in the EA multilateral agreement (MLA), due to be signed in 2008. The MLA means that CPA will be officially recognised in other EU countries. Working arrangements between CPA and UKAS are developing and plans are in hand for the first joint CPA/UKAS laboratory assessment. 

Control of POCT kits was covered by Dr Susanne Ludgate, Clinical Director (Devices) at the MHRA, our “local friendly Regulatory Authority”. The MHRA covers a total of some 80,000 devices on the UK market, bought with a capital cost of about £10 billion annually. Devices evaluated recently by the MHRA include blood glucose monitors, coagulation monitors, helicobacter tests and cholesterol tests. Dr Ludgate pointed out that CE marking under the In Vitro Diagnostic Medical Devices Directive merely demonstrates compliance with essential requirements of safety and performance. The regulations were not brought in for public health protection, but to enable suppliers to supply on a level playing field. They are not very good at regulating POCT and do not cover such issues as clinical usefulness, specificity or sensitivity. She encouraged all laboratories to make active use of the adverse incident reporting system run by the MHRA. Manufacturers and suppliers have many reasons for not reporting adverse events and therefore feedback from users is important, even for trivial incidents. In 2003 the MHRA received a total of 8,795 reports resulting in 46 device alerts and 958 manufacturer improvements.

In previous years, at other venues, lunchtime at the CPA conference has proved to be somewhat of a lottery, but the College of Physicians is to be congratulated on the quality of its service. A friendly Rotweiller directed delegates to one of six serving points and courteous efficient staff pro-actively assisted us.

After lunch Professor Sir John Lilleyman, Medical Director of the National Patient Safety Agency (NPSA), treated us to an entertaining but serious lecture on what could possibly go wrong in NHS healthcare. Can we ensure that we have “right patient – right lab tests”? Some sort of error arises during 10% of hospital admissions in the UK, ranging from the trivial to the fatal. As Medical Director of the NPSA he is well equipped to enquire whether we are absentmindedly

doing the wrong thing, carefully doing the wrong thing, or deliberately doing the wrong thing? Most of us have fumed at the hassle caused by system errors, basic design faults, safety problems, standardisation problems and misidentification errors. Over the years technology has reduced many sources of error, but managers will always have a responsibility to create an open and fair culture in which good teaching and training creates a safety-conscious organisation.

Blood Transfusion Centres and hospital blood banks will be affected this year by the implementation of the European Blood Directives, covering blood safety and quality. The implementation of the directives was covered by Mr Tom Kelly from the Department of Health who has just come to the end of a one-year secondment from the National Blood Authority. The directives cover the whole process from blood collection to blood transfusion – from “vein to vein”. There will eventually be three linked directives, two of which are already transposed into UK law. The directives identify two functional entities, blood transfusion centres and hospital blood banks. The regulations came into force on the 8th February 2005, but the UK government has agreed to defer implementation of them for nine months until the 8th November 2005. The biggest impact of the regulations may well be on hospital blood banks, who do not have to be licensed, but do have to satisfy requirements on traceability, reporting adverse incidents, quality systems and reporting compliance to the “competent authority” (which may inspect the blood bank if it so chooses). An NHS Operational Impact Group will shortly make recommendations to help hospitals address the impact of the directive and assess the resource implications of the changes – form an orderly queue. 

The final sessions of the day were addressed as usual to all things CPA. Dr Ken Scott, CPA Chief Executive, addressed the implications of mandatory enrolment in accreditation schemes. From an initial stance of mandatory “accreditation” the government moved to mandatory “enrolment… as soon as practicably possible”. CPA would have found it helpful to be advised of this decision before it was announced on the Hansard website. Dr Scott presented data from the six years since 1998. In contrast to the government’s stated aims, with the exception of Biochemistry the three other main pathology disciplines all had less departments with full accreditation in 2004 than they did in 1998 (both in absolute numbers and as percentages). The total number of departments in the accreditation system has risen from 945 in 1998 to 1,145 in 2004, with perhaps another 200 laboratories out there who have never been

in the accreditation system at all. At present if a laboratory fails to enrol there is no penalty, perhaps illustrating the deficiencies in regulation highlighted by Dr David Burnett earlier in the day. Mandatory enrolment may highlight, but will not solve the problems of pathology in the UK.

