Developing and enhancing all the professional activities for a successful future of Laboratory Medicine

AUTORI

ABSTRACT

Laboratory Medicine has undergone significant evolution in recent decades, shifting its focus from emphasizing high quality in technical aspects to achieving diagnostic excellence. The “Manifesto” proposed by Plebani et al. some years ago, underscores the central role of Laboratory Medicine in the diagnostic-therapeutic process, outlining the challenges and opportunities facing the discipline. It emphasizes the crucial role of laboratory professionals in addressing these challenges and promoting its advancement. The competencies and roles of laboratory professionals in different laboratory activities need continuous development and re-evaluation to effectively manage the rapid advancement of science and technology, the complex organizational models, the increasing burden of chronic diseases, decentralized healthcare systems, and disparities in Health Information Technology access. Furthermore, the ability to collaborate with clinical specialists is emphasized as essential for highlighting the value of laboratory medicine in the clinical pathway. Similarly, the support of professionals from different disciplines in using new management tools and technologies, such as artificial intelligence and big data, can ensure the reliability of derived information and compliance with ethical considerations, data privacy, and security. In conclusion, the Manifesto advocates for a patient-centered approach and the recognition of laboratory professionals’ skills and abilities to secure a promising future for Laboratory Medicine. It emphasizes the importance of adaptation, collaboration, and continuous development to meet the challenges of an evolving healthcare landscape. The successful future of Laboratory Medicine depends on the dedication and expertise of its professionals in a rapidly changing context

THE CONTEXT
In recent decades, there has been an evolution in the awareness about the Laboratory Medicine as a clinical discipline, shifting the focus from technical and analytical components to the diagnostic aspects. The “Manifesto” proposed by Plebani M et al, represents both a starting point and an ending point of this process in continuous evolution and transformation (1-3).
The vision and the concepts developed over the last years, in fact, have emphasized and structured the current belief of the central role of Laboratory Medicine in the diagnostic-therapeutic pathway, highlighting the needs to be satisfied and the projects to be developed in order to guarantee the strengthening of Laboratory Medicine as a clinical discipline, the consolidation of its position among the essential services in healthcare system, the recognition of the laboratory performance effectiveness in terms of patient safety (4-5).
In this context, some critical aspects have been highlighted, for example:
– increasing complexity of science and technology, which in many cases has advanced much more rapidly than professionals’ ability to integrate this innovation into safe, effective, and efficient healthcare;
– organizational models, resulting from institutional choices, the logic of which often interferes with the value creation process;
– longer life expectancy, that significantly increases the burden of chronic diseases and the inadequate allocation of resources for chronic disease care;
– a healthcare system highly decentralized, often bureaucratic, costly, and challenging to manage;
– insufficient investments and disparities concerning the access to Health Information Technology, limiting the technologists’ capacity to improve the quality of care.
The Manifesto draws attention to laboratory professionals as the primary resource that healthcare services can rely on to effectively manage critical aspects and guarantee the progress of discipline in different areas of activities and expertise. The point 9 of the Manifesto, in particular, emphasizes the importance of developing and enhancing professional activities through the achieving of a high level of competence of laboratory professionals and integrating additional professional figures capable of managing the new management tools and approaches (such as: informatics systems, technologies, software, machines, statistic methods, learning application, and so on) made available by continuous advancements.
It is a reminder to look towards the future of Laboratory Medicine, taking into consideration the evolving needs of the competencies and roles of laboratory professionals, as well as the concept of value creation. These are central themes for achieving performances that have an impact on improving patient outcome and managing their state of health.
Education and continuous training for the new generation of laboratory professionals, encompassing all the aspects in which Laboratory Medicine is involved, have to be encouraged to promote the acquisition of specific technical-scientific and administrative skills, as well as a deeper understanding of the healthcare system This understanding requires focusing attention on the patients, acknowledging their complexity, and adopting a multi-disciplinary and multi-professional approach. This shift transforms the laboratory management from a single specialty to a broader range of specialties, both medical and non-medical.

