Integrating molecular testing into clinical applications

This chapter examines the principal issues surrounding the integration of molecular testing into the clinical laboratory environment. The clinical laboratory environment in the United States is one of the most extensively regulated areas of medical practice and comes under the federal Clinical Laboratory Improvement Amendments Act (CLIA) of 1988 and the corresponding federal regulations. Any implementation of molecular diagnostic is therefore governed by the provisions of the CLIA. The CLIA includes the following areas of laboratory testing: proficiency testing, pre-analytic testing, analytic testing, and personnel requirements. The clinical laboratory differs significantly both from the research laboratory in practice and from a regulatory point of view. Careful attention should be paid to issues such as patient privacy and reimbursement for molecular testing. In common with all areas of medical practice, reimbursement for molecular testing at the federal level (Medicare) is based on the current Common Procedural Terminology coding system.