Maria Salinas

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.

Objectives: To show the procalcitonin (PCT) test demand from an emergency department (ED) over several years, to decrease PCT measurement via a computerized algorithm based on C-reactive protein (CRP) value, and to evaluate the subsequent economic savings. Study Design: A cross-sectional study was performed from January 1, 2018, to May 31, 2019, to evaluate an intervention to avoid PCT measurement in the ED of Hospital Universitario San Juan in Alicante in Spain, when CRP values are low. Methods: A PCT result of at least 1.5 ng/mL was agreed upon with ED providers in our study as the value for clinical decision-making, with values less than 1.5 ng/mL considered negative. We retrospectively reviewed all PCT and CRP values for ED patients and calculated the diagnostic indicators for PCT at 4 different CRP cutoffs using the PCT quantification as the gold standard. From July 1, 2019, to April 30, 2021, the agreed-upon strategy was implemented, and we counted the PCT tests avoided and calculated the savings. Results: PCT was not measured when CRP values were less than the selected CRP cutoff of 0.8 mg/dL, at which false-negative results were 1% and the 99th percentile of PCT was 1.5 ng/mL. In the postintervention period, 1091 PCT values were not measured and $11,553.69 was saved. Conclusions: An intervention to decrease PCT measurement in the ED designed by the clinical laboratory staff in consensus with requesting clinicians and based on CRP values decreased PCT testing and generated significant economic savings.

Resumen: Introducción: En las últimas décadas está evolucionando el posicionamiento de la Medicina de Laboratorio en el proceso médico asistencial de atención al paciente y también el modelo de laboratorio; de un modelo tradicional, con solo intervención, a un modelo líder, que además de intervenir condiciona la decisión clínica. La mejora en tecnología y automatización ha permitido también al profesional de laboratorio centrarse en la primera y última fase del ciclo de laboratorio, la solicitud de pruebas, y la acción tras su resultado, las etapas con más errores, y donde principalmente se debe actuar para conseguir una mejora en la calidad asistencial del paciente. Contenido: Se muestra el diseño y la implantación de intervenciones de gestión de la demanda de pruebas de laboratorio, logrando el diagnóstico de la enfermedad oculta, y mejorando la adherencia a las guías clínicas y la seguridad del paciente. Resumen: Se expondrán los puntos clave en el proceso de gestión de la demanda, tanto de exceso como de defecto. Perspectivas: El objetivo de la revisión es lograr que el profesional del laboratorio se involucre en el diseño e implantación de intervenciones de gestión de la demanda y en la creación de ese nuevo modelo de Laboratorio Líder.

Background: Rheumatoid arthritis (RA) is a chronic progressive autoimmune inflammatory disease with significant morbidity and mortality. The course of the disease can be modified if diagnosis is early and treatment appropriate. Aim: In this study, we aimed to evaluate a new strategy for early identification of RA patients in primary care settings (the ‘diagnostic bottleneck’) based on serological biomarkers and to manage inappropriate rheumatoid factor (RF) laboratory test requests. Method: A two-arm study was carried out. The first arm corresponded to a retrospective observational descriptive study of patients referred for RF testing from primary care using the current laboratory workflow. The second arm included the following prospective interventions: cancelation of RF requests corresponding to patients with previous negative results for RF over a one-year period; and automatic reflex testing antibodies against cyclic citrullinated proteins (anti-CCP) for patients displaying RF values >30 IU/ml. Outcomes from both arms were then compared. Findings: As double positivity for RF and anti-CCP notably increases the positive likelihood ratio of RA. The intervention enabled a reduction of 2813 tests in 22 months. Moreover, the frequency of unnecessary referrals was reduced from 22% to 8.2%, while that of missed patients decreased slightly (from 21% to 16%), with the number of patients diagnosed per RF request remaining unchanged. In terms of costs, we saved 19.4 RF tests per anti-CCP test added. We developed a simple and cost-effective strategy for reducing the time to diagnosis of RA that can improve patients’ quality of life. This approach was supported by primary and specialised care.

