scholarly journals Features of the Functioning of the National Metrological System in the Health Sector

2020 ◽  
pp. 59-65
Author(s):  
A. B. Glebov ◽  
I. V. Chizhik ◽  
N. M. Parkhomenko ◽  
O. V. Dengub
Keyword(s):  
Proficiency Testing ◽  
Metrological Support ◽  
National Level ◽  
Laboratory Medicine ◽  
Healthcare Sector ◽  
Measuring Instruments ◽  
Technical Competence ◽  
Medical Laboratories ◽  
Proficiency Testing Schemes ◽  
Metrological System

The legislative requirements for metrological support in the healthcare sector, the issues of ensuring metrological traceability and the hierarchical scheme of calibrations and measurements in laboratory medicine according to the recommendations of JCTLM and their adaptation at the national level are considered. The features of the provided metrological control of measuring instruments for medical purposes, including when conducting their compliance assessment with the requirements of technical regulations. The current state of affairs in the confirmation of the technical competence of medical laboratories, including the need for their participation in proficiency testing schemes through inter-laboratory comparisons, in the transition from certification to accreditation is considered. The analysis of the used methods and means of calibration and reference measurements proposed by JCTLM and other leading orga­nizations in the field of laboratory medicine is observed. Information is provided on the work carried out by the SE «Ukrmetrteststandart» for metrological support of medical measuring instruments. The necessity of legal improvement, the regulatory and methodological base of the metrological system in the field of healthcare is substantiated. As a result of the work performed, the authors consider: the legislative base of metrological support in the field of healthcare is not perfect and in need of refinement of the profile of the central executive authorities in order to build technically sound organizational and regulatory frameworks for metrological support in this area; proficiency testing through interlaboratory comparisons in the field of laboratory medicine is an effective tool for confirming the technical competence of the laboratory. Laboratories should parti­cipate in proficiency testing schemes on a regular basis. Proficiency testing providers should pay particular attention to the method of determining reference values of indicators in proficiency testing samples, using predominantly metrologically sound procedures based on the use of standards, certified reference materials and/or reference measurement methods; the heads of medical laboratories should be careful about the choice of suppliers of legal acts in the metrology.

Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)

2015 ◽  
Vol 53 (8) ◽  
Author(s):  
Marc H.M. Thelen ◽  
Florent J.L.A. Vanstapel ◽  
Christos Kroupis ◽  
Ines Vukasovic ◽  
Guilaime Boursier ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Position Paper ◽  
European Federation ◽  
Medical Field ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Flexible Scope ◽  
Scientific Disciplines

AbstractThe recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national bodies responsible for accreditation describe the scope of every laboratory accreditation in a way that leaves no room for doubt about the range of competence of the particular laboratories. According to EA recommendations scopes may be fixed, mentioning every single test that is part of the accreditation, or flexible, mentioning all combinations of medical field, examination type and materials for which the laboratory is competent. Up to now national accreditation bodies perpetuate use of fixed scopes, partly by inertia, partly out of fear that a too flexible scope may lead to over-valuation of the competence of laboratories, most countries only use fixed scopes. The EA however promotes use of flexible scopes, since this allows for more readily innovation, which contributes to quality in laboratory medicine. In this position paper, the Working Group Accreditation and ISO/CEN Standards belonging to the Quality and Regulation Committee of the EFLM recommends using an approach that has led to successful introduction of the flexible scope for ISO15189 accreditation as intended in EA-4/17 in The Netherlands. The approach is risk-based, discipline and competence-based, and focuses on defining a uniform terminology transferable across the borders of scientific disciplines, laboratories and countries.

Proficiency testing in analytical chemistry, microbiology and laboratory medicine: discussions on current practice and future directions

2015 ◽  
Vol 20 (4) ◽  
pp. 339-344 ◽  
Author(s):  
Brian Brookman ◽  
Owen Butler ◽  
Michael Koch ◽  
Tracey Noblett ◽  
Ulf Örnemark ◽  
...  
Keyword(s):  
Analytical Chemistry ◽  
Proficiency Testing ◽  
Current Practice ◽  
Laboratory Medicine ◽  
Future Directions

SYSTEM OF STANDARDIZATION AND METROLOGICAL SUPPORT OF SPEED DEFECTIVE MEANS OF RAILS IN THEIR PRODUCTION AND OPERATION

2021 ◽  
pp. 14-29
Author(s):  
V. F. Tarabrin
Keyword(s):  
Metrological Support ◽  
High Speed ◽  
Dynamic Testing ◽  
Flaw Detection ◽  
Measuring Instruments ◽  
High Speed Rail ◽  
Technical Control ◽  
Instrument Control ◽  
Factory Testing ◽  
Production And Operation

The importance of standardization and metrological support for high-speed rail flaw detection is noted. JSC “Firm TVEMA” has created a service for quality, factory testing and metrological support. The data on the development and development of the production of JSC “Firma TVEMA” of a complex of removable and mobile technical means of NDT with maximum automation of instrument control and processing of control data, creation of a quality service, factory testing and metrological support are given. It is shown that the service includes structural subdivisions: the department of metrology and quality, a metrological laboratory, a testing laboratory, a technical control bureau that provide scientific and methodological support for the development of measuring instruments, testing, verification and calibration of flaw detection instruments during their production and operation. JSC “Firma TVEMA” organized the production and delivery of models of rail defects to railways with primary certification by the metrological laboratory for dynamic testing of mobile NDT vehicles. A test section was put into operation at the Experimental Ring of JSC VNIIZhT with certified defect models, which made it possible to accumulate research material for the further development of high-speed flaw detectors.

