The use of preanalytical quality indicators: a Turkish preliminary survey study
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Bagnu Orhan
,
Derya Sonmez
Abstract
Objectives
The utilization of reliable quality indicators (QIs) proven to be suitable for monitoring and improvement tools is one of the best choices to minimize of the risk of errors in all laboratory processes called as total testing process (TTP). In 2008, a Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) established by International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) developed the Model of Quality Indicators (MQI) complying with requirements of the ISO 15189:2012 standard for laboratory accreditation. They have also been dealing with harmonizing the QIs in most laboratories worldwide since then. The present study was set out to investigate the frequency of using IFCC WG-LEPS’ pre-QIs by Turkish laboratories and to assess the conformity of them, by taking into account Turkey’s conditions.
Methods
A survey consisting nine questions was applied in 81 laboratories using SurveyMonkey.
Results
According to the survey results, most of the laboratories reported they have used pre-QIs in the quality standards of health prepared by Turkish Ministry of Health (MOH). A part of IFCC WG-LEPS’ pre-QIs were being utilized by more than 80% of the laboratories, the rest of which only used by 10% of laboratories.
Conclusions
The majority of the medical laboratories have been using the pre-QIs included in the guidelines of Quality Standards prepared by the MOH. The pre-QIs are partially compatible with IFCC WG-LEPS’ pre-QIs. The definitions of IFCC WG-LEPS’ pre-QIs may also be revised to make them more clear and understandable by IFCC WG-LEPS. The insufficiency of Health Information Management Systems (HIMS) limits the use of pre-QIs proposed by IFCC WG-LEPS. Finally, the education of relevant personnel about the use of HIMS and pre-QIs is very crucial to harmonize and to extend the use of IFCC WG-LEPS’ pre-QIs in Turkish medical biochemistry laboratories.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
This study was presented as an oral presentation in XXVIIth Balkan Clinical Laboratory Federation Meeting BCLF 2019-XXX. National Congress of the Turkish Biochemical Society TBS 2019.
References
1. Sciacovelli, L, Panteghini, M, Lippi, G, Sumarac, Z, Cadamuro, J, Galoro, CAO, et al. Defining a roadmap for harmonizing quality indicators in laboratory medicine: a consensus statement on behalf of the IFCC Working Group “Laboratory Error and Patient Safety” and EFLM Task and Finish Group “performance specifications for the extra-analytical phases”. Clin Chem Lab Med 2017;55:1478–88. https://doi.org/10.1515/cclm-2017-0412.Suche in Google Scholar PubMed
2. Sciacovelli, L, Lippi, G, Sumarac, Z, West, J, Garcia Del Pino Castro, I, Furtado Vieira, K, et al. Quality indicators in laboratory medicine: the status of the progress of IFCC Working Group “Laboratory Errors And Patient Safety” project. Clin Chem Lab Med 2017;55:348–57. https://doi.org/10.1515/cclm-2016-0929.Suche in Google Scholar PubMed
3. Plebani, M. Errors in laboratory medicine and patient safety: the road ahead. Clin Chem Lab Med 2007;45:700–7. https://doi.org/10.1515/cclm.2007.170.Suche in Google Scholar
4. Plebani, M, Astion, ML, Barth, JH, Chen, W, de Oliveira Galoro, CA, Escuer, MI, et al. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med 2014;52:951–8. https://doi.org/10.1515/cclm-2014-0142.Suche in Google Scholar PubMed
5. Sciacovelli, L, Plebani, M. The IFCC Working Group on laboratory errors and patient safety. Clin Chim Acta 2009;404:79–85. https://doi.org/10.1016/j.cca.2009.03.025.Suche in Google Scholar PubMed
6. International Organization for Standardization. ISO 15189:2012: medical laboratories: particular requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization; 2012.Suche in Google Scholar
7. Plebani, M, Sciacovelli, L, Aita, A, Padoan, A, Chiozza, M. Quality indicators to detect pre-analytical errors in laboratory testing. Clin Chim Acta 2014;432:44–8. https://doi.org/10.1016/j.cca.2013.07.033.Suche in Google Scholar PubMed
8. Plebani, M. Quality indicators to detect pre-analytical errors in laboratory testing. Clin Biochem Rev 2012;33:85–8. PMID: 22930602, PMCID: PMC3428256.10.1016/j.cca.2013.07.033Suche in Google Scholar
9. Sciacovelli, L, Sonntag, O, Padoan, A, Zambon, CF, Carraro, P, Plebani, M. Monitoring quality indicators in laboratory medicine does not automatically result in quality improvement. Clin Chem Lab Med 2011;50:463–9. https://doi.org/10.1515/CCLM.2011.809.Suche in Google Scholar PubMed
