Intelligent Quality Management 2 with IntraSpect™ technology for quality control of GEM® Premier™ 5000 blood gas analyzers— A novel application of the patient sample as its own control

BACKGROUND: Quality control (QC) in point-of-care (POC) testing has been greatly improved by automatic control processes, such as the Intelligent Quality Management (iQM®) technology found in GEM Premier blood gas analyzers (Werfen, Bedford, MA). The 2nd generation technology, iQM2, provides additional capabilities, notably the incorporation of IntraSpect software that monitors the response curves of individual tests to detect transient errors caused by micro-clots, micro-bubbles or any event that disturbs the sensor response during sample data acquisition. IntraSpect is a novel form of patient-based, real-time quality control (PBRTQC). METHODS: IntraSpect pattern recognition software monitors the last 15 measurements of each patient-response curve. Control limits for slope coefficients have been established from theoretical models and empirical data. Abnormal measurement behavior is flagged to identify transient errors that invalidate test results. Results from 1,013,391 patient samples were collected on 4,985 GEM Premier 5000 cartridges and 2,765 instruments in clinical use worldwide. RESULTS AND CONCLUSIONS: Total pre-analytic and transient errors detected by IntraSpect were 1.91% worldwide. iQM2 with IntraSpect technology provides a unique control function detecting transient errors that would otherwise go undetected with traditional QC. Together with the statistical QC technology in iQM2, pre-analytic, analytic, and transient analytic errors are detected much faster—seconds versus hours—than by traditional statistical QC.