Analytic Testing

The CLIA has detailed requirements for the analytic phase of the testing process. These include the procedure manual, which is a step-by-step set of instructions on how the test should be performed, the process for method calibration, the procedures for preparation of reagents, the use of controls, establishment of the reference range, reporting procedures, and analytical parameters such as sensitivity and specificity. There are no specific CLIA requirements that are unique to molecular testing, and therefore the molecular diagnostics laboratory has to adapt requirements from related areas such as clinical chemistry and microbiology to molecular testing. Some of the accrediting organizations have checklists that include specific requirements for molecular testing. These can provide useful guidance on procedures even for a laboratory that is not accredited by one of these organizations.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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