Helping Small Laboratories Meet Standards with Confidence.

Operating a compliant laboratory involves more than accurate testing. Understanding CLIA certification, fees, and regulatory responsibilities is essential. These provisions address CLIA program administration, laboratory certification, and applicable fees. CLIA fee schedules set once every two years and are published in the Federal Register. They are influenced by factors including: • Testing complexity: The complexity level of testing performed. • Test volume: The number of

In previous posts, we have looked at the various levels of CLIA certification; certificates of waiver, Provider performed microscopy, Registration, Compliance and Accreditation. We have briefly looked at what each means and the requirements associated with each one. Now, starting with 42 CFR § 493.551 we will look at general requirements for laboratories. A laboratory may opt to be accredited by a private non-profit accrediting organization, or in some states with a laborato

In my two previous posts, I discussed CLIA-waived testing and Provider-Performed Microscopy (PPM). As we move into the next level of laboratory testing, I want to step back and review some key definitions that will help put the regulatory requirements into context. There are five types of CLIA certificates: Certificate of Waiver: For laboratories performing only waived testing. Certificate for Provider-Performed Microscopy (PPM): For laboratories performing only PPM and, pote