Introduction In this issue ...

· The CPA & UKAS Partnership
· CPA Annual Conference
· CPA New Standards
· Changes to CPA Organisational Structure
· CPA Haematology SAC
· CPA Clinical Biochemistry SAC
· CPA Genetics SAC
· Structure and Function of the Professional Advisory Committee

The partnership is the culmination of discussions, which started with a joint statement of intent in 1998 to co-operate in areas of mutual interest and benefit. It is the recently introduced international standards for laboratory accreditation [ISO 17025 & ISO 15189] however, that enables UKAS and CPA to capitalise on common criteria thereby making a partnership possible and desirable.

A Council has been set up to oversee the development of the partnership. Dr Bryan Smith, UKAS Chairman, chaired the inaugural meeting on 26th February 2002; Sir Duncan Nichol, CPA Chairman, assumed the Chair in October 2002. 

The partnership will retain the individual corporate identities of UKAS and CPA and each partner will maintain respective control over professional [technical] decisions and standards. UKAS shall retain the Government’s sole recognition status as the National Accreditation Body.

The Council continues to meet regularly to discuss the development and activities of the partnership. A number of policies have been agreed to facilitate the partnership, including exchange of information, confidentiality, competition. Details of these can be found on the websites together with more information on both organisations.

www.ukas.com 
www.cpa-uk.co.uk

for the spring of 2003 with similar topics and speakers. Also, we are committed to a heavy programme of the second phase of CPA assessor re-training during 2003.

We hope that you will be able to join us for our Conference 2004.

CPA NEW Standards

The new CPA laboratory standards have been up-dated with very minor changes. The new document is now on the CPA website www.cpa-uk.co.uk. In addition, we have posted a separate document highlighting the changes made.

The new CPA standards are scheduled for implementation from April 2003. This is an appropriate time to ask whether the current advisory committee structure meets CPA’s needs now and in the future. Following discussion, a proposal for change was put forward to the CPA shareholders for consultation and has now been agreed. We have also changed the organisation within Central Office and both changes are described below. 

Central Office Organisation
We have created three administrative teams within CPA office, each will have an administrative lead plus supporting staff. Each team will be responsible for specific areas of the United Kingdom. We aim to provide a faster turn-round time to applicants and to provide a more consistent service as all correspondence can now be directed to named individuals within the organisation. 

The teams are as follows:

TEAM #1
Areas - Scotland, Northern Ireland, Northern & Yorkshire and North West regions of England.
Team Members - Rachel Boyer (lead)
Sarah Hey, Neil Miles
Enquiries: 0114 251 5805 
email: rachel@cpa-uk.co.uk

TEAM #2
Areas Wales, London and South West regions of England.
Team Members - Sandra Barker (lead), David Barma, Emma Peacock
Enquiries:  0114 251 5806 
email: sandra@cpa-uk.co.uk

TEAM #3
Areas Trent, West Midlands, South Eastern and Eastern regions of England.
Team Members -  David McGowan (lead), Angela Satchwell, Paul Widdowson
Enquiries:  0114 251 5807 
email: dmcgowan@cpa-uk.co.uk


Advisory Committee Structure
In the ten years since CPA’s 

incorporation, it has retained the 
original structure of Specialty Advisory Committees (SACs) with an overarching Joint Advisory Committee (JAC). This comprised six SACs with a total membership of fifty, and one JAC consisting of the six SAC Chairmen and the Company Officers.

The structure has served CPA well; its strengths being its professional representation, diversity and expertise of members and the input from all the sub-specialties. The weaknesses are an inconsistency of implementation of the standards and decision making, and the impression that information was mostly disseminated downwards from the JAC. In addition, the JAC was not professionally representative.

The Board has agreed to put in its place a Professional Advisory Committee (PAC). This is a single committee with twenty one members (including Company Officers). The PAC offers increased strength of decision making by a core group. The first meeting of this committee was held on Monday 16 December 2002.

