Application of Failure Modes and Effects Analysis (FMEA) During the Pre-analytical Phase in a Greek Biochemistry Laboratory

2019 ◽  
Vol 8 (3) ◽  
pp. 22-35 ◽  
Author(s):  
Marilena Stamouli ◽  
Antonia Mourtzikou ◽  
Petros L Karkalousos ◽  
Zoe Athanasiadou ◽  
Evaggelia Marasidi ◽  
...  
Keyword(s):  
Failure Modes ◽  
Patient Treatment ◽  
Test Results ◽  
Clinical Laboratories ◽  
Bibliographic Data ◽  
Potential Failure ◽  
Analytical Phase ◽  
Fmea Analysis ◽  
Analytical Errors ◽  
Made In

It is well known that the results from clinical laboratories support diagnosis, prognosis and patient treatment. Thus, test results must be relevant, accurate and reliable for patient care. Despite all the automation, errors that are classified as pre-analytical, analytical and post-analytical, are still present. International bibliographic data estimates that approximately 62.0% of the errors made in clinical laboratories are due to errors during the pre-analytical stage. The effect of the pre-analytical errors on the laboratory results has consequences that in many cases can lead to reduction of laboratory quality. In this study, the authors run a failure modes and effects analysis (FMEA) to analyze potential failure risks within the pre-analytical phase, in order to classify them according to severity and likelihood, based on the experience. In the present article, the authors performed an FMEA analysis of the pre-analytical phase of the testing process of a biochemistry laboratory.

Assessment of Failure Risks in Laboratories During the Pandemic

2022 ◽  
pp. 230-243
Author(s):  
Antonia Mourtzikou ◽  
Marilena Stamouli ◽  
Georgia Kalliora ◽  
Panagiotis Koumpouros ◽  
Ioanna Petraki ◽  
...  
Keyword(s):  
Failure Modes ◽  
False Negative ◽  
Patient Treatment ◽  
Acid Extraction ◽  
Test Results ◽  
Negative Results ◽  
Clinical Laboratories ◽  
False Negative Results ◽  
Pcr Technology ◽  
Analytical Phase

Clinical laboratories produce test results that support the diagnosis, prognosis, and patient treatment. Test results must be relevant, accurate, and reliable for patient care. International bibliographic data estimate that approximately 62.0% of the errors made in clinical laboratories are due to errors during the pre-analytical stage. This chapter presents a failure modes and effects analysis (FMEA) to analyze potential failure risks within the pre-analytical phase and classify them according to severity and likelihood. FMEA allows molecular laboratories to lower costs and drive better outcomes through high-quality nucleic acid extraction, sensitive detection, and accurate quantification. RT-PCR technology continues to be the gold standard for the clinical detection of SARS-CoV-2 RNA in individuals suspected of COVID-19. It is essential to use highly sensitive assays to detect active infections and reduce the likelihood of false-negative results.

Performance evaluation of a coagulation laboratory using Sigma metrics

2018 ◽  
Vol 31 (6) ◽  
pp. 600-608
Author(s):  
Muhammad Shariq Shaikh ◽  
Sidra Asad Ali ◽  
Anila Rashid ◽  
Farheen Karim ◽  
Bushra Moiz
Keyword(s):  
Test Results ◽  
Statistical Tool ◽  
Content Type ◽  
Sigma Level ◽  
Clinical Laboratories ◽  
Laboratory Test Results ◽  
World Class ◽  
Low Performance ◽  
Monitoring Performance ◽  
Analytical Errors

Purpose Two-thirds of medical decisions are based on laboratory test results. Therefore, laboratories should practice strict quality control (QC) measures. Traditional QC processes may not accurately reflect the magnitude of errors in clinical laboratories. Six Sigma is a statistical tool which provides opportunity to assess performance at the highest level of excellence. The purpose of this paper is to evaluate performance of the coagulation laboratory utilizing Sigma metrics as the highest level of quality. Design/methodology/approach Quality indicators of the coagulation laboratory from January 1, 2009, to December 31, 2015, were evaluated. These QIs were categorized into pre-analytical, analytical and post-analytical. Relative frequencies of errors were calculated and converted to Sigma scale to determine the extent of control over each process. The Sigma level of 4 was considered optimal performance. Findings During the study period, a total of 474,655 specimens were received and 890,535 analyses were performed. These include 831,760 (93.4 percent) routine and 58,775 (6.6 percent) special tests. Stat reporting was requested for 166,921 (18.7 percent). Of 7,535,146 total opportunities (sum of the total opportunities for all indicators), a total of 4,005 errors were detected. There were 2,350 (58.7 percent) pre-analytical, 11 (0.3 percent) analytical and 1,644 (41 percent) post-analytical errors. Average Sigma value obtained was 4.8 with 12 (80 percent) indicators achieving a Sigma value of 4. Three (20 percent) low-performance indicators were: unacceptable proficiency testing (3.8), failure to inform critical results (3.6) and delays in stat reporting (3.9). Practical implications This study shows that a small number of errors can decrease Sigma value to below acceptability limits. If clinical laboratories start using Sigma metrics for monitoring their performance, they can identify gaps in their performance more readily and hence can improve their performance and patient safety. Social implications This study provides an opportunity for the laboratorians to choose and set world-class goals while assessing their performance. Originality/value To the best of the authors’ knowledge and belief, this study is the first of its kind that has utilized Sigma metrics as a QC tool for monitoring performance of a coagulation laboratory.

