El Pathological Anatomy Service of Parc Taulí has received the UNE-EN ISO 15189:2013 accreditation granted by the National Accreditation Entity (ENAC) in the specific area of the diagnosis of gynecological pathology that includes biopsy samples and gynecological pieces and the detection and genotyping of the human papilloma virus (HPV).
An auditor expert in process management and an auditor expert in the technologies and tests that have been accredited have intervened in the ISO 15189 accreditation process. In order to achieve accreditation, the system of making retrospective and prospective reviews of the diagnoses carried out in the Service has been incorporated, and participation in quality programs of external agencies has been expanded.
The Pathological Anatomy Service in 2017 obtained the certification of its Quality Management System in accordance with the UNE-EN ISO 9001:2015 standard for the following activities: "Anatomopathological and molecular diagnostics of biopsies, cytology, autopsies and biomarkers. Assistance, organizational, teaching and research aspects".
The new accreditation is more focused on guaranteeing the quality of diagnostics and analytical test results, unlike ISO 9001 which ensures that processes conform to what is established. ISO 15189 is applicable for those tests carried out that do not have the CE-IVD marking, European regulations that regulate the quality requirements of both technological equipment and the reagents and products used to obtain test results vitro.
The director of the Pathological Anatomy Service, Joan Carles Ferreres, emphasizes that this new accreditation "it represents a qualitative leap compared to the ISO of 2017, since it guarantees that the diagnoses we make are within quality standards and that we have equipped ourselves with mechanisms to guarantee that this is the case".
The coordinator of the quality of the Service, Joana Gallardo, stands out "that the certification is the result of more than a year and a half of work by a team of forty-four professionals: pathologists, pathological anatomy residents, molecular biologists, cytotechnicians, technicians specializing in pathological anatomy and cytopathology, and administrative staff". These professionals respond to practically all the needs of the institution regarding the morphological and molecular diagnosis of anatomopathological samples.
Three hospitals in Catalonia are accredited with ISO 15189 for part of the anatomopathological diagnosis: the Hospital de Bellvitge and Parc Taulí the part of gynecological pathology (biopsies and gynecological cytology and HPV) and the Hospital de Sant Pau the part of tumors bones and soft parts. Other hospitals have only molecular tests accredited. Parc Taulí is the center of reference for the detection of HPV in Sabadell and in outpatient clinics and hospitals in Terrassa and also carries out the study of cytology from Sabadell outpatient clinics.
In the Pathological Anatomy Service, a wide range of technological resources, many of them molecular studies, is applied to the morphological diagnosis of the samples, in the cases where it is necessary, to guarantee the achievement of maximum reliability in the diagnosis . Last year, 20.907 biopsies (31.657 samples), 15.356 cytologies and 8.376 HPV determinations were diagnosed, among other studies.
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