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Six sigma for clinical lab

Sweta Kulkarni, R Ramesh, A R Srinivasan, C R Wilma Delphine Silvia
Preanalytical steps are the major sources of error in clinical laboratory. The analytical errors can be corrected by quality control procedures but there is a need for stringent quality checks in preanalytical area as these processes are done outside the laboratory. Sigma value depicts the performance of laboratory and its quality measures. Hence in the present study six sigma and Pareto principle was applied to preanalytical quality indicators to evaluate the clinical biochemistry laboratory performance. This observational study was carried out for a period of 1 year from November 2015-2016...
January 2018: Indian Journal of Clinical Biochemistry: IJCB
Cristiano Ialongo, Sergio Bernardini
BACKGROUND: The International Federation of Clinical Chemistry and Laboratory Medicine has introduced in recent times the turnaround time (TAT) as mandatory quality indicator for the postanalytical phase. Classic TAT indicators, namely, average, median, 90th percentile and proportion of acceptable test (PAT), are in use since almost 40 years and to date represent the mainstay for gauging the laboratory timeliness. In this study, we investigated the performance of the Six Sigma Z-score, which was previously introduced as a device for the quantitative assessment of timeliness...
October 17, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
Sten Westgard, Victoria Petrides, Sharon Schneider, Marvin Berman, Jörg Herzogenrath, Anthony Orzechowski
Assay performance is dependent on the accuracy and precision of a given method. These attributes can be combined into an analytical Sigma-metric, providing a simple value for laboratorians to use in evaluating a test method's capability to meet its analytical quality requirements. Sigma-metrics were determined for 37 clinical chemistry assays, 13 immunoassays, and 3 ICT methods on the Alinity ci system. METHODS: Analytical Performance Specifications were defined for the assays, following a rationale of using CLIA goals first, then Ricos Desirable goals when CLIA did not regulate the method, and then other sources if the Ricos Desirable goal was unrealistic...
December 2017: Clinical Biochemistry
Marko Ris, Sandra Božičević, Vanja Radišić Biljak, Marijana Vučić Lovrenčić
OBJECTIVES: Ion-exchange high-performance liquid chromatography (IE-HPLC) has long been used as a reproducible and versatile analytical tool for HbA1c measurement. In this study, we performed analytical verification and quality assessment of the recently introduced small IE-HPLC Tosoh HLC-723GX HbA1c analyzer, and a comparison of results to immunoassay (IA) and capillary electrophoresis (CE). DESIGN AND METHODS: The total imprecision of Tosoh HLC-723GX was verified according to CLSI EP15-A2 protocol using commercial control materials (C-QC) and pooled human whole blood samples (HWB)...
April 2017: Practical Laboratory Medicine
Hai-Jian Zhao, Tian-Jiao Zhang, Jie Zeng, Cui-Hua Hu, Rong Ma, Chuan-Bao Zhang
BACKGROUND: Hemoglobin A1c (HbA1c) measurement is of great value for the diagnosis and monitoring of diabetes. Many manufacturers have developed various experiments to determine the HbA1c concentration. However, the longitudinal use of these tests requires strict quality management. This study aimed to analyze the quality of HbA1c measurement systems in China using six sigma techniques to help improve their performances. METHODS: A total of 135 laboratories were involved in this investigation in 2015...
May 5, 2017: Chinese Medical Journal
Erna Lenters-Westra, Emma English
BACKGROUND: As a reference laboratory for HbA1c, it is essential to have accurate and precise HbA1c methods covering a range of measurement principles. We report an evaluation of the Abbott Enzymatic (Architect c4000), Roche Gen.3 HbA1c (Cobas c513) and Tosoh G11 using different quality targets. METHODS: The effect of hemoglobin variants, other potential interferences and the performance in comparison to both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the National Glycohemoglobin Standardization Program (NGSP) reference systems was assessed using certified evaluation protocols...
August 28, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
Tamer C Inal, Ozlem Goruroglu Ozturk, Filiz Kibar, Salih Cetiner, Selcuk Matyar, Gulcin Daglioglu, Akgun Yaman
BACKGROUND: Organizing work flow is a major task of laboratory management. Recently, clinical laboratories have started to adopt methodologies such as Lean Six Sigma and some successful implementations have been reported. This study used Lean Six Sigma to simplify the laboratory work process and decrease the turnaround time by eliminating non-value-adding steps. METHODS: The five-stage Six Sigma system known as define, measure, analyze, improve, and control (DMAIC) is used to identify and solve problems...