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.

Imprecision of Laboratory Determinations and Diagnostic Accuracy: Theoretical Considerations

1974 ◽  
Vol 13 (03) ◽  
pp. 151-158 ◽  
Author(s):  
D. A. B. Lindbebo ◽  
Fr. R. Watson
Keyword(s):  
Mathematical Model ◽  
Diagnostic Accuracy ◽  
Diagnostic Process ◽  
Clinical Laboratories ◽  
Non Linear ◽  
Theoretical Considerations ◽  
Made In

Recent studies suggest the determinations of clinical laboratories must be made more precise than at present. This paper presents a means of examining benefits of improvement in precision. To do this we use a mathematical model of the effect upon the diagnostic process of imprecision in measurements and the influence upon these two of Importance of Diagnosis and Prevalence of Disease. The interaction of these effects is grossly non-linear. There is therefore no proper intuitive answer to questions involving these matters. The effects can always, however, be calculated.Including a great many assumptions the modeling suggests that improvements in precision of any determination ought probably to be made in hospital rather than screening laboratories, unless Importance of Diagnosis is extremely high.

ЦИФРОВОЙ ИЗОЛЯТОР В СПЕЦИАЛИЗИРОВАННОМ КОРПУСЕ, ВЫПОЛНЕННОМ ПО ТЕХНОЛОГИИ LTCC

2020 ◽  
Vol 96 (3s) ◽  
pp. 392-395
Author(s):  
В.А. Бутузов ◽  
А.Е. Назаренко ◽  
Н.Ю. Дмитриев ◽  
В.А. Трофимов ◽  
В.А. Косевский ◽  
...  
Keyword(s):  
Low Temperature ◽  
Data Rate ◽  
Test Results ◽  
Made In

Представлены результаты разработки цифрового изолятора на основе интегрального микротрансформатора в специализированном корпусе, выполненном по технологии низкотемпературной совместно обжигаемой керамики (LTCC). Согласно результатам измерений тестовых образцов максимальная скорость передачи данных разработанного цифрового изолятора - не менее 30 Мбит/с. The paper presents the results of the development of a digital insulator based on an integral microtransformer in a specialized package made in technology of low-temperature co-fired ceramics. The isolator is a microassembly consisting of a transceiver chip and an integrated transformer. According to the test results, the maximum data rate speed of the developed digital insulator is not less than 30 Mbit/s.

Study on shear performance of the connection with external stiffening ring between square steel tubular column and unequal-depth steel beams

2020 ◽  
pp. 136943322098166
Author(s):  
Shuhao Yin ◽  
Bin Rong ◽  
Lei Wang ◽  
Yiliang Sun ◽  
Wuchen Zhang ◽  
...  
Keyword(s):  
Failure Modes ◽  
Plastic Hinge ◽  
Steel Tube ◽  
Nonlinear Finite Element ◽  
Steel Beams ◽  
Finite Element Models ◽  
Test Results ◽  
Panel Zone ◽  
Load Paths ◽  
Shear Performance

This paper studies the shear performance of the connection with the external stiffening ring between the square steel tubular column and unequal-depth steel beams. Two specimens of interior column connections were tested under low cyclic loading. The deformation characteristics and failure modes exhibited by the test phenomena can be summarized as: (1) two specimens all exhibited shear deformation in steel tube web of the panel zone and (2) weld fracture in the panel zone and plastic hinge failure at beam end were observed. Besides, load-displacement behaviors and strain distributions have been also discussed. The nonlinear finite element models were developed to verify the test results. Comparative analyses of the bearing capacity, failure mode, and load-paths between the equal-depth and unequal-depth beam models have been carried out.

