The Implementation of Clinical Laboratory Quality Indicators in the Era of the COVID-19 Pandemic

2022 ◽  
pp. 215-229
Author(s):  
Antonia Mourtzikou ◽  
Marilena Stamouli ◽  
Georgia Kalliora ◽  
Ioanna Petraki ◽  
Christina Seitopoulou ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Quality Indicators ◽  
Six Sigma ◽  
Laboratory Testing ◽  
Laboratory Tests ◽  
Clinical Laboratory ◽  
Iso 15189 ◽  
Pareto Method ◽  
Analytical Phase

The use of quality indicators (QIs) and risk assessment are valuable tools for maintaining the quality of laboratory tests. Both are requirements of ISO 15189: 2012 and are usually based on standard statistical and empirical data. In this chapter, the authors focus on evaluating clinical laboratory quality indicators in the era of the COVID-19 pandemic. The goal is to pose and discuss, based on the authors' experience, the quality evaluation and risk assessment through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. QIs were evaluated using the Six Sigma method. Moreover, FMEA risk analysis was performed, and the degree of risk priority was assessed using the Pareto method. The results show that in the analytical phase, the laboratory's performance is satisfactory, while the pre-and post-analytical phases need further preventive/corrective actions.

Quality Indicators for the Performance Evaluation at a Biochemistry Laboratory

2020 ◽  
Vol 9 (2) ◽  
pp. 18-33
Author(s):  
Zoi S. Athanasiadou ◽  
Antonia Mourtzikou ◽  
Marilena Stamouli ◽  
Petros Karkalousos
Keyword(s):  
Quality Indicators ◽  
Six Sigma ◽  
Risk Evaluation ◽  
Statistical Data ◽  
Statistical Tool ◽  
Iso 15189 ◽  
Biochemical Laboratory ◽  
Pareto Method ◽  
Analytical Phase

The use of quality indicators and risk evaluation are valuable tools for maintaining the quality of laboratory tests. There are both requirements of ISO 15189: 2012 and are usually based on common statistical and empirical data. The purpose of the present study was the quality quantification and risk evaluation through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. Statistical data was collected for the period from 1/12/2017 to 28/2/2018, using the LIS of Biochemical Laboratory. QIs were evaluated using the Six Sigma method and the Pareto statistical tool. FMEA risk analysis was performed, while the degree of risk priority with the Pareto method. The results show that in the analytical phase the QIs give us satisfactory values, while those in the pre- and post- analytical phases need further preventive/corrective actions in order to overcome the problems raised by the QIs. Thus, the fully automatization and computerization of the laboratory is needed.

Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals

2020 ◽  
Vol 58 (3) ◽  
pp. 350-356 ◽  
Author(s):  
Martina Zaninotto ◽  
Mario Plebani
Keyword(s):  
Patient Safety ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Careful Evaluation ◽  
The Matrix ◽  
Analytical Phase

AbstractThe recently raised concerns regarding biotin interference in immunoassays have increased the awareness of laboratory professionals and clinicians of the evidence that the analytical phase is still vulnerable to errors, particularly as analytical interferences may lead to erroneous results and risks for patient safety. The issue of interference in laboratory testing, which is not new, continues to be a challenge deserving the concern and interest of laboratory professionals and clinicians. Analytical interferences should be subdivided into two types on the basis of the possibility of their detection before the analytical process. The first (type 1) is represented by lipemia, hemolysis and icterus, and the second (type 2), by unusual constituents that are not undetectable before analysis, and may affect the matrix of serum/plasma of individual subjects. Type 2 cannot be identified with current techniques when performing the pre-analytical phase. Therefore, in addition to a more careful evaluation and validation of the method to be used in clinical practice, the awareness of laboratory professionals should be raised as to the importance of evaluating the quality of biological samples before analysis and to adopt algorithms and approaches in the attempt to reduce problems related to erroneous results due to specific or non-specific interferences.

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.

scholarly journals Pre-Analytical Workstations as a Tool for Reducing Laboratory Errors

2010 ◽  
Vol 29 (4) ◽  
pp. 315-324 ◽  
Author(s):  
Giorgio Rin
Keyword(s):  
Quality Improvement ◽  
Clinical Laboratory ◽  
Error Reduction ◽  
Laboratory Errors ◽  
Continuous Quality ◽  
Complex Process ◽  
Preanalytical Phase ◽  
Analytical Phase ◽  
Total Testing Process

