La rete di Medicina di Laboratorio del terzo millennio

Abstract

On January 12, 2026, the Italian Council of Ministers approved a draft enabling law (DDL) implementing the 2026 Stability Law. This bill marks, among other things, a departure from Ministerial Decree 77 of May 22, 2022, entitled "Regulation establishing models and standards for the development of community-based healthcare in the National Health Service." The bill aims to reorganize community-based and hospital-based healthcare by December 31, 2026, but the already scheduled implementing decrees and related decrees remain to be issued. The enabling law, in short, provides for the reorganization and strengthening of local and hospital care and the revision of the organizational model of the National Health Service, established 43 years ago, innovating the reforms set out in Legislative Decree 502 of 30/12/92 and subsequent amendments (Legislative Decree 517 of 7/12/93 and Legislative Decree 229 of 19/6/99). The enabling law thus represents a fundamental step towards a more efficient, modern and more people-oriented National Health Service, in compliance with the principles of equity and continuity of care. Laboratory Medicine, which represents another strategic pillar of the National Health Service, cannot be excluded from this process of change. Today, the need to orient Laboratory Medicine towards models that integrate clinical value, appropriateness and sustainability is highly topical. In the debate on sustainability, diagnostics in the last decade has often been seen as an expense item to be contained even if at the same time it impacts the 70% of clinical decisions, accounting for approximately 2.5% of healthcare spending. Diagnostics is not a cost; it is, in fact, a strategic decision. This statement overturns the traditional view that considers diagnostic activities in healthcare as a mere expense to be reduced. Instead, they represent an investment in knowledge, efficiency, and prevention, capable of generating value, future savings, and a competitive advantage. The reform of the National Health Service aims to build a more modern and integrated care model, capable of overcoming the traditional separation between community and hospital healthcare, especially considering that community healthcare was one of the areas that showed the greatest criticality during the Covid-19 pandemic. Community and hospitals must be considered as parts of a single system, therefore the reform envisages the strengthening of community medicine, supported by investments from the National Recovery and Resilience Plan (PNRR). It is not conceived as an alternative to hospitals, but as a component of a unified system. This path, according to the Ministry, must be translated into not only in new structures and investments, but also in organizational and cultural change capable of bringing the NHS more closely aligned with citizens' real needs. Laboratory Medicine, especially with decentralized analyses, could play a prominent role by evolving the hub-and-spoke model into a network model. The transport of biological samples will also play a decisive role in improving the system's efficiency, but there is a need for national legislation that overcomes regional fragmentation, at least with a framework law that leaves room for the specificities of individual regions, especially for decentralized analyses and the transport of biological samples, allowing them to adopt organizational models that better meet their needs. Information technology (IT) is also essential in this area for the traceability and quality of the entire process. In this sector too, new technologies, not only instrumental (e.g., drones), can revolutionize the specific sector with solutions tailored to specific situations (e.g., islands, mountain resorts, etc.). In this context, the Technical Document on Point-of-Care Testing (POCT) in the Local Area, supporting the implementation of Ministerial Decree 77/2022, published by the National Health Agency for Regional Services (AgeNaS) in January 2026, is particularly important. The ever-increasing availability of POCT equipment is driving continuous change in the medical landscape, making care, based on Evidence-Based Medicine (EBM), increasingly personalized for patients. The new role of POCT Manager requires technical training, typically provided by graduates in Biomedical Laboratory Techniques, with participation in specific advanced training courses and second-level Master's degrees in POCT management, which must be included in postgraduate university training. The POCT Manager works to optimize the use of rapid tests both in hospital settings (e.g., emergency rooms, intensive care units, etc.) and in the community. In our opinion, these figures must also receive a salary appropriate to the new professional role, as already initiated in some regions with specific competition notices (e.g., Veneto, Lombardy, Tuscany, and Emilia Romagna) with the role of Specialist Professional Function which provides an additional allowance on top of the basic salary. A Position and Performance Allowance must also be added as an organizational or professional position. The POCT Manager is entitled to additional compensation. For similar positions, the position (additional) compensation may vary, according to local collective bargaining agreements, with gross annual amounts defined based on the complexity and grade of the role. AGENAS views the Laboratory Medicine Department not as a simple laboratory, but as a functional unit integrated into the care pathway, capable of ensuring appropriate responses to clinical needs while optimizing financial resources. The Agenas Guidelines propose the reorganization of Laboratory Medicine within the National Health System (NHS) through a structural Department or integrated models. The goal is to overcome fragmentation, ensuring sustainability, quality (appropriateness), and the development of technical skills within a defined care network.