biochimica clinica

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OPINIONI - Opinions

Volume:

Biochimica Clinica, Vol.47, SS2 S8-11

Pubblicato on-line:

Settembre 12, 2023

DOI:

10.19186/BC_2023.064

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Introductory remarks and future perspectives

AUTORI

Mario Plebani
Honorary Professor of Clinical Biochemistry and Clinical Molecular Biology, University of Padova, Italy and Adjunct Professor, Department of Pathology, University of Texas, medical Branch, Galveston -USA

ABSTRACT

Laboratory medicine and health care systems are changing rapidly due to increasing demands from the public regarding availability, quality and equity and these changes are significantly affecting the role of laboratory professionals. New competencies should be defined to be in alignment with the mission and vision of both clinical laboratories and health care systems, and, first and foremost to meet patients’ and clinicians’ needs. Aim of this paper is to review the content of already published Manifesto(s) and to move the discussion towards a new Manifesto for the future of laboratory professional.

INTRODUCTION
Clinical medicine and health care systems are changing rapidly due to increasing demands from the public regarding availability, quality and equity. Laboratory medicine, which should be regarded as irreplaceable in modern clinical medicine, has consistently changed over the past decades (1). Clinical laboratories have progressed from performance of easy analytical assays in small physicians’ offices, to huge and highly automated facilities, which are frequently set aside from hospitals and patients. In addition, the nature of laboratory testing is significantly changed and improved: from information primarily used for patient and disease monitoring to invaluable information for predicting disease susceptibility, for establishing effective preventative measures, for making diagnoses, especially at an early stage, but also for prognosticating and monitoring diseases, as well as for personalizing therapies and improving outcomes (2). These changes are significantly affecting the role of laboratory professionals: the continuing expansion in biomedical knowledge, the rapid development of methodology and technology, and all other organizational changes are likely to significantly impact the demands placed on the education of future laboratory scientists. New competencies should be defined to be in alignment with the mission and vision of both clinical laboratories and health care systems, and, first and foremost to meet patients’ and clinicians’ needs. A recently published paper aimed to examine the necessary competencies needed to pursue a career as a biomedical laboratory scientist, reached the conclusion that ”none of the scientific competencies reached consensus” (3), even if some  publications have been published to discuss the future importance of critical and analytic thinking in the professions of laboratory medicine and management. The main core competencies in that study relate to quality, quality assurance, and accuracy, as well as different aspects of safety, respect, and trustworthiness (towards patients/clients and colleagues), including communication; nothing in these that could distinguish them from generic competencies for any other health sciences profession.
A MANIFESTO FOR THE FUTURE OF LABORATORY MEDICINE PROFESSIONALS
The previous Manifesto(s)
In 2019, two Manifesto(s) for the future of laboratory medicine have been published by the same authors, the first one being mainly addressed to laboratory professionals (4), while the second one was conceived for spreading the information to clinicians and other stakeholders (5). Although the contents of the two papers are similar, the ten points of each Manifesto are slightly different as shown in Tables 1 and 2.
Towards a new Manifesto for the future of laboratory professionals
In 2023, the Board of Directors of the Italian Society of Clinical Biochemistry (SIBIoC) has decided to dedicate a Strategic Conference to discuss the future of laboratory medicine and its professionals, starting from the Manifesto(s) already published, by inviting speakers and discussants to deliver lectures dealing with each and all points of these papers. I was asked to introduce the discussion highlighting the need to eventually update and integrate the previously published Manifesto(s), taking into consideration some recent developments and changes in both the healthcare systems and clinical laboratories. The 10 points to be discussed are summarized in Table 3
Value-based medicine
In medicine, value is defined as outcomes of care divided by the costs of providing that care (6). In laboratory medicine, a well-defined link between laboratory quality and patient outcomes has proven to be elusive, as the “ultimate” measures of patient status reflect the combined activities of clinicians, nurses, laboratory and radiology professionals (7). However, as emphasized by George D. Lundberg “Laboratory tests that matter are those that produce actionable results to bring a positive outcome benefit for the patient” (8).
Value-based medicine should be based on 10 fundamental rights:
– the right test
– for the right patient
– at the right time
– the right sample collection and identification
-the right sample handling (eventually right  transportation)
– the right analytical results
  – the right notification of laboratory report
– to allow the right interpretation
  – the right utilization of laboratory information
– to achieve the right outcomes
Value-based medicine, in addition, should integrate efforts to achieve clinical effectiveness to the increasingly important topic of sustainability which is based on projects to introduce green procurement strategies, as well as to promote waste reduction, water and energy conservation (9).
Quality in the total testing process
Quality should be ensured throughout the total testing process (TTP) to allow the right clinical decision-making process and obviate any risk to patient safety. Laboratory and laboratory-related errors have long been a neglected issue, and the vulnerability of the extra-analytical phases of the TTP was demonstrated only relatively recently (10,11). However, a body of evidence has been collected in the last decades to demonstrate that, despite a dramatic reduction of analytical errors, the vulnerability of extra-analytical phases of the testing cycle may lead to significant risks of diagnostic errors (12,13). Many efforts have been performed to reduce pre-analytical errors through both technology innovations (e.g. automated labelling devices, pre-analytical work stations) and by improving the competence and training of laboratory professionals (14,15). In addition, thanks to the longstanding focus on the analytical performances of laboratory tests, we have lost sight of the outcomes of laboratory information. Process measures are absolutely essential to improve quality in the TTP, but the ultimate quality of laboratory information should be assessed by using outcome indicators.