I didn’t think I had a lot in common with the Queen but when I looked back over the past few years of the Haematology SAC I find that my memory is not what it used to be. Is Tara identical to Central Birmingham?  Did the SAC talk SHOT all the time?  Some people may think so but in fact much of the work of the SAC has been involved with deliberations over contentious issues where there has been a difference of opinion.  The consistent interpretation of whether the CPA standards have been met during a particular inspection visit has been one of the most difficult issues for CPA in general.  Sometimes inspectors have clearly got it wrong and sometimes the objections from the Department being inspected have been unreasonable.  In my experience however the SAC members have always tried to be fair and consistent and if a particular grey area still remains uncertain after discussion then the host department is usually given the benefit of the doubt.  Looking back over the minutes I see

that we have discussed issues such as staffing numbers, on-call rotas, transport of blood around hospitals, security of blood bank and satellite fridges, lack of air conditioning in departments, merging of laboratories (haematology and clinical chemistry) and merging of Trusts (networks). A regular and difficult agenda item has been the different interpretations of the standards by different inspectors. The SAC have long held the view that a smaller number of dedicated inspectors was required. There are clear difficulties in establishing this format and with the advent of the new standards and the likely difficulty in recruiting haematology inspectors this is clearly now a major issue for CPA.

I cannot list all the SAC members over the years but I can state that they all provided thoughtful knowledgeable and helpful advice. I am also grateful for the information I received on issues not strictly covered by the CPA standards. The Queen has told us that there are dark forces of which we have

little knowledge but Brian Warner (IBMS representative) knows a great deal about cycling in the dark and Ivor Cavill (BSH, BSCH and Plaid Cymru representative) knows how to herd sheep in the dark. But there were no sheep in the SAC. All were strong-willed individuals who expressed their views. I remember Sam Machin (Rhett Butler) crossing swords with Ivor Cavill – just because he was Welsh. I remember Brenda Gibson advising me how to preserve my hair style wearing a cycling helmet. I remember David Gorst receiving an invitation to join the SAC in the morning and receiving notification of its dissolution in the afternoon. And I remember Edwina Currie (Scarlett O’Hara) telling me that grey hair was attractive. But now my memory is playing tricks. This is all in the past. The future for haematologists and CPA beckons. For tomorrow is another day. 


Jim Murray
Outgoing Chairman
Haematology SAC

CPA Clinical
Biochemistry SAC

The main problems that the SAC had to face during the year were a reflection on the staffing issues within the Pathology Service.

· Staffing and Direction mainly associated with standards B1 and B2 were specifically problematic. Standard B1 indicating a problem of recruitment to the service. There was also an increasing trend towards Consultant cover being shared between local Trust laboratories. This may be a reflection of networking between departments within local areas. 
The continued problems of recruitment of BMS staff were also evident. Surprisingly job descriptions seemed to be an area of non-compliance in a number of Trusts.

· Facilities and equipment was also an area of partial/non-compliance. This was mainly a reflection on the increasing use of established laboratories that have not grown in keeping with their workload and staffing. 
A number of laboratories were having problems with aspects associated with Point of Care Testing.

· Staff development and education was generally improved in that there was less partial/non-compliance relating to staff appraisal.
Many laboratories were experiencing a low participation in CPD. This could be a reflection on staffing levels and opportunities within their areas.

· Evaluation regarding EQA and IQC was not a problematic area. Although audit did occur as non-compliance in many laboratories again this may be a reflection on staffing and workload rather than commitment to audit.

I would like to take this opportunity to thank all of my colleagues on the SAC, for all their help and useful advice on CPA matters.

Martin Nicholson
Outgoing Chairman
Clinical Biochemistry SAC

CPA Genetics SAC

The SAC in Genetics was, for a long while, something of an anomaly. For historic reasons it not only encompassed Clinical Cytogenetics and Molecular Genetics, but also semenology – as a carrier of genetic information perhaps? The largest contrast however, between this SAC and the others, was its virtual nature – this SAC had not met for some very many years. The SAC business was entirely conducted by E-mail and telephone, quietly and efficiently. This mutation was very well suited to the circumstances of delivery of genetics services – regionally based with far fewer units delivering the service than the other pathology disciplines. As ex-chair I would like to thank my predecessor for developing the process and, of course, my colleagues on the SAC for their constant help and wisdom.


