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OBJECTIVE: To assess the association between ketonuria and hyperemesis gravidarum (HG) disease severity. STUDY DESIGN: We included pregnant women hospitalised for HG who participated in the Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding (MOTHER) trial and women who were eligible, chose not to be randomised and agreed to participate in the observational cohort. Between October 2013 and March 2016, in 19 hospitals in the Netherlands, women hospitalised for HG were approached for study participation. The presence of ketonuria was not required for study entry. Ketonuria was measured at hospital admission with a dipstick, which distinguishes 5 categories: negative and 1+ through 4 + . The outcome measures were multiple measures of HG disease severity at different time points: 1) At hospital admission (study entry): severity of nausea and vomiting, quality of life and weight change compared to pre-pregnancy weight, 2) One week after hospital admission: severity of nausea and vomiting, quality of life and weight change compared to admission, 3) Duration of index hospital admission and readmission for HG at any time point RESULTS: 215 women where included. Ketonuria was not associated with severity of nausea and vomiting, quality of life or weight loss at hospital admission, nor was the degree of ketonuria at admission associated with any of the outcomes 1 week after hospital admission. The degree of ketonuria was also not associated with the number of readmissions. However, women with a higher degree of ketonuria had a statistically significant longer duration of hospital stay (per 1+ ketonuria, difference: 0.27 days, 95 % CI: 0.05 to 0.48). CONCLUSIONS: There was no association between the degree of ketonuria at admission and severity of symptoms, quality of life, maternal weight loss, or number of readmissions, suggesting that ketonuria provides no information about disease severity or disease course. Despite this, women with a higher degree of ketonuria at admission were hospitalised for longer. This could suggest that health care professionals base length of hospital stay on the degree of ketonuria. Based on the lack of association between ketonuria and disease severity, we suggest it has no additional value in the clinical management of HG.

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BACKGROUND: There is little knowledge about neonatal complications in GH and PE and induction at term, we aim to assess whether they can be predicted from clinical data. METHODS: We used data of the HYPITAT trial and evaluated whether adverse neonatal outcome (Apgar score < 7, pH < 7.05, NICU admission) could be predicted from clinical data. Logistic regression, ROC analysis and calibration were used to identify predictors and evaluate the predictive capacity in an antepartum and intrapartum model. RESULTS: We included 1153 pregnancies, of whom 76 (6.6%) had adverse neonatal outcome. Parity (primipara OR 2.75), BMI (OR 1.06), proteinuria (dipstick +++ OR 2.5), uric acid (OR 1.4) and creatinine (OR 1.02) were independent antepartum predictors; In the intrapartum model, meconium stained amniotic fluid (OR 2.2), temperature (OR 1.8), duration of first stage of labour (OR 1.15), proteinuria (dipstick +++ OR 2.7), creatinine (OR 1.02) and uric acid (OR 1.5) were predictors of adverse neonatal outcome. Both models showed good discrimination (AUC 0.75 and 0.78), but calibration was limited (Hosmer-Lemeshow p = 0.41, and p = 0.20). CONCLUSIONS: In women with GH or PE at term, it is difficult to predict neonatal complications, possibly since they are rare in the term pregnancy. However, the identified individual predictors may guide physicians to anticipate requirements for neonatal care.

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The management of human resources is a major issue for laboratory accreditation, since it allows to show the proofs of competency assessment, a basis to ensure the confidence. In this paper, the main processes involved are described: the general process for the management of human resources and the authorization for personnel process. Guidelines for document control are also proposed. At least, examples are given to facilitate the implementation of these guidelines in a medical laboratory.

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Compliance to EN ISO 22870 standard for point-of-care testing (POCT) accreditation is close to those of EN ISO 15189 in central laboratory. However, it is mandatory to master the elements which are specific to POCT. In this paper, we describe the two main processes involved to help medical biologists to achieve standard requirements, particularly in the risk assessment study. The first process concerns the deployment of a POCT device in a hospital outside laboratory and the second is the classical process of medical biology testing, outlining the steps which are different from the laboratory testing process. Furthermore, we reference, in front of each sub-process described, the different articles published in the present volume detailing specific guidelines to master them.

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EN ISO 22870 requires the medical laboratory director to form a multidisciplinary group for the management of point-of-care testing activities and to appoint a person responsible for this group. This article proposes to define the composition (representatives of the medical laboratory, care units owning point-of-care devices, administration), missions (introduction, follow-up and evaluation of point-of-care devices) and the decision circuit of this group and to describe the profile of the head and the tasks assigned.

