On April 8, 2016, the Centers for Medicare & Medicaid (CMS) released a statement defining which on-board controls can be considered equivalent to external QC. For IQCP not to be required for an instrument, its on-board control system needs to:
- Have a similar matrix to that of patient specimens
- Be treated in the same manner as patient specimens
- Go through all elements of the analytic process as applicable
Radiometer is proud to reconfirm our 2015 announcement that both the ABL90 FLEX and ABL800 FLEX blood gas analyzers meet the above requirements.
The two 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).
What does this mean for labs with Radiometer blood gas analyzers? Below we have summarized each product’s quality system to help you determine if an IQCP plan may be required.
ABL800 FLEX Series
The ABL800 FLEX series of blood gas analyzers all use the AUTOCHECK system for quality control. AUTOCHECK was found to be substantially equivalent to the manual quality control process by the FDA in 510(k) 992859. Since the AUTOCHECK module treats the QC ampoules and sampling process exactly as if introduced manually.
Radiometer recommends: IQCP is NOT required for the ABL800 FLEX Series analyzer
The ABL90 FLEX blood gas analyzer utilizes the AQM system for quality management. The heart of the system is three dedicated levels of NIST traceable quality control solutions contained in sealed pouches. During the QC measurement process the QC materials are treated in the same manner as a patient sample, including the inlet probe, completely challenging the entire analytic process as would be done with a manual external QC solution.
Radiometer recommends: IQCP is NOT required for the ABL90 FLEX analyzer
ABL80 FLEX Series
The ABL80 FLEX series of analyzers utilizes the QC3 system for quality management. This robust system provides a System Cycle which includes three levels of NIST traceable QC every 8 hours, a 30-minute System Check to further verify system performance and an Analysis Check with each patient sample to ensure accurate results. Because the QC3 system does not process the internal QC solutions through the sample probe used for patient specimens.
Radiometer recommends: IQCP should be developed for the ABL80 FLEX Series analyzers
Determining the right solution for your laboratory
Ultimately, the decision to create an IQCP plan for your Radiometer analyzer must be made by your laboratories’ administration. Discussions with CAP and Joint Commission indicate it will be important for your laboratory director to perform an eligibility determination to conclude if an IQCP plan is required for your laboratory instruments. Please also consider the requirements of other accreditation bodies including your state’s department of health, if applicable.
Radiometer has created an IQCP tool to better assist you in the development of your plan. The tool can be downloaded by Radiometer customers through the customer web portal, www.MyRadiometer.com