Description
Clinical and Laboratory Standards Institute document MM19-A–Establishing Molecular Testing in Clinical LaboratoryEnvironments; Approved Guideline provides a framework for decision making and implementation of clinical moleculardiagnostics, and is intended for those in established clinical laboratories that are implementing a molecular program for the firsttime. 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, withemphasis 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 discussedin detail.
Importantly, separate sections are devoted to each of the following subspecialty areas: heritable diseases, oncology and malignanthematology, pharmacogenomics, and infectious diseases. Each of these sections addresses special considerations for moleculartesting for each subspecialty
Product Details
- Published:
- 11/01/2011
- ISBN(s):
- 1562387731
- Number of Pages:
- 256
- File Size:
- 1 file , 3.8 MB
