Point of Care Testing
An increasing number of test kits and appliances are now available for use at a patient’s bedside, or in an ambulatory setting, in order to obtain instant results.
This is known as Point of Care Testing, and is defined by regulatory agencies as “all analytical laboratory testing activities provided by an institution, but outside the physical facilities of the central laboratories, usually by non-laboratory employees”.
The FDA reviews, approves, and categorizes laboratory tests into complexities. Waived tests are considered simple and having an insignificant risk of erroneous results. These include tests approved for home use.
The POCT unit of the clinical laboratories concerns itself primarily with non-waived tests. They are responsible for ensuring regulatory compliance and proper training of staff administering non-waived point of care tests at the URMC campus and URMC off-site locations.
URMC staff and associates can find additional information on POCT on the URMC intranet: