Introduction

In this issue ...
· Requirements for compliance with CPA Standard E4 "Staff Appraisal".
· Statement clarifying the roles of CPA, the Royal College of Pathologists' Steering Committee and the National Quality Assurance Advisory Panels for Histology and Cytology.
· Expert advice on microbiology laboratory safety and the accreditation process.

Other news items ...
· CPA Annual Conference 2000
· Change of SAC Chairman for Microbiology
· Christmas and New Year holidays

Under the terms of the NHS Executive's Letter EL(98)2 CPA(UK) Ltd assumed responsibility of exercising oversight for EQA Schemes in Cellular Pathology as of 1st January 1998. At the same time the Royal College of Pathologists set up a Steering Committee for EQA in Histopathology/Cytopathology which has an advisory and supporting role for Scheme Organisers and which, in conjunction with the National Quality Assurance Advisory Panel for Histopathology and Cytopathology, develops scoring criteria and monitoring arrangements.

To clarify the roles of CPA, the Steering Committee and the Panel, they are as follows:
1. CPA oversees EQA provision by a process of EQA Scheme Accreditation, similar to that of Laboratory Accreditation but incorporating additional EQA specific standards and administered by an EQA Advisory Committee. CPA has no role in the day to day running of schemes nor does it have any role in the monitoring of participants' performance.
2. The College Steering Committee advises and assists Scheme Organisers in the organisation, running and development of schemes, in the development of performance criteria and undertakes the auditing of scheme activities. It also provides a route for complaints by scheme participants which have not been resolved locally. The Committee also offers its services to advise Scheme Organisers on their CPA applications.
3. The Panel approves Schemes' scoring systems and definitions of sub-standard performance prior to accreditation and has a key role in the identification and management of persistent sub-standard performance when it has been brought to the attention of the Panel by the Scheme Organisers.
It should be noted that any Scheme seeking CPA accreditation must have the benefit of Steering Committee advice and must establish appropriate arrangements with the Panel.

Dr D J Goldie
Chief Executive (EQA), CPA(UK) Ltd

Dr P F Roberts
Chairman RCPath Steering Committee for EQA in Histopathology and Cytopathology

Professor J C E Underwood
Chairman National Quality Assurance Advisory Panel (Histopathology and Cytopathology)

Inspections for CPA accreditation purposes often highlight laboratory safety problems or related areas. This is demonstrated in the number of referrals to the SAC for Microbiology, where the majority concern the application of, and guidance on safety aspects especially in relation to Facilities and Equipment Section C, standards 1, 5 and 11.

Whereas most laboratory staff now recognise and accept the problems associated with the handling of pathogenic microbes, a commitment to health and safety and the attainment of a total quality management system within the laboratory may be considered similar requirements and, therefore, any quality organisation will apply sound management principles to all health and safety aspects of its work. This requires the active involvement and support of all the staff in a safety culture. Due diligence in respect of health and safety is one of the important quality criteria in assessing laboratories to prevailing standards.

With new technologies, boundaries between scientific disciplines are becoming blurred and now many microbiologists find themselves not just handling microbiological cultures but also performing analyses using commercially available chemical kits in the laboratory. Such practices require a review of laboratory techniques to ensure all staff members are protected from any introduced chemical hazards. For example, the class 1 microbiological safety cabinet should be maintained to the appropriate British Standard (currently BS5726, shortly to be replaced with BS EN 12469). This includes an operator protection factor test to be performed at least annually and preferably every 6 months, depending on the quantity and hazardous nature of the pathogens being handled. Whilst this test ensures the safety cabinet will effectively protect handlers from micro-organisms they are not fume cupboards and should not be used as such; a different standard is applicable, especially for the final removal of fumes from the laboratory. A fume cupboard is not

HEPA filtered and many solvents may affect the integrity of such a filter. Moreover, safety cabinets are not spark proof and thus the potential hazard of fire may be introduced.