PROFESSIONAL ACTIVITIES IN LABORATORY MEDICINE
Concerted efforts have been made in order to guarantee the development and valorization of professional activities in Laboratory Medicine, which encompasse the identification of tasks, responsibilities, and functions of professionals and include activities related to diagnostic testing, data analysis, quality assurance, research, and more. Among these:
– performing specific tasks, such as analytical examinations, interpretation of results, and implementation of diagnostic algorithms;
– participating in meetings, conferences, or training sessions to enhance professional skills;
– managing administrative and/or organizational aspects, such as planning of activities, budgeting, or personnel management;
– interacting with users, patients, or colleagues to provide professional services or advice;
– keeping knowledge and skills up-to-date through continuous training and professional development.
The different activities can be included in some areas of competencies and roles, as reported below (6-7).

Clinical

The role of consultant, as well as leader in the diagnostic-therapeutic pathway, as an active member of multi-disciplinary and multi-professional teams, is very important in the process of value creation and in ensuring the effectiveness and uniformity of care. Effective collaboration with other researchers, clinicians, and stakeholders, in interdisciplinary teams, is essential to leverage collective expertise and resources. Moreover, the team work brings diverse perspectives and skills to patient care, resulting in a more comprehensive and holistic approach aligning with the best available evidence and guidelines. A clinical expertise in Laboratory Medicine is required in order to provide suggestions for the results interpretation and diagnostic algorithms as well as in designing standardized protocols and procedures in order to ensure that patients receive the highest standard of care based on consistent and evidence-based information.

Managerial

The managing of laboratories with increasingly large and complex operational system and networks, structured in accordance with mission and policies centered on satisfaction of the patient needs, is a pivotal role of laboratory professional. An effective organizational managing is crucial and includes the achievement of setting goals on time. The collaboration with healthcare providers, partners, and stakeholders to enhance the organization’s capabilities and the relationship with institutions, are important aspects to consider in order to promote the organization’s objectives. In addition, the pursuit of decision-making processes with integrity and adherence to ethical standards, especially when dealing with patient care and sensitive information, has to be prioritized.
In this context, leadership is a pivotal feature that plays a crucial role in effectively organizing and managing complex laboratory activities, while prioritizing patient satisfaction, and in providing high-quality healthcare services and achieving positive patient outcomes.

Development and management of innovation

In the field of Research and Development, laboratory professional represents a promoter playing a fundamental role in advancing scientific knowledge and developing innovative solutions through:
– verifying and enhancing increasingly sophisticated methodologies;
– identifying biomarkers with high-value prognostic and predictive;
– ensuring that resources are allocated efficiently.
This requires continuous updating about latest advancements, the development of the new techniques/methodologies, or the adapting of used ones, and the research of performance more and more efficiently and effectively. The final aim is providing valuable information to guide patient care or treatment strategies and define personalizing treatment plans, making healthcare more precise and effective.

Quality and Safety

It is a responsibility of laboratory professional to be ensure continuous quality improvement initiatives through the promotion of performances increasingly reliable (quality, safety) and effective (appropriateness, interpretation), and the achievement of high competency of the staff. Establishing a culture of quality within the laboratory and encouraging staff to identify and propose opportunities for improvement, as well as participate in quality improvement projects, are initiatives that promote the reliability of performance. Laboratory professionals are engaged in the implementation and monitoring of different assurance tools, for example:
– a comprehensive quality management system (QMS) in order to standardize/harmonized the processes, monitor performance, and continuously improve quality. This includes the compliance with the internationally recognized standards, such as ISO 15189;
– robust quality assurance programs to verify and monitor the accuracy and reliability of laboratory tests;
– strict safety protocols to protect both laboratory staff and patients, maintaining a safe work environment, and adhering to safety regulations;
– robust data management systems to ensure accurate and secure storage of patient information and test results;
– introduction and updates of regulations and standards in laboratory medicine to ensure the compliance with all relevant requirements.
The implementation of strategies for improvement and the commitment of the staff to quality and safety, creates the conditions necessary to ensure better patient management and outcomes.