Laboratory services centered on clinical needs
The increasingly essential role of laboratory testing in clinical and therapeutic pathways requires a paradigmatic change from current organization models. Today the most prevalent business model involved in delivery of laboratory and other diagnostic services seems to be “primarily designed and executed in individual silos driven by internal activities and managed according to performance metrics that match the discipline itself rather than the products of services to improve clinical pathways, clinical and economical outcomes and patient safety” (1). There is the need to restore the true nature of laboratory medicine services, stopping the glide towards the commodity vision (16-18).
Laboratory networks which include decentralized testing sites
Clinical laboratories can no longer work in isolation. Networking is needed to provide high quality services while maintaining efficiency. In addition, the role of decentralized testing options (e.g. POCT, pharmacies, home care and wearables) is increasingly important to provide better patient access and equity (19).
Valuable and reliable clinical-therapeutic pathways
The role of laboratory testing has to be better appreciated taking into consideration the patient journey and in particular clinical and therapeutic pathways. Lippi and Plebani have reported the value of laboratory testing in some clinical and therapeutic pathways for common and serious clinical conditions such as cardiovascular diseases, cancer, thromboembolism, sepsis (20). The participation to the design and implementation of these clinical-diagnostic pathways is a fundament duty for laboratory professionals who should be actively involved in multidisciplinary teamworking.
Integrated diagnostics and multidisciplinary teams
Several lines of evidence attest that the role of the so-called “integrated diagnostics”, defined as “convergence of imaging, pathology, and laboratory tests with advanced information technology (IT)”, will overwhelmingly emerge in the foreseeable future, allowing to make earlier and more accurate diagnoses, but also contributing to save a large amount of human and economic resources. The paper by Plebani and Ciaccio in this issue of the Journal deals with this issue and provides more information on this point (21).
Clinical laboratory stewardship
In a seminal paper, Desmond Burke highlighted that “new and expensive treatments, introduction of difficult to interpret complex tests, a greater reliance on nurse practitioners as deliverers of primary care and patient-initiated testing, all make it likely that in the future greater emphasis will be placed on appropriate use of cost-effective laboratory tests. The most promising solution to inappropriate utilization of laboratory services is a greater reliance on clinical laboratory consultants” (22). Clinical laboratory stewardship should require appropriate education and knowledge to provide advice in both test request (pre-pre-analytical phase) and interpretation of laboratory results (post-post-analytical phase) (18).
Introduction of innovation by adopting health technology assessment
Both sustaining and disruptive innovations have been introduced in clinical laboratories not always to address unmet clinical and user needs (23). The Theranos story is an example of a potential innovations that, however, did not undergo to evidence-based validation criteria and were found to be totally inaccurate and unreliable. Theranos’ use of laboratory developed tests was, in fact, far from legitimate and Elizabeth Holmes, the founder of this failed diagnostic start-up, was sentenced to more than 11 years in prison. In a recently published paper, “doctors and patients must demand evidence. Doctors will need to think carefully about whether a test should even be ordered in the first place. Holmes is facing years in prison partly because of how easily she convinced the public to believe her lies” (24). This is a lesson we have to learn as validation and verification of all innovative techniques and methods must be always be performed adopting existing not only guidelines for analytical performances, but also health technology assessment to verify the sustainability and value of innovation in health care systems (25).
Reimbursement models based not on test volumes but on the effectiveness and value of laboratory information.
Traditional reimbursement systems for laboratory tests present formidable barriers to change, as the fee-for-service reimbursement systems consolidate the vision of laboratory tests as commodities, offer little incentive to develop integrated diagnostics and to adopt bundled payment programs. New reimbursement models are needed to link laboratory services to outcomes, benefits for both patients and clinicians, and to effectiveness and sustainability for the health care system.
Recruitment, education and training of new professionals assuring mentorship
Recently published papers have clearly demonstrated that technology is not enough to assure quality in laboratory testing, including steps such as blood collection which sometimes is considered a “simple” procedure, as competent and well-trained phlebotomists have found to be needed in this pre-pre-analytical phase (26). New competencies, skills and expertise have to be identified as fundamental topics of education and training programs. In this context, it is crucial to improve the culture on ethics in laboratory medicine as many challenges, including the adoption of Artificial Intelligence, the issue of direct-to-consumer testing, privacy in genomic era requires appropriate answers.
FINAL REMARKS
The new Manifesto aims to decline trends and future developments in laboratory medicine in new and improved knowledge, skills and competences for future laboratory professionals. This, in turn, is an opportunity to open a debate on the future of laboratory medicine and its professionals by involving not only laboratory scientists but also clinicians, in vitro diagnostics (IVD) managers, patient representatives and other stakeholders. The design of a valuable future for laboratory professionals, is indeed a duty for Scientific Societies, Academia and all other organizational bodies.
CONFLICT OF INTEREST
None

BIBLIOGRAFIA

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