The Centers for Medicare and Medicaid Services (CMS) is offering laboratories with blood gas analyzers using an internal quality system, the option of implementing an Individualized Quality Control Plan (IQCP) plan beginning January 1, 2016. CMS’s announcement document S&C: 13-54-CLIA explains that an IQCP plan is required “When the manufacturer’s instructions for quality control are absent or less stringent than the Analytic Systems control procedures listed in Table 1”. The reference to table 1 points to the CLIA regulations for external quality control (Federal Register 493.1256c, 493.1267b, c) which must be followed if the laboratory does not choose to implement an IQCP plan.
The CLIA regulations for external blood gas quality control require running one QC solution for each eight hours of testing, spanning the test range. Also, the CMS interpretative guidelines per section 493.1256(c)* requires the control materials to be “…treated in the same manner as patient specimens, and go through all analytic phases of testing as applicable.
For Radiometer blood gas analyzers this means:
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 that an IQCP is NOT required for the ABL800 FLEX Series analyzer.
ABL90 FLEX
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 that an 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 that an IQCP plan should be developed for the ABL80 FLEX Series.
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
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.
For more information:
Jamie Perkins
Direct: (657) 286-1177
Email: jperkins@radiometeramerica.com
www.radiometeramerica.com
250 S. Kraemer Blvd, Brea, CA 92821
Mailstop: B1.SW.11