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https://www.readbyqxmd.com/read/28507355/estimation-of-uncertainty-measurement-a-prerequisite-of-iso1589-accreditation-for-clinical-laboratories
#1
Sahar Iqbal, Aamir Ijaz, Shaheen Sharafat
OBJECTIVE: To estimate relative expanded uncertainty measurement of routine clinical chemistry analytes for international organisation for standardisation 15189 accreditation. METHODS: This cross-sectional study was conducted at Dow International Medical College, Karachi, from September 2013 to May 2014. During the process of international organisation for standardisation 15189 accreditation, measurement uncertainty was estimated for 13 clinical chemistry analytes using top-down approach...
May 2017: JPMA. the Journal of the Pakistan Medical Association
https://www.readbyqxmd.com/read/28415022/simultaneous-determination-of-tryptophan-and-8-metabolites-in-human-plasma-by-liquid-chromatography-tandem-mass-spectrometry
#2
Lysiane Boulet, Patrice Faure, Patrice Flore, Julien Montérémal, Véronique Ducros
Tryptophan (Trp) is an essential amino-acid and the precursor of many biologically active substances such as kynurenine (KYN) and serotonin (5HT). Its metabolism is involved in different physiopathological states, such as cardiovascular diseases, cancer, immunomodulation or depression. Hence, the quantification of Trp catabolites, from both KYN and 5HT pathways, might be usefulfor the discovery of novel diagnostic and follow-up biomarkers. We have developed a simple method for quantification of Trp and 8 of its metabolites,involved in both KYN and 5HT pathways, using liquid chromatography coupled to tandem mass spectrometry...
April 4, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28245184/an-approach-for-estimating-measurement-uncertainty-in-medical-laboratories-using-data-from-long-term-quality-control-and-external-quality-assessment-schemes
#3
Andrea Padoan, Giorgia Antonelli, Ada Aita, Laura Sciacovelli, Mario Plebani
BACKGROUND: The present study was prompted by the ISO 15189 requirements that medical laboratories should estimate measurement uncertainty (MU). METHODS: The method used to estimate MU included the: a) identification of quantitative tests, b) classification of tests in relation to their clinical purpose, and c) identification of criteria to estimate the different MU components. Imprecision was estimated using long-term internal quality control (IQC) results of the year 2016, while external quality assessment schemes (EQAs) results obtained in the period 2015-2016 were used to estimate bias and bias uncertainty...
February 28, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
https://www.readbyqxmd.com/read/28222014/verification-of-examination-procedures-in-clinical-laboratory-for-imprecision-trueness-and-diagnostic-accuracy-according-to-iso-15189-2012-a-pragmatic-approach
#4
Giorgia Antonelli, Andrea Padoan, Ada Aita, Laura Sciacovelli, Mario Plebani
Background The International Standard ISO 15189 is recognized as a valuable guide in ensuring high quality clinical laboratory services and promoting the harmonization of accreditation programmes in laboratory medicine. Examination procedures must be verified in order to guarantee that their performance characteristics are congruent with the intended scope of the test. The aim of the present study was to propose a practice model for implementing procedures employed for the verification of validated examination procedures already used for at least 2 years in our laboratory, in agreement with the ISO 15189 requirement at the Section 5...
February 21, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
https://www.readbyqxmd.com/read/28153366/quality-indicators-for-the-total-testing-process
#5
REVIEW
Mario Plebani, Laura Sciacovelli, Ada Aita
ISO 15189:2012 requires the use of quality indicators (QIs) to monitor and evaluate all steps of the total testing process, but several difficulties dissuade laboratories from effective and continuous use of QIs in routine practice. An International Federation of Clinical Chemistry and Laboratory Medicine working group addressed this problem and implemented a project to develop a model of QIs to be used in clinical laboratories worldwide to monitor and evaluate all steps of the total testing process, and decrease error rates and improve patient services in laboratory testing...
