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ISO 15189:2012 establishes the requirements for clinical sample management, ensuring quality of process and laboratory information management. The accreditation authority, ENAC in Spain, established the requirements for the authorized use of the label in reports issued by accredited laboratories. These recommendations are applicable to the postanalytical processes and the professionals involved. The Standard requires laboratories to define and document the duration and conditions of sample retention. Laboratories are also required to design an internal quality control scheme to verify whether postanalytical activities attain the expected standards. Information management requirements are also established and laboratories are required to design a contingency plan to ensure the communication of laboratory results. Instructions are finally provided about the correct use of the accreditation label in laboratory reports. A range of nations and scientific societies support that clinical laboratories should be required to obtain accreditation. With ISO 15189 being the most specific standard for demonstrating technical performance, a clear understanding of its requirements is essential for proper implementation.

The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and the personnel involved (laboratory management and staff). We describe the criteria and information required to review and validate analytical results and ensure that clear reports are sent to requesters. These criteria also guarantee that results are transcribed in a reliable way and that all necessary information is provided for the correct interpretation of results. Likewise, the requirements for the correct release of laboratory results are described, with special emphasis on the release of alarming or critical results. In some European countries, clinical laboratories are required to hold partial or full ISO 15189 accreditation, which is a global trend. Therefore, understanding ISO 15189 requirements is imperative for a progressive and more effective implementation of the Standard.

Background and aims: Clinical trials have shown that intensive low‐density lipoprotein cholesterol (LDL‐C) lowering improves cardiovascular outcomes among patients with atherosclerotic cardiovascular disease (ASCVD), but data are limited in real clinical practice, particularly for patients with ASCVD informing different territories. Methods: FRENA was a prospective registry of consecutive outpatients with coronary, cerebrovascular or peripheral artery disease. We compared the incidence of recurrent events in patients with sustained LDL‐C levels <70 mg/dl compared with those with ≥70 mg/dl. Results: As of December 2018, 1182 patients were eligible for this study. Among them, 172 (14.5%) had mean LDL‐C levels ≤70 mg/dl, and 1010 (85.5%) had <70 mg/dl. Their clinical characteristics at baseline were similar. During 5 years of follow‐up, 252 patients (21%) suffered major adverse cardiovascular events (MACE). The incidence rates of MACE were 3.42 events per 100 patient‐years (95% confidence interval [95% CI] 2.17–5.14) in patients with levels <70 mg/dl and 5.57 (95% CI, 4.87–6.34) in those with ≥70 mg/dl; the rate ratio was 0.61 (95% CI, 0.39–0.92), p = 0.019. On multivariable analysis, patients with LDL‐C levels <70 mg/dl were at lower risk for MACE (hazard ratio [HR]: 0.61 [95% CI, 0.39–0.93] p < 0.05). MACE reduction was driven by a decrease in coronary and peripheral events with no significant effect on stroke. Conclusions: Long‐term sustained LDL‐C <70 mg/dl in the clinical practice is associated with reduction in cardiovascular and peripheral vascular events with no apparent effect on stroke. [ABSTRACT FROM AUTHOR]

In this work, a simple, fast and dry method for the fabrication of a thermochromic product with a high load of VO2(M1) consisting of the controlled heat treatment of pure vanadium nanoparticles in air is presented. After a complete design of experiments, it is concluded that the most direct way to attain the maximum transformation of V into VO2(M1) consists of one cycle with a fast heating ramp of 42 °C s−1, followed by keeping 700 °C for 530–600 seconds, and a subsequent cooling at 0.05 °C s−1. Careful examination of these results lead to a second optimum, even more suitable for industrial production (quicker and less energy‐intensive because of its lower temperatures and shorter times), consisting of subjecting V to two consecutive cycles of temperatures and times (625 °C for 5 minutes) with similar preheating (42 °C s−1) but a much faster postcooling (∼ 8 °C s−1). These green reactions only use the power for heating a tube open to atmosphere and a vanadium precursor; without assistance of reactive gases or catalysts, and no special vacuum or pressure requirements. The best products present similar thermochromic properties but higher thermal stability than commercial VO2 particles. These methods can be combined with VO2 doping. [ABSTRACT FROM AUTHOR]

Background: The presence of miRNAs in human reproductive tissue is intriguing and suggests the possibility that these important regulatory molecules play a role in reproductive function. However, the regulatory role of miRNAs in reproductive tissue remains poorly understood with a significant amount of controversial and contradicting data. Objectives: To systematically review the high‐quality studies published to date investigating miRNAs associated with male human reproduction in order to describe their roles and relations with infertility and update the knowledge in the field. Materials and methods: A comprehensive systematic review of the published literature in MEDLINE–PubMed and EMBASE databases from the earliest available online indexing year until June 2018 (complimentary search until July 2019) was performed, in accordance with the PRISMA guidelines. We have included descriptive, case–control, cross‐sectional, and observational prospective and retrospective studies in which fertile/infertile men were well‐defined. The primary outcome was the miRNA expression in testis, epididymis, sperm cells, seminal plasma, and extracellular vesicles (i.e., exosomes and microvesicles). Results: We identified 25,204 articles, of which 42 were selected for qualitative analysis. Of the 42 articles included, 15 evaluated the miRNAs in testis, five in epididymis, 13 in spermatozoa, and 11 in seminal plasma and/or extracellular vesicles. Two studies tackled more than one sub‐group. As far as miRNA presence and content, the results of this systematic review indicated that every tissue/cell contains a well‐defined and stable population of miRNAs that could be potentially related to spermatogenesis and embryogenesis. Discussion and conclusion: Our systematic review of descriptive and observational studies shows a consistent relationship between aberrant miRNA expression and infertility. Therefore, it seems reasonable that measuring the expression of particular miRNAs might be useful not only as infertility biomarkers, but also for developing therapeutic strategies. [ABSTRACT FROM AUTHOR]