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Implementation is the main step of the point-of-care testing (POCT) device installation process to comply with EN ISO 22870. The multidisciplinary POCT management group is in charge to align that process with the standards but also with the French regulation (ordinance 2010-49 of 13 January 2010) which authorizes POCT only in case of urgent therapeutic decisions. This article defines two reports to be prepared during the deployment of a POCT device : a report that justifies the use of a POCT device, taking into account a risk-benefit analysis and a report that justifies the choice of the device including proofs of conformity of its installation.

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In this paper, we focus on the additional requirements of EN ISO 22870 compared to those described in Chapter 4: Quality Management of EN ISO 15189. They concern the quality policy, the management reviews and the audits. Thus, we propose a template of quality policy statement, and specific requirements for conducting management review of POCT are given. Finally, a questionnaire for performing an audit of POCT activities is proposed. The composition and activities of the multidisciplinary group for the supervision of POCT activities, which is also a specific requirement of EN ISO 22870, is discussed in another article of this volume.

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This article proposes to organize the documentation system of point-of-care testing (POCT) to meet the requirements of EN ISO 22870. In a first part, we propose provisions to improve the control of documents circulating outside the laboratory and aimed at non-laboratory staff. Then we review POCT-related records and we propose an organization facilitating their audit. In the last part, a model of POCT quality plan is proposed : in addition to the quality manual, this document defines the specific measures taken in order to ensure the control of POCT.

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Quality of point-of-care examinations depends on the quality assurance system settled. This paper describes the different tools used to control the pre-examination, examination and post-examination procedures taking part in the quality of patient care according to the requirements of the standard EN ISO 22870 and EN ISO 15189 as well. They include mainly: For the pre-examination phase, the sample traceability and for the analytical phase, the practice of internal quality control and the participation in external quality assessment programme.

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In this paper, guidelines are proposed to fulfill the requirements of EN ISO 22870 standard regarding the management of point-of-care testing (POCT) nonconformities. In the first part, the main nonconformities that may affect POCT are given, the means for resolution and the control of adverse events are proposed. In the second part, we propose recommendations in case of unavailability of a point-of-care testing device from the occurring of the adverse event, to the restarting of the device.

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For point-of-care-testing (POCT), the French regulation on medical biology states allows a unique situation where a delayed validation of results is possible. This paper proposes guidelines to organize POCT post-analytical phase in agreement with the local regulation and ISO 22870 requirements. In the first part, organization of POCT validation is detailed (since analysis results reading by the physician until validation of results by the medical biologist and their integration into the patient record). In a second part, elements to include in POCT presentation of results are discussed and a model is proposed.

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Echinoderms are known to readily incorporate metals in their calcified endoskeleton. It is currently unclear if this has an impact on the skeleton function or if this can be considered as a detoxification mechanism. In the present work, populations of the sea urchin Echinus acutus and the starfish Asterias rubens were studied in stations distributed along a metal contamination gradient in a Norwegian fjord (Sørfjord). Ossicles involved in major mechanical functions - sea urchin spine and starfish ambulacral plate - were analyzed for their metal concentration (Cd, Cu, Pb and Zn) and their biometric and mechanical properties. Starfish plates were more contaminated by Cd, Pb and Zn than sea urchin spines. Cu concentrations were at background levels. In E. acutus, metals principally affected size. In A. rubens, material stiffness and toughness were decreased in the most contaminated station. This reduction is attributed either to the direct incorporation of metals in the calcite lattice and/or to deleterious effects of metals during skeleton ontogenesis. The contrasting incorporation of metals in the skeleton of the two investigated species accounts for the different impact of the metals, including in terms of fitness. The present results clearly indicate that, at least in A. rubens, incorporation of metals in the skeleton cannot be considered as a detoxification mechanism.

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Two pregnant patients with a sustained symptomatic maternal supraventricular arrhythmia are presented. Both patients were treated with direct-current cardioversion. Electrical cardioversion during pregnancy is a rarely applied but highly effective procedure in the treatment of maternal cardiac arrhythmias and is assumed safe for both mother and child. However, once foetal viability is reached, monitoring of the foetal heart rate is advised and facilities for immediate caesarean section should be available.

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We report the first experimental demonstration of the echo-enabled harmonic generation technique, which holds great promise for generation of high-power, fully coherent short-wavelength radiation. In this experiment, coherent radiation at the 3rd and 4th harmonics of the second seed laser is generated from the so-called beam echo effect. The experiment confirms the physics behind this technique and paves the way for applying the echo-enabled harmonic generation technique for seeded x-ray free electron lasers.