10. WG-LEPS quality indicators in laboratory medicine. Available from: http://217.148.121.44/MqiWeb/Page_QualityIndicators.jsf [Accessed 7 Mar 2019].Suche in Google Scholar
11. Ministry of Health Quality Standards in Health. Available from: https://dosyamerkez.saglik.gov.tr/Eklenti/3460,skshastanesetiv5r1pdf.pdf?0. [Accessed 22 Oct 2019].Suche in Google Scholar
12. IFCC Working Group-Laboratory Errors And Patient Safety (WG-LEPS) quality indicators projects. Available from: http://www.ifcc.org/ifcc-education-division/working-groups-special-projects/laboratory-errors-and-patient-safety-wg-leps/quality-indicators-project/ [Accessed 6 Apr 2020].Suche in Google Scholar
13. Clinical and Laboratory Standards Institute (CLSI). Development and use of quality indicators for laboratory improvement, 2nd ed. CLSI guideline QMS12. Available from: https://clsi.org/standards/products/quality-management-systems/documents/qms12/.Suche in Google Scholar
14. Lukić, V. Laboratory information system–where are we today?. J Med Biochem 2017;36:220–4. https://doi.org/10.1515/jomb-2017-0021.Suche in Google Scholar PubMed PubMed Central
15. Plebani, M, Sciacovelli, L, Aita, A. Quality indicators for the total testing process. Clin Lab Med 2017;37:187–205. https://doi.org/10.1016/j.cll.2016.09.015.Suche in Google Scholar PubMed
16. Guideline for venous blood collection (phlebotomy). Prepared by the preanalytic phase Working Group of the Turkish Biochemical Society. Available from: https://www.eflm.eu/files/efcc/Venous%20Blood%20Collection%20-Turkish%20NS.pdf [Accessed 22 Oct 2019].Suche in Google Scholar
© 2020 Walter de Gruyter GmbH, Berlin/Boston
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- Frontmatter
- Editorial
- Home pregnancy tests: quality first
- Review
- Non-invasive determination of uric acid in human saliva in the diagnosis of serious disorders
- Opinion Papers
- Basophil counting in hematology analyzers: time to discontinue?
- The role of laboratory hematology between technology and professionalism: the paradigm of basophil counting
- Recommendations for validation testing of home pregnancy tests (HPTs) in Europe
- General Clinical Chemistry and Laboratory Medicine
- The use of preanalytical quality indicators: a Turkish preliminary survey study
- The Italian External Quality Assessment (EQA) program on urinary sediment by microscopy examination: a 20 years journey
- Non-HDL-C/TG ratio indicates significant underestimation of calculated low-density lipoprotein cholesterol (LDL-C) better than TG level: a study on the reliability of mathematical formulas used for LDL-C estimation
- Evaluation of the protein gap for detection of abnormal serum gammaglobulin level: an imperfect predictor
- Impact of routine S100B protein assay on CT scan use in children with mild traumatic brain injury
- Using machine learning to develop an autoverification system in a clinical biochemistry laboratory
- Effect of collection matrix, platelet depletion, and storage conditions on plasma extracellular vesicles and extracellular vesicle-associated miRNAs measurements
- Pneumatic tube transportation of urine samples
- Evaluation of the first immunosuppressive drug assay available on a fully automated LC-MS/MS-based clinical analyzer suggests a new era in laboratory medicine
- A validated LC-MS/MS method for the simultaneous quantification of the novel combination antibiotic, ceftolozane–tazobactam, in plasma (total and unbound), CSF, urine and renal replacement therapy effluent: application to pilot pharmacokinetic studies
- Immunosuppressant quantification in intravenous microdialysate – towards novel quasi-continuous therapeutic drug monitoring in transplanted patients
- Reference Values and Biological Variations
- Reference intervals for venous blood gas measurement in adults
- Cardiovascular Diseases
- Detection and functional characterization of a novel MEF2A variation responsible for familial dilated cardiomyopathy
- Diabetes
- Evaluation of the ARKRAY HA-8190V instrument for HbA1c
- Infectious Diseases
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- Letter in reply to the letter to the editor of Harte JV and Mykytiv V with the title “A panhaemocytometric approach to COVID-19: a retrospective study on the importance of monocyte and neutrophil population data”
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- Reformulated Architect® cyclosporine CMIA assay: improved imprecision, worse comparability between methods
- Urine-to-plasma contamination mimicking acute kidney injury: small drops with major consequences
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