Containment level 3 laboratories remain a constant source of problems especially with regard to their sealability for fumigation1,2. The requirement is for a "sealed laboratory" so that gaseous disinfection can take place after the accidental spillage of a hazardous microbe. Many laboratories lack the attention to details such as the sealing of services including gas, water and heating pipes and electrical conduits. A pre-inspection check on the sealability of laboratory is therefore an excellent idea and may be performed using a "smoke test". This is similar to the integrity testing of fume cupboards and ducts and may be accomplished in a number of ways. These are by use of a hand held smoke generating tube and systematically checking all entry and exit areas of the laboratory, whilst the room is under negative pressure to the exterior or alternatively sealing the entry door using a flexible gas tight tape and then filling the room to opacity with smoke from a commercially available generator. (Similar to that used by fire brigades for training purposes.) Leakage of the smoke into an adjacent area may be detected visually. Often a combination of these methods is used, however both methods will detect minor air leaks in the room integrity. The Health and Safety Executive will inspect a laboratory if requested or can make an unannounced visit if they wish. Such advice or by employing bona fide commercial companies for this purpose will, with appropriate certification, be acceptable to CPA inspectors.

Laboratory policies are often reviewed in the light of new requirements, for example many NHS Trusts have now banned the use of Glutaraldehyde3 in their hospitals, as the disinfectant has been shown to be a respiratory sensitiser and now has a legally enforceable maximum exposure limit (MEL) of 0.05 ppm, with no safe level of exposure being identified. When substitutions are made in order to replace toxic chemicals it is essential

that any substance used for replacement is rigorously risk assessed and its conditions of use taken into account to ensure that the substance is not assessed in isolation, which may cause the inadvertent introduction of a more hazardous substance into the laboratory. For example, given the above information a laboratory with an established disinfectant policy using Glutaraldehyde may now wish to use hypochlorite extensively. A risk assessment may only review the corrosive aspects of the new disinfectant. However, there is a chemical reaction between hypochlorite and formaldehyde which under the high humidity conditions necessary for both room and safety cabinet fumigation forms a powerful lung carcinogen, bis-chloromethyl ether.

Similarly the standard for laboratory benches has long been a problem area since the days of solid wooden pathology benches1,2. The requirements in law are that a bench should be impervious to water and resistant to acids and alkalis. Whilst a well varnished wooden bench will meet this standard, the maintenance required to ensure the bench is always impervious to water etc. is very labour intensive and thus costly. Ultimately a good quality solid laminate bench will become the normal standard and wooden benches with their open pore (absorptive) structure will be replaced, as has happened in the food industry under Food Hygiene Regulations.

All laboratories produce large volumes of waste, some of which may be infectious. Waste management and the need to autoclave microbiological waste is often highlighted in laboratory inspections. Many laboratories produce far more contaminated waste than can readily be autoclaved within their laboratories. Such a lack of immediate facilities should not be a bar to accreditation, but a well researched and documented waste management operating procedure is essential4. Health and safety enforcement bodies will insist that all containment level 3 waste is autoclaved on site. However, there is a potential for containment level 2 waste to be transported off site for autoclaving, or more usually, direct

Continued..

Appraisal of Consultant Staff
Mansel Haeney, Chief Executive (Accreditation)

incineration. This should not be considered best practice but may be essential if infectious waste is not to become stockpiled. Such a system requires the use of sealed, tamper-proof robust containers, labelled with appropriate hazard warnings. The waste contractor removing the waste from the hospital site, must be licensed to handle infectious clinical waste, and in future this may require the input from a Dangerous Goods Safety Adviser (Transport of Dangerous Goods (Safety Advisers) Regulations 1999).

The laboratory should perform an audit trail to ensure they are aware of what quantity of waste is to be transported and how often; where the waste is transported to; and how and when it is destroyed. It should be remembered that such waste contracts are expensive to maintain and manage; the cost should be compared with that of installing and maintaining an additional autoclave in the microbiology department.

Therefore, the cost of non conformance to safety standards can be high, not only in terms of the loss of quality of the science performed, but ultimately in terms of serious accidents within our laboratories and also loss of patient care.

References

1 Control of Substances Hazardous to Health Regulations 1994 (Schedule 9), Health and Safety Commission, HSE Books, Sudbury. ISBN 0-7176-1308-9.

2 Categorisation of Biological Agents according to Hazard and Categories of Containment. 4th edition plus Supplement (1995) and (1998). Advisory Committee on Dangerous Pathogens, HSE Books, Sudbury. ISBN 0-7176-1038-1.

