scholarly journals How to meet ISO15189:2012 pre-analytical requirements in clinical laboratories? A consensus document by the EFLM WG-PRE

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Pieter Vermeersch ◽  
Glynis Frans ◽  
Alexander von Meyer ◽  
Seán Costelloe ◽  
Giuseppe Lippi ◽  
...  
Keyword(s):  
Quality Management System ◽  
Clinical Chemistry ◽  
European Federation ◽  
Consensus Recommendation ◽  
Iso 15189 ◽  
Consensus Document ◽  
Analytical Phase ◽  
Total Testing Process ◽  
Analytical Requirements ◽  
Analytical Requirement

Abstract The International Organization for Standardization (ISO) 15189:2012 standard aims to improve quality in medical laboratories through standardization of all key elements in the total testing process, including the pre-analytical phase. It is hence essential that accreditation bodies, assessing laboratories against ISO15189:2012, pay sufficient attention to auditing pre-analytical activities. However, there are significant differences in how technical auditors interpret the pre-analytical requirements described in ISO15189:2012. In this consensus document, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Pre-analytical Phase (WG-PRE) sets out to review pre-analytical requirements contained in ISO15189:2012 and provide guidance for laboratories on how to meet these requirements. The target audience for this consensus document is laboratory professionals who wish to improve the quality of the pre-analytical phase in their laboratory. For each of the ISO requirements described in ISO15189:2012, members of EFLM WG-PRE agreed by consensus on minimal recommendations and best-in-class solutions. The minimal consensus recommendation was defined as the minimal specification which laboratories should implement in their quality management system to adequately address the pre-analytical requirement described in ISO15189:2012. The best-in-class solution describes the current state-of-the-art in fulfilling a particular pre-analytical requirement in ISO15189:2012. We fully acknowledge that not every laboratory has the means to implement these best-in-class solutions, but we hope to challenge laboratories in critically evaluating and improving their current procedures by providing this expanded guidance.

scholarly journals Patient Safety in Laboratory Medicine

2020 ◽  
pp. 325-338
Author(s):  
Mario Plebani ◽  
Ada Aita ◽  
Laura Sciacovelli
Keyword(s):  
Patient Safety ◽  
Clinical Decision Making ◽  
Quality Management System ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Main Task ◽  
Iso 15189 ◽  
Preventive Actions ◽  
Total Testing Process ◽  
The Right

AbstractLaboratory medicine in the healthcare system has recently been recognized as a fundamental service in the clinical decision-making process. Therefore, the notion of patient safety in laboratory medicine must be recognized as the assurance that harm to patients will be avoided, safe care outcomes will be enhanced through error prevention, and the total testing process (TTP) will be continuously improved.Although the goal for patient safety is zero errors, and although laboratory professionals have made numerous efforts to reduce errors in the last few decades, current research into laboratory-related diagnostic errors highlights that: (a) errors occur at every step of the TTP, mainly affecting phases at clinical interfaces; (b) despite the improvement strategies adopted, analytical quality remains a challenge; (c) errors are linked not only to clinical chemistry tests, but also to new, increasingly complex diagnostic testing.Medical laboratories must therefore implement effective quality assurance tools to identify and prevent errors in order to guarantee the reliability of laboratory information. Accreditation in compliance with the International Standard ISO 15189 represents the first step, establishing processes with excellence requirements and greater expectations of staff competency. Another important step in preventing errors and ensuring patient safety is the development of specific educational and training programs addressed to all professionals involved in the process, in which both technical and administrative skills are integrated. A wide variety of information is provided by a robust quality management system and consensus-approved Quality Indicators (QI) that identify undesirable events, evaluate the risk to the patient, and call for corrective and preventive actions. However, the effectiveness of the system depends on the careful analysis of data collected and on staff awareness of the importance of laboratory medicine to the healthcare process. The main task of the new generation of laboratory professionals should be to gain experience in “clinical laboratory stewardship.” In order to safeguard patients, laboratory professionals must assist clinicians in selecting the right test for the right patient at the right time and facilitate the interpretation of laboratory information.

