Guest Lab Consultant Libby Knollmeyer: The Pros and Cons of Moving from a Waived Medical Lab to a Non-Waived (Certificate of Compliance) Lab
Many physicians have some type of lab testing capability in their practices, with most practice labs classified as Waived Labs, which means having a Certificate of Waiver. This Certificate enables a practice to perform simple tests including tests such as urine dipsticks, rapid Strep A for sore throats, Mono Tests, pregnancy slide tests on urine, and Rapid Flu tests.
There is little effort required to become or maintain a Waived Lab
There are no personnel qualification requirements, and the only regulation is to “follow the manufacturer’s instructions” on the test packages. In order to obtain a Certificate of Waiver, an application form (the CMS116 form) must be completed and submitted to CLIA at the state CLIA office. The CLIA office will issue a CLIA identification number and the practice will receive a bill for the Certificate of Waiver for $150. Life is wonderfully simple at a Certificate of Waiver level.
