Promoting sustainability in nursing and midwifery clinical laboratories: Strategies for resource reduction, reuse, and recycling.

BACKGROUND: The impacts of climate change on planetary health are multifaceted and threaten public health gains made since World War II. Healthcare is the fifth largest global emitter of greenhouse gas emissions, demanding significant efforts to transition to an environmentally sustainable future. Addressing these issues will require collective societal action. In this regard, universities have a dual responsibility - (1) to tackle complex social, economic, and environmental challenges by championing sustainability initiatives designed to positively impact planetary health; and (2) to ensure that graduates are equipped with the knowledge, attitudes and skills needed to steward planetary health towards a more sustainable future. The future nursing and midwifery workforce must be educated to mitigate the health sector's impact on the environment, advocate for action on climate change, prepare for ongoing health impacts of unpredictable climate and environmental changes, and help communities and healthcare systems become more climate resilient. WHAT THIS PAPER CONTRIBUTES: To help increase nursing and midwifery educators' and students' capacity to support planetary-health related interventions, the overarching purpose of this paper is to provide a series of exemplars that illustrate sustainability initiatives used in four university-based clinical skills laboratories. These initiatives each demonstrate a commitment to the United Nation's Sustainable Development Goals and can be used to help embed the importance of planetary health in student learning.

[Management Practice of Outsourcing Hospital Tests to Independent Clinical Laboratories].

With the development of medical technology and the deepening of medical reform, hospital laboratory test continues to expand. Affected by factors such as technology and cost, the business of outsourcing laboratory test to independent clinical laboratories develops rapidly. However, this cooperation mode has not been carried out for a long time and lacks systematic management experience. Through the analysis of the motivation of hospital delivery, this study expounds the classification, judgment basis and requirements for suppliers of third-party clinical laboratory delivery, as well as the operation practice of laboratory test delivery, so as to provide reference for more standardized and effective testing delivery for hospitals.

A dataset examining the impact of direct electronic medical record interfacing on the accuracy of point-of-care urinalysis results.

Point-of-care testing is widely used in a variety of clinical settings. While this testing provides immediate and actionable clinical information, it is prone to error in both the interpretation and reporting of results. Point-of-care urinalysis presents unique opportunities for errors, ranging from variation in visual interpretation to input of results. The data included here represent the results from 63,279 urinalyses from 36,780 unique patients performed over a span of three years at an academic medical center and its associated clinics. The data include the patient age/legal sex, methodology (instrument and test strip used), and the available test results (color, clarity, glucose, bilirubin, ketones, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocyte esterase). Additionally, we include the method of interface between the testing instrumentation and our electronic medical record (EMR). These fell into one of three broad categories: "Interfaced" (results directly transmitted from the urinalysis instrument to the EMR via specialized data interface), "Manual" (results input by selecting from a drop-down menu in the laboratory information system), and "Enter/Edit" (results typed freely into a text field in the EMR). Analysis of this data was primarily a direct comparison of detectable errors (typos, uninterpretable results, and results outside the reportable range) as a function of the method of entry into the EMR. Secondary analysis comparing the impact of restricting drop-down menu options for urine color and clarity was also performed. These data are of use to others as they are diverse in terms of the test performed and the method of interface. Others may wish to analyze these data when making decisions as to how to perform and report these tests and when estimating risks of error with various methods of data entry.

Clinical testing panels for ALS: global distribution, consistency, and challenges.

Objective: In 2021, the Clinical Genome Resource (ClinGen) amyotrophic lateral sclerosis (ALS) spectrum disorders Gene Curation Expert Panel (GCEP) was established to evaluate the strength of evidence for genes previously reported to be associated with ALS. Through this endeavor, we will provide standardized guidance to laboratories on which genes should be included in clinical genetic testing panels for ALS. In this manuscript, we aimed to assess the heterogeneity in the current global landscape of clinical genetic testing for ALS. Methods: We reviewed the National Institutes of Health (NIH) Genetic Testing Registry (GTR) and members of the ALS GCEP to source frequently used testing panels and compare the genes included on the tests. Results: 14 clinical panels specific to ALS from 14 laboratories covered 4 to 54 genes. All panels report on ANG, SOD1, TARDBP, and VAPB; 50% included or offered the option of including C9orf72 hexanucleotide repeat expansion (HRE) analysis. Of the 91 genes included in at least one of the panels, 40 (44.0%) were included on only a single panel. We could not find a direct link to ALS in the literature for 14 (15.4%) included genes. Conclusions: The variability across the surveyed clinical genetic panels is concerning due to the possibility of reduced diagnostic yields in clinical practice and risk of a missed diagnoses for patients. Our results highlight the necessity for consensus regarding the appropriateness of gene inclusions in clinical genetic ALS tests to improve its application for patients living with ALS and their families.

