[Impact of a in situ laboratory on physician expectancy]. / Incidence de la présence d'un laboratoire de biologie médicale in situ sur la réponse aux attentes des cliniciens.

Biological examinations are essential for clinicians' medical care. The aim of this study is to assess clinicians' expectations in healthcare facilities and their perception of medical biology in different types of organization. We performed a prospective transversal study by electronic questionnaire conducted among 242 practitioners in four healthcare facilities. The aspects explored were as follows: quality, reliability, rendering time of examination results and biology platform support. Analyses were conducted after rectification of the sample by weight. Sixty one clinicians responded (25.2% [19.7-30.7]). The rendering time of examination is the main criterion mentioned with a requirement of less than one hour in case of emergency (81.5% [71.8-91.2] of the answers) to less than 72 hours for specialized examinations (81.5% [71.8-91.2] of the answers). Better collaboration with biologists is expected by clinicians (54.7% [50.9-58.5]). Satisfaction with the biology platform support and rendering time of emergency cases results was significantly (p <0.005) lower in facilities without an on-site laboratory. In conclusion, although medical biology performance is generally satisfactory within medical facilities, it remains nonetheless affected when the laboratory is not on site. The rendering time of examination, depending on the biology platform support functions and the proximity of the laboratory, remains the main criterion. Clinician-biologist collaboration, which increases of the medico-economic efficiency of patient's healthcare, appears as an essential criterion in a structural conception of medical biology.

[Hemolysis interferences on frequently required stat analysis: a French multicentric study]. / Interférence de l'hémolyse sur les examens de biologie médicale utilisés en biochimie d'urgence : étude multicentrique nationale.

Hemolysis should lead to changes in test results. Our study evaluated the impact of hemolysis on 26 blood measurements of stat biochemistry markers (sodium, potassium, chloride, urea, creatinine, glucose, total protein, calcium, magnesium, inorganic phosphorus, uric acid, C-reactive protein, total bilirubin, ASAT, ALAT, LDH, creatine kinase, alkaline phosphatase, γ glutamyl-transferase, lipase, alcohol, iron, ß hCG, troponins, natriuretic peptides) determined with 13 different types of instruments in 17 hospital laboratories. Four pools of samples (collected from lithium heparin or EDTA or sodium fluoride tubes, according to the measured parameters) were overloaded with five increasing concentrations of whole blood lysate (final concentration from 0 to 2.000 mg/dL). Replication was performed for each assay, average values were calculated and differences between results with and without lysate were analyzed. A difference exceeding the square root of the sum of both squared analytic and biologic imprecisions for each analyte, was judged to be significant. Except homogeneous and expected impact of hemolysis on certain parameters like potassium, LDH... (due to their intra-erythrocyte concentration) a heterogeneous effect was found for other parameters, according to the analyzer and/or to the methodology. In summary, this study confirms the importance of mastering the measurement of the hemolysis and leads to several recommendations: (i) biologists should have a good knowledge of the impact of hemolysis on the measurements they perform, depending on their chosen analyzers; (ii) if an interference is noticed, it is recommended to add to the result a relevant comment and to check that the comment is properly edited in the laboratory computer software and appears on printed and transmitted results.

[Recommendations for the prescription, implementation and interpretation of medical examinations in biology in the context of severe poisoning]. / Recommandations pour la prescription, la réalisation et l'interprétation des examens de biologie médicale dans le cadre des intoxications graves.

A multidisciplinary working group named "Toxicology and clinical biology" and whose members belong to the French Society of Clinical Biology (SFBC), Critical Care Medicine Society of French Language (SRLF), the French Society of Medical Emergency (SFMU), the French Society of Analytical Toxicology (SFTA), the Society of Clinical Toxicology (STC), and the National College of Biochemistry (CNBH) updated the professional practice recommendations published in 2003. These recommendations aimed the biologists who are not specialized in toxicology and more largely all the health professionals involved the management of severely poisoned patients. Among the data published in the initial edition, only the major table dealing with severe poisonings was updated, as all other supplements remained valid. The current revised table details poisonings due to fifty-five different xenobiotics and presents their main clinical features, useful biomarkers of toxicity, methods of identification or assays available in the emergent setting with their respective relevance and recommended delays to obtain their result. Assessments with a good agreement among the working group members regarding all laboratory issues for poisoning management are presented. A table updates the list of the main currently useful antidotes. A section on the value and place of toxicology screening was added.

