- Incorporates the molecular study of the human papillomavirus
The Central Clinical Laboratory, which serves six public hospitals in the Community of Madrid, has renewed and expanded the scope of the accreditation granted by the National Accreditation Entity (ENAC). Specifically, this year the molecular study of the human papillomavirus (HPV) has been included in the scope and evidence has been provided that has allowed the activity to be endorsed under the new version of the ISO 15189:2023 standard, which places emphasis on safety. of the patient, the risk-based approach and the promotion of continuous improvement.
The accreditation process involves a thorough evaluation of the laboratory's management and technical requirements, such as the qualification of personnel, the necessary equipment and infrastructure, whether it applies validated and appropriate work methods and procedures, and whether it ensures the traceability of measurements and calibrations. That is, it involves formal and public recognition of technical competence.
This organism functions as a ring formed by a central laboratory, located at the Infanta Sofía Hospital in San Sebastián de los Reyes, and six other peripheral ones. It serves six public hospitals in the region (Infanta Sofía, Infanta Leonor, Henares, Infanta Cristina, Sureste and Tajo) and three Primary Care Directorates (North, South and Southeast), with more than 160 health centers, local offices , in addition to residences and health centers, with a current assigned population of nearly 1.300.000 citizens.
Scope of accreditation since 2015
The Central Clinical Laboratory obtained this accreditation in 2015, which at that time included most of the activity of the core, as well as hematimetry and flow cytometry. In 2016, 2017 and 2019, it was renewed and expanded its scope to other areas, such as autoimmunity, cytogenetics, molecular biology, study of urine sediments and positive blood culture.
In November 2020, in the midst of the COVID-19 pandemic, it passed the system maintenance review audit and a year later it decided to include the flexible scope model in the area of molecular biology, also incorporating the Molecular study of SARS- CoV-2, obtaining accreditation for this study in March 2022. A few months later, in July of that year, it also opted for changing the accreditation model of the core of the central laboratory, going from a fixed to a flexible scope that allows the incorporation of techniques.
Finally, in 2023 the first external audit carried out in the core of the central laboratory, after a complete change of technology, also including, as mentioned before, the HPV PCR study. Currently, the scope of accredited information produced annually by the central laboratory is greater than 92%.
