1. Introduction to method evaluation and quality management

The current nature of conducting medical transactions and procedures has revealed that most of the underlying medical decisions are arrived at utilizing laboratory data. As a result, there is the great significance that the outcomes emanating from the laboratory be of the high degree of accuracy. Determination and upholding of accuracy call for considerable cost and potential, involving the utilization of several approaches in accordance with the underlying test's complexity [1]. Invariably, commencing the entire decision-making process, one is entitled to acknowledge the necessary quality besides knowing how to measure the quality. In conjunction with that, there are several statistical techniques deployed to enable the medical practitioner to measure the resultant quality. Prior to enacting a modern test, there is the essence of determining whether the test can be pursued acceptably wherein method evaluation is deployed in verifying the acceptability that accrues to the new approaches before reporting the results to the patient. Immediately, an approach has been enacted, a necessity prevails regarding that the laboratory ensures its validity over time. Quality control is the process that facilitates the upholding of the validity accruing to the laboratory over time. All the two concepts—method evaluation and quality control—are effective constituents of quality management. Invariably, quality management entails that the aggregate testing process is directed to the chief goal of enhancing the accuracy that accrues to the laboratory results [2]. This chapter presents the basic statistical concepts besides providing a universal overview regarding the procedures crucial for enacting a new method to ensure its persistent accuracy.