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.

scholarly journals Practical Guidance for Clinical Microbiology Laboratories: Implementing a Quality Management System in the Medical Microbiology Laboratory

2018 ◽  
Vol 31 (3) ◽  
Author(s):  
Roberta B. Carey ◽  
Sanjib Bhattacharyya ◽  
Sue C. Kehl ◽  
Larissa M. Matukas ◽  
Michael A. Pentella ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Daily Practice ◽  
Microbiology Laboratory ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Roles And Responsibilities ◽  
Technical Requirements ◽  
Total Testing Process

SUMMARY This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages “systems thinking” by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum.

Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)

2017 ◽  
Vol 55 (1) ◽  
pp. 27-31 ◽  
Author(s):  
Michael Cornes ◽  
Edmée van Dongen-Lases ◽  
Kjell Grankvist ◽  
Mercedes Ibarz ◽  
Gunn Kristensen ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Venous Blood ◽  
Laboratory Medicine ◽  
European Federation ◽  
Blood Collection ◽  
Sample Collection ◽  
Blood Draw ◽  
Preanalytical Phase ◽  
Analytical Phase

AbstractIt has been well reported over recent years that most errors within the total testing process occur in the pre-analytical phase (46%–68.2%), an area that is usually outside of the direct control of the laboratory and which includes sample collection (phlebotomy). National and international (WHO, CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have been a number of studies recently looking at whether order of draw remains a problem with modern phlebotomy techniques and materials, or it is an outdated practice followed simply because of historical reasons. In the following article, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols are not always followed or possible, EFLM WG-PRE supports the continued recommendation of ensuring a correct order of draw for venous blood collection.

National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017

2018 ◽  
Vol 57 (2) ◽  
pp. 195-203 ◽  
Author(s):  
Min Duan ◽  
Xudong Ma ◽  
Jing Fan ◽  
Yanhong Guo ◽  
Wei Wang ◽  
...  
Keyword(s):  
Quality Indicators ◽  
Clinical Chemistry ◽  
Turnaround Time ◽  
Laboratory Medicine ◽  
General Information ◽  
Critical Values ◽  
Medical Quality ◽  
Clinical Laboratories ◽  
Analytical Phase ◽  
Total Testing Process

Abstract Background As effective quality management tools, quality indicators (QIs) are widely used in laboratory medicine. This study aimed to analyze the results of QIs, identify errors and provide quality specifications (QSs) based on the state-of-the-art. Methods Clinical laboratories all over China participated in the QIs survey organized by the National Health Commission of People’ Republic of China from 2015 to 2017. Most of these QIs were selected from a common model of QIs (MQI) established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All participants were asked to submit general information and original QIs data through a medical quality control data collection system. The results of QIs were reported in percentages and sigma, except turnaround time (TAT) which was measured in minutes. The 25th, 50th and 75th percentiles were, respectively, calculated as three levels of QSs, which were defined starting from the model proposed during the 1st Strategic Conference of the EFLM on “Defining analytical performance 15 years after the Stockholm Conference on Quality Specification in Laboratory Medicine”. Results A total of 76 clinical laboratories from 25 provinces in China continuously participated in this survey and submitted complete data for all QIs from 2015 to 2017. In general, the performance of all reported QIs have improved or at least kept stable over time. Defect percentages of blood culture contamination were the largest in the pre-analytical phase. Intra-laboratory TAT was always larger than pre-examination TAT. Percentage of tests covered by inter-laboratory comparison was relatively low than others in the intra-analytical phase. The performances of critical values notification and timely critical values notification were the best with 6.0σ. The median sigma level of incorrect laboratory reports varied from 5.5σ to 5.7σ. Conclusions QSs of QIs provide useful guidance for laboratories to improve testing quality. Laboratories should take continuous quality improvement measures in all phases of total testing process to ensure safe and effective tests.

scholarly journals EFLM WG-Preanalytical phase opinion paper: local validation of blood collection tubes in clinical laboratories