Mrs Cheryl Blair, CPA Executive Manager, presented the final session of the day on the financial implications of developments within CPA and in medical laboratories over the last five to ten years. Again it may have come as a surprise to many delegates to learn that CPA made a financial loss in the last two years. Demand for assessment visits has increased while income has decreased due to a number of factors mainly the formation of merged Trusts and networks. The requirement for mandatory enrolment in an accreditation programme will also increase the demands on the service, 44 new laboratories had applied to be enrolled in the six weeks prior to the CPA conference. Expenditure had increased due to the introduction of the new standards and the requirement for all assessors to be retrained. CPA’s income is also erratic, being governed by the registration date of each laboratory. In the six days between Christmas and New Year 2003, prior to the introduction of the new standards, CPA received 120 new applications. There is a serious shortfall in assessor time due to retirement, “expert fatigue”, shortage of staff and new consultant contracts. For example, in 1997 there were 57 trained consultant haematology assessors; in 2004 there were only 12. Due to these issues there is a necessity for change and CPA are now implementing a proposal to appoint a cohort of full time paid assessors. One of CPA’s major strengths has been its basis of peer evaluation and this will be retained, but supplemented by full time paid assessors.

CPA are this year introducing a new financial payment system of an annualised fee, to include the registration fee and the visit fee. The fee has been increased to cover the costs of providing the new service and all laboratories will have received invoices for this fee during the month of April. The future turnover for CPA is estimated at £3 million per annum, 0.001% of the total UK annual pathology budget. CPA has come a long way since its inception and it is to be hoped that these new financial arrangements will give it a firm financial footing as it develops its UKAS partnership and improves on its already high credibility within the European Union. It was pleasing to see that there appeared to be a large measure of support for these developments from the audience. 

Ray Russell
CPA Professional Advisory Committee member

The CPA Trust, a registered charity, was set up in 2004 to support the development of improvements in the quality of medical laboratory services. Up till now this support has taken the form of funding EQA pilot schemes. However, the Trustees have been considering other possible avenues for promoting quality in medical laboratories.

With this in mind the Trustees have decided to extend the funding to other projects or supporting bursaries to individuals working in

IMPORTANT NOTICE
Annual Registration and Visit Dates

It is our aim to ensure an evenly distributed workload pattern for our assessment teams over each four-year cycle. In order to achieve this it will be necessary to adjust the registration and visit dates of some laboratories. We will cause as little disruption to your current schedule as possible.

By the end of July every laboratory enrolled with CPA will have received notification of their planned 

DIARY DATES

Assessor and Applicant Updates
One day Seminars 2005

This is a reminder to all CPA assessors and applicants about the Update sessions.  We aim to provide up-to-date information to our assessors and at the same time provide the opportunity to applicants to assist you with your own preparations for assessment.  The sessions are free to assessors and a registration fee of £75 to applicants.

The programme will include:
·           News from CPA
·           Assessor findings to date
·           Writing reports
·           QMS and continual improvement
·           Annual Management Review
·           Update from CPA Professional Advisory
            Committee

Venues and dates are as follows:

Please contact CPA Office to secure your place.

Assessor Training Courses 
Week commencing 6 February 2006 - Birmingham

 During the week commencing 6 February 2006 we shall be running the training courses for both full time and peer assessors.  Further details have not been finalised so if you are waiting to be trained please note the proposed date.

CPA Annual Conference 2006
Tuesday 14 March 2006 – The Royal Society of Medicine, London

Christmas / New Year - 2005 / 2006

CPA Central Office will be closed from Monday 26 December 2005 to Monday 2 January 2006 inclusive