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Leontine Mulder, Renate van der Molen, Carin Koelman, Ester van Leeuwen, Anja Roos, Jan Damoiseaux
ISO 15189:2012 requires validation of methods used in the medical laboratory, and lists a series of performance parameters for consideration to include. Although these performance parameters are feasible for clinical chemistry analytes, application in the validation of autoimmunity tests is a challenge. Lack of gold standards or reference methods in combination with the scarcity of well-defined diagnostic samples of patients with rare diseases make validation of new assays difficult. The present manuscript describes the initiative of Dutch medical immunology laboratory specialists to combine efforts and perform multi-center validation studies of new assays in the field of autoimmunity...
March 12, 2018: Autoimmunity Reviews
Charlotte Oris, Yoan Clavel, Matthieu Jabaudon, Annick Pialat, Hadj Abdelkader Mohamed, Frédérique Lioret, Vincent Sapin, Damien Bouvier
Background: Blood gas analyzers are o0.ften integrated into point-of-care testing provisions. International standards (ISO 22870 and 15189) as adapted to French COFRAC regulations make accreditation of point-ofta-care testintag obligatory. We installed and assessed 12 GEM PREMIER 4000 analyzers for pH, p CO2 , p O2 , Na+ , K+ , Cl- , Ca2+ , lactate, hemoglobin and oxyhemoglobin (O2 Hb) at Clermont-Ferrand Hospital. These instruments were distributed across 11 care sites in the hospital...
March 2018: Practical Laboratory Medicine
Irene M L W Körver-Keularts, Ping Wang, Huub W A H Waterval, Leo A J Kluijtmans, Ron A Wevers, Claus-Dieter Langhans, Camilla Scott, Daphna D J Habets, Jörgen Bierau
Since organic acid analysis in urine with gaschromatography-mass spectrometry (GC-MS) is a time-consuming technique, we developed a new liquid chromatography-quadrupole time-of-flight mass spectrometry (LC-QTOF/MS) method to replace the classical analysis for diagnosis of inborn errors of metabolism (IEM). Sample preparation is simple and experimental time short. Targeted mass extraction and automatic calculation of z-scores generated profiles characteristic for the IEMs in our panel consisting of 71 biomarkers for defects in amino acids, neurotransmitters, fatty acids, purine, and pyrimidine metabolism as well as other disorders...
February 12, 2018: Journal of Inherited Metabolic Disease
Brigitte Lamy, Agnès Ferroni, Claes Henning, Christian Cattoen, Patrice Laudat
BACKGROUND: Quality assurance and quality management are driving forces for controlling blood culture best practices but should not be disconnected from the end-point target, i.e., patient value. AIMS: This article is intended to help microbiologists implement blood culture accreditation that is actually beneficial to patient management. SOURCES: Experience from a nationwide taskforce for promoting quality assurance and competence in clinical microbiology laboratories, guidelines on blood culture...
February 1, 2018: Clinical Microbiology and Infection
Mario Plebani, Laura Sciacovelli, Daniela Bernardi, Ada Aita, Giorgia Antonelli, Andrea Padoan
The communication of laboratory results to physicians and the quality of reports represent fundamental requirements of the post-analytical phase in order to assure the right interpretation and utilization of laboratory information. Accordingly, the International Standard for clinical laboratories accreditation (ISO 15189) requires that "laboratory reports shall include the information necessary for the interpretation of the examination results". Measurement uncertainty (MU) is an inherent property of any quantitative measurement result which express the lack of knowledge of the true value and quantify the uncertainty of a result, incorporating the factors known to influence it...
February 2, 2018: Clinical Biochemistry
Louis Mine, Morgane Petit, Valérie Nivet-Antoine, Jean-Louis Beaudeux, Carole Hennequin
Radiometer® has developed a point-of-care test for fast PCT measurement on whole blood in micromethod on a AQT90 FLEX® instrument. We have verified the analytical performances of the AQT90 FLEX® PCT assay in heparinized macrotube and EDTA microtube for pediatric use, according to modified French Society of Clinical Biology (SFBC) protocol to the requirements of the standard NF EN ISO 15189: 2012. The samples (n=61, 30 macrotubes, 31 microtubes) were analyzed by the Brahms Kryptor Compact Plus® reference method vs the AQT90 FLEX®...
January 1, 2018: Annales de Biologie Clinique
Siham Aboulmakarim, Amal Benbella, Houyam Hardizi, Rachid Bezad
The validation of methods in medical biology is a fundamental step in which the laboratory defines its analytical objectives, characterizes the performance of the technique according to the level of quality it fixes and discusses the results obtained. The objective of this work is to contribute to respect the requirements of ISO 15189 in terms of performance verification of a manual qualitative technique of medically assisted procreation (PMA): morphological identification of the oocyte, the zygote and the embryo, harmonization of professional practices and assessment of competences by associating the bibliographic approach and above all by justifying its choices...
