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Point of Care Testing

An increasing number of test kits and analyzers 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 is responsible for ensuring regulatory compliance and proper training of any staff administering waived and/or non-waived point of care tests at the URMC campus and approved UR Medicine off-site locations. UR Medicine locations holding only a Limited Service Laboratory Permit are approved for waived testing only.   

UR Medicine staff and associates can click here to find additional information on POCT on the URMC intranet (please note that this is only accessible to internal URMC users).