The use of extra-analytical phase quality indicators by clinical laboratories: the results of an international survey

2016 ◽  
Vol 54 (11) ◽  
Author(s):  
Mario Plebani ◽  
Maurice O’Kane ◽  
Pieter Vermeersch ◽  
Janne Cadamuro ◽  
Wytze Oosterhuis ◽  
...  
Keyword(s):  
Quality Indicators ◽  
International Survey ◽  
Clinical Laboratories ◽  
Analytical Phase

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.

Monitoring of quality indicators for detection of mycobacteria in clinical laboratories

2021 ◽  
Vol 79 (1) ◽  
pp. 96-98
Author(s):  
Émilie Cardot Martin ◽  
Pierre Cahen ◽  
Thomas Yung ◽  
Claudine Renaux ◽  
Marc Vasse ◽  
...  
Keyword(s):  
Quality Indicators ◽  
Clinical Laboratories

Identification and prioritization of quality indicators in clinical genetics: An international survey

2009 ◽  
Vol 151C (3) ◽  
pp. 179-190 ◽  
Author(s):  
Barbara C. Zellerino ◽  
Sharon A. Milligan ◽  
Jonathon R. Gray ◽  
Marc S. Williams ◽  
Ron Brooks
Keyword(s):  
Quality Indicators ◽  
Clinical Genetics ◽  
International Survey

scholarly journals Quality Indicators of the Pre-Analytical Phase

2012 ◽  
Vol 31 (3) ◽  
pp. 174-183 ◽  
Author(s):  
Nada Majkić-Singh ◽  
Zorica Šumarac
Keyword(s):  
Health Care ◽  
Patient Safety ◽  
Quality Indicators ◽  
Task Force ◽  
Improve Patient Safety ◽  
Laboratory Data ◽  
Sample Collection ◽  
Laboratory Errors ◽  
Analytical Phase ◽  
Total Testing Process

Quality Indicators of the Pre-Analytical PhaseQuality indicatorsare tools that allow the quantification of quality in each of the segments of health care in comparison with selected criteria. They can be defined as an objective measure used to assess the critical health care segments such as, for instance, patient safety, effectiveness, impartiality, timeliness, efficiency, etc. In laboratory medicine it is possible to develop quality indicators or the measure of feasibility for any stage of the total testing process. The total process or cycle of investigation has traditionally been separated into three phases, the pre-analytical, analytical and post-analytical phase. Some authors also include a »pre-pre« and a »post-post« analytical phase, in a manner that allows to separate them from the activities of sample collection and transportation (pre-analytical phase) and reporting (post-analytical phase). In the year 2008 the IFCC formed within its Education and Management Division (EMD) a task force calledLaboratory Errors and Patient Safety (WG-LEPS)with the aim of promoting the investigation of errors in laboratory data, collecting data and developing a strategy to improve patient safety. This task force came up with the Model of Quality Indicators (MQI) for the total testing process (TTP) including the pre-, intra- and post-analytical phases of work. The pre-analytical phase includes a set of procedures that are difficult to define because they take place at different locations and at different times. Errors that occur at this stage often become obvious later in the analytical and post-analytical phases. For these reasons the identification of quality indicators is necessary in order to avoid potential errors in all the steps of the pre-analytical phase.

Performance criteria and quality indicators for the pre-analytical phase

2015 ◽  
Vol 53 (6) ◽  
Author(s):  
Mario Plebani ◽  
Laura Sciacovelli ◽  
Ada Aita ◽  
Michela Pelloso ◽  
Maria Laura Chiozza
Keyword(s):  
Quality Indicators ◽  
Performance Criteria ◽  
Analytical Quality ◽  
Performance Targets ◽  
Laboratory Services ◽  
Quality Specifications ◽  
Analytical Phase ◽  
Total Testing Process ◽  
The Individual

AbstractThe definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for analytical quality specifications.

