TEST COMPLEXITY
There are three levels of test complexity: Waived, Non-waived, and High. The Federal Drug Administration (FDA) determines the level of complexity for each laboratory test, both inside and outside of the laboratory. At SFGH, POCT offered are either Waived or Non-waived.
Waived tests utilize technically simple methods and are expected to cause little or no harm to a patient if performed incorrectly. Waived tests can be further divided into instrument-based (e.g., glucose) and non-instrument-based tests, which include fecal occult blood, vaginal pH, urine chemstrips and pregnancy tests.
Non-waived testing (moderately complex testing in POCT settings) are usually instrument-based, require a higher skill level, and generally carry a higher level of risk to the patient if performed incorrectly (e.g., blood gases). Provider Performed Microscopy Procedures (PPMP) are considered moderately complex and include a set of defined microscopic procedures (e.g., saline wet mounts) that are performed by independently licensed (MDs, DOs) and mid-level practitioners (e.g., NPs, CNMs, PAs).
High complexity testing is not performed outside of the Clinical Laboratory at SFGH.