February 15, 2017: Journal of Clinical Laboratory Analysis
Florian Scherrer, Jean-Pierre Bouilloux, Ors'Anton Calendini, Didier Chamard, François Cornu
The mandatory accreditation of clinical laboratories in France provides an incentive to develop real tools to measure performance management methods and to optimize the management of internal quality controls. Six sigma methodology is an approach commonly applied to software quality management and discussed in numerous publications. This paper discusses the primary factors that influence the sigma index (the choice of the total allowable error, the approach used to address bias) and compares the performance of different analyzers on the basis of the sigma index...
February 1, 2017: Annales de Biologie Clinique
Ronda F Greaves, Lisa Jolly, Michaela F Hartmann, Chung Shun Ho, Richard K T Kam, John Joseph, Conchita Boyder, Stefan A Wudy
BACKGROUND: Serum dihydrotestosterone (DHT) is an important analyte for the clinical assessment of disorders of sex development. It is also reportedly a difficult analyte to measure. Currently, there are significant gaps in the standardisation of this analyte, including no external quality assurance (EQA) program available worldwide to allow for peer review performance of DHT. We therefore proposed to establish a pilot EQA program for serum DHT. METHODS: DHT was assessed in the 2015 Royal College of Pathologists of Australasia Quality Assurance Programs' Endocrine program material...
March 1, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
Remona E David, Minodora Dobreanu
BACKGROUND: Development of quality measurement principles is a strategic point for each clinical laboratory. Preexamination process is the most critical and the most difficult to be managed. The aim of this study is to identify, quantify, and monitor the nonconformities of the pre-analytical process using quality indicators that can affect the patient's health safety in four different locations of a Romanian private clinical laboratory. METHODS: The study group consisted of all the analysis requests received by the departments of biochemistry, hematology, and coagulation from January through March 2015...
2016: Clinical Laboratory
Cristiano Ialongo, Sergio Bernardini
Almost thirty years of systematic analysis have proven the turnaround time to be a fundamental dimension for the clinical laboratory. Several indicators are to date available to assess and report quality with respect to timeliness, but they sometimes lack the communicative immediacy and accuracy. The six sigma is a paradigm developed within the industrial domain for assessing quality and addressing goal and issues. The sigma level computed through the Z-score method is a simple and straightforward tool which delivers quality by a universal dimensionless scale and allows to handle non-normal data...
2016: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
M S Shaikh, B Moiz
INTRODUCTION: Around two-thirds of important clinical decisions about the management of patients are based on laboratory test results. Clinical laboratories are required to adopt quality control (QC) measures to ensure provision of accurate and precise results. Six sigma is a statistical tool, which provides opportunity to assess performance at the highest level of excellence. The purpose of this study was to assess performance of our hematological parameters on sigma scale in order to identify gaps and hence areas of improvement in patient care...
April 2016: International Journal of Laboratory Hematology
Elizabeta Topic, Nora Nikolac, Mauro Panteghini, Elvar Theodorsson, Gian Luca Salvagno, Marijana Miler, Ana-Maria Simundic, Ilenia Infusino, Gunnar Nordin, Sten Westgard
Laboratory medicine is amongst the fastest growing fields in medicine, crucial in diagnosis, support of prevention and in the monitoring of disease for individual patients and for the evaluation of treatment for populations of patients. Therefore, high quality and safety in laboratory testing has a prominent role in high-quality healthcare. Applied knowledge and competencies of professionals in laboratory medicine increases the clinical value of laboratory results by decreasing laboratory errors, increasing appropriate utilization of tests, and increasing cost effectiveness...
October 2015: Clinical Chemistry and Laboratory Medicine: CCLM
Yang Fei, Wei Wang, Falin He, Kun Zhong, Zhiguo Wang
BACKGROUND: The aim of this study was to use Six Sigma(SM) (Motorola Trademark Holdings, Libertyville, IL) techniques to analyze the quality of point-of-care (POC) glucose testing measurements quantitatively and to provide suggestions for improvement. MATERIALS AND METHODS: In total, 151 laboratories in China were included in this investigation in 2014. Bias and coefficient of variation were collected from an external quality assessment and an internal quality control program, respectively, for POC glucose testing organized by the National Center for Clinical Laboratories...
