[Accreditation of the toxicological screening: recommendations of the SFBC-SFTA group]. / Accréditation du criblage toxicologique : recommandations du groupe SFBC-SFTA.

Toxicological screening is a specific approach to analytical toxicology that uses analytical tools such as GC-MS, LC-UV (diode array) or LC-MS. Toxicological screening allows the detection and simultaneous identification of a large number of compounds. The results may be based on the use of one or more techniques. As part of the accreditation process for medical biology examinations according to standard NF EN ISO 15189, the group from SFTA and SFBC recommends an approach to accredit toxicological screening. Indeed, the complexity of the accreditation of this analysis comes in particular from the high number of compounds that can be detected. Validation parameters are discussed in the specific context of toxicological screening by considering two distinct approaches: the simple identification of compounds, or the identification and estimation of a range of concentration related to clinical outcomes.

A Cross-Reactivity of Fenofibric Acid With MDMA DRI Assay.

BACKGROUND: Within the framework of routine fitness examinations, French Air Force military crew underwent urine testing for 3,4 methylenedioxymetamphetamine (MDMA [ecstasy]). The cross-reactivity of a dyslipidemic drug, fenofibrate, with an MDMA immunoassay was studied and confirmed on a large population sample. METHODS: A 3-year retrospective study was performed on the MDMA DRI Ecstasy Assay on the Unicel DXC 600. In the event of positive test result, a confirmatory testing was carried out by gas chromatography/mass spectrometry (GC/MS) to establish the presence of MDMA. When analysis by GC/MS did not confirm the presence of MDMA, a false-positive result was suspected and the samples were analyzed by high-performance liquid chromatography-mass spectrometry to identify a potential interfering substance. RESULTS: A total of 15,169 urine samples, from 7,803 patients, were tested for 3 years. Of the tested samples, 22 (0.15%) were positive by DRI Ecstasy Assay. None of them were positive by GC/MS. A cross-reactivity of fenofibrate's metabolite with MDMA using this assay was systematically found. CONCLUSION: Fenofibrate's interference with MDMA immunoassay was confirmed. Fenofibrate being widely prescribed, physicians had to be alerted that this treatment could lead to false-positive results.

Immunoglobulin D and cardiac amyloidosis: development and a case illustration.

Amyloidosis results from extra-cellular deposition of proteins which interfere with tissue function. We report the case of a patient with pathological heart involvement which is caused by immunoglobulin D amyloidosis, and review current data on the amyloidois diagnosis and management.

The implementation of a multinational "walking blood bank" in a combat zone: The experience of a health service team deployed to a medical treatment facility in Afghanistan.

BACKGROUND: We present here a description of the experience in whole-blood transfusion of a health service team deployed to a medical treatment facility in Afghanistan from June 2011 to October 2011. The aim of our work was to show how a "walking blood bank" could provide a sufficient supply. METHODS: We gathered the blood-group types of military personnel deployed to the theater of operations to evaluate our "potential walking blood bank," and we compared these data with our needs. RESULTS: Blood type frequencies among our "potential walking blood bank" were similar to those observed in European or American countries. Our resources could have been limited because of a low frequency of B blood type and negative rhesus in our "potential walking blood bank." Because of the large number of potential donors in the theater of operations, the risk of blood shortage was quite low and we did not face blood shortage despite significant transfusion requirements. Actually, 93 blood bags were collected, including rare blood types like AB and B blood types. CONCLUSION: In our experience, this international "walking blood bank" provided a quick, safe, and sufficient blood supply. More research in this area is needed, and our results should be confirmed by further prospective trials. LEVEL OF EVIDENCE: Therapeutic study, level V.

Working towards accreditation by the International Standards Organization 15189 Standard: how to validate an in-house developed method an example of lead determination in whole blood by electrothermal atomic absorption spectrometry.

Laboratories working towards accreditation by the International Standards Organization (ISO) 15189 standard are required to demonstrate the validity of their analytical methods. The different guidelines set by various accreditation organizations make it difficult to provide objective evidence that an in-house method is fit for the intended purpose. Besides, the required performance characteristics tests and acceptance criteria are not always detailed. The laboratory must choose the most suitable validation protocol and set the acceptance criteria. Therefore, we propose a validation protocol to evaluate the performance of an in-house method. As an example, we validated the process for the detection and quantification of lead in whole blood by electrothermal absorption spectrometry. The fundamental parameters tested were, selectivity, calibration model, precision, accuracy (and uncertainty of measurement), contamination, stability of the sample, reference interval, and analytical interference. We have developed a protocol that has been applied successfully to quantify lead in whole blood by electrothermal atomic absorption spectrometry (ETAAS). In particular, our method is selective, linear, accurate, and precise, making it suitable for use in routine diagnostics.

[Disseminated intravascular coagulation in solid tumours]. / Coagulation intravasculaire disséminée et tumeurs solides.

Disseminated intravascular coagulation (DIC) is a complex abnormality of hemostasis with dramatic consequences and long described as associated with tumors. Yet the diagnosis and management of paraneoplastic DIC are poorly defined. The purpose of this paper is to review DIC associated with solid tumors, at the pathophysiological and therapeutic levels in particular. We also report data from a recent retrospective series of patients with DIC in the context of a solid tumor, to illustrate the epidemiological, clinical and prognostic.

[Internal audit in medical laboratory: what means of control for an effective audit process?]. / Audit interne dans un laboratoire de biologie médicale: quels moyens de maîtrise pour un processus d'audit efficace ?

To prepare the French Accreditation Committee (COFRAC) visit for initial certification of our medical laboratory, our direction evaluated its quality management system (QMS) and all its technical activities. This evaluation was performed owing an internal audit. This audit was outsourced. Auditors had an expertise in audit, a whole knowledge of biological standards and were independent. Several nonconformities were identified at that time, including a lack of control of several steps of the internal audit process. Hence, necessary corrective actions were taken in order to meet the requirements of standards, in particular, the formalization of all stages, from the audit program, to the implementation, review and follow-up of the corrective actions taken, and also the implementation of the resources needed to carry out audits in a pre-established timing. To ensure an optimum control of each step, the main concepts of risk management were applied: process approach, root cause analysis, effects and criticality analysis (FMECA). After a critical analysis of our practices, this methodology allowed us to define our "internal audit" process, then to formalize it and to follow it up, with a whole documentary system.