Validation of iQM Active Process Control Technology

Westgard, James O.; Fallon, Kevin D.; Mansouri, Sohrab

doi:10.1097/00134384-200303000-00001

Cited by 20 publications

(13 citation statements)

References 4 publications

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“…Ancy et al report that more and more hospitals recognize the value of broadening the range of measurements obtained from automated blood gas analyzers [12] . In addition to these vital aspects, POCT is fundamentally useful, particularly for blood gases, in that it reduces pre-analytical errors, which alone account for some 62% of medical errors [13] , [14] , [15] . Rapid, reliable, easy-to-maintain cassette analyzers are currently available which are ideally suited to this kind of testing for the user (physicians, nurses and midwives).…”

Section: Introductionmentioning

confidence: 99%

“…At the Clermont-Ferrand university teaching hospital, as part of a transfer of activity to the medical biochemistry laboratory, the blood gas analysis equipment was upgraded. For this purpose, Werfen equipment was selected, particularly for its analytical performance and ease of use for both clinical and laboratory staff; but most importantly, for the supplier's fully independent iQM system [6] , [7] , [13] , [17] , [18] . In all, 12 GEM PREMIER 4000 analyzers were deployed across 11 sites, throughout two hospitals, CHU Gabriel Montpied and CHU Estaing.…”

Section: Introductionmentioning

confidence: 99%

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Method validation of a set of 12 GEM® Premier™ 4000 blood gas analyzers for point-of-care testing in a university teaching hospital

Oris

Clavel

Jabaudon

et al. 2018

Practical Laboratory Medicine

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BackgroundBlood gas analyzers are o0.ften integrated into point-of-care testing provisions. International standards (ISO 22870 and 15189) as adapted to French COFRAC regulations make accreditation of point-ofta-care testintag obligatory. We installed and assessed 12 GEM PREMIER 4000 analyzers for pH, pCO2, pO2, Na+, K+, Cl-, Ca2+, lactate, hemoglobin and oxyhemoglobin (O2Hb) at Clermont-Ferrand Hospital. These instruments were distributed across 11 care sites in the hospital.MethodsPrecision was studied at two control levels for each parameter. Comparisons between GEM analyzers were performed (on 30 samples) for pH, pCO2, pO2, Na+, K+, Cl-, Ca2+, lactate, hemoglobin and O2Hb; and between GEM analyzers and the central laboratory for Na+, K+, Cl-, Ca2+ and hemoglobin (on 30–50 samples). Uncertainty in measurement (UM) was evaluated with an approach using reproducibility and accuracy data.ResultsThe coefficients of variation (CVs) were in line with recommendations, except for the repeatability CV for pO2. All CVs were below 4%. All comparisons complied with recommendations. Uncertainties of measurement were also validated.ConclusionOur results met standard requirements and the 12 analyzers were assessed as suitable for point-of-care testing in services of academic medical centers, as exemplified at Clermont-Ferrand hospital.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Method validation of a set of 12 GEM® Premier™ 4000 blood gas analyzers for point-of-care testing in a university teaching hospital

Oris

Clavel

Jabaudon

et al. 2018

Practical Laboratory Medicine

View full text Add to dashboard Cite

show abstract

“…Furthermore, ARLs can be converted to units of time to characterize the average time until a rejection occurs, as illustrated in a published validation study of a new IQC technology. 28 …”

Section: Predict Iqc Performancementioning

confidence: 99%

“…Results of a validation study indicate that the error detection capabilities far exceed that expected of traditional IQC procedures. 28 …”

Section: What About Electronic Qc Versus Liquid Iqc?mentioning

confidence: 99%

Internal quality control: planning and implementation strategies

Westgard

2003

Ann Clin Biochem

140

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The rst essential in setting up internal quality control (IQC) of a test procedure in the clinical laboratory is to select the proper IQC procedure to implement, i.e. choosing the statistical criteria or control rules, and the number of control measurements, according to the quality required for the test and the observed performance of the method. Then the right IQC procedure must be properly implemented. This review focuses on strategies for planning and implementing IQC procedures in order to improve the quality of the IQC. A quantitative planning process is described that can be implemented with graphical tools such as power function or critical-error graphs and charts of operating speci cations. Finally, a total QC strategy is formulated to minimize cost and maximize quality.A general strategy for IQC implementation is recommended that employs a threestage design in which the rst stage provides high error detection, the second stage low false rejection and the third stage prescribes the length of the analytical run, making use of an algorithm involving the average of normal patients' data.

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“…2 The iQM system is conceptually consistent with EP23-A, Laboratory Quality Control Based on Risk Management, which was approved and published by the Clinical and Laboratory Standards Institute (CLSI) in October 2011. [3][4][5] This document provides guidance based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test. Therefore, blood gas analysis is recognized as context-specific (e.g.…”

Section: Introductionmentioning

confidence: 99%

Reliability analysis of GEM® Premier™ technology: a multicenter study

et al. 2015

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This paper describes how specific blood gas analyzer characteristics can support the emerging clinical and organizational user's needs while ensuring patient safety. A oneyear data set from two Italian hospitals was analyzed from 10 different blood gas analyzers. Performance measurements in terms of mean down time (MDT) were calculated to show how technical characteristics declared by the manufacturer compare to the analyzer availability in real clinical settings. Results show a high level of reliability for the analyzed technology, associated with very low MDT of each sensor integrated in the cartridge. Moreover, results show a high level of efficiency in cartridge usage. Such results are consistent with the specification of the GEM ® Premier™ maintenance-free technology and are particularly relevant in the point-of-care testing setting.

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Validation of iQM Active Process Control Technology

Cited by 20 publications

References 4 publications

Method validation of a set of 12 GEM® Premier™ 4000 blood gas analyzers for point-of-care testing in a university teaching hospital

Method validation of a set of 12 GEM® Premier™ 4000 blood gas analyzers for point-of-care testing in a university teaching hospital

Internal quality control: planning and implementation strategies

Reliability analysis of GEM® Premier™ technology: a multicenter study

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