Julie L V Shaw, Saranya Arnoldo, Ihssan Bouhtiany, Davor Brinc, Miranda Brun, Christine Collier, Anna Fuezery, Angela W S Fung, Yun Huang, Sukhbir Kaur, Michael Knauer, Elie Kostantin, Lyne Labrecque, Felix Leung, Vinita Thakur, Allison Venner, Paul Yip, Vincent De Guire
{"title":"葡萄糖即时检测标准化质量指标整合建议。","authors":"Julie L V Shaw, Saranya Arnoldo, Ihssan Bouhtiany, Davor Brinc, Miranda Brun, Christine Collier, Anna Fuezery, Angela W S Fung, Yun Huang, Sukhbir Kaur, Michael Knauer, Elie Kostantin, Lyne Labrecque, Felix Leung, Vinita Thakur, Allison Venner, Paul Yip, Vincent De Guire","doi":"10.1515/cclm-2025-0448","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>Quality indicator (QI) monitoring is essential to quality assurance for point of care testing (POCT). QI standardization is needed in the POCT field to provide clear guidance to hospitals and produce National and International benchmarks. A central aim was to standardize POCT QIs with existing QIs of the MQI program recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for central laboratory testing for integration in Comparison programs.</p><p><strong>Methods: </strong>Process mapping and risk assessment of the POC glucose testing process were used to establish potential QI. Group consensus was used to rank each potential QI based on the ability to retrieve data for the specific QI. Higher scores were attributed to QI where data could be retrieved electronically and automatically. The highest scoring QI were chosen for follow-up. Members of the working group (authors) were asked to submit data from their own institutions for each QI to evaluate the feasibility of monitoring each QI and to develop preliminary benchmarks.</p><p><strong>Results: </strong>Five QI recommendations are provided for glucose POCT, including: positive patient identification, operator training, internal quality control monitoring, external quality assessment and critical results follow-up. Preliminary QI data are presented along with implementation strategies and challenges associated with each recommended QI.</p><p><strong>Conclusions: </strong>This study builds upon previous work by the Canadian Society of Clinical Chemists in developing a process to establish QIs for POCT based on process mapping and risk assessment. The recommended QIs are applicable to most other types of POCT, in addition to glucose testing.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Recommendations for the integration of standardized quality indicators for glucose point-of-care testing.\",\"authors\":\"Julie L V Shaw, Saranya Arnoldo, Ihssan Bouhtiany, Davor Brinc, Miranda Brun, Christine Collier, Anna Fuezery, Angela W S Fung, Yun Huang, Sukhbir Kaur, Michael Knauer, Elie Kostantin, Lyne Labrecque, Felix Leung, Vinita Thakur, Allison Venner, Paul Yip, Vincent De Guire\",\"doi\":\"10.1515/cclm-2025-0448\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>Quality indicator (QI) monitoring is essential to quality assurance for point of care testing (POCT). 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Members of the working group (authors) were asked to submit data from their own institutions for each QI to evaluate the feasibility of monitoring each QI and to develop preliminary benchmarks.</p><p><strong>Results: </strong>Five QI recommendations are provided for glucose POCT, including: positive patient identification, operator training, internal quality control monitoring, external quality assessment and critical results follow-up. Preliminary QI data are presented along with implementation strategies and challenges associated with each recommended QI.</p><p><strong>Conclusions: </strong>This study builds upon previous work by the Canadian Society of Clinical Chemists in developing a process to establish QIs for POCT based on process mapping and risk assessment. 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Recommendations for the integration of standardized quality indicators for glucose point-of-care testing.
Objectives: Quality indicator (QI) monitoring is essential to quality assurance for point of care testing (POCT). QI standardization is needed in the POCT field to provide clear guidance to hospitals and produce National and International benchmarks. A central aim was to standardize POCT QIs with existing QIs of the MQI program recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for central laboratory testing for integration in Comparison programs.
Methods: Process mapping and risk assessment of the POC glucose testing process were used to establish potential QI. Group consensus was used to rank each potential QI based on the ability to retrieve data for the specific QI. Higher scores were attributed to QI where data could be retrieved electronically and automatically. The highest scoring QI were chosen for follow-up. Members of the working group (authors) were asked to submit data from their own institutions for each QI to evaluate the feasibility of monitoring each QI and to develop preliminary benchmarks.
Results: Five QI recommendations are provided for glucose POCT, including: positive patient identification, operator training, internal quality control monitoring, external quality assessment and critical results follow-up. Preliminary QI data are presented along with implementation strategies and challenges associated with each recommended QI.
Conclusions: This study builds upon previous work by the Canadian Society of Clinical Chemists in developing a process to establish QIs for POCT based on process mapping and risk assessment. The recommended QIs are applicable to most other types of POCT, in addition to glucose testing.
期刊介绍:
Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically.
CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France).
Topics:
- clinical biochemistry
- clinical genomics and molecular biology
- clinical haematology and coagulation
- clinical immunology and autoimmunity
- clinical microbiology
- drug monitoring and analysis
- evaluation of diagnostic biomarkers
- disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes)
- new reagents, instrumentation and technologies
- new methodologies
- reference materials and methods
- reference values and decision limits
- quality and safety in laboratory medicine
- translational laboratory medicine
- clinical metrology
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