scholarly journals Excellence in clinical laboratories: the standard ISO 15189:2007

2010 ◽  
Vol 25 (2) ◽  
Author(s):  
Antonio Scipioni ◽  
Cristina Marangoni ◽  
Anna Mazzi ◽  
Antonietta Cavallaro
Keyword(s):  
Iso 15189 ◽  
Clinical Laboratories ◽  
Standard Iso 15189

Quality management in medical laboratories

2010 ◽  
Vol 30 (02) ◽  
pp. 55-62
Author(s):  
M. Fritzer-Szekeres
Keyword(s):  
Quality Management ◽  
Medical Laboratory ◽  
Management Systems ◽  
The European Union ◽  
Quality Management Systems ◽  
Iso 17025 ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Systems Quality ◽  
Standard Iso 15189

SummaryDuring the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable.

Request form and the standard ISO 15189

2006 ◽  
Vol 10 (11) ◽  
pp. 640-641
Author(s):  
Xavier Fuentes-Arderiu
Keyword(s):  
Request Form ◽  
Iso 15189 ◽  
Standard Iso 15189

Could standard ISO 15189 be useful for the conundrum of CA 19-9/GI Monitor measurement?

2007 ◽  
Vol 45 (7) ◽  
Author(s):  
Romolo M. Dorizzi ◽  
Sandra Meneghelli ◽  
Maria Rocca ◽  
Anna Ferrari
Keyword(s):  
Iso 15189 ◽  
Standard Iso 15189

No Absract available

scholarly journals Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mᵃ Liboria López Yeste ◽  
Silvia Izquierdo Álvarez ◽  
Antonia R. Pons Mas ◽  
Luisa Álvarez Domínguez ◽  
Fernando Marqués García ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Test Results ◽  
Correct Interpretation ◽  
Laboratory Management ◽  
Iso 15189 ◽  
Effective Implementation ◽  
Clinical Laboratories ◽  
Global Trend ◽  
Laboratory Results ◽  
Critical Results

Abstract The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and the personnel involved (laboratory management and staff). We describe the criteria and information required to review and validate analytical results and ensure that clear reports are sent to requesters. These criteria also guarantee that results are transcribed in a reliable way and that all necessary information is provided for the correct interpretation of results. Likewise, the requirements for the correct release of laboratory results are described, with special emphasis on the release of alarming or critical results. In some European countries, clinical laboratories are required to hold partial or full ISO 15189 accreditation, which is a global trend. Therefore, understanding ISO 15189 requirements is imperative for a progressive and more effective implementation of the Standard.

scholarly journals Improved RT-PCR SARS-Cov2 results interpretation by indirect determination of cut-off cycle threshold value

2020 ◽  
Author(s):  
Khelil Mohamed Mokhtar
Keyword(s):  
Real Time ◽  
Clinical Laboratory ◽  
Threshold Value ◽  
Mixed Data ◽  
Rt Pcr ◽  
Data Set ◽  
Iso 15189 ◽  
Indirect Determination ◽  
Clinical Laboratories

ABSTRACTClinical laboratories of the developing world are overwhelmed with RT-PCR SARS-Cov2 testing demands. It is of paramount importance that each clinical laboratory use an appropriate cut-off value in the interpretation of SARS-Cov2 real-time RT–PCR results, which is specific to their laboratory performances as ISO 15189 recommendations stipulate. We applied an indirect statistical method to a large mixed data set of Ct values (ORF1ab and N) to estimate cut-off Ct value (∼32 cycles).we conclude that the use of indirect statistical approaches to estimate cut-off value in the interpretation of SARS-Cov2 real-time RT–PCR results may improve differential diagnosis of COVID-19 cases with low risk of infectivity, and may help to better estimates of the burden of COVID-19 disease.

An Integrated Fuzzy VIKOR Method for Performance Management in Healthcare

2017 ◽  
pp. 40-61 ◽  
Author(s):  
Ehsan Shekarian ◽  
Salwa Hanim Abdul-Rashid ◽  
Ezutah Udoncy Olugu
Keyword(s):  
Performance Management ◽  
Evaluation Method ◽  
Multiple Criteria Decision Making ◽  
Poor Quality ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Standard Iso 15189

