CLSI MM19-Ed2

Establishing Molecular Testing in Medical Laboratory Environments - 2nd Edition

Provides a framework for decision-making and implementation of clinical molecular diagnostics and is intended for those in established medical laboratories that are implementing a molecular program for the first time. When implementing any diagnostic test, many factors should be considered before the test is available for use in patient care. CLSI MM19 focuses on the laboratory path of workflow, including safety and the QMS, with an emphasis on considerations for molecular diagnostics. An organized approach to strategic planning is presented, and relevant regulatory requirements and an implementation plan are discussed in detail. Importantly, special considerations are provided for each of the following molecular subspecialty areas: heritable diseases, oncology and malignant hematology, pharmacogenomics, and infectious diseases.