Clinical Evaluation of Metagenomic Next-Generation Sequencing Method for the Diagnosis of Suspected Ascitic Infection in Patients with Liver Cirrhosis in a Clinical Laboratory.

Metagenomic next-generation sequencing (mNGS), mostly carried out in independent clinical laboratories, has been increasingly applied in clinical pathogen diagnosis. We aimed to explore the feasibility of mNGS in clinical laboratories and analyze its potential in the diagnosis of infectious ascites. Two reference panels composed of 12 strains commonly appearing in peritonitis were constructed to evaluate the performance metrics based on in-house mNGS protocols. The mNGS clinical detection value was analyzed in 211 ascitic samples and compared with culture and composite standards. Finally, eight patients with cirrhosis were prospectively enrolled to verify the clinical value of mNGS in peritoneal infection diagnosis. The mNGS analytical performance showed that the assay had great linearity, specificity, stability, interference, and limits of detection of 33 to 828 CFU/mL. The sensitivity and specificity of mNGS for bacterial or fungal detection using culture standards were 84.2% and 82.0%, respectively. After adjustment using digital PCR and clinical judgment, the sensitivity and specificity increased to 87.2% and 90.1%, respectively. Compared with culture, mNGS detected a broad range of pathogens and more polymicrobial infections (49% versus 9%, P < 0.05). The pathogen results were obtained within 24 h using mNGS in eight prospective cases, which effectively guided antibiotics therapy. mNGS testing in clinical laboratories affiliated with a hospital has certain advantages. It has unique superiority in pathogens detection, particularly in patients with polymicrobial infections. However, considering spectrum characteristics and test cost, pertinent pathogen panels should be developed in clinical practice. IMPORTANCE This study established and evaluated a complete metagenomics next-generation sequencing assay to improve the diagnosis of suspected ascitic infection in a clinical laboratory affiliated with a hospital. The assay is superior to traditional culture testing and will aid in the early and accurate identification of pathogens, particularly in patients with polymicrobial infections. This assay is also essential for precision therapy and can reduce the incidence of drug resistance stemming from irrational use of antibiotics.

From classroom to clinic: Biochemistry lab for pre-health majors.

Undergraduate laboratory courses are vital for both enhancing student learning and preparing students for their future careers. Despite their importance, laboratory courses are often met with a lack of enthusiasm from students. For pre-health students specifically, laboratory courses are commonly seen as part of a check-list that needs to be completed in order to achieve future education or a career, instead of seeing the information that is taught in laboratories as essential preparation. A one-semester biochemistry laboratory module was designed to demonstrate the real-life applications of experimental techniques. This laboratory module introduced students to common clinical measurements and included learning metabolite analysis through hands-on experiments, connections to simulated patient visits, generation of a research question, and implementation of a student-designed independent experiment. Surveys indicate that this approach was helpful in creating a greater understanding of the applicability of undergraduate laboratory concepts appealing specifically to pre-health students. Additionally, students found this module to provide a variety of gained benefits, knowledge, and confidence in performing scientific techniques. The outcomes of this laboratory module indicate its success and potential to be used in curricula as an effective way to engage pre-health students in an undergraduate biochemistry laboratory.

Embedding education into clinical laboratory professional training to foster sustainable development and greener practice.

It has become apparent that the climate crisis is reaching critical levels and Governments and key organisations are recognising the need for change. A review of current literature reveals very little published research concerning the impact of clinical laboratory practice on the carbon footprint of healthcare. For a clinical laboratory to become more environmentally sound, key target areas of focus are required. With sustainability becoming a key consideration for course development, employing educational principles such as Education for Sustainable Development (ESD) in the form of Sustainability in Quality Improvement (SusQI), Quality Improvement objectives can be met, while benefitting the patient and the environmental impact of organisation.

Management Practice of Outsourcing Hospital Tests to Independent Clinical Laboratories / 中国医疗器械杂志

With the development of medical technology and the deepening of medical reform, hospital laboratory test continues to expand. Affected by factors such as technology and cost, the business of outsourcing laboratory test to independent clinical laboratories develops rapidly. However, this cooperation mode has not been carried out for a long time and lacks systematic management experience. Through the analysis of the motivation of hospital delivery, this study expounds the classification, judgment basis and requirements for suppliers of third-party clinical laboratory delivery, as well as the operation practice of laboratory test delivery, so as to provide reference for more standardized and effective testing delivery for hospitals.

