Laboratory Services Leadership Flashcards
Regulatory agencies, CAP Competency Assessment, Corrective Action & Assessment Process (7 cards)
1
Q
What is CLIA?
A
Clinical Laboratory Improvement Amendments-
establishes the quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.
3 federal agencies are responsible for CLIA: the FDA, CMS, and CDC.
Food and Drug Administration
Center for Medicaid Services
Center for Disease Control
2
Q
What does the FDA do?
A
Categorize tests based on complexity…
3
Q
What does CMS do?
A
4
Q
What does the CDC do?
A
5
Q
What the acronym CLIAC stand for?
A
The Clinical Laboratory Improvement Advisory Committee
6
Q
What are the following CLIA regulations?
42 CFR 493.1235
42 CFR 493.1413(b)(8)
42 CFR 493.1451(b)(8)
A
7
Q
A