March 2017: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/28149267/successful-iso-15189-accreditation-in-the-bethzatha-advanced-medical-laboratory-in-ethiopia
#6
Nardos Abebe
No abstract text is available yet for this article.
December 2016: EJIFCC
https://www.readbyqxmd.com/read/28132949/impact-of-a-pneumatic-tube-system-transport-on-hemostasis-parameters-measurement-the-experiment-of-cochin-universitary-hospital-ap-hp-paris-france
#7
REVIEW
Leyla Calmette, Firas Ibrahim, Isabelle Gouin, Marie-Hélène Horellou, Élisabeth Mazoyer, Michaela Fontenay, Claire Flaujac
Samples transported by pneumatic tube system are submitted to forces of acceleration and deceleration which can affect laboratory parameters. At Cochin hospital, majority of samples of hemostasis, except for platelets tests, are transported by pneumatic tube system. The objective of this study was to evaluate the impact of a pneumatic tube system (PTS) transport compared to hand-delivered transport on samples and to qualify Cochin hospital PTS according to requirements of standard ISO 15189. A bibliographical study was made and showed that pneumatic tube system particularly influences platelets tests...
February 1, 2017: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/28025028/ifcc-approved-hplc-reference-measurement-procedure-for-the-alcohol-consumption-biomarker-carbohydrate-deficient-transferrin-cdt-its-validation-and-use
#8
François Schellenberg, Jos Wielders, Raymond Anton, Vincenza Bianchi, Jean Deenmamode, Cas Weykamp, John Whitfield, Jan-Olof Jeppsson, Anders Helander
Carbohydrate-deficient transferrin (CDT) is used as a biomarker of sustained high alcohol consumption. The currently available measurement procedures for CDT are based on various analytical techniques (HPLC, capillary electrophoresis, nephelometry), some differing in the definition of the analyte and using different reference intervals and cut-off values. The Working Group on Standardization of CDT (WG-CDT), initiated by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), has validated an HPLC candidate reference measurement procedure (cRMP) for CDT (% disialotransferrin to total transferrin based on peak areas), demonstrating that it is suitable as a reference measurement procedure (RMP) for CDT...
February 2017: Clinica Chimica Acta; International Journal of Clinical Chemistry
https://www.readbyqxmd.com/read/27988505/quality-indicators-in-laboratory-medicine-the-status-of-the-progress-of-ifcc-working-group-laboratory-errors-and-patient-safety-project
#9
Laura Sciacovelli, Giuseppe Lippi, Zorica Sumarac, Jamie West, Isabel Garcia Del Pino Castro, Keila Furtado Vieira, Agnes Ivanov, Mario Plebani
The knowledge of error rates is essential in all clinical laboratories as it enables them to accurately identify their risk level, and compare it with those of other laboratories in order to evaluate their performance in relation to the State-of-the-Art (i.e. benchmarking) and define priorities for improvement actions. Although no activity is risk free, it is widely accepted that the risk of error is minimized by the use of Quality Indicators (QIs) managed as a part of laboratory improvement strategy and proven to be suitable monitoring and improvement tools...
March 1, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
https://www.readbyqxmd.com/read/27923229/hands-on-experience-accreditation-of-pathology-laboratories-according-to-iso-15189
#10
Alexandar Tzankov, Luigi Tornillo
Accreditation is a procedure by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks according to certain standards. Accreditation of pathology laboratories according to ISO 15189 is now becoming more and more a matter of course in continental Europe. This review describes some practical experience aspects with our own pathology laboratory accreditation according to ISO 15189, and outlines the advantages, addresses critical points, and discusses certain caveats of this process...