3 Glutaraldehyde. Health Services Circular HSC 1998/208. NHS Executive, Department of Health, London.

4 Health Guidance Note. Safe disposal of clinical waste whole hospital policy guidance. (1995) NHS Estates, The Stationery Office, London. ISBN 0-11-322196-7.

STANDARD E4: There is a staff appraisal system

Guidelines:

1. There should be documentary evidence of regular appraisal for all members of staff.

2. There is confirmatory evidence of support for needs identified through the appraisal process.

3. All staff members undertaking appraisal should be trained in appraisal techniques. Other staff should be familiar with the purpose and process of appraisal.

When CPA first went 'live' in 1992, it was widely recognised that 'all the standards were equal but some were more equal than others'. While non-compliances with standards relating to professional direction or health and safety matters, for instance, were enforced strictly, others such as E4 (then E5) were interpreted more flexibly. Many laboratories had rudimentary or non existent systems of staff appraisal at first : now, nearly all have them, at least for most groups of staff. In university hospital pathology departments, consultants with academic appointments are well used to appraisal; so are doctors in training, through regular annual appraisal and documented assessments. Biomedical and clinical scientists have generally welcomed the introduction of appraisal. Within the laboratory, the missing link in the appraisal process is the NHS Consultant Pathologist. While some Trusts have successful annual appraisal and planning programmes, these are the exception not the rule.

Recognising this significant gap in Standard E4, CPA (UK) Ltd has been in dialogue with the Pathology Subcommittee of the Central Consultants and Specialists Committee of the BMA, the British Association of Medical Managers, and the Royal College of Pathologists. In August 1998, the BMA published its statement on 'Appraisal for Senior Hospital Doctors'(1).

The term 'appraisal' is open to misinterpretation but CPA believes that there should be some form of regular discussion between an individual consultant and the clinical or medical director, looking at the consultant's personal and professional development and providing a framework of support that enables the consultant to fulfil his or her responsibilities to the organisation.

The key element is that the appraisal process is supportive not confrontational. Appraisal is designed to help the individual to progress : it should consider job plans, service management, teaching, training and CPD. Appraisal is also a two-way process : it includes the organisation's responsibility to the consultant in providing appropriate support and facilities as well as the consultant's responsibilities to the organisation to meet the job plan and agreed key objectives. Appraisal, in this context, is not an assessment of the professional competence of the individual consultant : this aspect is rightly the responsibility of the General Medical Council assisted by the Royal Colleges.

In the light of recent developments, the Board of CPA has agreed that the appraisal of the non-clinical work of consultant staff is a necessary requisite for full compliance with Standard E4. Consultant staff appraisal should be in place by 1 April 2000: after this date, lack of appraisal will become a condition for accreditation.

Reference

1. British Medical Association.

Appraisal for Senior Hospital Doctors : Statement from the Central Consultants and Specialists Committee (CCSC). August 1998.

Microbiology Specialist Advisory Committee Chairman

We would like to take this opportunity to wish Professor Colin Roberts a long and happy retirement. Colin has been a member of the CPA Microbiology SAC from the beginning. In 1992 he was the PHLS nominated representative and was subsequently nominated by the Royal College of Pathologists. He has been Chairman of the Committee since April 1996. He will be missed by everyone at CPA and his contribution has been greatly appreciated.

Dr Mark Hastings from the Queen Elizabeth Hospital, Birmingham has succeeded him as Chairman.

CPA Annual Conference 2000

This will be held in London on 15 March 2000; details will be mailshot to all addresses on the CPA database during the first week in January. The registration fee has been maintained at £95.

The programme will include:

· modernisation of pathology
· report on the manpower research project commissioned by CPA
· the revised CPA standard
· how to write a standard operating procedure
· how to prepare a Quality Manual.

Diary Dates

15 March 2000

15-17 May 2000

26 September 2000

28 September 2000

3 October 2000

4 October 2000

10 October 2000

11 October 2000

To be advised

CPA Annual Conference - London

Pathology 2000 - Birmingham

Inspector Update - Edinburgh

Inspector Update - London

Inspector Update - Bristol

Inspector Update - Birmingham

Inspector Update - London

Inspector Update - Sheffield

CPA(EQA) Inspector Update & Participants Meeting