Importance of Interpretative Comments in Clinical Biochemistry - a Practitioner's Report.

Interpretative comment (IC) from the clinical biochemist is a professional obligation. Most of the Nepalese clinical laboratories use only predefined comments on the report, while few laboratories do not provide comments at all. Apart from doctors, other healthcare professionals and sometimes patients themselves seek laboratory expert opinion in the interpretation of obtained results. The non-availability of patient's medical record or limited communication with physicians as well as insufficient professional knowledge impacts the quality of interpretative comments in Nepal. This report is intended to emphasize that the task of providing IC is becoming more important in the context of Nepal. Similarly, this report also guides those who provide interpretative comments.

A Systematic Review of Internet of Things in Clinical Laboratories: Opportunities, Advantages, and Challenges.

The Internet of Things (IoT) is the network of physical objects embedded with sensors, software, electronics, and online connectivity systems. This study explores the role of IoT in clinical laboratory processes; this systematic review was conducted adhering to the PRISMA Statement 2020 guidelines. We included IoT models and applications across preanalytical, analytical, and postanalytical laboratory processes. PubMed, Cochrane Central, CINAHL Plus, Scopus, IEEE, and A.C.M. Digital library were searched between August 2015 to August 2022; the data were tabulated. Cohen's coefficient of agreement was calculated to quantify inter-reviewer agreements; a total of 18 studies were included with Cohen's coefficient computed to be 0.91. The included studies were divided into three classifications based on availability, including preanalytical, analytical, and postanalytical. The majority (77.8%) of the studies were real-tested. Communication-based approaches were the most common (83.3%), followed by application-based approaches (44.4%) and sensor-based approaches (33.3%) among the included studies. Open issues and challenges across the included studies included scalability, costs and energy consumption, interoperability, privacy and security, and performance issues. In this study, we identified, classified, and evaluated IoT applicability in clinical laboratory systems. This study presents pertinent findings for IoT development across clinical laboratory systems, for which it is essential that more rigorous and efficient testing and studies be conducted in the future.

Era of Molecular Diagnostics Techniques before and after the COVID-19 Pandemic.

Despite the growth of molecular diagnosis from the era of Hippocrates, the emergence of COVID-19 is still remarkable. The previously used molecular techniques were not rapid enough to screen a vast population at home, in offices, and in hospitals. Additionally, these techniques were only available in advanced clinical laboratories.The pandemic outbreak enhanced the urgency of researchers and research and development companies to invent more rapid, robust, and portable devices and instruments to screen a vast community in a cost-effective and short time. There has been noteworthy progress in molecular diagnosing tools before and after the pandemic. This review focuses on the advancements in molecular diagnostic techniques before and after the emergence of COVID-19 and how the pandemic accelerated the implantation of molecular diagnostic techniques in most clinical laboratories towardbecoming routine tests.

Flowing through laboratory clinical data: the role of artificial intelligence and big data.

During the last few years, clinical laboratories have faced a sea change, from facilities producing a high volume of low-cost test results, toward a more integrated and patient-centered service. Parallel to this paradigm change, the digitalization of healthcare data has made an enormous quantity of patients' data easily accessible, thus opening new scenarios for the utilization of artificial intelligence (AI) tools. Every day, clinical laboratories produce a huge amount of information, of which patients' results are only a part. The laboratory information system (LIS) may include other "relevant" compounding data, such as internal quality control or external quality assessment (EQA) results, as well as, for example, timing of test requests and of blood collection and exams transmission, these data having peculiar characteristics typical of big data, as volume, velocity, variety, and veracity, potentially being used to generate value in patients' care. Despite the increasing interest expressed in AI and big data in laboratory medicine, these topics are approaching the discipline slowly for several reasons, attributable to lack of knowledge and skills but also to poor or absent standardization, harmonization and problematic regulatory and ethical issues. Finally, it is important to bear in mind that the mathematical postulation of algorithms is not sufficient for obtaining useful clinical tools, especially when biological parameters are not evaluated in the appropriate context. It is therefore necessary to enhance cooperation between laboratory and AI experts, and to coordinate and govern processes, thus favoring the development of valuable clinical tools.