2017: Pathobiology: Journal of Immunopathology, Molecular and Cellular Biology
https://www.readbyqxmd.com/read/27848925/analytical-performances-of-hemoclot-protein-c-reagent-on-acl-top-analyzer
#11
COMPARATIVE STUDY
Leyla Calmette, Nicole Charpentier, Caroline Tircot, Delphine Bigot, Claire Dunois, Jean Amiral, Marcelle Tetegan, Sonnthida Sep Hieng, Jean-Yves Peltier
Our study aimed to evaluate and validate according to standard NF EN ISO 15189 the original protocol ajustement of Hemoclot Protein C (PC) (Hyphen BioMed), clotting-based assay of PC on ACL TOP analyzer (Werfen/Instrumentation Laboratory). We evaluated the performance in terms of imprecision and we validate additional parameters in range B required by the SH GTA 04 (COFRAC): repeatability, reproducibility, detection and quantification limits, limits of linearity, stability, inter-samples and inter-reagents contamination, inaccuracy, evaluation of interferences (hemolysis, bilirubinemia and chyles)...
December 1, 2016: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/27843164/implementation-research-a-mentoring-programme-to-improve-laboratory-quality-in-cambodia
#12
Lucy A Perrone, Vireak Voeurng, Sophat Sek, Sophanna Song, Nora Vong, Chansamrach Tous, Jean-Frederic Flandin, Deborah Confer, Alexandre Costa, Robert Martin
OBJECTIVE: To implement a mentored laboratory quality stepwise implementation (LQSI) programme to strengthen the quality and capacity of Cambodian hospital laboratories. METHODS: We recruited four laboratory technicians to be mentors and trained them in mentoring skills, laboratory quality management practices and international standard organization (ISO) 15189 requirements for medical laboratories. Separately, we trained staff from 12 referral hospital laboratories in laboratory quality management systems followed by tri-weekly in-person mentoring on quality management systems implementation using the LQSI tool, which is aligned with the ISO 15189 standard...
October 1, 2016: Bulletin of the World Health Organization
https://www.readbyqxmd.com/read/27777860/the-study-of-statistical-methods-for-evaluating-the-comparability-of-routine-chemistry-analytes-among-3-routine-laboratory-measurement-systems-in-china
#13
Kun Zhong, Wei Wang, Chuanbao Zhang, Falin He, Shuai Yuan, Zhiguo Wang
BACKGROUND: Clinical laboratory tests are important for clinicians to make diagnostic decisions, but discrepancies may directly lead to incorrect diagnosis. We would like to introduce some statistical methods to evaluate the comparability of chemistry analytes while comparing the performances of different measurement systems. METHODS: We used a panel of 10 fresh-frozen single donation serum samples to assess assays for the measurement of glucose and other 13 analytes...
2016: SpringerPlus
https://www.readbyqxmd.com/read/27771203/-molecular-diagnosis-of-human-papillomaviruses-hpv-what-test-s-in-clinical-practice
#14
REVIEW
D Guenat, D Riethmuller, R Ramanah, A Morel, F Aubin, C Mougin, J-L Prétet
Prescription of an HPV test in practice will enable the clinician to optimize the monitoring and the management of patients, especially in the context of cervical cancer screening. Numerous HPV tests are available that present different analytical and clinical sensitivity and specificity. International recommendations on clinical performance of HPV tests used for cervical cancer screening have been published by a group of experts, and tests that meet these performance criteria should be used. Apart from the HPV detection kit, the whole circuit from sampling to report of the results must be considered...
November 2016: Journal de Gynécologie, Obstétrique et Biologie de la Reproduction
https://www.readbyqxmd.com/read/27683499/experience-of-implementing-iso-15189-accreditation-at-a-university-laboratory
#15
Patricia Solis-Rouzant
The present article summarizes the authors' experience with the implementation of a quality management system based on ISO 17025 and ISO 15189 standards at university laboratories. The accreditation of the analytical procedures at the Universidad Mariano Gálvez represented a challenge due to the unique nature of an educational institution and the difference in nature to the standards implemented. Sample handling and care of the patient were combined to achieve an integrated management system. We explain the development of the management system, the obstacles and benefits of the system and concluding that it is possible to design a management system based on ISO 15189 for the university lab that allowed delivering results assuring technical competence to patient care and welfare...
