by TERESA A. SCOTT, MT(ASCP)
According to the CLIA regulations, “laboratories eligible for a certificate of waiver must follow manufacturers' instructions for performing the test.” This is also a requirement for non-waived testing. Many people think that they are fulfilling this requirement if they follow the step-by-step procedure for the test process included in the instructions. However, there is much more involved than just following the procedural steps.
Manufacturer’s instructions are found in instrument operator’s manuals and in package inserts; however, this article focuses on the instructions found in package inserts. In addition to the procedural steps, the package inserts include information and instructions for
by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP)
There may be circumstances when laboratories consider the option to modify an FDA-cleared or approved test system. These may be due to the specific needs of the population served, or based on cost/benefit analyses of instrumentation and reagent use; or based on the logistics of in-house testing capabilities. CLIA allows clinical laboratories to modify their FDA-approved tests, and even to develop their own tests, known as laboratory-developed tests (LDTs), as long as they follow the requirements to validate the performance characteristics of their modified or in-house developed tests.