Primeras aportaciones de diagnóstico de laboratorio frente al COVID-19 en el Hospital Central de la Defensa “Gómez Ulla” / First contributions of laboratory diagnostics against COVID-19 at the Hospital Central de la Defensa

Antecedentes y objetivos: La enfermedad por coronavirus-19 se ha extendido por todo el mundo notificándose hasta la fecha 3.446.072casos en nuestro país. Esto ha supuesto un reto en el Sistema Sanitario Español. El objetivo del estudio es describir las adaptaciones,los parámetros analíticos y microbiológicos de pacientes diagnosticados clínicamente de infección por SARS-CoV-2 en las primerassemanas de la pandemia.Material y métodos: Estudio retrospectivo observacional, se incluyeron 180 pacientes atendidos por el servicio de Urgencias de nuestro hospital entre el 9 de marzo y el 24 de abril de 2020, clínicamente diagnosticados de COVID19. Se analizaron datos demográficos,analíticos y microbiológicos de ellos.Resultados: La edad media de los pacientes fue 64 años y el 60,6% eran hombres. El 86,1% tuvo RT-PCR positiva, el 3,9% negativay en el 10% un resultado no concluyente. Se detectaron anticuerpos IgG en el 84,4% y anticuerpos IgM en el 85,6%.El 26,0% denuestros pacientes presentó linfopenia y el 13,6% trombocitopenia. El 67,4% y el 77,3% tenían respectivamente niveles de dímero Dy fibrinógeno por encima del rango normal. Se notificaron niveles séricos elevados de ALT (45,0%), AST (30,5%), LDH (71,9%),proteína C reactiva (74,5%) y procalcitonina (11,9%).Se encontraron altas concentraciones de ferritina en el 75,2 %.Conclusiones: Las alteraciones observadas en los parámetros analíticos son las más comunes en casos de COVID19. La elevación deestos se han considerado marcadores pronósticos de gravedad y mortalidad. (AU)

First contributions of laboratory diagnosis against Covid-19 at Hospital Central de la Defensa Gómez UllaSUMMARY:Antecedents and objectives:The coronavirus disease 2019 (COVID-19) has spread worldwide to be reported to date 3.446.072 cases inSpain which causes a very challenging situation for the Spanish Health Care System.This study aims to describe the adjustments, analytical and microbiological parameters of patients clinically diagnosed with SARSCoV-2 infection in the first weeks of the pandemic.Material and methods:A retrospective observational study. 180 patients have been included in the study since they were treated by ouremergency unit for a period beginning on March 9 ending on April 24, 2020. They were clinically diagnosed with COVID-19. Thestudy provides analysis on their demographic, analytical and microbiological data.Results: The average patient was 64 years old and 60.6 % were men. 86.1 % obtained a positive RT-PCR, 3.9 % a negative one. The 10% left provided an inconclusive result. IgG antibodies were detected in 84.4 % and IgM antibodies in 85.6 %. 26.0 % of our patientssuffered from lymphopenia and 13.6 % thrombocytopenia. 67.4 % and 77.3 % had respectively D-dimer and fibrinogen levels abovethe normal range. High serum levels of ALT (45.0 %), AST (30.5 %), LDH (71.9 %), C-reactive protein (74.5 %), and procalcitonin(11.9 %) were reported. High ferritin concentrations were found in 75.2 %.Conclusions: The alterations observed in the analytical parameters are the most common in cases of COVID-19. These high levelrates have been considered prognostic markers of severity and mortality. (AU)

Effects of the COVID-19 pandemic on the activity of clinical laboratories in Spain, evolution in the 2019-2021 period.

Objectives: To assess the impact of the COVID-19 pandemic on the activity of clinical laboratories in Spain. Methods: A descriptive, observational, retrospective, multicenter study. Results: Between March and December 2020, there was a statistically significant decrease in the number of test requests (-17.7%, p=<0.001) and total tests performed (-18.3%, p<0.001) with respect to the same period in 2019. A decrease was observed in the number of requests from primary care (-37.4%) (p<0.001) and in the number of foecal occult blood (-45.8%); qualitative urine (-30.1%); PSA (-28.5%); TSH (-27.8%); total cholesterol (-27.2%) and HbA1c (-24.7%) tests performed, p<0.001. A significant increase was found in the number of requests from ICUs (76.6%, p<0.001) and number of IL-6 (+22,350.9), D-dimer (+617.2%), troponin (+46.8%) and arterial blood gas (+3.9%) tests carried out, p<0.001. During the first months of 2021, there were significant changes in the number of requests for qualitative urine (-8.7%, p<0.001), PSA (-6.3%, p=0.009), IL-6 (+66,269.2, p<0.001), D-dimer (+603.6%, p<0.001), troponin (+28.7%, p<0.001), arterial blood gas (+26,2%, p=0.014) and ferritin (+16.0%, p=0.002) tests performed. Conclusions: There were changes in the origin and number of test requested to clinical laboratories in Spain. The number of requests for the evaluation and monitoring of COVID-19 patients increased, whereas requests for the control of non-COVID patients and for population screening decreased. Long-term analysis reveals that the volume of tests performed for the control of chronic diseases returned to normal over time, whereas the increase observed in the volume of tests performed for the management of COVID-19 patients is maintained.

