Medical Laboratory Accreditation - The Road Ahead

Abstract

Medical laboratories can seek recognition as being compliant with particular standards through a number of different systems. Recognition of medical laboratories handling clinical specimens as distinct from those dealing with the results of pre-clinical studies are in their infancy in most European countries. A laboratory accreditation system contains three elements, the organisation or authority which conducts the inspections or assessments and grants accreditation (and may also set the standards), the inspection or assessment which seeks to establish compliance with the standards, and crucial to the whole process the standards themselves. In most European countries the emphasis has been on development of standards and quality manuals and practical experience in all three elements of accreditation is, with a few exceptions, is very limited. In other parts of the world, such as USA, Canada and Australia there is depth of experience from which other countries can learn. Accreditation systems in different parts of the world have developed in different ways but almost always with the active involvement of laboratory professionals. In Europe different countries have one, or occasionally more, National bodies mandated by government to accredit laboratories according to EN 45001:1989, ‘General criteria for the operation of testing laboratories’-ISO/IEC Guide 25 or to accredit certifying bodies who perform third party assessments to ISO 9000 quality systems standards. These bodies for example SWEDAC in Sweden, RvA in The Netherlands and UKAS in the UK are members of the European Co-operation for Accreditation (EA). National members of EA conduct themselves in accordance to the ISO/IEC Guide 58:1993 ‘Calibration and testing laboratory accreditation systems General requirements for operation and recognition’. An EA Committee in the Health Care Sector has been formed encompassing a sub group on laboratory accreditation. The membership of this subgroup is not limited to official National bodies (3-4) but includes 3 members from accrediting bodies such as Clinical Pathology Accreditation (UK)Ltd from the United Kingdom and CCKLTest from The Netherlands who work closely with their respective official National bodies. UKAS has recently signed a ‘Declaration of Intent to Cooperate’ with CPA(UK)Ltd) and RvA has trained inspectors together with CCKLTest for a number of years. In addition there are on the sub committee, 6 members from the pathology professions and one member from the European Diagnostics Manufacturers Association (EDMA). At the present time there are a multiplicity of draft international standards; ISO 9001:2000 ‘Quality management systems requirements’, ISO/IEC DIS 17025 ‘General requirements for the competence of testing and calibration laboratories’ (Revision of EN45001:1989-ISO/ IEC Guide 25) and ISO/CD 15189 ‘Quality Management in the medical laboratory’, which could be used by medical laboratories to signify compliance with standards of excellence. An understanding of the evolutionary history of these standards and the work of other groups such as the European Communities Confederation of Clinical Chemistry (EC4) is important in trying to understand the convergence of the certification and accreditation approaches to the recognition of a quality laboratory service. The word standard has different meanings in different settings, in ‘ISOspeak’ it means a normative document in which there are clauses and sub clauses whereas with the College of American Pathologists (CAP) and Clinical Pathology Accreditation (UK)Ltd the clause level is called a standard and the standard may or may not have clauses. In the past the countries, such as the USA, with longer history of hospital and medical laboratory accreditation have tended not to be as involved in the formulation of international standards through ISO. In recent years however the National Council for Clinical Laboratory Standards (NCCLS) have held the Secretariat for ISO/TC 212/ WG1 which is responsible for the emerging ISO/CD 15189, the first international standard specifically for quality management in medical laboratories. It is important that standards should be written clearly, be practicable and credible and verifiable on inspection and preferably be generic in form, that is applicable to all disciplines or situations. International standards should be written in accordance with ISO Directive, ISO/IEC Directives, Part 3:1997, Rules for the structure and drafting of individual documents and can have a number of distinct intentions. Three of the most important are (a) to specify a product, material process or system (requirements), (b) to give recommendations (guidelines) and (c) to clarify concepts and/or classify terms and vocabulary (concepts and vocabulary). Requirements are written using the auxilary verb, ‘shall’ and recommendations using ‘should’. Standards which are written as guidelines are often explanatory to a parallel generic standard of requirements. It is the task of the accreditation organisations or authorities to conduct the inspections or assessments and grant accreditation. It is vital that these inspections are done in an objective manner as possible. The frequency and length of inspections varies in different countries as does the nature, content and length of the training of inspectors. Some countries use full time inspectors but generally inspectors are practising laboratory professionals and the practicalities of maintaining an inspection frequency of less than once every four years are very real. It is proposed that, an intermediate reporting mechanism perhaps through the laboratory submitting an internal ‘management review’ report annually to the accrediting organisation, would mitigate these difficulties. In Europe, the EA Health Care Sector sub group on laboratory accreditation has a major role to play in seeking a harmonised approach to the assessment process and to standard setting whilst respecting the European Community principle of subsidiarity. Subsidiarity, (an uncomfortable addition to the English language) means allowing decisions to be made at the lowest practicable level and this means in Europe at national level. The role of EA should be to ensure that the national accrediting organisations conduct inspections or assessments in compliance with ISO/IEC Guide 58 and that the standards for medical laboratories used by individual organisations meet as a minimum the requirements set out in ISO 15189. In Europe as in other parts of world groupings of countries into organisations such as EA will ensure harmonisation, remove barriers to trade and the free movement of laboratory professionals whilst maintaining the high standards of practice essential to the proper care of patients. The ‘Road Ahead’ looks set to have many road works and diversions which will impede progress, but as Bill Gates says at the end of his book concerning the information highway, ‘The network will draw us together, if that’s what we choose, or let us scatter ourselves into a million mediated communities’, The choice is ours! n