Evaluation of Sigma metric approach for monitoring the performance of automated analyzers in hematology unit of Alexandria Main University Hospital

El-Neanaey, Wafaa A.; AbdEllatif, Nihal Mahmoud; Elwafa, Reham Abdel Haleem Abo

doi:10.1111/ijlh.13660

Cited by 5 publications

(5 citation statements)

References 21 publications

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“…Out of parameters included except HCT all parameters achieved marginal to word class performance. The studies done in Spain (39), Romania (40), Indonesia (5), India (8) and Egypt (41), also reported similar nding with current study. The poor performance for HCT may relate to study period.…”

Section: Discussionsupporting

confidence: 88%

Analytical performance evaluation of Hematology analyzers using Sigma metrics

Berta,

Melku,

Adane

et al. 2023

Preprint

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Introduction: In clinical laboratory, the performance of the hematology analyzers should be checked routinely to ensure that the desired quality is achieved. Therefore, the aim of the study was to assess the performance of hematology analyzers using sigma metrics. Method The study included all daily internal quality control data of hematology analyzer prospectively from August to October 2022. Data was collected by trained laboratory professionals using record formats. The sigma values of each CBC parameter were calculated using the formula: Sigma = (TEa – Bias) / CV. The data of TEa were adopted from five different guidelines. The bias of all complete blood count parameters was calculated from the laboratory mean of the daily IQC data and the target value of the manufacturer in the insert kit. A coefficient of variation was also calculated using IQC data. Results The current study found an inconsistent sigma value, based on sources TEa. Except HCT out 5 parameters included based on CLIA guideline, except MCV, MCHC, RDW, MPV and Basophil out of 15 parameters included based on EFLM 2022 minimum guideline, except Hb and PLT out of 9 parameters included based on SOTA guideline other parameters meets minimum specification. On the other hand, all parameters included in Rilibak and Standards of Spanish guideline achieved minimum specification. Conclusion Sigma values of the CBC parameters have significantly varied depends on the TEa sources. So, the source of TEa needs harmonization. Additionally, suggested that the laboratory to optimize local Westgard rules for each parameter.

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Section: Discussionsupporting

confidence: 88%

Analytical performance evaluation of Hematology analyzers using Sigma metrics

Berta,

Melku,

Adane

et al. 2023

Preprint

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“…In addition, biological variation might contribute for the difference. 32,41 In side of other parameters, the finding of the previous studies, 1,18 is inconstant for WBC, Hb and PLT with compared with current study. The possible reason for the inconsistence of the result could be difference of analysis method, study period, instrument of analysis.…”

Section: Discussioncontrasting

confidence: 38%

“…Clinical laboratories are dynamic and complex organizations that have a critical role in patient diagnosis, treatment, and management. 1 In clinical medicine, it's critical to standardize and harmonized testing procedures to deliver precise, timely, and accurate results. 2 This improves the clinical decision making and allows good adherence to available guidelines.…”

Section: Introductionmentioning

confidence: 99%

“…2 Studies have shown that laboratory defects are more common in the pre-and post-analytical phases than in the analytical phase. 1,2 Advanced laboratory technologies and automation have reduced the incidence of defects during the analytical phase. 3 Also, the frequency of defects in the analytical phase has decreased as a result of the application of quality control mechanisms such as internal quality control (IQC) and external quality assurance (EQA).…”

Section: Introductionmentioning

confidence: 99%

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Analytical Performance Evaluation of Hematology Analyzer Using Various TEa Sources and Sigma Metrics

Berta,

Melku,

Adane

et al. 2023

PLMI

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In clinical laboratory, the performance of the hematology analyzer should be checked routinely to ensure the desired quality. Therefore, the aim of the study was to assess the analytical performance of hematology analyzer using sigma metrics. Methods:The study included all daily internal quality control (IQC) data of hematology analyzer prospectively from August to October 2022. Data was collected using record formats by trained laboratory professionals. The sigma values of each CBC parameter were calculated using the formula: Sigma = (TEa -Bias) / CV. The TEa data were adopted from five different guidelines to calculate sigma value of the laboratory based on different specification. The bias of all complete blood count (CBC) parameters was calculated from the laboratory mean of the daily IQC data and the target value of the manufacturer in the insert kit. A coefficient of variations was also calculated using IQC data. Results: The current study found that sigma value of the analyzer varied based on source of TEa. Except HCT out 5 parameters included based on CLIA guideline, except MCV, MCHC, RDW, MPV and Basophil out of 15 parameters included based on EFLM 2022 minimum guideline, except Hb and PLT out of 9 parameters included based on SOTA guideline other parameters meets minimum specification (<3 sigma value). On the other hand, all parameters included in Rilibak and Standards of Spanish guideline achieved minimum specification (>3 sigma value). Conclusion: Sigma values of the CBC parameters have significantly varied depends on the TEa sources. So, it is recommended laboratory to use alternative sigma value based on its preference. Additionally, it is suggested that the laboratory to design local Westgard rules for each parameter based on sigma value.

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“…The impact of the TEa can be illustrated by examining the formula for the calculation of the sigma value, with the higher the TEa, the higher the sigma value. Further work to standardize TEa for laboratory testing is needed 16 …”

Section: Statistical Methods For Daily Quality Controlmentioning

confidence: 99%

Practical application of mathematical calculations and statistical methods for the routine haematology laboratory

Padmore

Petersen

Chennette

et al. 2022

Int J Lab Hematology

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Background: Statistical analyses are embedded as critical functions in the routine haematology laboratory.Aim: This educational article is aimed at providing an overview of these topics and practical application examples.Materials, Methods, and Results: Topics covered include mathematical conversion between units, maintaining a quality control (QC) system, statistical methods for reagent validation, and determining uncertainty of measurement (UoM).Discussion: Additional considerations may be required when a regional laboratory program is in place, such as the harmonization of INR results and determination of therapeutic reference intervals for unfractionated heparin therapy. Conclusion:The coauthors of this manuscript are fortunate to be part of regional network of hospital laboratories, the Eastern Ontario Regional Laboratory Association (EORLA).

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Evaluation of Sigma metric approach for monitoring the performance of automated analyzers in hematology unit of Alexandria Main University Hospital

Cited by 5 publications

References 21 publications

Analytical performance evaluation of Hematology analyzers using Sigma metrics

Analytical performance evaluation of Hematology analyzers using Sigma metrics

Analytical Performance Evaluation of Hematology Analyzer Using Various TEa Sources and Sigma Metrics

Practical application of mathematical calculations and statistical methods for the routine haematology laboratory

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