Pre-Analytical Workstations as a Tool for Reducing Laboratory ErrorsReducing errors and improving quality are an integral part of Laboratory Medicine. Laboratory testing, a highly complex process commonly called the total testing process (TTP), is usually subdivided into three traditional (pre-, intra-, and post-) analytical phases. A series of papers published from 1989 drew the attention of laboratory professionals to the pre-analytical phase, which currently appears to be more vulnerable to errors than the other phases. Consequently, the preanalytical phase should be the main target for further quality improvement. Therefore, identifying the critical steps in the pre-analytical phase is a prerequisite for continuous quality improvement, further error reduction and thus for improving patient safety. Use of automated systems where feasible, and use of error reduction/improved quality as a factor when selecting instrumentation are the main tools we have to insure high quality and minimize errors in the pre-analytical phase. The reasons for automation of the pre-analytical phase have become so compelling that it is no longer simply a competitive advantage for laboratories, but rather a competitive necessity. These systems can impact on the clinical/laboratory interface and affect the efficiency, effectiveness and quality of care.

scholarly journals QUALIMETRIC METHOD OF ASSESSING RISKS OF LOW QUALITY PRODUCTS

2021 ◽  
Vol 2021 (4) ◽  
pp. 4769-4774
Author(s):  
ROMAN TRISHCH ◽  
◽  
OLESIA NECHUIVITER ◽  
KOSTIANTYN DYADYURA ◽  
OLEKSANDR VASILEVSKYI ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Quality Management ◽  
Product Quality ◽  
Density Function ◽  
Quality Indicators ◽  
Quality Management System ◽  
Significant Risk ◽  
Scientific Papers ◽  
Quality Of Products

Risk assessment is an integral part of an enterprise's quality management system. The risk of low quality products is the most significant risk, as it is directly related to the concept of enterprise competitiveness. The paper analyzes the scientific papers related to the assessment of the quality of products, processes and services, their disadvantages, possible limits of application. It is proposed to use mathematical dependences to obtain estimates of product quality indicators on a dimensionless scale. Knowing the density function of random variables of product quality indicators and knowing the mathematical dependence of their estimates on a dimensionless scale, it is proposed to obtain the density function of estimates. Knowing the function of the density of estimates of quality indicators, it is proposed to find the probabilities of risks of the assessment of quality indicators in any given interval on a dimensionless scale. A method for assessing the risks of low quality products has been developed

scholarly journals Determination of errors that compromise the quality of laboratory service in a tertiary hospital

2017 ◽  
Vol 8 (1) ◽  
pp. 64-70
Author(s):  
Kenneth Kipruto Kimengech ◽  
Stanley Kinge Waithaka ◽  
Jackson Onyuka ◽  
Christine Sekadde Kigondu
Keyword(s):  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Common Knowledge ◽  
Tertiary Hospital ◽  
Chemistry Laboratory ◽  
Laboratory Service ◽  
Laboratory Errors ◽  
Analytical Errors

Background: Clinical Laboratory testing is a highly complex process that entails numerous procedures. Although it has been known that laboratory testing services are safe, it is increasingly becoming a common knowledge that they are not that safe. Studies have indicated that there are a number of errors that occur due to laboratory testing processes. These errors may not be realized easily during the testing process, but they make significant impact on the results given.Aims and Objective: To determine the levels of pre-analytical, analytical, and post analytical errors found in the analysis of Clinical Laboratory specimen at Kenyatta National Hospital.Materials and Methods: A prospective and descriptive study was carried out at Clinical Chemistry Laboratory, Department of Laboratory Medicine, Kenyatta National Hospital. A total of 346 request forms, specimens/samples and dispatched results were scrutinized and errors documented as per the different variables in the different phases, over a period of three months and the findings were analyzed.Results: Results of the study showed that Preanalytical errors were most common with a frequency of 148(42.8%), followed by analytical errors 114 (32.9%) and post analytical errors 84 (24.3%), respectively.Conclusions: The study concludes that pre-analytical, analytical, and post analytical errors are errors that compromise the quality of laboratory service delivery, which impacts on the patient management and diagnosis. Clinical laboratory errors can be minimized if due diligence and professionalism is adhered in the laboratory.Asian Journal of Medical Sciences Vol.8(1) 2017 64-70

NADH Preparations as They Affect Reliability of Serum Lactate Dehydrogenase Determinations

1973 ◽  
Vol 19 (11) ◽  
pp. 1255-1258 ◽  
Author(s):  
Arnold J Berry ◽  
John A Lott ◽  
George F Grannis
Keyword(s):  
Lactate Dehydrogenase ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Extended Period ◽  
Serum Lactate ◽  
Serum Lactate Dehydrogenase ◽  
Governmental Regulation ◽  
Commercial Kits ◽  
Clinical Laboratory Testing

Abstract We observed large variations in the activity of lactate dehydrogenase (EC 1.1.1.27) in serum when random lots of NADH were used in its determination. The imprecision, caused by variable amounts of lactate dehydrogenase inhibitor in the NADH preparations, was greatly lessened by using only a single lot of NADH; reliability was improved further by selecting an NADH preparation having a negligible amount of inhibitor. A method is described for assessing the quality of commercial NADH preparations, so as to have a satisfactory reagent and to maintain continuously comparable results over an extended period of time. The results have possible relevance for proposed governmental regulation of commercial kits and reagents used for clinical laboratory testing, and for improved intraand inter-laboratory comparability of lactate dehydrogenase determinations.