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BACKGROUND: Fluid therapy induces haemodilution related to plasma volume expansion. The aim of our study was to compare haemodilution after a single hydroxyethyl starches (HES) 130/0.4 infusion in two groups of patients, one with and one without sepsis. We hypothesized that a single HES challenge would induce similar sustained haemodilution in both groups. METHODS: In this prospective preliminary study, patients predicted to require a single further volume-expander infusion were included immediately before receiving 500 ml of 6% HES 130/0.4 over a 15-min period. No additional fluid was administered over the next 8 h. Haematocrit, and serum albumin and protein were determined immediately before HES infusion then after 1, 2, 3, 4, and 8 h. RESULTS: Twelve patients were included in each group. In both groups, all three haemodilution markers had significantly lower values after 1 h than at baseline. None of the values after 1 and 3 h differed significantly between the two groups. Neither did any of the other study variables show significant differences between the groups with and without sepsis. CONCLUSION: We found that a starch-based compound was as effective in inducing haemodilution in patients with sepsis as in controls without sepsis, suggesting that HES may remain within the intravascular space even in patients with sepsis. Haemodilution parameters such as haematocrit, serum albumin and serum protein are useful for assessing the duration of plasma volume expansion induced by fluid therapy in critically ill patients.

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In August 2003, France sustained an exceptional heat wave. Heat-generated pathologies (dehydratation, heat stroke, cardio-vascular diseases) were responsible for additional biological analysis orders at the Saint-Antoine Hospital biochemistry laboratory in Paris from 4 to 18 august, compared to the same period in 2002. Variations were: + 17.6% for analysis orders, + 30.1% for ionograms, + 28.9% for plasma troponins I and + 58.6% for blood gazes analysis. Women and patients older than 75 years ratios were higher in august 2003. Biochemistry results analysis showed higher frequency of elevated plasma sodium, creatinine and troponin in 2003, confirming that most of patients admitted during heat wave were affected by heat-related diseases. Finally, laboratory excess activity was performed and quality was maintained, in spite of reduced staff and unusual climatic conditions.

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The short-lived results of angioplasty for venous stenosis of a dialysis access led to stent placement. Its migration is a rare but dangerous complication, because of its final destination, that is right heart or pulmonary artery. We report on such a case and compare it with three cases found in literature.

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OBJECTIVE: To study the pathogenesis of the host response during bacterial translocation, a rat model was designed for prolonged follow-up after injury. DESIGN: A prospective, controlled animal study. SETTING: Animal laboratory. SUBJECTS: Young male Wistar rats. INTERVENTIONS: Antibiotic decontamination of rats was performed 4 days before intragastric inoculation with a selected Escherichia coli strain (10(10) bacteria/kg of body weight). Two days later, the rats received a lipopolysaccharide injection or not (control group) and were observed for 3 days. They were then killed. A reference group (pair-fed healthy animals) was studied in parallel. MEASUREMENTS AND MAIN RESULTS: During observations, urinary total nitrogen loss and 3-methylhistidine excretion were determined daily. When the rats were killed, mesenteric lymph nodes (MLNs), spleen, and liver were aseptically removed and cultured. Colonies identified as translocated E. coli were counted in each organ. Intracellular amino acid free pools were measured in extensor digitorum longus and anterior tibialis. Endotoxin induces bacterial translocation of bacteria from gut lumen to MLNs (100% vs. 59% in the lipopolysaccharide-untreated control group; p < .05) and dissemination to spleen and liver (65% and 45% of positive cultures after endotoxemia, respectively, vs. 6% and 12% in the control groups). No translocation occurred in the reference group. Evidence for the hypermetabolic response was seen in lipopolysaccharide-treated and infected rats, but protein catabolism was more closely related to the occurrence of bacterial dissemination to spleen and liver than to translocation alone (e.g., the cumulative 3-methylhistidine excretion during the observation period was 4.07+/-0.18 micromol in uninfected rats, 4.48+/-0.29 in rats with positive MLN cultures alone and 6.17+/-0.30 in MLN, spleen, or liver infected rats; 1 vs. 2, NS; 3 vs. 1, and 3 vs. 2, p < .05). CONCLUSIONS: Gut barrier failure is associated with a deep excessive catabolic response in the host. The mechanism by which the metabolic state affects the resistance to infection apparently involves amino acid metabolism.

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