Approaching sustainability in Laboratory Medicine.

INTRODUCTION: Clinical laboratories and the total testing process are major consumers of energy, water, and hazardous chemicals, and produce significant amounts of biomedical waste. Since the processes in the clinical laboratory and the total testing process go hand in hand it mandates a holistic, and comprehensive approach towards sustainability. CONTENT: This review article identifies the various sources and activities in Laboratory Medicine that challenge sustainability and also discusses the various approaches that can be implemented to achieve sustainability in laboratory operations to reduce the negative impact on the environment. SUMMARY: The article highlights how the integration of technological advancements, efficient resource management, staff training and sensitization, protocol development towards sustainability, and other environmental considerations contributes significantly to a sustainable healthcare ecosystem. OUTLOOK: Variables and resources that negatively impact the environment must be identified and addressed comprehensively to attain a long-lasting level of carbon neutrality.

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.

Digital transformation and sustainability in healthcare and clinical laboratories.

Healthcare, and in particular, clinical laboratories, are major contributors to carbon emissions and waste. Sustainability in healthcare has shifted from an environmental concern towards a holistic definition that includes balancing socio-ecological and socio-technical systems, including health services effectiveness and cost efficiency. Digital transformation can reduce waste and the cost of services by enhancing effectiveness while maintaining quality. Digital health interventions can provide personalized patient-centered care on a global scale and include decision support systems that have the potential to improve the performance and quality of healthcare. The right interfaces must be used so that the advantages of going digital are felt throughout the health system: a successful and sustainable implementation of digital innovation depends on its integration into a functional health ecosystem. Telehealth has the potential to reduce carbon emissions due to the reduced daily commute of health professionals, although research is limited. Recently, economic models have changed from the linear "take-make-dispose" to circular models based on recycling and upcycling that have the goal of keeping products, components, and materials at their highest utility and value. The previous linear models threaten human health and well-being and harm natural ecosystems.

India-discovered levonadifloxacin & alalevonadifloxacin: A review on susceptibility testing methods, CLSI quality control and breakpoints along with a brief account of their emerging therapeutic profile as a novel standard-of-care.

BACKGROUND: Levonadifloxacin (intravenous) and alalevonadifloxacin (oral prodrug) are novel antibiotics based on benzoquinolizine subclass of fluoroquinolone, licensed for clinical use in India in 2019. The active moiety, levonadifloxacin, is a broad-spectrum antibiotic with a high potency against methicillin-resistant Staphylococcus. aureus, multi-drug resistant pneumococci and anaerobes. OBJECTIVE: This review, for the first time, critically analyses the antimicrobial susceptibility testing methods, Clinical Laboratory & Standards Institute (CLSI)-quality control of susceptibility testing and breakpoints of levonadifloxacin. Further, the genesis, discovery and developmental aspects as well as therapeutic profile of levonadifloxacin and alalevonadifloxacin are briefly described. CONTENTS: In order to aid the scientific and clinician communities with a single comprehensive overview on all the key aspects of levonadifloxacin and alalevonadifloxacin, the present article covers the reference MIC and disk diffusion methods for levonadifloxacin susceptibility testing that were approved by CLSI and the reference ranges for quality control strains published in the CLSI M100 document. The breakpoints of levonadifloxacin were derived in concordance to US FDA, European Committee on Antibiotic Susceptibility Testing (EUCAST) and CLSI approaches. Further, the article provides a brief account of challenges encountered during the discovery stages of levonadifloxacin and alalevonadifloxacin, activity spectrum and safety benefits accruing from structural novelty-linked mechanism of action. Further, the review also covers in vitro and in vivo activities, registrational clinical studies and patient-friendly features of levonadifloxacin/alalevonadifloxacin. Cumulatively, levonadifloxacin has a potential to offer a long awaited new standard-of-care treatment for the resistant Gram-positive bacterial infections.

Development and Implementation of a Standard Format for Clinical Laboratory Test Results.

OBJECTIVES: Surprisingly, laboratory results, the principal output of clinical laboratories, are not standardized. Thus, laboratories frequently report results with identical meaning in different formats. For example, laboratories report a positive pregnancy test as "+," "P," or "Positive." To assess the feasibility of a widespread implementation of a result standard, we (1) developed a standard result format for common laboratory tests and (2) implemented a feedback system for clinical laboratories to view their unstandardized results. METHODS: In the largest integrated health care system in America, 130 facilities had the opportunity to collaboratively develop the standard. For 15 weeks, clinical laboratories received a weekly report of their unstandardized results. At the study's conclusion, laboratories were compared with themselves and their peers by metrics that reflected their unstandardized results. RESULTS: We rereviewed 156 million test results and observed a 51% decline in the rate of unstandardized results. The number of facilities with fewer than 23 unstandardized results per 100,000 (Six Sigma σ > 5) increased by 58% (52 to 82 facilities; ß = 1.79; P < .001). CONCLUSIONS: This study demonstrated significant improvement in the standardization of clinical laboratory results in a relatively short time. The laboratory community should create and promulgate a standardized result format.

Fermented Carica papaya and Morinda citrifolia as Perspective Food Supplements for the Treatment of Post-COVID Symptoms: Randomized Placebo-Controlled Clinical Laboratory Study.

