Testing In Research Laboratories

As research laboratories report new molecular findings in inherited and acquired diseases, it is not uncommon for clinical laboratories to receive requests to send patient samples to research laboratories for testing. This is an area in which the clinical laboratory must be careful to avoid noncompli-ance with CLIA regulations. One of the requirements of the CLIA is that certified laboratories must not send samples for patient testing to a non-CLIA-certified laboratory. This rule applies even if the research laboratory is the only one in the world to offer a particular test. Such samples should not be handled by a CLIA- certified laboratory, and the ordering physician should find some other means of arranging for testing if it is considered necessary. For example, it may be possible for testing to be performed under a research protocol. In this case the local institutional review board may be able to offer useful guidance on the creation and implementation of an appropriate protocol.

There are good reasons to be cautious about performing clinical testing in a research setting. The standards that one expects in a CLIA-certified laboratory are designed to promote quality and improve the accuracy of patient testing. Laboratories that do not follow these extensive requirements may not have all of the necessary protocols and procedures in place to offer the same quality of test result. Research laboratories are often part of academic institutions that may or may not carry malpractice insurance coverage in the event that a reported test result is erroneous.

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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