An important step forward in the fight against cancer in Italy was taken with the accreditation of the first structures for prevention and treatment of oncological diseases. The 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 have been accredited by Accredia, the Italian Accreditation Body, according to the international standard 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 laboratories to conduct the tests following the requirements defined in the ISO 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, including 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 accreditation of the laboratory of the Oncological Reference Center of Aviano includes 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 accreditation includes 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. The accreditation also covers the screening for research into Soft Tissue Sarcomas and the mutagenic analysis with the NGS system and Sanger sequencing.