Revision of Standards The revised version of the CPA handbook will be available in May and mailshot to all addresses held on the CPA database. The two standards where there are significant changes to wording are re-printed below for advanced information.

Rewording of Standard B1
The changes to standard B1 will enable CPA to proceed to register departments previously excluded because of the restrictions of the standard, e.g. semen analysis services, molecular biology departments.

B1 Each discipline is professionally directed by a consultant pathologist or clinical scientist of equivalent status, or another specialist with appropriate qualifications and experience.

Guidelines:
1 Evidence of training and/or experience in that specialty as normally exemplified either by the MRCPath or its equivalent in that specialty or by appointment as a Consultant or equivalent in that specialty by a properly constituted NHS Appointments Advisory Committee.
2 Evidence of continuing practice and experience in that specialty; and
3 Evidence of participation in continuing professional development relevant to that specialty.
4 There must be adequate arrangements for cover during staff absences.

5 For laboratories without on-site consultants the following points need to be satisfied for each discipline:

i) A written definition of the sessional input for each consultant sufficient to meet the needs of the service.

ii) Documented attendance at regular departmental meetings to review service issues and set standards.

iii) Regular on-site laboratory attendance as needed to match the needs of the service; normally at least weekly.

iv) Interpretive consultant advice should be available readily and within a timescale appropriate to the urgency of the clinical situation.

v) Clinicians should be aware of the availability of consultant advice and have ready access to it at all times.

6 In exceptional circumstances, it may be appropriate for the professional direction to be provided by a consultant from a specialty other than pathology. In such circumstances, the following points need to be satisfied:

i) Evidence that the laboratory is providing a limited range of specialised tests directed by an appropriately trained consultant demonstrating special qualifications or skills in the area of these tests.

ii) Guidelines 1-4 must also be satisfied, except that a relevant postgraduate qualification other than MRCPath is acceptable.

iii) There should be formal acknowledgement by the manager of the owning institution that the consultant is an appropriate person to provide professional direction of the laboratory, with endorsement by the on-site pathology consultants where appropriate.

Rewording of Standard F1

F1 The department must have a formal policy for internal quality control and must participate in approved External Quality Assessment Schemes.

Guidelines:
1 The department must have a formal policy for internal quality control procedures that extends through the department's repertoire. (See also Standard D8)

2 Material used for internal quality control must be prepared and stored under safe and appropriate conditions.

3 Quantitative analyses require multiple levels of internal quality control.

4 The results of internal quality control must be validated by designated staff at the time of testing.

5 For qualitative analyses there must be documentation of positive and negative test control materials.

6 The department must fully participate in approved External Quality Assessment Schemes corresponding to its repertoire, and evidence of satisfactory performance will be sought.

i) Approved EQA Schemes are schemes that are accredited by CPA(EQA) or by another organisation accrediting to similar standards (based upon ISO Guide 43) which must include appropriate Steering Committee and Panel reporting arrangements.

ii) Where no such accredited scheme exists for a particular analyte or test laboratories are encouraged to participate in non-approved schemes or pilot schemes.

Meeting of EQA Providers February 9th 1999Stephen Jeffcoate,Chairman CPA(EQA) Advisory Committee

"Quis custodiet ipsos custodes?" "Who shall control the controllers themselves" is a question as relevant to the provision of high quality pathology services in the UK today as it was to the politics of Rome two millennia ago. Accreditation of EQA schemes is occupying a pivotal position of increasing relevance in pathology and over 60 people came to a meeting at the Royal College of Pathologists in February, the second annual meeting which brings together EQA Providers, existing and intending, with the CPA officers and members of the CPA(EQA) Advisory Committee.

Progress so far - in the development and application of standards for EQA providers, in the inspection, reporting and decision-making process - was reviewed for the areas of pathology, chemistry, immunology, microbiology, haematology, which have been largely, though not yet completely, covered by the process. Some differences in comparison with laboratory accreditation by CPA have emerged, most notably the discontinuation of qualifiers such as "provisional" and "conditional" to the term "accreditation" which must, in the context of EQA schemes and their participating laboratories, be considered to have an "all-or-none" status.

Most of the emphasis of the meeting was on the future: the importance of the new F1 standard [cross reference]; the extension of EQA accreditation to other disciplines - histopathology, cytopathology, molecular and cyto- genetics; CPA's encouragement and financial support for pilot EQA initiatives; the implications of international developments, standards and guidelines - especially ISO Guide 43.

The new F1 standard for CPA laboratory accreditation - though it still combines internal QC and EQA practices, an anomaly which will be addressed in the major standards revision exercise currently being undertaken - has been drafted to incorporate many of the current and predicted circumstances for EQA users and providers. Thus the use of the term "approved" in reference to EQA schemes is a strengthening of the previous "recognised" as applied by the Joint Working Group but guideline 6(i) makes it clear that this "approval" (i.e. accreditation) is not a CPA monopoly provided accreditation follows similar standards based on ISO Guide 43 and appropriate Steering Committee and Panel reporting arrangements are in place. Guideline 6 to F1 also states - as did the previous version - that evidence of satisfactory performance will be sought. This is likely to take on increasing relevance for laboratory accreditation and underlines the vital importance of ensuring that EQA schemes define, identify and respond to satisfactory and, by implication, unsatisfactory performance in a clear and appropriate manner.

Extension of EQA and EQA accreditation into the remaining disciplines where no approved schemes currently operate has created much discussion - as recent pages of the College Bulletin reveal. The chairman of the College's Steering Committee on EQA for Histopathology and Cytopathology, Dr Philip Roberts, informed the meeting very clearly of the strategy of this committee, of developments and of problems. There appears to be growing support for EQA initiatives in these disciplines - in some parts of the UK at least - provided they are carried out appropriately, which is where CPA(EQA) plays its key role. It remains a considerable challenge however to those charged with implementation.

