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Interview with Dr. Mª Antònia Llopis Diaz, Director of Clinical Laboratories at the Hospital Assistance Directorate in the Catalan Institute of Health

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4 March 2025 Interviews

“Offering ENAC accredited services brings great peace of mind and confidence to our users, doctors and patients”

The Pathological Anatomy Service of the Joan XXIII University Hospital has recently obtained ENAC accreditation for their diagnostic activity, specifically in the areas of Histopathology, Cervico-vaginal Cytology and complementary techniques (Histochemistry and Immunohistochemistry). With this accreditation, the Catalan Institute of Health now has ENAC-accredited services in all its hospitals with different scopes according to the UNE-EN ISO 15189 standard. Specifically, these are the clinical laboratory or pathological anatomy services of the Joan XXIII University Hospital in Tarragona, the Bellvitge University Hospital, the Dr. Josep Trueta University Hospital in Girona, the Vall d'Hebron University Hospital in Barcelona, the Verge de la Cinta Hospital in Tortosa, the Arnau de Vilanova University Hospital in Lleida and the Germans Trias I Pujol University Hospital in Badalona and the Viladecans Hospital.

Dr. Mª Antònia Llopis Díaz, Director of Clinical Laboratories in the Hospital Assistance Directorate of the Catalan Institute of Health (ICS), explains the motivations for putting their trust in accrediting their diagnostic services and the benefits it has brought them.

From the moment the Bellvitge University Hospital obtained the first accreditation for its Clinical Laboratories in 2008, to the present day. What has motivated you to put your trust in accreditation??

The initial motivation for seeking the ENAC accreditation was to ensure that our laboratories met the highest standards of quality and technical competence.

ICS clinical laboratories have more than 25 years’ experience in quality management system certification, when they started in 1998 with ISO 9002. With the transition to ISO 9001 and the incorporation of process management, the ICS clinical laboratories' Quality group was created, an international benchmark in the search for quality indicators and specifications.

Therefore, accreditation has been a logical consequence of our trajectory in quality management and continuous improvement. It has meant taking a step further, providing us with external validation of our processes, which are carried out by expert professionals within Laboratory Medicine.

We continue to rely on accreditation because it drives us towards innovation and keeping up with best practices. Thereby, year after year, new techniques are incorporated within the scope of these accreditations, helping our services achieve global excellence.

How has the overall experience of the accreditation process been (from application to granting accreditation)?

The accreditation process has been rigorous but very enriching. Since the initial application, we have worked closely with ENAC to review and improve our procedures. Detailed assessment and audits have allowed us to identify areas for improvement and strengthen our quality management systems. Granting us accreditation has been a recognition of the effort and dedication of our entire team.

UNE-EN ISO 15189 is the reference standard for clinical laboratories. What has the ENAC accreditation in accordance with the standard brought you over the years?

Having ENAC accreditation in accordance with the UNE-EN ISO 15189 standard has brought us numerous benefits. It has helped us standardize our processes, improve the accuracy and reliability of our results, and increase operational efficiency.

In addition, it has strengthened our culture of quality and facilitated our continuous staff training, ensuring that everyone is aligned with international standards.

What do you think offering ENAC-accredited services brings to your users, doctors and patients?

Offering ENAC accredited services brings a great peace of mind and confidence to our users, doctors and patients.

They know that they are receiving high-quality services which meet international standards. For doctors, this means they can rely on the accuracy and reliability of lab results, which is crucial for diagnosing and treating patients. For patients, it represents a commitment to their well-being and safety.


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