The use of six sigma methodology to evaluate the analytical performances of clinical chemistry analyzers

2016 ◽  
Vol 43 (1) ◽  
pp. 1-8
Author(s):  
Özlem Gülbahar ◽  
Murat Kocabıyık ◽  
Mehmed Zahid Çıracı ◽  
Canan Demirtaş ◽  
Fatma Uçar ◽  
...  
Keyword(s):  
Six Sigma ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Total Quality ◽  
Biochemical Tests ◽  
Analytical Process ◽  
World Class ◽  
Six Sigma Methodology ◽  
Analytical Platforms

AbstractIntroduction:In our study, we aimed to evaluate the analytical process performances of the biochemistry tests in the analysis systems that were widely used in the clinical laboratories by using the six-sigma methodology.Methods:The analytical performances of four different analytical platforms (Beckman Coulter-Olympus AU2700, Abbott-Architect C8000, Roche-Cobas 8000, and Siemens-ADVIA 2400) running 18 biochemical tests (urea, creatinine, uric acid, total bilirubin, AST, ALT, ALP, LDH, HDL-C, CaResults:The parameters that have σ≥6 which means in world class are HDL-C and ALP in all four systems, while only NaDiscussion and conclusion:To improvement and monitoring of the analytical process performance as a part of total quality of a clinical laboratory to provide continuous improving, sigma levels can be used as it is a reliable method.

scholarly journals Prevention of extra-analytical phase errors by non-analytical automation in clinical laboratory

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ebubekir Bakan ◽  
Nuri Bakan
Keyword(s):  
Clinical Laboratory ◽  
Phase Error ◽  
Diagnostic Errors ◽  
Substantial Part ◽  
Laboratory Diagnostics ◽  
Total Quality ◽  
Error Sources ◽  
Laboratory Errors ◽  
Analytical Phase

Abstract During previous decades, significant improvements in laboratory errors have become a substantial part of reducing preventable diagnostic errors. In clinical laboratory practice, the errors in the testing process are primarily associated with extra-analytical phase error sources, influencing the test result quality profoundly. Thus, the management of these critical error sources makes their effects preventable thanks to automation and computer sciences. The implementation of non-analytical automated systems requires a risk management strategy based on laboratory’s workflow and bottlenecks. Then, the improvements can be measured and evaluated by the usage of quality indicators (QI). Consequently, the total quality of laboratory diagnostics and higher patient safety is closely dependent on this type of automation. This review will help laboratory professionals, managers, and directors improve the total testing processes (TTP). The automation technologies have added a serious impact on the proficiency of laboratory medicine. Several instrumentations have now partially or entirely automated many manual tasks to improve standardization, organization, efficiency, and TTP quality. The implementation of non-analytical automation has made them manageable. As a result, non-analytical automation within and outside the clinical laboratory will necessarily lessen the error sources’ effect on the total test process, enhancing the quality of the test results.

scholarly journals THE CLINICAL AND LABORATORY TESTS OF THE EFFECTIVENESS OF KRIOCYSTEKTOMY OF ODONTOGENOUS CYSTS, OVERGROWN THE BOTTOM OF THE MAXILLARY SINUS

2017 ◽  
Vol 21 (3) ◽  
pp. 144-147
Author(s):  
N. V Semennikova ◽  
E. S Tukenov ◽  
A. S Kovalenko ◽  
Vladimir Ivanovich Semennikov
Keyword(s):  
Nasal Cavity ◽  
Maxillary Sinus ◽  
Preventive Maintenance ◽  
Laboratory Testing ◽  
Laboratory Tests ◽  
Clinical Laboratory ◽  
Reactive Protein ◽  
Upper Jaw ◽  
Clinical Laboratory Testing

For the purpose of an increase in the effectiveness in the treatment of odontogenous cysts in the region of upper jaw and preventive maintenance of different complications we have proposed the procedure of kriocystektomy. The clinical laboratory testing of the effectiveness of its use with the application of roentgenography, densitometry, laser thermometry of gum into the region of the arrangement of cysts, the results of investigating of S-reactive protein (mg/ml), factor of the necrosis of tumor (FNO-α, pg/ml), it is lactoferrini, a quantity of factor of an increase in the fibroblasts -β - of oFRF-β (ng/ml) they showed the normalization of all indices on 30 day after operation in all 33 inspected patients with the odontogenous cysts, which germinate the bottom of the upper maxillary cavity and nasal cavity. Obtained data are the highly informative proof of simplicity, rationality and safety of the developed regime of kriocystektomy during the reatment of odontogenous cysts.

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