Applying sigma metrics to assess quality control processes in the transfusion transmissible infection screening laboratory of a blood center
In the field of healthcare, quality and efficiency are of paramount importance to ensure the provision of safe and reliable diagnostic services. Blood screening laboratories play a critical role in detecting and preventing the spread of infectious diseases, ensuring the safety of blood transfusions,...
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| description | In the field of healthcare, quality and efficiency are of paramount importance to ensure the provision of safe and reliable diagnostic services. Blood screening laboratories play a critical role in detecting and preventing the spread of infectious diseases, ensuring the safety of blood transfusions, and supporting medical diagnoses. To enhance the quality of processes in such laboratories, the Six Sigma methodology has gained significant recognition for its ability to systematically identify and minimize variations, thereby improving overall efficiency and reducing errors. This retrospective study aims to explore the application of Six Sigma metrics in the context of blood screening laboratories, providing an in-depth analysis of its implementation, benefits, and challenges. The performance of three serology assays, i.e., anti-HCV, HIV Ag/Ab combo, and HBsAg, using internal quality control (IQC) daily data extracted from six Alinity i instruments (Abbott GmbH, Germany), from February to April 2023, was evaluated. Mean, standard deviation (SD), and coefficient of variation (CV%) was calculated for positive controls. Bias was calculated using peer group data. Sigma metrics were calculated using allowable total error (TEa %) based on difference between the observed mean of the positive control and the s/co cut-off of assay. The observed CV% for positive controls was ≤10%. The TEa% ranged from 66% to 79% for the analytes using the observed mean. All the assays showed Six Sigma performance (σ>6) with and without bias. The study observed that the serology assays showed very high sigma values (σ>6) and thus, simplified statistical quality control (SQC) design based on Westgard Sigma rules could be implemented without compromising blood safety. |
| doi_str_mv | 10.1371/journal.pone.0312422 |
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Blood screening laboratories play a critical role in detecting and preventing the spread of infectious diseases, ensuring the safety of blood transfusions, and supporting medical diagnoses. To enhance the quality of processes in such laboratories, the Six Sigma methodology has gained significant recognition for its ability to systematically identify and minimize variations, thereby improving overall efficiency and reducing errors. This retrospective study aims to explore the application of Six Sigma metrics in the context of blood screening laboratories, providing an in-depth analysis of its implementation, benefits, and challenges. The performance of three serology assays, i.e., anti-HCV, HIV Ag/Ab combo, and HBsAg, using internal quality control (IQC) daily data extracted from six Alinity i instruments (Abbott GmbH, Germany), from February to April 2023, was evaluated. Mean, standard deviation (SD), and coefficient of variation (CV%) was calculated for positive controls. 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The study observed that the serology assays showed very high sigma values (σ>6) and thus, simplified statistical quality control (SQC) design based on Westgard Sigma rules could be implemented without compromising blood safety.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0312422</identifier><identifier>PMID: 39446744</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Antigens ; Assaying ; Bias ; Biology and Life Sciences ; Blood ; Blood & organ donations ; Blood banks ; Blood products ; Blood transfusion ; Blood Transfusion - standards ; Blood transfusions ; Coefficient of variation ; Communicable diseases ; Control equipment ; Disease transmission ; Engineering and Technology ; Error reduction ; Health aspects ; Hematology ; Hepatitis B ; Hepatitis B surface antigen ; Hepatitis C ; Hepatitis C virus ; HIV ; Human immunodeficiency virus ; Humans ; Immune system ; Immunoassay ; Infection ; Infectious diseases ; Laboratories ; Mean ; Medical care ; Medical examination ; Medical laboratories ; Medical research ; Medicine and Health Sciences ; Medicine, Experimental ; Methods ; Middleware ; Performance evaluation ; Prevention ; Quality Control ; Quality management ; Research and Analysis Methods ; Retrospective Studies ; Safety regulations ; Serology ; Six Sigma ; Testing ; Total Quality Management</subject><ispartof>PloS one, 2024-10, Vol.19 (10), p.e0312422</ispartof><rights>Copyright: © 2024 Bhatnagar et al. 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This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. 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Blood screening laboratories play a critical role in detecting and preventing the spread of infectious diseases, ensuring the safety of blood transfusions, and supporting medical diagnoses. To enhance the quality of processes in such laboratories, the Six Sigma methodology has gained significant recognition for its ability to systematically identify and minimize variations, thereby improving overall efficiency and reducing errors. This retrospective study aims to explore the application of Six Sigma metrics in the context of blood screening laboratories, providing an in-depth analysis of its implementation, benefits, and challenges. The performance of three serology assays, i.e., anti-HCV, HIV Ag/Ab combo, and HBsAg, using internal quality control (IQC) daily data extracted from six Alinity i instruments (Abbott GmbH, Germany), from February to April 2023, was evaluated. Mean, standard deviation (SD), and coefficient of variation (CV%) was calculated for positive controls. 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Blood screening laboratories play a critical role in detecting and preventing the spread of infectious diseases, ensuring the safety of blood transfusions, and supporting medical diagnoses. To enhance the quality of processes in such laboratories, the Six Sigma methodology has gained significant recognition for its ability to systematically identify and minimize variations, thereby improving overall efficiency and reducing errors. This retrospective study aims to explore the application of Six Sigma metrics in the context of blood screening laboratories, providing an in-depth analysis of its implementation, benefits, and challenges. The performance of three serology assays, i.e., anti-HCV, HIV Ag/Ab combo, and HBsAg, using internal quality control (IQC) daily data extracted from six Alinity i instruments (Abbott GmbH, Germany), from February to April 2023, was evaluated. Mean, standard deviation (SD), and coefficient of variation (CV%) was calculated for positive controls. Bias was calculated using peer group data. Sigma metrics were calculated using allowable total error (TEa %) based on difference between the observed mean of the positive control and the s/co cut-off of assay. The observed CV% for positive controls was ≤10%. The TEa% ranged from 66% to 79% for the analytes using the observed mean. All the assays showed Six Sigma performance (σ>6) with and without bias. The study observed that the serology assays showed very high sigma values (σ>6) and thus, simplified statistical quality control (SQC) design based on Westgard Sigma rules could be implemented without compromising blood safety.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>39446744</pmid><doi>10.1371/journal.pone.0312422</doi><tpages>e0312422</tpages><orcidid>https://orcid.org/0000-0003-3155-5829</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Antigens Assaying Bias Biology and Life Sciences Blood Blood & organ donations Blood banks Blood products Blood transfusion Blood Transfusion - standards Blood transfusions Coefficient of variation Communicable diseases Control equipment Disease transmission Engineering and Technology Error reduction Health aspects Hematology Hepatitis B Hepatitis B surface antigen Hepatitis C Hepatitis C virus HIV Human immunodeficiency virus Humans Immune system Immunoassay Infection Infectious diseases Laboratories Mean Medical care Medical examination Medical laboratories Medical research Medicine and Health Sciences Medicine, Experimental Methods Middleware Performance evaluation Prevention Quality Control Quality management Research and Analysis Methods Retrospective Studies Safety regulations Serology Six Sigma Testing Total Quality Management |
| title | Applying sigma metrics to assess quality control processes in the transfusion transmissible infection screening laboratory of a blood center |
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