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.

scholarly journals Verification of reference intervals in routine clinical laboratories: practical challenges and recommendations

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Yesim Ozarda ◽  
Victoria Higgins ◽  
Khosrow Adeli
Keyword(s):  
Clinical Laboratory ◽  
Local Population ◽  
Age Groups ◽  
External Source ◽  
Reference Intervals ◽  
Laboratory Method ◽  
Test Results ◽  
Multicenter Studies ◽  
Clinical Laboratories ◽  
Laboratory Test Results

Abstract Reference intervals (RIs) are fundamental tools used by healthcare and laboratory professionals to interpret patient laboratory test results, ideally enabling differentiation of healthy and unhealthy individuals. Under optimal conditions, a laboratory should perform its own RI study to establish RIs specific for its method and local population. However, the process of developing RIs is often beyond the capabilities of an individual laboratory due to the complex, expensive and time-consuming process to develop them. Therefore, a laboratory can alternatively verify RIs established by an external source. Common RIs can be established by large, multicenter studies and can subsequently be received by local laboratories using various verification procedures. The standard approach to verify RIs recommended by the Clinical Laboratory Standards Institute (CLSI) EP28-A3c guideline for routine clinical laboratories is to collect and analyze a minimum of 20 samples from healthy subjects from the local population. Alternatively, “data mining” techniques using large amounts of patient test results can be used to verify RIs, considering both the laboratory method and local population. Although procedures for verifying RIs in the literature and guidelines are clear in theory, gaps remain for the implementation of these procedures in routine clinical laboratories. Pediatric and geriatric age-groups also continue to pose additional challenges in respect of acquiring and verifying RIs. In this article, we review the current guidelines/approaches and challenges to RI verification and provide a practical guide for routine implementation in clinical laboratories.

scholarly journals LabRS: A Rosetta stone for retrospective standardization of clinical laboratory test results

2017 ◽  
Vol 25 (2) ◽  
pp. 121-126 ◽  
Author(s):  
Ronald George Hauser ◽  
Douglas B Quine ◽  
Alex Ryder
Keyword(s):  
Laboratory Tests ◽  
Standardized Test ◽  
Clinical Laboratory ◽  
Secondary Data ◽  
The United States ◽  
Test Results ◽  
Original Result ◽  
Clinical Laboratories ◽  
Laboratory Test Results ◽  
Standardization Process

Abstract Objective Clinical laboratories in the United States do not have an explicit result standard to report the 7 billion laboratory tests results they produce each year. The absence of standardized test results creates inefficiencies and ambiguities for secondary data users. We developed and tested a tool to standardize the results of laboratory tests in a large, multicenter clinical data warehouse. Methods Laboratory records, each of which consisted of a laboratory result and a test identifier, from 27 diverse facilities were captured from 2000 through 2015. Each record underwent a standardization process to convert the original result into a format amenable to secondary data analysis. The standardization process included the correction of typos, normalization of categorical results, separation of inequalities from numbers, and conversion of numbers represented by words (eg, “million”) to numerals. Quality control included expert review. Results We obtained 1.266 × 109 laboratory records and standardized 1.252 × 109 records (98.9%). Of the unique unstandardized records (78.887 × 103), most appeared &lt;5 times (96%, eg, typos), did not have a test identifier (47%), or belonged to an esoteric test with &lt;100 results (2%). Overall, these 3 reasons accounted for nearly all unstandardized results (98%). Conclusion Current results suggest that the tool is both scalable and generalizable among diverse clinical laboratories. Based on observed trends, the tool will require ongoing maintenance to stay current with new tests and result formats. Future work to develop and implement an explicit standard for test results would reduce the need to retrospectively standardize test results.

scholarly journals Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mᵃ Liboria López Yeste ◽  
Silvia Izquierdo Álvarez ◽  
Antonia R. Pons Mas ◽  
Luisa Álvarez Domínguez ◽  
Fernando Marqués García ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Test Results ◽  
Correct Interpretation ◽  
Laboratory Management ◽  
Iso 15189 ◽  
Effective Implementation ◽  
Clinical Laboratories ◽  
Global Trend ◽  
Laboratory Results ◽  
Critical Results

Abstract The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and the personnel involved (laboratory management and staff). We describe the criteria and information required to review and validate analytical results and ensure that clear reports are sent to requesters. These criteria also guarantee that results are transcribed in a reliable way and that all necessary information is provided for the correct interpretation of results. Likewise, the requirements for the correct release of laboratory results are described, with special emphasis on the release of alarming or critical results. In some European countries, clinical laboratories are required to hold partial or full ISO 15189 accreditation, which is a global trend. Therefore, understanding ISO 15189 requirements is imperative for a progressive and more effective implementation of the Standard.

scholarly journals Post-analytical phase: Improvement of the communication of test results by the development of a computer software in biochemistry laboratory at CHU Batna.