[Proposed recommendations for the practical use of internal quality controls (IQC) in a medical biology laboratory]. / Propositions de recommandations pour l'utilisation pratique des contrôles internes de qualité (CIQ) dans un laboratoire de biologie médicale.

We propose a set of recommendations and practices to optimize the use of quality control of medical biology examinations. The fundamentals are reviewed: definition of a series of analysis, IQC at one or more level, Westgard alert rules and rejection, practical remedial actions to take for the technician, corrective and preventive actions to be implemented by the biologist. We have also formalized three flowcharts to guide the technician in their daily practice to ensure analytical quality of investigations carried out. These decision trees are the result of the experience submitted by an accredited and professional laboratory attentive to the ongoing improvement of IQC. This article can provide useful assistance to biologists for accreditation but also aims to foster collaboration reliable medical biology laboratory at the appropriate management of patients.

[Evaluation of the AFSSAPS clinical practice guidelines on prevention and treatment of thrombo-embolic disease in medicine (2009), in comparison with those of the American College of Chest Physicians (ACCP 2008) with the help of the AGREE tool]. / Évaluation du référentiel de l'Afssaps sur la prévention et le traitement de la maladie thromboembolique veineuse en médecine (2009) par comparaison à celui de l'American College of Chest Physicians (ACCP 2008) à l'aide de la grille AGREE.

We have evaluated the methodological quality of the AFSSAPS French clinical practice guidelines on prevention and treatment of thrombo-embolic disease in medicine, published in 2009. We have evaluated in parallel the similar recommendations from north-America on the subject (ACCP 2008). Our evaluation tool was the AGREE instrument which is consensual at an international level, in particular at the WHO (World Health Organisation) and at the European Union. The methodological quality of the AFSSAPS guidelines is sub-optimal, significantly lower than that of the ACCP guidelines. Compared with the ACCP guidelines, the weakest points of the AFSSAPS guidelines are about rigor of development (AGREE domain 3), applicability (AGREE domain 5) and editorial independence (AGREE domain 6). The main common shortcoming in quality of both guidelines is about lack of stakeholder involvement (AGREE domain 2). A more important implication of methodologists might explain why the ACCP guidelines reach a higher level of quality than those of the AFSSAPS guidelines. We do not make judgments about the content of the recommendations of the AFSSAPS or of the ACCP.

[Evaluation of the methodological quality of the Rémic (microbiology guidelines - bacteriology and mycology) of the Société française de microbiologie]. / Évaluation de la qualité méthodologique du Rémic (référentiel en microbiologie médicale - bactériologie et mycologie) de la Société française de microbiologie, 3(e) édition (2007).

We have evaluated the methodological quality of the Rémic (microbiology guidelines - bacteriology and mycology) of the Société française de microbiologie (edition2007), using to AGREE criteria, which are consensual at an international level, in particular at the the World Health Organisation (WHO) and at the European Union. The methodological quality of the Rémic appears to be sub-optimal. These shortcomings in quality are mainly observed in AGREE domain n° 5 (applicability), in AGREE item n° 5 (patients' opinions were not considered), and in AGREE item n° 23 (conflicts of interest were not declared). The users of the Rémic must be aware of these few methodological shortcomings in order for them to be careful before they put its recommendation in practice. In conclusion, we advise the editors of the Rémic to insert at least a methodological chapter in their next edition.

[Study on turnaround time of biological analysis in urgent need in hospital laboratories]. / Étude sur les délais de rendu de résultats d'examens biologiques demandés en urgence dans les laboratoires hospitaliers.

We have assessed turnaround time (TAT) for urgent laboratory analysis. Twelve hospital laboratories participated to this study. All laboratories have organized a classification of a management system of urgent analyses. The TAT reporting were relatively homogeneous for 12 laboratories. We have defined TAT as time of specimen receipt in the laboratory to time of results reporting. This TAT divides into 4 groups: close to 50 minutes for analyses as TP, D-dimeres, CRP (C Protein Reactive), HCG, troponin, alcoholhemia, K, lipase; 35 minutes for the cytology of cerebrospinal fluid; 25 minutes for complete blood cell count and 15 minutes for blood gases. All laboratories have accepted to TAT as a quality indicator. Quality indicator data should be collected in time to identify and correct problems to implemente effective interventions and to standardize processes among clinical laboratories.