Lorraine Gaunt
Outgoing Chairman
Genetics SAC

and the Association of Clinical Pathologists and also in the case of Clinical Biochemistry, the Association of Clinical Biochemists. The Institute of Biomedical Science appoints the five Biomedical Scientists and the Independent Healthcare Association appoints their representative. The advisors in Transfusion Medicine, Cytopathology, Virology and H&I are appointed by agreement between all the relevant shareholding bodies of CPA.
All of the appointees must meet with the approval of the CPA Board. They are expected to be experienced assessors with CPA and will be required to sign the same Code of Conduct and Letter of Engagement as for CPA assessors.

5 Meetings The PAC meets once per month throughout the year and it is particularly important that each Pathology discipline is represented by at least one of the relevant members. Members are expected to have at least a 50% attendance record. Matters that require a vote are settled on the basis of a simple majority.

6 Other Duties of PAC Members The consideration of applications for registration, annual reviews, assessors’ reports and departmental submissions of corrective action following non-compliance are the responsibility of the PAC members. These are normally done between meetings on a postal basis. The workload will be split equally, by CPA Office staff, between both members of a single discipline on a monthly basis. Issues that cannot be resolved by the individual members, alone or in co-operation, are referred to the PAC for consideration at its next meeting.

7 Reporting Mechanism The PAC will submit a written report of its activities to each Board meeting. The Chairman of the PAC will present this.

Introduction
It is desirable that Immunology Assessors should have guidelines regarding the needs of Professional Direction to ensure that they are assessing a minimum standard of safe professional practice, whether it be at a hub or satellite service. These need to be flexible enough to encompass the wide range of individual practice yet have certain core attributes which can be generally agreed to be minimum standards. It is also desirable that Applicant Laboratories understand what the Assessors will be expecting to find. The following represent Guidance produced by the CPA’s SAC in Immunology and approved by JAC.

Principles
Major centres, because they must provide interpretative and clinical cover on a daily basis, need the daily presence of a consultant and around the clock availability of opinion. It follows that single handed practice is clinically unacceptable in major centres and consultant / clinical scientist rotas must be constructed to provide the cover required. Any arrangement must be subject to regular review and demonstrably meet service needs.

Many Major Centres find they are operating a Hub and Satellite arrangement to cover the needs of professional direction of limited Immunology services in neighbouring Trusts. This requires appropriate sessions are committed to provide a safe effective service on both hub and satellite sites.

Professional Direction requirements are necessarily more demanding for a Hub laboratory. This is a comprehensive laboratory and clinical service and will comprise the major responsibility of the Consultant Immunologists.

Satellite arrangements should not compromise Hub activities. No more than 20% total sessional time should normally be committed to Satellite activities by each of the hub consultants. This is to cover all satellite related activity whether carried out at the satellite or the hub and should take account of time spent travelling.

Executive control of the immunology service is essential at the Hub and is desirable at the Satellites. Executive control is defined as direct managerial responsibility for all the activities of the department; day-to-day involvement in the activities of the department

as defined below; and ability to influence all necessary managerial and clinical decisions, including those regarding staffing (recruitment and rotation), to run a safe, effective, clinically appropriate and clinically governable specialist laboratory service (management responsibility for immunology may be exercised through the Head of Multidisciplinary Laboratory if necessary, this is the usual arrangement at satellites). Executive control also incorporates full and meaningful involvement in the future development of the immunology service through the business planning process.

To be effective these functions must be supported by the management structure and practices of both the hub and satellite departments. They require allocation of appropriate sessions for departmental activities and management/administration (to include relevant managerial and departmental meetings). This should be documented by a service level agreement [SLA] with any satellite department and or in the job description / job plan of the Immunologist.

A breakdown of the areas of activity and guide to the time required is provided below:

¨ Interpretative advice and laboratory supervision (on-site by telephone, E-mail, fax and in person): at least 3 sessions for the hub. Between half and one session per week for each satellite laboratory flexibly arranged. A consultant opinion should always be available at the hub and readily available to the satellite departments.

¨ Laboratory hands-on activities (where a regular commitment): dependent on the service delivered.

¨ BMS, Clinical Scientist and SpR education and other teaching: at least 0.5 session (1 session if SpR on staff).

¨ Administration: 1 session per individual, 2 additional sessions per hub for the head of department.