2016 ◽  
Vol 54 (5) ◽  
Author(s):  
Giuseppe Lippi ◽  
Michael P. Cornes ◽  
Kjell Grankvist ◽  
Mads Nybo ◽  
Ana-Maria Simundic
Keyword(s):  
Clinical Chemistry ◽  
European Federation ◽  
Blood Collection ◽  
Healthcare Facilities ◽  
Hospital Administrators ◽  
Consensus Document ◽  
Preanalytical Phase ◽  
Blood Collection Tubes ◽  
Validation Experiments

AbstractThe selection or procurement of blood collection devices in healthcare facilities is often an underestimated issue. This is probably due to different factors including the lack of knowledge of policymakers, hospital administrators and even laboratory managers about the importance of preanalytical quality and phlebotomy process, as well as to the absence of reliable guidelines or recommendations on how to precisely assess the quality of blood collection devices around the globe. With the awareness that a gap remains between manufacturers’ and local validation of blood collection devices, the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has drafted a consensus document aimed to provide a set of essential requisites, technical criteria (e.g. presence of physical defects, malfunctioning, safety problems) and clinical issues for supporting laboratory professionals in organization blood collection tubes tenders and validating new devices before local routine implementation. The laboratory professionals should also make sure that the tenders accurately and strictly define the responsibilities for validation experiments and the potential consequences in the case the validation outcome shows that tubes due not fulfill the expectations.

The use of preanalytical quality indicators: a Turkish preliminary survey study

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Bagnu Orhan ◽  
Derya Sonmez ◽  
Hikmet Can Cubukcu ◽  
Oguzhan Zengi ◽  
Humeyra Ozturk Emre ◽  
...  
Keyword(s):  
Quality Indicators ◽  
Clinical Chemistry ◽  
Quality Standards ◽  
Survey Study ◽  
Iso 15189 ◽  
Laboratory Errors ◽  
Medical Laboratories ◽  
Information Management Systems ◽  
Survey Results ◽  
Total Testing Process

AbstractObjectivesThe utilization of reliable quality indicators (QIs) proven to be suitable for monitoring and improvement tools is one of the best choices to minimize of the risk of errors in all laboratory processes called as total testing process (TTP). In 2008, a Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) established by International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) developed the Model of Quality Indicators (MQI) complying with requirements of the ISO 15189:2012 standard for laboratory accreditation. They have also been dealing with harmonizing the QIs in most laboratories worldwide since then. The present study was set out to investigate the frequency of using IFCC WG-LEPS’ pre-QIs by Turkish laboratories and to assess the conformity of them, by taking into account Turkey’s conditions.MethodsA survey consisting nine questions was applied in 81 laboratories using SurveyMonkey.ResultsAccording to the survey results, most of the laboratories reported they have used pre-QIs in the quality standards of health prepared by Turkish Ministry of Health (MOH). A part of IFCC WG-LEPS’ pre-QIs were being utilized by more than 80% of the laboratories, the rest of which only used by 10% of laboratories.ConclusionsThe majority of the medical laboratories have been using the pre-QIs included in the guidelines of Quality Standards prepared by the MOH. The pre-QIs are partially compatible with IFCC WG-LEPS’ pre-QIs. The definitions of IFCC WG-LEPS’ pre-QIs may also be revised to make them more clear and understandable by IFCC WG-LEPS. The insufficiency of Health Information Management Systems (HIMS) limits the use of pre-QIs proposed by IFCC WG-LEPS. Finally, the education of relevant personnel about the use of HIMS and pre-QIs is very crucial to harmonize and to extend the use of IFCC WG-LEPS’ pre-QIs in Turkish medical biochemistry laboratories.

scholarly journals Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

2017 ◽  
Vol 55 (4) ◽  
Author(s):  
Giuseppe Lippi ◽  
Geoffrey S. Baird ◽  
Giuseppe Banfi ◽  
Karin Bölenius ◽  
Janne Cadamuro ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Diagnostic Testing ◽  
Laboratory Medicine ◽  
Therapeutic Monitoring ◽  
European Federation ◽  
Preanalytical Phase ◽  
Total Testing Process ◽  
The Many ◽  
High Degree