Hb Charlieu [alpha106(G13)Leu-->Pro (alpha1)]: a new phenotypically silent hemoglobin variant associated with a mild alpha-thalassemia phenotype.

A chronic microcytosis and hypochromia without any iron deficiency were observed in an 11-year-old boy of French Caucasian origin. The same hematological findings were also found for his mother. No abnormal hemoglobin (Hb) was detected using isoelectric focusing, cation exchange liquid chromatography and reversed phase liquid chromatography of the globin chains but DNA sequencing revealed a CTG>CCG transition at codon 106 (Leu-->Pro) of the alpha1-globin gene in both of them. As the alpha/beta mRNA ratios, determined by reverse-transcriptase real-time quantitative polymerase chain reaction (PCR), are not concordant with an alpha-thalassemia (alpha-thal) state, we hypothesize that the underlying physiopathologic mechanism is an assembling defect of the Hb Charlieu molecule, rather than an instability of the alpha(Charlieu) mRNA. Moreover, genetic counseling and patient information are required in this family to prevent potentially severe alpha-thalassemias in following generations.

[Comparative study of G8 glycated haemoglobin testing system and the Integra 800 immunoassay]. / Etude comparative du dosage de l'hémoglobine glyquée par la méthode CLHP sur G8 (R) versus Intégra 800 (R).

We compared the results of two methods of measurement of HbA(1c) before replacing the current method on Integra 800 by the HPLC method on an apparatus recently put on the market, the G8. The comparative study of the results for 119 patients was carried out. The reproducibility obtained with the G8 method is good with CV = 0 for the control Level 1 at 5.6%, CV = 0.6% for Level 2 at 10.5% and CV = 0.73% for the Bio-Rad control at 5.7%. The comparison of the results of HbA(1c) gives the Passing - Bablock equation: Y (G8) = X (Integra) + 0.10 with r = 0,996. Systematic bias is of 0.092% and the ratio of the G8/Integra averages of 1.014 (7.43 %/7.34 %). Only 8 results out of the 119 are out of limits of more than 0.4% between the two methods. They are only 4 after bringing together the results by correlation. The two methods provide results with exactitude in conformity with the recommendations of the French governmental agency (Afssaps). The G8 method is slightly better regarding accuracy and precision.

Determination of total bilirubin in whole blood from neonates: results from a French multicenter study.

BACKGROUND: Jaundice is frequent in neonates and can cause severe complications, especially in premature neonates, particularly the risk of developing acute bilirubin encephalopathy. Our purpose was to verify if determination of total bilirubin (TBIL) in whole blood on an ABL 735 blood gas analyzer with a spectrophotometer module could provide an analytical alternative to chemical methods of TBIL measurement. METHODS: Our multicenter comparative study involved four hospital laboratories. We studied the repeatability and reproducibility of ABL 735 TBIL measurements in two control sera of medium (N1, 58.1 micromol/L) and high (N2, 275.3 micromol/L) TBIL levels. The same study was simultaneously conducted on four chemistry instruments (two LX 20, one Integra 800 and one Hitachi 917) using four Jendrassik-Grof derived methods. At one site, repeatability was performed with two adult whole-blood samples containing low and high TBIL levels (55.1 and 312.6 micromol/L). RESULTS: Repeatability tests provided coefficients of variation (CVs) between 0.67% and 1.86% on the ABL 735 system, vs. 0.35% and 1.96% for the chemistry instruments. Reproducibility tests for the same control sera resulted in CVs between 1.01% and 3.55% for the ABL 735 and between 0.52% and 3.65% for the chemistry instruments. Recovery for the N1 and N2 control sera was 102-120%. A correlation study of TBIL determination in whole blood vs. plasma was conducted on 473 neonatal blood samples. Correlation coefficients between whole blood and plasma TBIL ranged from 0.969 to 0.994. Passing-Bablok equations were y=1.17x+9.7 [site 1 (IP)], y=1.01x+5.6 [site 2 (JPB, MR)], and y=1.00x-20 [site 3 (AS)]. Only 10% of the results fell outside the 10% range in the bias-corrected Bland-Altman difference plot for the ABL 735 method compared to traditional laboratory methods. CONCLUSIONS: The ABL 735 instrument is reliable for measuring TBIL in 70-microL whole blood samples from neonates. Thus, this method might allow significant blood savings in preterm neonates. Correlation with the reference method for plasma or sera must be established to ensure good follow-up of patients.