A Pilot Study on the Evaluation of Clinical Chemistry Laboratory Test Performance using Six Sigma Metrics

2019 ◽  
Vol 4 (2) ◽  
pp. 31-36
Author(s):  
Pier Angeli Medina ◽  
◽  
Jenny Matibag ◽  
Sarah Jane Datay-Lim ◽  
Elizabeth Arcellana-Nuqui
2015 ◽  
Vol 56 (1) ◽  
pp. 54 ◽  
Author(s):  
Justice Afrifa ◽  
SethA Gyekye ◽  
WilliamKBA Owiredu ◽  
RichardKD Ephraim ◽  
Samuel Essien-Baidoo ◽  
...  

2021 ◽  
Author(s):  
Monika Garg ◽  
Neera Sharma ◽  
Saswati Das

Background:The concept of sigma metrics & lean six sigma is well known in the field of healthcare. However not many labs utilize the six sigma metrics for maintenance of high quality laboratory performance. A minimum value of 3 σ is desired in any clinical laboratory & values of σ≥6 are regarded as gold standard for obtaining high quality lab reports. Aims &Objectives: To calculate bias, cv & sigma metrics from the IQC & EQC data in order to ascertain extent of quality management in our lab. Materials &Methods:An extensive study of sample processing and quality practices was carried out in the Central Laboratory of Department of Biochemistry; PGIMER &Dr. RML Hospital, New Delhi; from Feb 2020 to July 2020. The IQC used(both level I & level II) were from Biorad Laboratories India (lyphochek assayed chemistry control) & the EQC used was from Randox Laboratories, UK. All the controls were run on Beckman Coulter clinical chemistry analyser AU 680. Total 14 clinical parameters were analysed & subsequently; Mean, S.D., CV, bias & σ were calculated through their respective formulas. Results:Sigma level was more than 6 for both levels of IQC was observed for Amylase. It indicates world class performance. Total bilirubin, AST, Triglyceride & HDL depicted σ values between 3.1 to 6 for both L1 & L2. Iron showed σ value of 5.5 in L1 whereas it was 3.78 in L2. Conclusion:-:- Sigma metrics in clinical laboratory is an essential technique to ascertain poor assay performance, along with assessment of the efficiency of existing laboratory process.


2018 ◽  
Vol 10 (02) ◽  
pp. 194-199 ◽  
Author(s):  
B. Vinodh Kumar ◽  
Thuthi Mohan

Abstract OBJECTIVE: Six Sigma is one of the most popular quality management system tools employed for process improvement. The Six Sigma methods are usually applied when the outcome of the process can be measured. This study was done to assess the performance of individual biochemical parameters on a Sigma Scale by calculating the sigma metrics for individual parameters and to follow the Westgard guidelines for appropriate Westgard rules and levels of internal quality control (IQC) that needs to be processed to improve target analyte performance based on the sigma metrics. MATERIALS AND METHODS: This is a retrospective study, and data required for the study were extracted between July 2015 and June 2016 from a Secondary Care Government Hospital, Chennai. The data obtained for the study are IQC - coefficient of variation percentage and External Quality Assurance Scheme (EQAS) - Bias% for 16 biochemical parameters. RESULTS: For the level 1 IQC, four analytes (alkaline phosphatase, magnesium, triglyceride, and high-density lipoprotein-cholesterol) showed an ideal performance of ≥6 sigma level, five analytes (urea, total bilirubin, albumin, cholesterol, and potassium) showed an average performance of <3 sigma level and for level 2 IQCs, same four analytes of level 1 showed a performance of ≥6 sigma level, and four analytes (urea, albumin, cholesterol, and potassium) showed an average performance of <3 sigma level. For all analytes <6 sigma level, the quality goal index (QGI) was <0.8 indicating the area requiring improvement to be imprecision except cholesterol whose QGI >1.2 indicated inaccuracy. CONCLUSION: This study shows that sigma metrics is a good quality tool to assess the analytical performance of a clinical chemistry laboratory. Thus, sigma metric analysis provides a benchmark for the laboratory to design a protocol for IQC, address poor assay performance, and assess the efficiency of existing laboratory processes.


2019 ◽  
Vol 6 (5) ◽  
pp. 1524
Author(s):  
Kavita Aggarwal ◽  
Saurav Patra ◽  
Viyatprajna Acharya ◽  
Mahesh Agrawal ◽  
Sri Krushna Mahapatra

Background: Six sigma is a powerful tool which can be used by laboratories for assessing the method quality, optimizing Quality Control (QC) procedure, change the number of rules applied, and frequency of controls run .The aim of this study was to quantify the defects or errors in the analytical phase of laboratory testing by sigma metrics and then represent the sigma value in Method Decision Chart.Methods: A retrospective study was conducted in a tertiary care hospital in Bhubaneswar, India. The clinical chemistry laboratory has been NABL accredited for the past 5 years and strictly quality checked.  Internal and external quality control data was collected for a period of six months from January - June 2018 for 20 biochemical analytes. Sigma metrics for each parameter was calculated and plotted on method decision chart.Results: The sigma metrics for level 2 indicated that 6 out of the 20 analytes qualified Six Sigma quality performance. Of these seven analytes failed to meet minimum sigma quality performance with metrics less than three and another seven analytes performance with sigma metrics was between three and six. For level 3, the data collected indicated that seven out of 20 analytes qualified Six Sigma quality performance, six analytes had sigma metrics less than 3 and seven analytes had sigma metrics between 3 and 6.Conclusion: In our study Sigma value was highest for amylase and lowest for potassium. Use of alternative methods and/ or change of reagents can be done for potassium to bring the sigma value within an acceptable range.


1962 ◽  
Vol 8 (5) ◽  
pp. 538-545 ◽  
Author(s):  
Nathan Radin

Abstract A punched-card system was developed to simplify the administrative aspects of the clinical chemistry laboratory. In it a three-part requisition and samples are matched and given a laboratory number. The third copy of the original laboratory requsition is a charge card also used as a name file for the day. Prepunched cards, coded for laboratory tests, are used for each test requested. The laboratory number is stamped and punched on each test card. All test cards are then sorted into laboratory test groups, after which the laboratory data and results are recorded on them. Cards are then sorted for laboratory number and rematched with the original laboratory requisitions, which remained in numerical order. Results are then copied directly onto the requisitions. The system is more efficient, less susceptible to error, and simpler than other laboratory record systems.


1983 ◽  
Vol 14 (3) ◽  
pp. 301-316
Author(s):  
ARVIND K. N. NANDEDKAR ◽  
A. BLANK ◽  
JACOB ROOTENBERG

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