[SFBC Working Group on sources of errors in laboratory medicine: objectives and key areas of work]. / Groupe de travail SFBC Sur les sources d'erreurs en biologie clinique: Objectifs et axes de travail.

Laboratory medicine plays a crucial role in patient care, contributing to approximately 70 % of clinical decisions. In collaboration with clinicians, laboratory medicine specialists perform analyses that are useful for diagnosis, screening and prevention. Laboratories are known for their efficiency, which is reached through a rigorous quality system. However, errors can occur, especially given the complexity of the total testing process. These errors may lead to severe consequences, such as incorrect diagnoses or delays in treatment. Errors can occur at every stage of the total testing process, those related to the pre-analytical phase being the most prevalent. To reduce medical errors related to laboratory processes, it is essential to provide training for medical and paramedical staff, optimize production automation, and leverage technological advancements. These considerations have led to the creation of a French Working Group on Sources of Errors in Laboratory Medicine, under the aegis of the French lean society of clinical chemistry and laboratory medicine (Société Française de Biologie Clinique - SFBC). The objectives of this working group are to produce an educational handbook on sources of errors in laboratory medicine, provide training for clinical chemists, and conducting applied research projects to better understand the mechanisms behind specific errors. Ultimately, the aim is to minimize errors and enhance the quality of laboratory tests.

A vision to the future: value-based laboratory medicine.

The ultimate goal of value-based laboratory medicine is maximizing the effectiveness of laboratory tests in improving patient outcomes, optimizing resources and minimizing unnecessary costs. This approach abandons the oversimplified notion of test volume and cost, in favor of emphasizing the clinical utility and quality of diagnostic tests in the clinical decision-making. Several key elements characterize value-based laboratory medicine, which can be summarized in some basic concepts, such as organization of in vitro diagnostics (including appropriateness, integrated diagnostics, networking, remote patient monitoring, disruptive innovations), translation of laboratory data into clinical information and measurable outcomes, sustainability, reimbursement, ethics (e.g., patient empowerment and safety, data protection, analysis of big data, scientific publishing). Education and training are also crucial, along with considerations for the future of the profession, which will be largely influenced by advances in automation, information technology, artificial intelligence, and regulations concerning in vitro diagnostics. This collective opinion paper, composed of summaries from presentations given at the two-day European Federation of Laboratory Medicine (EFLM) Strategic Conference "A vision to the future: value-based laboratory medicine" (Padova, Italy; September 23-24, 2024), aims to provide a comprehensive overview of value-based laboratory medicine, projecting the profession into a more clinically effective and sustainable future.

The hierarchy of needs for laboratory medicine requires a foundational care delivery model.

Under the collective weight of growing test volume, staffing constraints, and Medicare reimbursements cuts, an enhancement-based, alternative payment structure focused on rewarding the laboratory's care delivery efforts via benchmarking is appealing. However, achieving a value-based payment model requires the development of an inclusive laboratory care delivery model (LCDM) framework. Today, a holistic, practical LCDM framework for laboratory medicine does not exist. However, such creation is essential for establishing unifying tenants of practice for value-tracing by which standardized key performance and population health indicators can be derived. LAB-CARES is the first step in formulating an LCDM with the primary objective of defining and streamlining the processes and strategies necessary to deliver and articulate the value of diagnostic excellence across the healthcare system. The goal of LAB-CARES is to maximize efficiencies, enhance quality, disseminate clinical expertise, increase patient safety, and promote integrative practice. LAB-CARES is designed to improve an individual patient's quality of life (longitudinal laboratory results - beyond one test) and their surrounding communities (e.g., through surveillance and prevention - beyond one patient). Further professional conversation and efforts are paramount to integrate LAB-CARES as a formalized structure within the healthcare landscape.

A step forward in the diagnosis of urinary tract infections: from machine learning to clinical practice.