Abstract It is now undeniable that laboratory testing is vital for the diagnosis, prognostication and therapeutic monitoring of human disease. Despite the many advances made for achieving a high degree of quality and safety in the analytical part of diagnostic testing, many hurdles in the total testing process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years. Hence, this collective article follows the previous three opinion papers that were published by the EFLM WGPRE on the same topic, and brings together the summaries of the presentations that will be given at the 4th EFLM-BD meeting “Improving quality in the preanalytical phase through innovation” in Amsterdam, 24–25 March, 2017.

scholarly journals Quality of Control of Clinical-Biochemical Laboratories – Serbian Case

2014 ◽  
Vol 2 (2) ◽  
pp. 219-223 ◽  
Author(s):  
Vinko Peric ◽  
Dusan Jaric ◽  
Sonja Ketin ◽  
Admira Konicanin ◽  
Rade Biocanin
Keyword(s):  
Quality Management System ◽  
Work Group ◽  
Clinical Chemistry ◽  
Iso 17025 ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Quality Of Control ◽  
Good Laboratory ◽  
In The Beginning

In the last 20 years in medical laboratories, numerous activities regarding quality and accreditation system were taken. Approach to this problem in European countries is different, so the task of the Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4) to help the efforts to harmonize this issue. External quality control in clinical-chemical laboratories imposed the need for the implementation of quality management system. »Good laboratory practice« and its principles were adopted by nominated bodies, both international and national. In the beginning, the standard ISO 9001 was applied for certification and for accreditation EN 45001 and ISO Guide 25, which are prepared for testing and calibration laboratories. Standard ISO 17025 is the successor of the previous documents and for now it is a reference for mentioned laboratories. Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4) made an amendment of the requirements for medical laboratories, which this standard describes. Standard draft ISO 15189 was adopted on February 2003 as a final version with requirements for medical laboratories.

Study of the Pre-Analytical Phase of an ISO 15189: 2012-Certified Cytopathology Laboratory: A 5-Year Institutional Experience

2018 ◽  
Vol 63 (1) ◽  
pp. 56-62 ◽  
Author(s):  
Smita Chandra ◽  
Harish Chandra ◽  
Anuradha Kusum ◽  
Dushyant Singh Gaur
Keyword(s):  
Quality Management ◽  
Total Quality Management ◽  
Quality Management System ◽  
Medical Institute ◽  
Sudden Increase ◽  
Total Quality ◽  
Continuous Training ◽  
Iso 15189 ◽  
The North ◽  
Analytical Phase

Objective: Total quality management, which basically involves pre-analytical, analytical, and postanalytical phases, is relatively more difficult in cytopathology due to descriptive reports and subjective variability. The pre-analytical phase of total quality management constitutes a major burden of errors in the laboratory and it has not been widely studied in cytopathology except in cervical Pap smears. The present study was therefore conducted to study the pre-analytical phase over 5 years from April 2013 until May 2018 at an ISO 15189: 2012-certified cytopathology laboratory, in a resource-limited setting. It was also intended to study the level of satisfaction of the patients and the training of the professionals provided in the cytology lab so as to improve and maintain high quality standards. Methods: The study included all the documents relating to the quality program used in the last 5 years in a medical institute situated in the north sub-Himalayan region of India. All the data were recorded and analysed for pre-analytical analysis of the total quality management system. Results: In total, 20,130 samples were received for cytological investigation. The total number of errors which were detected in the cytopathology lab were 1,430, constituting 7.1% of the total investigations done. The pre-analytical phase errors comprised 57% of the total errors (815/1,430), analytical errors constituted 11% (157/1,430), while postanalytical errors represented 32% (458/1,430). Incompletely filled requisition forms constituted the most common pre-analytical error (38%). There was a gradual decrease in the errors with time, but with a sudden increase between January to June 2015 due to new technicians joining during that period. Conclusion: Pre-analytical quality management is an essential component for maintaining the quality and reducing the errors in the cytopathology lab. Documentation, continuous training, and maintenance of internal and external quality control with quality charts are the key for successful quality management. The identification of non-conformance with root-cause analysis and provision of scope for continuous improvement is vital for quality improvement in the lab. Patient satisfaction is an important aspect of quality in the lab, which should be combined with the satisfaction of the personnel working in the lab.

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