According to the IFCC statement (International Federation of Clinical Chemistry and Laboratory Medicine) It is in the interest of patients, society and governments that Medical Laboratories operate at a high level of professional and expert competence.
- Decisions about diagnosis, prognosis, and treatment are often based on the results and interpretation of laboratory tests. Erroneous results or interpretations can cause irreversible harm to the patient.
- Users of medical laboratory services (patients, doctors) may not have sufficient ability to assess whether the laboratory is operating at the desired level.
- Patients and, to some extent, doctors may be limited in their choice of laboratory.
- Those who pay for often expensive laboratory tests (taxpayers, patients, and health insurance companies) want to be sure that laboratories produce valid information.
Laboratory accreditation means the formal recognition of the professional and organizational competence of a laboratory to perform a specific service, as described in the scope of the laboratory accreditation. Competence is key to the transparency, reliability and comparability of laboratory activities.
According to the IFCC, it is in the interest of every well-functioning Medical Laboratory to have its competence independently assessed. Based on the positive result of the assessment according to the relevant standards, the laboratory can then publicly demonstrate the high quality of its work.
Accreditation is based on the principles of:
- independence,
- non-discriminatory approach,
- clearly defined and documented assessment criteria,
- transparency of assessment processes.
An accredited laboratory provides services at a high professional level and demonstrates:
- compliance with the requirements specified in the relevant standard,
- the functionality of the established quality management system, including internal and external quality assurance, which is documented in the quality manual, or in other related documents.
- Experts recommended by individual professional medical societies, trained in the requirements of relevant standards, accreditation principles and audit practices, participate in the assessment within the framework of accreditation.
Accreditation of medical laboratories is carried out according to the internationally valid standard ČSN EN ISO 15189, as recommended by IFCC organizations and health insurance payers.
Accreditation and legislation
Accreditation is currently regulated in the European Union by a set of regulations of the European Parliament and of the Council No. 765/2008. An accreditation system operating according to binding rules contributes to strengthening mutual trust in the professional competence of conformity assessment bodies and therefore trust in the output documents issued by them (test reports/result sheets or certificates of conformity). Public authorities of the EU Member States should consider accreditation as a privileged means of demonstrating the professional competence of conformity assessment bodies.
Accreditation of medical laboratories is a regular agenda of accreditation bodies associated in EA (European Co-operation for Accreditation) or ILAC (International Laboratory Accreditation Co-operation).
These accreditation bodies operate in accordance with the requirements of ISO/IEC 17011 and compliance with these requirements set out in this international standard is subject to regular audits, the successful completion of which is a condition for being a signatory to the EA Multilateral Agreement (EA MLA) or ILAC (ILAC MRA).
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