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

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.

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ebubekir Bakan ◽  
Fatma Zuhal Umudum

AbstractExtra-analytical automation is of critical importance in patient safety with respect to accurate, fast test result reporting. Through the previous decades, significant improvements in laboratory errors have been achieved by technological facilities, which have become a substantial part of the reduction of preventable diagnostic errors. In clinical laboratory practice, the total testing process (TTP) is under the effect of error sources: preanalytical, analytical, and post-analytical variables. Since many extra-analytical processes within and outside the clinical laboratory may be automated, management of the extra-analytical phase can prevent errors, resulting in the total quality of laboratory diagnostics and customer satisfaction. The automation technologies have added a serious impact on the proficiency of clinical laboratories. To improve standardization, organization, efficiency, and quality of TTP, many manual tasks have now been partially or entirely automated by labor-saving instrumentations. The implementation of extra-analytical automation in the laboratory processes has recently made them standardized and manageable. Depending on the workload and workflow of the clinical laboratory, it is of critical importance to implement adequate systems, providing standardization of the TTP and resulting in high-quality test results.


2010 ◽  
Vol 29 (4) ◽  
pp. 315-324 ◽  
Author(s):  
Giorgio Rin

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.


Author(s):  
Mario Plebani

AbstractA body of evidence collected in the last few decades demonstrates that the pre- and post-analytical phases of the testing cycle are more error-prone than the analytical phase. However, the paradigm of errors and quality in laboratory medicine has been questioned, analytical mistakes continuing to be a major cause of adverse clinical outcomes and patient harm. Although the brain-to-brain concept is widely recognized in the community of laboratory professionals, there is lack of clarity concerning the inter-relationship between the different phases of the cycle, interdependence between the pre-analytical phase and analytical quality, and the effect of the post-analytical steps on the quality of ultimate laboratory information. Analytical quality remains the “core business” of clinical laboratories, but laboratory professionals and clinicians alike should never lose sight of the fact that pre-analytical variables are often responsible for erroneous test results and that quality biospecimens are pre-requisites for a reliable analytical phase. In addition, the pressure for expert advice on test selection and interpretation of results has increased hand in hand with the ever-increasing complexity of tests and diagnostic fields. Finally, the data on diagnostic errors and inappropriate clinical decisions made due to delay or misinterpretation of laboratory data underscore the current need for greater collaboration at the clinical-laboratory interface.


Author(s):  
Kavitha Manoharan ◽  
Hemavathi Manoharan ◽  
Chetna Sharma

Background: Laboratory diagnostics is the fast-growing field which contributes 70% of clinical diagnosis. Laboratory information has a profound impact on patient diagnosis. Research has demonstrated most of the laboratory errors occur in the pre-analytical phase. Incorrect and incomplete filling of information on the laboratory request forms can significantly impact the quality of laboratory results, and it affects patient outcome and resources. We, therefore, evaluated the extent of incomplete laboratory forms in our center.Methods: The study was a retrospective study conducted on all request forms received over 1 month from June 15, 2018, to July 15, 2018, in the Clinical Pathology Department of ESI hospital, Coimbatore, during working hours were analyzed for the frequency of incomplete data.Results: Only the patient’s name appeared in all the forms. Consultant in charge of requesting laboratory tests (99%) was the most omitted parameter. No clinical details or location/ward details of the patient was provided in 90.7% and 7% of the cases. Age and gender did not appear in 21.9% and 22%, respectively. Date of request, doctor’s signature, and hospital number were missing on 8.4%, 27.6%, and 4.4%, respectively.Conclusions: The study has demonstrated the level completion of laboratory request forms was suboptimal. This may be responsible for many pre-analytical errors. There should be closer interaction between clinicians and laboratory physician to improve the quality of laboratory services and resource management.


2020 ◽  
Vol 58 (3) ◽  
pp. 350-356 ◽  
Author(s):  
Martina Zaninotto ◽  
Mario Plebani

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.


2012 ◽  
Vol 31 (4) ◽  
pp. 265-270 ◽  
Author(s):  
Mario Plebani

Summary Laboratory medicine, as a specialty that had prioritised quality control, has always been at the forefront of error reduction. In the last decades, a dramatic decrease of analytical errors has been experienced, while a relatively high frequency of errors has been documented in the pre-analytical phase. Most pre-analytical errors, which account for up to 70% of all mistakes made in laboratory diagnostics, arise during patient preparation, and sample collection, transportation, preparation for analysis and storage. However, while it has been reported that the pre-analytical phase is error-prone, only recently has it been demonstrated that most of these errors occur in the »pre-pre-analytical phase«, which comprises the initial procedures of the testing process performed outside the laboratory walls by healthcare personnel outside the direct control of the clinical laboratory. Developments in automation and information technologies have played a major role in decreasing some pre-analytical errors and, in particular, the automation of repetitive, errorprone and bio-hazardous pre-analytical processes performed within the laboratory walls has effectively decreased errors in specimen preparation, centrifugation, aliquot preparation, pipetting and sorting. However, more efforts should be made to improve the appropriateness of test request, patient and sample identification procedures and other pre-analytical steps performed outside the laboratory walls.


2017 ◽  
Vol 8 (1) ◽  
pp. 64-70
Author(s):  
Kenneth Kipruto Kimengech ◽  
Stanley Kinge Waithaka ◽  
Jackson Onyuka ◽  
Christine Sekadde Kigondu

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


2016 ◽  
Vol 43 (1) ◽  
pp. 1-8
Author(s):  
Özlem Gülbahar ◽  
Murat Kocabıyık ◽  
Mehmed Zahid Çıracı ◽  
Canan Demirtaş ◽  
Fatma Uçar ◽  
...  

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.


Author(s):  
Osman Sianipar

In a clinical laboratory services pre-analytical phase has plays an important role in term of quality and patient safety. Pre-analytical phase is a phase before analyzing sample in laboratory which  includes  patient preparation, sampling, labeling, sample transportation, sample storage,  and preservation of samples that might influence the laboratory results. In this phase it involves interaction between patient, doctor, laboratory personels, and other staff outside the laboratory. Therefore, it could be assumed that in this phase many sample are collected, many laboratory tests are requested, many individuals are involved and therefore laboratory errors might be occured. Laboratory errors can occur either in pre-analytical, analytical, or post analytical phases but the most frequently errors occur in pre-analytical phase. In this article, quality improvement efforts in pre-analytical phase will be discussed in order to minimize pre-analytical error. 


2022 ◽  
pp. 215-229
Author(s):  
Antonia Mourtzikou ◽  
Marilena Stamouli ◽  
Georgia Kalliora ◽  
Ioanna Petraki ◽  
Christina Seitopoulou ◽  
...  

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.


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