scholarly journals A Matrix FMEA Analysis of Variable Delivery Vane Pumps

Energies ◽  
2021 ◽  
Vol 14 (6) ◽  
pp. 1741
Author(s):  
Joanna Fabis-Domagala ◽  
Mariusz Domagala ◽  
Hassan Momeni
Keyword(s):  
Risk Analysis ◽  
Failure Modes ◽  
High Reliability ◽  
Matrix Analysis ◽  
Hydraulic Systems ◽  
Vane Pump ◽  
End Effects ◽  
Root Cause ◽  
Preventative Measures ◽  
Fmea Analysis

Hydraulic systems are widely used in the aeronautic, machinery, and energy industries. The functions that these systems perform require high reliability, which can be achieved by examining the causes of possible defects and failures and by taking appropriate preventative measures. One of the most popular methods used to achieve this goal is FMEA (Failure Modes and Effects Analysis), the foundations of which were developed and implemented in the early 1950s. It was systematized in the following years and practically implemented. It has also been standardized and implemented as one of the methods of the International Organization for Standardization (ISO) 9000 series standards on quality assurance and management. Apart from wide application, FMEA has a number of weaknesses, which undoubtedly include risk analysis based on the RPN (Risk Priority Number), which is evaluated as a product of severity, occurrence, and detection. In recent years, the risk analysis has been very often replaced by fuzzy logic. This study proposes the use of matrix analysis and statistical methods for performing simplified RCA (Root Cause Analysis) and for classification potential failures for a variable delivery vane pump. The presented methodology is an extension of matrix FMEA and allows for prioritizing potential failures and their causes in relation to functions performed by pump components, the end effects, and the defined symptoms of failure of the vane pump.

scholarly journals Surface Contamination by Antineoplastics in Hospitals: An Observational Study for Mapping of Potential Contamination Associated with Handling Excreta of Babies through Diaper Management

2020 ◽  
Vol 4 (3-4) ◽  
pp. 119-125
Author(s):  
Marie Palamini ◽  
Geneviève Mercier ◽  
Jean-François Bussières
Keyword(s):  
Bone Marrow ◽  
Exploratory Study ◽  
Research Team ◽  
Failure Modes ◽  
Hospital Setting ◽  
Marrow Transplant ◽  
Mother And Child ◽  
Potential Failure ◽  
Key Steps ◽  
Hazardous Drugs

AbstractBackgroundIn the hospital setting, trace contamination with hazardous medications comes primarily from the manipulation of containers used in preparing and administering drugs. However, some traces of medications also come from the excreta of patients.MethodsThis descriptive exploratory study involved direct observation and discussion. The aim was to map potential contamination associated with handling babies’ excreta through diaper management. The study was conducted at CHU Sainte Justine (Montréal, Québec, Canada), a 500-bed mother and child facility with 38 beds for hematology-oncology and bone marrow transplant. A list of key steps related to the management of diapers by a parent or caregiver on a pediatric unit was established by the investigators. A data collection grid was then developed and reviewed by a member of the research team.ResultsA total of six diaper changes, by six distinct individuals, were observed in August and September 2019. Transport of a soiled diaper for weighing outside the baby’s room by an additional caregiver was also observed and recorded. In total, 25 individual steps in diaper management and 28 potential failure modes were identified through mapping.ConclusionsChanging a baby’s diaper involves many individual steps, which are subject to numerous failure modes that can contribute to contamination with traces of hazardous drugs. A good understanding of these process steps and failure modes is desirable to better train caregivers and parents to reduce trace contamination with hazardous drugs.

scholarly journals Experimental and Numerical Investigation on the Steel Reinforced Grout (SRG) Composite-to-Concrete Bond

2020 ◽  
Vol 4 (4) ◽  
pp. 182
Author(s):  
Luciano Ombres ◽  
Salvatore Verre
Keyword(s):  
Bond Length ◽  
Failure Modes ◽  
Peak Load ◽  
Element Model ◽  
Test Results ◽  
Shear Tests ◽  
Bond Slip ◽  
Bond Behavior ◽  
Direct Shear Tests ◽  
Inorganic Matrix

In the paper, the bond between a composite strengthening system consisting of steel textiles embedded into an inorganic matrix (steel reinforced grout, SRG) and the concrete substrate, is investigated. An experimental investigation was carried out on medium density SRG specimens; direct shear tests were conducted on 20 specimens to analyze the effect of the bond length, and the age of the composite strip on the SRG-to-concrete bond behavior. In particular, the tests were conducted considering five bond length (100, 200, 250, 330, and 450 mm), and the composite strip’s age 14th, 21st, and 28th day after the bonding. Test results in the form of peak load, failure modes and, bond-slip diagrams were presented and discussed. A finite element model developed through commercial software to replicate the behavior of SRG strips, is also proposed. The effectiveness of the proposed numerical model was validated by the comparison between its predictions and experimental results.

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