November 2015: EJIFCC
https://www.readbyqxmd.com/read/27683498/the-accreditation-experience-of-clinical-laboratories-and-blood-banks-in-mexico
#16
Sandra Quintana
The accreditation of clinical laboratories and blood banks based on ISO 15189 is now being consolidated in Mexico, and is coordinated by the Mexican accreditation entity innovative strategies, A.C. (ema) and supported by the activities of the committee of clinical laboratories and blood banks. The active participation in working groups formed by the technical committee of clinical laboratories and blood banks in specific areas, has contributed to the formulation of technical documents and criteria of evaluation that strengthen the current accreditation scheme...
November 2015: EJIFCC
https://www.readbyqxmd.com/read/27683497/laboratory-accreditation-in-argentina
#17
María Amelia Acuña, Cesar Collino, Gustavo A Chiabrando
Laboratory accreditation is an essential element in the healthcare system since it contributes substantially to decision-making, in the prevention, diagnosis, treatment and follow-up of the health status of the patients, as well as in the organization and management of public healthcare. Therefore, the clinical biochemistry professional works continuously to provide reliable results and contributes to the optimization of operational logistics and integration of a laboratory into the health system. ISO 15189 accreditation, ensures compliance of the laboratory to minimize instances of error through the planning, prevention, implementation, evaluation and improvement of its procedures, which provides skill areas that involve both training undergraduate and graduate professionals in clinical biochemistry...
November 2015: EJIFCC
https://www.readbyqxmd.com/read/27683495/quality-management-systems-in-the-clinical-laboratories-in-latin-america
#18
Alba C Garzon
The implementation of management systems in accordance with standards like ISO 9001:2008 (1,2) in the clinical laboratories has conferred and added value of reliability and therefore a very significant input to patient safety. As we know the ISO 9001:2008 (1) a certification standard, and ISO 15189:2012 (2) an accreditation standard, both, at the time have generated institutional memory where they have been implemented, the transformation of culture focused on correct execution, control and following, evidence needed and the importance of register...
November 2015: EJIFCC
https://www.readbyqxmd.com/read/27614351/preanalytical-errors-in-medical-laboratories-a-review-of-the-available-methodologies-of-data-collection-and-analysis
#19
REVIEW
Jamie West, Jennifer Atherton, Seán J Costelloe, Ghazaleh Pourmahram, Adam Stretton, Michael Cornes
Preanalytical errors have previously been shown to contribute a significant proportion of errors in laboratory processes and contribute to a number of patient safety risks. Accreditation against ISO 15189:2012 requires that laboratory Quality Management Systems consider the impact of preanalytical processes in areas such as the identification and control of non-conformances, continual improvement, internal audit and quality indicators. Previous studies have shown that there is a wide variation in the definition, repertoire and collection methods for preanalytical quality indicators...
January 2017: Annals of Clinical Biochemistry
https://www.readbyqxmd.com/read/27580180/risk-analysis-of-the-preanalytical-process-based-on-quality-indicators-data
#20
Zlata Flegar-Meštrić, Sonja Perkov, Andrea Radeljak, Mirjana Marijana Kardum Paro, Ingrid Prkačin, Ana Devčić-Jeras
BACKGROUND: Improving quality and patient safety in the medical biochemistry laboratory accredited according to the International Standard Organization (ISO 15189:2012) requires the patient-centered evaluation of errors based on the implementation of quality indicators (QIs) across the total testing process. Our main goal was to achieve quality improvement of the preanalytical process in an emergency laboratory which had the highest error rate using risk management principles. METHODS: Failure mode and effects analysis (FMEA) was applied to analyze predefined preanalytical QIs and score laboratory failures for the failure demerit value (FDV), probability of failure (PF) and probability of failure remedy (PFR)...
March 1, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
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