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

BACKGROUND: Blood 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, pCO(2), pO(2), Na(+), K(+), Cl(-), Ca(2+), lactate, hemoglobin and oxyhemoglobin (O(2)Hb) at Clermont-Ferrand Hospital. These instruments were distributed across 11 care sites in the hospital. METHODS: Precision was studied at two control levels for each parameter. Comparisons between GEM analyzers were performed (on 30 samples) for pH, pCO(2), pO(2), Na(+), K(+), Cl(-), Ca(2+), lactate, hemoglobin and O(2)Hb; and between GEM analyzers and the central laboratory for Na(+), K(+), Cl(-), Ca(2+) and hemoglobin (on 30–50 samples). Uncertainty in measurement (UM) was evaluated with an approach using reproducibility and accuracy data. RESULTS: The coefficients of variation (CVs) were in line with recommendations, except for the repeatability CV for pO(2). All CVs were below 4%. All comparisons complied with recommendations. Uncertainties of measurement were also validated. CONCLUSION: Our 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.