Assessment of laboratory errors and best laboratory practices

2016 ◽  
Vol 5 (07) ◽  
pp. 4704
Author(s):  
Syed Riaz Mehdi* ◽  
Sharique Ahmad ◽  
Noorin Zaidi
Keyword(s):  
External Quality Control ◽  
External Quality ◽  
Iso 15189 ◽  
Laboratory Errors ◽  
Control Programs ◽  
Medical Laboratories ◽  
Laboratory Error ◽  
Active Communication ◽  
Total Testing Process ◽  
Five Phases

Laboratory error is defined by ISO 22367 as “Failure of planned actions to be completed as intended or use a wrong plan to achieve an aim”. Lundeberg in 1981 outlined the concept of Total Testing Process (TTP) and Plebani elaborated it further and classified the whole testing process into five phases of Pre-Pre Analytic, Pre Analytic, Analytic, Post Analytic and Post - Post Analytic. The errors have to be identified and resolved in each phase of the process. The medical laboratories have to run Internal and External Quality Control programs and abide by the guidelines of ISO 15189 in order to be accredited by bodies like JCI, CAP or NABL. Active communication and regular interaction between the clinicians and the laboratory is recommended during Pre Analytic and Post Analytic phases of TTP in order to achieve the target of Best Laboratory Practices. 

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.

The Implementation of Cloud-Based Telemedical Applications for External Quality Control Purposes in the Field of Cytopathology

2014 ◽  
Vol 3 (3) ◽  
pp. 22-36 ◽  
Author(s):  
Stavros Archondakis ◽  
Abraham Pouliakis ◽  
Niki Margari ◽  
Petros Karakitsos
Keyword(s):  
Quality Control ◽  
Proficiency Testing ◽  
Low Cost ◽  
Control Measures ◽  
External Quality Control ◽  
External Quality ◽  
Iso 15189 ◽  
Proficiency Testing Scheme ◽  
Testing Scheme ◽  
Quality Control Tool

The aim of this study was to analyze in details the implementation of an accredited proficiency testing scheme by cytopathology labs wishing to establish external quality control measures according to ISO 15189:2012. The proficiency testing scheme was based on simple Cloud-based telemedical applications and was enthusiastically accepted by all colleagues due to its simplicity and its low cost. Six major cytopathology laboratories contributed fifty conventional pap smears with histological confirmation from their registries voluntarily. Twenty board-certified cytopathologists reviewed the smears voluntarily and recorded their diagnoses. Four major diagnostic categories of cytological reports were used for statistical purposes. In addition to diagnosis, reviewers also commented on overall smears quality. Ten smears in which diagnostic interobserver accordance was almost perfect were selected for further study. A characteristic video from each one of the 10 selected smears was transferred via a simple cloud application to password-protected accounts for remote review by independent cytopathologists. Contributor's and reviewer's diagnoses were collected, recorded and statistically evaluated. The statistical evaluation of each participation' s results were a valuable external quality control tool for each participating laboratory and its members.

External Quality Assessment in the Examination of Blood Films for Malarial Parasites Within Ontario, Canada

2000 ◽  
Vol 124 (1) ◽  
pp. 57-60 ◽  
Author(s):  
Sam Thomson ◽  
Reinhard C. Lohmann ◽  
Linda Crawford ◽  
Ruby Dubash ◽  
Harold Richardson
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Good Practice ◽  
Further Education ◽  
Educational Strategies ◽  
External Quality ◽  
Medical Laboratories ◽  
Detection And Identification ◽  
Total Testing Process

Abstract Objective.—To assess laboratory practice in the examination of blood films for malarial parasites. Method.—Ontario medical laboratories, licensed by the Ministry of Health, are required to participate in external quality assessment by the Laboratory Proficiency Testing Program, which assesses performance of laboratory assays and also examines the total testing process. Educational strategies are used to improve performance. Results.—A 1995 survey indicated shortcomings in detection and identification of malarial parasites in blood films. Consequently, recommendations for the investigation of malarial parasites in blood were issued. In 1996 and 1997, 16 workshops were conducted. A 1997 follow-up external quality assessment survey indicated that problems persist as 27% of laboratories failed to correctly speciate Plasmodium falciparum. Good Practice Guidelines were issued in 1998. Conclusion.—Further education and assessment are required. Laboratories lacking expertise must establish referral arrangements with more proficient laboratories.

scholarly journals Aspergillus Polymerase Chain Reaction—An Update on Technical Recommendations, Clinical Applications, and Justification for Inclusion in the Second Revision of the EORTC/MSGERC Definitions of Invasive Fungal Disease

2021 ◽  
Vol 72 (Supplement_2) ◽  
pp. S95-S101
Author(s):  
P Lewis White ◽  
Stephane Bretagne ◽  
Angela M Caliendo ◽  
Juergen Loeffler ◽  
Thomas F Patterson ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Invasive Fungal Disease ◽  
Fungal Disease ◽  
External Quality Control ◽  
Chain Reaction ◽  
External Quality ◽  
Control Programs ◽  
Polymerase Chain Reaction Testing ◽  
Polymerase Chain ◽  
Technical Recommendations

Abstract Aspergillus polymerase chain reaction testing of blood and respiratory samples has recently been included in the second revision of the EORTC/MSGERC definitions for classifying invasive fungal disease. This is a result of considerable efforts to standardize methodology, the availability of commercial assays and external quality control programs, and additional clinical validation. This supporting article provides both clinical and technical justifications for its inclusion while also summarizing recent advances and likely future developments in the molecular diagnosis of invasive aspergillosis.