Food supplements based on fermented Carica papaya and Morinda citrifolia, known for their immune modulating, redox balancing, and anti-inflammatory effects, were added to conventional treatment protocols prescribed to patients recovering after severe and moderate COVID-19 disease in order to alleviate long-lasting post-COVID symptoms. A randomized single-center placebo-controlled clinical laboratory study was designed and performed (total number of participants 188, with delta variant of virus 157, with omicron 31). Clinical statuses were assessed using computer tomography, electrocardiography, a questionnaire, and physical endurance. Plasma cytokines (IL-6, IL-8, IL-17A, and INF-gamma), nitrate/nitrite ratio, antioxidant activity (AOA), and polymorphonuclear leukocyte (PMN) ATP levels were determined before and 20 days following the addition of 28 g of fermented supplements twice per day. The capacity of PMN to phagocyte and the oral-nasal-pharyngeal microbiota were assessed. Clinical symptoms, IL-6, IL-8, and nitric oxide metabolites diminished significantly compared to the placebo group and their background expression. The PMN capacity to phagocyte, AOA, and ATP content remarkably increased. The oral-nasal-pharyngeal microbiota were unchanged. On these grounds, we suggest that fermented tropical fruits could efficiently diminish post-COVID clinical symptoms through several immune-modulating, redox balancing, and pro-energy mechanisms.

Consideration for the validation of clinical laboratory methods in nonclinical fields.

In new drug development, cells or animals are treated with the selected candidate compound to confirm its efficacy and safety in nonclinical studies. Clinical laboratory tests are carried out using samples from experimental animals in these studies. The clinical laboratory test method validation in nonclinical fields should be conducted keeping in mind that the circumstances differ from those in clinical settings. However, the validation procedures have not been systematically integrated into any standard. The considerations in this paper set out systematically practical guidance for the validation of quantitative analytical methods for fluid samples collected from animal studies, for the purpose of ensuring that laboratory test method validation is conducted in nonclinical fields at an enough level.

Real evidence to assess clinical testing interference risk (REACTIR): A strategy using real world data to assess the prevalence of interfering substances in patients undergoing clinical laboratory testing.

INTRODUCTION: Laboratory test interferences can cause spurious test results and patient harm. Knowing the frequency of various interfering substances in patient populations likely to be tested with a particular laboratory assay may inform test development, test utilization and strategies to mitigate interference risk. METHODS: We developed REACTIR (Real Evidence to Assess Clinical Testing Interference Risk), an approach using real world data to assess the prevalence of various interfering substances in patients tested with a particular type of assay. REACTIR uses administrative real world data to identify and subgroup patient cohorts tested with a particular laboratory test and evaluate interference risk. RESULTS: We demonstrate the application REACTIR to point of care (POC) blood glucose testing. We found that exposure to several substances with the potential to interfere in POC blood glucose tests, including N-acetyl cysteine (NAC) and high dose vitamin C was uncommon in most patients undergoing POC glucose tests with several key exceptions, such as burn patients receiving high dose IV-vitamin C or acetaminophen overdose patients receiving NAC. CONCLUSIONS: Findings from REACTIR may support risk mitigation strategies including targeted clinician education and clinical decision support. Likewise, adaptations of REACTIR to premarket assay development may inform optimal assay design and assessment.

Independent and combined effects of biotin and hemolysis on high-sensitivity cardiac troponin assays.

OBJECTIVES: This study compared the independent and combined effects of hemolysis and biotin on cardiac troponin measurements across nine high-sensitivity cardiac troponin (hs-cTn) assays. METHODS: Parallel cTn measurements were made in pooled lithium heparin plasma spiked with hemolysate and/or biotin using nine hs-cTn assays: Abbott Alinity, Abbott ARCHITECT i2000, Beckman Access 2, Ortho VITROS XT 7600, Siemens Atellica, Siemens Centaur, Siemens Dimension EXL cTnI, and two Roche Cobas e 411 Elecsys Troponin T-hs cTnT assays (outside US versions, with and without increased biotin tolerance). Absolute and percent cTn recovery relative to two baseline concentrations were determined in spiked samples and compared to manufacturer's claims. RESULTS: All assays except the Ortho VITROS XT 7600 showed hemolysis and biotin interference thresholds equivalent to or greater than manufacturer's claims. While imprecision confounded analysis of Ortho VITROS XT 7600 data, evidence of biotin interference was lacking. Increasing biotin concentration led to decreasing cTn recovery in three assays, specifically both Roche Cobas e 411 Elecsys Troponin T-hs assays and the Siemens Dimension EXL. While one of the Roche assays was the most susceptible to biotin among the nine studied, a new version showed reduced biotin interference by approximately 100-fold compared to its predecessor. Increasing hemolysis also generally led to decreasing cTn recovery for susceptible assays, specifically the Beckman Access 2, Ortho VITROS XT 7600, and both Roche Cobas e 411 Elecsys assays. Equivalent biotin and hemolysis interference thresholds were observed at the two cTn concentrations considered for all but two assays (Beckman Access 2 and Ortho VITROS XT 7600). When biotin and hemolysis were present in combination, biotin interference thresholds decreased with increasing hemolysis for two susceptible assays (Roche Cobas e 411 Elecsys and Siemens Dimension EXL). CONCLUSIONS: Both Roche Cobas e 411 Elecsys as well as Ortho VITROS XT assays were susceptible to interference from in vitro hemolysis at levels routinely encountered in clinical laboratory samples (0-3 g/L free hemoglobin), leading to falsely low cTn recovery up to 3 ng/L or 13%. While most assays are not susceptible to biotin at levels expected with over-the-counter supplementation, severely reduced cTn recovery is possible at biotin levels of 10-2000 ng/mL (41-8,180 nmol/L) for some assays. Due to potential additive effects, analytical interferences should not be considered in isolation.