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In recent years, the increasing digitalization of health technologies and systems for collecting and storing health data has allowed for the creation of value from data and its use. However, this has led to the need to implement risk management regarding the protection and loss of health data. Observational studies, by nature, do not pose direct additional risks to the health of patients. However, the privacy of patients' needs to be preserved. This document, by presenting the obligations introduced by the current Regulation and delving into its impacts on governance, security, and management of health data, aims to provide technical-organizational measures to support the use of health data for research purposes in retrospective observational studies, particularly in laboratory medicine. It should be noted that this document is merely illustrative with reference to the cases analyzed and does not intend in any way to eliminate the evaluations of the Data Protection Officer (DPO) of the involved structures, as well as the necessary and timely risk assessment reserved for the Data Controller (DC). The document therefore aims to support the researcher in the task of providing the DPO and the DC with all the preliminary information regarding the study, in order to simplify and speed up the evaluation process. Accordingly, the document has been structured so that the researcher can benefit not only from information on the current legislation but also from informal tools such as dialogue windows with the lawyer and the analysis of real-world case studies. [ABSTRACT FROM AUTHOR]

Introduction: monoclonal antibodies therapeutic (t-mAbs) are used in the treatment of multiple myeloma (MM). They are composed of IgG-k and may interfere with the patient's endogenous IgG-k monoclonal component (MC). The Hydrashift test (Sebia, Lisses, FR), the daratumumab immunofixation reflex test (DIRA test), is able to eliminate interference by t-mAbs. This work aims to determine how many DIRA tests were performed in the laboratory of the Department of Laboratory Medicine of Modena (Italy) and how the DIRA test has been used in our daily practice and its impact on the clinical management of the patient as well. Methods: the DIRA test was applied by the laboratory on patients selected on the basis of: their clinical history, of monoclonal components, comparison with previous electrophoresis, the characteristic pattern of the gamma zone, and evidence of an additional peak in the gamma zone. The data were extracted from the laboratory information system. Results: from August 2021 to December 2022 we performed the DIRA test on 240 samples for a total of 160 patients. 198 (82.5%) samples came from onco-haematological wards or day hospitals, the remaining 17.5% included samples from external sampling centers or non-onco-haematological. In 88 (55%) patients the DIRA test was positive. Conclusions: the use of the DIRA test allowed a correct diagnosis in 55% of the patients undergoing electrophoretic examination. DIRA is an inexpensive test, easily performed in any laboratory; however, an effective use of the test requires a close collaboration between haematologists and the laboratory. [ABSTRACT FROM AUTHOR]

Reimbursement model may have a significant impact on the behaviour of healthcare providers about the overall cost and resulting quality of care. In this light, there is increasing interest in exploring models that align improved patient outcomes and cost-effective care. Healthcare systems and payers are looking at alternative payment models, such as bundled payments or value-based reimbursement, aimed to promote better patient outcomes and overall value of care rather than just the amount of services provided. These alternative models may be more effective in promoting cost-effective and high-quality laboratory testing associating financial incentives with patient health outcomes. In this review, alternative reimbursement models in Laboratory Medicine are examined in order to develop a wider agenda for evaluating the effects of laboratory investigations and to provide a more objective and effective evaluation of the economic value and the impact on patient outcomes of laboratory testing. Value-Based Healthcare is a healthcare delivery model aimed to provide the best possible patient outcomes related to the cost of care. It is fundamental to develop further models based on Value-Based Payment Models, supporting the value of care rather than the volume of services provided; this way, it will be possible to demonstrate the key role of effective diagnostic information of Laboratory Medicine. It seems fundamental to develop a Value-Based Laboratory system, merging the "production process cost evaluations" with assessed outcomes related to the cost and value of laboratory test delivered, with the aim to promote a Value-Based Healthcare and Value-Based Reimbursement in Laboratory Medicine [ABSTRACT FROM AUTHOR]

The protein concentration in urine is a valuable parameter in assessing kidney function. Usually, blood proteins do not pass through the renal filter in healthy subjects; proteinuria, which can sometimes be detected as a simple, occasional laboratory finding, is a relatively common condition of which those affected are unaware. Epidemiologically, it is a condition that involves almost 10% of the population worldwide. The mechanisms underlying the release of proteins by the kidneys are different: a newly detected proteinuria may precede the onset of renal disease or systemic diseases, and the physician must appropriately evaluate it. This paper provides a hint of epidemiology, some notes of pathophysiology, an overview of the types of proteinuria, a rundown on laboratory techniques and a brief, certainly not exhaustive, review of some non-oncological pathologies associated with proteinuria. The aim is to show the extent to which proteinuria can play a decisive role in the patient's overall assessment. The urine protein test, a basic, non-invasive test, easy to perform by any laboratory, even the most poorly equipped, is a fundamental indicator of a subject's health status in combination with other markers. Thus, it confirms once again the crucial role of the laboratory in providing the physician with necessary diagnostic and prognostic data that is easy to perform, inexpensive and yet of great benefit for the patient management. [ABSTRACT FROM AUTHOR]

Point of care testing (POCT) identifies laboratory diagnostic tests conducted near the site of patient care, outside the laboratory, usually performed by healthcare personnel not professionally trained in laboratory medicine. When used appropriately, POCT could improve the patient's outcomes providing faster results and earlier therapeutic strategies. In the Province of Modena, a decentralized and multi-professional POCT diagnostic system consisting of 383 instruments was developed to integrate the clinical and diagnostic pathways supporting fast clinical decisions, to improve outcomes and to optimize the clinical patient pathways. POCT instruments were installed not only in emergency rooms of three hospitals but also in specific settings as the Community hospital (OSCO), oncological and emergency settings and neonatal intensive care. Furthermore, 264 glucometers were located in various departments of three hospitals. This system provides multiple advantages for: patients reducing waiting time and long-distance travelling from home, healthcare professionals improving skills, autonomy and responsibility, reducing workload and promoting collaboration, and the healthcare system giving continuity in the therapeutic and assistance pathways ensuring a high analytical quality and costs reduction. To implement a successful POCT network main factors are to be developed : a multidisciplinary team composed by physicians, nurses and laboratory technicians working together, the continuous training and education of operators and a close connectivity between POCTs and central laboratory. [ABSTRACT FROM AUTHOR]

We report the case of a diabetic woman from west Africa with a presumptive diagnosis of HbSS previously suggested in another laboratory. However, during analysis for HbA1c with a novel instrument for capillary electrophoresis capable of both HbA1c and hemoglobin variants analysis, we suspected and later confirmed (with a centralized molecular study) the presence of a double heterozigosity for a beta gene defect, namely HbS and Hereditary Persistence of Fetal Hemoglobin (HbS/HPFH). Our case highlights the importance of ruling out any possible interference affecting the HbA1c measurement that could compromise its interpretation, posing a risk for erroneous clinical management of diabetes mellitus. The availability of both high resolution HbA1c and hemoglobin variants analysis on the same instrument could lead to a rapid presumptive identification of previously unknown or misdiagnosed hemoglobinopathies. [ABSTRACT FROM AUTHOR]