Acreditacion

PRINCIPLES OF CLINICAL LABORATORY ACCREDITATION
A POLICY STATEMENT BY THE INTERNATIONAL FEDERATION OF CLINICAL CHEMISTRY AND LABORATORY MEDICINE (IFCC) and THE WORLD ASSOCIATION OF SOCIETIES OF PATHOLOGY AND LABORATORY MEDICINE (WASPaLM)

1. THE PURPOSES AND NATURE OF LABORATORY ACCREDITATION It is in the interests of patients, of society, and of governments that clinical laboratories operateat high standards of professional and technical competence, for the following reasons: • Decisions about diagnosis, prognosis and treatment are frequently based on the results and interpretations of laboratory tests, and irreversible harm may be caused by erroneous results • Users of clinical laboratory services (both patients and clinicians) may not have sufficient technical knowledge to allowthem to determine whether a laboratory operates at a satisfactory level • Patients, and to a lesser extent clinicians, may have no choice about the laboratory to be used • Laboratory testing can be expensive and the patients, insurance organisations, or governments who pay for testing expect the laboratory to provides valid information

1

• It is in the interests of competent laboratories thattheir competence is verified through a process of inspection, comparison against appropriate standards, and public affirmation of their good standing. Accreditation is an external audit of the ability of a laboratory to provide a high quality service. This requires a laboratory to submit information demonstrating: • conformity with published accreditation standards, • existence of a managementsystem addressing internal and external measures of quality, outlined in a quality management manual, and • a qualified expert appraisal by an accreditation body. 2. SCOPE AND ADMINISTRATION • Inspection and accreditation processes should include all laboratories and in-vitro diagnostic activities, including physician office laboratories and point-of-care testing. • Accreditation should be based oninspection visits and peer review, in addition to provision of information to an inspection agency. The aims of the accreditation system should include improvement of standards of practice through dissemination of information and through continuing professional education. • Standard-setting and the inspection process should be implemented by accreditation bodies in which medical and scientificprofessional societies are strongly represented. Government agencies or health insurance organisations should participate in these bodies to the extent necessary to ensure acceptance and public accountability of the accreditation system. The accreditation system should be revised regularly. The major responsibility for standard-setting remains with the medical and scientific professionals engaged inclinical laboratory work.

3. ASSESSMENT CRITERIA Standards should be defined by the accreditation body and assessed by peer review. The standards should include: • Organisation and administration This includes the existence of an appropriate administrative and staffing structure, with documentation of accountability and responsibilities. • Staff qualifications There must be sufficient staffwith appropriate education and training, with provision for continuing education and assurance of staff competencies.

2

Staff performing testing should have post-secondary education in appropriate scientific disciplines, and training in laboratory procedures. Laboratory directors may have initial university qualifications in medicine or science, or another initial university qualificationdeemed appropriate by individual national policy; but must have specialised post-graduate professional education and training in clinical laboratory work. • Facilities The working environment must be safe for staff and patients, and sufficient and appropriate for the work. Equipment, materials and reagents must be of suitable quality and appropriate for the purposes for which they are used. •...