¨ Research : 1 session where relevant, more if academic.

¨ CPD activities, clinical audit and related activities: 1 session per individual.

The above is intended as guidance to the minimum acceptable. Diagnostic service consultant sessions committed at the hub must reflect the extent of the

repertoire, the complexity of the work and workload. They will also be influenced by the inclusion of clinical scientists in the laboratory team. 

Additional specialist activities or regional or national services (PRU, EQA, specialised immunodeficiency or allergy investigations etc.) should attract additional sessions which should be clearly identified when introducing and upgrading services.

Availability to work Clinical Sessions must NOT compromise laboratory commitments and be laid out in the consultants job description / job plan. Clinical sessions average between 2 and 5 per week for most consultants. (commonly 2-3 for OPD, 1 for ward consults, +/- 1 for inpatient work if appropriate). 

Clinical sessions should not be "double-booked" for laboratory supervision or interpretation. These sessions are allocated to OP and IP activities and any follow-up investigations or administration resulting from these. It is impractical and unsatisfactory to do two things at once and is probably not safe practice or clinically governable. It would not be expected of any other profession.

Sessional commitments to satellite laboratories should include travelling time, thus discouraging the formation of impractical links between far off satellite laboratories. The travelling time should NOT come from hub commitments.

Alternative means of achieving safe and clinically governable satellite practice (Electronic data transfer etc.) that potentially save time are available. They cannot be a complete substitute for attending the satellite regularly. These would need to be assessed on an individual basis.

No consultant should have more than an 11 session weekly commitment on a long-term basis.

A consultant whose activities cover 2 directorates will need appropriate recognition of the time needed to effectively participate in the management meetings of both Medical and Pathology directorates:

As hub departments commit to the supervision of satellites they should ensure and be able to demonstrate to Assessors that the hub practice is not compromised by satellite activities. 

CPA Immunology SAC 2002

· dealing with differing opinions given by the referring and receiving departments (G4, G5)

· data entry in the referring laboratory’s system, especially avoiding transcription errors and duplicate reporting (D2)

· urgent reports (G3) 

· reviewing the receiving department’s accreditation status, EQA performance and turnaround times (E6, H5)

· assessing the satisfaction of the users (H2).

3 RECORDS

In order for assessors to establish compliance with these recommendations there shall be records kept in the referring and receiving departments.
These records shall include:
· copies of the policy and procedure(s) described above

· lists of the referred material with dates of sending specimens, receiving reports and the return of material

· results of audits

· discussions with users

· evidence of current accreditation status and EQA participation of the receiving department.

* Routine Histopathology is work included in the repertoire of a department, normally carried out on-site. It does not refer to work referred for a specialist opinion. 

A Practical Guide to Accreditation in Laboratory Medicine 

This book has been written by David Burnett, OBE PhD FRCPath, author of “Understanding Accreditation in the Laboratory”. David is Chairman of the CPA (UK) Ltd Standards Revision Group and is also a respected member of the British Standards Institute. 

His book is published by the Association of Clinical Biochemists and can be ordered from them at ACB Venture Publications.

ISBN 0 902429 39 6 Ł35
For an order form contact: www.acb.org.uk 
Tel: 020 7403 8001
Fax: 020 7403 8006

We understand that discounts are available for bulk purchases.

EQA PILOT SCHEME FUNDING 2003/4

At its December meeting the CPA Board accepted the recommendations of the EQA Committee that the following Pilot Schemes should be supported in the sixth year of pilot funding.

– Leptospira Serology EQA Scheme
(Mr M Palmer, PHLS Laboratory, Hereford)

– Neonatal Haemoglobinopathy Screening
(Dr E J Parker-Williams, UKNEQAS(H), Watford)

– DNA Diagnostics in Haemoglobinopathies
(Dr E J Parker-Williams, UKNEQAS(H), Watford)

– Clinical Cytogenetics
(Dr R J Hastings, Churchill Hospital, Oxford)

– UK NEQAS for Kidney Function Investigations 
(Dr J Baron, St Helier Hospital, Carshalton and
Dr D Bullock, UKNEQAS, Birmingham)

There was only one other application received which the CPA(EQA) Committee was unable to support.



David Goldie
Chief Executive (EQA)