Radiometer’s ABL90 FLEX and ABL800 FLEX on-board controls meet CLIA & CMS requirements
Brea, CA, April 20, 2016
Great news! The Centers for Medicare & Medicaid (CMS) released a clarification on April 8, 2016 defining which on-board controls can be considered equivalent to external QC, which can be summarized as follows:
- Have a similar matrix to that of patient specimens
- Are treated in the same manner as patient specimens
- Go through all elements of the analytic process as applicable
We are proud to reconfirm our announcement from last year that both the ABL90 FLEX and ABL800 FLEX meet the above requirement. These analyzers feature on-board control systems that use 3 or more levels of dedicated, NIST traceable QC material that tests the entire patient sample pathway, including the sample inlet, thus fulfilling the CLIA regulations for external quality control (Federal Register 493.1256c, 493.1267b, c).
To view the entire CMS “Policy Clarification on Acceptable Control Materials Used when Quality Control (QC) is Performed in Laboratories” memorandum, click this link:
To watch our on-demand webinar ‘IQCP Demystified - Practical considerations for your blood gas analyzer’, click this link:
Please contact us for support documentation about how the ABL90 FLEX and ABL800 FLEX blood gas analyzer’s on-board control systems comply with the CLIA regulations.
If you have further questions regarding IQCP and your Radiometer blood gas analyzer please contact your local Radiometer Representative, or call our Technical Support Team at (800) 736-0600 option 4.
Phone: (800) 736-0600
250 S. Kraemer Blvd, Mailstop: B1.SW.11
Brea, CA 92821