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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
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
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
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...
October 19, 2016: Journal de Gynécologie, Obstétrique et Biologie de la Reproduction
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
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
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
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
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...
September 9, 2016: Annals of Clinical Biochemistry
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)...
August 31, 2016: Clinical Chemistry and Laboratory Medicine: CCLM
Alexandra Luquain, Francine Arbez-Gindre, Isabelle Bedgedjian, Sophie Felix, Jean-Marie Harimenshi, Ionela-Marcela Mihai, Franck Monnien, Cristina Singeorzan, Séverine Valmary-Degano
Before molecular analysis is performed, morphological control with an estimation of the tumour cell percentage (%TC) could have a major impact on mutation detection. Accreditation according to NF EN ISO 15189 commands an authorization through evaluation of skills. The objective of this work was to validate the empowerment of pathologists to estimate %TC in tissue sample prior to molecular analysis. The accreditation technical guidance methods in Medical biology and histopathology were taken as references...
August 2016: Annales de Pathologie
Remona E David, Minodora Dobreanu
BACKGROUND: Development of quality measurement principles is a strategic point for each clinical laboratory. Preexamination process is the most critical and the most difficult to be managed. The aim of this study is to identify, quantify, and monitor the nonconformities of the pre-analytical process using quality indicators that can affect the patient's health safety in four different locations of a Romanian private clinical laboratory. METHODS: The study group consisted of all the analysis requests received by the departments of biochemistry, hematology, and coagulation from January through March 2015...
2016: Clinical Laboratory
Deborah A Payne, Katarina Baluchova, Katell H Peoc'h, Ron H N van Schaik, K C Allen Chan, Masato Maekawa, Cyril Mamotte, Graciela Russomando, François Rousseau, Parviz Ahmad-Nejad
BACKGROUND: Multiple organizations produce guidance documents that provide opportunities to harmonize quality practices for diagnostic testing. The International Organization for Standardization ISO 15189 standard addresses requirements for quality in management and technical aspects of the clinical laboratory. One technical aspect addresses the complexities of the pre-examination phase prior to diagnostic testing. METHODS: The Committee for Molecular Diagnostics of the International Federation for Clinical Chemistry and Laboratory Medicine (also known as, IFCC C-MD) conducted a survey of international molecular laboratories and determined ISO 15189 to be the most referenced guidance document...
June 16, 2016: Clinica Chimica Acta; International Journal of Clinical Chemistry
Yoshihiko Kadosaka, Reiko Suzuki, Masamichi Yoshika, Koji Tsuta
Clinical laboratory tests have been indispensable for medical services in recent years, and such a situation is associated with the offering of accurate test results by clinical laboratory units. A large number of facilities wishing to achieve ISO 15189 Certification follow preparatory procedures with support from consulting companies. However, in our facility, a limited budget did not allow us to use such services. As a solution, we participated in the Future Lab Session in OSAKA (FLS), a support group for the achievement of ISO 15189 Certification, when it was organized...
February 2016: Rinsho Byori. the Japanese Journal of Clinical Pathology
Hisako Katagiri, Junko Yamagata
We introduce our efforts to utilize education, training, competence assessment, and quality control of personnel engaged in urinary sediment and blood cell morphology examinations in our laboratory. There are no standard samples for these morphological examinations, and standardization has not been completed for all types of blood cells or urinary sediment components. We had been carrying out simultaneous microscopic examination involving trainee staff and senior laboratory technologists as a means of education and evaluation, but acceptance criteria were unclear...
February 2016: Rinsho Byori. the Japanese Journal of Clinical Pathology
Katsuji Shimoda
"Accreditation Activities for Medical Laboratories in Japan" Audits for transition to ISO 15189:2012 continue to progress. Besides the continual increase of accreditations for medical laboratory testing and pathological examinations, preparations for the addition of physiological testing to the scope of accreditation have finally been completed. As a part of the revision to Japan's Medical Service Act, the external evaluation of medical laboratories is now a requirement to approve clinical trial core hospitals...
February 2016: Rinsho Byori. the Japanese Journal of Clinical Pathology
Graham R Lee, Maria C Fitzgibbon, Paula O'Shea
Purpose - Internal quality control (IQC) represents an essential risk management tool within the total testing pathway (TTP) that contributes to the overall objective of assuring the quality of results produced in medical laboratories. Controlling analytical phase quality alone requires significant expertise and input by scientifically trained staff. This effort has escalated exponentially following the publication of the International Organisation for Standardisation (ISO)15189:2012 requirements for quality and competence in medical laboratories...
June 13, 2016: International Journal of Health Care Quality Assurance
Cécile Florin, Olivier Garraud, Serge Molliex, Brigitte Tardy, Lydia Campos, Carine Scherrer
The Innovance VWF:Ac test (Siemens) has the particularity to assess the binding capacity of von Willebrand factor (VWF) to recombinant platelet GPIb mutated in the absence of ristocetin. Our study aimed to evaluate and validate according to standard NF EN ISO 15189 the original protocol adaptation on STA-R Evolution series analyser (Diagnostica Stago). We evaluated the performance in terms of imprecision and we validate additional parameters necessary in range B as recommended by the SH GTA 04 (Cofrac). We compared the new assay with the reference assay: ristocetin cofactor activity (VWF:RCo) performed on the BCS-XP analyser by testing retrospectively samples from 82 healthy normal subjects and 61 patients with von Willebrand disease (VWD)...
June 1, 2016: Annales de Biologie Clinique
Ian Farrance, Tony Badrick, Kenneth A Sikaris
There appears to be a growing debate with regard to the use of "Westgard style" total error and "GUM style" uncertainty in measurement. Some may argue that the two approaches are irreconcilable. The recent appearance of an article "Quality goals at the crossroads: growing, going, or gone" on the well-regarded Westgard Internet site requires some comment. In particular, a number of assertions which relate to ISO 15189 and uncertainty in measurement appear misleading. An alternate view of the key issues raised by Westergard may serve to guide and enlighten others who may accept such statements at face value...
August 1, 2016: Clinical Chemistry and Laboratory Medicine: CCLM
Sophie Lafontaine, Christine Prin-Mathieu, Aurélie Velay, Odette Agulles, Evelyne Schvoerer, Hélène Jeulin
BACKGROUND: The International Standard ISO 15189 based on the ISO 9001:2008 emphasizes specific requirements for quality and ability of medical laboratories. The accreditation of medical laboratories according to ISO 15189 includes the validation of biological methods, which depends on collection of bibliographic data and experimental proofs. Moreover, these results must be compared to provider data sheets and independent scientific data. In the immunodiagnostic field, independent published data are deeply lacking...
2016: Clinical Laboratory
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