Application of delta checks in clinical laboratories / 中华检验医学杂志

The delta checks are one of the patient-based quality control options to identify the errors and the significant changes in patients′ condition. Compared with the traditional internal quality control method, the delta checks have the characteristics of real-time monitoring, with no additional detecting cost, thus the delta checks are widely used in clinical laboratories. In addition, the delta checks are also useful in the auto-verification system to screen out the abnormal results for manual verification. This article reviewed the delta checks′ development history, parameters selection, application values in quality control and auto-verification.

The commercial genetic testing landscape for Parkinson's disease.

INTRODUCTION: There have been no specific guidelines regarding which genes should be tested in the clinical setting for Parkinson's disease (PD) or parkinsonism. We evaluated the types of clinical genetic testing offered for PD as the first step of our gene curation. METHODS: The National Institutes of Health (NIH) Genetic Testing Registry (GTR) was queried on 12/7/2020 to identify current commercial PD genetic test offerings by clinical laboratories, internationally. RESULTS: We identified 502 unique clinical genetic tests for PD, from 28 Clinical Laboratory Improvement Amendments (CLIA)-approved clinical laboratories. These included 11 diagnostic PD panels. The panels were notable for their differences in size, ranging from 5 to 62 genes. Five genes for variant query were included in all panels (SNCA, PRKN, PINK-1, PARK7 (DJ1), and LRRK2). Notably, the addition of the VPS35 and GBA genes was variable. Panel size differences stemmed from inclusion of genes linked to atypical parkinsonism and dystonia disorders, and genes in which the link to PD causation is controversial. CONCLUSION: There is an urgent need for expert opinion regarding which genes should be included in a commercial laboratory multi-gene panel for PD.

Detection of SARS-CoV-2 antibodies formed in response to the BNT162b2 and mRNA-1237 mRNA vaccine by commercial antibody tests.

BACKGROUND: With rapid approval of SARS-CoV-2 vaccines, the ability of clinical laboratories to detect vaccine-induced antibodies with available high-throughput commercial assays is unknown. We aimed to determine if commercial serology assays can detect vaccine-induced antibodies (VIAs) and understand the vaccination response. METHODS: This cohort study recruited healthcare workers and residents of long-term care facilities (receiving the BNT162b2 and mRNA-1273 products, respectively) who underwent serum collection pre-vaccination (BNT162b2 group), 2-weeks post vaccination (both groups), and pre-2nd dose (both groups). Sera were tested for the presence of SARS-CoV-2 IgG using four commercial assays (Abbott SARS-CoV-2 IgG, Abbott SARS-CoV-2 IgG II Quant, DiaSorin Trimeric S IgG, and GenScript cPASS) to detect VIAs. Secondary outcomes included description of post-vaccination antibody response and correlation with neutralizing titers. RESULTS: 225 participants (177 receiving BNT162b2 and 48 receiving mRNA-1273) were included (median age 41 years; 66-78% female). Nucleocapsid IgG was found in 4.1% and 21.9% of the BNT162b2 (baseline) and mRNA-1273 (2-weeks post first dose). All anti-spike assays detected antibodies post-vaccination, with an average increase of 87.2% (range 73.8-94.3%; BNT162b2), and 25.2% (range 23.8-26.7%; mRNA-1273) between the first and last sampling time points (all p < 0.05). Neutralizing antibodies were detected at all post-vaccine timepoints for both vaccine arms, with increasing titers over time (all p < 0.05). CONCLUSIONS: Anti-spike vaccine-induced SARS-CoV-2 IgG are detectable by commercially available high-throughput assays and increases over time. Prior to second dose of vaccination, neutralizing antibodies are detectable in 73-89% of individuals, suggesting most individuals would have some degree of protection from subsequent infection.