Administrative

Traditionally, laboratories were often seen as places dedicated to scientific research and experimental/routine analysis, with a focus on technical and scientific aspects. There is now a growing awareness of the importance of administrative activities in the context of organizing and managing a laboratory, because they play a crucial role in ensuring efficiency and effectiveness. It is highlighted that they support other laboratory activities, including the management of human resources, budget and finance, supply and procurement planning, regulatory compliance, and other organizational responsibilities. Several factors have influenced the need to improve the knowledge and competencies related to these activities among laboratory professionals, as it is necessary to maximize operational efficiency, comply with regulations requirements, and optimize the allocation of financial resources, attracting funding and collaborations. As a consequence, the administrative activities should be ever more recognized as fundamental activities to guarantee the laboratory efficiency and the achievement of its scientific and operational goals

COMPETENCES REQUIRED TO LABORATORY PROFESSIONALS

As above described, the laboratory professionals are involved in more and more activities that are not only focused on the analysis of samples and the providing of reliable results, but in many other activities that allow the effective management of the laboratory in the healthcare context. This requires the integration of different skills, knowledge, and experiences to perform tasks successfully within the specific roles (2,6,8). Some examples are reported:
– Assessor, which requires the assessment of technology suitability in a given clinical context, or whether the performance level is complied with the appropriate intended use of the used methodology;
– Interpreter, which means accurately interpreting the knowledge and analyze data, including awareness of potential sources of error, bias, or clinical inappropriateness;
– Communicator, in order to communicate results and information in a way that is understandable to patients and other healthcare professionals but also being able to interact with the stakeholders implementing effectiveness diagnostic therapeutic processes and an adequate use of tests.
– Stewardship, responsible management of patient data to ensure the fundamental trust between physicians and patients and to promote research and innovation in various fields, including Artificial Intelligence.
– Advocate of privacy, understanding the risks associated with data security and privacy, as well as supporting ethics and equity in healthcare is also essential.
The evolving epidemiological landscape and the spread of chronic-degenerative diseases (such as diabetes, neurodegenerative conditions, and oncological diseases) require, for example, higher coordination needs than in the past and the necessity to integrate specialized knowledge.
Moreover, some functional characteristics are essential for effectively carrying out assigned roles, integrating specific competencies, and enhancing an individual’s overall performance. These characteristics go beyond mere skills or competencies and pertain to the inherent qualities that individuals should possess to fulfill their roles. They can improve the person’s ability to face the challenges, adapt to changing circumstances, and positively influence own outcomes. Important, in fact, is the ability of flexibility and dynamism within own role for enhanced internal collaboration and the mastery of cross-cutting skills (i.e. communication, quality management, risk management). The communication ability allows establishing and maintaining successful partnerships among professions and stakeholders, each with its own responsibilities and autonomy, to create a multi-disciplinary and multi-professional team supported by the laboratory’s mission and clinical-organizational leadership for the creation of shared value.

