Clinical and Laboratory Standards Institute guideline POCT04—Essential Tools for Implementation and Management of a Point-of-Care Testing Program provides users of in vitro diagnostic devices outside the medical laboratory with information and recommendations for good laboratory practice and for producing reliable test results regardless of where the test is performed. Point-of-care testing (POCT), also known as bedside testing or near-patient testing, is intended to provide more rapid test results than can be achieved in central or satellite laboratory settings. This option is particularly important in critical care areas, such as the intensive care unit, emergency rooms, burn units, emergency transport vehicles, and operating rooms, as well as in skilled nursing facilities and hospices. POCT has also been used to expedite treatment decisions and provide convenience for the patient or client.

Several changes have been made in this edition; chief among them is the introduction of the concept of quality management based on risk assessment (see Subchapter 2.2.3) for POCT sites. This guideline also contains updated recommendations regarding infection control and patient and testing personnel safety (see Subchapter 2.3).

Many potential sites are eligible for point-of-care testing (POCT). To achieve producing patient test results comparable with those from the medical laboratory, this guideline provides essential tools for implementing and managing POCT in both clinical and nonclinical settings. Depending on the location, individuals who may perform POCT and for whom this guideline is intended include: 

• Nurses and physicians in acute care units in hospitals and emergency rooms
• Cardiac perfusionists in operating rooms
• Visiting home nurses 
• Emergency medical technicians 
• Nurses in clinics, schools, and colleges 
• Pharmacists and pharmacy technicians in pharmacies
• Non–health care professionals at various employment settings, such as drug rehabilitation centers, law enforcement facilities, public screening sites, insurance companies, and physician office laboratories (POLs) 

This guideline does not cover patient self-testing and the handling of results generated in this manner. Additionally, this guideline only applies to tests that involve the collection of patient specimens. Thus, examination devices such as breath analyzers, transcutaneous meters, and continuous glucose monitoring devices are outside the scope of this guideline.