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<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Tab1 Konnick PractLabMed2020 21.png|240px]]</div>
<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Fig1 Karaattuthazhathu NatJLabMed23 12-2.png|260px]]</div>
'''"[[Journal:The regulatory landscape of precision oncology laboratory medicine in the United States: Perspective on the past five years and considerations for future regulation|The regulatory landscape of precision oncology laboratory medicine in the United States: Perspective on the past five years and considerations for future regulation]]"'''
'''"[[Journal:Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study|Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study]]"'''


The [[Regulatory compliance|regulatory]] landscape for precision [[oncology]] in the United States is complicated, with multiple governmental regulatory agencies with different scopes of jurisdiction. Several regulatory proposals have been introduced since the [[Food and Drug Administration]] released draft guidance to regulate [[laboratory developed test]]s in 2014. Key aspects of the most recent proposals and discussion of central arguments related to the regulation of precision oncology laboratory tests provides insight to stakeholders for future discussions related to regulation of [[laboratory]] [[Medical test|tests]]. ('''[[Journal:The regulatory landscape of precision oncology laboratory medicine in the United States: Perspective on the past five years and considerations for future regulation|Full article...]]''')<br />
For the release of precise and accurate reports of [[Medical test|routine tests]], its necessary to follow a proper [[quality management system]] (QMS) in the [[clinical laboratory]]. As one of the most popular QMS tools for process improvement, Six Sigma techniques and tools have been accepted widely in the [[laboratory]] testing process. Six Sigma gives an objective assessment of analytical methods and instrumentation, measuring the outcome of a process on a scale of 0 to 6. Poor outcomes are measured in terms of defects per million opportunities (DPMO). To do the performance assessment of each clinical laboratory [[analyte]] by Six Sigma analysis and to plan and chart out a better, customized [[quality control]] (QC) plan for each analyte, according to its own sigma value ... ('''[[Journal:Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study|Full article...]]''')<br />
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Revision as of 16:52, 29 April 2024

Fig1 Karaattuthazhathu NatJLabMed23 12-2.png

"Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study"

For the release of precise and accurate reports of routine tests, its necessary to follow a proper quality management system (QMS) in the clinical laboratory. As one of the most popular QMS tools for process improvement, Six Sigma techniques and tools have been accepted widely in the laboratory testing process. Six Sigma gives an objective assessment of analytical methods and instrumentation, measuring the outcome of a process on a scale of 0 to 6. Poor outcomes are measured in terms of defects per million opportunities (DPMO). To do the performance assessment of each clinical laboratory analyte by Six Sigma analysis and to plan and chart out a better, customized quality control (QC) plan for each analyte, according to its own sigma value ... (Full article...)
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