Accredia / Medical analyses / Prevention and treatment of oncological diseases: one step further with accreditation

Prevention and treatment of oncological diseases: one step further with accreditation

24 November 2022

The medical laboratories of the Oncological Center of Aviano and the Pediatric Oncohematology of Padua are accredited according to the UNI EN ISO 15189 standard. The first structures to obtain accreditation in Italy for medical analyses dedicated to the fight against cancer.

An important step forward in the fight against tumours was taken with the accreditation of the Italian medical laboratories of the IRCSS Oncological Reference Center – Department of Research and Advanced Cancer Diagnostics in Aviano (province of Pordenone) and of the University Hospital of Padua UOC Pediatric Oncohematology. Both laboratories have been accredited by Accredia according to the international standard UNI EN ISO 15189 “Medical laboratories – Requirements for quality and competence”.

This is the first case of accreditation in Italy of two structures entirely dedicated to medical analysis for the prevention, diagnosis, treatment and rehabilitation of oncological diseases. To issue the accreditation, Accredia verified the competence of the laboratory to conduct the tests following the requirements defined in the standard. These checks are repeated periodically to ensure that the requirements are maintained over time.

Accreditation according to ISO 15189 ensures quality laboratory medical care in line with a standard of excellence that brings together the best rules defined at an international level, recognized and adopted throughout the world, for the benefit of both patients and healthcare professionals. Laboratory medicine is of increasingly central importance within the system of prevention, diagnosis, monitoring and guidance of therapies, including oncological ones. It is estimated that today about 80% of clinical decisions are based on tests performed by medical laboratories.

The standard provides for the verification, both in terms of conformity of the management system and of technical adequacy of the laboratory, of all the processes involved in the conduct of the accredited tests, in terms of: personnel competence, appropriateness of the tests, sampling and transport of samples, work environment, metrological traceability of results, quality assurance, interpretation of test results by medical staff and communication of the outcome to the patient.

The attestation issued by Accredia flanks, without replacing it, the so-called institutional accreditation of the National Health Service, and is a complementary tool, aimed at improving health services and the efficiency of the medical laboratory, and ensuring that the results of the analyses are reliable, with the aim of protecting public health and offering the community safe and quality healthcare.

In particular, the laboratory of the Oncological Reference Center of Aviano has accredited the tests concerning the therapeutic monitoring of oncolytic drugs, the research into mutations and somatic rearrangements, genetic tests for mutations and germline polymorphisms.

The Pediatric Oncohematology Laboratory of Padua has accredited research regarding the main genetic-molecular lesions associated with leukemia, such as NOTCH1 and FBXW7 mutations, the t(8;14) and t(2;5) translocations. It has also accredited the screening for research into Soft Tissue Sarcomas and the mutagenic analysis with the NGS system and Sanger sequencing.