Policies and practices in the field of laboratory hematology in Croatia – a current overview and call for improvement

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Vanja Radišić Biljak ◽  
Ivana Lapić ◽  
Valentina Vidranski ◽  
Ivona Herceg ◽  
Franciska Tomić ◽  
...  
Keyword(s):  
National Level ◽  
Daily Basis ◽  
Internal Quality ◽  
Routine Practice ◽  
Medical Laboratories ◽  
Routine Work ◽  
Comprehensive Survey ◽  
Total Testing Process ◽  
Laboratory Hematology ◽  
Hematology Analyzers

Abstract Objectives In 2019 The Croatian Working Group for Laboratory Hematology, on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine, wanted to explore the background in field of laboratory hematology routine practice among Croatian laboratories in order to develop future strategies for producing national recommendations, if needed. Methods During April and May 2019, a comprehensive survey covering all main parts of the total testing process within the field of laboratory hematology among Croatian medical laboratories was conducted. The survey comprised 49 inquiries. Data was collected using Survey Monkey (Palo Alto, CA, USA). All collected data was anonymized. Results The response rate was 72%. There is still a substantial number of laboratories that have only three-part differential hematology analyzers (9%). Furthermore, a very high number of laboratories did not perform analyzer verification prior to implementation into routine work (31%). Out of those who have verified their analyzers, a diversity of guidelines and recommendations were used. Nearly 10% of the laboratories do not have a defined policy regarding specimen rejection. The majority of the participants perform internal quality control daily (83%), however, only 51% of respondents evaluate the agreement between different hematology analyzers on daily basis. Although more than 90% of Croatian laboratories have a defined policy regarding specimen rejection, only 61% of respondents continuously monitor quality indicators in routine practice. Conclusions The survey revealed substantial differences in all aspects of laboratory hematology practices among Croatian medical laboratories, indicating the need for universal recommendations at the national level.

Use of proficiency testing schemes for motorcycle exhaust emissions laboratory: Brazilian experience

2014 ◽  
Vol 8 (3) ◽  
pp. 116-121
Author(s):  
Paulo Roque Martins Silva ◽  
Valnei Smarçaro da Cunha ◽  
Werickson Fortunato de Carvalho Rocha ◽  
Marcello Depieri ◽  
Gabriel Fonseca Sarmanho ◽  
...  
Keyword(s):  
Proficiency Testing ◽  
Exhaust Emissions ◽  
Proficiency Testing Schemes

scholarly journals Quality and the College of American Pathologists

2011 ◽  
Vol 135 (11) ◽  
pp. 1441-1441 ◽  
Author(s):  
Timothy Craig Allen ◽  
M Elizabeth H. Hammond ◽  
Stanley J. Robboy
Keyword(s):  
Patient Care ◽  
Proficiency Testing ◽  
Laboratory Medicine ◽  
Laboratory Accreditation ◽  
Site Specific ◽  
Testing Program ◽  
Patent Quality ◽  
Accreditation Program ◽  
Specific Cancer ◽  
Medicine Quality

The College of American Pathologists (CAP) is dedicated to pathology and laboratory medicine quality. The CAP's Laboratory Accreditation Program, Proficiency Testing Program, Q-Probes and Q-Tracks, site-specific cancer checklists, webinars, annual meetings, and Advanced Practical Pathology series are all focused on providing superior patent quality. The CAP is synonymous with quality in pathology and laboratory medicine. As pathology practice becomes more sophisticated, the CAP's many programs will increasingly help pathologists provide appropriate, personalized patient care.

scholarly journals Quality: Walk the Walk

2011 ◽  
Vol 135 (11) ◽  
pp. 1384-1386 ◽  
Author(s):  
Timothy Craig Allen
Keyword(s):  
Proficiency Testing ◽  
Laboratory Medicine ◽  
Laboratory Accreditation ◽  
Site Specific ◽  
Testing Program ◽  
Personalized Care ◽  
Accreditation Program ◽  
Specific Cancer ◽  
Medicine Quality

The College of American Pathologists (CAP) is dedicated to pathology and laboratory medicine quality. The CAP's Laboratory Accreditation Program, Proficiency Testing Program, Q-Probes and Q-Tracks, site-specific cancer checklists, webinars, annual meetings, and Advanced Practical Pathology series are all focused on providing superior patient quality. The CAP is synonymous with quality in pathology and laboratory medicine. As pathology practice becomes more sophisticated, the CAP's many programs will increasingly help pathologists provide appropriate, personalized care.

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