Objectives: Urinary tract infections (UTIs) are common infections within the Emergency Department (ED), causing increased laboratory workloads and unnecessary antibiotics prescriptions. The aim of this study was to improve UTI diagnostics in clinical practice by application of machine learning (ML) models for real-time UTI prediction. Methods: In a retrospective study, patient information and outcomes from Emergency Department patients, with positive and negative culture results, were used to design models - 'Random Forest' and 'Neural Network' - for the prediction of UTIs. The performance of these predictive models was validated in a cross-sectional study. In a quasi-experimental study, the impact of UTI risk assessment was investigated by evaluating changes in the behaviour of clinicians, measuring changes in antibiotic prescriptions and urine culture requests. Results: First, we trained and tested two different predictive models with 8692 cases. Second, we investigated the performance of the predictive models in clinical practice with 962 cases (Area under the curve was between 0.81 to 0.88). The best performance was the combination of both models. Finally, the assessment of the risk for UTIs was implemented into clinical practice and allowed for the reduction of unnecessary urine cultures and antibiotic prescriptions for patients with a low risk of UTI, as well as targeted diagnostics and treatment for patients with a high risk of UTI. Conclusion: The combination of modern urinalysis diagnostic technologies with digital health solutions can help to further improve UTI diagnostics with positive impact on laboratory workloads and antimicrobial stewardship.

External quality assessment performance in ten countries: an IFCC global laboratory quality project.

OBJECTIVES: This study aimed to assess the validity of external quality assessment (EQA) laboratory results across various cultural and environmental contexts and to identify potential improvement areas. METHODS: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a 2-year study (2022 and 2023) in which EQA materials, related software and online training was provided by a commercial vendor to 100 laboratories in ten IFCC member society countries. The results were analysed on a monthly basis by the TF-GLQ, to show the number of submissions per country, tests per lab, acceptability rates, random failures and to get a measure of which analytes performed poorly. RESULTS: The EQA material was dispatched on a quarterly basis. Some countries had problems with customs releasing the material in a timely manner, resulting in laboratories not receiving them on time leading to no submission. We report here the results for the second year of the survey. The number of examinations varied between laboratories, ranging from seven to 84 analytes. Of the ten countries surveyed, six averaged greater than 90 % acceptable results over the whole 12-months cycle, one had unacceptable results for two of the nine months they returned results and the other four were considered to not perform to an acceptable standard. CONCLUSIONS: All 100 participating laboratories indicated satisfaction with the EQA survey and related services, including on-site training, and report handling. However, specimen receiving issues, suggest benefits in dispatching materials for a full 12-month cycle. Significant discrepancies in EQA performance indicate that four countries require long-term assistance, training and guidance. To ensure reliable patient results, promoting EQA in certain countries is essential to achieve the required level of quality.

Managing laboratory test ordering: a challenge in the new laboratory medicine model.

Introduction: The role of Laboratory Medicine in patient care has evolved in the last decades. The same has occurred to the laboratory model, which has evolved from a traditional model where the laboratory is merely involved in clinical decision-making to a leading model where the laboratory is not only involved but also determines decision-making. The advent of new technologies and automation of processes have enabled laboratory professionals to focus on the first and last phase of the analytical process namely, test ordering and decision-making based on laboratory results. These phases are more error-prone than the analytical phase, and where action must be taken to improve the quality of patient care. Content: We share our experience in the design and establishment of laboratory test demand management interventions that facilitated diagnosis of occult disease, improved adherence to clinical guidelines, and optimized patient safety. Summary: A description is provided of key points in the management of laboratory test over/underutilization. Outlook: The objective of this review is to promote the involvement of laboratory professionals in the design and implementation of demand management interventions and in the development of the new Leader Laboratory model.

Comparison of Autolumo A2000 Plus and Architect i2000 for detection of hepatitis B virus serological markers.

Serological detection of hepatitis B virus markers plays a vital role in the diagnosis, treatment, prognosis, and therapeutic surveillance of hepatitis B. To compare the diagnostic performance of Autolumo A2000Plus and Abbott Architect i2000 systems in the detection of hepatitis B infection markers. A total of 6 HBV seroconversion panels and 743 participants were enrolled in this study, including 383 HBV-infected patients and 360 healthy adults. Clinical diagnostic information, laboratory results, and HBV genotyping were collected to evaluate the diagnostic performance of the A2000Plus and i2000 systems in detecting HBV infection markers. The results showed that the total percent agreement of HBV markers was all >90 % in both detection systems among the six seroconversion panels and 743 serum samples from the population. The χ2 values of the Chi-square test among hepatitis B virus serological markers in both analyzers were between 550.7 and 743.0, p < 0.0001. HBV marker consistency test results show perfect consistency between the two analyzers, with Kappa values ranging from 0.854 to 1.000. For specific samples, including Hepatitis B patients with Genotype C, chronic hepatitis B, hepatitis B-related cirrhosis, and hepatocellular carcinoma, spearman correlation analysis showed HBsAg correlation coefficients ranging from 0.8532 to 0.9745, p < 0.001 in both analyzers. In conclusion, Autolumo A2000Plus diagnostic performance in consistency and correlation is comparable to Abbott Architect i2000 when detecting markers of hepatitis B infection. The Autolumo A2000Plus system can be used as a reliable instrument for HBV marker detection.

