Usually POC tests are only those classified as waived or moderately complex. The specific regulatory requirements which apply to each category depend on your laboratory s situation. The key is taking a few minutes to assess the situation. In some cases, the requirements imposed on POCT are co-dependent on several regulators. Typically, they require the laboratory to establish the relationship of test results generated at different sites.
Clinicians have the right to expect quality results.
Waived tests are exempt from regulation, including QC, PT and inspection. Moderately complex tests must meet all of the CLIA requirements including QC, PT, procedure manuals, QA, personnel requirements and inspection. These requirements can be accomplished through using common lots of QC materials or twice per year split sample programs. The keys are organization and documentation. Again, proper organization around a common PT program is one of the most cost effective ways to meet this requirement.