Clinical Decision Support Systems (CDSS) have been implemented in almost all healthcare settings. Laboratory medicine (LM), is one of the most important structured health data stores, but efforts are still needed to clarify the use and scope of these tools, especially in the laboratory setting. The aim is to clarify CDSS concept in LM, in the last decade. There is no consensus on the definition of CDSS in LM. A theoretical definition of CDSS in LM should capture the aim of driving significant improvements in LM mission, prevention, diagnosis, monitoring, and disease treatment. We identified the types, workflow and data sources of CDSS. The main applications of CDSS in LM were diagnostic support and clinical management, patient safety, workflow improvements, and cost containment. Laboratory professionals, with their expertise in quality improvement and quality assurance, have a chance to be leaders in CDSS.

Magnesium is one of the most abundant cations in the body and acts as a cofactor in more than 600 biochemical reactions. Hypomagnesemia is a highly prevalent condition, especially in subjects with comorbid conditions, but has received less attention than other electrolyte disturbances. This review will discuss magnesium physiology, absorption, storage, distribution across the body, and kidney excretion. After reviewing the regulation of magnesium homeostasis, we will focus on the etiology and clinical presentation of hypomagnesemia. The role of laboratory medicine in hypomagnesemia will be the main purpose of this review, and we will discuss the laboratory tests and different samples and methods for its measurement. Although free magnesium is physiologically active, total serum magnesium is the most commonly used measurement in laboratory medicine and is apt for clinical purposes; however, it is not appropriately used, and many patients with hypomagnesemia remain undiagnosed and not treated. Using information technologies, laboratory medicine can largely improve the diagnosis and treatment of hypomagnesemia through the design and establishment of automatic demand management and result management interventions by acting in the first and last steps of the laboratory cycle, test requests, and actions taken after test results, to unmask patients with hypomagnesemia and improve the number of patients undergoing treatment.

Article Laboratory Medicine: from just testing to saving lives was published on May 9, 2023 in the journal Clinical Chemistry and Laboratory Medicine (CCLM) (volume 0, issue 0).

Background: There are nonestablished protocols in use for first-line allergy screening based on IgE testing. These protocols attempt to address an unmet need for sustainability of clinical laboratories, at a time when demand is increasing. Objective: To present a novel protocol for first-line allergy screening and to evaluate the implementation benefits for patients, the health care system, and payers. Methods: We carried out an observational retrospective study analyzing 4359 interventions on primary care testing requests. Interventions included overriding redundant serum IgE (sIgE) testing for allergen mixes, extracts included in mixes, low-prevalence extracts, and milk and egg molecular components without previous positive results when exposed to extracts. We also added prevalent allergen testing. Results: The strategy saved 683 tests from being performed unnecessarily. Test volume decline was primarily driven by the cancelation of 2186 egg and milk components tests; 561 tests were added for mixes, together with 942 allergen extracts tests. Discussion: The results of this study show how the allergy laboratory plays a key role in actively managing demand for sIgE testing, leading to optimized diagnosis.

Background: New tools for health information technology have been developed in recent times, such as Clinical Decision Support (CDS) systems, which are any digital solutions designed to help healthcare professionals when making clinical decisions. The study aimed to show how we have adopted a CDS system in the San Juan de Alicante Clinical Laboratory and facilitate the implementation of our protocol in other clinical laboratories. We have user experience and the motivation to improve healthcare tools. The improvement, measurement, and monitoring of interventions and laboratory tests has been our motto for years. Materials and methods: A descriptive research was conducted. All stages in the design of the project are as follows: 1. Set up a multidisciplinary workgroup. 2. Review patients’ data. 3. Identify relevant data from main sources. 4. Design the likely outcomes. 5. Define a complete integration scenario. 6. Monitor and track the impact. To set up this protocol, two new software systems were implemented in our laboratory: AlinIQ CDS v8.2 as Rule Engine, and AlinIQ AIP Integrated Platform v1.6 as Business Intelligence (BI) tool. Results: Our protocol shows the workflow and actions that can be done with a CDS system and also how it could be integrated with other monitoring systems, as well as some examples of KPIs and their outcomes. Conclusions: CDS could be a great strategic asset for clinical laboratories to improve the integration of care, optimize the use of laboratory tests, and add more clinical value to physicians in the interpretation of results.