The medical laboratory is important for diagnostic analysis. It helps to monitor and screen for diseases or disorders. The lab also helps doctors to make a clinical decision for patient care.
The medical lab has many policies that regulate tests and procedures. The force behind the policies is the Clinical Laboratory Improvement Amendments (CLIA). CLIA controls laboratory testing and require clinical laboratories to be certified by their state and with the Center for Medicare and Medicaid Services (CMS) before they can take samples for diagnostic testing. There are different certificates that clinical laboratories can get from CLIA that are centered on the kinds of tests they conduct. There are certain agencies that act on behalf of CLIA.…show more content… The CMS analytical validity review is intended to determine if a specific test finds what it is supposed to find (i.e. the analyte it is intended to detect) when laboratories perform testing on patient specimens. Therefore, the analytical validation must be performed by the laboratory intending to use the test on patient specimens. Furthermore, the laboratory’s analytical validation of a LDT is reviewed during its routine biennial survey – after the laboratory has already started testing. Moreover, the routine CLIA survey does not include a review of the clinical validation of a LDT – that is, the accuracy with which the test identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient. In contrast, the FDA’s review of analytical validity is done prior to the marketing of the test system, and therefore, prior to the use of the test system on patient specimens in the clinical diagnosis/treatment context. Further, the FDA’s analytical validity review is more in-depth and more comprehensive than that of the CLIA program, and it is focused on the test system’s safety and effectiveness. As a result, FDA review may uncover errors in test design or
