Teaching Method Validation in the Clinical Laboratory Science Curriculum

Tara C Moon; Vicky A LeGrys

doi:10.29074/ascls.21.1.19

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Tara C Moon, MS CLS(NCA)⇑
1. is assistant professor, Division of Clinical Laboratory Science, The University of North Carolina at Chapel Hill, Chapel Hill NC
Vicky A LeGrys, DA CLS(NCA)
1. is professor, Division of Clinical Laboratory Science, The University of North Carolina at Chapel Hill, Chapel Hill NC

Address for Correspondence: Tara C Moon MS CLS(NCA), Suite 4100 Bondurant Hall, Campus Box 7145, Division of Clinical Laboratory Science, The University of North Carolina at Chapel Hill, Chapel Hill NC 27599-7145. (919) 843-4353, (919) 966-5200 (fax). tmoon{at}med.unc.edu.

Extract

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

Despite the attention that quality in the laboratory has received as of late and the new regulations and policies that have resulted, it remains an area that can be improved. Many method validation procedures are still carried out inappropriately or are interpreted incorrectly.³ In the past, when the Joint Commission on Accreditation of…

ABBREVIATIONS: ASCLS = American Society for Clinical Laboratory Science; CLIA = Clinical Laboratory Improvement Amendment; CLS = Clinical Laboratory Science; JCAHO = Joint Commission on Accreditation of Healthcare Organizations; NAACLS = National Accrediting Agency for Clinical Laboratory Science.