![]() Quality varies significantly from manufactures to manufactures and method to method. Conclusion: Chemistry tests are not commodities. Glucose, Urea, Uric Acid, Calcium, Phosphorous, total bilirubin, in normal levels and Urea, Creatinine, total and direct bilirubin in pathologic level have intermediate sigma metric 4-6. Some of analytes have poor sigma metric <3 such as Creatinine and ALP in normal level and Calcium in pathologic level. Result: The sigma value >6 was observed for most analytes. All function and statistical analysis were done in our Private laboratories. Method and material: Imprecision was determined from the cumulative Levey-jenning SD over the 6 month, bias was calculated from the external quality records, Finally, analytical sigma metric estimates were calculated for each Analytes by the following equation: sigma metric: (TEa – Bias)/CV. Conclusion: Application of six sigma principles would significantly helps in improving IQC process as well provides the scientific basis for recommendation of amount of QC that is actually needed.īackground: To assess the analytical performance of quality trough external quality assesses and internal quality program data on sigma scale. No significant difference was found in both COBAS equipments in context to sigma value. Urea and Creatinine analytes performed poorly on the sigma scale with sigma < 3, signifying needs improvement in these methods. For parameters-Albumin, Alanine aminotransferase (L1), Total Cholesterol, Total Bilirubin, Glucose (L1), Total Protein the sigma values were found between 3 & 6, signifying more QC rules to be implemented. Results: Satisfactory sigma values (> 6) were derived for Alkaline Phosphatase, Aspartate aminotransferase, Alanine aminotransferase (L2), Triglycerides, Uric acid, Glucose (L2) signifying less stringent QC rules in an order to achieve high error detection and low false rejection. Process sigma was calculated using CV%, Percentage bias and TEa values of various parameters were taken from Clinical Laboratories Improvement Act (CLIA) guidelines. For all 12 analytes the coefficient of variation was calculated for both the levels of IQC, percentage bias was calculated from EQAS. Materials and Method: Internal Quality control (QC) and proficiency testing data for 12 clinical chemistry analytes for two COBAS 400 Plus clinical biochemistry auto-analyzers were analyzed retrospectively over a period of 12 months from July 2012 to June 2013. We aimed to gauge our clinical biochemistry laboratory performance on sigma metrics. It is quantitative goal for process performance. Nowadays six sigma is the newest version of total quality management. The evaluation of laboratory performance is critical to maintain accurate laboratory results. ![]() Please visit the website designated for your country if you are not automatically routed to it.Introduction: Accurate test results are the core of healthcare system since physician's decisions mostly depends on the laboratory results. Ortho-Clinical Diagnostics takes no responsibility whatsoever for the accessibility of product information on this supra-regional website for the EMEA region that may conflict with local legal requirements of the individual user’s country. This may particularly concern information on products prohibited from being advertised to non-healthcare professionals. Please contact a representative of Ortho-Clinical Diagnostics for further information about the products and services described.Īs the supra-regional corporate website of Ortho-Clinical Diagnostics, this website may contain information on products that you may not be able to access on the website designed for your country due to legal restrictions. Products presented on this website are for general information only. Ortho-Clinical Diagnostics reserves the right to accept or reject any offer to purchase any products or services. No information on this website shall be construed as an offer to sell any product to any particular customer or in any particular jurisdiction. Please be advised that this is the corporate website of Ortho-Clinical Diagnostics for the entire EMEA region. Please confirm with your local commercial team. New QuidelOrtho branding may not be available in all markets, subject to country specific regulatory approval. Product availability may vary from country to country and is subject to varying regulatory requirements. Please remember to consult your local legal restrictions, regulations, registrations or intended uses in the country of your origin. *This website contains information which is targeted to a wide range of audiences and could contain product details or information otherwise not valid or applicable to your country. The availability of the products is subject to compliance with the regulatory requirements of each market. Ortho Clinical Diagnostics, publishes this site and is solely responsible for its content.
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