Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline
|Publication Date:||1 August 2006|
There are many potential sites for POCT. Test operators may include nurses and physicians in acute care units in hospitals and emergency rooms; cardiac perfusionists in operating rooms; visiting home nurses in patients'/clients' homes; emergency medical technicians in ambulances; nurses in clinics, schools, and colleges; pharmacists and pharmacy technicians in pharmacies; and nonhealthcare workers at various employment settings, such as drug rehabilitation centers, law enforcement facilities, public screening sites, and insurance companies. A physician's office laboratory (POL) is another example of a setting for POCT. Patient self-testing and the handling of results generated by it are outside the scope of this document. Additionally, this guideline only applies to tests that involve the collection of patient specimens. Thus, analytical devices such as transcutaneous meters and continuous glucose monitoring devices are outside the scope of this document.