Conditions of Participation by UK Clinical Laboratories in External Quality Assessment Schemes.

Staff responsible for the management of a clinical laboratory need to monitor the quality of the service they provide. Objective evidence of the quality of individual investigations, available through participation in external quality assessment schemes (EQAS), is of particular importance for this purpose. These conditions apply to any laboratory offering a service to patients in the United Kingdom directly or indirectly (e.g. by generating data for the Committee on Safety of Medicines or for medical research).

EQAS cover a wide range of investigations across the disciplines of pathology. Each Scheme has a Steering Committee that advises the Organiser on its overall operation. Executive responsibility for maintaining satisfactory standards of investigation in clinical laboratories in the public and private sectors is vested in National Quality Assurance Advisory Panels (NQAAP) which represent the professional bodies and are not Government agencies. At present there are Advisory Panels for Chemical Pathology, Haematology (including Blood Transfusion), Medical Microbiology, Immunology, Histopathology (including Cytology) and Cytogenetics [and Molecular Genetics], and further Panels are being constituted as required.

The Head of the laboratory will be responsible for registering the laboratory with the scheme as a participant in the appropriate EQAS(s), indicating which investigations within the Scheme the laboratory performs and for which it should be registered, and ensuring any necessary payment is made. All such investigations which the laboratory performs as a clinical service must be included in participation. Any changes in the laboratory's requirements in this respect, or in information necessary for effective Scheme operation, must be notified in writing and in advance to the appropriate Organiser.

Samples, reports and routine correspondence may be addressed to a named deputy, but correspondence from Organisers and NQAAP concerning poor performance or unsatisfactory return rates will be sent directly to the Head of the laboratory.

EQAS samples must be treated in the same way as clinical samples.

The EQAS code of the laboratory and the assessment of individual performance is confidential to the participant, and will not be released by the Scheme Organisers to any third party other than the Chairman and members of the appropriate NQAAP and, in specified circumstances, the Chairman of the Joint Working Group on Quality Assurance without the written permission of the Head of the laboratory. The identity of the participants (name of laboratory and Head of Department) and the tests for which they are registered (but not details of performance) may be released, on request to the Scheme Organiser, to the Health Authority, hospital/private company in which the laboratory is situated.

Each Scheme has criteria for poor performance. When a laboratory shows poor performance or fails to return results, the Organiser will generally make informal contact with the participant. If performance fails to improve, the Organiser will notify the Chairman of the appropriate NQAAP. Advice is then offered to the Head of the laboratory by contact in writing or, where appropriate and very rarely, following a visit to the laboratory from a NQAAP member or appropriate expert (if agreed). If a problem becomes intractable, a NQAAP may enlist the help of the Chairman of the Joint Working Group on Quality Assurance.


A NQAAP may, with the written permission of the Head of a laboratory, correspond with the Authority responsible for the laboratory about deficiencies in staff or equipment which, in the opinion of the NQAAP members, prevent the laboratory from maintaining a satisfactory standard.

If the problem remains unresolved and the participant's poor performance persists, the NQAAP Chairman will submit a full report to the Chairman of the JWG. With specialist advice, a sub group of appropriate composition nominated by the JWG would be formed for a site meeting. If such action fails to resolve the problem and with the agreement of the specialist members of the group, the Chairman will inform the Medical Director, or nearest equivalent within the organisation, of the Trust or Institution of the problem, the steps which have been taken to rectify it and, if it has been identified, the cause of the problem.

Problems relating to EQAS, including complaints from participating laboratories, which cannot be resolved by the appropriate Organiser, Steering Committee or NQAAP will be referred to the Chairman of the Joint Working Group on Quality Assurance.

All reports, and the data they contain, issued by EQAS Organisers are Copyright and may not be published in any form without the permission of the appropriate Steering Committee.

Dennis Kilshaw, Secretary, Joint Working Group on Quality Assurance.