Welcome...

I am pleased to introduce the first of a regular series of CPA Newsletters. I hope that you will find it both informative and informal. The document is designed to keep all parties up to date with current CPA activities and future developments, and will ensure all our readers are aware of changes in policy or personnel as they happen. There will also be reports on international developments, how this affects the revision of the CPA standards, and our meetings with colleagues working towards the harmonisation of accreditation of medical laboratories across Europe.

The first issue provides a summary of the responsibilities of the various committees within the organisation and how they interact with each other. Future issues will provide an insight into the duties of individual members of CPA Central Office staff. Each issue will contain an article from one of the CPA Advisory Committee Chairmen on a topic hopefully of interest to most readers. The first is by Dr Adrian Morley, Chairman of the Histopathology/Cytology SAC, explaining recent developments with the accreditation of cervical cytology screening departments.

Cheryl Blair

The Specialist Advisory Committees form the third tier of CPA's committee structure, lying below the CPA Board and the Joint Advisory Committee. There is a SAC for each of the specialties recognised by CPA, numbering six in total.
Specialist Advisory Committees comprise members nominated by each of the CPA sponsoring bodies relevant to that particular discipline. Each member currently has a four year term of office. In addition each SAC has an observer from the National EQA Advisory Panel in that speciality. Typically the SACs have between six and twelve members each. From this number the CPA Board appoints a Chairman.
The functions of the Specialist Advisory Committees are, in essence:
a) to define and review standards;
b) to draw up guidelines relevant to inspectors in that discipline and to revise these as necessary;
c) to participate in the revision of other CPA documentation such as the Application Form and the Inspection Report form;
d) to deal with the initial assessment of each Application Form received by CPA in that specialty;
e) to advise CPA of suitable inspectors for each inspection and to advise those inspectors of any particular points that need special attention;

f) to assess the inspectors' report post-inspection and to deal with any anomalies that may arise from the report;
g) with the help of CPA Central office, to ensure that any inconsistencies in reports between specialties are discussed and if possible removed;
h) to decide whether faults identified by the inspectors warrant the referral of the laboratory, the imposition of conditions, or the identification of points which will be checked at the next Annual Registration review;
i) to deal with the subsequent responses from laboratories to the reports. These may be in the form of an objection to a decision that has been made in the Inspection Report or details of changes that have been carried out in response to an imposed condition.
In each case the matter is dealt with by the SAC chairman with advice where necessary from members of the SAC either at a formal SAC meeting or, in order to minimise delays, by phone.
In addition, the SAC gives advice to the Joint Advisory Committee, and through that forum to the CPA Board, about suggested modifications to the current practices of CPA that arise out of experience or out of the ever-changing and evolving

practice of Clinical Pathology in each of its specialities.
The SAC many obtain further advice from the professional bodies and learned societies that have nominated its members. Thus the IBMS has provided advice about giving results over the telephone and the procedures for dealing with inadequately labelled samples, and the Royal College of Pathologists and the Association of Clinical Biochemists have advised about levels of senior staffing in Biochemistry Departments and the role of those senior posts.
It is the SAC's responsibility to ensure that there are sufficient numbers of adequately trained inspectors; it also gives advice about dealing with inspectors that have been reported as providing a less than satisfactory performance.
The SACs also liaise closely with the CPA headquarters staff whose help and experience enable the business of the SAC to be undertaken with some degree of efficiency. The help given and work done by CPA staff is relevant across the whole range of the SAC's activities, but the SAC chairmen are particularly dependent upon CPA staff for the initial vetting of the Inspectors' Reports and for ensuring that there is, as far as is possible, consistency in the reports from all specialties.

The JAC is comprised of the Chairmen of the discipline specific Specialist Advisory Committees plus the Chairman of the CPA(EQA) Committee and the Chief Executives of CPA and CPA(EQA).
Regular meetings and telephone conferences allow for consideration of a wide range of policy decisions arising from the evolutionary process of CPA and advice is given both to the CPA Board and Secretariat. This multi-disciplinary approach is essential since many of the problems which arise relate to decisions affecting all pathology disciplines and thereby allows for adoption of a uniform policy by CPA. The standards and guidelines are the bedrock upon which CPA is built and since developments are constantly occurring in pathology the JAC regularly reviews and revises CPA documentation to ensure that the inspection process reflects up-to-date pathology practice. The JAC seeks appropriate advice both from the parent shareholder organisations and also from the inspectors via the inspector update meetings.