January 1, 2018: Annales de Biologie Clinique
Tiziana Rubeca, Stefano Rapi, Silvia Deandrea, Morena Malaspina, Basilio Ubaldo Passamonti, Elena Grassi, Anna Maria Cioccarelli, Enrico Marchetti, Michela Boni, Filippo Cellai, Marco Pradella, Franco Gattafoni, Sabrina Rotolo
BACKGROUND: in Italy, colorectal cancer screening is included as part of the Italian National Health Service - SSN (Servizio Sanitario Nazionale) Essential Levels of Care - LEA (Livelli Essenziali Assistenziali) and the European Guidelines, which specify quantitative FIT-Hb testing as the best strategy for organised screening programmes. To ensure consistent operating standards in Member States, European regulations require the implementation of certification and accreditation requirements for diagnostic and care-related processes...
September 2017: Epidemiologia e Prevenzione
Estelle Bugni, Richard Cohen, Cécile Mazellier
Medical biology laboratories rely especially on internal quality control (IQC) to monitor the performance of equipment and ensure results reliability. Strategies for these controls vary considerably from one laboratory to another. Some laboratories use Westgard's rules to detect drifts and are faced with a large number of false rejections caused by frequent runs of control samples and strategies that activate all rejection rules, regardless of the analyte considered. To minimize these rejections, some laboratories have combined several theories, sometimes despite the relevance of the resulting strategy...
December 1, 2017: Annales de Biologie Clinique
Richard J Zarbo, Jacqueline R Copeland, Ruan C Varney
Objectives: To develop a business subsystem fulfilling International Organization for Standardization 15189 nonconformance management regulatory standard, facilitating employee engagement in problem identification and resolution to effect quality improvement and risk mitigation. Methods: From 2012 to 2016, the integrated laboratories of the Henry Ford Health System used a quality technical team to develop and improve a management subsystem designed to identify, track, trend, and summarize nonconformances based on frequency, risk, and root cause for elimination at the level of the work...
October 1, 2017: American Journal of Clinical Pathology
Sofia O Viegas, Khalide Azam, Carla Madeira, Carmen Aguiar, Carolina Dolores, Ana P Mandlaze, Patrina Chongo, Jessina Masamha, Daniela M Cirillo, Ilesh V Jani, Eduardo S Gudo
BACKGROUND: Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL) in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation. METHODS: The NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme as a strategy to implement a quality management system...
2017: African Journal of Laboratory Medicine
George Alemnji, Lisa Edghill, Giselle Guevara, Sacha Wallace-Sankarsingh, Rachel Albalak, Sebastien Cognat, John Nkengasong, Jean-Marc Gabastou
BACKGROUND: Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. OBJECTIVES: We report the development of a stepwise process for quality systems improvement in the Caribbean Region. METHODS: The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a user-friendly framework called 'Laboratory Quality Management System - Stepwise Improvement Process (LQMS-SIP) Towards Accreditation' to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements...
2017: African Journal of Laboratory Medicine
Laila O AbdelWareth, Fasila Pallinalakam, Faisal Ibrahim, Peter Anderson, Muneezeh Liaqat, Bryson Palmer, Jonathan Harris, Saber Bashir, Adnan Alatoom, Manuel Algora, Ahmad Alduaij, Imran Mirza
CONTEXT: - This review examines challenges and opportunities in preparing laboratories in a startup phase for accreditation by both College of American Pathologists (CAP) and International Organization for Standardization (ISO) 15189 in an international setting as it relates to our experience at Cleveland Clinic Abu Dhabi Laboratory. It also discusses some of the strategies used in executing those projects and the added advantages in perusing both types of accreditations. OBJECTIVES: - To share our experience with CAP and ISO 15189 accreditations in a startup international operation in relation to the challenges encountered and implementation strategy success factors...
August 31, 2017: Archives of Pathology & Laboratory Medicine
Jacques-Albert Dromigny, Emmanuel Robert
To comply with the pre-analytical requirements of ISO EN 15189, we investigated the stability of potassium, a very critical and sensitive analyte. We took into count effects of duration, temperature and transport after 10 hours storage of human whole blood in serum and plasma. Blood of 12 healthy subjects was analyzed after 4, 6, 8 and 10 hours of storage. Three study groups were designed: samples stored in laboratory at room temperature, transported by car during 4 hours at a temperature of 21±1̊C, with or without previous thermal shock (20 min at 4±1 ̊C) before transportation...
August 1, 2017: Annales de Biologie Clinique
Frank Schneider, Caroline Maurer, Richard C Friedberg
The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program...
September 2017: Annals of Laboratory Medicine
Philippe Hoffmann
Legislation and ISO 15189 international standard provide that the clinical laboratories shall organize the communication of the biological assay results, especially with the establishment of a list of critical assays, whose results shall be reported during doctor's on call period but also through restricting result transmission to biologically validated results. Actually continuous validation and immediate procession of the medical records belonging to patients in emergency situation are not always possible, because of the biologist's workload and the other activities he is responsible for...
June 1, 2017: Annales de Biologie Clinique
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
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...
June 1, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
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...
October 26, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
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...
August 28, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
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