By Patti Williams

Instrumentation Laboratory (IL) has launched “Intelligent Quality Management” (iQM), a new system of automated quality assurance for blood gas analyzers. Now available with IL’s GEM Premier 3000, iQM provides active, continuous, real-time quality processing, with a comprehensive system that eliminates the need for conventional external Quality Control (QC). The system provides major improvements over traditional and auto QC methods, including significant reduction in time to error detection, and thus, greater accuracy in test results and patient safety. Performed automatically with no human intervention required, iQM also takes corrective action when errors are detected, and provides detailed documentation to demonstrate compliance.

What it does
iQM combines intelligent software, Process Control (PC) solutions, and Calibration Validation Product (CVP) to monitor all critical components of the GEM Premier 3000. This intelligent quality management system replaces the use of traditional QC. It validates cartridge integrity, identifies changes that affect the analytical performance, recognizes failure patterns and diagnoses the cause of the failure, automatically performs corrective actions, automatically documents the failure and corrective actions taken, and produces the reports required by regulatory agencies.

How it works
Unlike external forms of QC, iQM monitors performance real-time, conducting system checks, sensor checks, process stability checks and failure pattern checks.

System checks include fluidics checks to test sample integrity, reagent solutions, and the peristaltic pump. Additionally, system checks test mechanical components of the cartridge, such as the valve position and sample arm position, as well as the instrument heater block and electronics. If any system failure is found, iQM confirms the nature of the failure, then either rejects the cartridge or halts instrument operation.

Sensor checks are performed using three different solutions, each at different intervals. Process Control solutions are run following the same path as a patient sample, ensuring that the entire system is validated. One solution is run automatically after every patient sample, ensuring continuous quality control. The other two solutions are automatically run ever four and twenty-four hours. iQM confirms any sensor failure, and either suppresses the result of a failed parameter, or disables any sensor that shows persistent failure.

Process stability checks are also automatically performed in order to verify the process control solution stability during the life of a cartridge. In the event of process stability failure, the cartridge is rejected.

Failure pattern checks are conducted to identify any common sources of failure. Sources of failure, such as micro-clots or interference substances, leave “fingerprints” on the sensors. These fingerprints are read as patterns that iQM can detect and correct. If the problem cannot be corrected, the sensor will be disabled.

In order to assure quality results from a blood gas analyzer, hospital staff must perform daily liquid QC. This process, as well as monitoring, interpreting, and documenting the results, places a significant burden on hospital staff members who may lack the time or expertise to identify problems and take the appropriate corrective actions.

The alternative QC methods, namely on-board quality control and electronic QC (EQC), may not adequately address all the issues. On-board automated QC systems are not capable of continually monitoring the system functionality, and do not address the difficulty of manual diagnosis, corrective action and documentation. EQC can only confirm the operation of the instrument’s measurement circuitry and its computational components, leaving many components of the system unchecked.

iQM continually monitors operation of the entire testing process, including sensors, fluidics, and electronics, then automatically performs and documents corrective actions. iQM features continuous, real-time control, automatic corrective action, automatic documentation, automated operation and total analytical system QC, all integrated in the Gem Premier 3000 cartridges.

iQM Performance
In extensive evaluation and field-testing, iQM has shown that it detects errors usually detected by external QC, such as a sensor failure or a micro- clot. It further detects clinically significant errors that are not detected by external QC, such as benzalkonium and other interference substances. And, iQM detects these errors hours before external QC would warn the user of a potential problem.

iQM was developed by a team of scientists at IL. Dr. James Westgard, an authority in quality management and the father of the widely used “Westgard Rules,” was involved in assessing the performance of iQM. Statistical analysis performed by Dr. Westgard has demonstrated the ability of iQM to reduce the time to error detection from hours with traditional QC, to minutes with iQM, resulting in a significant improvement in quality of results and patient safety.

iQM Benefits
iQM provides laboratories and point-of-care testing locations the assurance of reliable test results while significantly reducing time and costs of conducting QC. Key benefits of iQM include the immediate detection and diagnosis of errors, and the confidence that optimal quality control protocol is followed at all times, regardless of time of day and operator training. This helps to assure the quality of each patient’s test results, enabling appropriate medical decisions based on accurate information. With iQM, samples are not run when there is risk of reporting incorrect results.

iQM reduces costs by eliminating manual processes associated with traditional QC. It performs QC functions and corrections without human intervention, eliminating the time and cost of troubleshooting. It also eliminates the labor required to maintain quality control procedures, train operators, perform routine maintenance, and complete documentation reports required by regulatory agencies.

Available only on the GEM Premier 3000, iQM is a new system of QC designed to improve the accuracy of test results, reduce cost and, ultimately, enhance patient care.

Patti Williams is senior product manager at Instrumentation Laboratory. She can be reached at 781-861-0710.