Clinical and Laboratory Standards Institute document MM19-P-Establishing Molecular Testing in Clinical Laboratory
Environments; Proposed Guideline provides a framework for decision making and implementation of clinical molecular
diagnostics, and is intended for those in established clinical laboratories that are implementing a molecular program for the first
time. When implementing any diagnostic test for patient care, many elements should be addressed before the test is brought "online." This document focuses on the path of workflow, including laboratory safety and the quality management system, with
emphasis on considerations for molecular diagnostics. An organized approach to strategic planning with SWOT (strengths,
weaknesses, opportunities, and threats) is presented. Relevant regulatory requirements and the implementation plan are discussed
in detail.
Importantly, separate sections are devoted to each of the following subspecialty areas: heritable diseases, oncology and malignant
hematology, pharmacogenomics, and infectious diseases. Each of these sections addresses special considerations for molecular
testing for each subspecialty.
| ISBN(s) : | 1562387529 |
| Number of Pages : | 254 |
| Published : | 05/01/2011 |
