After consolidating the application of the ISO 15189 accreditation standard in traditional laboratory medicine disciplines, Accredia, the Italian Accreditation Body, is extending accreditation to medical analysis laboratories that perform neonatal screening.

Extended newborn screening (ENS) is one of the most advanced areas of preventive healthcare. Through a drop of blood collected in the first hours of life, ENS allows for the early detection of over 50 rare diseases. This improves the quality of life for patients and their families while reducing costs for the National Health Service.

In Italy, screening is regulated by Law 167/2016, which provides for mandatory neonatal diagnostic tests to prevent and treat hereditary metabolic diseases. However, the law’s effectiveness depends on the system’s ability to ensure uniform execution and reliable results. Currently, only some of the laboratories performing SNE are accredited by Accredia.

A project for individuals and society

ENS is a critical area of clinical and social importance, requiring a dedicated approach from the conformity assessment system. This approach should aim to build an accreditation model that respects the unique characteristics of the public health sector while guaranteeing technical competence and reliable results.

To begin this new chapter in laboratory medicine, Accredia has chosen to start by listening. The first objective was understanding the specific operational characteristics of screening programs, regional networks, organizational flows, and the needs of the professionals involved.

The project is now in the initial phase of stakeholder involvement—including healthcare institutions, scientific societies, professional associations, and citizen representatives—and the strategy will be gradual and participatory. It started with laboratories that have proven experience and well-established quality systems. Then, it will progressively extend accreditation to other centres according to a shared plan.

The strategy of dialogue and cooperation

This approach follows Accredia’s efforts to promote ISO 15189 accreditation for medical laboratories throughout Italy. These efforts began about a decade ago, when Italy was far behind other European countries.

Over the past eight years, Accredia has developed and consolidated the ISO 15189 accreditation system, achieving accreditation for 50 medical laboratories and establishing a national model based on collaboration, active listening, and the gradual implementation of requirements.

From the beginning, Accredia understood that the success of ISO 15189 accreditation depended on listening carefully to medical laboratory workers. To this end, the Accreditation Body collaborated with major Italian scientific societies, including SIBioC, SIPMeL, AMCLI, SIAPeC, and SIGU, which represent various disciplines within laboratory medicine.

Together, they defined the scope of accreditation using clear, discipline-specific language to bridge the gap between standard requirements and professional practice.

The national scientific societies also helped identify sector experts, who were then trained by Accredia to become technical assessors. Training sessions were organized to interpret the requirements and address challenging aspects such as measurement uncertainty, verification, and validation.

A gradual and realistic approach

A key element of the Italian experience was the progressive introduction of requirements, which allowed laboratories to adapt step by step. Accredia encouraged laboratories to begin with a limited number of validated examinations and extend their accredited scope during subsequent surveillance as their quality systems matured.

This pragmatic approach has been successful, helping in reducing difficulties, build confidence, and demonstrate that ISO 15189 accreditation can be a driver of improvement rather than a burden.

To promote a culture of quality and raise awareness among professionals and the general public about the value of competence and accreditation in healthcare, Accredia participated in scientific congresses, professional meetings, and television programs.

Meanwhile, Accredia collaborated with national and regional authorities to define requirements for medical laboratories. One notable example is the Autonomous Province of Trento, which, after developing a feasibility plan with Accredia, made accreditation mandatory for medical laboratories. This marked an important step toward harmonization and improved quality across the system.

All disciplines included

Today, all major fields of laboratory medicine — clinical biochemistry, hematology, microbiology, genetics, and pathology — are represented among accredited laboratories. Genetics, in particular, is experiencing significant growth, reflecting innovation and confidence in the accreditation process.

Accredia has also extended accreditation to pre-analytical processes and point-of-care testing (POCT), taking a comprehensive approach to quality throughout the diagnostic process.

Listening, supporting, and growing together

The Italian experience demonstrates that addressing professionals’ challenges, recognizing their expertise, and gradually introducing requirements are essential for developing a robust and shared accreditation system.

Through dialogue and cooperation, Accredia has helped laboratories view ISO 15189 as a trusted ally for improving quality, competence, and confidence in healthcare services rather than as an external obligation.