An Italian program of external quality control for quantitative assays based on real-time PCR with Taq-Man™ probes

2005 ◽  
Vol 43 (5) ◽  
Author(s):  
Claudia Casini Raggi ◽  
Paolo Verderio ◽  
Mario Pazzagli ◽  
Ettore Marubini ◽  
Lisa Simi ◽  
...  
Keyword(s):  
Quality Control ◽  
Nucleic Acids ◽  
Real Time ◽  
Real Time Pcr ◽  
Clinical Laboratory ◽  
Reference Curve ◽  
External Quality Control ◽  
External Quality ◽  
Control Programs ◽  
Molecular Tests

AbstractQuantitative real-time PCR techniques are increasingly being used for the measurement of nucleic acids in research applications as well as in the clinical laboratory. It is therefore important that external quality control programs (EQA) are implemented for the evaluation of the analytical aspects common to molecular tests based on quantitative PCR. The aim of this study was the development of an Italian program of external quality control for quantitative assays based on real-time PCR with Taq-Man™ probes to compare the analytical performance of 42 laboratories. Participants were provided with a set of reagents (cDNA for reference curve preparation, primers-probe mix and three unknown samples) and requested to perform a conventional assay using the master mix employed in their laboratories. The quantitative results in unknown samples were analyzed. The results of our study showed clear heterogeneity in performance. Two of the 42 laboratories provided results indicating contamination during the experiment, whereas six did not provide values for at least one of the six standard points. Only 12 laboratories gave results that were both precise and accurate for all the samples tested. Regarding imprecision, 17 laboratories appeared to deviate in at least one result, whereas inaccuracy showed an inverse dose-dependent trend. Finally, 12 laboratories were not able to measure the sample with the lowest concentration. Ten of these laboratories were equipped with the same instruments. The results of this first round of analytical EQA of real-time PCR-based methods seem to indicate high variability among laboratories carrying out the same experimental protocol. These findings could have implications for any assay based on this type of technique. This survey demonstrates the importance of experimental EQAs of methodological proficiency testing. Our approach has proved useful for comparing the analytical aspects shared by all diagnostic laboratories applying quantitative assays for the measurement of nucleic acids based on the use of Taq-Man™ probes and real-time platforms.

scholarly journals An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes

2017 ◽  
Vol 55 (11) ◽  
Author(s):  
Andrea Padoan ◽  
Giorgia Antonelli ◽  
Ada Aita ◽  
Laura Sciacovelli ◽  
Mario Plebani
Keyword(s):  
Quality Control ◽  
Measurement Uncertainty ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Internal Quality ◽  
Test Results ◽  
External Quality ◽  
Iso 15189 ◽  
Medical Laboratories

AbstractBackground:The present study was prompted by the ISO 15189 requirements that medical laboratories should estimate measurement uncertainty (MU).Methods:The method used to estimate MU included the: a) identification of quantitative tests, b) classification of tests in relation to their clinical purpose, and c) identification of criteria to estimate the different MU components. Imprecision was estimated using long-term internal quality control (IQC) results of the year 2016, while external quality assessment schemes (EQAs) results obtained in the period 2015–2016 were used to estimate bias and bias uncertainty.Results:A total of 263 measurement procedures (MPs) were analyzed. On the basis of test purpose, in 51 MPs imprecision only was used to estimate MU; in the remaining MPs, the bias component was not estimable for 22 MPs because EQAs results did not provide reliable statistics. For a total of 28 MPs, two or more MU values were calculated on the basis of analyte concentration levels. Overall, results showed that uncertainty of bias is a minor factor contributing to MU, the bias component being the most relevant contributor to all the studied sample matrices.Conclusions:The model chosen for MU estimation allowed us to derive a standardized approach for bias calculation, with respect to the fitness-for-purpose of test results. Measurement uncertainty estimation could readily be implemented in medical laboratories as a useful tool in monitoring the analytical quality of test results since they are calculated using a combination of both the long-term imprecision IQC results and bias, on the basis of EQAs results.

External quality control programs

1983 ◽  
Vol 4 (4) ◽  
pp. 441-466 ◽  
Author(s):  
Paul L. Canner ◽  
William F. Krol ◽  
Sandra A. Forman
Keyword(s):  
Quality Control ◽  
External Quality Control ◽  
External Quality ◽  
Control Programs

The usefulness of quality indicators of preanalitical phase in medical labs, according to the Quality standards requirements, ISO 15189:2013 and WG-LEPS recommendation, Jan 2017

2019 ◽  
Vol 55 (2) ◽  
pp. 113-120
Author(s):  
Mirosława Pietruczuk ◽  
Łukasz Kraszula ◽  
Anna Jasińska ◽  
Piotr Kuna ◽  
Makandjou-Ola Eusebio
Keyword(s):  
Clinical Information ◽  
Information Management System ◽  
Error Rates ◽  
Iso 15189 ◽  
Laboratory Errors ◽  
Analytical Process ◽  
Laboratory Error ◽  
Medical Diagnostic ◽  
The Mean ◽  
One Year

This paper presents the usefulness of pre-analytical process in medical diagnostic laboratories, recommended by WG-LEPS, according to departmental requirements and ISO 15189, with regard to clinical hospital laboratory. It is known that the pre-analytical process generates over 70% of all laboratory errors. The tested materials are laboratory test referrals data for a period of one year (2017), mainly from the Laboratory Information Management System. The study includes the mean annual pre-laboratory error rates. The results showed low error rates in the areas related to the laboratory testing. The highest error rates were found in the field relevant to clinical information and data that are not related the laboratory processing.

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