Get up to speed on the Clinical Laboratory Improvement Amendments (CLIA) and how this regulation affects your lab by attending AACC’s upcoming webinar, “CLIA Update 2015: Hear What's in the Works.”
“CLIA’88 is a living regulation, meaning that it can be adapted and refined in response to changes in the laboratory practice environment,” according to AACC’s summary of the webinar, which takes place Oct. 22.
One of the things that speaker Karen Dyer, MT (ASCP) DLM, plans to address is how CMS currently regulates the use of blood glucose monitors under CLIA’88. Dyer is director of the Division of Laboratory Services with the Centers for Medicare and Medicaid Services.
As Dyer has explained in previous talks, blood glucose monitoring systems (BGMS) are seen as “off label” in the event they haven’t been cleared for use in certain patient populations. CLIA regulations call for performance specifications for any BGMS test that labs decide to use off label.
“If CLIA surveyors note use of BGMS in a facility, they will evaluate if the system is being used per the manufacturer’s instructions or ‘off label.’ If any noncompliance is identified, a written statement of deficiencies will be issued to the laboratory” following an outcomes survey process, Dyer stated during her presentation at AACC’s annual meeting and conference expo in Atlanta this past July.
She’ll also discuss CLIA’s implementation of CMS Individualized Quality Control Plan and the agency’s plans to revise current proficiency testing (PT) requirements, including what tests are subject to PT.
Lab directors, medical technologists, point-of-care testing coordinators, and people responsible for regulatory compliance issues in their lab are encouraged to attend this session.
Register online to listen in on this informative webinar on the CLIA regulations and their impact on laboratory medicine.