Teaching Method Validation in the Clinical Laboratory Science Curriculum (Clinical PRACTICE‪)‬

With the Clinical Laboratory Improvement Amendment's (CLIA) final rule, the ability of the Clinical Laboratory Scientist (CLS) to perform method validation has become increasingly important. Knowledge of the statistical methods and procedures used in method validation is imperative for clinical laboratory scientists. However, incorporating these concepts in a CLS curriculum can be challenging, especially at a time of limited resources. This paper provides an outline of one approach to addressing these topics in lecture courses and integrating them in the student laboratory and the clinical practicum for direct application. Central to the role of any clinical laboratory scientist is the desire to report accurate patient results. Method validation is an imperative part of that process. There are many occasions when practitioners use the concepts of method validation such as establishing new methods, implementing commercial tests, or performing periodic assessments of established methods. The American Society for Clinical Laboratory Science (ASCLS) includes these skills in its definition of the CLS profession and scope of practice. (1) Additionally, method validation is a requirement of laboratory regulations which state that performance of new methods be verified prior to reporting patient test results and periodic assessment of accuracy and precision must occur. (2)