New initiatives and technical advances in pathology also need the sharp scrutiny of external evaluation and this is why CPA undertakes to support "pilot schemes" in areas where developments of real or potential

clinical significance are occurring. Progress reports on three of these were given: by Dr A Reid, Glasgow, on troponin assays as markers of myocardial damage; Dr J Hawkins, London, on HIV1-RNA measurement; Dr J Waters, Birmingham, on clinical cytogenetics. These reports each illustrated a vital role of CPA(EQA) in fostering new initiatives. Dr Goldie reported on the recent round of applications for pilot scheme funding in which four applications were supported. The reasons for lack of favourable outcome for the other applicants were either that the scheme was not considered to be EQA, it was at too early a stage of development, or that the clinical use was too restricted.

Finally, Dr David Bullock took us carefully and clearly through the tangled web of European and global initiatives, committees, standards and their implications. CPA is at least up to speed here, if not ahead of the field, but in partnership with UKAS will need to keep a sharp eye on developments. It is clear that accreditation of EQA schemes, as of pathology services themselves, is here to stay.

In the open discussion which ended the meeting, various concerns and suggestions were brought up some of them familiar themes to those experienced in EQA such as the problem of "cheating" in EQA, the need for appropriate internal responses to occasional poor performance (as in standard F2) and ethical issues over the use of patient material. Publicity on availability of pilot schemes including those given CPA financial support was recommended.

It was a lively and informative afternoon and a reflection of the ever increasing role of external scrutiny in pathology (as in medicine as a whole) and the need to ensure, through accreditation, that as far as possible EQA remains efficient and effective, educational as well as regulatory, and above all relevant to the needs of health service staff and the public they serve.

Cytogenetics Staff Working from Home or Outside the Main Laboratory Base
Alan McDermott,
Chairman of the Genetics SAC

Background
Potential problems associated with laboratory staff working from home were first considered by the Joint Advisory Committee over two years ago. At that time the disciplines predominantly involved were cytology and cytogenetics. Initially, in order to ensure that CPA standards were maintained and consistently applied between disciplines, attempts were made to draft common guidelines on screening or analysis undertaken at home or elsewhere "off-site".

During the course of these deliberations, the Department of Health announced that it was adopting the recommendations of the official enquiry which followed some highly publicised cytology screening errors. These recommendations included the cessation of home screening which had been identified as a source of some of the errors. The phasing out of home working, by April 1999, became a CPA requirement for the accreditation of cytology services.

Following the introduction of this requirement for cytology, it was concluded that cytogenetics was likely to face the same potential problems and JAC proposed that the same standard should be applied to both specialties. The proposal met with vigorous opposition from the cytogenetics profession which put forward an argued case for the safe retention of home screening for cytogenetics, conditional upon specific standards being met. The standards outlined below have been adopted by CPA, following consultation with the Association of Clinical Cytogeneticists, Royal College of Pathologists, Department of Health, and the CPA SAC in Genetics.

CPA Policy and Practice
The following is a summary of the essential standards and guidelines.
1 Standards for home working or other off-site screening/analysis
· CPA accredited laboratories must ensure that any screening or analysis undertaken outside the accredited laboratory premises meets standards which are compatible with CPA accreditation. This applies to work undertaken by
- Staff employed by the laboratory who work at home ("home workers").
- Individuals employed under other contractual arrangements who work at home or in other non-accredited premises.
- Other laboratories, either NHS or private.
·The employment of home workers, or other arrangements for off-site screening/analysis, should be clearly indicated on the application form for accreditation or notified to CPA if such arrangements occur during periods between annual re-registration.

2 Guidelines (Summary)
· Home workers must have appropriate qualifications, experience and training necessary for unsupervised working (defined in guidelines).
· There should be specific protocols for analytical work undertaken at home.
· The home worker must be able to arrange a quiet, undisturbed workplace within the home and be equipped with a microscope of appropriate quality.
· There should be arrangements to ensure patient confidentiality.
· The home worker must form part of the usual line management structure of the host cytogenetics department and should attend the host laboratory on regular (weekly) basis to ensure continuity, ongoing training, and familiarity with changing practice.
3 Off-site screening/analysis in other circumstances
· CPA standards and guidelines must apply.
· Other laboratories, NHS or private, to which slides are referred for screening/analysis must be CPA accredited or hold equivalent accreditation.

The above guidelines will be made available to applicant cytogenetics departments and will comprise part of the Inspector Checklist.

Laboratory accreditation registration /annual registration fee structure

To date, all departments registering with CPA have been charged a flat rate registration fee, at present £350 per annum. In order for CPA to maintain income in the light of the loss of registrations due to rationalization of services a proposed new registration fee structure has been agreed by Board members and will be put in place during 1999.
· The baseline registration fee will be maintained at £350 per discipline.

· A charge of £100 will be levied for each additional discipline included in the application.

Example 1
Department of Clinical Biochemistry with a substantial Immunology section:
Current fee: £350 per department
Proposed fee: £450 per combined department

Example 2
Combined department of Clinical Biochemistry and Haematology:
Current fee: £350 per department (£700)
Proposed fee: £450 per combined department

Example 3
Small independent multi-disciplinary department (with 4 disciplines)
Current fee: £350
Proposed fee: £650 maximum

As this will be an added burden to smaller multi-disciplinary departments it was agreed that the baseline registration fee would be increased by £100 per annum to a maximum of £650 over three years in order to allow time for the registration fees to be included in budgets.

· A charge of £250 will be levied for each additional site included in the application. This would not be levied on near patient testing facilities.

Example:
Two departments of Haematology merging over two Trusts.
Current fee: £350 per department (£700)
Proposed fee: £600 per merged department