October 2015: Diabetes Technology & Therapeutics
Chuanbao Zhang, Haijian Zhao, Jing Wang, Jie Zeng, Zhiguo Wang
BACKGROUND: Recently, Six Sigma techniques have been adopted by clinical laboratories to evaluate laboratory performance. Measurement procedures in laboratories can be categorized as "excellent", "good", and "improvement needed" based on sigma (σ) metrics of σ ≥ 6, 3 ≤ σ < 6, and σ < 3, respectively. The quality goal index (QGI) was further investigated for measurement procedures with σ ≤ 3. Improvements of the procedures were recommended based on QGI: QGI < 0.8 indicates that the precision of the procedure needs to be improved; QGI > 1...
2015: Clinical Laboratory
Lena Jafri, Aysha Habib Khan, Farooq Ghani, Shahid Shakeel, Ahmed Raheem, Imran Siddiqui
INTRODUCTION: Quality indicators for assessing the performance of a laboratory require a systematic and continuous approach in collecting and analyzing data. The aim of this study was to determine the frequency of errors utilizing the quality indicators in a clinical chemistry laboratory and to convert errors to the Sigma scale. MATERIALS AND METHODS: Five-year quality indicator data of a clinical chemistry laboratory was evaluated to describe the frequency of errors...
July 2015: Scandinavian Journal of Clinical and Laboratory Investigation
James O Westgard, Sten A Westgard
BACKGROUND: There is a need to assess the quality being achieved for laboratory examinations that are being utilized to support evidence-based clinical guidelines. Application of Six Sigma concepts and metrics can provide an objective assessment of the current analytical quality of different examination procedures. METHODS: A "Sigma Proficiency Assessment Chart" can be constructed for data obtained from proficiency testing and external quality assessment surveys to evaluate the observed imprecision and bias of method subgroups and determine quality on the Sigma scale...
September 1, 2015: Clinical Chemistry and Laboratory Medicine: CCLM
Justice Afrifa, Seth A Gyekye, William K B A Owiredu, Richard K D Ephraim, Samuel Essien-Baidoo, Samuel Amoah, David L Simpong, Aaron R Arthur
BACKGROUND: Sigma metrics provide a uniquely defined scale with which we can assess the performance of a laboratory. The objective of this study was to assess the internal quality control (QC) in the clinical chemistry laboratory of the University of Cape Cost Hospital (UCC) using the six sigma metrics application. MATERIALS AND METHODS: We used commercial control serum [normal (L1) and pathological (L2)] for validation of quality control. Metabolites (glucose, urea, and creatinine), lipids [triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C)], enzymes [alkaline phosphatase (ALP), alanine aminotransferase (AST)], electrolytes (sodium, potassium, chloride) and total protein were assessed...
January 2015: Nigerian Medical Journal: Journal of the Nigeria Medical Association
Angeles Giménez-Marín, Francisco Rivas-Ruiz, Maria Del Mar Pérez-Hidalgo, Pedro Molina-Mendoza
INTRODUCTION: This study describes quality indicators for the pre-analytical process, grouping errors according to patient risk as critical or major, and assesses their evaluation over a five-year period. MATERIALS AND METHODS: A descriptive study was made of the temporal evolution of quality indicators, with a study population of 751,441 analytical requests made during the period 2007-2011. The Runs Test for randomness was calculated to assess changes in the trend of the series, and the degree of control over the process was estimated by the Six Sigma scale...
2014: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
Yash Pal Agrawal, Maria Cid, Sten Westgard, Thomas S Parker, Ryan Jaikaran, Daniel M Levine
BACKGROUND: A global tacrolimus proficiency study recently showed clinically significant variability between laboratories, the inability of a common calibrator to harmonize methods, and differences in patient classification depending on the test method. The authors evaluated (1) the effect of a change in methodology on patient classification based on tacrolimus blood concentration and (2) the ability of 2 methods to position the concentration in a given specimen within the correct range...
December 2014: Therapeutic Drug Monitoring
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