The Importance of Reagent Lot Registration in External Quality Assurance/Proficiency Testing Schemes

Stavelin, Anne; Riksheim, Berit Oddny; Christensen, Nina Gade; Sandberg, Sverre

doi:10.1373/clinchem.2015.247585

Cited by 24 publications

(10 citation statements)

References 11 publications

(11 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…All of the patient samples were freshly collected and were not pooled before the analysis. Furthermore, all of the reagents used were from the same lot number in order to avoid any effects of between-lot variations (18,19).…”

Section: Discussionmentioning

confidence: 99%

Commutability of a Whole-Blood External Quality Assessment Material for Point-of-Care C-Reactive Protein, Glucose, and Hemoglobin Testing

et al. 2019

Self Cite

View full text Add to dashboard Cite

BACKGROUND The optimal situation in external quality assessment (EQA) is to use commutable materials. No previous study has examined the commutability of a whole-blood material for point-of-care (POC) testing. The aim of this study was to determine the commutability of the Norwegian Quality Improvement of Laboratory Examinations (Noklus) organization's “in-house” whole-blood EQA material for C-reactive protein (CRP), glucose, and hemoglobin for frequently used POC instruments in Norway and to determine the possibility of using a common target value for each analyte. METHODS The study was performed according to the Clinical and Laboratory Standards Institute guidelines. The EQA material was pooled stabilized EDTA venous whole-blood containing different concentrations of the analytes. The EQA material and native routine patient samples were analyzed using 17 POC and 3 hospital instruments. The commutability was assessed using Deming regression analysis with 95% prediction intervals for each instrument comparison. RESULTS The EQA material was commutable for all CRP and hemoglobin POC instruments, whereas for glucose the material was commutable for all POC instruments at the lowest concentration analyzed [126.0 mg/dL (7.0 mmol/L)] and for 3 POC instruments at all of the concentrations analyzed. CONCLUSIONS Noklus EQA participants using CRP and hemoglobin POC instruments now receive results that are compared with a reference target value, whereas the results for participants using glucose POC instruments are still compared with method-specific target values. Systematic deviations from a reference target value for the commutable glucose POC instruments can be calculated, and this additional information can now be offered to these participants and to the manufacturers.

show abstract

Section: Discussionmentioning

confidence: 99%

Commutability of a Whole-Blood External Quality Assessment Material for Point-of-Care C-Reactive Protein, Glucose, and Hemoglobin Testing

et al. 2019

Self Cite

View full text Add to dashboard Cite

show abstract

“…with a method re-standardisation. The most detailed system may be to include lot numbers of reagents and calibrators in the EQA classification scheme to ensure appropriate comparability and to identify possibly faulty products ( 22 ). This requirement for a detailed method classification system may lead to difficulties with the complexity of the information required from participants and with displaying on the report.…”

Section: Methods Classificationsmentioning

confidence: 99%

The role of EQA in harmonization in laboratory medicine – a global effort

Jones

2017

Biochem Med

View full text Add to dashboard Cite

There are many activities currently being undertaken in the field of laboratory medicine under the broad heading of “harmonization”. These include traceability of results to international reference standards, processes to align results from assays where traceability has not been achieved (analytical harmonization) and international or national clinical guidelines based on studies from many parts of the world. Many of these issues are global in nature, with clinical evidence derived from studies performed in all parts of the world and multinational diagnostic companies providing assays worldwide. As with all aspects of medicine, progress can only be assured where these is evidence of effectiveness of the activities. External Quality Assurance (EQA) programs are designed to meet this need. Currently EQA processes have significant limitations in meeting the global needs of the laboratory medicine community. This paper aims to identify the steps that can be taken to allow current and future EQA programs to provide information on global variation in results. It is only by being aware of result differences that steps can be taken to improve performance.

show abstract

“…Another disadvantage is that peer group evaluation is made impossible to identify a poor performance result when all reagents from the participants are affected. This is the reason why reagents' batch number should be recorded and took into consideration during evaluation by the EQA provider, contacting to the manufacturer when batch effects are observed [20,21]. In spite of previous limitations, this type of EQA allows to measure the quality of the results with respect to the method and the other laboratories in the same group.…”

Section: Quality Control In Laboratorymentioning

confidence: 99%

Quality Management Systems for Laboratories and External Quality Assurance Programs

Valdivieso-Gómez¹,

Aguilar‐Quesada²

2018

Quality Control in Laboratory

View full text Add to dashboard Cite

A quality management system (QMS) plans, controls, and improves the elements that impact on the achievement of the desired results by the laboratory and on the satisfaction of the users. There are different standards that establish requirements for the implementation of a quality management system for laboratories, and a cross comparison between them is shown. Additionally, external quality assurance or assessment (EQA) programs offer multiple benefits to laboratories: method validation, comparing of results with other laboratories, testing problem identification, accreditation requirement compliance, and credibility. In order to control the quality of the procedures, these programs are a tool to keep the laboratory procedures and every variable involved in (staff, equipment, and method) well controlled. In the frame of a quality management system, benefits from external quality assurance programs are discussed, and different available designs are reviewed. On the other hand, previous benefits will be real only if reported results for each program are analyzed in detail. Because additional advantages are achieved when the EQA results are integrated in the quality management system of the laboratory, a procedure is proposed. In addition, results from external quality assurance programs corroborate the usefulness of internal controls implemented by the laboratory as part of its quality management system.

show abstract

The Importance of Reagent Lot Registration in External Quality Assurance/Proficiency Testing Schemes

Cited by 24 publications

References 11 publications

Commutability of a Whole-Blood External Quality Assessment Material for Point-of-Care C-Reactive Protein, Glucose, and Hemoglobin Testing

Commutability of a Whole-Blood External Quality Assessment Material for Point-of-Care C-Reactive Protein, Glucose, and Hemoglobin Testing

The role of EQA in harmonization in laboratory medicine – a global effort

Quality Management Systems for Laboratories and External Quality Assurance Programs

Contact Info

Product

Resources

About