2014 ◽  
Vol 1 (2) ◽  
pp. 70-74
Author(s):  
Redouane Amine Cherif ◽  
◽  
Malika Boucetta ◽  
Yasmina Chaouche Khouane ◽  
Rachida Derghal ◽  
...  
Keyword(s):  
Reference Values ◽  
Clinical Laboratory ◽  
Computer Software ◽  
Visual Basic ◽  
Specific Reference ◽  
Test Results ◽  
Electronic File ◽  
Wrong Diagnosis ◽  
Analytical Phase ◽  
Total Testing Process

Background: A quality system in a clinical laboratory involves supervision of all the phases of the total testing process: pre-analytical, analytical, and post-analytical. Misinterpretations during the last phase may cause a wrong diagnosis. Aim: Improvement of the interpretation of test results in the laboratory of biochemistry - CHU Batna, by the introduction of computer software ensuring better delivery and interpretation of results. Method: The updating of the reference values was based on the biochemistry analysis guides and equipment method sheets used in the biochemistry laboratory. The development of the software used two programs, Visual Basic 6 for the interface and Access 2007 for setting up the database. The first version of the software includes only general biochemistry. Results and Discussion: The analysis report obtained by the software developed presents specific reference values to each patient, and allows a record of results as an electronic file that can be archived and/or sent directly to the requesting service in the case of the presence of an intranet. In the future, the development of this first version of the software will focus on the introduction of tumor markers and hormonology with regular reviews of the reference values.

Towards a new paradigm in laboratory medicine: the five rights

2016 ◽  
Vol 54 (12) ◽  
Author(s):  
Mario Plebani
Keyword(s):  
Clinical Laboratory ◽  
Laboratory Data ◽  
Diagnostic Errors ◽  
Laboratory Medicine ◽  
Expert Advice ◽  
Test Results ◽  
Analytical Quality ◽  
New Paradigm ◽  
Analytical Phase

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.

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.

scholarly journals Diagnostic Challenges on the Laboratory Detection of Lupus Anticoagulant

Biomedicines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 844
Author(s):  
Armando Tripodi
Keyword(s):  
Lupus Anticoagulant ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
State Of The Art ◽  
Diagnostic Procedures ◽  
External Quality ◽  
Glycoprotein I ◽  
Current State ◽  
Clinical Laboratories

Lupus anticoagulant (LA) is one of the three laboratory parameters (the others being antibodies to either cardiolipin or β2-glycoprotein I) which defines the rare but potentially devastating condition known as antiphospholipid syndrome (APS). Testing for LA is a challenging task for the clinical laboratory because specific tests for its detection are not available. However, proper LA detection is paramount for patients’ management, as its persistent positivity in the presence of (previous or current) thrombotic events, candidate for long term anticoagulation. Guidelines for LA detection have been established and updated over the last two decades. Implementation of these guidelines across laboratories and participation to external quality assessment schemes are required to help standardize the diagnostic procedures and help clinicians for appropriate management of APS. This article aims to review the current state of the art and the challenges that clinical laboratories incur in the detection of LA.

scholarly journals Assessment of antinuclear antibodies by indirect immunofluorescence assay: report from a survey by the American Association of Medical Laboratory Immunologists

2020 ◽  
Vol 58 (9) ◽  
pp. 1489-1497 ◽  
Author(s):  
Lisa K. Peterson ◽  
Anne E. Tebo ◽  
Mark H. Wener ◽  
Susan S. Copple ◽  
Marvin J. Fritzler
Keyword(s):  
Indirect Immunofluorescence ◽  
Antinuclear Antibodies ◽  
Current Practice ◽  
Clinical Laboratory ◽  
Immunofluorescence Assay ◽  
Indirect Immunofluorescence Assay ◽  
Medical Laboratory ◽  
International Consensus ◽  
Clinical Laboratories ◽  
Reading Interpretation

AbstractBackgroundThe indirect immunofluorescence assay (IFA) using HEp-2 cell substrates is the preferred method by some for detecting antinuclear antibodies (ANA) as it demonstrates a number of characteristic staining patterns that reflect the cellular components bound as well as semi-quantitative results. Lack of harmonized nomenclature for HEp-2 IFA patterns, subjectivity in interpretation and variability in the number of patterns reported by different laboratories pose significant harmonization challenges. The main objectives of this study were to assess current practice in laboratory assessment of HEp-2 IFA, identify gaps and define strategies to improve reading, interpretation and reporting.MethodsWe developed and administered a 24-item survey based on four domains: educational and professional background of participants, current practice of HEp-2 IFA testing and training, gap assessment and the perceived value of International Consensus on Antinuclear Antibody Patterns (ICAP) and other factors in HEp-2 IFA assessment. The Association of Medical Laboratory Immunologists (AMLI) and American Society for Clinical Pathology administered the survey from April 1 to June 30, 2018, to members involved in ANA testing. This report summarizes the survey results and discussion from a dry workshop held during the 2019 AMLI annual meeting.ResultsOne hundred and seventy-nine (n = 179) responses were obtained where a significant number were clinical laboratory scientists (46%), laboratory directors (24%), supervisors (13%) or others (17%). A majority of respondents agreed on the need to standardize nomenclature and reporting of HEp-2 IFA results. About 55% were aware of the ICAP initiative; however, among those aware, a significant majority thought its guidance on HEp-2 IFA nomenclature and reporting is of value to clinical laboratories. To improve ICAP awareness and further enhance HEp-2 IFA assessment, increased collaboration between ICAP and the clinical laboratory community was suggested with emphasis on education and availability of reference materials.ConclusionsBased on these suggestions, future efforts to optimize HEp-2 IFA reading, interpretation and reporting would benefit from more hands-on training of laboratory personnel as well as continuous collaboration between professional organizations, in vitro diagnostic manufacturers and clinical laboratories.

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