Seronegative celiac disease with transient protein-losing enteropathy and vitamin B12 deficiency in a pediatric patient: Case report.

Key Clinical Message: Early recognition and management of seronegative celiac disease, even in the absence of typical serological markers, can prevent complications and ensure better health outcomes in pediatric patients. Consideration of a gluten-free diet in similar cases can lead to significant clinical improvement. Abstract: Celiac disease, characterized by its diverse clinical manifestations, often necessitates adherence to a gluten-free diet, particularly in pediatric patients for optimal growth and development. This report presents the case of an 11-year-old male who exhibited recurrent symptoms of fever and diarrhea progressing to edema and pallor, with a history dating back to age 3. Laboratory findings revealed pancytopenia, hypoalbuminemia, and proteinuria. Despite negative serological markers, noninvasive tests, along with clinical improvement on a gluten-free diet and supportive measures within a month, suggested celiac disease complicated by transient protein-losing enteropathy and vitamin B12 deficiency. It is important to note that other malabsorption disorders can also show clinical improvement following a gluten-free diet. Additionally, the antibiotic treatment received by the patient could have addressed other possible causes of malabsorption, complicating the differential diagnosis. This case highlights the importance of early recognition and management of celiac disease, especially in pediatric patients, to prevent complications and promote optimal health outcomes.

Spindle epithelial tumor with thymus-like element (SETTLE)-Report of a rare thyroid carcinoma.

Spindle epithelial tumor with thymus-like element should be included in the differential diagnosis of thyroid gland cancers, particularly in medullary carcinoma, younger patients and indolent clinical presentation, because it may influence treatment and prognosis.

Health disparities among incarcerated populations: a crucial laboratory and pathology review.

BACKGROUND: The United States notoriously has one of the highest rates of incarceration in the world, yet scant attention to the health care needs of those incarcerated exists within laboratory medicine and pathology training and education. This article explores health disparities among incarcerated and released individuals regarding diagnostic laboratory testing and pathology services. METHODS: A literature search was conducted for articles published between 2002 and 2023 using keywords including "healthcare," "incarcerated," "laboratory services," "pathology services," and "health insurance for prisoners." Central themes were extracted and discussed to reveal the realities of health care during and after release from incarceration. Excluded from the analysis were articles about the immediate or extended family of incarcerated persons. RESULTS: Incarcerated individuals have an increased risk for the development and exacerbation of communicable and noncommunicable diseases and mental health disorders, which results in exceedingly high morbidity and mortality rates. CONCLUSION: Policy changes are needed to mitigate disparities and improve health outcomes for incarcerated and released persons. Central to these disparities is decreased access to laboratory and pathology services, impeded by inadequate health care funding for these carceral institutions. Providing additional funding to the carceral system's health care budget is necessary to improve access to pathology and laboratory services.

Laboratory Preparation for Digital Medicine in Healthcare 4.0: An Investigation Into the Awareness and Applications of Big Data and Artificial Intelligence.

Background: Healthcare 4.0. refers to the integration of advanced technologies, such as artificial intelligence (AI) and big data analysis, into the healthcare sector. Recognizing the impact of Healthcare 4.0 technologies in laboratory medicine (LM), we seek to assess the overall awareness and implementation of Healthcare 4.0 among members of the Korean Society for Laboratory Medicine (KSLM). Methods: A web-based survey was conducted using an anonymous questionnaire. The survey comprised 36 questions covering demographic information (seven questions), big data (10 questions), and AI (19 questions). Results: In total, 182 (17.9%) of 1,017 KSLM members participated in the survey. Thirty-two percent of respondents considered AI to be the most important technology in LM in the era of Healthcare 4.0, closely followed by 31% who favored big data. Approximately 80% of respondents were familiar with big data but had not conducted research using it, and 71% were willing to participate in future big data research conducted by the KSLM. Respondents viewed AI as the most valuable tool in molecular genetics within various divisions. More than half of the respondents were open to the notion of using AI as assistance rather than a complete replacement for their roles. Conclusions: This survey highlighted KSLM members' awareness of the potential applications and implications of big data and AI. We emphasize the complexity of AI integration in healthcare, citing technical and ethical challenges leading to diverse opinions on its impact on employment and training. This highlights the need for a holistic approach to adopting new technologies.

