本归档文件不再通过CLSI共识文件开发流程进行审查。然而，本文件自2017年3月起在技术上有效。由于它对实验室社区的价值，它被保留在CLSI的图书馆中。临床和实验室标准协会文件MM19-A——在临床实验室环境中建立分子检测；经批准的指南为临床分子诊断的决策和实施提供了框架，适用于在已建立的临床实验室中首次实施分子项目的人员。在为患者护理实施任何诊断测试时，在测试上线之前，应解决许多问题。本文件侧重于工作流程的路径，包括实验室安全和质量管理体系，以及 强调分子诊断的注意事项。 本文介绍了一种利用SWOT（优势、劣势、机会和威胁）进行战略规划的有组织方法。详细讨论了相关监管要求和实施计划。重要的是，单独的章节专门讨论以下每个子专业领域:遗传性疾病、肿瘤学和恶性血液学、药物基因组学和传染病。这些章节中的每一部分都讨论了分子生物学的特殊注意事项 每个子专业的测试

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of March 2017. Because of its value to the laboratory community, it is being retained in CLSI's library.Clinical and Laboratory Standards Institute document MM19-A--Establishing Molecular Testing in Clinical Laboratory Environments; Approved 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