Recommendations for detection and management of unsuitable samples in clinical laboratories

2007 ◽  
Vol 45 (6) ◽  
Author(s):  
Giuseppe Lippi ◽  
Giuseppe Banfi ◽  
Mauro Buttarello ◽  
Ferruccio Ceriotti ◽  
Massimo Daves ◽  
...  
Keyword(s):  
Clinical Biochemistry ◽  
Large Body ◽  
Laboratory Methods ◽  
Clinical Laboratories ◽  
Specimen Collection ◽  
Quality Programs ◽  
Unsuitable Samples ◽  
Analytical Phase ◽  
Total Testing Process

AbstractA large body of evidence attests that quality programs developed around the analytical phase of the total testing process would only produce limited improvements, since the large majority of errors encountered in clinical laboratories still prevails within extra-analytical areas of testing, especially in manually intensive preanalytical processes. Most preanalytical errors result from system flaws and insufficient audit of the operators involved in specimen collection and handling responsibilities, leading to an unacceptable number of unsuitable specimens due to misidentification, in vitro hemolysis, clotting, inappropriate volume, wrong container or contamination from infusive routes. Detection and management of unsuitable samples are necessary to overcome this variability. The present document, issued by the Italian Inter-society SIBioC-SIMeL-CISMEL (Society of Clinical Biochemistry and Clinical Molecular Biology-Italian Society of Laboratory Medicine-Italian Committee for Standardization of Hematological and Laboratory Methods) Study Group on Extra-analytical Variability, reviews the major causes of unsuitable specimens in clinical laboratories, providing consensus recommendations for detection and management.Clin Chem Lab Med 2007;45:728–36.

scholarly journals An international survey on anti-neutrophil cytoplasmic antibodies (ANCA) testing in daily clinical practice

2018 ◽  
Vol 56 (10) ◽  
pp. 1759-1770 ◽  
Author(s):  
Jan Damoiseaux ◽  
Ingmar Heijnen ◽  
Christel Van Campenhout ◽  
Catharina Eriksson ◽  
Nicole Fabien ◽  
...  
Keyword(s):  
International Standards ◽  
Proteinase 3 ◽  
International Survey ◽  
Test Results ◽  
Survey Analysis ◽  
Substantial Variation ◽  
International Consensus ◽  
Inflammatory Conditions ◽  
Clinical Laboratories ◽  
Testing Algorithms

Abstract Background: Detection of anti-neutrophil cytoplasmic antibodies (ANCA) is important for the diagnosis of the ANCA-associated vasculitides (AAV). For AAV, especially ANCA directed against myeloperoxidase (MPO) and proteinase 3 (PR3) are most relevant. ANCA with less well-defined specificities may, however, also be detected in other inflammatory and non-inflammatory conditions. Methods: A questionnaire, initiated by the European Autoimmunity Standardisation Initiative (EASI), was used to gather information on methods and testing algorithms used for ANCA in clinical laboratories of 12 European countries (EASI survey). Results: Four hundred and twenty-nine responses were included in the EASI survey analysis which revealed differences within countries and between countries. Laboratories overall were poor in adherence to international consensus on ANCA testing. Substantial variation was observed with respect to the use of ANCA indirect immunofluorescence (IIF) in the algorithm, application of distinct methods for MPO- and PR3-ANCA, the daily availability of new ANCA results, and interpretation of test results. Conclusions: Awareness of these differences may stimulate further harmonization and standardization of ANCA testing. This may be promoted by an update of the international ANCA consensus and the introduction of international standards.

Brazilian laboratory indicators benchmarking program: three-year experience on pre-analytical quality indicators

Diagnosis ◽  
2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Wilson Shcolnik ◽  
Fernando Berlitz ◽  
Cesar Alex de O. Galoro ◽  
Vinicius Biasoli ◽  
Rafael Lopes ◽  
...  
Keyword(s):  
Patient Safety ◽  
Best Practices ◽  
Quality Indicators ◽  
Monitoring Program ◽  
Laboratory Medicine ◽  
Comparative Performance ◽  
Pathology Laboratory ◽  
Pareto Chart ◽  
Laboratory Errors ◽  
Analytical Phase

