Description:
This
course will cover CAP and CLIA requirements for validations of new laboratory
methods, including discussion of common problems related to validation, such as
testing on body fluids. Good laboratory
practices for validation are also discussed.
CAP requirements are emphasized, though CLIA provisions are also
discussed.
Learning Objectives:
- Outline
appropriate validation processes, which meet CAP requirements, for implementing
new tests in the laboratory.
- Detail
the current status of validation requirements for tests developed by the
laboratory.
- Define
validation requirements for laboratory tests that are modified by the
laboratory.
Author(s):
Stephen J. Sarewitz, MD, FCAP
Launched: 2013