Validation of a quality assessment system for blood gas and electrolyte testing

Toffaletti, John G.; McDonnell, Elizabeth H.; Ramanathan, Lakshmi; Tolnai, Judit; Templin, Rozanna; Pompa, Lynn

doi:10.1016/j.cca.2007.03.021

Cited by 18 publications

(8 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…4 Testing (analytical phase) is carried out according to an established proven protocol, conforming to manufacturer recommendations. 3,38 The following aspects of analysis should be monitored and corrective action taken as indicated:…”

Section: Bga 80 Assessment Of Quality Of Test and Validity Of Resultsmentioning

confidence: 99%

See 1 more Smart Citation

AARC Clinical Practice Guideline: Blood Gas Analysis and Hemoximetry: 2013

et al. 2013

View full text Add to dashboard Cite

We searched MEDLINE, CINAHL, and Cochrane Library database for articles published between January 1990 and December 2012. The update of this clinical practice guideline is based on 237 clinical trials, 54 reviews, and 23 meta-analyses on blood gas analysis (BGA) and hemoximetry. The following recommendations are made following the Grading of Recommendations Assessment, Development, and Evaluation scoring system. BGA and hemoximetry are recommended for evaluating a patient's ventilatory, acid-base, and/or oxygenation status. BGA and hemoximetry are suggested for evaluating a patient's response to therapeutic interventions. BGA and hemoximetry are recommended for monitoring severity and progression of documented cardiopulmonary disease processes. Hemoximetry is recommended to determine the impact of dyshemoglobins on oxygenation. Capillary BGA is not recommended to determine oxygenation status. Central venous BGA and hemoximetry are suggested to determine oxygen consumption in the setting of early goaldirected therapies. For the assessment of oxygenation, a peripheral venous P O 2 is not recommended as a substitute for an arterial blood measurement (P aO 2 ). It is not recommended to use venous P CO 2 and pH as a substitute for arterial blood measurement of P aCO 2 and pH. It is suggested that hemoximetry is used in the detection and evaluation of shunts during diagnostic cardiac catheterization.

show abstract

Section: Bga 80 Assessment Of Quality Of Test and Validity Of Resultsmentioning

confidence: 99%

“…1 1,4,5,7 and/or the sample requirements of the analyzer(s). 38 Attempts should be made to keep sample sizes as small as is technically feasible, to limit blood loss, particularly in neonates. 1 6.1.6 the presence of dyshemoglobins.…”

Section: Bga 40 Contraindicationsmentioning

confidence: 99%

AARC Clinical Practice Guideline: Blood Gas Analysis and Hemoximetry: 2013

et al. 2013

View full text Add to dashboard Cite

show abstract

“…The training and accreditation of the users, both clinical and laboratory staff, are also essential steps, and must be traceable [3] , [4] . A hospital biologist oversees POCT [1] , [5] , [6] , [7] .…”

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

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.

show abstract

“…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

View full text Add to dashboard Cite

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.

show abstract

Validation of a quality assessment system for blood gas and electrolyte testing

Cited by 18 publications

References 2 publications

AARC Clinical Practice Guideline: Blood Gas Analysis and Hemoximetry: 2013

AARC Clinical Practice Guideline: Blood Gas Analysis and Hemoximetry: 2013

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

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

Contact Info

Product

Resources

About