AbstractObjectivesIn the laboratory medicine segment, benchmarking is the process in which institutions seek to compare with the macro environment (performance comparison and best practices with different laboratories) and improve their results based on quality indicators. The literature has highlighted the vulnerability of the pre-analytical phase in terms of risks and failures and the use of interlaboratory comparison as an opportunity to define a strategic performance benchmark aligned with the laboratory medicine sector, which has been a promising strategy to ensure continuous improvement, identifying within the pre-analytical process the critical activities to guarantee patient safety. In this context, this paper aims to present the three-year experience (2016–2018) of the Benchmarking Program and Laboratory Indicators – in Portuguese, Programa de Benchmarking e Indicadores Laboratoriais (PBIL) – with emphasis on pre-analytical indicators and their comparison against literature references and other programs of benchmarking in the area of laboratory medicine. PBIL is organized by the Brazilian Society of Clinical Pathology/Laboratory Medicine (SBPC/ML) in conjunction with Controllab and coordinated by a Brazilian group with representatives from different countries.MethodsThe data presented in this paper involving the performance results of 180 laboratories with active participation. Results are presented in percentage (%, boxplot graphical in quartiles) and Sigma metric, recognized as the metric that best indicates the magnitude of failures in a process. The Pareto Chart was used to facilitate ordering and to identify the main errors in the pre-analytical phase. The Radar Chart was made available in this work for the purpose of comparing the results obtained in Sigma by the PBIL and IFCC Working Group Laboratory Errors and Patient Safety (WG LEPS).ResultsIn the study period, just over 80% of the pre-analytical failures are related to Blood culture contamination (hospital-based and non-hospital-based laboratories), Recollect and Non-registered exams, with failure rates of 2.70, 1.05 and 0.63%, respectively. The performance of the PBIL program participants was in line with the literature references, and allowed to identify benchmarks in the laboratory medicine market, target of PBIL, with best practices were observed for some indicators.ConclusionsThe results of the program demonstrate the importance of an ongoing program comparative performance-monitoring program for setting more robust goals and consequently reducing laboratory process failures. Even with these promising premises and results, the contextualized analysis of the program indicators, point to a still significant number of failures in our market, with possibilities for improvement in order aiming to ensure more robust and effective processes.

scholarly journals Workflow Optimization in a Clinical Laboratory using Lean management principles in the pre-analytical phase

2020 ◽  
Author(s):  
Pablo Letelier ◽  
Neftalí Guzmán ◽  
Gustavo Medina ◽  
Luis Calcumil ◽  
Pamela Huencho ◽  
...  
Keyword(s):  
User Satisfaction ◽  
Emergency Services ◽  
Clinical Laboratory ◽  
Clinical Results ◽  
Test Results ◽  
Lean Management ◽  
Workflow Optimization ◽  
Delivery Times ◽  
Clinical Laboratories ◽  
Analytical Phase

BACKGROUND: The application of the Lean methodology in clinical laboratories can improve workflow and user satisfaction through the efficient delivery of analytical results. The purpose of this study was to optimise delivery times of the test results at a clinical laboratory, using Lean management principles in the pre-analytical phase. METHODS: A prospective study with a quasi- experimental design was implemented. Staff functions were restructured and sample flows were modified. Delivery times of clinical results (glucose and haematocrit) from the Medicine and Adult Emergency services for years 2017 and 2018 were compared. RESULTS: A reduction (p < 0.05) in turnaround times in the delivery of glucose test results at the adult emergency service was observed (84 to 73 min, 13%, pre and post). In addition, there was a non-significant reduction in the turnaround times for glucose (Medicine) and haematocrit in both services. In the analytical and post-analytical phase (not intervened), an increase in turnaround times was observed in some cases. CONCLUSIONS: Other studies have indicated that the application of the Lean methodology in clinical laboratories improves workflow, increasing effectiveness and efficiency. This study showed an improvement in the delivery time of test results (glucose – Emergency), giving rise to a culture of cooperation and continuous improvement. It would, however, be essential to address the management model integrating the analytical and post-analytical phases.

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