There is also a requirement for the JAC to consider CPA's future in relation to international laboratory accreditation and currently the Standards Revision Group is assessing this aspect.
Some of the decisions on policy are easily reached whereas others have wide reaching consequences requiring extensive discussion at JAC and Board levels. Examples of the latter are Standard B1 relating to professional direction of laboratories and Standard E5 dealing with staff appraisal. For Standard B1 most laboratories are straightforward but for a small number the work may be of a high standard but their professional direction does not comply with current CPA requirements. The JAC in consultation with the Board and CPA shareholders continues to explore ways in which such laboratories might in future comply with some modification of this standard. The question of appraisal for consultant pathologists has been considered for some time by the JAC and in conjunction with recent BMA advice is likely to be implemented soon.

Most of the large number of laboratories undergoing the accreditation process provide few problems and conditions imposed are corrected within the time limits set by CPA. Unfortunately a very small number of laboratories may have serious deficiencies requiring referral whilst others may fail to resolve the conditions within the time scale required. An important responsibility of the JAC is to carefully assess all these laboratories and offer guidance if appropriate since the committee members are fully aware of the consequences for laboratories of referral or removal from the CPA list. These decisions are always taken to the Board for ratification.
CPA has gained extensive experience in providing an effective accreditation process but must continue to adapt to the national and international changes occurring in pathology. The JAC is a forum for considering these changes and for ensuring that CPA is provided with advice which allows the organisation to continue to develop and provide a high quality accreditation process.

The Other Side of the Business - CPA(EQA)
DJ Goldie
Chief Executive (EQA)

Cytology and the Accreditation Process
Adrian Morley, Chairman of the Histopathology/Cytopathology SAC

Over the last three years CPA has undertaken a general oversight role for the provision of EQA schemes in the UK. This development was at the request of the Department of Health and followed the development of proposals by a Working Party in 1995 accepted by the Department and the CPA Board early in 1996. Initially CPA's responsibility excluded Cellular Pathology and Genetics but as of January 1998 these specialties are also included in CPA's remit.
The main way in which CPA discharges it's responsibilities is by a process of EQA Scheme Accreditation, analogous in many ways to laboratory Accreditation and indeed sharing many of the same standards. However another important part of CPA's role is it's responsibility for EQA Scheme development exercised through funding Pilot Schemes.
The EQA activities are centred around the multidisciplinary CPA(EQA) Committee chaired by Dr. Stephen Jeffcoate and with a membership drawn from all the main disciplines in Pathology. The Committee considers applications for accreditation from EQA Scheme organisers, identifies suitable inspectors and, in due course, considers the inspectors' reports. To date good progress has been made in accrediting schemes in Clinical Biochemistry, Microbiology, Immunology and, to a lesser extent, in Haematology.
Accreditation of schemes in Cellular Pathology and Genetics is presently getting underway applications are expected in the near future.
CPA funded the first round of EQA Pilot Schemes in the early part of this year, with support going to six schemes in Cellular Pathology, Clinical Biochemistry, Genetics and Microbiology. Invitations have now gone out to apply for the second round of funding and successful applicants will be identified early in 1999.
An up to date list of CPA(EQA) Accredited Schemes can be found on the CPA Website and further developments will be reported in future editions of the Newsletter.

