Validation Protocol: First Step of a Lean-Total Quality Management Principle in a New Laboratory Set-up in a Tertiary Care Hospital in India

@article{Das2011ValidationPF,
  title={Validation Protocol: First Step of a Lean-Total Quality Management Principle in a New Laboratory Set-up in a Tertiary Care Hospital in India},
  author={Barnali Das},
  journal={Indian Journal of Clinical Biochemistry},
  year={2011},
  volume={26},
  pages={235-243}
}
Method validation is pursued as the first step in establishing Lean-Total Quality Management in a new clinical laboratory, in order to eliminate error in test results. Validation of all the new tests were done (with particular reference to alkaline phosphatase) by verifying reference intervals, analytical accuracy and precision, inter-assay and intra-assay variations, analytical sensitivity, limit of detection, linearity and reportable range, i.e. (i) Analytical measurement range (AMR) and (ii… CONTINUE READING
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