CLIA Flashcards
who regulates all laboratory (except research) testing on human samples?
federal law
Why was CLIA passed?
to establish quality standards for all laboratory testing to ensure accuracy, reliability and timeliness of patient test results.
What must all labs have in order to test on human specimens?
all labs must have a CLIA license
What does it mean that the CLIA regulations are “site-neutral”?
they are the same regardless of location, testing, size, type of lab
who is responsible for all aspects of lab operations?
director
what is the testing personnel responsible for?
education, on site training, yearly competency assessment
what are the procedure manual requirements
specific guidelines for each test performed. must be approved and signed by director yearly, and with each procedural change. must be available to all testing persons.
What are the PT requirements?
PT is needed for the site to maintain CLIA certification. Lab enrolls in approved PT program. Lab is tested 4 times a year. PT program sends lab unknown specimen and lab must treat it like a patient specimen. Test results sent back to PT program for “grading”. Lab must pass or lose its CLIA certification.