In the CPA accreditation process cytology has been linked with histopathology reflecting the situation in many hospitals .
Many inspectors, both consultants and biomedical scientists, were able to inspect both histopathology and cytopathology. Recent events culminating in the Executive Letter EL/97/83 (17/12/97) have made CPA review the inspection process. The problems leading to ministerial action have been failures in the quality and accuracy of the cervical screening service and have involved laboratories with and without CPA accreditation
EL/97/83 indicated that all cervical screening laboratories should begin the process of application for inspection for accreditation by CPA (UK) Ltd or any other body accrediting to an equivalent standard by June 1998. Clearly the intention is to prevent problems arising which result in unacceptable levels of dyskaryotic smears requiring re-screening, recall and treatment, and the damage to patients health and confidence which results.
An acceptable service requires two elements : these are (1) a sound organisational structure, (2) evidence of satisfactory function or output. The CPA accreditation process looks in detail at the organisational structure and accreditation indicates that the laboratory should be capable of providing a safe, accurate service. It also looks for evidence of satisfactory output by looking in detail at the day-to-day processes and for evidence that all appropriate audit and quality assurance procedures are being undertaken. The fact that inspections are undertaken by experienced peers gives CPA confidence that accredited laboratories are working to high standards and achieving them.
It would be naïve to claim that CPA accreditation guarantees that a service was safe and accurate in the past or will continue to be so in the future. Quality assurance is a matter for Regional Directors of Public Health and their Quality Assurance Teams together with the NHS Screening Programme. The cervical screening action plan sets out comprehensive guidance on achievable standards (Achievable Standards, the Pritchard Report etc). It is the local knowledge and expertise of Quality Assurance Teams which ensures that the service remains safe, accurate and within acceptable boundaries, and importantly sounds an early warning of failure.

There is no doubt that trust and confidence built up locally does much to ensure early detection and correction of problems, both personal and organisational.
The Executive Letter in making accreditation mandatory has not changed the CPA policy or its role in the accreditation of cytopathology. In producing new guidelines and re-training our inspectors we believe that we are providing them with the tools required. In asking for documents such as KC61 or its equivalent we are looking at general pointers of performance which are in the public domain. Inspectors do not look at the records of performance of individuals, but they do ask for evidence of satisfactory performance. Thus the question to be asked is "Do screening staff have satisfactory pick-up rates?" and not "Tell me the names of those with unsatisfactory pick-up rates". If answers to these non-personal questions indicate that there is a problem, CPA will question whether the appropriate action has been taken with the Quality Assurance Team and would urge this course of action.
Thus the combination of accreditation and quality assurance provide the best available assurance to the government and public of the safety and value of a service with high standards and achievements. The areas of overlap between the CPA approach and the QA Teams is small. The comprehensive approach of CPA in looking at the cytology screening service in the context of its association with histopathology has done much to ensure adequate staffing and resources. The role of CPA inspectors has been to support the guidelines produced by authoritative bodies. As new guidelines appear inspectors will look at them against the appropriate CPA standards and if they are judged to be of general importance they will be incorporated for future visits. Guidelines do not represent an exclusive list of requirements and additions to the guidelines are constantly being made. Standards remain but inevitably interpretations evolve.
The changed circumstances evoked by the Executive Letter provide an opportunity for looking in detail at both Accreditation and Quality Assurance to ensure that the goal of both organisations in providing a safe and accurate diagnostic service is achieved. In our wish to avoid overlap we must ensure that we do not leave gaps.

Joint Statement
Clinical Pathology Accreditation (UK) Ltd and The United Kingdom Accreditation Service (UKAS) have signed a statement expressing their intention to work together. The United Kingdom Accreditation Service is the UK national accreditation body responsible for assessing and accrediting the competence of organisations in the fields of measurement, testing, inspection and certification of systems, products and personnel.

The statement of intent reads as follows:-

Clinical Pathology Accreditation (UK) Ltd and the United Kingdom Accreditation Service (UKAS)

In recognition of their common aims of providing confidence in the services of medical laboratories and departments in the UK, seeking to improve the quality and standard of work carried out by these organisations, a reduction in multiple assessments and harmonisation of approaches to accreditation in Europe, Clinical Pathology Accreditation (UK) Ltd and the United Kingdom Accreditation Service (UKAS) hereby express their intention to cooperate in areas of mutual interest and benefit.
Key areas which have been identified for cooperation are:

· Determination of the criteria to be used in Europe for the operation of medical laboratories and departments.

·Alignment of accreditation body practices and procedures for the assessment and accreditation of medical laboratories and departments to recognised European and International standards.

· Training and Use of assessors

· Combined visits, on request, to organisations which need both CPA and UKAS accreditation

In order to achieve closer cooperation, CPA and UKAS will maintain a constructive dialogue, informing each other of developments in this field, both in the UK and Europe. Where feasible and desirable, joint ventures will be undertaken with respect to assessment practices and procedures. By working together, CPA and UKAS seek to promote and encourage best practice in the UK and to influence the development of such practices both in Europe and internationally.

End of statement Cheryl Blair 22 September 1998