Division of Pathology and Laboratory Medicine, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.
J Mol Diagn. 2010 Jan;12(1):51-7. doi: 10.2353/jmoldx.2010.090082. Epub 2009 Dec 10.
One of the hurdles to achieving personalized medicine has been implementing the laboratory processes for performing and reporting complex molecular tests. The rapidly changing test rosters and complex analysis platforms in molecular diagnostics have meant that many clinical laboratories still use labor-intensive manual processing and testing without the level of automation seen in high-volume chemistry and hematology testing. We provide here a discussion of design requirements and the results of implementation of a suite of lab management tools that incorporate the many elements required for use of molecular diagnostics in personalized medicine, particularly in cancer. These applications provide the functionality required for sample accessioning and tracking, material generation, and testing that are particular to the evolving needs of individualized molecular diagnostics. On implementation, the applications described here resulted in improvements in the turn-around time for reporting of more complex molecular test sets, and significant changes in the workflow. Therefore, careful mapping of workflow can permit design of software applications that simplify even the complex demands of specialized molecular testing. By incorporating design features for order review, software tools can permit a more personalized approach to sample handling and test selection without compromising efficiency.
实现个性化医学的一个障碍是实施执行和报告复杂分子测试的实验室流程。分子诊断中快速变化的测试清单和复杂的分析平台意味着许多临床实验室仍然使用劳动密集型的手动处理和测试，而没有在大容量化学和血液学测试中看到的自动化水平。我们在这里提供了一套实验室管理工具的设计要求和实施结果的讨论，这些工具包含了个性化医学中使用分子诊断所需的许多元素，特别是在癌症中。这些应用程序提供了样品访问和跟踪、材料生成和测试所需的功能，这些功能是个体化分子诊断不断发展的需求所特有的。在实施过程中，这里描述的应用程序提高了更复杂分子测试集报告的周转时间，并显著改变了工作流程。因此，仔细映射工作流程可以设计出简化甚至是专门分子测试复杂需求的软件应用程序。通过整合订单审查设计功能，软件工具可以在不影响效率的情况下，允许对样品处理和测试选择采用更个性化的方法。