HTA model for laboratory medicine technologies: overview of approaches adopted in some international agencies.

The Health Technology Assessment (HTA) Working Group of the Emerging Technology Division of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) aims to develop a methodological approach for producing structured HTA information for laboratory medicine technologies. This approach seeks to support decision-making processes at the country, regional, and/or hospital levels regarding the introduction of specific technologies. The focus of this model will primarily be on defining assessment elements within the domains of 'organizational aspects' and 'costs and economic evaluations', potentially differentiated by the type of diagnostic technology (e.g., genetic tests, molecular tests). To achieve this project's goal, a literature review and examination of websites of international HTA agencies have been conducted. The research aims to identify multidisciplinary methodological approaches used to assess laboratory diagnostic technologies and to pinpoint the domains and assessment elements utilized. We found 7 methodological articles describing methodological approaches adopted to assess laboratory diagnostic technologies. Among the HTA organizations considered, 23 reports were found, of which 7 were produced by the European Network of HTA (EUnetHTA), 4 by the National Institute for Health and Care Excellence Diagnostic Assessment Program (NICE DAP), and 12 by other HTA agencies. The EUnetHTA reports were rapid collaborative assessments covering various domains, while the NICE DAP reports focused on diagnostic guidances, including descriptions of technologies, clinical need and practice, diagnostic tests, accuracy, effectiveness, and cost-effectiveness. Finally, a survey targeting laboratory professionals will be conducted to introduce assessment elements, differentiated by the type of diagnostic technology, primarily for organizational and economic domains.

Considerations for applying emerging technologies in paediatric laboratory medicine.

Emerging technology in laboratory medicine can be defined as an analytical method (including biomarkers) or device (software, applications, and algorithms) that by its stage of development, translation into broad routine clinical practice, or geographical adoption and implementation has the potential to add value to clinical diagnostics. Paediatric laboratory medicine itself may be considered an emerging area of specialisation that is established relatively recently following increased appreciation and understanding of the unique physiology and healthcare needs of the children. Through four clinical (neonatal hypoglycaemia, neonatal hyperbilirubinaemia, sickle cell disorder, congenital adrenal hyperplasia) and six technological (microassays, noninvasive testing, alternative matrices, next generation sequencing, exosome analysis, machine learning) illustrations, key takeaways of application of emerging technology for each area are summarised. Additionally, nine key considerations when applying emerging technology in paediatric laboratory medicine setting are discussed.

EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) recommendations for reinforcing cyber-security and managing cyber-attacks in medical laboratories.

The healthcare systems are a prime target for cyber-attacks due to the sensitive nature of the information combined with the essential need for continuity of care. Medical laboratories are particularly vulnerable to cyber-attacks for a number of reasons, including the high level of information technology (IT), computerization and digitization. Based on reliable and widespread evidence that medical laboratories may be inadequately prepared for cyber-terrorism, a panel of experts of the Task Force Preparation of Labs for Emergencies (TF-PLE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has recognized the need to provide some general guidance that could help medical laboratories to be less vulnerable and better prepared for the dramatic circumstance of a disruptive cyber-attack, issuing a number of consensus recommendations, which are summarized and described in this opinion paper.

Advancing value-based laboratory medicine.

Following the COVID-19 pandemic, the concepts of value-based medicine (VBM) and value-based laboratory medicine (VBLM) are receiving increasing interest to improve the quality, sustainability and safety of healthcare. Laboratory medicine is well positioned to support the transition to value-based healthcare as it helps to improve clinical outcomes and healthcare sustainability by reducing the time to diagnosis, improving diagnostic accuracy, providing effective guidance for tailored therapies and monitoring, and supporting screening and wellness care. However, the perception of the value of laboratory medicine is still limited, to the extent that it has been defined a "profession without a face", often lacking visibility to patients and the public. In addition, in recent decades, clinical laboratories have sought to improve the ration between outcomes and costs by increasing efficiency and reducing the cost per test rather than improving clinical outcomes. The aim of this paper is to propose a 10-point manifesto for implementing value-based laboratory medicine in clinical practice.