The internal quality control in the traceability era

AbstractTo be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their quality should fulfill acceptable measurement uncertainty (MU) as defined to fit the intended clinical use. With this aim, in vitro diagnostics (IVD) manufacturers should define a calibration hierarchy to assign traceable values to their system calibrators. Medical laboratories should know and verify how manufacturers have implemented the traceability of their calibrators and estimate the corresponding MU on clinical samples. Accordingly, the internal quality control (IQC) program should be redesigned to permit IVD traceability surveillance through the verification by medical laboratories that control materials, provided by the manufacturer as a part of measuring systems, are in the clinically suitable validation range (IQC component I). Separately, laboratories should also monitor the reliability of employed IVD measuring systems through the IQC component II, devoted to estimation of MU due to random effects and to obtaining MU of provided results, in order to apply prompt corrective actions if the performance is worsening when compared to appropriate analytical specifications, thus jeopardizing the clinical validity of test results.

Download Full-text

АВТОМАТИЗАЦІЯ РОБОЧОГО МІСЦЯ ЛІКАРЯ-БІОХІМІКА ГЕНЕТИКА

Medical Informatics and Engineering ◽

10.11603/mie.1996-1960.2015.3.5007 ◽

2015 ◽

Author(s):

V. Z. Stetsyuk ◽

A. Y. Savytskyi ◽

T. P. Ivanova ◽

N. V. Olkhovych ◽

S. P. Kyryachenko ◽

...

Keyword(s):

Quality Control ◽

Calibration Curve ◽

Lysosomal Enzymes ◽

Internal Quality Control ◽

Internal Quality ◽

Research Activity ◽

Laboratory Results ◽

Biochemical Research ◽

And Control ◽

Analytical Errors

In the laboratory of medical genetics NCSH «OKHMATDYT» to identify the reliability of laboratory results and control the number and frequency of errors, carry out internal quality control. In order to evaluate the results of measurements of samples and eliminate harmful analytical errors developed and introduced software that allows you to build a calibration curve and process the results of biochemical research activity of lysosomal enzymes.

Download Full-text

Role and Responsibilities of Laboratory Medicine Specialists in the Verification of Metrological Traceability of in Vitro Medical Diagnostics / Uloga I Odgovornosti Specijalista Laboratorijske Medicine U Verifikaciji Metrološke Sledljivosti In Vitro Medicinske Dijagnostike

Journal of Medical Biochemistry ◽

10.1515/jomb-2015-0004 ◽

2015 ◽

Vol 34 (3) ◽

pp. 282-287 ◽

Cited By ~ 21

Author(s):

Federica Braga ◽

Ilenia Infusino ◽

Mauro Panteghini

Keyword(s):

Quality Control ◽

Measurement Uncertainty ◽

Clinical Laboratory ◽

Metrological Traceability ◽

Uncertainty Budget ◽

Medical Diagnostics ◽

Internal Quality ◽

Clinical Laboratories ◽

Laboratory Results

Summary To be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their quality should fulfill acceptable measurement uncertainty as defined to fit the intended clinical use. With this aim, in vitro diagnostics (IVD) manufacturers should define a calibration hierarchy to assign traceable values to their system calibrators and to fulfill during this process uncertainty limits for calibrators, which should represent a proportion of the uncertainty budget allowed for clinical laboratory results. It is therefore important that, on one hand, the laboratory profession clearly defines the clinically acceptable uncertainty for relevant tests and, on the other hand, endusers may know and verify how manufacturers have implemented the traceability of their calibrators and estimated the corresponding uncertainty. Important tools for IVD traceability surveillance are quality control programmes through the daily verification by clinical laboratories that control materials of analytical systems are in the manufacturer’s declared validation range [Internal Quality Control (IQC) component I] and the organization of Exter nal Quality Assessment Schemes meeting metrological criteria. In a separate way, clinical laboratories should also monitor the reliability of employed commercial systems through the IQC component II, devoted to estimation of the measurement uncertainty due to random effects, which includes analytical system imprecision together with individual laboratory performance in terms of variability.

Download Full-text

An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2016-0896 ◽

2017 ◽

Vol 55 (11) ◽

Cited By ~ 15

Author(s):

Andrea Padoan ◽

Giorgia Antonelli ◽

Ada Aita ◽

Laura Sciacovelli ◽

Mario Plebani

Keyword(s):

Quality Control ◽

Measurement Uncertainty ◽

Quality Assessment ◽

External Quality Assessment ◽

Internal Quality ◽

Test Results ◽

External Quality ◽

Iso 15189 ◽

Medical Laboratories

AbstractBackground:The present study was prompted by the ISO 15189 requirements that medical laboratories should estimate measurement uncertainty (MU).Methods:The method used to estimate MU included the: a) identification of quantitative tests, b) classification of tests in relation to their clinical purpose, and c) identification of criteria to estimate the different MU components. Imprecision was estimated using long-term internal quality control (IQC) results of the year 2016, while external quality assessment schemes (EQAs) results obtained in the period 2015–2016 were used to estimate bias and bias uncertainty.Results:A total of 263 measurement procedures (MPs) were analyzed. On the basis of test purpose, in 51 MPs imprecision only was used to estimate MU; in the remaining MPs, the bias component was not estimable for 22 MPs because EQAs results did not provide reliable statistics. For a total of 28 MPs, two or more MU values were calculated on the basis of analyte concentration levels. Overall, results showed that uncertainty of bias is a minor factor contributing to MU, the bias component being the most relevant contributor to all the studied sample matrices.Conclusions:The model chosen for MU estimation allowed us to derive a standardized approach for bias calculation, with respect to the fitness-for-purpose of test results. Measurement uncertainty estimation could readily be implemented in medical laboratories as a useful tool in monitoring the analytical quality of test results since they are calculated using a combination of both the long-term imprecision IQC results and bias, on the basis of EQAs results.

Download Full-text