Evolution of competences

The process of continuous evolution and transformation of Laboratory Medicine imposes the continuous revision of roles and competences of laboratory professionals in order to guarantee the effectiveness of the entire system (9).
The competences are subjected to a continuous adaptive process:
– to retrain or acquire new skills in order to perform different roles or tasks, as previous skills are no longer relevant or useful (Reskilling);
– to reduce in the required level of skills to perform certain functions, especially repetitive ones (Deskilling);
– to acquire new skills or enhancing existing ones in order to advance in one’s current role or add value to an organization (Upskilling) (10).
A topic in discussion regards the paradox between the high specialization required in a specific area of discipline and, simultaneously, the management of situations that requires knowledge and skills across different specialized domains. High levels of specialization enable the development of in-depth knowledge in the specific area and achievement of greater competence of professionals. However, at the organizational level, they lead to increased differentiation and fragmentation of expertise, making it challenging to manage patients in all their complexity. The integration of professionals from different disciplines, among all stakeholders of Laboratory Medicine and taking into account all activities in which it is involved, is therefore needed to assure the realization of laboratory mission (11).
The introduction of new management tools (such as technologies, informatics tools and digitalization, data analysis approaches) has further highlighted this need requiring for example engineers, biostatisticians, or data scientists. They can indeed support the governance of digitization, e-health, telemedicine and the use of emerging methodologies like Big Data and artificial intelligence which are some of the new challenges that have already emerged (12).
However, in order to adequately use these innovative tools in an interconnected healthcare system, laboratories should strive to provide and exchange consistent and harmonized results and information to provide high-quality interpretations and maintain an unwavering commitment to accuracy and reliability. The outcomes of laboratory analyses and experiments have direct implications for patient diagnoses and treatment decisions, as well as for the advancement of scientific knowledge. Therefore, ensuring the accuracy and reliability of results is of paramount importance.
Advances in utilizing Big Data and artificial intelligence suggest that patient data and some interconnected aspects can be analyzed by computer systems to identify more powerful and effective evaluations. The application of these technologies is numerous, ranging from reducing errors to developing diagnostic algorithms that support clinical decisions, and from creating systems that facilitate data integration and aggregation for extracting valuable information, to enabling the sharing of information between clinicians and patients.
In this context the laboratory professionals must not only be proficient in the operation of complex tools, but also possess a deep understanding of the principles underlying these technologies. In fact, there is an awareness among many professionals of the risk of negative impact that the inappropriate use of these tools can deal. Moreover, as stewards of patient data and research findings, laboratory professionals bear the responsibility of safeguarding sensitive information and upholding ethical standards. They must ensure data privacy, security, and compliance with relevant regulations and standards, all while contributing to the ethical and equitable use of these tools and data-driven healthcare (13).
Laboratory professionals should gain skills to become data scientists and to collaborate with Information Technology professionals in order to use these technologies consciously and responsibly (8,14).
In addition, to perform administrative activities effectively, several skills are required. Understanding the principles of proper budget management is often necessary to prioritize tasks, manage the resource, meet deadlines and handle multiple responsibilities. Familiarity with data management tools and systems, and specialized relevant software is also increasingly important in today’s digital age. Similarly, the ability to adapt to changes, which can be challenging (whether in procedures, technology, or organizational structure) and finding practical solutions quickly, is a necessary skill. Moreover, generating reports that are understandable and interpretable to describe situations and considerations and/or propose projects and objectives is part of administrative responsibilities.

CONCLUSION

The future of Laboratory Medicine needs professionals from different disciplines, both medical and non-medical, to collaborate based on their different competencies, roles and responsibilities.
Collaboration should be founded on the integration of specific competencies (clinical, technical-scientific, administrative, functional skills) in line with the laboratory’s mission, along with a broader vision of the healthcare system that centers on patients and their health needs. Plebani M. introduced the motto “in science equal, in practice diffeerent” promoting collaborative work to effectively achieve and safeguard the laboratory’s objectives (1,15).
The concept of value creation in Laboratory Medicine is closely linked to the awareness and responsibility of laboratory professionals, who must valorize all activities in laboratory medicine to become an attractive force for new professionals. Achieving high-quality performance is a prerequisite for attracting new and high-quality talents (1).
In conclusion, the Manifesto emphasizes competencies, professionalism, and talents rather than policies in pursuit of economies of scale. It advocates for a more patient-centered approach and the valorization of the skills and abilities of laboratory professionals to drive the organization towards success. It underlines that the prospect of a promising future for Laboratory Medicine depends on the dedication and expertise of its professionals.
When thinking about the future, it’s essential to realize how the concepts of the present and the future converge into a single perspective of global acceleration. Every day, we witness that the future of our imagination is already unfolding. Laboratory professionals must be prepared to face the ongoing challenges of evolution and transformation by: analyzing the context, developing the best strategies to address it, adapting to a continuous development of their knowledge and skills, and promoting collaborations with all stakeholders. This way, laboratory professionals will be able to ensure a future for Laboratory Medicine in which its true value is recognized.

CONFLICT OF INTEREST
None

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