Poor quality control has become a major threat to medical laboratory services, especially in the developing countries. It has become necessary to assess and rank the quality of diagnostic services in medical laboratories using systematic approaches. The main aim of this research is to develop and apply a quantitative method in ranking medical laboratory services. This method is based on a combination of Vlsekriterijumska Optimizacija I Kompromisno Resenje (VIKOR) with fuzzy set theory. VIKOR is a multiple criteria decision making technique which focuses on ranking and selection from a set of alternatives, and determines the compromise solution for a problem with different criteria. This approach aids decision makers to achieve the most acceptable decision amidst numerous alternatives. In the present evaluation method, international standard ISO 15189 (Medical Laboratories Particular Requirements for Quality and Competence) proposed by International Organization for Standardization (ISO) is used as a fundamental source of selected attributes of a medical laboratory. The study compares three medical laboratories to each other and ranks them. This study will be a valuable and effective contribution in enhancing both qualitative and quantitative criteria in the field of medical laboratory services. Finally, some directions for further studies are proposed.

scholarly journals External quality assessment programs in the context of ISO 15189 accreditation

2018 ◽  
Vol 56 (10) ◽  
pp. 1644-1654 ◽  
Author(s):  
Laura Sciacovelli ◽  
Sandra Secchiero ◽  
Andrea Padoan ◽  
Mario Plebani
Keyword(s):  
Quality Assessment ◽  
Specific Activity ◽  
External Quality Assessment ◽  
International Standards ◽  
Fundamental Importance ◽  
External Quality ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Clinical Laboratories ◽  
The Right

Abstract Effective management of clinical laboratories participating in external quality assessment schemes (EQAS) is of fundamental importance in ensuring reliable analytical results. The International Standard ISO 15189:2012 requires participation in interlaboratory comparison [e.g. external quality assessment (EQA)] for all tests provided by an individual laboratory. If EQAS is not commercially available, alternative approaches should be identified, although clinical laboratories may find it challenging to choose the EQAS that comply with the international standards and approved guidelines. Great competence is therefore required, as well as knowledge of the characteristics and key elements affecting the reliability of an EQAS, and the analytical quality specifications stated in approved documents. Another skill of fundamental importance is the ability to identify an alternative approach when the available EQAS are inadequate or missing. Yet the choice of the right EQA program alone does not guarantee its effectiveness. In fact, the fundamental steps of analysis of the information provided in EQA reports and the ability to identify improvement actions to be undertaken call for the involvement of all laboratory staff playing a role in the specific activity. The aim of this paper was to describe the critical aspects that EQA providers and laboratory professionals should control in order to guarantee effective EQAS management and compliance with ISO 15189 accreditation requirements.

Quality Management and Quality Assurance in Medical Laboratories

2015 ◽  
pp. 136-153
Author(s):  
Kyriacos C. Tsimillis ◽  
Sappho Michael
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Comprehensive Analysis ◽  
Small Country ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Certification And Accreditation ◽  
Recent Developments ◽  
Laboratory Examinations ◽  
Standard Iso 15189

This chapter deals with issues of quality management and quality assurance in medical laboratories. Basic terms and their role in quality assurance in laboratory examinations are analyzed and discussed. Clarifications on certification and accreditation are given with a comprehensive analysis of the procedures they refer to and their implementation for particular tasks. The implementation of the international standard ISO 15189 is presented with reference to some recent developments. The chapter has been prepared to help medical laboratories in an introductory understanding of quality assurance issues and encourage them to proceed with the implementation of the standard ISO 15189 and not as a detailed guide. Some practical considerations rising from the experience of a small country such as Cyprus are also discussed.

An Integrated Fuzzy VIKOR Method for Performance Management in Healthcare

2018 ◽  
pp. 1100-1121
Author(s):  
Ehsan Shekarian ◽  
Salwa Hanim Abdul-Rashid ◽  
Ezutah Udoncy Olugu
Keyword(s):  
Performance Management ◽  
Evaluation Method ◽  
Multiple Criteria Decision Making ◽  
Poor Quality ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Standard Iso 15189

Poor quality control has become a major threat to medical laboratory services, especially in the developing countries. It has become necessary to assess and rank the quality of diagnostic services in medical laboratories using systematic approaches. The main aim of this research is to develop and apply a quantitative method in ranking medical laboratory services. This method is based on a combination of Vlsekriterijumska Optimizacija I Kompromisno Resenje (VIKOR) with fuzzy set theory. VIKOR is a multiple criteria decision making technique which focuses on ranking and selection from a set of alternatives, and determines the compromise solution for a problem with different criteria. This approach aids decision makers to achieve the most acceptable decision amidst numerous alternatives. In the present evaluation method, international standard ISO 15189 (Medical Laboratories Particular Requirements for Quality and Competence) proposed by International Organization for Standardization (ISO) is used as a fundamental source of selected attributes of a medical laboratory. The study compares three medical laboratories to each other and ranks them. This study will be a valuable and effective contribution in enhancing both qualitative and quantitative criteria in the field of medical laboratory services. Finally, some directions for further studies are proposed.

Sign in / Sign up

Export Citation Format

Share Document